Food and Drug Regulations Règlement sur les aliments et drogues

C.R.C., c. 870 Subsections 31(1) and (3) of the *Legislation Revision and Consolidation Act*, in force on June 1, 2009, provide as follows: C.R.C., ch. 870 OFFICIAL STATUS OF CONSOLIDATIONS

Act means the Food and Drugs Act, except in Parts G and J; (Loi) ... LAYOUT NOTE CARACTÈRE OFFICIEL DES CODIFICATIONS Les paragraphes 31(1) et (3) de la *Loi sur la révision et la codification des textes législatifs*, en vigueur le 1er juin 2009, prévoient ce qui suit : Codifications comme élément de preuve 31 (1) Tout exemplaire d’une loi codifiée ou d’un règlement codifié, publié par le ministre en vertu de la présente loi sur support papier ou sur support électronique, fait foi de cette loi ou de ce règlement et de son contenu. Tout exemplaire donné comme publié par le ministre est réputé avoir été ainsi publié, sauf preuve contraire. [...] Incompatibilité — règlements (3) Les dispositions du règlement d’origine avec ses modifications subséquentes enregistrées par le greffier du Conseil privé en vertu de la *Loi sur les textes réglementaires* l’emportent sur les dispositions incompatibles du règlement codifié publié par le ministre en vertu de la présente loi. MISE EN PAGE Les notes apparaissant auparavant dans les marges de droite ou de gauche se retrouvent maintenant en caractères gras juste au-dessus de la disposition à laquelle elles se rattachent. Elles ne font pas partie du texte, n’y figurant qu’à titre de repère ou d’information. NOTE Cette codification est à jour au 11 novembre 2024. Les dernières modifications sont entrées en vigueur le 17 juin 2024. Toutes modifications qui n’étaient pas en vigueur au 11 novembre 2024 sont énoncées à la fin de ce document sous le titre « Modifications non en vigueur ».

TABLE OF PROVISIONS A.01.001 PART A Administration A.01.001 General A.01.010 Interpretation A.01.020 and A.01.021 Analysts; Inspectors A.01.040 Importations A.01.045 Exports A.01.049 Transhipments A.01.050 Sampling A.01.060 Tariff of Fees A.01.060.1 Labelling of Food and Drugs in Pressurized Containers A.01.065 Security Packaging A.01.066 Exemptions A.01.066 Application A.01.067 Advertising A.01.068 Sale B.01.001 PART B Foods B.01.001 DIVISION 1 B.01.001 General B.01.350 Nutrition Symbols B.01.350 Mandatory Information B.01.351 Presentation of Nutrition Symbol B.01.355 Location of Nutrition Symbol TABLE ANALYTIQUE Règlement concernant les aliments et drogues A.01.001 PARTIE A Administration A.01.001 Dispositions générales A.01.010 Interprétation A.01.020 et A.01.021 Analystes; inspecteurs A.01.040 Importations A.01.045 Exportation A.01.049 Transbordements A.01.050 Échantillons A.01.060 Honoraires d’analyse A.01.060.1 Étiquetage des contenants d’aliments et de drogues sous pression A.01.065 Emballage de sécurité A.01.066 Exemptions A.01.066 Application A.01.067 Publicité A.01.068 Vente B.01.001 PARTIE B Aliments B.01.001 TITRE 1 B.01.001 Dispositions générales B.01.350 Symboles nutritionnels B.01.350 Renseignements obligatoires B.01.351 Présentation du symbole nutritionnel B.01.355 Emplacement du symbole nutritionnel B.01.358 Prohibitions — Resemblance to Nutrition Symbol B.01.400 Interpretation B.01.401 Nutrition Labelling B.01.401 Core Information B.01.402 Additional Information B.01.405 Foods for Enterprise or Institution B.01.406 Basis of Information B.01.450 Presentation of Nutrition Facts Table B.01.451 Location of Nutrition Facts Table B.01.452 Orientation of Nutrition Facts Table B.01.453 Application B.01.454 Standard and Horizontal Formats TABLE B.01.455 Simplified Formats TABLE B.01.455.1 Simplified Formats — Single-serving Prepackaged Products TABLE B.01.456 Dual Format — Foods Requiring Preparation TABLE B.01.457 Aggregate Format — Different Kinds of Foods B.02.001 DIVISION 2 Alcoholic Beverages B.02.010 Whisky B.02.030 Rum B.02.040 Gin B.02.050 Brandy B.02.070 Liqueurs and Spirituous Cordials B.02.080 Vodka B.02.090 Tequila B.02.091 Mezcal B.02.100 Wine B.02.120 Cider B.02.130 Beer B.03.001 DIVISION 3 Baking Powder B.04.001 DIVISION 4 B.05.001 DIVISION 5 Coffee B.06.001 DIVISION 6 Food Colours B.07.001 DIVISION 7 B.08.001 DIVISION 8 B.08.003 Milk B.08.028.1 Goat’s Milk B.08.030 Cheese TABLE B.08.056 Butter B.09.001 DIVISION 9 B.10.003 DIVISION 10 B.02.050 Eau-de-vie B.02.070 Liqueurs et cordiaux spiritueux B.02.080 Vodka B.02.090 Tequila B.02.091 Mezcal B.02.100 Vin B.02.120 Cidre B.02.130 Bière B.03.001 TITRE 3 Poudre à pâte B.04.001 TITRE 4 Produits du cacao et produits de chocolat B.05.001 TITRE 5 Café B.06.001 TITRE 6 Colorants pour aliments B.07.001 TITRE 7 Épices, condiments et assaisonnements B.08.001 TITRE 8 Produits laitiers B.08.003 Lait B.08.028.1 Lait de chèvre B.08.030 Fromage TABLEAU B.08.056 Beurre B.09.001 TITRE 9 Graisses et huiles B.10.003 TITRE 10 Préparations aromatisantes B.11.001 DIVISION 11 B.11.002 Vegetables B.11.101 Fruits B.11.120 Fruit Juices B.11.150 Fruit Flavoured Drinks B.11.201 Jams B.11.220 Marmalade B.11.240 Jelly B.11.250 Mincemeat B.11.260 Boiled Cider B.12.001 DIVISION 12 B.13.001 DIVISION 13 B.13.021 Bread B.13.060 Breakfast Cereal B.14.001 DIVISION 14 B.14.063 Meat Stews B.14.070 Meat Specialties B.14.073 Meat Product Extender B.15.001 DIVISION 15 Adulteration of Food B.16.001 DIVISION 16 TABLE XI B.17.001 DIVISION 17 Salt B.18.001 DIVISION 18 B.18.001 Sweetening Agents B.18.025 Honey B.19.001 DIVISION 19 Vinegar B.20.001 DIVISION 20 Tea B.21.001 DIVISION 21 B.21.020 Prepared Fish B.21.031 Froglegs B.22.001 DIVISION 22 B.22.016 Poultry Meat Stews B.22.027 Poultry Product Extender B.23.001 DIVISION 23 Food Packaging Materials B.24.001 DIVISION 24 B.24.100 Formulated Liquid Diets B.25.001 DIVISION 25 B.25.001 Interpretation B.25.002 Infant Foods B.25.010 Human Milk Fortifiers B.26.001 DIVISION 26 B.26.001 Food Irradiation B.26.001 Interpretation B.26.002 Application B.26.004 Records B.26.005 Changes to the Table B.27.001 DIVISION 27 B.28.001 DIVISION 28 B.28.001 Novel Foods B.28.001 Interpretation B.29.001 DIVISION 29 B.29.001 Interpretation B.29.002 Nutrition Labelling B.29.002 Core Information B.29.005 Basis of Information TABLE B.29.010 Simplified Formats TABLE TABLE TABLE B.29.013 Aggregate Format — Different Kinds of Supplemented Foods TABLE TABLE TABLE C.01.001 PART C Drugs C.01.001 DIVISION 1 C.01.001 General C.01.014 Assignment and Cancellation of Drug Identification Numbers C.01.014.7 Shortages of Drugs and Interruption and Discontinuation of Sale of Drugs C.01.015 Tablet Disintegration Times C.01.016 Prohibition C.01.019 Issue-Related Summary Report C.01.020 Maintenance of Records C.01.020.1 Provision of Information Under Section 21.8 of Act C.01.021 Limits of Drug Dosage C.01.028 Cautionary Statements and Child Resistant Packages C.01.036 Miscellaneous C.01.040.2 Colouring Agents C.01.040.3 Prescription Drugs C.01.050 Information — Serious Risk of Injury to Human Health C.01.051 Recalls C.01.061 Limits of Variability C.01.001 PARTIE C Drogues C.01.001 TITRE 1 C.01.001 Dispositions générales C.01.014 Attribution et annulation de l’identification numérique des drogues C.01.014.7 Pénuries de drogues et interruption et cessation de la vente de drogues C.01.015 Temps de désagrégation des comprimés C.01.016 Interdiction C.01.017 Rapports sur les réactions indésirables graves à une drogue — fabricants C.01.018 Rapport de synthèse annuel et fiches d’observation C.01.019 Rapport de synthèse relatif à un sujet de préoccupation C.01.020 Tenue de dossiers C.01.020.1 Fourniture de renseignements en application de l’article 21.8 de la Loi C.01.021 Doses limites des drogues C.01.028 Mises en garde et emballages protège-enfants C.01.036 Divers C.01.040.2 Colorants C.01.040.3 Drogues sur ordonnance C.01.048 Distribution de drogues à titre d’échantillons C.01.050 Renseignements — risque grave de préjudice à la santé humaine C.01.051 Retrait du marché C.01.052 Évaluations ordonnées en vertu de l’article 21.31 de la Loi C.01.053 Activités ordonnées en vertu de l’article 21.32 de la Loi C.01.061 Limites de variabilité C.01.071 Mercuric Chloride Tablets C.01.101 Synthetic Sweeteners C.01.131 Aminopyrine and Dipyrone C.01.134 Coated Potassium Salts C.01.401 Antibiotics C.01.430 to C.01.432 Chloramphenicol C.01.600 Veterinary Drugs C.01.625 Contraceptive Drugs C.01A.001 DIVISION 1A C.01A.001 Interpretation C.01A.002 Application C.01A.005 Application C.01A.008 Issuance C.01A.016 Suspension C.02.001 DIVISION 2 Good Manufacturing Practices C.02.003 Sale C.02.003.3 Use in Fabrication C.02.004 Premises C.02.005 Equipment C.02.006 Personnel C.02.007 Sanitation C.02.009 Raw Material Testing C.02.011 Manufacturing Control C.02.013 Quality Control Department C.02.016 Packaging Material Testing C.02.018 Finished Product Testing C.02.020 Records C.02.025 Samples C.02.027 Stability C.02.029 Sterile Products C.02.030 Medical Gases C.03.001 DIVISION 3 C.03.001 SCHEDULE C DRUGS C.03.201 Radiopharmaceuticals C.03.301 Positron-emitting Radiopharmaceuticals C.03.301 Interpretation C.03.302 Application C.03.303 Prohibition C.03.304 Purpose of Study C.03.305 Requirements C.03.306 Research Ethics Board C.03.307 Application for Authorization C.03.308 Additional Information C.03.309 Authorization C.03.310 Notice C.03.311 Good Clinical Practices C.03.312 Labelling C.03.313 Submission of Information C.03.315 Records C.03.316 Discontinuance of a Study C.03.317 Suspension C.03.318 Reinstatement C.03.319 Cancellation C.04.001 DIVISION 4 C.04.001 SCHEDULE D DRUGS C.04.050 Bacterial Vaccines, Products Analogous to Bacterial Vaccines C.04.060 Typhoid Vaccine C.04.065 Pertussis Vaccine C.04.070 B.C.G. (Bacille Calmette-Guerin) Vaccine C.04.090 Products Analogous to Bacterial Vaccines C.04.100 Virus and Rickettsial Vaccines C.04.110 Smallpox Vaccine C.04.122 Poliomyelitis Vaccine C.04.128 Poliovirus Vaccine, Live, Oral C.04.137 Bacteriophage C.04.140 Toxins, Toxoids C.04.140 Schick Test Reagents C.04.160 Diphtheria Toxoid C.04.180 Tetanus Toxoid C.04.210 Antitoxins, Antisera C.04.550 Insulin Preparations C.04.553 Insulin Injection or Insulin C.04.557 Insulin Zinc Suspension — Rapid C.04.563 Insulin Zinc Suspension — Medium C.04.569 Insulin Zinc Suspension — Prolonged C.04.575 Globin Insulin with Zinc C.04.582 NPH Insulin or Isophane Insulin C.04.590 Protamine Zinc Insulin C.04.597 Sulphated Insulin C.04.650 Labelling of Insulin Preparations C.04.675 Anterior Pituitary Extracts C.05.001 DIVISION 5 C.05.001 Interpretation C.05.002 Application C.05.003 Prohibition C.05.004 General C.05.005 Application for Authorization C.05.006 Authorization C.05.007 Notification C.05.008 Amendment C.05.009 Additional Information and Samples C.05.010 Sponsor’s Obligations C.05.011 Good Clinical Practices C.05.012 Labelling C.05.013 Records C.05.013 Submission of Information and Samples C.05.015 Discontinuance of a Clinical Trial C.05.016 Suspension and Cancellation C.06.001 DIVISION 6 C.06.001 General C.06.002 Conjugated Estrogens C.06.003 Conjugated Estrogens for Injection C.04.582 Insuline NPH ou insuline isophane C.04.590 Insuline-zinc-protamine C.04.597 Insuline sulfurisée C.04.650 Étiquetage des préparations insulinique C.04.675 Extraits hypophysaires (lobe antérieur) C.05.001 TITRE 5 Drogues destinées aux essais cliniques sur des sujets humains C.05.001 Définitions C.05.002 Champ d’application C.05.003 Interdiction C.05.004 Disposition générale C.05.005 Demande d’autorisation C.05.006 Autorisation C.05.007 Notification C.05.008 Modification C.05.009 Renseignements complémentaires et échantillons C.05.010 Obligations du promoteur C.05.010 Bonnes pratiques cliniques C.05.011 Étiquetage C.05.012 Registres C.05.013 Présentation de renseignements et d’échantillons C.05.014 Rapport sur les réactions indésirables graves et imprévues à la drogue C.05.015 Cessation d’un essai clinique C.05.016 Suspension et annulation C.06.001 TITRE 6 C.06.001 Dispositions générales C.06.002 Œstrogènes conjugués C.06.003 Œstrogènes conjugués pour injection C.06.004 Conjugated Estrogens Tablets C.06.120 Digitoxin C.06.121 Digitoxin Tablets C.06.130 Digoxin C.06.131 Digoxin Elixir C.06.132 Digoxin Injection C.06.133 Digoxin Tablets C.06.161 Esterified Estrogens C.06.162 Esterified Estrogens Tablets C.06.170 Gelatin C.06.250 Thyroid C.07.001 DIVISION 7 C.07.001 Interpretation C.07.002 Application C.07.003 Application for Authorization C.07.004 Authorization C.07.007 Notice to Commissioner of Patents C.07.008 Marking and Labelling C.07.010 Records C.08.001 DIVISION 8 C.08.001 New Drugs C.08.009.01 Pre-positioning of Designated COVID-19 Drugs C.08.009.1 Disclosure of Information in Respect of Clinical Trials C.08.010 Sale of New Drug for Emergency Treatment C.08.012 Sale of Medicated Feeds C.08.013 Experimental Studies C.08.013 Conditions of Sale C.08.014 Experimental Studies Certificate C.08.016 Labelling C.08.017 Conditions of Experimental Study C.08.018 Suspension or Cancellation of Experimental Studies Certificate C.09.001 DIVISION 9 C.09.001 Non-prescription Drugs C.09.010 Analgesics C.09.010 General C.09.020 Acetaminophen C.09.030 Salicylates C.10.001 DIVISION 10 Access to Drugs in Exceptional Circumstances C.11.001 DIVISION 11 D.01.001 PART D D.01.002 DIVISION 1 D.02.001 DIVISION 2 D.03.001 DIVISION 3 D.05.001 to D.05.007 DIVISION 4 [Repealed, SOR/2003-196, s. 105] D.05.001 to D.05.007 DIVISION 5 E.01.001 PART E Cyclamate Sweeteners E.01.002 Sale E.01.003 Advertising E.01.004 Labelling G.01.001 PART G G.01.001 DIVISION 1 G.01.001 Definitions G.01.002 Application G.01.002 Agricultural implants G.01.004 Application of Parts C and D G.01.005 Possession G.01.005 Authorized persons G.01.006 Test Kits G.01.007 Application for registration number G.01.008 Issuance of registration number G.01.009 Cancellation of registration number G.02.001 DIVISION 2 G.02.001 Authorized Activities G.02.001 General G.02.002 Dealer’s Licences G.02.002 Preliminary Requirements G.02.002 Eligible persons G.02.004 Ineligibility G.02.006 Issuance of Licence G.02.006 Application G.02.007 Issuance G.02.008 Validity G.02.009 Refusal G.02.010 Renewal of Licence G.02.010 Application G.02.011 Renewal G.02.012 Validity G.02.013 Refusal G.02.014 Amendment of Licence G.02.014 Application G.02.015 Amendment G.02.016 Validity G.02.017 Refusal G.02.018 Application G.02.019 Approval G.02.020 Refusal G.02.021 Prior notice G.02.022 Notice — five days G.02.023 Notice — 10 days G.02.024 Notice of cessation of activities G.02.025 Changes to Terms and Conditions of Licence G.02.027 Suspension and Revocation of Licence G.02.027 Suspension G.02.028 Revocation G.02.029 Return of licence G.02.030 Import Permits G.02.030 Application G.02.031 Issuance G.02.032 Validity G.02.033 Return of permit G.02.034 Refusal G.02.035 Providing copy of permit G.02.006 Demande G.02.007 Délivrance G.02.008 Validité G.02.009 Refus G.02.010 Renouvellement de la licence G.02.010 Demande G.02.011 Renouvellement G.02.012 Validité G.02.013 Refus G.02.014 Modification de la licence G.02.014 Demande G.02.015 Modification G.02.016 Validité G.02.017 Refus G.02.018 Changements exigeant une approbation préalable du ministre G.02.018 Demande G.02.019 Approbation G.02.020 Refus G.02.021 Changements exigeant un avis au ministre G.02.021 Avis préalable G.02.022 Avis — cinq jours G.02.023 Avis — dix jours G.02.024 Avis — cessation des opérations G.02.025 Changement des conditions de la licence G.02.025 Ajout ou modification de conditions G.02.026 Suppression d’une condition G.02.027 Suspension et révocation de la licence G.02.027 Suspension G.02.028 Révocation G.02.029 Retour de la licence G.02.030 Permis d’importation G.02.030 Demande G.02.031 Délivrance G.02.032 Validité G.02.033 Retour du permis G.02.034 Refus G.02.035 Production d’une copie du permis G.02.036 Declaration G.02.037 Suspension G.02.038 Revocation G.02.039 Return of permit G.02.040 Export Permits G.02.040 Application G.02.041 Issuance G.02.042 Validity G.02.043 Return of permit G.02.044 Refusal G.02.045 Providing copy of permit G.02.046 Declaration G.02.047 Suspension G.02.048 Revocation G.02.049 Return of permit G.02.050 Identification G.02.050 Name G.02.051 Sale of Controlled Drugs G.02.052 Sale to pharmacist G.02.053 Sale to practitioner G.02.054 Provision to hospital employee G.02.055 Sale to exempted person G.02.057 Written order G.02.058 Verbal order G.02.060 Packaging and Transportation G.02.060 Packaging — sale and provision G.02.061 Transport G.02.062 Thefts, Losses and Suspicious Transactions G.02.062 Protective measures G.02.063 Theft or loss — licence and permit G.02.064 Theft or unexplainable loss — controlled drug G.02.065 Suspicious transaction G.02.067 Destruction of Controlled Drugs G.02.067 Destruction at site G.02.068 Destruction elsewhere than at site G.02.069 Application for prior approval G.02.070 Approval G.02.071 Documents G.02.072 Information — general G.02.073 Verbal order G.02.074 Explainable loss of controlled drug G.02.075 Destruction G.02.077 Retention period G.02.078 Location G.02.079 Quality of documents G.03.001 DIVISION 3 G.03.001 General information G.03.002 Sale of Controlled Drugs G.03.002 No sale without prescription G.03.002.2 Exception — notice of retraction G.03.003 Sale to practitioner — order G.03.004 Prescription file G.03.005 Provision to hospital G.03.006 Refilling prescription G.03.007 Records G.03.007 Written order or prescription G.03.008 Verbal order or prescription G.03.010 Retention period G.03.011 General Obligations of Pharmacist G.03.011 Providing information and assisting inspector G.03.012 Loss or theft — protective measures G.03.013 Loss or theft — report G.03.014 Return, Sale and Transfer G.03.014 Written order G.03.015 Record G.03.017.1 Notice of Prohibition of Sale G.03.017.3 Notice of retraction G.04.001 DIVISION 4 Practitioners G.04.001 Restriction G.04.002 Records G.04.002 Record of controlled drugs sold or provided G.04.002A General Obligations of Practitioner G.04.002A Requirements G.04.004.1 Notice of Prohibition of Sale G.04.004.1 Request by practitioner G.04.004.3 Notice of retraction G.05.001 DIVISION 5 Hospitals G.05.001 Record — controlled drugs G.05.002 Providing information and assisting inspector G.05.003 Selling, providing or administering controlled drug G.05.004 Loss or theft G.06.001 DIVISION 6 TABLE OF PROVISIONS G.06.002 Labelling — test kit G.06.003 Identification or analysis of controlled drug G.06.004 Advertising G.06.005 Record keeping — specific cases SCHEDULE PART I PART II PART III J.01.001 PART J Restricted Drugs J.01.001 Definitions J.01.002 General J.01.004 Possession J.01.004 Authorized persons J.01.005 Test Kits J.01.006 Application for registration number J.01.007 Issuance of registration number J.01.008 Cancellation of registration number J.01.009 Authorized Activities J.01.009 General J.01.010 Dealer’s Licences J.01.010 Preliminary Requirements Règlement sur les aliments et drogues TABLE ANALYTIQUE G.06.001 Étiquetage — drogue dispensée conformément à une ordonnance G.06.002 Étiquetage — nécessaire d’essai G.06.003 Identification ou analyse de drogues contrôlées G.06.004 Publicité G.06.005 Conservation des documents — cas spécifiques G.06.006 Renseignements fournis par le ministre à un organisme régissant la profession d’infirmier G.06.007 Préavis de la demande d’ordonnance de restitution ANNEXE PARTIE I PARTIE II PARTIE III J.01.001 PARTIE J Drogues d’usage restreint J.01.001 Définitions J.01.002 Dispositions générales J.01.002 Inscription accélérée temporaire J.01.003 Non-application — membre d’un corps policier J.01.004 Possession J.01.004 Personnes autorisées J.01.005 Nécessaires d’essai J.01.005 Opérations autorisées J.01.006 Numéro d’enregistrement — demande J.01.007 Numéro d’enregistrement — attribution J.01.008 Numéro d’enregistrement — annulation J.01.009 Distributeurs autorisés J.01.009 Opérations autorisées J.01.009 Exigences générales J.01.010 Licences de distributeur autorisé J.01.010 Exigences préalables J.01.010 Eligible persons J.01.013 Ineligibility J.01.014 Issuance of Licence J.01.014 Application J.01.015 Issuance J.01.016 Validity J.01.017 Refusal J.01.018 Renewal of Licence J.01.018 Application J.01.019 Renewal J.01.020 Validity J.01.021 Refusal J.01.022 Amendment of Licence J.01.022 Application J.01.023 Amendment J.01.024 Validity J.01.025 Refusal J.01.026 Application J.01.027 Approval J.01.028 Refusal J.01.029 Prior notice J.01.030 Notice — five days J.01.031 Notice — 10 days J.01.032 Notice of cessation of activities J.01.033 Changes to Terms and Conditions of Licence J.01.035 Suspension and Revocation of Licence J.01.035 Suspension J.01.036 Revocation J.01.037 Return of licence J.01.038 Import Permits J.01.038 Application J.01.010 Personnes admissibles J.01.011 Responsable principal J.01.012 Responsable qualifié J.01.013 Inadmissibilité J.01.014 Délivrance d’une licence J.01.014 Demande J.01.015 Délivrance J.01.016 Validité J.01.017 Refus J.01.018 Renouvellement de la licence J.01.018 Demande J.01.019 Renouvellement J.01.020 Validité J.01.021 Refus J.01.022 Modification de la licence J.01.022 Demande J.01.023 Modification J.01.024 Validité J.01.025 Refus J.01.026 Changements exigeant une approbation préalable du ministre J.01.026 Demande J.01.027 Approbation J.01.028 Refus J.01.029 Changements exigeant un avis au ministre J.01.029 Avis préalable J.01.030 Avis — cinq jours J.01.031 Avis — dix jours J.01.032 Avis — cessation des opérations J.01.033 Changement des conditions de la licence J.01.033 Ajout ou modification de conditions J.01.034 Suppression d’une condition J.01.035 Suspension et révocation de la licence J.01.035 Suspension J.01.036 Révocation J.01.037 Retour de la licence J.01.038 Permis d’importation J.01.038 Demande J.01.039 Issuance J.01.040 Validity J.01.041 Return of permit J.01.042 Refusal J.01.043 Providing copy of permit J.01.044 Declaration J.01.045 Suspension J.01.046 Revocation J.01.047 Return of permit J.01.048 Export Permits J.01.048 Application J.01.049 Issuance J.01.050 Validity J.01.051 Return of permit J.01.052 Refusal J.01.053 Providing copy of permit J.01.054 Declaration J.01.055 Suspension J.01.056 Revocation J.01.057 Return of permit J.01.058 Identification J.01.058 Name J.01.059 Sale of Restricted Drugs J.01.059 Sale to institution J.01.061 Provision for identification or analysis J.01.062 Packaging — sale and provision J.01.063 Labelling J.01.064 Transport J.01.065 Thefts, Losses and Suspicious Transactions J.01.065 Protective measures — licences and permits J.01.066 Protective measures — restricted drugs J.01.067 Theft or loss — licences and permits J.01.068 Theft or loss — restricted drugs J.01.069 Suspicious transaction J.01.071 Destruction of Restricted Drugs J.01.071 Destruction at site J.01.073 Application for prior approval J.01.074 Approval J.01.075 Documents J.01.076 Information — general J.01.077 Explainable loss of restricted drug J.01.078 Destruction J.01.080 Institutions J.01.081 Information J.01.082 Method of recording information J.01.083 Information J.01.084 Record Keeping J.01.084 Retention period J.01.085 Location J.01.086 Quality of documents J.01.087 Written notification SCHEDULE PART I PART II PART III SCHEDULE F SCHEDULE K SCHEDULE K.1 SCHEDULE K.2 SCHEDULE L SCHEDULE M ANNEXE K Ration quotidienne normale de diverses substances alimentaires ANNEXE K.1 ANNEXE K.2 ANNEXE L ANNEXE M

(2)

The adequate directions for use required to be shown on the inner and outer labels of a drug pursuant to subparagraph C.01.004(1)(c)(iii) shall be in both the French and English languages if the drug is available for sale without prescription in an open self-selection area. A.01.016 All information that is required by these Regulations to appear on a label of a food or a drug, other than a drug for human use in dosage form, shall be A.01.017 Every label of a drug for human use in dosage form shall meet the following conditions: (a) the information that is required by these Regulations to appear on the label shall be (ii) readily discernible to the purchaser or consumer under the customary conditions of purchase and use, and (iii) expressed in plain language; and (b) the format of the label, including the manner in which its text and any graphics are displayed on it, shall not impede comprehension of the information referred to in paragraph (a). A.01.022 An inspector shall perform the functions and duties and carry out the responsibilities in respect of foods and drugs prescribed by the Act, and these Regulations. A.01.023 The authority of an inspector extends to and includes the whole of Canada. (a) certify that the person named therein is an inspector for the purpose of the Act; and (b) be signed by (i) the Minister and the person named in the certificate, in the case of an inspector on the staff of the Department. A.01.025 If authorized by a regulation made pursuant to the Broadcasting Act, inspectors shall act as representatives of the Canadian Radio-television and Telecommunications Commission for the purpose of enforcing the provisions of regulations made by the Canadian Radio-television and Telecommunications Commission concerning the advertising of any article to which the Food and Drugs Act applies, or concerning recommendations for the prevention, treatment or cure of a disease or ailment. A.01.026 An inspector may, for the proper administration of the Act or these Regulations, take photographs of (a) any article that is referred to in subsection 23(2) of the Act; (b) any place where, on reasonable grounds, he believes any article referred to in paragraph (a) is (i) manufactured, prepared, preserved, packaged, or stored; (c) any label or advertising material that relates to an article referred to in paragraph (a). manufactured, prepared, preserved, packaged or stored; and (c) anything that, on reasonable grounds, he believes is used or capable of being used for the manufacture, preparation, preservation, packaging or storing of any article referred to in paragraph (a). A.01.040 Subject to section A.01.044, no person shall import into Canada for sale a food or drug the sale of which in Canada would constitute a violation of the Act or these Regulations. A.01.041 An inspector may examine and take samples of any food or drug sought to be imported into Canada. A.01.042 If an inspector examines or takes a sample of a food or drug under section A.01.041, the inspector may submit it to an analyst for analysis or examination. A.01.043 If an inspector, on examination of a sample of a food or drug or on receipt of a report of an analyst of the result of an analysis or examination of the sample, is of the opinion that the sale of the food or drug in Canada would constitute a violation of the Act or these Regulations, the inspector shall so notify in writing the collector of customs concerned and the importer. A.01.044 (1) Where a person seeks to import a food or drug into Canada for sale and the sale would constitute a violation of the Act or these Regulations, that person may, if the sale of the food or drug would be in conformity with the Act and these Regulations after its relabelling or modification, import it into Canada on condition that (a) the person gives to an inspector notice of the proposed importation; and (b) the food or drug will be relabelled or modified as may be necessary to enable its sale to be lawful in Canada.

CHAPITRE 870

LOI SUR LES ALIMENTS ET DROGUES Règlement sur les aliments et drogues Règlement concernant les aliments et drogues

(2)

No person shall sell a food or drug that has been imported into Canada under subsection (1) unless the food or drug has been relabelled or modified within three months after the importation or within such longer period as may be specified by (b) in the case of food, the Minister or the President of the Canadian Food Inspection Agency. A.01.045 A certificate referred to in section 37 of the Act shall be signed and issued by the exporter in the form set out in Appendix III. A.01.046 An exporter that issues a certificate referred to in paragraph 37(1)(c) of the Act in respect of a drug shall retain a copy of the certificate for five years after the day on which the drug is exported. A.01.047 (1) For the purposes of paragraph 37(1)(d) of the Act, a drug that, by virtue of paragraph A.01.048(a), is required to be fabricated, packaged/labeled, tested, distributed or wholesaled in accordance with an establishment licence must be fabricated, packaged/labeled, tested, distributed or wholesaled by the holder of such a licence that has paid fees in connection with the licence in accordance with the Fees in Respect of Drugs and Medical Devices Order.

PARTIE A

Administration Dispositions générales A.01.001 Le présent règlement peut être cité sous le titre : Règlement sur les aliments et drogues. A.01.002 Lorsqu’il y a lieu, les dispositions du présent règlement établissent les normes de composition, de concentration, d’activité, de pureté, de qualité ou autre propriété de la substance alimentaire ou de la drogue, auxquelles elles se rapportent. A.01.003 [Abrogé, DORS/94-289, art. 1] Interprétation A.01.010 Dans le présent règlement, centimètre cube ou son abréviation cc. sont censées interchangeables avec le mot millilitre et son abréviation ml.; (cubic centimetre) conjoint de fait S’entend au sens de l’article 2 du Code criminel; (common-law partner) Directeur [Abrogé, DORS/2018-69, art. 1] drogue sur ordonnance Drogue figurant sur la Liste des drogues sur ordonnance, avec ses modifications successives, ou faisant partie d’une catégorie de drogues figurant sur cette liste; (prescription drug) emballage de sécurité désigne un emballage doté d’un dispositif de sûreté qui offre au consommateur une assurance raisonnable que l’emballage n’a pas été ouvert avant l’achat; (security package) manufacturer [Repealed, SOR/97-12, s. 1] outer label means the label on or affixed to the outside of a package of a food or drug; (étiquette extérieure) SOR/2018-69, s. 27. SOR/2018-69, s. 27. (a) “Lot number”; (d) “(L)”. SOR/85-140, s. 1. (a) clearly and prominently displayed on the label; and (b) readily discernible to the purchaser or consumer under the customary conditions of purchase and use. SOR/2014-158, s. 1; SOR/2022-143, s. 1(F). (i) prominently displayed on it, SOR/2014-158, s. 2. Analysts; Inspectors A.01.020 and A.01.021 [Repealed, SOR/81-935, s. 1] A.01.024 The certificate of designation required pursuant to subsection 22(2) of the Act shall (ii) [Repealed, SOR/2000-184, s. 60] SOR/80-500, s. 1; SOR/92-626, s. 1; SOR/95-548, s. 8; SOR/2000-184, s. 60; SOR/2018-69, s. 27. SOR/2022-197, s. 2. (ii) labelled or tested; or (iii) displayed for sale; and SOR/89-814, s. 1. Importations SOR/92-626, s. 2(F). SOR/2017-18, s. 1(E). SOR/84-300, s. 2(E); SOR/2017-18, s. 2. (a) in the case of a drug, the Minister; or SOR/92-626, art. 3; SOR/95-548, s. 5; SOR/2000-184, s. 61; SOR/2000-317, s. 18; SOR/2018-69, s. 27. Exports SOR/80-318, s. 1; SOR/90-814, s. 2. SOR/2022-100, s. 1. SOR/2022-100, s. 1. (a) the provisions of Division 1A of Part C; (b) the provisions of Division 2 of Part C, except section C.02.003.2 and paragraphs C.02.009(5)(b), C.02.016(3)(b) and C.02.018(3)(c); (c) sections C.03.001 to C.03.013; and (d) the provisions of Division 4 of Part C, except (i) sections C.04.003, C.04.019, C.04.020, C.04.054, C.04.055, C.04.080, C.04.082 to C.04.085 and C.04.091, (ii) sections C.04.101 and C.04.102, paragraph C.04.117(c), sections C.04.118 to C.04.120, C.04.126 and C.04.127, paragraph C.04.128(a) and sections PART A Administration Exports Sections A.01.048-A.01.050

(2)

Words and expressions used in this section have the same meaning as in subsection C.01A.001(1). A.01.048 For the purposes of subsection 37(1.2) of the Act, the following provisions are prescribed in relation to drugs: Food and Drug Regulations Transhipments A.01.049 For the purposes of paragraph 38(c) of the Act, all drugs must be in bond. A.01.050 When taking a sample of an article under paragraph 23(2)(i) of the Act, an inspector shall inform the owner of the article or the person from whom the sample is being obtained of the inspector’s intention to submit the sample or a part of it to an analyst for analysis or examination, and (a) where, in the opinion of the inspector, division of the procured quantity would not interfere with analysis or examination (i) divide the quantity into three parts, (ii) identify the three parts as the owner’s portion, the sample, and the duplicate sample and where only one part bears the label, that part shall be identified as the sample, (iii) seal each part in such a manner that it cannot be opened without breaking the seal, and (iv) deliver the part identified as the owner’s portion to the owner or the person from whom the sample was obtained and forward the sample and the duplicate sample to an analyst for analysis or examination; or (b) where, in the opinion of the inspector, division of the procured quantity would interfere with analysis or examination (i) identify the entire quantity as the sample, (ii) seal the sample in such a manner that it cannot be opened without breaking the seal, and (iii) forward the sample to an analyst for analysis or examination. A.01.051 Where the owner or the person from whom the sample was obtained objects to the procedure followed by an inspector under section A.01.050 at the time the sample was obtained, the inspector shall follow both procedures set out in that section if the owner or the person from whom the sample was obtained supplies him with a sufficient quantity of the article. A.01.060 The cost of analysing a sample other than for the purpose of the Act, for a department of the Government of Canada for the purpose of legal action is $15. Labelling of Food and Drugs in Pressurized Containers flame projection means the ability of the pressurized contents of an aerosol container to ignite and the length of that ignition, when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981; (projection de flamme) flashback means that part of the flame projection that extends from its point of ignition back to the aerosol container when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981; (retour de flamme) A.01.061 (1) Subject to section A.01.063, in the case of a food or a drug packaged in a disposable metal container designed to release pressurized contents by use of a manually operated valve that forms an integral part of the container, the principal display panel of the inner and outer labels of the food or drug shall display, in accordance with sections 15 to 18 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following information: (a) the hazard symbol set out in Column II of item 10 of Schedule II to those Regulations, accompanied by the signal word “CAUTION / ATTENTION”; and

C

04.137, C.04.138, C.04.146, C.04.147, C.04.169, C.04.170, C.04.187 and C.04.190, (iii) sections C.04.218 to C.04.220 and C.04.239 to C.04.241, (iv) sections C.04.555, C.04.556, C.04.561, C.04.562, C.04.567, C.04.568, C.04.573, C.04.574, C.04.578, C.04.580, C.04.581, C.04.588, C.04.589, C.04.593, C.04.595 and C.04.596, and (v) sections C.04.601, C.04.602, C.04.650 to C.04.656, C.04.676, C.04.677 and C.04.680 to C.04.683. SOR/2022-100, s. 1. SOR/2022-100, s. 1. Sampling Règlement sur les aliments et drogues

(2)

Subject to section A.01.063, one panel of the inner and outer labels of a food or drug referred to in subsection (1) shall display, in the size required by paragraph 19(1)(b) of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following additional hazard statement: “Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C.

PARTIE A Administration

Exportation

(3)

The requirements of subsections (1) and (2) do not apply in relation to a drug or food if the Minister determines that the design of the container, the materials used in its construction or the incorporation of a safety device eliminates its potential hazard. A.01.062 (1) Subject to section A.01.063, if a food or drug is packaged in a container described in subsection A.01.061(1) and has a flame projection of a length set out in column I of any of items 1 to 3 of the table to this subsection or a flashback as set out in column I of item 4 of that table, as determined by official method DO-30, Determination of Flame Projection, dated October 15, 1981, the principal display panel of the inner and outer labels of the food or drug shall display, in accordance with sections 15 to 18 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following information: (b) in both official languages, the signal word set out in Column III of the same item; and (c) in both official languages, the primary hazard statement set out in Column IV of the same item.

Articles A.01.048-A.01.050

(2)

In addition to the requirements of subsection (1), one panel of the inner label and outer labels of a food or drug referred to in that subsection shall display, in the size required by paragraph 19(1)(b) of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following additional hazard statement: "Do not use in presence of open flame or spark.

C

04.137, C.04.138, C.04.146, C.04.147, C.04.169, C.04.170, C.04.187 et C.04.190, (iii) les articles C.04.218 à C.04.220 et C.04.239 à C.04.241, (iv) les articles C.04.555, C.04.556, C.04.561, C.04.562, C.04.567, C.04.568, C.04.573, C.04.574, C.04.578, C.04.580, C.04.581, C.04.588, C.04.589, C.04.593, C.04.595 et C.04.596, (v) les articles C.04.601, C.04.602, C.04.650 à C.04.656, C.04.676, C.04.677 et C.04.680 à C.04.683. DORS/2022-100, art. 1. Transbordements A.01.049 Pour l’application de l’alinéa 38c) de la Loi, toute drogue doit être en douane. DORS/2022-100, art. 1. Échantillons A.01.050 L’inspecteur qui prélève un échantillon d’un article en vertu de l’alinéa 23(2)i) de la Loi avise le propriétaire de l’article ou la personne de qui il obtient l’échantillon de son intention de soumettre tout ou partie de l’échantillon à un analyste pour analyse ou examen, et : a) lorsque, de l’avis de l’inspecteur, la division de la quantité obtenue ne nuirait pas à l’examen ou à l’analyse, il doit (i) diviser la quantité prélevée en trois parties, (ii) identifier les trois parties comme la partie du propriétaire, l’échantillon et le double de l’échantillon, et si une partie seulement porte l’étiquette, cette partie doit constituer l’échantillon, (iii) sceller chaque partie de manière qu’elle ne puisse être ouverte sans briser le sceau, et (iv) remettre la partie identifiée comme la partie du propriétaire, au propriétaire ou à la personne chez qui l’échantillon a été prélevé et envoyer l’échantillon ainsi que le double à un analyste pour l’examen ou analyse; ou b) lorsque, de l’avis de l’inspecteur, la division de la quantité prélevée nuirait à l’analyse ou à l’examen, il doit (i) identifier la quantité entière de l’échantillon, SOR/90-814, s. 3; SOR/2021-46, s. 1. Tariff of Fees A.01.060.1 In sections A.01.061 and A.01.062, principal display panel [Repealed, SOR/2000-353, s. 2] SOR/92-15, s. 1; SOR/2000-353, s. 2; SOR/2001-272, s. 6. (b) the primary hazard statement “CONTAINER MAY EXPLODE IF HEATED. / CE CONTENANT PEUT EXPLOSER S’IL EST CHAUFFÉ.”. Contenu sous pression. Ne pas mettre dans l’eau chaude ni près des radiateurs, poêles ou autres sources de chaleur. Ne pas percer le contenant, ni le jeter au feu, ni le conserver à des températures dépassant 50 °C. SOR/81-816, s. 1; SOR/85-103, s. 1; SOR/92-15, s. 2; SOR/2001-272, s. 7; SOR/2018-69, s. 2. (a) the hazard symbol set out in Column II of the same item; Ne pas utiliser en présence d'une flamme nue ou d'étincelles." SOR/81-616, s. 2; SOR/82-429, s. 1; SOR/85-1023, s. 2; SOR/92-15, s. 3; SOR/2001-272, s. 8. A.01.063 (1) Where the labelled net contents of a container of a food or drug described in subsection A.01.061(1) or A.01.062(1) do not exceed 60 millilitres or 60 grams, the inner label may show only the information described in paragraph A.01.061(1)(a) or paragraph A.01.062(1)(a) and (b), as the case may be. SOR/81-616, s. 2; SOR/92-15, s. 4. A.01.064 [Repealed, SOR/93-243, s. 2] Security Packaging (a) a mouthwash; (c) for ophthalmic use.

(2)

Where the labelled net contents of a container of a food or drug described in subsection A.01.061(1) or A.01.062(1) exceeds 60 millilitres or 60 grams but does not exceed 120 millilitres or 120 grams, the inner label may show only the information described in subsection A.01.061(1) or subsection A.01.062(1), as the case may be.

(3)

Subsection (2) does not apply to lozenges. (a) on the inner label of the package; and SOR/85-141, s. 2; SOR/88-323, s. 1; SOR/92-664, s. 1. Exemptions Application A.01.066 Sections A.01.067 and A.01.068 do not apply to (b) a prescription drug. SOR/2007-288, s. 1; SOR/2013-122, s. 2. SOR/2007-288, s. 1; SOR/2021-46, s. 10. Sale SOR/2007-288, s. 1; SOR/2021-46, s. 10. PART B Foods DIVISION 1 B.01.001 (1) In this Part, (c) vitamin, mineral nutrient or amino acid, (c.1) supplemental ingredient, (d) essential oil, flavouring preparation, natural extractive, oleoresin, seasoning or spice, — d’une maladie, d’un désordre ou d’un état physique anormal énuméré à l’annexe A.1 de la Loi. DORS/2007-288, art. 1; DORS/2021-46, art. 10. Vente A.01.068 Est exemptée de l’application du paragraphe 3(2) de la Loi, en ce qui concerne sa vente par une personne, à titre de mesure préventive — mais non à titre de traitement ou de moyen de guérison — d’une maladie, d’un désordre ou d’un état physique anormal énuméré à l’annexe A.1 de la Loi, toute drogue qui est représentée par une étiquette ou dont la publicité auprès du grand public est faite par la personne en cause. DORS/2007-288, art. 1; DORS/2021-46, art. 10.

(3)

Where the labelled net quantity, in a container, of a food or drug referred to in subsection A.01.061(1) or A.01.062(1) is less than 30 mL or 30 g, the hazard symbol shall be of such size as to be capable of being circumscribed by a circle with a diameter of at least 6 mm.

PARTIE B

Aliments

(4)

Where a container of a food or drug, described in subsection (1) or (2) is sold in a package, the outer label may show only the information described in subsection A.01.061(1) and, where applicable, subsection A.01.062(2). A.01.065 (1) In this section, drug for human use means a drug that is intended for human use, whether the drug is (b) to be inhaled, ingested or inserted into the body; or

TITRE 1

Dispositions générales B.01.001 (1) Dans la présente partie, acides gras monoinsaturés, graisses monoinsaturées, gras monoinsaturés, lipides monoinsaturés ou monoinsaturés Acides gras cis-monoinsaturés; (monounsaturated fatty acids, monounsaturated fat, monounsaturates or monounsaturated) acides gras polyinsaturés, graisses polyinsaturées, gras polyinsaturés, lipides polyinsaturés ou polyinsaturés Acides gras polyinsaturés à interruption cis-méthylénique; (polyunsaturated fatty acids, polyunsaturated fat, polyunsaturates or polyunsaturated) acides gras polyinsaturés oméga-3, graisses polyinsaturées oméga-3, gras polyinsaturés oméga-3, lipides polyinsaturés oméga-3 ou oméga-3 Selon le cas : a) acide 9-cis, 12-cis, 15-cis octadécatriénoïque ou acide α-linolénique; b) acide 8-cis, 11-cis, 14-cis, 17-cis éicosatétraénoïque; c) acide 5-cis, 8-cis, 11-cis, 14-cis, 17-cis éicosapentaénoïque ou AEP; d) acide 7-cis, 10-cis, 13-cis, 16-cis, 19-cis docosapentaénoïque; (f) drug recommended for administration to animals that may be consumed as food; (produit chimique agricole) (f) the area occupied by the universal product code; (surface exposée disponible) e) acide 4-cis, 7-cis, 10-cis, 13-cis, 16-cis, 19-cis docosahexaénoïque ou ADH; (omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fat, omega-3 polyunsaturates, omega-3 polyunsaturated or omega-3) acides gras polyinsaturés oméga-6, graisses polyinsaturées oméga-6, gras polyinsaturés oméga-6, lipides polyinsaturés oméga-6, polyinsaturés oméga-6 ou oméga-6 Selon le cas : a) acide 9-cis, 12-cis octadécadiénoïque ou acide linoléique; b) acide 6-cis, 9-cis, 12-cis octadécatriénoïque; c) acide 8-cis, 11-cis, 14-cis eicosatriénoïque ou acide di-homo-γ-linolénique; d) acide 5-cis, 8-cis, 11-cis, 14-cis eicosatétraénoïque ou acide arachidonique; e) acide 7-cis, 10-cis, 13-cis, 16-cis docosatétraénoïque; f) acide 4-cis, 7-cis, 10-cis, 13-cis, 16-cis docosapentaénoïque; (omega-6 polyunsaturated fatty acids, omega-6 polyunsaturated fat, omega-6 polyunsaturates, omega-6 polyunsaturated or omega-6) acides gras trans, graisses trans, gras trans, lipides trans ou trans Acides gras insaturés qui contiennent une ou plusieurs liaisons doubles isolées ou non conjuguées de configuration trans; (trans fatty acids, trans fat, trans fatotrans) additif alimentaire s’entend de toute substance dont l’emploi est tel ou peut vraisemblablement être tel que cette substance ou ses sous-produits sont intégrés à un aliment ou en modifient les caractéristiques, à l’exclusion de ce qui suit : a) toute substance nutritive qui est employée, reconnue ou vendue couramment comme substance alimentaire ou comme ingrédient d’un aliment, b) vitamines, minéraux nutritifs et acides aminés, autres que ceux qui sont énumérés aux tableaux du Titre 16, b.1) ingrédients supplémentaires, Names for Ingredients and Components, prepared by the Canadian Food Inspection Agency and published on its website, as amended from time to time; (document sur les noms usuels d’ingrédients et de constituants) daily value means, in respect of a nutrient, the quantity applicable to the nutrient according to subsection B.01.001.1(2); (valeur quotidienne) energy value means, in respect of a food, the amount of energy made available to a person’s body when the chemical constituents of the food, including protein, fat, carbohydrate and alcohol, are metabolized following ingestion of the food by the person; (valeur énergétique) extended meat product means a meat product to which a meat product extender has been added; (produit de viande avec allongeur) extended poultry product means a poultry product to which a poultry product extender has been added; (produit de volaille avec allongeur) fish product means fish or prepared fish; (produit de poisson) c) épices, assaisonnements, préparations aromatisantes, essences, oléorésines et extraits naturels, d) produits chimiques agricoles autres que ceux visés aux tableaux du titre 16, e) matériaux d’emballage des aliments ou toute substance qui entre dans leur composition, et f) produits pharmaceutiques recommandés pour les animaux dont la chair peut être consommée par l’homme; (food additive) agent édulcorant Vise notamment tout aliment qui fait l’objet d’une norme dans le titre 18, mais non les additifs alimentaires visés aux tableaux du titre 16; (sweetening agent) agent gélatinisant désigne la gélatine, l’agar-agar et la carraghénine; (gelling agent) aliment non normalisé désigne tout aliment pour lequel la présente partie ne prescrit pas de norme; (unstandardized food) aliment supplément Produit ou mélange qui appartient à une catégorie d’aliments indiquant à la colonne I de la Liste des catégories autorisées d’aliments supplémentés et auquel a été ajouté un ingrédient supplémentaire, à l’exclusion des aliments suivants : a) les aliments à usage diététique spécial au sens de l’article B.24.001 qui sont visés à l’un ou l’autre des alinéas B.24.003(1) f) à f.2) et h) à j), même s’ils sont également des aliments sans gluten visés à l’alinéa B.24.003(1)g); b) les aliments étiquetés ou annoncés comme pouvant être consommés par : (i) des bébés au sens de l’article B.25.001, (ii) des enfants âgés d’au moins un mois de moins de quatre ans, (iii) des femmes enceintes ou qui allaitent; c) les aliments ci-après qui figurent à la colonne I du tableau de l’article D.03.002 : (i) ceux qui figurent à l’un des articles 1, 2.1, 2.2, 4, 5, 7, 8, 9.1, 10 à 13, 15, 17 à 19, 21 à 25 et 27, (ii) la glace préemballée; d) les aliments qui n’ont pas été transformés ou qui l’ont minimalement été; (b.1) supplemental ingredients; (d) agricultural chemicals, other than those listed in the tables to Division 16, gelling agent means gelatin, agar and carrageenan; (agent gélatinisant) list of cautionary statements means the list shown on the label of a supplemented food in accordance with subsection B.29.020(1); (liste des mises en garde) e) les boissons dont la teneur en alcool est de plus de 0,5%; (supplemented food) allongeur de produit de viande désigne un aliment qui est source de protéines et qui est présenté comme devant servir à augmenter le volume de produits de viande; (meat product extender) allongeur de produit de volaille désigne un aliment qui est source de protéines et qui est présenté comme devant servir à augmenter le volume de produits de volaille; (poultry product extender) apport nutritionnel recommandé pondéré Relativement à une vitamine ou à un minéral nutritif figurant à la colonne I du tableau III du titre 1 de la partie D ou à la colonne I du tableau II du titre 2 de cette partie, la quantité indiquée dans la colonne III; (weighted recommended nutrient intake) apport quotidien recommandé [Abrogée, DORS/2016-305, art. 1] à proximité À l’égard d’un renseignement figurant sur une étiquette ou un écriteau, qui est situé immédiatement à côté de celui-ci, sans texte ni illustration ni autre signe graphique intercalé; (close proximity) autorisation de mise en marché Autorisation de mise en marché délivrée par le ministre en vertu du paragraphe 30.3(1) de la Loi; (marketing authorization) bœuf attendri mécaniquement Bœuf coupé solide non cuit conditionné d’une des façons suivantes : a) sa surface est affaiblie du fait qu’elle est perforée par des lames, des aiguilles ou tout autre instrument similaire; b) une marinade ou toute autre solution attendrissante y est injectée; (mechanically tenderized beef) colorant alimentaire Tout colorant visé à l’article 2 de l’Autorisation de mise en marché d’additifs alimentaires comme colorants. (food colour) constituant désigne une unité alimentaire alliée, en tant qu’élément alimentaire individuel, à une ou plusieurs autres unités alimentaires pour former un ingrédient; (component) date limite de conservation désigne la date où la durée de conservation d’un produit préemballé prend fin; (durable life date) List of Permitted Supplemental Ingredients means the document entitled List of Permitted Supplemental Ingredients, published by the Government of Canada on its website, as amended from time to time; (Liste des ingrédients supplémentaires autorisés) List of Permitted Supplemental Food Categories means the document entitled List of Permitted Supplemental Food Categories, published by the Government of Canada on its website, as amended from time to time; (Liste des catégories autorisées d'aliments supplémentaires) (d) breads, breakfast cereals, rice and other grains, and alimentary pastes; (plat principal) marketing authorization means a marketing authorization issued by the Minister under subsection 30.3(1) of the Act; (autorisation de mise en marché) meat product means meat, meat by-product, prepared meat or prepared meat by-product; (produit de viande) of extending meat products; (allongeur de produit de viande) (b) the beef is injected with a marinade or other tenderizing solution; (bœuf attendri mécaniquement) monounsaturated fatty acids, monounsaturated fat, monounsaturates or monounsaturated means cis-monounsaturated fatty acids; (acides gras monoinsaturés, graisses monoinsaturées, gras monoinsaturés, lipides monoinsaturés ou monoinsaturés) multiple-serving prepackaged product means a prepackaged product other than a single-serving prepackaged product; (produit préemballé à portions multiples) nutrition facts table means the nutrition facts table that is required by subsection B.01.401(1) to be carried on the label of a prepackaged product; (tableau de la valeur nutritive) omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fat, omega-3 polyunsaturates, omega-3 polyunsaturated or omega-3 means (a) 9-cis, 12-cis, 15-cis octadecatrienoic acid or α-linolenic acid, (b) 8-cis, 11-cis, 14-cis, 17-cis eicosatetraenoic acid, (c) 5-cis, 8-cis, 11-cis, 14-cis, 17-cis eicosapentaenoic acid or EPA, (d) 7-cis, 10-cis, 13-cis, 16-cis, 19-cis docosapentaenoic acid, or (e) 4-cis, 7-cis, 10-cis, 13-cis, 16-cis, 19-cis docosahexaenoic acid or DHA; (acides gras polyinsaturés oméga-3, graisses polyinsaturées oméga-3, gras polyinsaturés oméga-3 ou oméga-3) c) dans le cas d’une étiquette apposée sur un aliment qui n’est pas un produit préemballé, la portion de l’étiquette apposée sur tout ou partie de la face ou de la surface de l’aliment qui est exposée ou visible dans les conditions normales ou habituelles de vente ou d’utilisation. (principal display panel) identifiant des aliments supplémentés avec mise en garde S’entend de l’identifiant que porte l’espace principal d’un aliment supplémenté en application du paragraphe B.29.021(1); (supplemented food caution identifier) ingrédient désigne une unité alimentaire alliée, en tant qu’élément alimentaire, à une ou plusieurs autres unités alimentaires pour former une denrée alimentaire prête à être vendue comme produit préemballé; (ingrédient) ingrédient à base de sucres À l’égard d’un produit préemballé : a) l’ingrédient qui est un monosaccharide ou un disaccharide, ou une combinaison de ceux-ci; b) l’ingrédient qui est un agent édulcorant autre que celui visé à l’alinéa a); c) tout autre ingrédient qui contient un ou plusieurs sucres et qui est ajouté au produit comme substitut fonctionnel d’un agent édulcorant; (sugars-based ingredient) ingrédient supplémentaire S’entend d’un élément nutritif, notamment d’une vitamine, d’un minéral nutritif ou d’un acide aminé, ou de toute autre substance qui figure à la colonne 1 de la Liste des ingrédients supplémentaires autorisés et qui est ajouté à titre d’ingrédient à un aliment conformément aux conditions d’utilisation applicables prévues aux colonnes 2 à 5; (supplemental ingredient) Liste de contaminants et d’autres substances adultérantes dans les aliments La Liste de contaminants et d’autres substances adultérantes dans les aliments, publiée par le ministre de la Santé sur son site Web, avec ses modifications successives; (List of Contaminants and Other Adulterating Substances in Foods) Liste des catégories autorisées d’aliments supplémentés Le document intitulé Liste des catégories autorisées d’aliments supplémentés, publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (List of Permitted Supplemented Food Categories) polyinsaturés oméga-3, lipides polyinsaturés oméga-3, polyinsaturates omega-3 ou omega-3) omega-6 polyunsaturated fatty acids, omega-6 polyunsaturated fat, omega-6 polyunsaturates, omega-6 polyunsaturated or omega-6 means (a) 9-cis, 12-cis octadecadienoic acid or linoleic acid, (b) 6-cis, 9-cis, 12-cis octadecatrienoic acid, (c) 8-cis, 11-cis, 14-cis eicosatrienoic acid or di-homo-γ-linolenic acid, (d) 5-cis, 8-cis, 11-cis, 14-cis eicosatetraenoic acid or arachidonic acid, (e) 7-cis, 10-cis, 13-cis, 16-cis docosatetraenoic acid, or (f) 4-cis, 7-cis, 10-cis, 13-cis, 16-cis docosapentaenoic acid; (acides gras polyinsaturés oméga-6, graisses polyinsaturées oméga-6, gras polyinsaturés oméga-6, lipides polyinsaturés oméga-6 ou oméga-6) parts per million [Repealed, SOR/2010-94, s. 1] parts per million or p.p.m. means parts per million by weight unless otherwise stated; (parties par million ou p.p.m.) per cent or % means per cent by weight, unless otherwise stated; (pour cent ou %) Liste des ingrédients supplémentaires autorisés Le document intitulé Liste des ingrédients supplémentaires autorisés, publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (List of Permitted Supplemental Ingredients) liste des mises en garde Liste qui figure sur l’étiquette d’un aliment supplémenté conformément au paragraphe B.29.020(1); (list of cautionary statements) nom usuel, en ce qui a trait à un aliment, désigne a) le nom de l’aliment imprimé en caractères gras non italiques dans une disposition de présent règlement, b) le nom prescrit par un autre règlement, ou c) si le nom de l’aliment n’est pas ainsi imprimé ou prescrit, le nom sous lequel l’aliment est généralement connu ou un nom qui n’est pas générique et qui le décrit; (common name) œuf de référence [Abrogée, DORS/2016-305, art. 1] œuf à jaune substitué désigne un aliment qui a) ne contient pas de jaune d’œuf mais qui contient de l’albumen d’œuf liquide, en poudre ou congelé ou un mélange de ces trois formes, b) est destiné à servir de substitut à l’œuf entier, et c) est conforme aux exigences de l’article B.22.032; (yolk-replaced egg) parties par million [Abrogée, DORS/2010-94, art. 1] parties par million ou p.p.m. S’entend de parties par million en poids, à moins d’indication contraire; (parts per million or p.p.m.) plat principal plat composé selon le Tableau des quantités de référence qui ne requiert pas l’ajout d’ingrédients lors de sa préparation, à l’exception de l’eau, et qui contient des aliments d’au moins deux catégories parmi les suivantes : a) les produits laitiers ainsi que leurs substituts, autres que le beurre, la crème, la crème sûre, la crème glacée, le lait glacé, le lait stérile et leurs substituts; b) les produits de viande, les produits de volaille et les produits d’animaux marins et d’animaux d’eau douce visés au titre 21 ainsi que leurs substituts, dont le tofu, le tofu, les légumineuses, les fruits à écales, les polyunsaturated fatty acids, polyunsaturated fat, polyunsaturates or polyunsaturated means cis-methylene interrupted polyunsaturated fatty acids; (acides gras polyinsaturés, graisses polyinsaturées, gras polyinsaturés, lipides polyinsaturés ou polyinsaturés) poultry product means poultry meat, prepared poultry meat, poultry meat by-product or prepared poultry meat by-product; (produit de volaille) (b) vegetables, fruit or grain products; (repas préemballé) graines, les beurres de fruits à écale ou de graines et les tartinades de légumineuses; c) les fruits et les légumes, autres que les pickles, les cornichons, les achards (relish), les olives et les garnitures; d) les pains, les céréales à déjeuner, le riz et autres grains et les pâtes alimentaires; (main dish) point Unité de mesure de la force du corps des caractères connu comme point PostScript et qui équivaut à 0,3527777778 mm; (point) pour cent ou % Pourcentage en poids, à moins d’indication contraire; (per cent or %) préparation aromatisante s’applique à tout aliment qui fait l’objet d’une norme du titre 10; (flavouring preparation) principale surface exposée s’agissant d’un produit préemballé : a) si son emballage a une surface exposée visible dans les conditions habituelles de vente ou d’utilisation, la totalité de cette surface, à l’exclusion du dessous, le cas échéant; b) si son emballage est muni d’un couvercle qui constitue sa partie exposée ou visible dans les conditions habituelles de vente ou d’utilisation, la totalité de la surface supérieure du couvercle; c) si son emballage n’a pas de surface en particulier qui soit exposée ou visible dans les conditions habituelles de vente ou d’utilisation, 40 % de la surface totale de l’emballage, à l’exclusion du dessous, le cas échéant, s’il est possible que cette proportion de la surface soit exposée ou visible dans ces conditions; d) si son emballage est un sac dont les surfaces sont d’égales dimensions, la surface totale de l’une d’elles; e) si son emballage est un sac dont les surfaces sont de dimensions différentes, la surface totale de l’une de ses plus grandes surfaces; f) malgré les alinéas a) à e), si son emballage n’a pas de surface exposée ou visible dans les conditions habituelles de vente ou d’utilisation sur laquelle une étiquette peut être apposée, la surface totale de l’un des côtés de l’étiquette mobile attachée à l’emballage; g) malgré les alinéas a) à e), si l’emballage contient du vin exposé pour la vente, toute partie de la surface de (d) if the package is a bag with surfaces of equal dimensions, the total area of one of the surfaces, l’emballage, à l’exclusion du dessus et du dessous, qui peut être vue sans qu’il soit nécessaire de tourner l’emballage; h) si son emballage est une enveloppe ou une bande si étroite par rapport à la dimension de l’aliment qu’elle contient qu’il n’est pas raisonnable de considérer que l’emballage a une surface exposée ou visible dans les conditions habituelles de vente ou d’utilisation, la face totale de l’un des côtés de l’étiquette mobile attachée à l’emballage; (principal display surface) produit chimique agricole Toute substance utilisable ou présentée comme étant utilisable dans un aliment, ou sur sa surface, pendant sa production, son entreposage ou son transport et dont l’utilisation donne lieu, ou dont on peut raisonnablement s’attendre à ce qu’elle donne lieu, à un résidu ou à un composé dérivé de la substance dans l’aliment ou sur sa surface, y compris tout produit antiparasitaire au sens du paragraphe 2(1) de la Loi sur les produits antiparasitaires, régulateur de croissance des végétaux, fertilisant ou tout adjuvant ou véhicule utilisé avec la substance. Sont toutefois exclus les produits suivants : a) les additifs alimentaires visés aux tableaux de l’article B.16.100 et utilisés conformément à ces tableaux; b) les substances nutritives utilisées, reconnues ou couramment vendues comme aliments ou comme ingrédients d’un aliment; c) les vitamines, minéraux nutritifs et acides aminés;

(2)

Subject to subsection (3), no person shall sell or import a drug for human use that is packaged and available to the general public in a self-service display, unless the drug is contained in a security package.

c.1) les ingrédients supplémentaires; d) les assaisonnements, épices, extraits naturels, huiles essentielles, oléorésines et préparations aromatisantes; e) les matériaux d’emballage des aliments ou toute substance qui entre dans leur composition; f) les drogues recommandées pour administration aux animaux pouvant être consommés comme aliments; (agricultural chemical) produit de poisson désigne du poisson ou du poisson préparé; (fish product) produit de viande désigne de la viande, des sous-produits de viande, de la viande préparée ou des sous-produits de viande préparée; (meat product) produit de viande avec allongeur désigne un produit de viande auquel un allongeur de produit de viande a été ajouté; (extended meat product) recommended daily intake [Repealed, SOR/2016-305, s. 1] reference amount means, in respect of a food set out in column 1 of the Table of Reference Amounts, the amount of that food set out in column 2; (quantité de référence) reference standard [Repealed, SOR/2016-305, s. 1] saturated fatty acids, saturated fat, saturates or saturated means all fatty acids that contain no double bonds; (acides gras saturés, graisses saturées, gras saturés, lipides saturés ou saturés) produit de volaille désigne de la viande de volaille, de la viande de volaille préparée, des sous-produits de viande de volaille ou des sous-produits de viande de volaille préparée; (poultry product) produit de volaille avec allongeur désigne un produit de volaille auquel un allongeur de produit de volaille a été ajouté; (extended poultry product) produit préemballé désigne un aliment contenu dans un emballage de manière à être normalement vendu, utilisé ou acheté par une personne; (prepackaged product) produit préemballé à portion individuelle Produit préemballé dont la quantité nette de l’aliment contenu dans l’emballage correspond à la portion indiquée pour cet aliment, tel qu’il est prévu à l’alinéa B.01.002A(1)(b); (single-serving prepackaged product) produit préemballé à portions multiples Produit préemballé qui n’est pas un produit préemballé à portion individuelle; (multiple-serving prepackaged product) quantité de référence S’agissant d’un aliment figurant à la colonne 1 du Tableau des quantités de référence, la quantité de cet aliment indiquée dans la colonne 2; (reference amount) ration quotidienne raisonnable, appliquée à un aliment énuméré à un poste de la colonne 1 de l’annexe K, désigne la quantité de cet aliment indiquée dans la colonne II de ladite annexe; (reasonable daily intake) repas préemballé Choix préemballé d’aliments destiné à une seule personne, qui ne requiert aucune autre préparation que le réchauffage et qui contient au moins deux portions usuelles, selon la description qui en est donnée dans la publication intitulée Guide alimentaire canadien pour manger sainement, autorisée par le ministre de la Santé nationale et du Bien-être social et publiée en 1992 par le ministère des Approvisionnements et Services : a) une portion de viande, poisson, volaille, légumineuses, noix, graines, œufs ou tout produit du lait autre que le beurre, la crème, la crème sure, le fromage à la crème, le lait glacé et le sorbet laitier; b) une portion de légumes, fruits ou produits céréaliers; (prepackaged meal) Répertoire des modèles de TVN Le document intitulé Étiquetage nutritionnel — Répertoire des modèles de tableaux de la valeur nutritive, publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (Directory of NFT Formats) (ii) prepackaged ice; (e) a beverage with an alcohol content of more than 0.5%; (aliment supplémenté) supplemented food caution identifier means the identifier carried on the principal display panel of a supplemented food under subsection B.29.021(1); (identifiant des aliments supplémentés avec mise en garde) supplemented food facts table means the supplemented food facts table required by subsection B.29.020(1) to be carried on the label of a supplemented food; (tableau des renseignements sur les aliments supplémentés) Répertoire des spécifications des symboles nutritionnels le document intitulé Étiquetage nutritionnel — Répertoire des spécifications des symboles nutritionnels, publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (Directory of Nutrition Symbol Specifications) simili-produit de viande désigne un aliment qui ne contient aucun produit de viande, produit de volaille ni produit de poisson mais qui a l’apparence d’un produit de viande; (simulated meat product) simili-produit de volaille désigne un aliment qui ne contient aucun produit de volaille, produit de viande ni produit de poisson mais qui a l’apparence d’un produit de volaille; (simulated poultry product) substitut de repas Préparation alimentaire qui, à elle seule, peut remplacer au moins un repas quotidien; (meal replacement) substitut fonctionnel d’un agent édulcorant À l’égard d’un produit préemballé, l’aliment — autre que l’édulcorant ou l’agent édulcorant, notamment les sucres — qui remplace un agent édulcorant et qui possède une ou plusieurs des fonctions suivantes : édulcorant, épaississant, texturant ou caramélisant; (functional substitute for a sweetening agent) sucres désigne toutes les monosaccharides et les disaccharides; (sugars) supplément nutritif Aliment vendu ou présenté comme supplément à un régime alimentaire dont l’apport en énergie et en éléments nutritifs essentiels peut ne pas être suffisant. Est exclue de la présente définition la fortifiant pour lait humain; (nutritional supplement) surface exposée disponible Relativement à un produit préemballé, les surfaces suivantes : a) le dessous de tout emballage décoratif ou la totalité de la surface des deux côtés de toute étiquette mobile attachée à l’emballage décoratif, la plus grande surface étant à retenir; b) la totalité de la surface des deux côtés de toute étiquette mobile attachée à un emballage sauf lorsque une étiquette ne peut être apposée sur ce sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat; Table of Reference Amounts means the document entitled Nutrition Labelling — Table of Reference Amounts for Food published by the Government of Canada on its website, as amended from time to time; (Tableau des quantités de référence) weighted recommended nutrient intake, in respect of a vitamin or mineral nutrient set out in column I of Table II to Division 1 of Part D or in column I of Table II to Division 2 of Part D, means the amount set out in column III; (apport nutritionnel recommandé pondéré) (c) meets the requirements of section B.22.032; (œuf à jaune substitué) c) la totalité de la surface de tout autre emballage, à l’exclusion de son dessous si son contenu fuit ou est endommagé lorsque l’emballage est retourné. Sont toutefois exclus : d) toute surface de l’emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat; e) toute partie d’un emballage, autre que l’emballage d’un aliment destiné à être consommé par une personne en une seule fois, qui est occupée pour être détruite lors de l’ouverture de celui-ci; f) tout espace occupé par le code universel des produits; (available display surface) surétiquetage Quantité d’une vitamine ou d’un minéral nutritif ajoutée à un aliment, dans les limites des bonnes pratiques industrielles, en sus de la quantité déclarée sur l’étiquette, afin d’assurer le maintien de cette quantité jusqu’à la fin de sa conservation; (overage) symbole nutritionnel Symbole apposé sur l’espace principal d’un produit préemballé en application du paragraphe B.01.350(1); (nutrition symbol) tableau de la valeur nutritive Tableau que porte l’étiquette d’un produit préemballé conformément au paragraphe B.01.401(1); (nutrition facts table) Tableau des mentions et des allégations autorisées concernant la teneur nutritive Le document intitulé Étiquetage nutritionnel — Tableau des mentions et des allégations autorisées concernant la teneur nutritive, publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (Table of Permitted Nutrient Content Statements and Claims) Tableau des quantités de référence Le document intitulé Étiquetage nutritionnel — Tableau des quantités de référence pour aliments, publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (Table of Reference Amounts) tableau des renseignements sur les suppléments Tableau que porte l’étiquette d’un aliment supplément conformément au paragraphe B.29.002(1); (supplemented foods facts table) Tableau des valeurs quotidiennes Le document intitulé Étiquetage nutritionnel — Tableau des valeurs quotidiennes, publié par le gouvernement du Canada sur son PART B Foods DIVISION 1 Sections B.01.001-B.01.001.1 agricultural chemical has the same meaning as in subsection (1). (produit chimique agricole) Règlement sur les aliments et drogues

(4)

Subject to subsection (5), a statement or illustration that draws attention to the security feature of the security package referred to in subsection (2) shall be carried (b) if the security feature is a part of the outer package, on the outer label.

PARTIE B Aliments

(5)

Subsection (4) does not apply if the security feature of a security package is self-evident and is an integral part of the immediate product container. (a) a drug included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act; or Advertising A.01.067 A drug is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1 to the Act. A.01.068 A drug is exempt from subsection 3(2) of the Act with respect to its sale by a person where the drug is represented by label or is advertised by that person to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1 to the Act. General agricultural chemical means any substance that is used, or represented for use, on a food during its production, storage or transport, and whose use results, or may reasonably be expected to result, in a residue, component or derivative of that substance in or on a food and includes any pest control product as defined in subsection 2(1) of the Pest Control Products Act, plant growth regulator, fertilizer or any adjuvant or carrier used with that substance. This definition does not include any (a) food additive that is listed in, and used in accordance with, the tables to section B.16.100, (b) nutritive substance that is used, recognized or commonly sold as food or as an ingredient of food, (e) food packaging material or any substance of which that material is composed, or available display surface, in respect of a prepackaged product, means (a) the bottom of an ornamental container or the total surface area of both sides of a tag attached to the ornamental container, whichever is greater, (b) the total surface area of both sides of a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, and (c) the total surface area of any other package, excluding the bottom if the contents of the package leak out or are damaged when the package is turned over, but does not include (d) any area of a package on which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, (e) any part of a package that is intended to be destroyed when it is opened, other than a package of a food that is intended to be consumed by one person at a single eating occasion, or close proximity, in respect of information that is shown on a label or a sign, means immediately adjacent to that information and without any intervening printed, written or graphic material; (à proximité) common name means, with reference to a food, (a) the name of the food printed in boldface type, but not in italics, in a provision of these Regulations, (b) the name prescribed by any other regulation, or (c) if the name of the food is not so printed or prescribed, the name by which the food is generally known or a name that is not generic and that describes the food; (nom usuel) Common Names for Ingredients and Components Document means the document entitled Common component means an individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an ingredient; (constituant) Directory of NFT Formats means the document entitled Nutrition Labelling — Directory of Nutrition Facts Table Formats published by the Government of Canada on its website, as amended from time to time; (Répertoire des modèles de TVN) Directory of Nutrition Symbol Specifications means the document entitled Nutrition Labelling — Directory of Nutrition Symbol Specifications, published by the Government of Canada on its website, as amended from time to time; (Répertoire des spécifications des symboles nutritionnels) durable life means the period, commencing on the day on which a prepackaged product is packaged for retail sale, during which the product, when it is stored under conditions appropriate to that product, will retain, without any appreciable deterioration, its normal wholesomeness, palatability, nutritional value and any other qualities claimed for it by the manufacturer; (durée de conservation) durable life date means the date on which the durable life of a prepackaged product ends; (date limite de conservation) flavouring preparation includes any food for which a standard is provided in Division 10; (préparation aromatisante) food additive means any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food, but does not include (a) any nutritive material that is used, recognized or commonly sold as an article or ingredient of food; (b) vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16, (c) spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives; (e) food packaging materials and components thereof; and (f) drugs recommended for administration to animals that may be consumed as food; (additif alimentaire) food colour means any colouring agent that is referred to in section 2 of the Marketing Authorization for Food Additives That May Be Used as Colouring Agents; (colorant alimentaire) fully hydrogenated, in respect of a fat or oil, means a fat or oil that is hydrogenated and has an iodine value of 4 or less; (entièrement hydrogéné) functional substitute for a sweetening agent means, in respect of a prepackaged product, a food — other than any sweetener or sweetening agent, including any sugars — that replaces a sweetening agent and that has one or more of the functions of the sweetening agent including, sweetening, thickening, texturing or caramelizing; (substitut fonctionnel d’un agent édulcorant) ingredient means an individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an integral unit of food that is sold as a prepackaged product; (ingrédient) List of Contaminants and Other Adulterating Substances in Foods means the List of Contaminants and Other Adulterating Substances in Foods, published by the Department of Health on its website, as amended from time to time; (Liste de contaminants et d'autres substances adultérantes dans les aliments) main dish means a combination dish, as set out in the Table of Reference Amounts, that does not require the addition of ingredients, other than water, for its preparation and that contains food from at least two of the following categories: (a) dairy products and their alternatives, except butter, cream, sour cream, ice cream, ice milk, sherbet and alternatives for those foods; (b) meat products, poultry products, marine and fresh water animal products referred to in Division 21, and their alternatives such as eggs, tofu, legumes, nuts, seeds, nut or seed butters and spreads made from legumes; (c) fruits and vegetables except pickles, relishes, olives and garnishes; and meal replacement means a formulated food that, by itself, can replace one or more daily meals; (substitut de repas) meat product extender means a food that is a source of protein and that is represented as being for the purpose mechanically tenderized beef means uncooked solid cut beef that is prepared in either of the following ways: (a) the integrity of the surface of the beef is compromised by being pierced by blades, needles or other similar instruments; or nutritional supplement means a food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients. It does not include a human milk fortifier; (supplément nutritif) nutrition symbol means a symbol that is carried on the principal display panel of a prepackaged product under subsection B.01.350(1); (symbole nutritionnel) ornamental container means a container that, except on the bottom, does not have a promotional or advertising material thereon, other than a trademark or common name and that, because of any design appearing on its surface or because of its shape or texture, appears to be a decorative ornament and is sold as a decorative ornament in addition to being sold as the container of a product; (emballage décoratif) overage means the amount of a vitamin or mineral nutrient that is, within the limits of good manufacturing practice, added to a food in excess of the amount declared on the label, in order to ensure that the amount of the vitamin or mineral nutrient declared on the label is maintained throughout the durable life of the food; (sur-titrage) point means the unit of measurement for type size that is known as a PostScript point and is equal to 0.3527777778 mm; (point) poultry product extender means a food that is a source of protein and that is represented as being for the purpose of extending poultry products; (allongeur de produit de volaille) prepackaged meal means a prepackaged selection of foods for one individual that requires no preparation other than heating and that contains at least one serving, as described in Canada’s Food Guide to Healthy Eating, published in 1992 by the Department of Supply and Services by authority of the Minister of National Health and Welfare, of (a) meat, fish, poultry, legumes, nuts, seeds, eggs or milk or milk products other than butter, cream, sour cream, ice-cream, ice milk and sherbet; and prepackaged product means any food that is contained in a package in the manner in which it is ordinarily sold to or used or purchased by a person; (produit préemballé) principal display panel means, despite the meaning assigned to that term in section A.01.010, (a) in the case of a label that is applied to a consumer prepackaged food within the meaning of section 1 of the Safe Food for Canadians Regulations, the principal display panel as described in paragraphs (a) to (c) of the definition of that term in that section, (b) in the case of a label that is applied to a prepackaged product other than a consumer prepackaged food subject to the Safe Food for Canadians Regulations, the part of the label that is applied to all or part of any side or surface of the container that is displayed or visible under normal or customary conditions of sale or use and, if the container does not have such a side or surface, the part of the label that is applied to any part of the container except on the bottom, or (c) in the case of a label that is applied to a food that is not a prepackaged product, the part of the label that is applied to all or part of the side or surface of the food that is displayed or visible under normal or customary conditions of sale or use; (espace principal) principal display surface, in respect of a prepackaged product, means (a) if the package has a surface that is displayed or visible under customary conditions of sale or use, the total area of that surface, excluding any surface that is the top of the package, (b) if the package has a lid that is the part of the package that is displayed or visible under customary conditions of sale or use, the total area of the top surface of the lid, (c) if the package does not have a particular surface that is displayed or visible under customary conditions of sale or use, 40% of the total surface area of the package, excluding any surface area that is its top and bottom, if it is possible for that proportion of the total surface area to be displayed or visible under customary conditions of sale or use, (e) if the package is a bag with surfaces of different dimensions, the total area of one of the largest surfaces, (f) despite paragraphs (a) to (e), if the package does not have a surface that is displayed or visible under customary conditions of sale or use to which a label can be applied, the total area of one side of a tag that is attached to the package, (g) despite paragraphs (a) to (e), if the package contains wine that is exposed for sale, any part of the surface of the package, excluding its top and bottom, that can be seen without having to turn the package, and (h) if the package is a wrapper or confining band that is so narrow in relation to the size of the food that it cannot reasonably be considered to have any surface that is displayed or visible under customary conditions of sale or use, the total area of one side of a tag that is attached to the package; (principale surface exposée) reasonable daily intake, in respect of a food set out in Column I of an item of Schedule K, means the amount of that food set out in Column II of that item; (ration quotidienne raisonnable) simulated meat product means any food that does not contain any meat product, poultry product or fish product but that has the appearance of a meat product; (simili-produit de viande) simulated poultry product means any food that does not contain any poultry product, meat product or fish product but that has the appearance of a poultry product; (simili-produit de volaille) single-serving prepackaged product means a prepackaged product in respect of which the net quantity of food in the package is the serving of stated size for the food as set out in paragraph B.01.002A(1)(b); (produit préemballé à portion individuelle) sugars means all monosaccharides and disaccharides; (sucres) sugars-based ingredient means, in respect of a prepackaged product, (a) an ingredient that is a monosaccharide or disaccharide or a combination of these; (b) an ingredient that is a sweetening agent other than one referred to in paragraph (a); and (c) any other ingredient that contains one or more sugars and that is added to the product as a functional substitute for a sweetening agent; (ingrédient à base de sucres) supplemental ingredient means a nutrient — including a vitamin, mineral nutrient or amino acid — or any other substance listed in column 1 of the List of Permitted Supplemental Ingredients and added as an ingredient to a food in accordance with the applicable conditions of use set out in columns 2 to 5; (ingrédient supplémentaire) supplemented food means a prepackaged product that belongs to a food category set out in column 1 of the List of Permitted Supplemented Food Categories and to which a supplemental ingredient has been added, but does not include (a) a food for special dietary use as defined in section B.24.001 and referred to in any of paragraphs B.24.003(1)(f) to (f.2) and (h) to (j), even if the food for special dietary use is also a gluten-free food referred to in paragraph B.24.003(1)(g); (b) a food that is labelled or advertised for consumption by (i) infants as defined in section B.25.001, (ii) children one year of age or older but less than four years of age, or (iii) women who are pregnant or breastfeeding; (c) any of the following foods set out in column I of the Table to section D.03.002: (i) a food referred to in any of items 1, 2.1, 2.2, 4, 5, 7, 8, 9.1, 10 to 13, 15, 17 to 19, 21 to 25 and 27, and (d) a food that has not been processed or that has been minimally processed; or sweetener means any sweetener that is referred to in section 2 of the Marketing Authorization for Food Additives That May Be Used as Sweeteners; (édulcorant) sweetening agent includes any food for which a standard is provided in Division 18, but does not include those food additives listed in the tables to Division 16; (agent édulcorant) Table of Daily Values means the document entitled Nutrition Labelling — Table of Daily Values published by the Government of Canada on its website, as amended from time to time; (Tableau des valeurs quotidiennes) Table of Permitted Nutrient Content Statements and Claims means the document entitled Nutrition Labelling — Table of Permitted Nutrient Content Statements and Claims, published by the Government of Canada on its website, as amended from time to time; (Tableau des mentions et des allégations autorisées concernant la teneur nutritive) trans fatty acids, trans fat or trans means unsaturated fatty acids that contain one or more isolated or non-conjugated double bonds in a trans-configuration; (acides gras trans, graisses trans, gras trans, lipides trans ou trans) unstandardized food means any food for which a standard is not prescribed in this Part; (aliment non normalisé) yolk-replaced egg means a food that (a) does not contain egg yolk but contains fluid, dried or frozen egg albumen or mixtures thereof, (b) is intended as a substitute for whole egg, and Food and Drug Regulations General

TITRE 1

Dispositions générales

(2)

The definitions in this subsection apply for the purposes of the Act. food additive has the same meaning as in subsection (1). (additif alimentaire)

Articles B.01.001-B.01.001.1

(3)

The following definitions apply in this Division. human milk fortifier has the same meaning as in section B.25.001. (fortifiant pour lait humain) human milk substitute has the same meaning as in section B.25.001. (succédané de lait humain)

(2)

Les termes ci-après sont définis comme il suit pour l’application de la Loi. additif alimentaire S’entend au sens du paragraphe (1). (food additive) produit chimique agricole S’entend au sens du paragraphe (1). (agricultural chemical)

(4)

For the purposes of the definitions supplemental ingredient and supplemented food in subsection (1), if a supplemented food is used as an ingredient in the manufacture of a second supplemented food, a supplemental ingredient in the first supplemented food is deemed to also have been added as a supplemental ingredient to — and not to be a component of an ingredient of — the second supplemented food if it is contained in the second supplemented food in accordance with the applicable conditions of use set out in columns 2 to 5 of the List of Permitted Supplemental Ingredients. B.01.001.1 (1) For the purpose of subsection (2), the term fat used in the Table of Daily Values means all fatty acids expressed as triglycerides.

(3)

Les définitions qui suivent s’appliquent au présent titre. fortifiant pour lait humain S’entend au sens de l’article B.25.001. (human milk fortifier) succédané de lait humain S’entend au sens de l’article B.25.001. (human milk substitute)

(2)

The daily value for a nutrient in a food is (i) set out in column 2, if the food is intended solely for children one year of age or older but less than four years of age, and (ii) set out in column 3, if the food is intended for children one year of age or older but less than four years of age or for children four years of age or older and adults; and (i) set out in column 2, if the food is intended solely for infants six months of age or older but less than one year of age, (ii) set out in column 3, if the food is intended for infants six months of age or older but less than one year of age or for children one year of age or older but less than four years of age, and (iii) set out in column 4, in any other case.

(4)

Pour l’application des définitions de aliment supplémenté et ingrédient supplémentaire, au paragraphe (1), l’ingrédient supplémentaire d’un aliment supplémenté qui est utilisé comme ingrédient dans la fabrication d’un autre aliment supplémenté est réputé également avoir été ajouté à cet autre aliment supplémenté à titre d’ingrédient supplémentaire et ne pas être un constituant d’un ingrédient de cet autre aliment supplémenté, s’il est contenu dans cet autre aliment supplémenté conformément aux conditions d’utilisation applicables prévues aux colonnes 2 à 5 de la Liste des ingrédients supplémentaires autorisés. B.01.001.1 (1) Pour l’application du paragraphe (2), le terme lipides utilisé dans le Tableau des valeurs quotidiennes s’entend de tous les acides gras exprimés sous forme de triglycérides.

(3)

Subsection (2) does not apply if the food is (b) a human milk substitute intended solely for infants less than six months of age. B.01.002 Each provision in this Part in which the symbol [S] appears between the provision number and the name of the food described in that provision prescribes the standard of composition, strength, potency, purity, quality or other property of that food and a provision in which the symbol does not appear does not prescribe a standard for a food. B.01.002A (1) For the purposes of this Part, a serving of stated size of a food shall be (a) based on the food as offered for sale; (b) in either of the following cases, the net quantity of the food in the package: (i) if the quantity of food in the package can reasonably be consumed by one person at a single eating occasion, or (ii) if the package contains less than 200% of the reference amount for the food; and (c) in all other cases, the amount indicated for the food according to the criteria set out in column 3A of the Table of Reference Amounts.

(2)

La valeur quotidienne d’un élément nutritif contenu dans un aliment est (a) in the case of a nutrient set out in column 1 of Part 1 of the Table of Daily Values, the quantity (b) in the case of a vitamin or mineral nutrient set out in column 1 of Part 2 of the Table of Daily Values, the quantity (a) a human milk fortifier; or SOR/2003-11, s. 2; SOR/2016-305, s. 2; SOR/2021-57, s. 2. SOR/79-752, s. 1. a) s’agissant d’un élément nutritif mentionné à la colonne 1 de la partie 1 du Tableau des valeurs quotidiennes, la quantité qui figure : (i) à la colonne 2, dans le cas d’un aliment destiné exclusivement aux enfants âgés d’au moins un an mais de moins de quatre ans, (ii) à la colonne 3, dans le cas d’un aliment destiné aux enfants âgés d’au moins un an mais de moins de quatre ans ou aux enfants âgés d’au moins quatre ans et aux adultes; b) s’agissant d’une vitamine ou d’un minéral nutritif mentionné à la colonne 1 de la partie 2 du Tableau des valeurs quotidiennes, la quantité de cette vitamine ou de ce minéral nutritif qui figure : (i) à la colonne 2, dans le cas d’un aliment destiné exclusivement aux bébés âgés d’au moins six mois mais de moins d’un an, (ii) à la colonne 3, dans le cas d’un aliment destiné aux bébés âgés d’au moins six mois mais de moins d’un an ou aux enfants âgés d’au moins un an mais de moins de quatre ans, (iii) à la colonne 4, dans les autres cas.

(2)

A serving of stated size of a food shall be expressed as follows: (a) in the case of a single-serving prepackaged product to which paragraph (1)(b) applies, per package and using the following units: (i) in grams, if the net quantity of the food is shown on the label by weight or by count, and (ii) in millilitres, if the net quantity of the food is shown on the label by volume; and (b) in the case of a multiple-serving prepackaged product to which paragraph (1)(c) applies, according to the following units set out in column 3B of the Table of Reference Amounts and according to the manner set out in that column: (i) the household measure that applies to the product, and (ii) the metric measure that applies to the product. (a) all prepackaged products other than (i) prepackaged confections, commonly known as one bite confections, that are sold individually, and (ii) prepackaged products consisting of fresh fruits or fresh vegetables that are packaged in a wrapper or confining band of less than 1/2 inch in width; (b) meat and meat by-products that are barbecued, roasted or broiled on the retail premises; (c) poultry, poultry meat or poultry meat by-products that are barbecued, roasted or broiled on the retail premises; (e) any substance or mixture of substances for use as a food additive or food additive preparation; and (f) flour and whole wheat flour that has been treated with gamma radiation from Cobalt 60 Source. (a) in the case of a prepackaged product, to the container in which the prepackaged product is sold; and (b) in the case of a food that is not a prepackaged product, to the food itself.

(3)

Le paragraphe (2) ne s’applique pas si l’aliment est : a) soit un fortifiant pour lait humain; b) soit un succédané de lait humain destiné exclusivement aux bébés âgés de moins de six mois. DORS/2003-11, art. 2; DORS/2016-305, art. 2; DORS/2021-57, art. 2. B.01.002 Dans la présente partie, la présence du symbole [N] entre le numéro d’une disposition et le nom de l’aliment visé indique que la disposition prescrit une norme de composition, d’activité, de pureté, de qualité ou toute autre propriété observable de cet aliment; l’absence de ce symbole indique qu’aucune norme n’est prescrite à l’égard de l’aliment visé. DORS/79-752, art. 1. B.01.002A (1) Pour l’application de la présente partie, la portion indiquée d’un aliment est : a) établie en fonction de l’aliment tel qu’il est vendu; b) dans l’un ou l’autre des cas ci-après, la quantité nette de l’aliment dans l’emballage lorsque : (i) cette quantité peut être raisonnablement consommée par une personne en une seule fois, SOR/88-559, s. 2; SOR/2003-11, s. 3; SOR/2016-305, s. 3. B.01.003 (1) The following foods shall carry a label when offered for sale: (d) horse-meat or horse-meat by-product;

(2)

The label shall be applied in such a manner that the container of the prepackaged product or the food, as the case may be, will bear the label at the time it is sold. B.01.005 (1) Subject to subsections (2) to (5), the information required to be shown on a label shall not be shown on that part of the label, if any, that is applied to the bottom of a food or container.

(2)

[Repealed, SOR/79-23, s. 2] SOR/79-23, s. 2. B.01.004 (1) All or part of the label referred to in section B.01.003 shall be applied SOR/84-300, s. 3. B.01.006 (1) The common name of the food shall be shown on the principal display panel. B.01.007 (1) In this section, packaging date means

(2)

The information required to be shown on a label may be shown on that part of the label, if any, that is applied to the bottom of a food or to the bottom of a container if such information is also shown in those parts of the label that are not applied to the bottom of the food or container.

(3)

Paragraphs (1.1)(b) and (c) do not apply to (a) prepackaged products consisting of fresh fruits or fresh vegetables; (d) prepackaged donuts. (a) the words “best before” and “meilleur avant” shall be shown grouped together with the durable life date unless a clear explanation of the significance of the durable life date appears elsewhere on the label; b) dans le cas où le produit préemballé a une durée de conservation de 90 jours ou moins et est emballé ailleurs que sur les lieux de vente au détail où il sera vendu : (i) la date limite de conservation, (ii) le mode d’entreposage du produit préemballé, s’il requiert des conditions d’entreposage différentes des conditions ambiantes normales; c) dans le cas où le produit préemballé a une durée de conservation de 90 jours ou moins et est emballé sur les lieux de vente au détail où il sera vendu : (i) la date d’emballage, (ii) la durée de conservation de l’aliment, sauf si elle est affichée près de l’aliment. (1.2) La date d’emballage visée à l’alinéa (1.1)c) doit répondre aux exigences des paragraphes (4) et (5) sauf en ce qui concerne les expressions « best before » et « meilleur avant » qui doivent être remplacées par celles de « packaged on » et « empaqueté le ».

(3)

Despite subsection (2), if the container of a prepackaged product is an ornamental container and the label is applied to the bottom of the container, the information required to be shown may be shown on the label that is applied to the bottom of the container.

(2)

L’alinéa (1.1)a) ne s’applique pas aux fruits ou légumes frais qui sont sur les lieux de vente au détail, sont préemballés de façon à être visibles et identifiables dans l’emballage.

(4)

Despite subsection (2), the information required by subparagraph B.01.007(1.1)(b)(i) and paragraphs B.24.103(g), B.24.202(d), B.24.304(h), B.25.020(1)(h) and B.25.057(1)(f) and (2)(f) may be shown on that part of the label that is applied to the bottom of the package if a reference to where that information is located on the label appears elsewhere on the label. (4.1) Despite subsection (2), the information required by paragraph B.27.005(a) may be shown on that part of the label that is applied to the bottom of the package.

(3)

Les alinéas (1.1)b) et c) ne s’appliquent pas : a) aux produits préemballés qui sont des fruits ou légumes frais préemballés; b) aux portions individuelles préemballées d’aliments qui sont servies avec des repas ou des casse-croûte par un restaurant ou une entreprise commerciale; c) aux portions individuelles préemballées d’aliments qui sont préparées dans un dépôt et vendues au moyen de distributeurs automatiques ou d’une cantine mobile; d) aux beignets préemballés.

(5)

Despite subsection (2), the nutrition facts table, supplemented food facts table and list of cautionary statements may be shown on that part of the label that is applied to the bottom of the food or container if the available display surface includes the bottom.

(4)

La date limite de conservation doit être indiquée de la manière suivante : a) les mots « meilleur avant » et « best before » doivent être regroupés avec la date limite de conservation à moins que cette date ne soit clairement expliquée ailleurs sur l’étiquette; (d) the day of the month shall be shown after the month and shall be expressed in numbers. JA for JANUARY FE for FEBRUARY MR for MARCH DE for DECEMBER SOR/79-23, s. 4; SOR/79-529, s. 2; SOR/88-291, s. 1; SOR/92-626, s. 6. B.01.008 (1) The following information shall be shown grouped together on any part of the label: (i) the information required to appear on the principal display panel, nutrition facts table or supplemented food facts table, (ii) the information required by subsection B.01.005(4), sections B.01.007, B.01.301, B.01.305, B.01.311, B.01.503, B.01.513 and B.01.601, paragraphs B.24.103(g), B.24.202(d), B.24.304(h), B.25.020(1)(e), (f) and (h), B.25.057(1)(f) and (2)(f), B.27.005(a) and sections B.29.020 and B.29.026, and (d) prepackaged meat and meat by-products that are barbecued, roasted or broiled on the retail premises; a) les renseignements exigés par le présent règlement, autres que : (i) ceux qui doivent figurer sur l’espace principal, dans le tableau de la valeur nutritive ou dans le tableau des renseignements sur les aliments supplémentés, (ii) ceux exigés par le paragraphe B.01.005(4), les articles B.01.007, B.01.301, B.01.305, B.01.311, B.01.503, B.01.513 et B.01.601, les alinéas B.24.103g), B.24.202d), B.24.304h), B.25.020(1)e), f) et h), B.25.057(1)f) et (2)f) et B.27.005a) et les articles B.29.020 et B.29.026, (iii) les mentions devant figurer sur l’étiquette d’un aliment supplémenté conformément à la colonne 5 de la Liste des ingrédients supplémentaires autorisés; b) lorsqu’un produit préemballé se compose de plus d’un ingrédient, une liste de tous les ingrédients, y compris, sous réserve de l’article B.01.009, les constituants, le cas échéant.

(2)

Notwithstanding subsection (1), the common name of a fresh fruit or fresh vegetable that is prepackaged in such a manner that the fruit or vegetable is visible and identifiable in the package is not required to be shown on the label. B.01.006.1 Except as otherwise provided in these Regulations or in the Safe Food for Canadians Regulations, if a prepackaged product is likely to be mistaken for another food, words describing the true nature of the prepackaged product so as to distinguish it from the other food shall appear on the principal display panel and may be in regard to (a) its type of liquid packaging medium, including brine, vegetable oil or syrup; (b) its style or form, including firm, extra firm, whole, sliced or diced; and (c) its condition, including dried, concentrated, reconstituted, carbonated or smoked, which, if shown, shall form part of the common name. (a) the date on which a food is placed for the first time in a package in which it will be offered for sale to a consumer; or (b) the date on which a prepackaged product is weighed by a retailer in a package in which it will be offered for sale for the first time to a consumer. (1.1) The following information shall be shown on any part of the label: (a) the identity and principal place of business of the person by or for whom the food was manufactured or produced; (b) where a prepackaged product having a durable life of 90 days or less is packaged at a place other than the retail premises from which it is to be sold, (i) the durable life date, and (ii) instructions for the proper storage of the prepackaged product if it requires storage conditions that differ from normal room temperature; and (c) where a prepackaged product having a durable life of 90 days or less is packaged on the retail premises from which it is to be sold, (i) the packaging date, and (ii) the durable life of the food, except when the durable life appears on a poster next to the food. (1.2) The packaging date referred to in paragraph (1.1)(c) shall be shown in the form and manner prescribed for the durable life date by subsections (4) and (5) and the terms “best before” and “meilleur avant” on the label shall be replaced by the terms “packaged on” and “empaqueté le”.

(2)

L’alinéa (1)b) ne s’applique pas a) aux produits préemballés, sauf les noix assorties, dont l’emballage se fait sur les lieux de vente au détail à partir du produit en vrac; b) aux portions individuelles préemballées d’aliment, destinées uniquement à être servies par un restaurant ou une autre entreprise commerciale avec les repas ou casse-croûte; c) aux portions individuelles préemballées d’aliment, préparées dans un dépôt de vivres et vendues au moyen de distributeurs automatiques ou d’une cantine mobile; d) aux viandes et sous-produits de la viande préemballés, cuits à la broche, rôtis ou grillés sur les lieux de la vente au détail; e) aux volailles, viandes de volaille, ou sous-produits de la viande de volaille préemballés, cuits à la broche, rôtis ou grillés sur les lieux de la vente au détail; f) au bourbon et aux produits préemballés régis par les normes de composition énoncées au titre 2; g) aux produits préemballés régis par les normes de composition du titre 19. (d) components of ingredients of a sandwich, if the sandwich is made with bread; and

(2)

Paragraph (1.1)(a) does not apply to fresh fruits or fresh vegetables that are prepackaged on retail premises in such a manner that the fruits or vegetables are visible and identifiable in the package. (b) prepackaged individual portions of food that are served by a restaurant or other commercial enterprise with meals or snacks; (c) prepackaged individual servings of food that are prepared by a commissary and sold by automatic vending machines or mobile canteens; or

(4)

to (10) [Repealed, SOR/2016-305, s. 4] SOR/2013-65, s. 5; SOR/85-593, s. 3; SOR/92-626, s. 7; SOR/93-145, s. 1; SOR/2003-11, s. 5; SOR/2012-43, s. 1; SOR/2016-305, s. 4; SOR/2022-143, s. 4; SOR/2022-143, s. 5; SOR/2022-169, s. 3. B.01.008.1 (1) Information appearing on the label of a prepackaged product according to sections B.01.008.2 to B.01.014, B.01.014.01 and B.29.020 shall be shown (d) in regular type, except as otherwise provided in those sections; and SOR/2016-305, s. 5; SOR/2022-168, s. 2; SOR/2022-169, s. 4. (a) consist of the term (i) “Ingredients”, “Ingredients:” or “Ingredients :” in the English version of the list, and (ii) “Ingrédients”, “Ingrédients:” or “Ingrédients :” in the French version of the list; (ii) a declaration referred to in subsection B.01.010.4(1), (iii) any statement referred to in subsection B.01.014(1), (iv) a nutrition facts table, (v) a supplemented food facts table, or (vi) a list of cautionary statements.

(4)

The durable life date shall be shown in the following manner: (b) where, for the sake of clarity, it is necessary to show the year in which the durable life date occurs, the year shall be shown first and shall be expressed by at least the last two numbers of the year; (c) the month shall be shown in words after the year, if the year is shown, and may be abbreviated as prescribed by subsection (5); and

(3)

In a list of ingredients, ingredients shall be shown

(5)

The month of the durable life date, when abbreviated, shall be abbreviated as follows and only one such abbreviation shall be used for the English language and the French language: AL for APRIL MA for MAY JN for JUNE JL for JULY AU for AUGUST SE for SEPTEMBER OC for OCTOBER NO for NOVEMBER

(4)

Despite paragraph (3)(a), the following ingredients may be shown at the end of the list of ingredients, in any order: (b) natural flavours and artificial flavours; (c) flavour enhancers; (d) food additives, except ingredients of food additive preparations or mixtures of substances for use as a food additive; (e) vitamins; (f) salts or derivatives of vitamins; (g) mineral nutrients; (h) salts of mineral nutrients; and (i) supplemental ingredients.

(6)

Except as otherwise provided in these Regulations, no person shall use a durable life date marking system on the label of a prepackaged product or in advertising a prepackaged product other than the marking system set out in this section.

(5)

In a list of ingredients, the components of an ingredient shall be shown (d) separated by a comma.

(7)

Paragraph (1.1)(b) does not apply to prepackaged fresh yeast, if (a) the date on which it is estimated that the product has lost its effectiveness is shown on the label in the form and manner prescribed for the durable life date by subsections (4) and (5); and (b) the terms “best before” and “meilleur avant” are replaced by the terms “use by” and “employez avant”. (a) any information required by these Regulations, other than: (iii) any statement required to be shown on the label of a supplemented food in accordance with column 5 of the List of Permitted Supplemental Ingredients; and (b) where a prepackaged product consists of more than one ingredient, a list of all ingredients, including, subject to section B.01.009, components, if any.

(7)

In a list of ingredients, the source of a food allergen or gluten shall be shown

(2)

Paragraph (1)(b) does not apply to (a) prepackaged products packaged from bulk on retail premises, except prepackaged products that are a mixture of nuts; (b) prepackaged individual portions of food that are intended solely to be served by a restaurant or other commercial enterprise with meals or snacks; (c) prepackaged individual servings of food that are prepared by a commissary and sold by automatic vending machines or mobile canteens; (e) prepackaged poultry, poultry meat or poultry meat by-products that are barbecued, roasted or broiled on the retail premises; (f) Bourbon whisky and prepackaged products subject to compositional standards in Division 2; or (g) prepackaged products subject to compositional standards in Division 19.

(8)

If the English and French versions of a list of ingredients appear on the label, they shall be displayed on a continuous surface of the available display surface, but need not be on the same continuous surface of the available display surface. auquel cas les constituants de l’ingrédient figurent plutôt immédiatement après cette source; b) dans l’ordre décroissant de leurs proportions respectives, en poids, dans l’ingrédient avant qu’ils ne soient combinés pour former celui-ci; c) en lettres minuscules, sauf dans les cas ci-après où des lettres majuscules sont utilisées : (i) s’il s’agit d’un additif alimentaire ou d’un ingrédient supplémentaire indiqué — en tout ou en partie — par son acronyme, la totalité de l’acronyme, (ii) le descripteur alphabétique utilisé dans le nom usuel d’un additif alimentaire, d’une vitamine, d’un ingrédient supplémentaire ou d’un microorganisme; d) séparés entre eux par une virgule.

(3)

Despite paragraph (1)(b), the following items are not required to be shown on the label of a prepackaged product: (a) wax coating compounds and their components, used as an ingredient or component of prepackaged fresh fruit or vegetables; (b) sausage casings, used as an ingredient or component of prepackaged sausages; (c) hydrogen, used as an ingredient or component of a prepackaged product if used for hydrogenation purposes; (e) added water used as an ingredient that has been removed during the manufacture of the prepackaged product. (a) in a single colour of type that is a visual equivalent of 100% solid black type on a white background or a uniform neutral background with a maximum 5% tint of colour; (b) in a single standard sans serif font that is not decorative and in a manner that the characters never touch each other or any differentiating feature under subsection B.01.008.2(2); (c) in type of normal or condensed width that is not scaled down so that the characters take up less space horizontally and, if a nutrition facts table or supplemented food facts table appears on the label, the width of type must be the same as that required for the type used to show the nutrients that appear in the nutrition facts table or the supplemental ingredients that appear in the supplemented food facts table, as the case may be; (e) in type that is the same height that is not less than 1.1 mm with identical leading of not less than 2.5 mm, except as otherwise provided in this section or those sections.

(6)

Malgré l’alinéa B.01.008(1)b) et les alinéas (5)a) et b) et sous réserve de l’article B.01.009, dans les cas où le présent règlement exige l’indication d’un ou de plusieurs constituants d’un ingrédient dans la liste des ingrédients, le nom de cet ingrédient n’a pas à être inclus dans la liste si tous ses constituants y figurent sous leur nom usuel et y figurent conformément au paragraphe (3) comme s’ils étaient des ingrédients.

(2)

Despite paragraph (1)(a), a list of ingredients appearing on the label of the following prepackaged products is not required to be shown on a white background or a uniform neutral background with a maximum 5% tint of colour: (a) a prepackaged product that is intended solely for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or an institution; and (b) a prepackaged product that is a ready-to-serve multiple-serving prepackaged product intended solely to be served in a commercial or industrial enterprise or an institution.

(7)

Dans le cas où une source d’allergène alimentaire ou de gluten figure à la liste des ingrédients, la source figure : a) immédiatement à la suite de l’ingrédient ou du constituant dont elle indique la source, conformément aux paragraphes B.01.010.1(8) et (10); b) en lettres minuscules uniquement; c) séparée par une virgule de toute autre source d’allergène alimentaire ou de gluten figurant pour un même ingrédient ou constituant.

(3)

Except as otherwise provided in subsection (4) and sections B.01.008.2 to B.01.010.4, if a nutrition facts table or supplemented food facts table appears on the label of a prepackaged product and the type size of the nutrients shown in the nutrition facts table or the supplemental ingredients shown in the supplemented food facts table is not less than 8 points, the information referred to in subsection (1) must be shown in type that is (a) the same height as the type in which the nutrients are shown in the nutrition facts table or the supplemental ingredients are shown in the supplemented food facts table, as the case may be; and (b) of a height that is not less than 1.4 mm with identical leading of not less than 3.2 mm.

(8)

Lorsque les versions française et anglaise de la liste des ingrédients figurent sur l’étiquette, elles sont présentées sur un espace continu de la surface exposée disponible, mais n’ont pas à être présentées sur le même.

(4)

A title that introduces a list of ingredients, a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1), a declaration referred to in subsection B.01.010.4(1) or a list of cautionary statements may be shown in type that is of a greater height than the type used to show the information in either the lists, the statement or the declaration, as the case may be.

(9)

Lorsque les versions anglaise et française de la liste des ingrédients sont présentées sur un même espace continu de l’étiquette, celle des versions qui suit l’autre

(5)

If more than one of the titles referred to in subsection (4) appears on a label, the characters of each title must be of the same height.

(2)

The term “Sugars” referred to in subsection (1) shall be shown in the list of ingredients (a) despite paragraph B.01.008.2(3)(b), entirely in lower case letters; and (a) a sweetening agent; SOR/2016-305, s. 6; SOR/2021-57, s. 5; SOR/2022-143, s. 7; SOR/2022-197, s. 4. B.01.009 (1) Components of ingredients or of classes of ingredients set out in the following table are not required to be shown on a label: TABLE Item Ingredient 1 butter 2 margarine 3 shortening 4 lard 6 monoglycerides 7 diglycerides 9 starches or modified starches 11 flour 12 soy flour 13 graham flour 14 whole wheat flour 15 baking powder 16 milks subject to compositional standards in sections B.08.003 to B.08.027 17 chewing gum base 18 sweetening agents subject to compositional standards in sections B.18.001 to B.18.018 19 cocoa, low-fat cocoa 20 salt Item Ingredient 21 vinegars subject to compositional standards in sections B.19.003 to B.19.007 22 Bourbon whisky and alcoholic beverages subject to compositional standards in sections B.02.001 to B.02.134 35 gelatin TABLE Item Preparation/Mixture 1 food colour preparations 2 flavouring preparations 3 artificial flavouring preparations 6 vitamin preparations 7 mineral preparations 9 rennet preparations (a) salt; (d) aspartame; (e) potassium chloride; (g) any supplemental ingredient. (a) peanut oil;

(6)

For the purpose of this section, the height of type means the height of the lower case letter “x”. B.01.008.2 (1) A list of ingredients shall be introduced by a title that shall (b) be shown in bold type; and (c) be shown without any intervening printed, written or graphic material appearing between the title and the first ingredient shown in the list.

(3)

For the purposes of subsection (2),

(2)

A list of ingredients shall be shown in a manner that clearly differentiates it on the label, by means of one or both of (a) graphics in the form of a solid-line border around the list or one or more solid lines appearing immediately above, below or at the sides of the list that are the same colour as that of the type used to show the information referred to in subsection B.01.008.1(1); and (b) a background colour that creates a contrast between the background colour of the list and the background colour used on the adjacent surface of the label, other than the surface used to display (i) a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1), (a) in descending order of their proportion by weight of the prepackaged product, determined before they are combined to form the prepackaged product; (b) in lower case letters, except that upper case letters shall be used to show (i) the first letter of each ingredient or, in the case of a food additive or supplemental ingredient shown in whole or in part by an acronym, the entire acronym, (ii) the alpha-descriptor that forms a part of the common name for a food additive, vitamin, supplemental ingredient or microorganism; and (c) separated by a bullet point or a comma. (a) spices, herbs and other seasonings, other than salt added separately, if the total weight of those other seasonings is no more than two per cent of the total weight of ingredients used in the manufacture of the prepackaged product excluding added water used as an ingredient that has been removed during its manufacture; (a) in parentheses, immediately after the ingredient, unless the source of a food allergen or gluten is shown immediately after the ingredient, in which case components of the ingredient shall be shown immediately after that source; (b) in descending order of their proportion by weight of the ingredient, determined before the components are combined to form the ingredient; (c) in lower case letters, except that upper case letters shall be used to show (i) in the case of a food additive or supplemental ingredient shown in whole or in part by an acronym, the entire acronym, and (ii) the alpha-descriptor that forms a part of the common name for a food additive, vitamin, supplemental ingredient or microorganism; and

(4)

Despite subsection (2) and subsection B.01.008.2(5), if a food contains ingredients of the same class, those ingredients may be shown by a class name if B.01.010.1 (1) The following definitions apply in this section and in sections B.01.010.2 to B.01.010.4. (a) almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios or walnuts; (b) peanuts; (c) sesame seeds; (d) wheat or triticale; (e) eggs; (f) milk; (g) soybeans; (h) crustaceans; (i) molluscs; (j) fish; or (k) mustard seeds. (allergen alimentaire) food allergen source, gluten source and added sulphites statement means a statement appearing on the label of a prepackaged product that indicates the source of a food allergen or gluten that is present in the product or the presence in the product of added sulphites in a total amount of 10 p.p.m. or more. (mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés) (i) barley, (ii) oats, (iii) rye, (iv) triticale, (v) wheat; or height, in respect of type, means the height of the lower case letter “x”. (hauteur) mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés Toute mention figurant sur l’étiquette d’un produit préemballé qui indique les sources d’allergènes alimentaires ou de gluten présents dans le produit et les sulfites qui y sont ajoutés et présents dans une quantité totale égale ou supérieure à 10 p.p.m. (food allergen source, gluten source and added sulphites statement) (a) the list of ingredients; or

(6)

Despite paragraph B.01.008(1)(b) and paragraphs (5)(a) and (b), but subject to section B.01.009, if one or more components of an ingredient are required by these Regulations to be shown in a list of ingredients, the ingredient is not required to be shown in the list if all components of the ingredient are shown in the list by their common names and in accordance with subsection (3) as if they were ingredients. (a) immediately after the ingredient or component to which it applies in accordance with subsections B.01.010.1(8) and (10); (b) entirely in lower case letters; and (c) separated by a comma from any other source of a food allergen or gluten that is shown for the same ingredient or component.

(5)

[Repealed, SOR/2019-98, s. 1] (a) in the list of ingredients

(9)

If the English and French versions of a list of ingredients appear on the same continuous surface of the label, the version that follows the other version shall not begin on the same line as that on which the other version ends, B.01.008.3 (1) If a prepackaged product contains one or more sugars-based ingredients, despite the order of presentation referred to in paragraph B.01.008.2(3)(a), the sugars-based ingredient or ingredients shall be shown in the list of ingredients, in parentheses, immediately following the term (a) “Sugars” in the English version of the list; and (b) “Sucres” in the French version of the list. (a) in descending order of the proportion by weight of all the sugars-based ingredients in the prepackaged product, before they are combined to form the product; and (b) separated from other ingredients by a bullet point or a comma.

(11)

For greater certainty, nothing in subsection (8) affects how an ingredient or component may be shown in the list of ingredients under paragraph B.01.010(3)(b). SOR/2012-28, s. 4; SOR/2016-305, ss. 7, 72; SOR/2019-98, s. 1; SOR/2021-46, s. 4E; SOR/2022-143, s. 16; SOR/2022-168, s. 5. (a) the list of ingredients; or

(3)

Each sugars-based ingredient mentioned immediately following the term “Sugars” shall be shown, (b) in the case of more than one sugars-based ingredient, (i) in descending order of its proportion by weight of the prepackaged product as prescribed by subsection B.01.008.2(3), and (ii) separated by a comma.

(5)

[Repealed, SOR/2019-98, s. 2] (a) if the sulphites are shown in the list of ingredients, constitutant, selon le cas, si elle figure à l’un ou l’autre des endroits suivants : a) dans la liste des ingrédients : (i) soit comme partie du nom usuel de l’ingrédient ou du constituant, (ii) soit entre parenthèses, immédiatement à la suite d’un autre ingrédient ou constituant, conformément au paragraphe (8); b) sous la mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés.

(4)

Subsections (1) to (3) do not apply to the following prepackaged products: (b) fruit or vegetable juice or vegetable drink that does not contain any sweetening agent, as well as any mixture of those juices and drinks, including any of those juices and drinks (i) to which fruit or vegetable purée or any mixture of those purées has been added, (ii) that are reconstituted, or (iii) that are a concentrate intended for dilution and consumption as juice or drink; (c) fruit or vegetable purée that does not contain any sweetening agent as well as any mixture of those purées; (d) prepackaged products that contain only one sugars-based ingredient that contains the word “sugar” in its common name; (e) formulated liquid diets, human milk fortifiers and human milk substitutes; and (f) prepackaged products that contain less than 0.5 g of sugars per serving of stated size.

(11)

Il est entendu que le paragraphe (8) est sans effet sur la façon dont les ingrédients ou constituants peuvent être indiqués dans la liste des ingrédients en vertu de l’alinéa B.01.010(3)b). DORS/2012-28, art. 4; DORS/2016-305, art. 7, 72; DORS/2019-98, art. 1; DORS/2021-46, art. 4D; DORS/2022-143, art. 16; DORS/2022-168, art. 5. B.01.010.2 (1) Au présent article et à l’article B.01.010.3, sulfites s’entend des additifs alimentaires mentionnés dans le document sur les noms usuels d’ingrédients et de constituants et qui sont présents dans un produit préemballé.

5 leaf lard

(2)

Il est entendu que la définition de sulfites au paragraphe (1) ne vise que les sulfites dont la présence dans le produit préemballé est le résultat de leur ajout à celui-ci.

8 rice

(3)

Si des sulfites sont présents dans un produit préemballé en une quantité totale égale ou supérieure à 10 parties par million et qu’aucun n’a à être indiqué dans la liste des ingrédients en application des articles B.01.008 ou B.01.009, ils figurent sur l’étiquette du produit : a) soit dans la liste des ingrédients; b) soit sous la mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés, auquel cas les exigences du paragraphe B.01.010.3(1) doivent être respectées.

10 breads subject to compositional standards in sections B.13.021 to B.13.029

(4)

Le paragraphe (3) ne s’applique pas aux sulfites présents dans les produits préemballés visés aux alinéas B.01.008(2)a) à e), sauf si l’étiquette de ces produits porte une liste des ingrédients.

23 cheese for which a standard is prescribed in Division 8, if the total amount of cheese in a prepackaged product is less than 10 per cent of that packaged product

(5)

[Abrogé, DORS/2019-98, art. 2]

24 jams, marmalades and jellies subject to compositional standards in sections B.11.201 to B.11.241 when the total amount of those ingredients is less than 5 per cent of a prepackaged product

(6)

Les sulfites devant figurer sur l’étiquette du produit en application du paragraphe (3) sont indiqués : a) s’ils figurent dans la liste des ingrédients :

25 olives, pickles, relish and horse-radish when the total amount of those ingredients is less than 10 per cent of a prepackaged product

(10)

Despite subparagraph (6)(a)(ii) and subsection (8), if sulphites are shown individually in a list of ingredients, (i) soit par l’un des noms usuels « agents de sulfitage » ou « sulfites », (ii) soit individuellement, par celui des noms d’additifs alimentaires indiqué dans le document sur les noms usuels d’ingrédients et de constituants, sauf lorsqu’il s’agit d’un des noms « dithionite de sodium », « anhydride sulfureux » ou « acide sulfureux », auquel cas ce nom doit être suivi, entre parenthèses, par l’un des noms usuels « agents de sulfitage » ou « sulfites »; b) s’ils figurent sous la mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés, par l’un des noms usuels « agents de sulfitage » ou « sulfites ».

26 vegetable or animal fats or oils for which a standard is prescribed in Division 9, and modified, interesterified or fully hydrogenated vegetable or animal fats or oils, if the total quantity of those fats and oils that are contained in a prepackaged product is less than 15 per cent of the prepackaged product

(7)

Les sulfites figurant dans la liste des ingrédients en application de l’alinéa (6)a) sont indiqués : a) s’ils sont des constituants d’un ingrédient figurant dans la liste des ingrédients, soit entre parenthèses immédiatement à la suite de l’ingrédient, soit à la fin de la liste des ingrédients où ils peuvent figurer dans n’importe quel ordre avec les autres ingrédients indiqués à la fin de la liste des ingrédients aux termes du paragraphe B.01.008.2(4); b) dans les autres cas, à la fin de la liste des ingrédients où ils peuvent figurer dans n’importe quel ordre avec les autres ingrédients indiqués à la fin de la liste des ingrédients aux termes du paragraphe B.01.008.2(4).

27 prepared meat, preserved meat, fish, poultry meat, meat by-product or poultry by-product when the total amount of those ingredients is less than 10 per cent of a prepackaged product that consists of an unstandardized food

(8)

Si des sulfites sont présents dans un produit préemballé en une quantité totale égale ou supérieure à 10 parties par million et qu’un ou plusieurs d’entre eux, d’une part, doivent figurer dans la liste des ingrédients en application des articles B.01.008 ou B.01.009 et, d’autre part, sont désignés individuellement par celui des noms « dithionite de sodium », « anhydride sulfureux » ou « acide sulfureux » qui s’applique, ce nom doit être suivi, entre parenthèses, de l’un des noms usuels « agents de sulfitage » ou « sulfites ».

28 alimentary paste that does not contain egg in any form or any flour other than wheat flour

(9)

Si la quantité totale de sulfites présents dans le produit préemballé est égale ou supérieure à 10 parties par million, les sulfites qui doivent figurer dans la liste des ingrédients en application des articles B.01.008 ou B.01.009 peuvent en plus figurer sur l’étiquette du produit sous la mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés, laquelle doit satisfaire aux exigences du paragraphe B.01.010.3(1).

29 bacterial culture

(10)

Malgré le sous-alinéa (6)a)(ii) et le paragraphe (8), si des sulfites sont désignés individuellement dans la liste (a) in the list of ingredients, B.01.010.3 (1) A food allergen source, gluten source and added sulphites statement must (B) “Contient”, “Contient :” or “Contient : ” in the French version of the statement, des ingrédients par l’un des noms « dithionite de so­dium », « anhydride sulfureux » ou « acide sulfureux », ce nom n’a pas à être suivi, entre parenthèses, de l’un des noms usuels « agents de sulfitage » ou « sulfites » si, selon le cas : a) dans la liste des ingrédients : (i) la mention « sulfite » figure dans le nom usuel d’un autre sulfite, (ii) l’un des noms usuels « agents de sulfitage » ou « sulfites » figure entre parenthèses à la suite d’un autre sulfite; b) sous la mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés, l’un des noms usuels « agents de sulfitage » ou « sulfites » figure sur l’étiquette du produit. B.01.010.3 (1) La mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés satisfait aux exigences suivantes : a) elle débute par un titre conforme aux précisions suivantes : (i) il est formé des mots suivants : (A) s’agissant de la version française de cette mention, « Contient », « Contient : » ou « Contient : », (B) s’agissant de la version anglaise de cette mention, « Contains », « Contains: » ou « Contains : »; (ii) il est en caractères gras, (iii) il figure sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé entre lui et le reste de la mention, (iv) si elle est précédée d’une mention visée au paragraphe B.01.014(1) et elle débute sur la ligne où se termine cette mention, il est présenté en caractères d’une hauteur plus grande d’au moins 0,2 mm que celle des caractères utilisés dans cette autre mention; a.1) elle suit, immédiatement, pour chaque version linguistique, toute mention visée au paragraphe B.01.014(1) qui figure dans la même langue ou, à défaut, la liste des ingrédients qui figure dans la même (a) the same source of a food allergen; SOR/2011-28, s. 4; SOR/2016-305, s. 9; SOR/2022-168, s. 7. langue, et, dans les deux cas, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé; a.2) elle est présentée sur le même espace continu que la mention ou la liste qui la précède immédiatement et de la même manière que la liste des ingrédients, conformément au paragraphe B.01.008.2(2); b) elle inclut tous les renseignements ci-après, que l’un ou plusieurs d’entre eux figurent ou non dans la liste des ingrédients : (i) la source de chacun des allergènes alimentaires présents dans le produit préemballé, (ii) chacune des sources de gluten présents dans le produit, (iii) l’un des noms usuels « agents de sulfitage » ou « sulfites », si la quantité totale de sulfites présents dans le produit est égale ou supérieure à 10 parties par million; c) elle indique les renseignements en caractères ordinaires ou gras, en lettres minuscules, sauf pour la première lettre de chaque mention, qui est une majuscule, et chaque renseignement est séparé des autres par une puce ou une virgule.

30 hydrolyzed plant protein

(2)

Malgré l’alinéa (1)b), les renseignements ci-après n’ont à figurer qu’une seule fois dans la mention applicable : a) une même source d’allergène alimentaire; b) une même source de gluten; c) l’un des noms usuels « agents de sulfitage » ou « sulfites ».

31 carbonated water

(3)

Lorsque les versions anglaise et française de la mention sont présentées sur un même espace continu de l’étiquette, celle des versions qui suit l’autre ne doit pas débuter sur la même ligne que celle où se termine cette autre version, sauf s’il s’agit d’un produit préemballé dont la surface exposée disponible est inférieure à 100 cm². DORS/2011-28, art. 4; DORS/2016-305, art. 9; DORS/2022-168, art. 7. B.01.010.4 (1) Si l’étiquette du produit préemballé porte un énoncé visant à signaler au consommateur la présence possible, dans le produit, d’une source d’allergène alimentaire ou de gluten ou d’un risque de contamination croisée, l’énoncé doit satisfaire aux exigences suivantes : SOR/2016-305, s. 10; SOR/2022-168, s. 8. SOR/2022-143, s. 12. B.01.012 (1) In this section, a) de ne pas inclure dans un produit préemballé un aliment qui est normalement un ingrédient ou constituant de son produit préemballé, ou b) de remplacer en tout ou en partie un aliment qui est normalement un ingrédient ou constituant de son produit préemballé par un autre aliment, la liste des ingrédients, pour la période de 12 mois à partir du moment où l’étiquette est apposée sur le produit préemballé, peut indiquer comme ingrédients ou constituants les aliments qui peuvent être omis et les aliments utilisables comme aliments de substitution si c) si tous les aliments utilisables comme ingrédients ou constituants pendant toute la période de 12 mois sont compris dans la liste d’ingrédients; d) s’il est clairement énoncé dans la liste d’ingrédients que l’aliment indiqué comme ingrédient ou constituant peut être omis du produit préemballé ou qu’un autre aliment peut être substitué à l’aliment figurant comme ingrédient ou constituant; et e) si les aliments qui peuvent être omis ou remplacés sont groupés avec la même catégorie d’aliments utilisés comme ingrédients ou constituants, et si les aliments compris dans chacun de ces groupes sont énumérés dans l’ordre décroissant de leurs proportions respectives, en poids, dans lesquelles ils seront probablement utilisés au cours de la période de 12 mois.

32 whey, whey powder, concentrated whey, whey butter and whey butter oil

(2)

Lorsqu’il est reconnu comme une pratique industrielle acceptable pour un fabricant de faire varier les proportions des ingrédients ou constituants dans un produit préemballé, la liste d’ingrédients, pour la période de 12 mois à compter du moment où l’étiquette est apposée sur le produit préemballé, peut indiquer les ingrédients ou constituants dans les mêmes proportions pendant toute la période de 12 mois si a) s’il est clairement énoncé dans la liste d’ingrédients que les proportions indiquées sont susceptibles de modification; et b) si les ingrédients ou constituants sont indiqués dans l’ordre décroissant de leurs proportions respectives, en poids, dans lesquelles ils seront probablement utilisés au cours de la période de 12 mois. DORS/2022-143, art. 12. B.01.012 (1) Dans le présent article, aliment spécial Aliment — autre qu’un fortifiant pour lait humain ou un aliment supplémenté — qui est : official languages means the English language and the French language; (langues officielles) a) soit un aliment ayant un caractère religieux particulier et utilisé pour les cérémonies religieuses; b) soit un aliment importé dont, à la fois : (i) l’usage n’est pas largement répandu chez la population du Canada en général, (ii) il n’existe aucun succédané facilement accessible, qui soit fabriqué, transformé, produit ou emballé au Canada et qui soit généralement reconnu comme un succédané valable; (specialty food) collectivité locale désigne une cité, un territoire d’un gouvernement métropolitain, une ville, une village, une municipalité ou tout autre territoire d’un gouvernement local mais ne comprend pas une collectivité locale située dans un district bilingue établi sous le régime de la Loi sur les langues officielles; (local government unit) langue maternelle désigne la première langue qu’on apprisse dans leur enfance des personnes vivant dans une région du Canada et qu’elles comprennent encore, tel qu’il a été établi d’après le recensement décennal précédant la date à laquelle l’aliment visé au paragraphe (3) est vendu au consommateur; (mother tongue) langues officielles désigne la langue française et la langue anglaise; (official languages) produit alimentaire d’essai désigne un aliment qui, avant la date de l’avis d’intention concernant cet aliment et dont il est question au paragraphe (5), n’était pas vendu au Canada et qui diffère considérablement de tout autre aliment vendu au Canada par sa composition, sa fonction, son état ou la forme de son emballage, et comprend un aliment visé à l’article B.01.054; (test market food) produit alimentaire local désigne un aliment qui est fabriqué, transformé, produit ou emballé dans une collectivité locale et vendu seulement a) dans la collectivité locale où il est fabriqué, transformé, produit ou emballé, b) dans une ou plusieurs collectivités locales situées dans le voisinage immédiat de la collectivité où il est fabriqué, transformé, produit ou emballé, ou c) dans la collectivité locale où il est fabriqué, transformé, produit ou emballé et dans une ou plusieurs collectivités locales situées dans le voisinage immédiat de ladite collectivité. (local food) Scotch Whisky Irish Whisky Highland Whisky Dry Gin Bourbon Tennessee Whisky Tequila Mezcal Rye Whisky Crème de Menthe Crème de Cacao Crème de Cassis Crème de Banane Triple Sec Anisette Crème de Noyau Brandy Sake or Saki Advocaat or Advokaat Kirsch Slivovitz Ouzo Cherry Brandy Liqueur Kummel Akvavit Aquavit Armagnac Marc Grappa Calvados Poire William Crème de Bleuets Curaçao Orange Liqueur de Fraise Mandarinette Prunelle de Bourgogne Chartreuse Pastis Fior d'Alpe Strega Campari Americano Apricot Brandy Liqueur Peach Brandy Liqueur Sloe Gin Manhattan Martini SOR/79-23, s. 9; SOR/79-259, s. 4; SOR/84-300, s. 6; SOR/93-603, s. 1; SOR/95-548, s. 6; SOR/2000-184, s. 62; SOR/2016-305, s. 11; SOR/2021-175, s. 1; SOR/2022-185, s. 7. SOR/92-626, s. 10; SOR/95-548, s. 5(F).

33 mould culture

(2)

The statement must (a) be shown in bold type; SOR/81-617, s. 2; SOR/88-569, s. 5; SOR/2003-11, s. 6; SOR/2016-305, s. 75(F); SOR/2018-108, s. 40; SOR/2022-168, s. 9 B.01.015 [Repealed, SOR/2022-168, s. 9] B.01.016 [Repealed, SOR/2022-168, s. 9] B.01.017 [Repealed, SOR/2022-168, s. 9] SOR/93-276, s. 2; SOR/94-719, s. 1; SOR/97-512, s. 1; SOR/2003-11, s. 10; SOR/2016-305, s. 75(F) B.01.019 [Repealed, SOR/2022-168, s. 10] B.01.020 [Repealed, SOR/2022-168, s. 10] SOR/2004-261, s. 1; SOR/2016-305, s. 75(F); SOR/2022-168, s. 10 B.01.022 [Repealed, SOR/2022-168, s. 11] "CAUTION, DO NOT USE AS SOLE SOURCE OF NUTRITION". SOR/78-685, s. 1; SOR/2021-57, s. 7. B.01.034 [Repealed, SOR/88-559, s. 7]

34 chlorinated water and fluorinated water

(10)

The statements referred to in subsections (3) and (6) to (8) shall be in both official languages in accordance with subsection B.01.012(2). B.01.037 [Repealed, SOR/88-559, s. 8] B.01.040 [Repealed, SOR/88-559, s. 9] SOR/87-660, s. 1. B.01.045 A food additive shall, (i) 3 parts per million of arsenic, and (ii) 10 parts per million of lead. (d) [Repealed, SOR/2010-142, s. 1] (e) [Repealed, SOR/97-512, s. 2] (f) [Repealed, SOR/2016-305, s. 12] (g) [Repealed, SOR/97-512, s. 2] SOR/82-383, s. 1; SOR/91-527, s. 2; SOR/92-632, s. 1; SOR/93-561, s. 1; SOR/93-276, s. 3; SOR/94-265, s. 4; SOR/94-779, s. 2; SOR/95-172, s. 2; SOR/97-512, s. 2; SOR/2010-142, s. 1; SOR/2016-305, s. 12. B.01.046 [Repealed, SOR/2016-74, s. 2] B.01.047 [Repealed, SOR/2016-74, s. 2] specified risk material means (a) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older; and (b) the distal ileum of cattle of all ages. (matériel à risque spécifié)

36 toasted wheat crumbs used in or as a binder, filler or breading in or on a food product

(2)

No person shall sell or import for sale food that contains specified risk material. SOR/2003-265, s. 1. B.01.048 (1) No person shall sell (d) a 5-nitroimidazole compound; and SOR/85-686, s. 1; SOR/87-426, s. 1; SOR/94-686, s. 1; SOR/97-510, s. 1; SOR/2003-292, s. 1; SOR/2016-74, s. 3. SOR/84-300, s. 8. SOR/2014-76, s. 1. (d) where consumed as directed, not less than 300 calories. SOR/2003-11, s. 13; SOR/2016-305, s. 75(F). b) de la vitamine A, de la thiamine, de la riboflavine, de la niacine ou de la niacinamide et de la vitamine C; c) une bonne source alimentaire de protéines; et d) si le produit est consommé de la façon indiquée, au moins 300 calories. DORS/2003-11, art. 13; DORS/2016-305, art. 75(F). B.01.054 (1) Afin de recueillir des renseignements à l’appui d’une modification au présent règlement, le ministre peut délivrer au fabricant ou au distributeur d’un aliment, lorsque l’aliment ou l’emballage, l’étiquetage ou l’annonce de celui-ci ne sont pas conformes aux exigences du présent règlement, une lettre d’autorisation de mise en marché temporaire permettant la vente de l’aliment décrit dans la lettre, l’étiquetage ou l’annonce de l’aliment décrit dans la lettre, pour une période déterminée, dans une région désignée, en quantité déterminée et de la manière précisée dans la lettre si a) le fabricant ou le distributeur lui a fourni les renseignements suivants : (i) la raison pour laquelle une autorisation de mise en marché temporaire de l’aliment est requise, (ii) une description de l’aliment, y compris un échantillon et un projet d’étiquette, (iii) une description de toute modification proposée aux exigences du présent règlement, (iv) des données suffisantes à prouver que la consommation de l’aliment ne sera pas nuisible à la santé de l’acheteur ni à celle du consommateur, (v) la quantité proposée d’aliment à vendre, (vi) la période projetée qui est requise pour une telle vente, (vii) la région proposée qui est désignée pour une telle vente, et (viii) toutes les autres données que le ministre pourrait lui demander; et b) le fabricant ou le distributeur de l’aliment a consenti (i) à décrire l’aliment sur une étiquette ou dans une réclame d’une manière qui ne soit ni fausse, ni trompeuse, ni mensongère, (ii) à se servir sur l’étiquette ou dans toute annonce des marques ou déclarations que le ministre pourrait exiger, (d) the quantity of the food that is authorized for sale; SOR/81-566, s. 1; SOR/85-275, s. 1; SOR/2018-69, s. 27. SOR/81-566, s. 1; SOR/85-275, s. 2; SOR/90-814, s. 4. B.01.056 [Repealed, SOR/2016-74, s. 4] B.01.060 to B.01.066 [Repealed, SOR/88-559, s. 10] SOR/88-336, s. 3; SOR/92-626, s. 11. SOR/92-626, s. 11. SOR/88-336, s. 3; SOR/2022-143, s. 13(E). SOR/94-262, s. 1. SOR/94-262, s. 1; SOR/2003-11, s. 14; SOR/2016-305, s. 13. B.01.092 Sections B.01.090 and B.01.091 do not apply in respect of side bacon, Wiltshire bacon, pork jowls, salt pork or salt beef. SOR/94-262, s. 1.

(2)

Subject to subsection (3), where a preparation or mixture set out in the table to this subsection is added to a food, the ingredients and components of the preparation or mixture are not required to be shown on the label of that food.

(4)

The words

4 spice or herb mixtures

(5)

and (6) [Repealed, SOR/88-559, s. 12] SOR/88-559, s. 12; SOR/2022-143, s. 14.

5 seasoning mixtures, other than those set out in item 4 and salt added separately, if the total weight of those seasoning ingredients is no more than 2% of the total weight of ingredients used in the manufacture of the prepackaged product excluding added water used as an ingredient that has been removed during its manufacture

(2)

Notwithstanding subsection (1),

8 food additive preparations

(5)

to (7) [Repealed, SOR/88-559, s. 13] SOR/84-300, s. 9; SOR/88-559, s. 13; SOR/2022-143, s. 15. B.01.103 (1) [Repealed, SOR/2022-143, s. 16]

10 food flavour-enhancer preparations

(2)

to (4) [Repealed, SOR/88-559, s. 14] SOR/88-559, s. 14; SOR/2022-143, s. 16. B.01.300 [Repealed, SOR/2003-11, s. 15] (a) in the case of the energy value, in Calories; (ii) niacin, if it is a supplemental ingredient; (ii) niacin if it is a supplemental ingredient; (i) for sodium, potassium, calcium, phosphorus, magnesium, iron, zinc, chloride, copper and manganese, in milligrams, and (ii) for iodide, chromium, selenium and molybdenum, in micrograms; (d) in the case of the mineral ion content of prepackaged water or ice, in parts per million; SOR/88-559, s. 15; SOR/2003-11, s. 16; SOR/2016-305, ss. 14, 75(F); SOR/2022-169, s. 9.

11 compressed, dry, active or instant yeast preparations

d.1) dans le cas d’un ingrédient supplémentaire autre qu’une vitamine ou un minéral nutritif visés au présent paragraphe, selon l’unité applicable prévue à la colonne 3 de la Liste des ingrédients supplémentaires autorisés; e) dans les autres cas, en grammes. (1.1) Malgré le paragraphe D.01.003(1) et pour l’application du présent article, la teneur en unités métriques des vitamines visées à l’alinéa (1)b.01) est déterminée en fonction de leur teneur en l’aliment supplémenté, et, le cas échéant, conformément à la colonne 5 de la Liste des ingrédients supplémentaires autorisés.

(3)

Where a preparation or mixture set out in the table to subsection (2) is added to a food, and the preparation or mixture contains one or more of the following ingredients or components, those ingredients or components shall be shown by their common names in the list of the ingredients of the food to which they are added as if they were ingredients of that food: (b) glutamic acid or its salts; (c) hydrolyzed plant protein; (f) any ingredient or component that performs a function in, or has any effect on, that food; and

(2)

Malgré le paragraphe (1), est permise, sur l’étiquette ou dans l’annonce d’un aliment, autre que dans le tableau de la valeur nutritive ou dans le tableau des renseignements sur les aliments supplémentés, le cas échéant, toute indication du pourcentage de la valeur quotidienne d’un élément nutritif contenu dans l’aliment, si les conditions suivantes sont réunies : a) dans le cas d’un aliment autre qu’un aliment supplémenté, l’élément nutritif figure à la colonne 1 des tableaux des articles B.01.401 ou B.01.402 et le pourcentage de la valeur quotidienne de l’élément nutritif doit ou peut être déclaré dans le tableau de la valeur nutritive; b) dans le cas d’un aliment supplémenté, l’élément nutritif figure à la colonne 1 des tableaux des articles B.29.002 ou B.29.003, ou est visé à la colonne 2 de l’article 18 du tableau de l’article B.29.002, et le pourcentage de la valeur quotidienne de l’élément nutritif doit ou peut être déclaré dans le tableau des renseignements sur les aliments supplémentés; c) le pourcentage de la valeur quotidienne de l’élément nutritif est déclaré par portion indiquée.

(4)

Notwithstanding subsections (1) and (2), where any of the following components is contained in an ingredient set out in the tables to those subsections, that component shall be shown in the list of ingredients: (b) fully hydrogenated peanut oil; and B.01.010 (1) In this section, common name includes a name set out in the Common Names for Ingredients and Components Document.

(3)

Toute indication visée aux paragraphes (1) ou (2) paraissant sur l’étiquette d’un aliment figure : a) soit en français et en anglais; b) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette de l’aliment aux termes du présent règlement peuvent n’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci. DORS/88-559, art. 15; DORS/2003-11, art. 16; DORS/2016-305, art. 14 et 75(F); DORS/2022-169, art. 9. B.01.302 Si l’étiquette d’un produit préemballé à portions multiples indique le nombre de portions que SOR/2016-305, s. 15; SOR/2018-108, s. 394; SOR/2022-169, s. 10. B.01.303 and B.01.304 [Repealed, SOR/2003-11, s. 17]

(2)

An ingredient or component shall be shown in the list of ingredients by its common name. (a) the ingredient or component set out in the Common Names for Ingredients and Components Document shall be shown in the list of ingredients by the common name of that ingredient or component that is set out in that Document; and (b) the ingredient or component set out in the Common Names for Ingredients and Components Document may be shown in the list of ingredients by the common name of that ingredient or component that is set out in that Document. (a) they consist of more than one component and are not listed in the table to subsection B.01.009(1); and (b) their components are shown (i) immediately after the class name of the ingredients of which they are components, in such a manner as to indicate that they are components of the ingredients, and (ii) in descending order of their collective proportion by weight of those ingredients. food allergen means any protein from any of the following foods, or any modified protein, including any protein fraction, that is derived from any of the following foods: gluten means (a) any gluten protein from the grain of any of the following cereals or from the grain of a hybridized strain that is created from at least one of the following cereals: (b) any modified gluten protein, including any gluten protein fraction, that is derived from the grain of any of the cereals referred to in paragraph (a) or from the grain of a hybridized strain referred to in that paragraph. (gluten)

(3)

Subsections (1) and (2) do not apply in respect of (d) the declaration of amino acids in the list of ingredients; contient le produit, ou celui qui sera obtenu si l’aliment est préparé selon les instructions fournies dans ou sur l’emballage, ce renseignement doit être déclaré sur le fondement de la portion indiquée figurant dans le tableau de la valeur nutritive ou dans le tableau des renseignements sur les aliments supplémentés du produit, selon le cas. DORS/2016-305, art. 15; DORS/2018-108, art. 394; DORS/2022-169, art. 10. B.01.303 et B.01.304 [Abrogés, DORS/2003-11, art. 17] B.01.305 (1) Est interdite, sur l’étiquette ou dans l’annonce d’un aliment, toute déclaration, expresse ou implicite, relativement aux protéines, à moins que l’aliment réponde aux critères mentionnés à la colonne 2 de l’article 8 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « source de protéines » visé à la colonne 1.

(2)

If a food allergen or gluten is present in a prepackaged product, the source of the food allergen or gluten, as the case may be, must be shown on the label of the product in (b) in a food allergen source, gluten source and added sulphites statement.

(2)

Est interdite, sur l’étiquette ou dans l’annonce d’un aliment autre qu’un aliment supplémenté, toute déclaration, expresse ou implicite, relativement aux acides aminés, à moins que : a) l’aliment réponde aux critères mentionnés à la colonne 2 de l’article 8 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « source de protéines » visé à la colonne 1; b) sa teneur en histidine, en isoleucine, en leucine, en lysine, en méthionine, en phénylalanine, en thréonine, en tryptophane et en valine soit exprimée en grammes par portion indiquée sur l’étiquette ou dans l’annonce.

(3)

Subsection (2) does not apply to a food allergen or gluten that is present in a prepackaged product as a result of cross-contamination.

(3)

Les paragraphes (1) et (2) ne s’appliquent pas : a) à une préparation pour régime liquide, à un fortifiant pour lait humain, à un succédané de lait humain ou à un aliment présenté comme contenant un succédané de lait humain; b) à un aliment présenté comme étant destiné à un régime sans gluten, à teneur réduite en protéines, à faible teneur en (nom de l’acide aminé) ou sans (nom de l’acide aminé); c) au mot « protéines » utilisé dans le nom usuel d’un ingrédient dans la liste d’ingrédients; d) à la déclaration des acides aminés dans la liste d’ingrédients; e) aux noms usuels figurant dans le document intitulé Noms usuels des ingrédients et des constituants, s’ils figurent dans la liste des ingrédients conformément à l’alinéa B.01.010(3)a). (g) any statement referred to in subsection B.01.014(1); (j) a statement of the protein content of a food as required by paragraph B.24.103(c), subparagraph B.24.202(a)(ii), paragraph B.24.304(b) or B.25.057(1)(a) or subparagraph B.25.057(2)(c)(i) or (d)(i); or B.01.306 to B.01.310 [Repealed, SOR/2003-11, s. 19] e) aux noms usuels mentionnés dans le document sur les noms usuels d’ingrédients et de constituants lorsqu’ils figurent dans la liste d’ingrédients aux termes de l’alinéa B.01.010(3)a); f) au nom usuel d’une préparation contenant un seul acide aminé qui peut être vendue comme aliment; g) à toute mention visée au paragraphe B.01.014(1); h) à toute mention ou allégation figurant à la colonne 4 de l’article 7 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive ayant trait au sujet « faible teneur en protéines » visé à la colonne 1; i) à la déclaration de la teneur en protéines dans le tableau de la valeur nutritive ou dans le tableau des renseignements sur les aliments supplémentés, selon le cas; j) à une mention de la teneur en protéines d’un aliment que l’exigent l’alinéa B.24.103c), le sous-alinéa B.24.202a)(ii), les alinéas B.24.304b) ou B.25.057(1)a) ou les sous-alinéas B.25.057(2)c)(i) ou d)(i); k) à la déclaration selon laquelle un aliment n’est pas une source de protéines.

(4)

Subsection (2) does not apply to a food allergen or gluten that is present in a prepackaged product referred to in paragraphs B.01.008(2)(a) to (e) unless a list of ingredients is shown on the product’s label.

(4)

Toute déclaration visée aux paragraphes (1) ou (2) paraissant sur l’étiquette d’un aliment figure : a) soit en français et en anglais; b) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette de l’aliment aux termes du présent règlement peuvent être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci. B.01.306 à B.01.310 [Abrogés, DORS/2003-11, art. 19] B.01.311 (1) Sous réserve des paragraphes (2) et (3), il est interdit, sur l’étiquette ou dans l’annonce d’un aliment, toute déclaration, expresse ou implicite, concernant l’action ou les effets de la valeur énergétique de l’aliment ou de tout élément nutritif contenu dans l’aliment.

(6)

The source of a food allergen required to be shown under subsection (2) must be shown (a) for a food allergen from a food referred to in one of paragraphs (a), (b) and (e) of the definition food allergen in subsection (1) or derived from that food, by the name of the food as shown in the applicable paragraph, expressed in the singular or plural; (b) for a food allergen from the food referred to in paragraph (c) of the definition food allergen in subsection (1) or derived from that food, by the name “sesame”, “sesame seed” or “sesame seeds”; (c) for a food allergen from a food referred to in one of paragraphs (d) and (f) of the definition food allergen in subsection (1) or derived from that food, by the name of the food as shown in the applicable paragraph; (d) for a food allergen from the food referred to in paragraph (g) of the definition food allergen in subsection (1) or derived from that food, by the name “soy”, “soybean” or “soybeans”; (e) for a food allergen from a food referred to in one of paragraphs (h) to (j) of the definition food allergen in subsection (1) or derived from that food, by the common name of the food that is set out in the Common Names for Ingredients and Components Document; and (f) for a food allergen from the food referred to in paragraph (k) of the definition food allergen in subsection (1) or derived from that food, by the name “mustard”, “mustard seed” or “mustard seeds”.

(2)

Toute mention ou allégation figurant à la colonne 1 du tableau suivant l’article B.01.603 est permise sur l’étiquette ou dans l’annonce d’un aliment. SOR/88-559, s. 15; SOR/2003-11, s. 20; SOR/2016-305, s. 75(F); SOR/2022-169, s. 12. SOR/2003-11, s. 20; SOR/2016-305, ss. 16, 75(F). Nutrition Symbols Mandatory Information (d) ready-to-serve multiple-serving prepackaged products that are intended solely to be served in a commercial or industrial enterprise or an institution; Symboles nutritionnels Renseignements obligatoires B.01.350 (1) Sauf disposition contraire du présent article, l’espace principal d’un produit préemballé porte un symbole figurant à l’annexe K.1 si les conditions ci-après sont réunies : a) le produit, tel qu’il est vendu, contient un élément nutritif visé à la colonne 1 du tableau du présent article; b) la teneur en cet élément nutritif, calculée en pourcentage de la valeur quotidienne, est égale ou supérieure au seuil applicable visé aux colonnes 2 à 7 de ce tableau.

(7)

The source of gluten required to be shown under subsection (2) must be shown (a) for gluten from the grain of a cereal referred to in one of subparagraphs (a)(i) to (v) of the definition gluten in subsection (1) or derived from that grain, by the name of the cereal as shown in the applicable subparagraph; and (b) for gluten from the grain of a hybridized strain created from one or more of the cereals referred to in subparagraphs (a)(i) to (v) of the definition gluten in subsection (1) or derived from that grain, by the names of the cereals as shown in the applicable subparagraphs.

(2)

Pour l’application du paragraphe (1), le pourcentage de la valeur quotidienne de l’élément nutritif est calculé sur la base de sa teneur, en poids, par portion indiquée ou par quantité de référence, selon la plus élevée de ces quantités.

(8)

For the purpose of paragraph (2)(a), the source of the food allergen or gluten must be shown in the list of ingredients, in parentheses, as follows: (a) immediately after the ingredient that is shown in that list, if the food allergen or gluten (i) is that ingredient, (ii) is present in that ingredient, but is not a component of or present in a component of that ingredient, or (iii) is, or is present in, a component of that ingredient and the component is not shown in the list of ingredients; or (b) immediately after the component that is shown in the list of ingredients, if the food allergen or gluten is in that component or is present in that component.

(3)

Malgré le paragraphe (2), dans le cas d’un produit préemballé dont la préparation requiert la reconstitution avec de l’eau ou un autre liquide ou l’ajout d’un autre ingrédient et dont la quantité de référence applicable se réfère uniquement à l’aliment dans sa forme préparée, le pourcentage de la valeur quotidienne de l’élément nutritif est calculé sur la base de sa teneur, en poids, par portion indiquée.

(9)

Despite subsection (2), the source of the food allergen or gluten must be shown on the label of the product in the food allergen source, gluten source and added sulphites statement if the food allergen or gluten (a) is, or is present in, an ingredient that is not shown in the list of ingredients, but is not a component of that ingredient or present in a component of that ingredient; or (b) is, or is present in, a component and neither the component nor the ingredient in which it is present is shown in the list of ingredients.

(4)

Le seuil visé aux colonnes 2 à 7 du tableau du présent article applicable au produit préemballé visé au paragraphe (3) est établi en fonction de sa portion indiquée et non de sa quantité de référence.

(10)

Despite subsection (8), the source of the food allergen or gluten is not required to be shown in parentheses immediately after the ingredient or component, as the case may be, if the source of the food allergen or gluten appears (i) as part of the common name of the ingredient or component, or (ii) in parentheses, under subsection (8), immediately after another ingredient or component; or (b) in the food allergen source, gluten source and added sulphites statement. B.01.010.2 (1) In this section and in section B.01.010.3, sulphites means the food additives that are set out in the Common Names for Ingredients and Components Document and are present in a prepackaged product.

(5)

Le paragraphe (1) ne s’applique pas : a) au contenant d’expédition, sauf si ce dernier et son contenu sont vendus comme produit préemballé individuel à un consommateur au niveau du commerce de détail; b) au produit préemballé dont la surface exposée disponible est de moins de 15 cm²; c) à la portion individuelle préemballée d’un aliment destinée uniquement à être servie avec des repas ou des casse-croûte par un restaurant ou une autre entreprise commerciale; d) au produit prêt-à-servir à portions multiples, prêt à servir et destiné uniquement à être servi par une entreprise commerciale ou industrielle ou une institution;

(2)

For greater certainty, the definition sulphites in subsection (1) includes only sulphites that are present in the prepackaged product as a result of being added.

(8)

For the purposes of subsection (6) in relation to sugars, the ingredients set out in paragraphs (7)(a), (b) and (d); (d) legumes. (i) milk ingredients, (ii) modified milk ingredients, (iii) grains, (iv) legumes, or (v) nuts or seeds. (c) a raw single ingredient marine or fresh water animal product; (d) a formulated liquid diet as defined in section B.24.001; (f) a nutritional supplement; TABLE Thresholds Requiring a Nutrition Symbol Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6 | Column 7 TABLEAU Seuils exigeant un symbole nutritionnel Colonne 1

(3)

If sulphites are present in a prepackaged product in a total amount of 10 parts per million or more and none are required to be shown in the list of ingredients under section B.01.008 or B.01.009, the sulphites must be shown on the label of the product in (b) the food allergen source, gluten source and added sulphites statement that complies with the requirements of subsection B.01.010.3(1).

Article

Colonne 2 Élément nutritif Colonne 3 Seuil pour produit préemballé autre que celui mentionné aux colonnes 5 à 7 À l’exception du produit mentionné à la colonne 4, produit préemballé dont la quantité de référence est supérieure à 30 g ou 30 mL Colonne 4 Produit préemballé dont la quantité de référence est de 30 g ou 30 mL Colonne 5 Plat principal préemballé dont la quantité de référence est de 200 g ou plus Colonne 6 Seuil pour produit préemballé destiné exclusivement aux enfants âgés d’au moins un an mais de moins de quatre ans À l’exception du produit mentionné à la colonne 7, produit préemballé dont la quantité de référence est supérieure à 30 g ou 30 mL Colonne 7 Produit préemballé dont la quantité de référence est de 30 g ou 30 mL Plat principal préemballé dont la quantité de référence est de 170 g ou plus 1 Gras saturés 15 % de la valeur quotidienne de la somme des acides gras saturés et des acides gras trans visée à la colonne 3 de la partie 1 du Tableau des valeurs quotidiennes 10 % de la valeur quotidienne de la somme des acides gras saturés et des acides gras trans visée à la colonne 3 de la partie 1 du Tableau des valeurs quotidiennes 30 % de la valeur quotidienne de la somme des acides gras saturés et des acides gras trans visée à la colonne 3 de la partie 1 du Tableau des valeurs quotidiennes 15 % de la valeur quotidienne de la somme des acides gras saturés et des acides gras trans visée à la colonne 2 de la partie 1 du Tableau des valeurs quotidiennes 10 % de la valeur quotidienne de la somme des acides gras saturés et des acides gras trans visée à la colonne 2 de la partie 1 du Tableau des valeurs quotidiennes 30 % de la valeur quotidienne de la somme des acides gras saturés et des acides gras trans visée à la colonne 2 de la partie 1 du Tableau des valeurs quotidiennes 2 Sucres 15 % de la valeur quotidienne de sucres visée à la colonne 3 de la partie 1 du Tableau des valeurs quotidiennes 10 % de la valeur quotidienne de sucres visée à la colonne 3 de la partie 1 du Tableau des valeurs quotidiennes 30 % de la valeur quotidienne de sucres visée à la colonne 3 de la partie 1 du Tableau des valeurs quotidiennes 15 % de la valeur quotidienne de sucres visée à la colonne 2 de la partie 1 du Tableau des valeurs quotidiennes 10 % de la valeur quotidienne de sucres visée à la colonne 2 de la partie 1 du Tableau des valeurs quotidiennes 30 % de la valeur quotidienne de sucres visée à la colonne 2 de la partie 1 du Tableau des valeurs quotidiennes 3 Sodium 15 % de la valeur quotidienne de sodium visée à la colonne 3 de la partie 1 du Tableau des valeurs quotidiennes 10 % de la valeur quotidienne de sodium visée à la colonne 3 de la partie 1 du Tableau des valeurs quotidiennes 30 % de la valeur quotidienne de sodium visée à la colonne 3 de la partie 1 du Tableau des valeurs quotidiennes 15 % de la valeur quotidienne de sodium visée à la colonne 2 de la partie 1 du Tableau des valeurs quotidiennes 10 % de la valeur quotidienne de sodium visée à la colonne 2 de la partie 1 du Tableau des valeurs quotidiennes 30 % de la valeur quotidienne de sodium visée à la colonne 2 de la partie 1 du Tableau des valeurs quotidiennes SOR/2022-168, art. 13; SOR/2022-169, s. 13. Presentation of Nutrition Symbol Présentation du symbole nutritionnel B.01.351 (1) Le symbole nutritionnel est présenté en noir et blanc et conformément au symbole applicable figurant à l’annexe K.1.

(4)

Subsection (3) does not apply to sulphites present in the prepackaged products referred to in paragraphs B.01.008(2)(a) to (e) unless a list of ingredients is shown on the product’s label.

(2)

Sous réserve du paragraphe (3), le symbole nutritionnel est présenté selon l’un des modèles suivants : SOR/2022-168, s. 13. TABLE Column 1 Range of principal display surface Column 2 Column 3 Nutrition symbol in unilingual horizontal format Column 4 Nutrition symbol in unilingual vertical format Column 5 Nutrition symbol in bilingual horizontal format Column 6 Nutrition symbol in bilingual vertical format 1 > 30 cm² Saturated fat (Sat fat), sugars and sodium 1(EH) and 1(FH) 1(EV) and 1(FV) 1(BH) 1(BV) 2(EH) and 2(FH) 2(EV) and 2(FV) 2(BH) 2(BV) Sugars and sodium 3(EH) and 3(FH) 3(EV) and 3(FV) 3(BH) 3(BV) Saturated fat (Sat fat) and sodium 4(EH) and 4(FH) 4(EV) and 4(FV) 4(BH) 4(BV) Saturated fat (Sat fat) 5(EH) and 5(FH) 5(EV) and 5(FV) 5(BH) 5(BV) Sugars 6(EH) and 6(FH) 6(EV) and 6(FV) 6(BH) 6(BV) Sodium 7(EH) and 7(FH) 7(EV) and 7(FV) 7(BH) 7(BV) 2 ≤ 30 cm² Saturated fat (Sat fat), sugars and sodium 1(EH) and 1(FH) 1(EV) and 1(FV) 1(BH) 1(BV) 8(EH) and 8(FH) 8(EV) and 8(FV) 8(BH) 8(BV) Sugars and sodium 9(EH) and 9(FH) 9(EV) and 9(FV) 9(BH) 9(BV) Saturated fat (Sat fat) and sodium 10(EH) and 10(FH) 10(EV) and 10(FV) 10(BH) 10(BV) Saturated fat (Sat fat) 11(EH) and 11(FH) 11(EV) and 11(FV) 11(BH) 11(BV) Sugars 12(EH) and 12(FH) 12(EV) and 12(FV) 12(BH) 12(BV) Sodium 13(EH) and 13(FH) 13(EV) and 13(FV) 13(BH) 13(BV) TABLEAU Symboles nutritionnels et modèles Colonne 1

(6)

Sulphites that are shown on a label of the product under subsection (3) must be shown as follows: (i) by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”, or (ii) individually by the name of the food additive that is set out in the Common Names for Ingredients and Components Document, except that the name “sodium dithionite”, “sulphur dioxide” or “sulphurous acid” must be followed, in parentheses, by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”; or (b) if the sulphites are shown in a food allergen source, gluten source and added sulphites statement, by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”.

Article

Colonne 2 Plage de la principale surface exposée Élément nutritif égal ou supérieur au seuil prévu au paragraphe B.01.350(1) Colonne 3 Symbole nutritionnel du modèle horizontal unilingue Colonne 4 Symbole nutritionnel du modèle vertical unilingue Colonne 5 Symbole nutritionnel du modèle horizontal bilingue Colonne 6 Symbole nutritionnel du modèle vertical bilingue 1 > 30 cm² Gras saturés (Gras sat.), sucres et sodium 1(FH) et 1(AH) 1(FV) et 1(AV) 1(HB) 1(VB) Gras saturés (Gras sat.) et sucres 2(FH) et 2(AH) 2(FV) et 2(AV) 2(HB) 2(VB) Sucres et sodium 3(FH) et 3(AH) 3(FV) et 3(AV) 3(HB) 3(VB) Gras saturés (Gras sat.) et sodium 4(FH) et 4(AH) 4(FV) et 4(AV) 4(HB) 4(VB) Gras saturés (Gras sat.) 5(FH) et 5(AH) 5(FV) et 5(AV) 5(HB) 5(VB) Sucres 6(FH) et 6(AH) 6(FV) et 6(AV) 6(HB) 6(VB) Sodium 7(FH) et 7(AH) 7(FV) et 7(AV) 7(HB) 7(VB) 2 ≤ 30 cm² Gras saturés (Gras sat.), sucres et sodium 1(FH) et 1(AH) 1(FV) et 1(AV) 1(HB) 1(VB) Gras saturés (Gras sat.) et sucres 8(FH) et 8(AH) 8(FV) et 8(AV) 8(HB) 8(VB) Sucres et sodium 9(FH) et 9(AH) 9(FV) et 9(AV) 9(HB) 9(VB) Gras saturés (Gras sat.) et sodium 10(FH) et 10(AH) 10(FV) et 10(AV) 10(HB) 10(VB) Gras saturés (Gras sat.) 11(FH) et 11(AH) 11(FV) et 11(AV) 11(HB) 11(VB) Sucres 12(FH) et 12(AH) 12(FV) et 12(AV) 12(HB) 12(VB) Sodium 13(FH) et 13(AH) 13(FV) et 13(AV) 13(HB) 13(VB) SOR/2022-168, s. 13. SOR/2022-168, s. 13. B.01.353 (1) Sous réserve du paragraphe (2), dans le cas d’un produit préemballé contenant un assortiment d’aliments dont au moins un requiert un symbole nutritionnel, les symboles nutritionnels sont présentés de façon à indiquer clairement les éléments nutritifs applicables contenus dans chaque aliment.

(7)

Sulphites that are shown in the list of ingredients under paragraph (6)(a) must be shown as follows: (a) sulphites that are a component of an ingredient that is shown in the list of ingredients must be shown either in parentheses immediately after the ingredient or at the end of that list where they may be shown in any order with the other ingredients that are shown at the end of that list in accordance with subsection B.01.008.2(4); and (b) in all other cases, the sulphites must be shown at the end of the list of ingredients where they may be shown in any order with the other ingredients that are shown at the end of that list in accordance with subsection B.01.008.2(4).

(2)

Dans le cas d’un produit préemballé contenant des ingrédients destinés à être alliés ou des aliments destinés à être consommés ensemble, le symbole nutritionnel présente les éléments nutritifs contenus dans le produit dans son ensemble. DORS/2022-168, art. 13. SOR/2022-168, s. 13. B.01.355 (1) A nutrition symbol must be displayed SOR/2022-168, s. 13. SOR/2022-168, s. 13. (a) a declaration referred to in subsection B.01.301(1) or (2); (b) a statement or claim referred to in subsection B.01.311(2) or (3); (c) a representation referred to in any of sections B.01.503 to B.01.513; (d) a statement or claim referred to in subsection B.01.601(1); or (ii) a statement or claim referred to in any of sections D.01.004 to D.01.007 and D.02.002 to D.02.005. SOR/2022-168, s. 13. Prohibitions — Resemblance to Nutrition Symbol SOR/2022-168, s. 13; SOR/2022-169, s. 14. Interpretation

(8)

If sulphites are present in a prepackaged product in a total amount of 10 parts per million or more and any of them are required to be shown in the list of ingredients under section B.01.008 or B.01.009, in the case of sulphites shown individually by the name “sodium dithionite”, “sulphur dioxide” or “sulphurous acid”, that name must be followed, in parentheses, by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”.

(2)

For the purpose of sections B.01.401 to B.01.603, the amount of vitamins shall be determined in accordance with section D.01.003. SOR/2003-11, s. 20; SOR/2016-305, s. 17. Nutrition Labelling Core Information Interdictions — Ressemblance au symbole nutritionnel B.01.358 (1) Il est interdit, relativement à un produit préemballé : a) de l’étiqueter en utilisant une déclaration, y compris un mot, une expression, une illustration, un signe, une marque, un symbole ou un dessin, qui est susceptible d’être confondue avec un symbole nutritionnel; b) d’en faire la publicité ou de le vendre s’il porte sur son étiquette toute déclaration visée à l’alinéa a).

(9)

If the total amount of sulphites present in the prepackaged product is 10 parts per million or more, sulphites that are required to be shown in a list of ingredients under section B.01.008 or B.01.009 may also be shown on the label of the product in a food allergen source, gluten source and added sulphites statement that complies with the requirements of subsection B.01.010.3(1). by the name “sodium dithionite”, “sulphur dioxide” or “sulphurous acid”, that name is not required to be followed, in parentheses, by one of the common names “sul­fites”, “sulfiting agents”, “sulphites” or “sulphiting agents” if (i) the term “sulfite” or “sulphite” appears in the common name of another sulphite, or (ii) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents” is shown in parentheses following another sulphite; or (b) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents” is shown in a food allergen source, gluten source and added sul­phites statement on the label of the product. (a) be introduced by a title that (i) consists of the terms (A) “Contains”, “Contains:” or “Contains :” in the English version of the statement, and (ii) is shown in bold type, (iii) is shown without any intervening printed, written or graphic material appearing between it and the rest of the statement, and (iv) if the statement is preceded by a statement referred to in subsection B.01.014(1) and begins on the line on which that statement ends, is shown in a type that is of a height that is at least 0.2 mm greater than the height of the type used in that statement; (a.1) appear, in respect of each linguistic version, immediately after any statement referred to in subsection B.01.014(1) appearing in the same language or, if there is no such statement, immediately after the list of ingredients appearing in the same language and, in either case, without any intervening printed, written or graphic material; (a.2) appear on the same continuous surface as the statement or list that immediately precedes it and be shown in the same manner as the list of ingredients is shown under subsection B.01.008.2(2); (b) include all of the following information, even if all or part of that information is also shown in the list of ingredients: (i) the source for each food allergen that is present in the prepackaged product, (ii) each source for the gluten that is present in the product, and (iii) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”, if the total amount of sulphites present in the product is 10 parts per million or more; and (c) show information entries in regular or bold type, using lower case letters except for the first letter of each entry, which shall be an upper case letter, and shall use a bullet point or comma to separate each entry.

(2)

Pour l’application du paragraphe (1), la déclaration ne comprend pas l’identifiant des aliments supplémentés avec mise en garde. DORS/2022-168, art. 13; DORS/2022-169, art. 14. Interprétation B.01.400 (1) Pour l’application des articles B.01.401 à B.01.603, lipides s’entend de tous les acides gras exprimés sous forme de triglycérides.

(2)

Despite paragraph (1)(b), the following information is not required to be shown in the statement more than once: (b) the same source of gluten; and (c) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”.

(2)

Pour l’application des articles B.01.401 à B.01.603, la teneur en vitamines est déterminée conformément à l’article D.01.003. DORS/2003-11, art. 20; DORS/2016-305, art. 17. Étiquetage nutritionnel Renseignements principaux B.01.401 (1) Sauf disposition contraire du présent article et des articles B.01.402 à B.01.406 et B.01.467 à B.01.469, l’étiquette de tout produit préemballé porte un tableau de la valeur nutritive indiquant exclusivement les renseignements visés à la colonne 1 du tableau du présent article, exprimés au moyen de la nomenclature indiquée dans la colonne 2, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4. (1.1) Pour l’application du paragraphe (1), la portion indiquée qui est exprimée en unité métrique dans le tableau de la valeur nutritive d’un produit préemballé sert de fondement pour établir les renseignements relatifs à la valeur énergétique et aux éléments nutritifs qui figurent dans le tableau de la valeur nutritive du produit. (1.2) Le pourcentage de la valeur quotidienne d’un minéral nutritif qui, aux termes du paragraphe (1), figure dans le tableau de la valeur nutritive d’un produit préemballé est établi sur la base de la teneur, en poids, du minéral nutritif dans le produit, par portion, divisée par 100 fois la teneur annuelle selon les règles d’écriture. (ii) [Repealed, SOR/2016-305, s. 18] (iv) a raw single ingredient marine or fresh water animal product, applicables prévues à la colonne 4 du tableau du présent article.

(3)

If the English and French versions of the statement appear on the same continuous surface of the label, the version that follows the other version shall not begin on the same line as that on which the other version ends, except in the case of a prepackaged product that has an available display surface of less than 100 cm². B.01.010.4 (1) If the label of a prepackaged product includes a declaration alerting consumers that, due to the risk of cross-contamination, the product may contain the source of a food allergen or gluten, (a) the declaration must appear immediately after (i) the food allergen source, gluten source and added sulphites statement, if there is one, (ii) any statement referred to in subsection B.01.014(1), if no food allergen source, gluten source and added sulphites statement appears on the label, or (iii) the list of ingredients, if neither of the statements referred to in subparagraph (ii) appears on the label; (b) the declaration must appear in both English and French if the statement or list immediately preceding it appears in both languages; (c) the declaration must appear on the same continuous surface as the statement or list that immediately precedes it and be shown in the same manner as the list of ingredients is shown under subsection B.01.008.2(2); (d) the declaration must appear without any intervening printed, written or graphic material between it and the statement or list that immediately precedes it, except that a solid line may appear before the declaration if the declaration begins on a different line than the line on which the statement or list ends; (e) the declaration must be shown in bold type if it begins on the line on which the statement or list that immediately precedes it ends and if it is not introduced by a title; (f) any title that introduces the declaration must be shown in bold type if the declaration begins on the line on which the statement or list that immediately precedes it ends; and (g) if the declaration is preceded by a statement referred to in subsection B.01.014(1) and begins on the line on which the statement ends, the title of the declaration — or the declaration itself, if no title appears — must be shown in a type that is of a height that is at least 0.2 mm greater than the height of the type used in the statement.

(2)

Le paragraphe (1) ne s’applique pas à un produit préemballé dans les cas suivants : a) tous les renseignements visés à la colonne 1 du tableau du présent article, autres que l’article 1 (« Portion indiquée »), peuvent être exprimés par « 0 » au tableau de la valeur nutritive conformément au présent article; b) le produit est, selon le cas : (i) une boisson dont la teneur en alcool est de plus de 0,5 %, (ii) [Abrogé, DORS/2016-305, art. 18] (iii) de la viande, un sous-produit de viande, de la viande de volaille ou un sous-produit de viande de volaille, cru et composé d’un seul ingrédient, (iv) un produit d’animaux marins ou d’animaux d’eau douce cru et composé d’un seul ingrédient, (v) un produit vendu uniquement dans l’établissement de détail où il est préparé et transformé à partir de ses ingrédients, y compris un pré-mélange si un ingrédient autre que de l’eau est ajouté au pré-mélange lors de la préparation et de la transformation du produit, (vi) un produit vendu uniquement dans un éventaire routier, une exposition d’artisanat, un marché aux puces, une foire, un marché d’agriculteurs ou une érablière par l’individu qui l’a transformé et préparé, (vii) une portion individuelle qui est vendue pour consommation immédiate et qui n’a fait l’objet d’aucun procédé pour en prolonger la durée de conservation, notamment l’utilisation d’un emballage spécial, (viii) un produit vendu uniquement dans l’établissement de détail où il est emballé, si l’étiquette du produit est un autocollant et que la surface exposée disponible du produit est de moins de 200 cm²; c) le produit est, selon le cas : (i) un légume frais, un fruit frais ou un mélange quelconque de légumes frais ou de fruits frais sans ingrédient ajouté, une orange à laquelle une couleur alimentaire a été ajoutée et un légume frais ou un

(2)

If the English and French versions of the declaration appear on the same continuous surface of the label, the version that follows the other version must not begin on the line on which the other version ends unless the prepackaged product has an available display surface of less than 100 cm². B.01.011 (1) Where it is an acceptable manufacturing practice for a manufacturer to (a) omit from his prepackaged product any food that is ordinarily an ingredient or component, or (b) substitute in whole or in part in his prepackaged product any other food for a food that is ordinarily an ingredient or component, the list of ingredients for the 12-month period commencing from the time the label is applied to the prepackaged product may show as ingredients or components the foods that may be omitted and the foods that may be used as substitutes if (c) all the foods that may be used as ingredients or components throughout the 12-month period are shown in the list of ingredients; (d) it is clearly stated as part of the list of ingredients that the food shown as an ingredient or component may not be present or that another food may be substituted for a food shown as an ingredient or component; and (e) the foods that may be omitted or substituted are grouped with the same class of foods that are used as ingredients or components and the foods within each such group are listed in descending order of the proportion by weight in which they will probably be used during the 12-month period.

(3)

Despite paragraphs (2)(a) and (b), subsection (1) applies to a prepackaged product if (c) [Repealed, SOR/2022-168, s. 14] (iv) the phrase “nutrition facts”, “valeur nutritive” or “valeurs nutritives”. fruit frais enrobé d’huile minérale, de paraffine, de vaseline ou de tout autre enduit protecteur, (ii) une portion individuelle préemballée d’un aliment, destinée uniquement à être servie par un restaurant ou une autre entreprise commerciale avec les repas ou casse-croûte, (iii) du lait, du lait partiellement écrémé, du lait écrémé, du lait de chèvre, du lait de chèvre partiellement écrémé, du lait de chèvre écrémé, du lait (indication de l’arôme), du lait partiellement écrémé (indication de l’arôme), du lait écrémé (indication de l’arôme) ou de la crème, vendus dans un contenant réutilisable en verre.

(2)

Where it is an acceptable manufacturing practice for a manufacturer to vary the proportions of ingredients or components of his prepackaged product, the list of ingredients for the 12-month period commencing from the time the label is applied to the prepackaged product may show the ingredients or components in the same proportions throughout the 12-month period if (a) it is clearly stated as part of the list of ingredients that the proportions indicated are subject to change; and (b) the ingredients or components are listed in descending order of the proportion by weight in which they will probably be used during the 12-month period. local government unit means a city, metropolitan government area, town, village, municipality or other area of local government but does not include any local government unit situated within a bilingual district established under the Official Languages Act; (collectivité locale) local food means a food that is manufactured, processed, produced or packaged in a local government unit and sold only in (a) the local government unit in which it is manufactured, processed or packaged, (b) one or more local government units that are immediately adjacent to the one in which it is manufactured, processed, produced or packaged, or (c) the local government unit in which it is manufactured, processed, produced or packaged and in one or more local government units that are immediately adjacent to the one in which it is manufactured, processed, produced or packaged; (produit alimentaire local) mother tongue means the language first learned in childhood by persons in any area of Canada and still understood by them as ascertained by the decennial census taken immediately preceding the date on which the food referred to in subsection (3) is sold to the consumer; (langue maternelle) specialty food means a food — other than a human milk fortifier or supplemented food — that (a) has special religious significance and is used in religious ceremonies; or (b) is an imported food (i) that is not widely used by the population as a whole in Canada, and (ii) for which there is no readily available substitute that is manufactured, processed, produced or packaged in Canada and that is generally accepted as being a comparable substitute; (aliment spécial) test market food means a food that, prior to the date of the notice of intention respecting that food referred to in subsection (5), was not sold in Canada in that form and that differs substantially from any other food sold in Canada with respect to its composition, function, state or packaging form and includes a food referred to in section B.01.054. (produit alimentaire d’essai)

(3)

Malgré les alinéas (2)a) et b), le paragraphe (1) s’applique dans les cas suivants : a) le produit contient une vitamine ou un minéral nutritif ajoutés; b) une vitamine ou un minéral nutritif est déclaré comme constituant d’un ingrédient du produit, sauf si l’ingrédient est de la farine; c) [Abrogé, DORS/2022-168, art. 14] d) le produit est de la viande, un sous-produit de viande, de la viande de volaille ou un sous-produit de viande de volaille hachés; e) l’étiquette du produit ou une annonce faite par le fabricant du produit ou sous ses ordres comporte, selon le cas : (i) une mention de la valeur énergétique, d’un élément nutritif figurant à la colonne 1 du tableau de la présente section ou à la colonne 1 du tableau de l’article B.01.402 ou de mention d’un composant de l’élément nutritif, autre qu’un renseignement prévu au titre 12 ou une mention du nom usuel de l’ingrédient dans la liste des ingrédients du produit, (ii) une déclaration indiquant expressément ou implicitement que le produit a des propriétés particulières liées à la nutrition ou à la santé, notamment une mention ou une allégation figurant à la colonne 4 du Tableau des mentions et des allégations autorisées concernant les nutriments, ou à la colonne 1 du tableau suivant l’article B.01.603 ou aux articles B.01.311, D.01.006 ou D.02.004, (iii) un nom, une mention, un logo, un symbole, un sceau d’approbation ou toute autre marque concernant la santé, (iv) les mentions « valeur nutritive », « valeurs nutritives » ou « nutrition facts ». (b) the energy value; (d) the amount of carbohydrate; (e) the amount of protein; (b) the energy value; (d) the amount of carbohydrate; (e) the amount of protein; (j) the % Daily Value interpretative statement. présent article qui ne peut être exprimée par « 0 » au tableau de la valeur nutritive; j) la mention « Source négligeable de (désignation de tout élément nutritif omis conformément au présent paragraphe) » ou, si le produit remplit les conditions du paragraphe B.01.455(3), la mention « Source négligeable d’autres éléments nutritifs ». (6.1) Le tableau de la valeur nutritive d’un produit préemballé à portion individuelle autre qu’un repas préemballé peut ne contenir que les renseignements suivants : a) la portion indiquée; b) la valeur énergétique; c) la teneur en lipides; d) la teneur en glucides; e) la teneur en protéines; f) la teneur en tout élément nutritif qui fait l’objet d’une déclaration visée au sous-alinéa (3)e)(ii); g) la teneur en un polyalcool, en une vitamine ou en un minéral nutritif ajoutés au produit, à l’exclusion de l’iodure ajouté à du sel de table ou à du sel d’usage domestique général et du fluorure ajouté à de l’eau ou à de la glace préemballées; h) la teneur en tout élément nutritif visé à la colonne des articles 4 et 5 du tableau du présent article et la somme des acides gras saturés et des acides gras trans si l’une de ces teneurs ou cette somme ne peut être exprimée par « 0 » au tableau de la valeur nutritive; i) la teneur en tout élément nutritif visé à la colonne des articles 8 et 11 du présent tableau et qui ne peut être exprimée par « 0 » au tableau de la valeur nutritive; j) l’énoncé interprétatif du % de la valeur quotidienne.

(2)

Subject to subsections (9), (10) and (11), all information required by these Regulations to be shown on the label of a food shall be shown in both official languages.

(7)

Le paragraphe (1) ne s’applique pas aux produits préemballés suivants : a) tout produit destiné uniquement à être utilisé comme ingrédient dans la fabrication d’autres produits préemballés destinés à être vendus au consommateur au niveau du commerce de détail ou comme ingrédient dans la préparation d’aliments par une entreprise commerciale ou industrielle ou une institution;

(3)

Subject to subsections (4) to (6), subsection (2) does not apply to a local food or test market food if (a) it is sold in a local government unit in which one of the official languages is the mother tongue of less than 10 per cent of the total number of persons residing in the local government unit; and (b) the information required by these Regulations to be shown on the label of a food is shown in the official language that is the mother tongue of at least 10 per cent of the total number of persons residing in the local government unit.

(8)

If the nutrition facts table on the label of a prepackaged product corresponds to Figure 6.5(B), 6.6(B), 6.5.1(B), 6.6.1(B), 7.3(B), 7.4(B), 7.3.1(B), 7.4.1(B), 17.2(E) and (F), 17.2.1(E) and (F), 24.1(E) and (F) to 24.6(E) and (F), 25.1(B) to 25.6(B), 26.1(B) to 26.4(B), 32.1(E) and (F) or 32.2(E) and (F) of the Directory of NFT Formats, the nutrition facts table is not required to show the % Daily Value interpretative statement referred to in item 16 of the table to this section. TABLE Core Information Column 1 Item Column 2 Information Column 3 Description Column 4 Unit 1 per package, (i) in grams or millilitres, in accordance with subparagraph B.01.002A(2)(a)(i) or (ii); and 2 Energy value “Calories”, “Total Calories” or “Calories, Total” (ii) in all other cases, to the nearest multiple of 1 Calorie; 3 “Fat”, “Total Fat” or “Fat, Total” Column 1 Item 4 Amount of saturated fatty acids 5 Amount of trans fatty acids Column 2 Information "Saturated Fat", "Saturated Fatty Acids", "Saturated" or "Saturates" "Trans Fat", "Trans Fatty Acids" or "Trans" Column 3 Description Column 4 Unit Manner of expression (ii) in all other cases, to the nearest multiple of 0.1 g; (ii) in all other cases, to the nearest multiple of 0.1 g; (ii) in all other cases, to the nearest multiple of 0.1 g; PART B Foods DIVISION 1 Nutrition Labelling

(4)

Where one of the official languages is the mother tongue of less than 10 per cent of the total number of persons residing in a local government unit and the other official language is the mother tongue of less than 10 per cent of the total number of persons residing in the same local government unit, subsection (3) does not apply.

Section B.01.401

Règlement sur les aliments et drogues

(5)

Subsection (3) does not apply to a test market food unless the person who intends to conduct the test marketing of the food has, six weeks prior to conducting the test marketing, filed with the President of the Canadian Food Inspection Agency a notice of intention in a form acceptable to the President.

PARTIE B Aliments

(6)

A test market food shall, for the purposes of subsection (3), cease to be a test market food upon the expiration of 12 cumulative months after the date on which it was first offered for sale as a test market food but any test market food that was acquired for resale by a person, other than the person who filed the notice of intention referred to in subsection (5), before the expiration of those 12 cumulative months, shall continue to be a test market food for the purposes of subsection (3) until it is sold.

TITRE 1

Étiquetage nutritionnel

(7)

Subsection (2) does not apply to a specialty food if the information required by these Regulations to be shown on the label thereof is shown in one of the official languages.

Article B.01.401

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (b) if it is 0.5 g or more, to the nearest multiple of 1 g. PART B Foods DIVISION 1 Nutrition Labelling

(8)

Where there are one or more surfaces on the label of a food that are of at least the same size and prominence as the principal display panel, the information required by these Regulations to be shown on the principal display panel may be shown on those surfaces. panel may be shown in one official language if such information is shown in the other official language on one of those other surfaces.

Section B.01.401

Règlement sur les aliments et drogues

(9)

Subsection (2) does not apply to the identity and principal place of business of the person by or for whom the food was manufactured, processed, produced or packaged for resale if this information is shown in one of the official languages.

PARTIE B Aliments

(10)

Subsection (2) does not apply to the following common names if the common name appears on the principal display panel in the following manner:

TITRE 1

Étiquetage nutritionnel

(11)

Subsection (2) does not apply to the label of a shipping container destined to a commercial or industrial enterprise or an institution, if (a) the shipping container and its contents are not resold as a one unit prepackaged product to a consumer at the retail level; and (b) all information required by these Regulations to be shown on a label of a food is shown in one of the official languages. B.01.013 (1) Unless specifically required by the Act or these Regulations, no reference, direct or indirect, to the Act or to these Regulations shall be made on any label of, or in any advertisement for, a food.

Article B.01.401

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (d) if it is 250 mg or more, to the nearest multiple of 50 mg. (d) if it is 250 mg or more, to the nearest multiple of 50 mg. PART B Foods DIVISION 1 Nutrition Labelling

(2)

Notwithstanding subsection (1), where a food complies with a standard established by these Regulations and the manufacturer of the food has substantiated, by means of the results of tests carried out before the statement is made or by other evidence that exists before the statement is made, that the food so complies, a statement that the food “complies with the standard for (name the common name of the food in respect of which the claim is made) in the Food and Drug Regulations” may be made on the label of, or in an advertisement for, the food. B.01.014 (1) The label of a food that contains aspartame must carry a statement warning individuals with phenylketonuria that the food contains phenylalanine or a statement to the effect that aspartame contains phenylalanine. (b) appear, in respect of each linguistic version, immediately after the list of ingredients appearing in the same language, either on the same line as the last ingredient in the list or on the following line, without any intervening printed, written or graphic material; and (c) appear on the same continuous surface as the list of ingredients and be shown in the same manner as the list is shown under subsection B.01.008.2(2). B.01.018 The label of a food that contains polydextrose shall indicate the amount of polydextrose expressed in grams per serving of stated size. B.01.021 (1) The label of a food that contains erythritol shall carry a statement indicating the amount of erythritol expressed in grams per serving of stated size unless the label carries a nutrition facts table or supplemented food facts table.

Section B.01.401

Règlement sur les aliments et drogues

(2)

The statement of the amount of erythritol shall be grouped together with the statement of the amount of any other sugar alcohols and the amount of polydextrose. B.01.023 The label of a food that is a table-top sweetener that contains aspartame, sucralose, acesulfame-potassium or neotame must carry a statement of the sweetness B.01.033 (1) Except in the case of a formulated liquid diet, human milk fortifier or human milk substitute, it is prohibited to sell a food represented in any manner as containing hydrolyzed or partially hydrolyzed collagen, hydrolyzed or partially hydrolyzed gelatin or hydrolyzed or partially hydrolyzed casein unless the label carries the following statement on the principal display panel in the same size type used for the common name:

PARTIE B Aliments

(2)

In this section, formulated liquid diet means a food that meets the requirements of sections B.24.101 to B.24.103. B.01.035 (1) Subject to subsection (8), where an irradiated food referred to in column 1 of the table to Division 26 is offered for sale as a prepackaged product, the principal display panel of the label applied to the package shall carry the symbol described in subsection (5).

TITRE 1

Étiquetage nutritionnel

(2)

Where an irradiated food referred to in column 1 of the table to Division 26 is not a prepackaged product and is offered for sale, a sign that carries the symbol described in subsection (5) shall be displayed immediately next to the food.

Article B.01.401

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. TABLEAU Renseignements principaux Colonne 1 | Colonne 2 | Colonne 3 | Colonne 4

(3)

The symbol required pursuant to subsection (1) or (2) shall appear in close proximity on the principal display panel referred to in subsection (1) or on the sign referred to in subsection (2) to one of the following statements or a written statement that has the same meaning: (a) "treated with radiation"; (b) "treated by irradiation"; or (c) "irradiated".

Article | Renseignements | Nomenclature | Unité | Règles d’écriture

1 | Portion indiquée | « Portion (portion indiquée) », « pour (portion indiquée) » ou « par (portion indiquée) » | La portion est exprimée : a) s’agissant d’un produit préemballé à portion individuelle : (i) par emballage, (ii) en grammes ou en millilitres tel qu’il est prévu aux sous-alinéas B.01.002A(2)a)(ii) et (iii); b) s’agissant d’un produit préemballé à portions multiples, selon les unités ci-après indiquées à la colonne 3B du Tableau des quantités de référence : (i) la mesure domestique applicable au produit, (ii) la mesure métrique applicable au produit.

(4)

No person shall sell a food referred to in column 1 of the table to Division 26 that has been irradiated in the manner set out in subsection B.26.003(2) unless the requirements of subsections (1) to (3) are met.

(1)

La portion exprimée en unité métrique est arrondie : a) lorsqu’elle est inférieure à 10 g ou 10 mL : au plus proche multiple de 0,1 g ou 0,1 mL; b) lorsqu’elle est égale ou supérieure à 10 g ou 10 mL : au plus proche multiple de 1 g ou 1 mL.

(5)

For the purposes of subsections (1) to (3), the symbol that indicates the irradiated food shall (a) have an outer diameter (i) in the case referred to in subsection (1), equal to or greater than the height of the numerical quantity prescribed by paragraph 229(1)(a) and subsections 229(2) and (3) of the Safe Food for Canadians Regulations for the declaration of net quantity of the package, and (ii) in the case referred to in subsection (2), not less than 5 cm; and (b) be in the following form:

(2)

La portion exprimée en fraction est présentée au numérateur et au dénominateur séparés d’une barre.

(6)

Notwithstanding subsection B.01.009(1), any food referred to in column 1 of the table to Division 26 that is an ingredient or component of a prepackaged product and that has been irradiated shall, if the food constitutes 10 per cent or more of the prepackaged product, be included in the list of ingredients and preceded by the statement “irradiated”.

(3)

La portion comparée à une « assiette » lorsque le terme « assiette » est mentionné dans les renseignements ou concerne un assortiment d’aliments incluant un plat ou une valeur composée. PART B Foods DIVISION 1 Nutrition Labelling

(7)

The label attached to a shipping container that contains a food set out in column 1 of the table to Division 26 that has been subjected to the maximum absorbed dose set out in column 5 shall carry the statement that is required by subsection (3) and the statement “Do not irradiate again.”.

Section B.01.401

Règlement sur les aliments et drogues

(8)

Where a shipping container constitutes the package of the prepackaged product, the label attached to the shipping container shall carry the statement required by subsection (7) but need not carry the symbol required by subsection (5).

PARTIE B Aliments

(9)

Any advertising of an irradiated food referred to in column 1 of the table to Division 26 shall identify the food as having been irradiated. B.01.042 Where a standard for a food is prescribed in this Part, (a) the food shall contain only the ingredients included in the standard for the food; (b) each ingredient shall be incorporated in the food in a quantity within any limits prescribed for that ingredient; and (c) if the standard includes an ingredient to be used as a food additive for a specified purpose, that ingredient shall be a food additive set out in one of the tables to section B.16.100 for use as an additive to that food for that purpose. B.01.043 Subject to section B.25.062, where a standard for a food is not prescribed in this Part, (a) the food shall not contain any food additives except food additives set out in a table to section B.16.100 for use as additives to that food for the purpose set out in that table; and (b) each such food additive shall be incorporated in the food in a quantity within any limits prescribed for that food and food additive in that table. B.01.044 Where the limit prescribed for a food additive in a table to section B.16.100 is stated to be “Good Manufacturing Practice”, the amount of the food additive added to a food in manufacturing and processing shall not exceed the amount required to accomplish the purpose for which that additive is permitted to be added to that food. (a) where specifications are set out in this Part for that additive, meet those specifications; (b) where no specifications are set out in this Part for the additive, meet the specifications for it, if any, set out in (i) the Food Chemicals Codex, tenth edition, 2016, published by the United States Pharmacopeial Convention, Rockville, MD, United States of America, as that or any subsequent edition, including their supplements, may be amended from time to time; or (ii) the Combined Compendium of Food Additive Specifications, prepared by the Joint FAO/WHO Expert Committee on Food Additives and published by the Food and Agriculture Organization of the United Nations, on the website of the Organization, as amended from time to time; and (c) in the case of a food colour for which no specifications exist under paragraph (a) or (b), contain no more than B.01.047.1 (1) The following definitions apply in this section. BSE means Bovine Spongiform Encephalopathy. (ESB)

TITRE 1

Étiquetage nutritionnel

(3)

Subsection (2) does not apply in respect of food that originates from a country that is designated as being free from BSE in accordance with section 7 of the Health of Animals Regulations.

Article B.01.401

Colonne 1

(4)

Subsection (2) does not apply in respect of food that is packaged for sale or imported for sale before the day on which this subsection comes into force. (a) any animal intended for consumption as food if any product containing any drug listed in subsection (2) has been administered to the animal; (b) any food that is derived from an animal if any product containing a drug listed in subsection (2) has been administered to the animal; or (c) any food that is derived from an animal if the food contains any residue of a drug listed in subsection (2).

Article

Colonne 2 Renseignements Nomenclature Colonne 3 Unité Colonne 4 Règles d'écriture 2 Valeur énergétique « Calories » ou « Calories totales » La valeur est exprimée en Calories par portion indiquée. La valeur est arrondie : a) lorsqu’elle est inférieure à 5 Calories : (i) si le produit répond aux critères mentionnés à la colonne 2 de l’article 1 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « sans énergie » visé à la colonne 1 à 0 Calorie, (ii) dans les autres cas; au plus proche multiple de 1 Calorie; b) lorsqu’elle est égale ou supérieure à 5 Calories sans dépasser 50 Calories : au plus proche multiple de 5 Calories; c) lorsqu’elle est supérieure à 50 Calories : au plus proche multiple de 10 Calories. 3 Teneur en lipides « Lipides » ou « Total des lipides » La teneur est exprimée : a) en grammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(2)

The drugs referred to in subsection (1) are (a) chloramphenicol and its salts and derivatives; (b) a 5-nitrofuran compound; (c) clenbuterol and its salts and derivatives; (e) diethylstilbestrol and other stilbene compounds. B.01.049 No person shall use, in labelling, packaging, advertising or selling a food that does not meet the requirements of the kashruth applicable to it, the word “kosher” or any letters of the Hebrew alphabet or any other word, expression, depiction, sign, symbol, mark, device or other representation that indicates or that is likely to create an impression that the food is kosher. B.01.050 A person must not use, in labelling, packaging, advertising or selling a food, the word “halal” — or any letters of the Arabic alphabet or any other word, expression, depiction, sign, symbol, mark, device or other representation that indicates or that is likely to create an impression that the food is halal — unless the name of the person or body that certified the food as halal is indicated on the label or package or in the advertisement or sale. B.01.053 No person shall sell a product represented as a ready breakfast or instant breakfast or by any similar designation unless each serving of stated size of the product contains (a) not less than 4.0 mg. iron; (b) Vitamin A, thiamine, riboflavin, niacin or niacinamide and Vitamin C; (c) a good dietary source of protein; and B.01.054 (1) In order to generate information in support of an amendment to the Regulations, the Minister may issue to the manufacturer or distributor of a food, where the food or the packaging, labelling or advertising of the food does not comply with the requirements of these Regulations, a Temporary Marketing Authorization Letter that authorizes the sale of the food described therein or the packaging, labelling or advertising of the food described therein for a specified period of time within a designated area and in a specified quantity, in the manner specified in the Letter if (a) the manufacturer or distributor of the food has supplied to the Minister the following information: (i) the purpose for which the temporary marketing authorization of the food is required, (ii) a description of the food including a sample and proposed label, (iii) a description of any proposed variation from the requirements of these Regulations, (iv) adequate data to show that the use of the food will not be detrimental to the health of the purchaser or user, (v) the proposed quantity of the food to be sold, (vi) the proposed period of time required for such sale, (vii) the proposed area designated for such sale, and (viii) such other data as the Minister may require; and (b) the manufacturer or distributor of the food has agreed to (i) describe the food on a label or in an advertisement in a manner that is not false, misleading or deceptive, (ii) use such marks or statements on the label or in any advertisement as the Minister may require, (iii) on request, submit to the Minister results of the temporary marketing, and (iv) on request, withdraw the product from sale where the Minister is of the opinion that it is in the public interest to do so.

(1)

La teneur arrondie : a) lorsqu’elle est inférieure à 0,5 g : (i) si le produit répond aux critères mentionnés à la colonne 2 de l’article 11 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « sans lipides » visé à la colonne 1 et si les teneurs en acides gras saturés et en acides gras trans exprimées en grammes par table de la valeur nutritive, ou sont omises de ce tableau conformément au paragraphe B.01.401(6), et qu’aucun autre acide gras n’est exprimé par une valeur supérieure à 0,3 g : à 0 g, (ii) dans les autres cas : au plus proche multiple de 0,1 g; b) lorsqu’elle est égale ou supérieure à 0,5 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g.

(2)

The Minister shall, in any Temporary Marketing Authorization Letter issued pursuant to subsection (1), set out (a) the common name and description of the food to be sold; (b) the name and address of the manufacturer or distributor of the food; (c) the purpose for which the temporary marketing of the food is authorized; (d.1) the type of packaging, labelling or advertising authorized in respect of the food where the Letter is intended to authorize a variation from a requirement of any provision of the Regulations respecting packaging, labelling or advertising; (e) the period of time during which the food may be sold; and (f) the designated area within which the food may be sold. B.01.055 (1) A manufacturer or distributor named in a Temporary Marketing Authorization Letter issued pursuant to subsection B.01.054(1) may, for the purpose set out in the Letter, sell the food in the manner authorized in the Letter and package, label or advertise that food in the manner authorized in the Letter for the period of time, within the designated area and in the quantity set out in the Letter.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 g » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 4 Teneur en acides gras saturés « Acides gras saturés », « Lipides saturés » ou « saturés » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : (i) si le produit répond aux critères mentionnés à la colonne 2 de l’article 18 du Tableau des mentions et des allégations PART B Foods DIVISION 1 Nutrition Labelling

(2)

No provision of these Regulations made pursuant to paragraph 30(1)(b) of the Act applies in respect of a food or the packaging, labelling or advertising of a food for which a Temporary Marketing Authorization Letter has been issued pursuant to subsection B.01.054(1) to the extent that the food, or the packaging, labelling or advertising of the food, as authorized in the Letter, does not comply with that provision. B.01.070 [S]. Mixed nuts or a mixture of nuts shall consist of a mixture of nuts in which not less than five per cent by weight of each type of nuts is present in the mixture. B.01.071 Where a prepackaged product is a mixture of nuts, the percentage and common name of the nut that is present in the product in the greatest amount by weight shall be applied to the principal display panel of the package in close proximity to the common name of the product. B.01.072 Notwithstanding any requirement prescribed in Part B, a food product that has been subjected to heat in the presence of a vaporized liquid solution of smoke derived from hardwood, hardwood sawdust or corn cobs may be described as “smoked”. B.01.080 (1) In this section, frozen means preserved by freezing temperature and does not include any surface freezing that may occur during holding and transportation.

Section B.01.401

Règlement sur les aliments et drogues

(2)

Where meat, meat by-products, poultry meat, poultry by-products or fish, or meat of any animal or flesh water animal, that has been frozen is thawed prior to sale, the words “previously frozen” shall be shown (a) on the principal display panel in close proximity to the common name of the food and in letters at least as legible and conspicuous as those used in the common name; (b) anywhere on the principal display panel in letters of not less than 1/4 of an inch (6.4 millimetres) in height; or (c) on a sign displayed adjacent to the food in letters that are easily visible and legible to a prospective purchaser.

PARTIE B Aliments

(3)

Where part of a food referred to in subsection (2) has been frozen and thawed prior to sale, the words “Made from fresh and frozen portions” or “Made from fresh and frozen (naming the food)” shall be shown in the manner described in paragraph (2)(a), (b) or (c). B.01.090 (1) No person shall offer for sale at retail any solid cut meat or solid cut poultry meat to which phosphate salts or water has been added, unless that meat or poultry meat is contained in a package and carries a label.

TITRE 1

Étiquetage nutritionnel

(2)

The label referred to in subsection (1) shall contain a statement of the minimum percentage of meat protein as part of the common name of the product on the principal display panel of the package in type that is as legible and conspicuous as any other type on that display panel, and in letters that are at least one half of the size of the letters used in the common name of the product but that are not less than 1.6 mm in height. B.01.091 The label of any solid cut meat or solid cut poultry meat that has had phosphate salts or water added to it, that is not cured and that is prepackaged at retail shall contain a statement of the ingredients contained in the food in accordance with subsections B.01.008.2(1) to (5) and (7). B.01.100 (1) The common name of a simulated meat product or simulated poultry product shall be the common name of the meat product or poultry product that it resembles, modified by the word “simulated”.

Article B.01.401

Colonne 1

(2)

The word “simulated” in the common name of a simulated meat product or simulated poultry product shall be shown in letters of at least the same size and prominence as those used in the remainder of the common name of that product.

Article

Colonne 2 Renseignements Nomenclature Colonne 3 Unité Colonne 4 Règles d'écriture 5 Teneur en acides gras trans « Acides gras trans », « Lipides trans » ou « trans » La teneur est exprimée en grammes par portion indiquée. a) lorsque la teneur est inférieure à 0,5 g : (i) si le produit répond aux critères mentionnés à la colonne 2 de l'article 22 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « sans acides gras trans » visé à la colonne 1 : à 0 g; (ii) dans les autres cas : au plus proche multiple de 0,1 g; b) lorsqu'elle est égale ou supérieure à 0,5 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu'elle est supérieure à 5 g : au plus proche multiple de 1 g. 6 Somme des acides gras saturés et des acides gras trans « Acides gras saturés + acides gras trans », « Lipides saturés + lipides trans » ou « saturés + trans » La somme est exprimée en pourcentage de la valeur quotidienne par portion indiquée. Le pourcentage est arrondi : a) lorsque la teneur en acides gras saturés et en acides gras trans déclarée est 0 g : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 7 Teneur en cholestérol « Cholestérol » La teneur : a) est exprimée en milligrammes par portion indiquée; b) peut aussi être exprimée en pourcentage de la valeur quotidienne par portion indiquée.

(3)

Where a simulated meat product or a simulated poultry product is not a prepackaged product, the common name of the product and the other information required by this section to be shown on the label of a simulated meat product or simulated poultry product shall be shown on a sign displayed on or adjacent to the product in letters that are legible and conspicuous to a prospective purchaser. (a) “contains no meat”, in the case of a simulated meat product, and (b) “contains no poultry”, in the case of a simulated poultry product, shall be shown on the principal display panel of the label of a simulated meat product or simulated poultry product in close proximity to the common name and in letters of at least the same size and prominence as those shown in the common name. B.01.101 (1) For the purposes of this section and section B.01.102, source of protein means any food that contains protein, but does not include spices, seasonings, flavours, artificial flavours, flavour enhancers, food additives and similar foods that contain only small amounts of protein.

(1)

La teneur est arrondie : a) si le produit répond aux critères mentionnés à la colonne 2 de l'article 27 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « sans cholestérol » visé à la colonne 1 : à 0 mg; b) dans les autres cas : au plus proche multiple de 1 mg.

(2)

The common name of a meat product extender shall be the common name of each food in the meat product extender that is a source of protein, plus (a) the word “meat”, or the common name of the meat product that is to be extended, plus the word “extender”; or (b) the words “extender for” plus the common name of the meat product that is to be extended.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est 0 mg : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 8 Teneur en sodium « Sodium » La teneur est exprimée : a) en milligrammes par portion indiquée;

(3)

The common name of a poultry product extender shall be the common name of each food in the poultry product extender that is a source of protein, plus (a) the word “poultry”, or the common name of the poultry product that is to be extended plus the word “extender”; or (b) the words “extender for” plus the common name of the poultry product that is to be extended.

(1)

La teneur est arrondie : a) lorsque elle est inférieure à 5 mg : (i) si le produit répond aux critères mentionnés à la colonne 2 PART B Foods DIVISION 1 Nutrition Labeling

(4)

Foods that are a source of protein in the meat product extender or poultry product extender shall be shown by their common names in the common name of the meat product extender or poultry product extender (a) in descending order of their proportion by weight of the meat product extender or poultry product extender; and (b) in letters of at least the same size and prominence as those used in the remainder of the common name of the meat product extender or poultry product extender. B.01.102 (1) The common name of an extended meat product or an extended poultry product shall be the common name of the meat product or poultry product that is extended, modified by the common name of each of the foods that are sources of protein in the extended meat product or extended poultry product. (a) the word or words “meat”, “meat product”, “poultry”, “poultry meat” or “poultry meat by-product” as the case may be, may be used in the common name of an extended meat product or extended poultry product as the common name of the food therein that is a source of protein derived from a meat product or poultry product; and (b) where it is an acceptable manufacturing practice for a manufacturer to omit from his meat product extender or poultry product extender any source of protein derived from a plant that is ordinarily an ingredient of that meat product extender or poultry product extender, or to substitute in whole or in part in his meat product extender or poultry product extender any source of protein derived from a plant for a source of protein that is ordinarily an ingredient of that meat product extender or poultry product extender, the word “plant” may be used in the common name of an extended meat product or extended poultry product as the common name of the food therein that is a source of protein derived from a plant.

Section B.01.401

Règlement sur les aliments et drogues

(3)

Foods that are a source of protein in an extended meat product or extended poultry product shall be shown by their common names in the common name of that product (a) in descending order of their proportion by weight of that product; and (b) in letters of at least the same size and prominence as those used in the remainder of the common name of that product.

PARTIE B Aliments

(4)

Where an extended meat product or extended poultry product is not a prepackaged product, the common name of that product and the information required by this section to be shown on the label of an extended meat product or extended poultry product shall be shown on a sign displayed on or adjacent to that product in letters that are legible and conspicuous to a prospective purchaser. B.01.301 (1) No person shall, on the label of or in any advertisement for a food, other than in the nutrition facts table or supplemented food facts table, if any, include a declaration of the food’s energy value or the amount of a nutrient or supplemental ingredient contained in the food unless it is declared in the following manner, per serving of stated size: (b) in the case of a vitamin referred to in subsection D.01.002(1) that is not one of the following vitamins, in the applicable unit set out in subsection D.01.003(1): (i) beta-carotene as a form of vitamin A or retinol, including its derivatives, as a form of vitamin A, or both, if either is a supplemental ingredient, and (b.01) in the case of the following vitamins, in the applicable unit set out in column 3 of the List of Permitted Supplemental Ingredients: (i) beta-carotene as a form of vitamin A or retinol, including its derivatives, as a form of vitamin A, or both, if either is a supplemental ingredient, and (b.1) in the case of the following mineral nutrients: (c) in the case of cholesterol, in milligrams; (d.1) in the case of a supplemental ingredient other than a vitamin or mineral nutrient referred to in this subsection, in the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients; and (e) in any other case, in grams. (1.1) Despite subsection D.01.003(1) and for the purposes of this section, the amount in metric units of the vitamins referred to in paragraph (1)(b.01) must be determined in terms of their amount in the supplemented food in accordance with column 5 of the List of Permitted Supplemental Ingredients, as applicable.

TITRE 1

Étiquetage nutritionnel

(2)

Despite subsection (1), a person may, on the label of or in any advertisement for a food, other than in the nutrition facts table or supplemented food facts table, if any, include a declaration of the percentage of the daily value of a nutrient contained in the food if (a) in the case of a food that is not a supplemented food, the nutrient is listed in column 1 of the table to section B.01.401 or the table to section B.01.402 and the percentage of the daily value of the nutrient is required or permitted to be declared in the nutrition facts table; (b) in the case of a supplemented food, the nutrient is listed in column 1 of the table to section B.29.002 or the table to section B.29.003, or referred to in column 2 of item 18 of the table to section B.29.002, and the percentage of the daily value of the nutrient is required or permitted to be declared in the supplemented food facts table; and (c) the percentage of the daily value of the nutrient is declared per serving of stated size.

Article B.01.401

Colonne 1

(3)

A declaration referred to in subsection (1) or (2) that appears on the label of a food shall be (a) in English and French; or (b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language. B.01.302 If the label of a multiple-serving prepackaged product indicates that the product contains or, if prepared as directed in or on the package, provides a specified number of servings or portions, that information must be based on the serving of stated size set out in the nutrition facts table or supplemented food facts table, as the case may be. B.01.305 (1) No person shall, on the label of or in any advertisement for a food, make a representation, express or implied, respecting a protein unless the food meets the conditions set out in column 2 of item 8 of the Table of Permitted Nutrient Content Statements and Claims for the subject “source of protein” set out in column 1.

Article

Colonne 2 Renseignements Nomenclature Colonne 3 Unité Colonne 4 Règles d'écriture b) en pourcentage de la valeur quotidienne par portion indiquée. de l’article 31 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « sans sodium ou sans sel » visé à la colonne 1 à 0 mg; (ii) dans les autres cas : au plus proche multiple de 1 mg; b) lorsqu’elle est égale ou supérieure à 5 mg sans dépasser 140 mg : au plus proche multiple de 5 mg; c) lorsqu’elle est supérieure à 140 mg : au plus proche multiple de 10 mg.

(2)

No person shall, on the label of or in any advertisement for a food, other than a supplemented food, make a representation, express or implied, respecting an amino acid unless (a) the food meets the conditions set out in column 2 of item 8 of the Table of Permitted Nutrient Content Statements and Claims for the subject “source of protein” set out in column 1; and (b) the label or advertisement includes a declaration of the amount of histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine contained in the food, expressed in grams per serving of stated size. (a) a formulated liquid diet, human milk fortifier, human milk substitute or food represented as containing a human milk substitute; (b) foods represented for use in gluten-free diets, protein restricted diets, low (naming the amino acid) diets and (naming the amino acid) free diets; (c) the word “protein” when used as part of the common name of an ingredient in the list of ingredients; (e) the common names that are set out in the Common Names for Ingredients and Components Document, if shown in the list of ingredients in accordance with paragraph B.01.010(3)(a); (f) the common name of a single amino acid preparation that may be sold as a food; (h) a statement or claim set out in column 4 of item 7 of the Table of Permitted Nutrient Content Statements and Claims respecting the subject “low in protein” set out in column 1; (i) a declaration of the amount of protein in the nutrition facts table or supplemented food facts table, as the case may be; (k) a statement that a food is not a source of protein.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 9 Teneur en glucides « Glucides » ou « Total des glucides » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. 10 Teneur en fibres « Fibres » ou « Fibres alimentaires » La teneur est exprimée : a) en grammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(4)

A representation referred to in subsection (1) or (2) that appears on the label of a food shall be (a) in English and French; or (b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language. B.01.311 (1) Subject to subsections (2) and (3), no person shall, on the label of or in any advertisement for a food, make a representation, express or implied, concerning the action or effect of the food’s energy value or of a nutrient contained in the food.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g.

(2)

The label of or advertisement for a food may carry a statement or claim set out in column 1 of the table following section B.01.603.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 g » à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 11 Teneur en sucres « Sucres » La teneur est exprimée : a) en grammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g.

(3)

Subject to section B.01.312, the label of or advertisement for a food may carry a statement or claim to the effect that the food’s energy value or a nutrient contained in the food is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 g » à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 12 Teneur en protéines « Protéines » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : au plus proche multiple de 0,1 g; 98 À jour au 11 novembre 2024 Dernière modification le 17 juin 2024 PART B Foods DIVISION 1 Nutrition Labelling

(4)

If a statement or claim described in subsection (3) concerns a nutrient not listed in column 1 of the tables to sections B.01.401 and B.01.402 — or, as the case may be, not listed in column 1 of the tables to sections B.29.002 and B.29.003 and not referred to in column 2 of item 18 of the table to section B.29.002 — the amount of the nutrient contained in the food must be expressed on any part of the label in grams per serving of stated size.

Section B.01.401

Règlement sur les aliments et drogues

(5)

A statement or claim referred to in subsection (2) or (3) that appears on the label of a food shall be (a) in English and French; or (b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language. B.01.312 (1) If a statement or claim described in subsection B.01.311(3) is made on the label of or in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include a declaration, per serving of stated size, of (a) the energy value, if the energy value is the subject of the statement or claim; or (b) the amount of the nutrient, if a nutrient is the subject of the statement or claim. (1.1) Subsection (1) does not apply if the statement or claim is made on the label of or in the advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating.

PARTIE B Aliments

(2)

If the statement or claim is made in an advertisement other than a radio or television advertisement, the declaration referred to in subsection (1) shall be (a) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and (b) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

TITRE 1

Étiquetage nutritionnel

(3)

If the statement or claim is made in a radio advertisement or in the audio portion of a television advertisement, the declaration referred to in subsection (1) shall immediately precede or follow the statement or claim.

Article B.01.401

Colonne 1

(4)

If the statement or claim is made in a television advertisement, the declaration referred to in subsection (1) shall be communicated (a) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions; or (b) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.

Article

13 14 15 Colonne 2 Renseignements Teneur en potassium Teneur en calcium Teneur en fer Colonne 3 Nomenclature « Potassium » « Calcium » « Fer » Colonne 4 Unité La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. Règles d'écriture

(5)

If the declaration referred to in subsection (1) is communicated in the visual mode of a television advertisement, it shall (a) appear concurrently with and for at least the same amount of time as the statement or claim; (b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and (c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once. B.01.350 (1) Except as otherwise provided in this section, the principal display panel of a prepackaged product must carry a symbol that is set out in Schedule K.1 if (a) the product, as offered for sale, contains a nutrient that is set out in column 1 of the table to this section; and (b) the amount of the nutrient, calculated as a percentage of the daily value, meets or exceeds the applicable threshold set out in columns 2 to 7 of that table.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 5 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 5 mg mais moins de 50 mg : au plus proche multiple de 10 mg; c) lorsqu’elle est égale ou supérieure à 50 mg mais moins de 250 mg : au plus proche multiple de 25 mg; d) lorsqu’elle est égale ou supérieure à 250 mg : au plus proche multiple de 50 mg.

(2)

For the purposes of subsection (1), the percentage of the daily value for the nutrient is calculated on the basis of the amount of the nutrient, by weight, per serving of stated size or per reference amount, whichever is greater.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est inférieure à 0,5 % : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %.

(3)

Despite subsection (2), if the prepackaged product requires reconstitution with water or another liquid or the addition of any other ingredient for its preparation and the reference amount applicable to the product only refers to the food in its prepared form, the percentage of the daily value for the nutrient is calculated on the basis of the amount of the nutrient, by weight, per serving of stated size.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 5 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 5 mg mais moins de 50 mg : au plus proche multiple de 10 mg; c) lorsqu’elle est égale ou supérieure à 50 mg mais moins de 250 mg : au plus proche multiple de 25 mg; d) lorsqu’elle est égale ou supérieure à 250 mg : au plus proche multiple de 50 mg.

(4)

In the case of a prepackaged product referred to in subsection (3), the applicable threshold set out in columns 2 to 7 of the table to this section is determined on the basis of the product’s serving of stated size rather than its reference amount.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est inférieure à 0,5 % : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %.

(5)

Subsection (1) does not apply to the following: (a) shipping containers, unless the containers and their contents are sold as a one unit prepackaged product to a consumer at the retail level; (b) prepackaged products with an available display surface of less than 15 cm²; (c) prepackaged individual portions of food that are intended solely to be served by a restaurant or other commercial enterprise with meals or snacks; (e) prepackaged products that are intended solely for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or an institution; (f) milk, partly skimmed milk, skim milk, goat’s milk, partly skimmed goat’s milk, skimmed goat’s milk, (naming the flavour) milk, (naming the flavour) partly skimmed milk, (naming the flavour) skim milk or cream sold in a refillable glass container; (g) sweetening agents, including maple sugar and maple syrup; (h) salt for table or general household use, celery salt, garlic salt, onion salt and any other seasoning salt if “salt” forms part of the common name of the food; (i) fats and oils referred to in Division 9, fish and other marine fats and oils, butter, ghee and margarine and other similar substitutes for butter; or (j) individual rations intended for use by military personnel engaged in operations or exercises.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,05 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,05 mg mais moins de 0,5 mg : au plus proche multiple de 0,1 mg; c) lorsqu’elle est égale ou supérieure à 0,5 mg mais moins de 2,5 mg : au plus proche multiple de 0,25 mg; PART B Foods DIVISION 1 Nutrition Labelling Sections B.01.401-B.01.402 Règlement sur les aliments et drogues

(6)

Subsection (1) does not apply, in respect of a nutrient, to the following prepackaged products if the only ingredients containing the nutrient are, in the case of saturated fat or sodium, ingredients set out in subsection (7) or, in the case of sugars, ingredients set out in subsection (8): (a) whole or cut fruits or vegetables, including frozen, canned or dried fruits or vegetables; (b) milk obtained from any animal, in liquid or powdered form; (c) whole eggs, including liquid, frozen or dried eggs, or whole egg mixes; (d) nuts, seeds or nut or seed butters in which less than 30% of the total fat content consists of saturated fat; (e) vegetable oils or marine oils in which less than 30% of the total fat content consists of saturated fat; (f) marine and fresh water animal products referred to in Division 21 in which less than 30% of the total fat content consists of saturated fat; or (g) any combination of the foods referred to in paragraphs (a) to (f).

PARTIE B Aliments

(7)

For the purposes of subsection (6) in relation to saturated fat and sodium, the ingredients are the following ingredients to which no saturated fat or sodium has been added: (a) whole or cut fruits or vegetables, including frozen, canned or dried fruits or vegetables; (b) milk obtained from any animal, in liquid or powdered form; (c) whole eggs, including liquid, frozen or dried eggs, or whole egg mixes; (d) nuts, seeds or nut or seed butters in which less than 30% of the total fat content consists of saturated fat; (e) vegetable oils or marine oils in which less than 30% of the total fat content consists of saturated fat; and (f) marine and fresh water animal products referred to in Division 21 in which less than 30% of the total fat content consists of saturated fat. (b) dairy products other than those referred to in paragraph (7)(b); (c) grains; and

TITRE 1

Étiquetage nutritionnel

(9)

Subsection (1) does not apply, in respect of saturated fat and sugars, to prepackaged products that are cheese or yogurt — including drinkable yogurt — that are made from dairy products, kefir or buttermilk unless (a) in the case of saturated fat, the product contains an ingredient, other than any of the following ingredients, that contains saturated fat: (iii) nuts or seeds in which less than 30% of the total fat content consists of saturated fat, (iv) vegetable oils or marine oils in which less than 30% of the total fat content consists of saturated fat, or (v) marine and fresh water animal products referred to in Division 21 in which less than 30% of the total fat content consists of saturated fat; and (b) in the case of sugars, the product contains an ingredient, other than any of the following ingredients, that contains sugars or the product contains any of the following ingredients to which sugars have been added: (i) whole or cut fruits or vegetables, including frozen, canned or dried fruits or vegetables, (ii) dairy products,

Articles B.01.401-B.01.402

Colonne 1 | Colonne 2 | Colonne 3 | Colonne 4

(10)

For the purposes of paragraphs (6)(a) and (7)(a), fruit does not include coconut.

Article | Renseignements | Nomenclature | Unité | Règles d'écriture

16 | Énoncé interprétatif du % de la valeur quotidienne | « 5 % ou moins c’est peu, 15 % ou plus c’est beaucoup » | [non-applicable] | d) lorsqu’elle est égale ou supérieure à 2,5 mg : au plus proche multiple de 0,5 mg. 2) Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. Le sous-titre « % valeur quotidienne » ou « % VQ » est suivi d’un astérisque qui renvoie à l’énoncé interprétatif du % de la valeur quotidienne figurant au tableau de la valeur nutritive. SOR/2003-11, s. 20; SOR/2001-176, s. 5; SOR/2016-305, ss. 18, 73, 75(F); SOR/2021-57, s. 9; SOR/2022-143, s. 18(E); SOR/2022-168, s. 14; SOR/2022-168, s. 52; SOR/2022-169, s. 15. DORS/2003-11, art. 20; DORS/2001-176, art. 5; DORS/2016-305, art. 18, 73 et 75(F); DORS/2021-57, art. 9; DORS/2022-143, art. 18(A); DORS/2022-168, art. 14; DORS/2022-168, art. 52; DORS/2022-169, art. 15.

(11)

Subsection (1) does not apply, in respect of sodium, to prepackaged products that are cheese made from dairy products.

(3)

The amount of omega-6 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids and monounsaturated fatty acids shall be in the nutrition facts table if Renseignements complémentaires B.01.402 (1) Le tableau de la valeur nutritive peut également indiquer les renseignements visés à la colonne 1 du tableau du présent article.

(12)

For the application of subsections (9) and (11), the prepackaged products must (a) have a reference amount of 30 g or 30 mL or less and contain 10% or more of the daily value for calcium per serving of stated size or per reference amount, whichever is greater; or (b) have a reference amount greater than 30 g or 30 mL and contain 15% or more of the daily value for calcium per serving of stated size or per reference amount, whichever is greater.

(2)

Les renseignements visés à la colonne 1 du tableau du présent article qui sont présentés dans le tableau de la valeur nutritive sont exprimés au moyen de la nomenclature indiquée dans la colonne 2, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4. (2.1) Pour l’application du paragraphe (2), la portion indiquée qui est exprimée en unité métrique dans le tableau de la valeur nutritive d’un produit préemballé sert de fondement pour établir les renseignements relatifs à la valeur énergétique et aux éléments nutritifs indiqués dans ce tableau de la valeur nutritive du produit. (2.2) Le pourcentage de la valeur quotidienne d’une vitamine ou d’un minéral nutritif qui, aux termes du paragraphe (2), figure dans le tableau de la valeur nutritive d’un produit préemballé est établi sur la base de la teneur en poids de la vitamine ou du minéral nutritif dans la portion indiquée, par portion indiquée, puis la teneur arrondie selon les règles d’arrondissement applicables prévues à la colonne 4 du tableau du présent article.

(13)

Subsection (1) does not apply to the following prepackaged products unless they are required to carry a nutrition facts table on their label: (a) a beverage with an alcohol content of more than 0.5%; (b) a raw single ingredient meat, meat by-product, poultry meat or poultry meat by-product that is not ground; (d) a product sold only in the retail establishment where it is prepared and processed from its ingredients, including from a pre-mix if an ingredient other than water is added to the pre-mix during the preparation and processing of the product; (e) a product sold only at a road-side stand, craft show, flea market, fair, farmers’ market or sugar bush by the individual who prepared and processed the product; (f) an individual serving that is sold for immediate consumption and that has not been subjected to a process to extend its durable life, including special packaging; (g) a product sold only in the retail establishment where it is packaged, if it is labelled by means of a sticker and has an available display surface of less than 200 cm²; or (h) a product with an available display surface of less than 100 cm². (13.01) Subsection (1) does not apply to a prepackaged product that is a raw single ingredient meat, meat by-product, poultry meat or poultry meat by-product that is ground unless it meets any of the conditions that are set out in paragraph B.01.401(3)(a), (b) or (e). (13.1) Subject to subsection (13.2), subsection (1) does not apply to a supplemented food that has an available display surface of less than 100 cm² other than a supplemented food that is referred to in paragraph B.29.018(2)(b). (13.2) Subsection (1) does not apply to a supplemented food that has an available display surface of less than 100 cm², whether or not the supplemented food is referred to in paragraph B.29.018(2)(b), if the supplemented food carries a supplemented food caution identifier.

(3)

Le tableau de la valeur nutritive indique la teneur en acides gras polyinsaturés oméga-6, en polyinsaturés oméga-3 et en monoinsaturés dans l’un ou l’autre des cas suivants : a) la teneur en un de ces groupes d’acides gras ou la teneur en acides gras polyinsaturés est indiquée dans le tableau ou sur l’étiquette du produit préemballé ou

(14)

If, as a result of the application of any provision in subsections (5) to (13.2), subsection (1) does not apply to a prepackaged product or does not apply to a prepackaged product in respect of a particular nutrient, that provision prevails over any other provision in subsections (5) to (13.2) that indicates otherwise.

(5)

[Repealed, SOR/2016-305, s. 19]

(15)

Despite any other provision in this section, the label of the following prepackaged products must not carry a symbol referred to in subsection (1): (a) a prepackaged product intended solely for infants six months of age or older but less than one year of age; (b) a human milk fortifier; (c) a human milk substitute or a food represented as containing a human milk substitute; (e) a meal replacement; (g) a food represented for protein-restricted diets; (h) a food represented for low (naming the amino acid) diets; and (i) a food represented for use in a very low energy diet as defined in section B.24.001. Threshold for a prepackaged product other than one referred to in columns 5 to 7 | Threshold for a prepackaged product intended solely for children one year of age or older, but less than four years of age Item | Nutrient | Prepackaged product with a reference amount greater than 30 g or 30 mL, unless the product is described in column 4 | Prepackaged product with a reference amount of 30 g or 30 mL or less | Prepackaged main dish with a reference amount of 200 g or more | Prepackaged product with a reference amount greater than 30 g or 30 mL, unless the product is described in column 7 | Prepackaged product with a reference amount of 30 g or 30 mL or less | Prepackaged main dish with a reference amount of 170 g or more

(8)

[Repealed, SOR/2018-108, s. 395] TABLE Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression 1 | Servings per package | “Servings per Container”, “(number of units) per Container”, “Servings per Package”, “Number of units per Package”, “Servings per | The quantity is expressed in number of servings. | (1) The quantity is rounded off Item 2 Column 1: Energy value Column 2: "kilojoules" or "kJ" Column 4: The value is rounded off to the nearest multiple of 10 kilojoules. [Repealed, SOR/2016-305, s. 19] Item 5 Column 1: Amount of polyunsaturated fatty acids Column 2: "Polyunsaturated Fat," "Polyunsaturated Fatty Acids," "Polyunsaturated" or "Polyunsaturates" Item 6 Column 1: Amount of omega-6 polyunsaturated fatty acids Column 2: "Omega-6," "Omega-6 Polyunsaturated Fat," "Omega-6 Polyunsaturated Fatty Acids," "Omega-6 Polyunsaturates" or "Omega-6 Polyunsaturated"

1 | Saturated fat | 15% of the daily value for the sum of saturated fatty acids and trans fatty acids set out in column 3 of Part 1 of the Table of Daily Values | 10% of the daily value for the sum of saturated fatty acids and trans fatty acids set out in column 3 of Part 1 of the Table of Daily Values | 30% of the daily value for the sum of saturated fatty acids and trans fatty acids set out in column 3 of Part 1 of the Table of Daily Values | 15% of the daily value for the sum of saturated fatty acids and trans fatty acids set out in column 2 of Part 1 of the Table of Daily Values | 10% of the daily value for the sum of saturated fatty acids and trans fatty acids set out in column 2 of Part 1 of the Table of Daily Values | 30% of the daily value for the sum of saturated fatty acids and trans fatty acids set out in column 2 of Part 1 of the Table of Daily Values

(2)

In all other cases: "Omega-6 Polyunsaturated Fat," "Omega-6 Polyunsaturated Fatty Acids," "Omega-6 Polyunsaturates" or "Omega-6 Polyunsaturated" Item 7 Column 1: Amount of omega-3 polyunsaturated fatty acids Column 2: "Omega-3," "Omega-3 Polyunsaturated Fat," "Omega-3 Polyunsaturated Fatty Acids," "Omega-3 Polyunsaturates" or "Omega-3 Polyunsaturated"

2 | Sugars | 15% of the daily value for sugars set out in column 3 of Part 1 of the Table of Daily Values | 10% of the daily value for sugars set out in column 3 of Part 1 of the Table of Daily Values | 30% of the daily value for sugars set out in column 3 of Part 1 of the Table of Daily Values | 15% of the daily value for sugars set out in column 2 of Part 1 of the Table of Daily Values | 10% of the daily value for sugars set out in column 2 of Part 1 of the Table of Daily Values | 30% of the daily value for sugars set out in column 2 of Part 1 of the Table of Daily Values

(2)

In all other cases: "Omega-3 Polyunsaturated Fat," "Omega-3 Polyunsaturated Fatty Acids," "Omega-3 Polyunsaturates" or "Omega-3 Polyunsaturated" PART B Foods DIVISION 1 Nutrition Labelling

3 | Sodium | 15% of the daily value for sodium set out in column 3 of Part 1 of the Table of Daily Values | 10% of the daily value for sodium set out in column 3 of Part 1 of the Table of Daily Values | 30% of the daily value for sodium set out in column 3 of Part 1 of the Table of Daily Values | 15% of the daily value for sodium set out in column 2 of Part 1 of the Table of Daily Values | 10% of the daily value for sodium set out in column 2 of Part 1 of the Table of Daily Values | 30% of the daily value for sodium set out in column 2 of Part 1 of the Table of Daily Values

B.01.351 (1) A nutrition symbol must be displayed in black and white and must be in accordance with the applicable symbol set out in Schedule K.1.

Section B.01.402

Règlement sur les aliments et drogues

(2)

Subject to subsection (3), a nutrition symbol must be presented in one of the following formats: (a) unilingual horizontal format, where two separate versions of the symbol are shown, one in English (EH) and one in French (FH); or (b) bilingual horizontal format (BH), where the symbol is shown in both official languages.

PARTIE B Aliments

(3)

If the principal display surface is less than or equal to 450 cm² and the width of the nutrition symbol in either of the horizontal formats that could apply exceeds the width of the principal display panel, the symbol must be presented in one of the following formats: (a) unilingual vertical format, where two separate versions of the symbol are shown, one in English (EV) and one in French (FV); or (b) bilingual vertical format (BV), where the symbol is shown in both official languages.

TITRE 1

Étiquetage nutritionnel

(4)

If, in accordance with subsection B.01.012(3) or (7), the information required by these Regulations may be shown on the label of a prepackaged product in English only or in French only and is shown in that language, the nutrition symbol may be displayed on the principal display panel of the product in that language only on a continuous surface of the available display surface.

Article B.01.402

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression 9 | [Repealed, SOR/2016-305, s. 19] (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (d) if it is 250 µg or more, to the nearest multiple of 100 µg. PART B Foods DIVISION 1 Nutrition Labelling

(5)

If a nutrition symbol is presented in a bilingual format, the order in which the languages appear may be reversed from the order shown in the applicable symbol set out in Schedule K.1. B.01.352 (1) The version of the nutrition symbol that must be carried on a prepackaged product that has a principal display surface that is within a range set out in column 1 of the table to this section and that contains a nutrient set out in column 2 in an amount that meets or exceeds the applicable threshold referred to in subsection B.01.350(1) is the version that is referred to in column 3 or 5 of the table or, if applicable, column 4 or 6 of the table.

Section B.01.402

Règlement sur les aliments et drogues

(2)

Despite subsection (1), a prepackaged product that has a principal display surface that is greater than 250 cm² may carry the applicable version of the nutrition symbol that is referred to in column 4, column 2, of Table 1 or 3 in the Directory of Nutrition Symbol Specifications if the product is sold only in the retail establishment where it is packaged and is labelled by means of a sticker.

PARTIE B Aliments

(3)

A nutrition symbol must be displayed in accordance with the applicable specifications set out in the Directory of Nutrition Symbol Specifications.

TITRE 1

Étiquetage nutritionnel

(4)

Despite subsection (3), a nutrition symbol may be displayed with larger dimensions than those set out in column 3 of the applicable table in the Directory of Nutrition Symbol Specifications if the symbol is enlarged in a proportional manner vertically and horizontally. Nutrition Symbols and Formats Nutrients that meet or exceed threshold in subsection B.01.350(1) Saturated fat (Sat fat) and sugars Saturated fat (Sat fat) and sugars B.01.353 (1) Subject to subsection (2), if a prepackaged product contains an assortment of foods and one or more of the foods requires a nutrition symbol, the nutrition symbols must be displayed in a manner that clearly indicates the applicable nutrients that are contained in each food.

Article B.01.402

Column 1 Item Column 2 Information Column 3 Description Column 4 Unit Manner of expression 16 Amount of vitamin D "Vitamin D" or "Vit D" (d) if it is 5 µg or more, to the nearest multiple of 1 µg. 17 Amount of vitamin E "Vitamin E" or "Vit E" (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. 18 "Vitamin K" or "Vit K" PART B Foods DIVISION 1 Nutrition Labelling

(2)

If a prepackaged product contains ingredients that are intended to be combined together or foods that are intended to be consumed together, the nutrition symbol must display the nutrients that are contained in the product as a whole. B.01.354 The characters and other elements of a nutrition symbol must not touch each other. Location of Nutrition Symbol (a) in the case of a prepackaged product with a principal display panel whose height is less than its width, on the right half of the panel; and (b) in the case of any other prepackaged product, on the upper half of the principal display panel.

Section B.01.402

Règlement sur les aliments et drogues

(2)

The nutrition symbol must be surrounded by a buffer that (a) has a width that is equal to or greater than that set out in column 4 of the applicable table in the Directory of Nutrition Symbol Specifications; and (b) does not contain any text or other graphic material.

PARTIE B Aliments

(3)

If a prepackaged product is cylindrical in shape, the outer edge of the buffer must be a minimum distance of 10% of the width of the principal display surface from the edge of the left or right side of that surface.

TITRE 1

Étiquetage nutritionnel

(4)

If it is impossible to comply with both paragraph (1)(a) and subsection (3), the nutrition symbol may be displayed partially in the left half of the principal display panel but only to the extent necessary to comply with that subsection. B.01.356 A nutrition symbol must be oriented in the same manner as most of the other information that appears on the principal display panel unless the panel is displayed in the vertical plane and most of the other information is not displayed parallel with the base of the package, in which case the symbol must be oriented in such a manner that the words appearing in it are parallel with the base. Prominence of Health-related Representations B.01.357 (1) If both a nutrition symbol and a health-related representation appear on the principal display panel of a prepackaged product and the representation relates to a nutrient that is referred to in the nutrition symbol, (a) the height of the upper case letters in the representation must not exceed the height of the upper case letters, excluding any accents, in the nutrition symbol, other than in the words “Health Canada” and “Santé Canada”; and (b) the height of the tallest ascender of the lower case letters in the representation must not exceed the height of the tallest ascender of the lower case letters in the nutrition symbol, other than in the words “Health Canada” and “Santé Canada”.

Article B.01.402

Column 1 Item Column 2 Information Column 3 Description Column 4 Unit Manner of expression 19 Amount of thiamine "Thiamine", "Thiamin", "Thiamine [Vitamin B1]", "Thiamine (Vit B1)", "Thiamin [Vitamin B1]" or "Thiamin (Vit B1)" (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 mg. 20 Amount of riboflavin (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 mg. 21 Amount of niacin "Niacin" PART B Foods DIVISION 1 Nutrition Labelling

(2)

If both a nutrition symbol and a health-related representation appear on the principal display panel of a prepackaged product and the representation does not relate to a nutrient that is referred to in the nutrition symbol, (a) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the nutrition symbol, other than in the words “Health Canada” and “Santé Canada”; and (b) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the nutrition symbol, other than in the words “Health Canada” and “Santé Canada”.

Section B.01.402

Règlement sur les aliments et drogues

(3)

In this section, health-related representation means (e) any other health-related statement, logo, symbol, seal of approval or mark, other than (i) the brand name or product name of a prepackaged product, or B.01.358 (1) It is prohibited to (a) label a prepackaged product with any representation, including a word, phrase, illustration, sign, mark, symbol or design, that is likely to be mistaken for a nutrition symbol; or (b) advertise or sell a prepackaged product that is labelled with a representation referred to in paragraph (a).

PARTIE B Aliments

(2)

For the purposes of subsection (1), a representation does not include a supplemented food caution identifier. B.01.400 (1) For the purpose of sections B.01.401 to B.01.603, fat means all fatty acids expressed as triglycerides. B.01.401 (1) Except as otherwise provided in this section and sections B.01.402 to B.01.406 and B.01.467 to B.01.469, the label of a prepackaged product shall carry a nutrition facts table that contains only the information set out in column 1 of the table to this section, expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4. (1.1) For the purpose of subsection (1), the serving of stated size set out in a nutrition facts table for a prepackaged product, as expressed in a metric unit, shall be used as the basis for determining the information appearing in the nutrition facts table in respect of the energy value and nutrient content of the product. (1.2) The percentage of the daily value for a mineral nutrient shown in the nutrition facts table for a prepackaged product in accordance with subsection (1) shall be established on the basis of the amount, by weight, of the mineral nutrient in the product, per portion, divided by 100 times the daily value set out in the table to this section. mineral nutrient per serving of stated size for the product, rounded off in the applicable manner set out in column 4 of the table to this section.

TITRE 1

Étiquetage nutritionnel

(2)

Subsection (1) does not apply to a prepackaged product if (a) all the information set out in column 1 of the table to this section, other than in respect of item 1 (“Serving of stated size”), may be expressed as “0” in the nutrition facts table in accordance with this section; (b) the product is (i) a beverage with an alcohol content of more than 0.5%, (iii) a raw single ingredient meat, meat by-product, poultry meat or poultry meat by-product, (v) sold only in the retail establishment where the product is prepared and processed from its ingredients, including from a pre-mix if an ingredient other than water is added to the pre-mix during the preparation and processing of the product, (vi) sold only at a road-side stand, craft show, flea market, fair, farmers’ market or sugar bush by the individual who prepared and processed the product, (vii) an individual serving that is sold for immediate consumption and that has not been subjected to a process to extend its durable life, including special packaging, or (viii) sold only in the retail establishment where the product is packaged, if the product is labelled by means of a sticker and has an available display surface of less than 200 cm²; or (c) the product is (i) a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating, (ii) a prepackaged individual portion of food that is intended solely to be served by a restaurant or other commercial enterprise with meals or snacks, or (iii) milk, partly skimmed milk, skim milk, goat's milk, partly skimmed goat's milk, skimmed goat's milk, (naming the flavour) milk, (naming the flavour) partly skimmed milk, (naming the flavour) skim milk or cream sold in a refillable glass container. (a) the product contains an added vitamin or mineral nutrient; (b) a vitamin or mineral nutrient is declared as a component of one of the product’s ingredients other than flour; (d) the product is a meat, meat by-product, poultry meat or poultry meat by-product that is ground; or (e) the label of the product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains (i) a reference to the energy value, a nutrient set out in column 1 of the table to this section or in column 1 of the table to section B.01.402 or a constituent of such a nutrient, other than information required by Division 12 or a reference to the common name of an ingredient in the list of ingredients for the product, (ii) a representation that expressly or implicitly indicates that the product has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004, (iii) a health-related name, statement, logo, symbol, seal of approval or mark, or

Article B.01.402

Column 1 Item Column 2 Information Column 3 Description Column 4 Unit Manner of expression "Vitamin B6" or "Vit B6" (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 mg. (d) if it is 50 µg DFE or more, to the nearest multiple of 10 µg DFE. "Vitamin B12" or "Vit B12" (d) if it is 0.25 µg or more, to the nearest multiple of 0.05 µg. PART B Foods DIVISION 1 Nutrition Labelling

(4)

Subsection (1) does not apply to a formulated liquid diet, human milk fortifier, human milk substitute, food represented as containing a human milk substitute, meal replacement, nutritional supplement, food represented for use in a very low energy diet or supplemented food.

Section B.01.402

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (d) if it is 2.5 µg or more, to the nearest multiple of 0.05 µg. (d) if it is 0.5 mg or more, to the nearest multiple of 0.1 mg. (d) if it is 50 mg or more, to the nearest multiple of 10 mg. (d) if it is 250 mg or more, to the nearest multiple of 50 mg. 29 Amount of iodide "Iodide" or "Iodine" (d) if it is 50 µg or more, to the nearest multiple of 10 µg. 30 Amount of magnesium "Magnesium" (d) if it is 50 mg or more, to the nearest multiple of 10 mg. 31 Amount of zinc "Zinc" PART B Foods DIVISION 1 Nutrition Labelling

(5)

The label of, or an advertisement for, a formulated liquid diet, human milk fortifier, human milk substitute, food represented as containing a human milk substitute, meal replacement, nutritional supplement, food represented for use in a very low energy diet or supplemented food shall not contain a nutrition facts table or the phrase “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.

Section B.01.402

Règlement sur les aliments et drogues

(6)

If, for a prepackaged product other than one intended solely for infants six months of age or older but less than one year of age, the information in respect of six or more of the energy value and nutrients referred to in column 1 of items 2 to 5 and 7 to 15 of the table to this section may be expressed as “0” in the nutrition facts table in accordance with this section, the nutrition facts table need only include the following information: (a) the serving of stated size; (c) the amount of fat; (f) the amount of any nutrient that is the subject of a representation referred to in subparagraph (3)(e)(ii); (g) the amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product, other than iodide added to salt for table or general household use or fluoride added to prepackaged water or ice; (h) the amount of any vitamin or mineral nutrient that is declared as a component of one of the prepackaged product’s ingredients other than flour; (i) the amount of any nutrient referred to in column 1 of any of items 4, 5, 7, 8, 10, 11 and 13 to 15 of the table. to this section that may not be expressed as “0” in the nutrition facts table; and (i) the statement “Not a significant source of (naming each nutrient that is omitted from the nutrition facts table in accordance with this subsection)” or, if the prepackaged product meets the condition specified in subsection B.01.455(3), the statement “Not a significant source of other nutrients”. (6.1) The nutrition facts table of a single-serving prepackaged product, other than one that is a prepackaged meal, need only include the following information: (a) the serving of stated size; (c) the amount of fat; (f) the amount of any nutrient that is the subject of a representation referred to in subparagraph (3)(e)(ii); (g) the amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product, other than iodide added to salt for table or general household use or fluoride added to prepackaged water or ice; (h) the amount of any nutrient referred to in column 1 of item 4 or 5 of the table to this section and the sum of saturated fatty acids and trans fatty acids if any of the amounts or the sum may not be expressed as “0” in the nutrition facts table; and (i) the amount of any nutrient referred to in column 1 of item 8 or 11 of the table to this section that may not be expressed as “0” in the nutrition facts table;

PARTIE B Aliments

(7)

Subsection (1) does not apply to a prepackaged product (a) that is intended solely for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or an institution; or (b) that is a multiple-serving ready-to-serve prepackaged product intended solely to be served in a commercial or industrial enterprise or an institution. Serving of stated size “Serving Size (naming the serving size)” or “Serving (naming the serving size)” The size is expressed (a) in the case of a single-serving prepackaged product, (b) in the case of a multiple-serving prepackaged product, in the following units set out in column 3B of the Table of Reference Amounts: (i) the household measure that applies to the product, and (ii) the metric measure that applies to the product.

TITRE 1

Étiquetage nutritionnel

(1)

The size when expressed in a metric unit is rounded (a) if it is less than 10 g or 10 mL, to the nearest multiple of 0.1 g or 0.1 mL; and (b) if it is 10 g or 10 mL or more, to the nearest multiple of 1 g or 1 mL.

Article B.01.402

Column 1 Item Column 2 Information Column 3 Description Column 4 Unit Manner of expression (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. 32 Amount of selenium “Selenium” (d) if it is 5 µg or more, to the nearest multiple of 1 µg. 33 Amount of copper “Copper” (d) if it is 0.05 mg or more, to the nearest multiple of 0.01 mg. 34 Amount of manganese “Manganese” Column 1 Item 35 Amount of chromium 36 Amount of molybdenum 37 Column 2 Information "Chromium" "Molybdenum" "Chloride" Column 3 Description Column 4 Unit Manner of expression (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. PART B Foods DIVISION 1 Nutrition Labelling

(2)

The size when expressed as a fraction is represented by a numerator and a denominator separated by a line.

Section B.01.402

Règlement sur les aliments et drogues

(3)

The size shall include the word “assorted” if the information in the nutrition facts table of a prepackaged product that contains an assortment of foods is set out as a composite value. The value is expressed in Calories per serving of stated size. The value is rounded off (a) if it is less than 5 Calories (i) if the product meets the conditions set out in column 2 of item 1 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of energy” set out in column 1, to “0” Calorie, and (b) if it is 5 Calories or more but not more than 50 Calories, to the nearest multiple of 5 Calories; and (c) if it is more than 50 Calories, to the nearest multiple of 10 Calories. Amount of fat The amount is expressed (a) in grams per serving of stated size; and

PARTIE B Aliments

(1)

The amount is rounded off (a) if it is less than 0.5 g The amount is expressed in grams per serving of stated size. The amount is expressed in grams per serving of stated size. (b) as a percentage of the daily value per serving of stated size. (i) if the product meets the conditions set out in column 2 of item 11 of the Table of Permitted Nutrient Content Statements and Claims for the subject "free of fat" set out in column 1 and the amounts of saturated fatty acids and trans fatty acids are declared as "0 g" in the nutrition facts table or are omitted from that table in accordance with subsection B.01.401(6) and no other fatty acids are declared in an amount greater than 0 g, to "0 g", and (b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.

TITRE 1

Étiquetage nutritionnel

(2)

The percentage is rounded off (a) if the amount is declared as "0 g", to "0%"; and (b) in all other cases, to the nearest multiple of 1%. The amount is rounded off (a) if it is less than 0.5 g (i) if the product meets the conditions set out in column 2 of item 18 of the Table of Permitted Nutrient Content Statements and Claims for the subject "free of saturated fatty acids" set out in column 1, to "0 g", and (b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. The amount is rounded off (a) if it is less than 0.5 g (i) if the product meets the conditions set out in column 2 of item 22 of the Table of Permitted Nutrient Content Statements and Claims for the subject "free of trans fatty acids" set out in column 1, to "0 g", and Food and Drug Regulations

Article B.01.402

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (d) if it is 250 mg or more, to the nearest multiple of 50 mg. TABLEAU Renseignements complémentaires Colonne 1 | Colonne 2 | Colonne 3 | Colonne 4

6 | The sum of saturated fatty acids and trans fatty acids | "Saturated Fat + Trans Fat", "Saturated Fatty Acids + Trans Fatty Acids", "Saturated + Trans" or "Saturates + Trans" | The sum is expressed as a percentage of the daily value per serving of stated size. | The percentage is rounded off

(a) if the amounts of saturated fatty acids and trans fatty acids are declared as "0 g", to "0%"; and (b) in all other cases, to the nearest multiple of 1%.

Article | Renseignements | Nomenclature | Unité | Règles d’écriture

1 | Portions par emballage | « Portions par contenant », « (nombre d’unités) par contenant », « Portions par emballage », « (nombre d’unités) par emballage », « portions par (type d’emballage) » ou « (nombre d’unités) par (type d’emballage) » | La quantité est exprimée en nombre de portions. | (1) La quantité est arrondie : a) lorsqu’elle est inférieure à 2, au plus proche multiple de 1; b) lorsqu’elle est égale ou supérieure à 2 sans dépasser 5 : au plus proche multiple de 0,5; c) lorsqu’elle est supérieure à 5 : au plus proche multiple de 1.

7 | Amount of cholesterol | "Cholesterol" | The amount

(a) is expressed in milligrams per serving of stated size; and (b) may also be expressed as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if the product meets the conditions set out in column 2 of item 27 of the Table of Permitted Nutrient Content Statements and Claims for the subject "free of cholesterol" set out in column 1, to "0 mg"; and (b) in all other cases, to the nearest multiple of 5 mg.

(2)

Si la quantité est arrondie, elle est précédée du mot « environ ».

(2)

The percentage is rounded off (a) if the amount is declared as "0 mg", to "0%"; and (b) in all other cases, to the nearest multiple of 1%.

(3)

Si le poids du produit varie, la quantité peut être déclarée « variable ». 2 | Valeur énergétique | « kilojoules » ou « kJ » | La valeur est exprimée en kilojoules par portion indiquée. | La valeur est arrondie au plus proche multiple de 10 kilojoules. 3 et 4 | [Abrogés, DORS/2016-305, art. 19] 5 | Teneur en acides gras polyinsaturés | « Acides gras polyinsaturés », « Lipides polyinsaturés » ou « polyinsaturés » | La teneur est exprimée en grammes par portion indiquée. | La teneur est arrondie : a) lorsqu’elle est inférieure à 1 g : au plus proche multiple de 0,1 g; b) lorsqu’elle est égale ou supérieure à 1 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. 6 | Teneur en acides gras polyinsaturés oméga-6 | (1) Si le tableau de la valeur nutritive indique la teneur en acides gras polyinsaturés : « oméga-6 », « Acides gras polyinsaturés oméga-6 », « Lipides polyinsaturés oméga-6 » ou « polyinsaturés oméga-6 »

8 | Amount of sodium | "Sodium" | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 5 mg (i) if the product meets the conditions set out in column 2 of item 31 of the Table of Permitted Nutrient Content Statements and Claims for the subject "free of sodium or salt" set out in column 1, to "0 mg"; and (ii) in all other cases, to the nearest multiple of 1 mg; (b) if it is 5 mg or more but not more than 140 mg, to the nearest multiple of 5 mg; and (c) if it is more than 140 mg, to the nearest multiple of 10 mg.

(2)

Dans les autres cas : « Acides gras polyinsaturés oméga-6 ». | La teneur est exprimée en grammes par portion indiquée. | La teneur est arrondie : a) lorsqu’elle est inférieure à 1 g : au plus proche multiple de 0,1 g; b) lorsqu’elle est égale ou supérieure à 1 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. « Lipides polyinsaturés oméga-6 » ou « polyinsaturés oméga-6 » 7 Teneur en acides gras (1) Si le tableau de la valeur nutritive indique la teneur en acides gras polyinsaturés : « oméga-3 », « Acides gras polyinsaturés oméga-3 », « Lipides polyinsaturés oméga-3 » ou « polyinsaturés oméga-3 »

(2)

The percentage is rounded off (a) if the amount is declared as "0 mg", to "0%"; and (b) in all other cases, to the nearest multiple of 1%.

(2)

Dans les autres cas : « Acides gras polyinsaturés oméga-3 », « Lipides polyinsaturés oméga-3 » ou « polyinsaturés oméga-3 » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 1 g : au plus proche multiple de 0,1 g; b) lorsqu’elle est égale ou supérieure à 1 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. 8 Teneur en acides gras monoinsaturés « Acides gras monoinsaturés », « Lipides monoinsaturés » ou « monoinsaturés » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 1 g : au plus proche multiple de 0,1 g; b) lorsqu’elle est égale ou supérieure à 1 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. 9 [Abrogé, DORS/2016-305, art. 19] 10 Teneur en fibres solubles « Fibres solubles » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. 11 Teneur en fibres insolubles « Fibres insolubles » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. 12 Teneur en polyalcools (1) Si l’aliment ne contient qu’un polyalcool : « Polyalcool », « Polyol » ou « (Nom du polyalcool) »;

9 | Amount of carbohydrate | "Carbohydrate", "Total Carbohydrate" or "Carbohydrate, Total" | The amount is expressed in grams per serving of stated size. | The amount is rounded off

(a) if it is less than 0.5 g, to "0 g"; and Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations

(2)

Dans les autres cas : « Polyalcools » ou « Polyols » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. 13 Teneur en amidon « Amidon » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. 14 Teneur en vitamine A « Vitamine A » ou « Vit A » La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

10 | Amount of fibre | “Fibre”, “Fiber”, “Dietary Fibre” or “Dietary Fiber” | The amount is expressed

(a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 5 µg : à 0 µg; b) lorsqu’elle est égale ou supérieure à 5 µg mais moins de 50 µg : au plus proche multiple de 10 µg; c) lorsqu’elle est égale ou supérieure à 50 µg mais moins de 250 µg : au plus proche multiple de 50 µg; d) lorsqu’elle est égale ou supérieure à 250 µg : au plus proche multiple de 100 µg.

(2)

The percentage is rounded off (a) if the amount is declared as “0 g”, to “0%”; and (b) in all other cases, to the nearest multiple of 1%.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 15 Teneur en vitamine C « Vitamine C » ou « Vit C » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

11 | Amount of sugars | “Sugars” | The amount is expressed

(a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,1 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,1 mg mais moins de 1 mg : au plus proche multiple de 0,2 mg; c) lorsqu’elle est égale ou supérieure à 1 mg mais moins de 5 mg : au plus proche multiple de 0,5 mg; d) lorsqu’elle est égale ou supérieure à 5 mg : au plus proche multiple de 1 mg.

(2)

The percentage is rounded off (a) if the amount is declared as “0 g”, to “0%”; and (b) in all other cases, to the nearest multiple of 1%.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 16 Teneur en vitamine D « Vitamine D » ou « Vit D » La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

12 | Amount of protein | “Protein” | The amount is expressed in grams per serving of stated size. | The amount is rounded off

(a) if it is less than 0.5 g, to the nearest multiple of 0.1 g; and

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,1 µg : à 0 µg; b) lorsqu’elle est égale ou supérieure à 0,1 µg mais moins de 1 µg : au plus proche multiple de 0,2 µg; c) lorsqu’elle est égale ou supérieure à 1 µg mais moins de 5 µg : au plus proche multiple de 0,5 µg; d) lorsqu’elle est égale ou supérieure à 5 µg : au plus proche multiple de 1 µg.

13 | Amount of potassium | “Potassium” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 5 mg, to “0 mg”; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. PART B Foods DIVISION 1 Nutrition Labelling

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to “0%”; and (b) in all other cases, to the nearest multiple of 1%.

Section B.01.402

Règlement sur les aliments et drogues

14 | Amount of calcium | “Calcium” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | The amount is rounded off (a) if it is less than 5 mg, to “0 mg”; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and Food and Drug Regulations

PARTIE B Aliments

15 | Amount of iron | “Iron” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

TITRE 1

Étiquetage nutritionnel

(1)

The amount is rounded off (a) if it is less than 0.05 mg, to “0 mg”; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and

Article B.01.402

Colonne 1

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to “0%”; and (b) in all other cases, to the nearest multiple of 1%.

Article

17 Colonne 2 Renseignements Tenueur en vitamine E Nomenclature « Vitamine E » ou « Vit E » Colonne 3 Unité La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. Colonne 4 Règles d'écriture

16 | % Daily Value interpretative statement | “*5% or less is a little, 15% or more is a lot” | [not applicable] | The “% Daily Value” or “% DV” subheading is followed by an asterisk in order to reference the % Daily Value interpretative statement shown in the nutrition facts table.

Food and Drug Regulations Food and Drug Regulations Food and Drug Regulations Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations Food and Drug Regulations Additional Information B.01.402 (1) The nutrition facts table may also contain information set out in column 1 of the table to this section.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,05 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,05 mg mais moins de 0,5 mg : au plus proche multiple de 0,1 mg; c) lorsqu’elle est égale ou supérieure à 0,5 mg mais moins de 2,5 mg : au plus proche multiple de 0,25 mg; d) lorsqu’elle est égale ou supérieure à 2,5 mg : au plus proche multiple de 0,5 mg.

(2)

If information set out in column 1 of the table to this section is included in the nutrition facts table, it shall be expressed using a description set out in column 2, in a unit set out in column 3 and in the manner set out in column 4. (2.1) For the purpose of subsection (2), the serving of stated size set out in a nutrition facts table for a prepackaged product, expressed in the metric unit, shall be used as the basis for determining the information appearing in the nutrition facts table in respect of the energy value and nutrient content of the product. (2.2) The percentage of the daily value for a vitamin or mineral nutrient shown in the nutrition facts table for a prepackaged product in accordance with subsection (2) shall be established on the basis of the amount, by weight, of the vitamin or mineral nutrient per serving of stated size for the product, rounded off in the applicable manner set out in column 4 of the table to this section. (a) the amount of any of those groups of fatty acids or the amount of polyunsaturated fatty acids is in the nutrition facts table or is shown on the label of the prepackaged product or in any advertisement for the product. product that is made or placed by or on the direction of the manufacturer of the product; or (b) the amount of any specific fatty acid is shown on the label of the prepackaged product or in any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 18 Tenueur en vitamine K « Vitamine K » ou « Vit K » La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(4)

If the label of a prepackaged product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains a representation, express or implied, that includes information that is set out in column 1 of the table to this section, that information shall also be in the nutrition facts table.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,05 µg : à 0 µg; b) lorsqu’elle est égale ou supérieure à 0,05 µg mais moins de 0,5 µg : au plus proche multiple de 0,1 µg; c) lorsqu’elle est égale ou supérieure à 0,5 µg mais moins de 2,5 µg : au plus proche multiple de 0,25 µg; d) lorsqu’elle est égale ou supérieure à 2,5 µg : au plus proche multiple de 0,5 µg.

(6)

The nutrition facts table shall show the amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product, except in the case of iodide added to salt for table or general household use or fluoride added to prepackaged water or ice.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 19 Tenueur en thiamine « Thiamine », « Thiamine (vitamine B1) » ou « Thiamine (vit B1) » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(7)

The nutrition facts table shall show the amount of any vitamin or mineral nutrient that is declared as a component of one of the prepackaged product’s ingredients other than flour.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,005 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,005 mg mais moins de 0,025 mg : au plus proche multiple de 0,01 mg; c) lorsqu’elle est égale ou supérieure à 0,025 mg mais moins de 0,25 mg : au plus proche multiple de 0,025 mg; d) lorsqu’elle est égale ou supérieure à 0,25 mg : au plus proche multiple de 0,05 mg.

(9)

If information set out in column 1 of the table to this section is included in the nutrition facts table, it shall be shown (a) in English and French; or (b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the product may be shown in that language only and is shown on the label in that language. Additional Information (a) if it is less than 2, to the nearest multiple of 1; (b) if it is between 2 and 5, to the nearest multiple of 0.5; and Column 3: The value is expressed in kilojoules per serving of stated size. Item 3 and 4 Column 3: The amount is expressed in grams per serving of stated size. Column 4: The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 20 Teneur en riboflavine « Riboflavine », La teneur est exprimée : « Riboflavine (vitamine a) en milligrammes par portion B2) » ou « Riboflavine indiquée; (vit B2) » b) en pourcentage de la valeur quotidienne par portion indi- quée.

(1)

If the nutrition facts table includes the amount of polyunsaturated fatty acids: Column 3: The amount is expressed in grams per serving of stated size. Column 4: The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.

(1)

La teneur est arrondie : a) lorsque la teneur déclarée est « 0 mg » à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 21 Teneur en niacine « Niacine » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indi- quée.

(1)

If the nutrition facts table includes the amount of polyunsaturated fatty acids: Column 3: The amount is expressed in grams per serving of stated size. Column 4: The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. Food and Drug Regulations

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,005 mg : à 0 mg; b) lorsqu’elle est égale ou supé- rieure à 0,005 mg mais moins de 0,05 mg : au plus proche multiple de 0,01 mg; c) lorsqu’elle est égale ou supé- rieure à 0,05 mg mais moins de 0,25 mg : au plus proche multiple de 0,025 mg; d) lorsqu’elle est égale ou supé- rieure à 0,25 mg : au plus proche multiple de 0,05 mg.

8 | Amount of monounsaturated fatty acids | “Monounsaturated Fat”, “Monounsaturated Fatty Acids”, “Monounsaturates” or “Monounsaturated” | The amount is expressed in grams per serving of stated size. | The amount is rounded off

(a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 22 Teneur en vitamine B6 « Vitamine B6 » ou La teneur est exprimée : « Vit B6 » a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indi- quée. PART B Foods DIVISION 1 Nutrition Labelling

10 | Amount of soluble fibre | “Soluble Fibre” or “Soluble Fiber” | The amount is expressed as grams per serving of stated size. | The amount is rounded off

(a) if it is less than 0.5 g, to “0 g”; and

Section B.01.402

Règlement sur les aliments et drogues

11 | Amount of insoluble fibre | “Insoluble Fibre” or “Insoluble Fiber” | The amount is expressed as grams per serving of stated size. | The amount is rounded off

(a) if it is less than 0.5 g, to “0 g”; and

PARTIE B Aliments

12 | Amount of sugar alcohol | (1) If the food contains only one type of sugar alcohol: “Sugar Alcohol”, “Polyol” or “[naming the sugar alcohol].”

TITRE 1

Étiquetage nutritionnel

(2)

In all other cases: “Sugar Alcohols” or “Polyols” | The amount is expressed as grams per serving of stated size. | The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and

Article B.01.402

Colonne 1 | Colonne 2 | Colonne 3 | Colonne 4

13 | Amount of starch | “Starch” | The amount is expressed as grams per serving of stated size. | The amount is rounded off

(a) if it is less than 0.5 g, to “0 g”; and

Article | Renseignements | Nomenclature | Unité | Règles d'écriture

23 | Teneur en folate | « Folate » | La teneur est exprimée : a) en microgrammes d'équivalents de folate alimentaire (EFA) par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

14 | Amount of vitamin A | “Vitamin A” or “Vit A” | The amount is expressed

(a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 5 µg, to “0 µg”; (b) if it is 5 µg or more but less than 50 µg, to the nearest multiple of 10 µg; (c) if it is 50 µg or more but less than 250 µg, to the nearest multiple of 50 µg; and

(1)

La teneur est arrondie : a) lorsque la teneur déclarée est « 0 µg EFA » : à 0 µg; b) dans les autres cas : au plus proche multiple de 1 µg.

(2)

The percentage is rounded off (a) if the amount is declared as 0 µg, to “0%”; and (b) in all other cases, to the nearest multiple of 1%.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg EFA » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 24 | Teneur en vitamine B12 | « Vitamine B12 » ou « Vit B12 » | La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

15 | Amount of vitamin C | “Vitamin C” or “Vit C” | The amount is expressed | (1) The amount is rounded off

Food and Drug Regulations The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(1)

La teneur est arrondie : a) lorsqu'elle est inférieure à 0,005 µg : à 0 µg; b) lorsqu'elle est égale ou supérieure à 0,005 µg mais moins de 0,05 µg : au plus proche multiple de 0,01 µg; c) lorsqu'elle est égale ou supérieure à 0,05 µg mais moins de 0,25 µg : au plus proche multiple de 0,025 µg; d) lorsqu'elle est égale ou supérieure à 0,25 µg : au plus proche multiple de 0,1 µg.

(1)

The amount is rounded off (a) if it is less than 0.1 µg, to "0 µg"; (b) if it is 0.1 µg or more but less than 1 µg, to the nearest multiple of 0.2 µg; (c) if it is 1 µg or more but less than 5 µg, to the nearest multiple of 0.5 µg; and

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 25 | Teneur en biotine | « Biotine » | La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(2)

The percentage is rounded off (a) if the amount is declared as 0 µg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%. The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(1)

La teneur est arrondie : a) lorsqu'elle est inférieure à 0,005 µg : à 0 µg; b) lorsqu'elle est égale ou supérieure à 0,005 µg mais moins de 0,05 µg : au plus proche multiple de 0,01 µg. PART B Foods DIVISION 1 Nutrition Labelling

(1)

The amount is rounded off (a) if it is less than 0.05 mg, to "0 mg"; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and

Section B.01.402

Règlement sur les aliments et drogues

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%. Amount of vitamin K The amount is expressed (a) in micrograms per serving of stated size; and

PARTIE B Aliments

(1)

The amount is rounded off (a) if it is less than 0.05 µg, to "0 µg"; Food and Drug Regulations The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

TITRE 1

Étiquetage nutritionnel

(1)

The amount is rounded off (a) if it is less than 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and

Article B.01.402

Colonne 1 | Colonne 2 | Colonne 3 | Colonne 4

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%. "Riboflavin", "Riboflavin (Vitamin B2)" or "Riboflavin (Vit B2)" The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

Article | Renseignements | Nomenclature | Unité | Règles d'écriture

26 | Teneur en acide pantothénique | « Acide pantothénique » ou « Pantothénate » | La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

The amount is rounded off (a) if it is less than 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,01 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,01 mg mais moins de 0,1 mg : au plus proche multiple de 0,02 mg; c) lorsqu’elle est égale ou supérieure à 0,1 mg mais moins de 0,5 mg : au plus proche multiple de 0,1 mg; d) lorsqu’elle est égale ou supérieure à 0,5 mg : au plus proche multiple de 0,5 mg.

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%. The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 27 | Teneur en choline | « Choline » | La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

The amount is rounded off (a) if it is less than 0.05 mg, to "0 mg"; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 1 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 1 mg mais moins de 10 mg : au plus proche multiple de 2 mg; c) lorsqu’elle est égale ou supérieure à 10 mg mais moins de 50 mg : au plus proche multiple de 5 mg; d) lorsqu’elle est égale ou supérieure à 50 mg : au plus proche multiple de 10 mg.

22 Amount of vitamin B6

The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 28 | Teneur en phosphore | « Phosphore » | La teneur est exprimée : a) en milligrammes par portion indiquée;

(1)

The amount is rounded off (a) if it is less than 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 5 mg : à 0 mg. PART B Foods DIVISION 1 Nutrition Labelling

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%.

Section B.01.402

Règlement sur les aliments et drogues

23 Amount of folate

"Folate" The amount is expressed (a) in micrograms of dietary folate equivalents (DFE) per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

PARTIE B Aliments

(1)

The amount is rounded off (a) if it is less than 1 µg DFE, to "0 µg DFE"; (b) if it is 1 µg DFE or more but less than 10 µg DFE, to the nearest multiple of 2 µg DFE; (c) if it is 10 µg DFE or more but less than 50 µg DFE, to the nearest multiple of 5 µg DFE; and

TITRE 1

Étiquetage nutritionnel

(2)

The percentage is rounded off (a) if the amount is declared as 0 µg DFE, to "0%"; and (b) in all other cases, to the nearest multiple of 1%.

Article B.01.402

Colonne 1

24 Amount of vitamin B12

The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

Article

Colonne 2 Renseignements Nomenclature Colonne 3 Unité Colonne 4 Règles d'écriture 29 Teneur en iode « Iodure » ou « Iode » La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

The amount is rounded off (a) if it is less than 0.005 µg, to "0 µg"; (b) if it is 0.005 µg or more but less than 0.05 µg, to the nearest multiple of 0.01 µg; (c) if it is 0.05 µg or more but less than 0.25 µg, to the nearest multiple of 0.025 µg; and

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 1 µg : à 0 µg; b) lorsqu’elle est égale ou supérieure à 1 µg mais moins de 10 µg : au plus proche multiple de 1 µg; c) lorsqu’elle est égale ou supérieure à 10 µg mais moins de 50 µg : au plus proche multiple de 5 µg; d) lorsqu’elle est égale ou supérieure à 50 µg : au plus proche multiple de 10 µg.

(2)

The percentage is rounded off (a) if the amount is declared as 0 µg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%. Food and Drug Regulations

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 30 Teneur en magnésium « Magnésium » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

25 Amount of biotin | "Biotin" | The amount is expressed

(a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 1 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 1 mg mais moins de 10 mg : au plus proche multiple de 2 mg; c) lorsqu’elle est égale ou supérieure à 10 mg mais moins de 50 mg : au plus proche multiple de 5 mg; d) lorsqu’elle est égale ou supérieure à 50 mg : au plus proche multiple de 10 mg.

(1)

The amount is rounded off (a) if it is less than 0.05 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. PART B Foods DIVISION 1 Nutrition Labelling

(2)

The percentage is rounded off (a) if the amount is declared as 0 µg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%.

Section B.01.402

Règlement sur les aliments et drogues

26 Amount of pantothenic acid | "Pantothenic Acid" or "Pantothenate" | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

PARTIE B Aliments

(1)

The amount is rounded off (a) if it is less than 0.01 mg, to "0 mg"; (b) if it is 0.01 mg or more but less than 0.1 mg, to the nearest multiple of 0.02 mg; (c) if it is 0.1 mg or more but less than 0.5 mg, to the nearest multiple of 0.05 mg; and

TITRE 1

Étiquetage nutritionnel

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%.

Article B.01.402

Colonne 1

27 Amount of choline | "Choline" | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

Article

31 32 33 Colonne 2 Renseignements Teneur en zinc Teneur en sélénium Teneur en cuivre Colonne 3 Nomenclature « Zinc » « Sélénium » « Cuivre » Colonne 4 Unité La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. Règles d'écriture

(1)

The amount is rounded off (a) if it is less than 1 mg, to "0 mg"; (b) if it is 1 mg or more but less than 10 mg, to the nearest multiple of 2 mg; (c) if it is 10 mg or more but less than 50 mg, to the nearest multiple of 5 mg; and

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,05 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,05 mg mais moins de 0,5 mg : au plus proche multiple de 0,01 mg; c) lorsqu’elle est égale ou supérieure à 0,5 mg mais moins de 2,5 mg : au plus proche multiple de 0,25 mg; d) lorsqu’elle est égale ou supérieure à 2,5 mg : au plus proche multiple de 0,5 mg.

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %.

28 Amount of phosphorous "Phosphorus"

The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. The amount is rounded off (a) if it is less than 5 mg, to "0 mg"; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and The percentage is rounded off (a) if the amount is declared as 0 mg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%. The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. The amount is rounded off (a) if it is less than 1 µg, to "0 µg"; (b) if it is 1 µg or more but less than 10 µg, to the nearest multiple of 2 µg; (c) if it is 10 µg or more but less than 50 µg, to the nearest multiple of 5 µg; and The percentage is rounded off (a) if the amount is declared as 0 µg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%. The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. The amount is rounded off (a) if it is less than 1 mg, to "0 mg"; (b) if it is 1 mg or more but less than 10 mg, to the nearest multiple of 2 mg; (c) if it is 10 mg or more but less than 50 mg, to the nearest multiple of 5 mg; and The percentage is rounded off (a) if the amount is declared as 0 mg, to "0%"; and (b) in all other cases, to the nearest multiple of 1%. The amount is expressed

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,1 µg : à 0 µg; b) lorsqu’elle est égale ou supérieure à 0,1 µg mais moins de 1 µg : au plus proche multiple de 0,2 µg; c) lorsqu’elle est égale ou supérieure à 1 µg mais moins de 5 µg : au plus proche multiple de 1 µg; d) lorsqu’elle est égale ou supérieure à 5 µg : au plus proche multiple de 1 µg.

(1)

The amount is rounded off Food and Drug Regulations (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. (a) if it is less than 0.05 mg, to “0 mg”; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %.

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to “0%”; and (b) in all other cases, to the nearest multiple of 1%. The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,0015 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,0015 mg mais moins de 0,025 mg : au plus proche multiple de 0,002 mg; c) lorsqu’elle est égale ou supérieure à 0,025 mg mais moins de 0,05 mg : au plus proche multiple de 0,005 mg; d) lorsqu’elle est égale ou supérieure à 0,05 mg : au plus proche multiple de 0,01 mg.

(1)

The amount is rounded off (a) if it is less than 0.1 µg, to “0 µg”; (b) if it is 0.1 µg or more but less than 1 µg, to the nearest multiple of 0.2 µg; (c) if it is 1 µg or more but less than 5 µg, to the nearest multiple of 0.5 µg; and

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. PART B Foods DIVISION 1 Nutrition Labelling

(2)

The percentage is rounded off (a) if the amount is declared as 0 µg, to “0%”; and (b) in all other cases, to the nearest multiple of 1%. The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

Section B.01.402

Règlement sur les aliments et drogues

(1)

The amount is rounded off (a) if it is less than 0.0015 mg, to “0 mg”; (b) if it is 0.0015 mg or more but less than 0.025 mg, to the nearest multiple of 0.002 mg; (c) if it is 0.025 mg or more but less than 0.05 mg, to the nearest multiple of 0.005 mg; and

PARTIE B Aliments

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to “0%”; and (b) in all other cases, to the nearest multiple of 1%. The amount is expressed (a) in milligrams per serving of stated size; and

TITRE 1

Étiquetage nutritionnel

(1)

The amount is rounded off (a) if it is less than 0.005 mg, to “0 mg”; Amount of chloride The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

Article B.01.402

Colonne 1

(1)

The amount is rounded off (a) if it is less than 0.05 µg, to “0 µg”; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and

Article

34 35 36 Colonne 2 Renseignements Teneur en manganèse « Manganèse » Teneur en chrome « Chrome » Teneur en molybdène « Molybdène » Colonne 3 Nomenclature Colonne 4 Unité Règles d’écriture La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. b) dans les autres cas : au plus proche multiple de 1 %.

(2)

The percentage is rounded off (a) if the amount is declared as 0 µg, to “0%”; and (b) in all other cases, to the nearest multiple of 1%.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,005 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,005 mg mais moins de 0,05 mg : au plus proche multiple de 0,01 mg; c) lorsqu’elle est égale ou supérieure à 0,05 mg mais moins de 0,25 mg : au plus proche multiple de 0,025 mg; d) lorsqu’elle est égale ou supérieure à 0,25 mg : au plus proche multiple de 0,05 mg.

(1)

The amount is rounded off (a) if it is less than 0.05 µg, to “0 µg”; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(2)

The percentage is rounded off (a) if the amount is declared as 0 µg, to “0%”; and (b) in all other cases, to the nearest multiple of 1%.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,05 µg : à 0 µg; b) lorsqu’elle est égale ou supérieure à 0,05 µg mais moins de 0,5 µg : au plus proche multiple de 0,1 µg; c) lorsqu’elle est égale ou supérieure à 0,5 µg mais moins de 2,5 µg : au plus proche multiple de 0,25 µg; d) lorsqu’elle est égale ou supérieure à 2,5 µg : au plus proche multiple de 0,5 µg.

(1)

The amount is rounded off (a) if it is less than 5 mg, to “0 mg”; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; Food and Drug Regulations (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(2)

The percentage is rounded off (a) if the amount is declared as 0 mg, to “0%”; and (b) in all other cases, to the nearest multiple of 1%. Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations Food and Drug Regulations Food and Drug Regulations Food and Drug Regulations Food and Drug Regulations Food and Drug Regulations Food and Drug Regulations Foods for Infants Six Months of Age or Older but Less Than One Year of Age B.01.403 (1) This section applies to a prepackaged product that is intended solely for infants six months of age or older but less than one year of age.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,05 µg : à 0 µg; b) lorsqu’elle est égale ou supérieure à 0,05 µg mais moins de 0,5 µg : au plus proche multiple de 0,1 µg; c) lorsqu’elle est égale ou supérieure à 0,5 µg mais moins de 2,5 µg : au plus proche multiple de 0,25 µg; d) lorsqu’elle est égale ou supérieure à 2,5 µg : au plus proche multiple de 0,5 µg.

(3)

The nutrition facts table of the product may omit the amount of saturated fatty acids, trans fatty acids and cholesterol.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. PART B Foods DIVISION 1 Nutrition Labelling Sections B.01.402-B.01.403 Règlement sur les aliments et drogues

(4)

Despite subsection (3), if the amount of cholesterol is in the nutrition facts table, the amounts of saturated fatty acids and trans fatty acids shall also be in the nutrition facts table.

PARTIE B Aliments

(5)

If the information in respect of five or more of the energy value and nutrients referred to in column 1 of items 2, 3 and 8 to 15 of the table to section B.01.401 may be expressed as “0” in the nutrition facts table of the prepackaged product in accordance with that section, the nutrition facts table need only include the following information: (a) the serving of stated size; (c) the amount of fat; (f) the amount of any nutrient that is the subject of a representation referred to in subparagraph B.01.401(3)(e)(ii); (g) the amount of any sugar alcohol, vitamin or mineral nutrient added to the product, other than fluoride added to prepackaged water or ice; (h) the amount of any vitamin or mineral nutrient that is declared as a component of one of the product’s ingredients other than flour; (i) the amount of any nutrient referred to in column 1 of any of items 8, 10 or 11 and 13 to 15 of the table to section B.01.401 that may not be expressed as “0” in the nutrition facts table; (j) except in the case described in paragraph (k), the statement “Not a significant source of (naming each nutrient that is omitted from the nutrition facts table in accordance with this subsection)”, but such a statement may be omitted in respect of saturated fatty acids, trans fatty acids and cholesterol; and Food for Use in Manufacturing Other Foods B.01.404 (1) Subject to section B.29.004, this section applies to a prepackaged product intended solely for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or an institution.

TITRE 1

Étiquetage nutritionnel

(2)

No person shall sell the product unless written nutrition information concerning the product accompanies the product when it is delivered to the purchaser. (a) shall include the information that would, but for subsection B.01.401(7), be required by sections B.01.401 and B.01.402 to be included in a nutrition facts table for the product; (b) may include other information that is permitted by section B.01.402 to be included in that nutrition facts table; and (c) shall be expressed in accordance with sections B.01.401 and B.01.402, subject to the following modifications, namely, (A) per gram or 100 grams of the food, if the net quantity of the food is declared on the label by weight or by count, or (B) per millilitre or 100 millilitres of the food, if the net quantity of the food is declared on the label by volume, (ii) information for other nutrients and the energy value set out in column 1 of the table to section B.01.401 or in column 1 of the table to section B.01.402 shall be expressed in the units referred to in column 3, (A) per gram or 100 grams of the food, if the net quantity of the food is declared on the label by weight or by count, or (B) per millilitre or 100 millilitres of the food, if the net quantity of the food is declared on the label by volume, (iv) the nutrition information shall be stated with a degree of precision that corresponds to the accuracy of the analytical methodology used to produce the information. B.01.405 (1) This section applies to a prepackaged product, other than a supplemented food, that is a ready-to-serve multiple-serving prepackaged product intended solely to be served in a commercial or industrial enterprise or an institution.

Articles B.01.402-B.01.403

Colonne 1

(2)

No person shall sell the product unless written nutrition information concerning the product accompanies the product when it is delivered to the purchaser. (a) shall include the information that would, but for subsection B.01.401(7), be required by sections B.01.401 and B.01.402 to be included in a nutrition facts table for the product; (b) may include other information that is permitted by section B.01.402 to be included in that nutrition facts table; and (c) shall be expressed in accordance with sections B.01.401 and B.01.402. B.01.406 (1) Subject to subsections (2) to (8), the information in the nutrition facts table shall be set out only on the basis of the prepackaged product as offered for sale.

Article

Colonne 2 Renseignements Colonne 3 Nomenclature Colonne 4 Unité Règles d’écriture 37 Teneur en chlorure « Chlorure » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(2)

If a prepackaged product contains separately packaged ingredients or foods that are intended to be consumed together, the information in the nutrition facts table shall be set out for each ingredient or food or for the entire product.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 % » à 0 %; b) dans les autres cas : au plus proche multiple de 1 %.

(3)

If a prepackaged product contains an assortment of foods of the same type and the typical serving consists of only one of those foods, the information in the nutrition facts table shall be set out (a) on the basis of each of the foods contained in the product, if the nutrition information set out in column 1 of the table to section B.01.401 for each of those foods is different; or (b) on the basis of one of the foods contained in the product, if the nutrition information set out in column 1 of the table to section B.01.401 for each of those foods is the same.

(1)

La teneur est arrondie : a) lorsque’elle est inférieure à 5 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 5 mg mais moins de 50 mg : au plus proche multiple de 10 mg; c) lorsqu’elle est égale ou supérieure à 50 mg mais moins de 250 mg : au plus proche multiple de 25 mg; d) lorsqu’elle est égale ou supérieure à 250 mg : au plus proche multiple de 50 mg.

(4)

If a prepackaged product contains an assortment of foods of the same type and the typical serving consists of more than one of those foods, the information in the nutrition facts table shall be set out for each of the foods contained in the product or as a composite value.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 % » à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. SOR/2003-11, s. 20; err., Vol. 137, No. 5; SOR/2005-98, s. 2(F); SOR/2016-305, ss. 19, 75(F); SOR/2018-108, s. 38. [SOR/2016-305, s. 20]

(5)

If a prepackaged product contains a food that is to be prepared in accordance with directions provided in or on the package or that is commonly combined with other ingredients or another food or cooked before being consumed, the nutrition facts table may also set out information for the food as prepared, in which case (a) the nutrition facts table shall set out the following information for the food as prepared, namely, (i) except in the case described in subparagraph (ii), the amount of the food expressed using the unit referred to in column 3 of subparagraph 1(b)(i) of the table to section B.01.401 as “about (naming the serving size)” or “about (naming the serving size) prepared” and, if applicable, in the manner specified in column 4 of subsections 1(1) and (2), and (ii) if the food is commonly served combined with another food, the amount of the other food expressed using the unit referred to in column 3 of subparagraph 1(b)(i) of the table to section B.01.401, (iii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.01.401, in the unit set out in column 3 and in the manner set out in column 4, and (iv) the information set out in column 1 of items 3, 6 to 8, 11 and 13 to 15 of the table to section B.01.401 and in column 1 of items 14 to 37 of the table to section B.01.402 that is declared as a percentage of the daily value in the nutrition facts table for the food as sold, expressed using a description set out in column 2, as a percentage of the daily value per serving of stated size and in the manner specified in column 4; and (b) the nutrition facts table may also set out the following information for the added ingredients or the other food, if it is declared in the nutrition facts table for the food as sold, namely, (i) the information set out in column 1 of items 3 to 5 and 7 to 12 of the table to section B.01.401, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7 and 8 and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4, (iii) the information set out in column 1 of item 2 of the table to section B.01.401, expressed using a description set out in column 2, in the unit set out in column 3 per serving of stated size of the food as prepared, and in the manner specified in column 4.

(2)

The nutrition facts table of the prepackaged product shall not contain the percentage of the daily value of fat, fibre, sugars, cholesterol or sodium or of the sum of saturated fatty acids and trans fatty acids. Aliments pour bébés âgés d’au moins six mois mais de moins d’un an [DORS/2016-305, art. 20] B.01.403 (1) Le présent article s’applique à tout produit préemballé destiné exclusivement aux bébés âgés d’au moins six mois mais de moins d’un an.

(6)

Subsection (5) does not apply in respect of a prepackaged product that is intended solely for infants six months of age or older but less than one year of age.

(2)

Le tableau de la valeur nutritive du produit préemballé ne peut indiquer le pourcentage de la valeur quotidienne des lipides, des fibres, des sucres, du cholestérol, du sodium ou de la somme des acides gras saturés et des acides gras trans.

(7)

Subject to subsection (8), the information in the nutrition facts table may also be set out on the basis of other amounts of a food that reflect different uses or different units of measurement of a food, in which case (a) the nutrition facts table shall set out the following information for each of the other amounts of food, namely, (ii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.01.401, in the unit set out in column 3 and in the manner set out in column 4, and (iii) the information set out in column 1 of items 3, 6 to 8, 11 and 13 to 15 of the table to section B.01.401, expressed using a description set out in column 2, in the unit set out in column 3 per serving of stated size of the food as prepared, and in the manner specified in column 4. B.01.401 and in column 1 of items 14 to 37 of the table to section B.01.402 that is declared as a percentage of the daily value in the nutrition facts table for the first amount of food for which information is declared, expressed using a description set out in column 2, as a percentage of the daily value per serving of stated size and in the manner specified in column 4; and (c) if the nutrition facts table is set out in a version of the aggregate format specified in section B.01.459 or B.01.464, it shall also set out the following information for each of the other amounts of food, if that information is declared in the nutrition facts table for the first amount of food for which information is declared, namely,

(3)

Les teneurs en acides gras saturés, en acides gras trans et en cholestérol peuvent être omises du tableau de la valeur nutritive.

(8)

If the nutrition facts table of a prepackaged product that is intended solely for infants six months of age or older but less than one year of age sets out information in accordance with subsection (7), it shall set out the information referred to in paragraphs (7)(a) and (c). of NFT Formats, having regard to matters such as order of presentation, dimensions, spacing and the use of upper and lower case letters and bold type.

(4)

Malgré le paragraphe (3), le tableau de la valeur nutritive qui indique la teneur en cholestérol doit également indiquer la teneur en acides gras saturés et la teneur en acides gras trans. (b) the energy value; (d) the amount of carbohydrate; (e) the amount of protein; (k) if the product meets the condition specified in subsection B.01.462(3), the statement “Not a significant source of other nutrients” or the statement referred to in paragraph (j). SOR/2003-11, s. 20; SOR/2016-305, ss. 21, 75(F).

(2)

The characters and rules in the nutrition facts table shall be displayed in a single colour that is a visual equivalent of 100% solid black type on a white background or on a uniform neutral background with a maximum 5% tint of colour. (a) shall be displayed in a single standard sans serif font that is not decorative and in such a manner that the characters never touch each other or the rules; and (b) may be displayed with larger dimensions than those specified in the applicable figure in the Directory of NFT Formats if all the characters in the table are enlarged in a uniform manner. (3.1) The type size shown in parentheses for a version referred to in a table to sections B.01.454 to B.01.459 or sections B.01.461 to B.01.464 is the minimum type size that may be used in a nutrition facts table to show nutrients set out in the tables to sections B.01.401 and B.01.402 in accordance with that version.

(5)

Si au moins cinq des renseignements relatifs à la valeur énergétique et aux éléments nutritifs visés à la colonne 1 des articles 2, 3 et 8 à 15 du tableau de l’article B.01.401 peuvent être exprimés, conformément à cet article, par « 0 » au tableau de la valeur nutritive du produit préemballé, le tableau peut ne contenir que les renseignements suivants : a) la portion indiquée; b) la valeur énergétique; c) la teneur en lipides; d) la teneur en glucides; e) la teneur en protéines; f) la teneur en tout élément nutritif qui fait l’objet d’une des déclarations visées au sous-alinéa B.01.401(3)(e)(ii); g) la teneur en un polyalcool, en une vitamine ou en un minéral nutritif ajoutés au produit, à l’exclusion du fluorure ajouté à de l’eau ou à de la glace préemballées; h) la teneur en une vitamine ou en un minéral nutritif déclaré comme constituant d’un ingrédient du produit, à l’exclusion de la farine; i) la teneur en tout élément nutritif visé à la colonne 1 des articles 8, 10, 11 et 13 à 15 du tableau de l’article B.01.401 qui ne peut être exprimé par « 0 » au tableau de la valeur nutritive; j) sauf dans le cas mentionné à l’alinéa k), la mention « Source négligeable de (désignation de tout élément nutritif omis conformément au présent paragraphe) »; la mention peut toutefois être omise en ce qui concerne les acides gras saturés, les acides gras trans et le cholestérol; k) si le produit remplit les conditions du paragraphe B.01.462(3), la mention « Source négligeable d’autres éléments nutritifs » ou la mention visée à l’alinéa j). DORS/2003-11, art. 20; DORS/2016-305, art. 21 et 75(F). Aliments utilisés dans la fabrication d’autres aliments B.01.404 (1) Sous réserve de l’article B.29.004, le présent article s’applique à tout produit préemballé qui est destiné uniquement à être utilisé comme ingrédient dans la fabrication d’autres produits préemballés destinés à être vendus au consommateur au niveau du commerce de détail ou comme ingrédient dans la préparation d’aliments par une entreprise commerciale ou industrielle ou une institution.

(4)

A rule that is specified in the applicable figure in the Directory of NFT Formats as being a 1 point rule or a 2 point rule may be displayed with larger dimensions in the nutrition facts table.

(3)

The nutrition information (i) information for vitamins referred to in subsection D.01.002(1) shall be expressed in the applicable unit referred to in subsection D.01.003(1), and information for mineral nutrients referred to in paragraphs D.02.001(1)(a) to (j), (l) to (n) and (p) shall be expressed in milligrams for sodium, potassium, calcium, phosphorus, magnesium, iron, zinc, chloride, copper and manganese and in micrograms for iodine, chromium, selenium and molybdenum, (iii) percentages of daily values and information on servings of stated size may be omitted, and SOR/2003-11, s. 20; SOR/2016-305, ss. 22, 73, 75(F); SOR/2022-169, s. 16. Foods for Enterprise or Institution

(6)

In a nutrition facts table consisting of a table in both English and French, the order of languages may be reversed from the order shown in the applicable figure in the Directory of NFT Formats. (a) in a table in English and a table in French on the same continuous surface of the available display surface; (b) in a table in both English and French on a continuous surface of the available display surface; or (e) in a table in English on a continuous surface of the available display surface and a table in French on another continuous surface of the available display surface that is of the same size and prominence as the first surface.

(3)

The nutrition information SOR/2003-11, s. 20; SOR/2016-305, s. 23; SOR/2022-169, s. 17. Basis of Information (v) [Repealed, SOR/2016-305, s. 24] (ii) the information set out in column 1 of items 5 to 8 and 10 to 13 of the table to section B.01.402, expressed using a description set out in column 2, in grams and in the manner specified in column 4, (i) the amount of the food expressed in a household measure and a metric measure and in the manner specified in column 4 of subitems 1(1) and (2) of the table to section B.01.401, et au moyen des règles d’écriture indiquées dans la colonne 4; (v) [Abrogé, DORS/2016-305, art. 24] b) le tableau peut également indiquer les renseignements ci-après en fonction des ingrédients ajoutés ou de l’autre aliment, s’ils sont déclarés dans le tableau de la valeur nutritive de l’aliment tel qu’il est vendu : (i) les renseignements visés à la colonne 1 des articles 3 à 5 et 7 à 12 du tableau de l’article B.01.401, exprimés au moyen de la nomenclature indiquée dans la colonne 2, en milligrammes pour ceux visés à la colonne 1 des articles 7 et 8 et en grammes pour ceux visés à la colonne 1 des articles 3 à 5 et 9 à 12 et au moyen des règles d’écriture indiquées dans la colonne 4, (ii) les renseignements visés à la colonne 1 des articles 5 à 8 et 10 à 13 du tableau de l’article B.01.402, exprimés au moyen de la nomenclature indiquée dans la colonne 2, en grammes et au moyen des règles d’écriture indiquées dans la colonne 4, (iii) les renseignements visés à la colonne 1 de l’article 2 de la tableau de l’article B.01.401, exprimés au moyen de la nomenclature indiquée dans la colonne 2, de l’unité indiquée dans la colonne 3, par portion indiquée de l’aliment préparé, et au moyen des règles d’écriture indiquées dans la colonne 4.

(2)

If in accordance with subsection B.01.012(3) or (7) the information required by these Regulations may be shown on the label of a prepackaged product in English only or in French only and is shown in that language, the nutrition facts table may be displayed on the label of the prepackaged product in a table in that language only on a continuous surface of the available display surface. B.01.452 (1) Subject to subsection (2), the nutrition facts table shall be oriented in the same manner as other information appearing on the label of the prepackaged product.

(6)

Le paragraphe (5) ne s’applique pas aux produits préemballés destinés exclusivement aux bébés âgés d’au moins six mois mais de moins d’un an.

(2)

If a version of a nutrition facts table cannot be oriented in the same manner as other information appearing on the label of the prepackaged product, it shall be oriented in another manner if there is sufficient space to do so and the food contained in the package does not leak out and is not damaged when the package is turned over.

(7)

Sous réserve du paragraphe (8), le tableau de la valeur nutritive peut aussi indiquer les renseignements en fonction d’autres quantités de l’aliment qui correspondent à différents usages ou unités de mesure de l’aliment, auquel cas : a) le tableau indique les renseignements ci-après pour chacune des autres quantités de l’aliment : (i) la quantité exprimée selon une mesure domestique et une mesure métrique et au moyen des règles d’écriture indiquées dans la colonne 4 du tableau de l’article B.01.401, aux paragraphes 1(1) et (2), (ii) la valeur énergétique, exprimée au moyen de la nomenclature indiquée dans la colonne 2 de l’article 2 du tableau de l’article B.01.401, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4, (iv) [Repealed, SOR/2016-305, s. 24] (b) [Repealed, SOR/2016-305, s. 24] (i) [Repealed, SOR/2016-305, s. 24] (ii) the information set out in column 1 of items 3 to 5 and 7 to 12 of the table to section B.01.401, expressed using a description set out in column 2, in grams and in the manner specified in column 4, and (iii) the information set out in column 1 of items 5 to 8 and 10 to 13 of the table to section B.01.402, expressed using a description set out in column 2, in grams and in the manner specified in column 4. SOR/2003-11, s. 20; SOR/2016-305, s. 24. [B.01.407 to B.01.449 reserved] Presentation of Nutrition Facts Table B.01.450 (1) Subject to subsections (2) to (6), the nutrition facts table shall be presented in accordance with the format specified in the applicable figure in the Directory

(3)

Subsection (1) does not apply in respect of a nutrition facts table that is set out on the top or bottom of a prepackaged product. B.01.453 (1) Sections B.01.454 to B.01.460 apply to prepackaged products other than those that are intended solely for infants six months of age or older but less than one year of age.

(3)

The characters in the nutrition facts table

(2)

Sections B.01.461 to B.01.465 apply to prepackaged products that are intended solely for infants six months of age or older but less than one year of age. Standard and Horizontal Formats

(5)

The information in the nutrition facts table shall be in accordance with sections B.01.400 to B.01.403 and B.01.406. SOR/2003-11, s. 20; SOR/2016-305, ss. 25, 74. Location of Nutrition Facts Table B.01.451 (1) Subject to subsection (2), the nutrition facts table shall be displayed on the label of the prepackaged product TVN, compte tenu notamment de l’ordre de présentation, des dimensions, des espacements et de l’emploi des majuscules, des minuscules et des caractères gras.

(2)

Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2)

Les caractères et les filets du tableau de la valeur nutritive sont monochromes et équivalent visuellement à de l’imprimerie noire en aplats de 100 % sur un fond blanc ou sur un fond neutre uniforme d’au plus 5 %.

(3)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in (b) the bilingual horizontal format in accordance with Figure 4.3(B), 4.4(B) or 4.5(B) of the Directory of NFT Formats; (c) the linear format in accordance with Figures 16.1(E) and (F) or 16.2(E) and (F) of the Directory of NFT Formats; (d) a version that is listed in column 1 of the table to this section, whose display on more than 15% of the available display surface would be required to display the nutrition facts table; or (e) a manner described in section B.01.466.

(3)

Les caractères dans le tableau de la valeur nutritive : a) sont normalisés, sans empattement, non décoratifs et inscrits de manière à ce qu’ils ne se touchent pas et ne touchent pas les filets; b) peuvent être de dimensions plus grandes que ceux indiqués dans la figure applicable du Répertoire des modèles de TVN si tous les caractères sont agrandis de façon uniforme. (3.1) La taille des caractères qui est indiquée entre parenthèses pour une version prévue à une table des articles B.01.454 à B.01.459 et B.01.461 à B.01.464 représente la taille minimale des caractères à utiliser, dans le tableau de la valeur nutritive, pour indiquer les éléments nutritifs figurant aux tableaux des articles B.01.401 et B.01.402 conformément à cette version.

(4)

For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included in that table.

(4)

Un filet de un ou deux points visé à la figure applicable du Répertoire des modèles de TVN peut être utilisé avec une force de corps plus grande dans le tableau de la valeur nutritive.

(5)

Despite subsections (2) and (3), if the prepackaged product is sold only in the retail establishment where the product is packaged, is labelled by means of a sticker and has an available display surface of 200 cm² or more, its nutrition facts table shall be set out in a version that is listed in column 1 of items 1 to 3 of Parts 1 to 3 of the table to this section, without regard to any condition specified in column 2.

(5)

Le tableau de la valeur nutritive indique les renseignements conformément aux articles B.01.400 à B.01.403 et B.01.406.

(6)

Despite subsections (2) and (3), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is Food and Drug Regulations (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) (nutrients to be shown in a type size of not less than 7 points (condensed)) (nutrients to be shown in a type size of not less than 7 points (condensed)) (nutrients to be shown in a type size of not less than 6 points (condensed)) (nutrients to be shown in a type size of not less than 6 points (condensed)) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations (nutrients to be shown in a type size of not less than 6 points (condensed)) | in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) | The versions in Parts 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) | The versions in Parts 1 to 3 and item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. B.01.455 (1) This section applies to a prepackaged product if it satisfies the condition set out in subsection B.01.401(6) and its nutrition facts table includes only the information referred to in paragraphs B.01.401(6)(a) to (j).

(6)

L’ordre de la langue indiqué dans la figure applicable du Répertoire des modèles de TVN peut être inversé lorsque le tableau de la valeur nutritive est composé d’un tableau en français et en anglais. DORS/2003-11, art. 20; DORS/2016-305, art. 25 et 74. Emplacement du tableau de la valeur nutritive B.01.451 (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive est présenté sur l’étiquette du produit préemballé : a) dans un tableau en français et un tableau en anglais sur le même espace continu de la surface exposée disponible; b) dans un tableau en français et en anglais sur tout espace continu de la surface exposée disponible; SOR/2003-11, s. 20. Orientation of Nutrition Facts Table SOR/2003-11, s. 20. Application SOR/2003-11, s. 20; SOR/2016-305, s. 26. B.01.454 (1) This section applies to a prepackaged product unless any of sections B.01.455 to B.01.459 applies to the product. (a) the bilingual standard format in accordance with Figure 3.5(B), 3.6(B) or 3.7(B) of the Directory of NFT Formats; PART B Foods DIVISION 1 Nutrition Labelling

(2)

Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

Section B.01.454

TABLE PART 1 Standard Format Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use 1 1.1(E) and (F) 2 1.2(E) and (F) 3 1.3(E) and (F) 4 1.4(E) and (F) 5 1.5(E) and (F) 6 1.6(E) and (F) Règlement sur les aliments et drogues

(3)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table containing only the information referred to in paragraphs B.01.401(6)(a) to (j) in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in (b) the bilingual simplified horizontal format in accordance with Figure 7.3(B) or 7.4(B) of the Directory of NFT Formats; (c) the simplified linear format in accordance with Figures 17.1(E) and (F) or 17.2(E) and (F) of the Directory of NFT Formats; (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or (e) a manner described in section B.01.466.

PARTIE B Aliments

(4)

Despite subsections (2) and (3), if the prepackaged product is sold only in the retail establishment where the product is packaged, is labelled by means of a sticker and has an available display surface of 200 cm² or more, its nutrition facts table shall be set out in a version that is listed in column 1 of items 1 to 3 of Parts 1 and 2 of the table to this section, without regard to any condition specified in column 2.

TITRE 1

Étiquetage nutritionnel

(5)

Despite subsections (2) and (3), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. | 1 | 5.1(E) and (F) | (nutrients to be shown in a type size of not less than 8 points) | (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations (nutrients to be shown in a type size of not less than 6 points (condensed)) | The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Simplified Horizontal Format (nutrients to be shown in a type size of not less than 7 points (condensed)) | The versions in Parts 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) | The versions in Parts 1 and 2 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Simplified Formats — Single-serving Prepackaged Products B.01.455.1 (1) This section applies to a single-serving prepackaged product, other than one that is a prepackaged meal, whose nutrition facts table includes only the information referred to in paragraphs B.01.401(6.1)(a) to (j).

Article B.01.454

TABLEAU

(2)

Subject to subsection (3), the nutrition facts table of the single-serving prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

PARTIE 1

Modèle standard Colonne 1 Figure du Répertoire des modèles de TVN (version) Colonne 2 Condition d’utilisation 1 1.1(F) et (A) (éléments nutritifs figurant en caractères d’au moins 8 points) 2 1.2(F) et (A) (éléments nutritifs figurant en caractères d’au moins 7 points) 3 1.3(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) 4 1.4(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) 5 1.5(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 6 points) 6 1.6(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 6 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART 2 Narrow Standard Format Column 1 | Column 2 Figure in Directory of NFT Formats (Version) | Condition of use Item 1 | 2.1(E) and (F) 2 | 2.2(E) and (F) 3 | 2.3(E) and (F) 4 | 2.4(E) and (F) PART 3 Bilingual Standard Format Column 1 | Column 2 Figure in Directory of NFT Formats (Version) | Condition of use Item 1 | 3.1(B) 2 | 3.2(B) 3 | 3.3(B) 4 | 3.4(B) ---

(3)

If it is not possible to display, in accordance with these Regulations, on 15% or less of the available display surface of the single-serving prepackaged product a nutrition facts table containing only the information referred to in paragraphs B.01.401(6.1)(a) to (j) in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in (b) the bilingual simplified horizontal format in accordance with Figure 7.3.1(B) or 7.4.1(B) of the Directory of NFT Formats; (c) the simplified linear format in accordance with Figures 17.1.1(E) and (F) or 17.2.1(E) and (F) of the Directory of NFT Formats; (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or (e) a manner described in section B.01.466.

PARTIE 2

Modèle standard étroit Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TVN (version) | Condition d’utilisation

(4)

Despite subsections (2) and (3), if the single-serving prepackaged product is sold only at the retail establishment where the product is packaged, is labelled by means of a sticker and has an available display surface of 200 cm² or more, its nutrition facts table shall be set out in a version that is listed in column 1 of items 1 to 3 of Part 1 of the table to this section, without regard to any condition specified in column 2.

Article

1 | 2.1(F) et (A) (éléments nutritifs figurant en caractères d’au moins 8 points) 2 | 2.2(F) et (A) (éléments nutritifs figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3 | 2.3(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4 | 2.4(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

(5)

Despite subsections (2) and (3), if the nutrition facts table of the single-serving prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. Bilingual Simplified Standard Format — Single-serving Prepackaged Products (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Simplified Horizontal Format — Single-serving Prepackaged Products (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in Part 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in Part 1 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Dual Format — Foods Requiring Preparation B.01.456 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes information referred to in subsection B.01.406(5), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

PARTIE 3

Modèle standard bilingue Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TVN (version) | Condition d’utilisation

(2)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.

Article

1 | 3.1(B) (éléments nutritifs figurant en caractères d’au moins 8 points) 2 | 3.2(B) (éléments nutritifs figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3 | 3.3(B) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4 | 3.4(B) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART B Foods DIVISION 1 Nutrition Labelling Sections B.01.454-B.01.455 Column 1 | Column 2 Figure in Directory of NFT Formats (Version) | Condition of use Item PART 4 Bilingual Horizontal Format Column 1 | Column 2 Figure in Directory of NFT Formats (Version) | Condition of use Item 1 | 4.1(B) 2 | 4.2(B) SOR/2003-11, s. 20; SOR/2016-305, ss. 27, 74. Simplified Formats Règlement sur les aliments et drogues

(3)

For the purpose of this section, in determining whether a version of a nutrition facts table can be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included in the table, together with the information referred to in subsection B.01.406(5).

PARTIE B Aliments

(4)

Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. Dual Format — Foods Requiring Preparation (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) (nutrients to be shown in a type size of not less than 7 points) (condensed)) (nutrients to be shown in a type size of not less than 7 points) (condensed)) (nutrients to be shown in a type size of not less than 6 points) (condensed)) (nutrients to be shown in a type size of not less than 6 points) (condensed)) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Dual Format — Foods Requiring Preparation (nutrients to be shown in a type size of not less than 8 points) Food and Drug Regulations (nutrients to be shown in a type size of not less than 7 points) (nutrients to be shown in a type size of not less than 7 points (condensed)) (nutrients to be shown in a type size of not less than 6 points (condensed)) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. B.01.457 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes separate information for each food or ingredient as provided in subsection B.01.406(2), paragraph B.01.406(3)(a) or subsection B.01.406(4), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

TITRE 1

Étiquetage nutritionnel

(2)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out (a) in the case of a product described in subsection B.01.406(2) or (4), in (i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of the Directory of NFT Formats, or (ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or (b) in the case of a product described in paragraph B.01.406(3)(a), in (i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of the Directory of NFT Formats, (ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or (iii) a manner described in section B.01.466.

Articles B.01.454-B.01.455

Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TVN (version) | Condition d’utilisation

(3)

For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each food or ingredient for which separate information is set out in the table.

Article

(nutriments figurant en caractères étroits d’au moins 6 points) | conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

(4)

Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to the package to which a permanent ornamental container is attached and the tag is of such a size, shape and design that the information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in subparagraph (2)(a)(i) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. B.01.458 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes separate information for different amounts of the food as provided in paragraph B.01.406(7)(a) without including the information referred to in paragraph B.01.406(7)(c), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

PARTIE 4

Modèle horizontal bilingue Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TVN (version) | Condition d’utilisation

(2)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.

Article

1 | 4.1(B) (nutriments figurant en caractères étroits d’au moins 7 points) | Les versions des parties 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 2 | 4.2(B) (nutriments figurant en caractères étroits d’au moins 6 points) | Les versions des parties 1 à 3 et de l’article 1 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. DORS/2003-11, art. 20; DORS/2016-305, art. 27 et 74. Modèles simplifiés B.01.455 (1) Le présent article s’applique à tout produit préemballé qui remplit la condition du paragraphe B.01.401(6) et dont le tableau de la valeur nutritive ne contient que les renseignements visés aux alinéas B.01.401(6)a) à j).

(3)

For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each amount of food for which separate information is set out in the table.

(2)

Sous réserve du paragraphe (3), le tableau de la valeur nutritive du produit préemballé est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(4)

Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points (condensed)) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Dual Format — Different Amounts of Food (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. B.01.459 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes separate information for different amounts of the food as provided in paragraphs B.01.406(7)(a) and (c), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3)

Si le tableau de la valeur nutritive qui ne contient que les renseignements visés aux alinéas B.01.401(6)a) à j) ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté de l’une des façons suivantes : (a) the bilingual simplified standard format in accordance with Figure 6.5(B) or 6.6(B) of the Directory of NFT Formats; TABLE PART 1 Simplified Standard Format | Column 1 | Column 2 | |----------|----------| | Figure in Directory of NFT Formats (Version) | Condition of use | Column 1 Column 2 Item Figure in Directory of NFT Formats (Version) Condition of use 2 5.2(E) and (F) 3 5.3(E) and (F) 4 5.4(E) and (F) 5 5.5(E) and (F) 6 5.6(E) and (F) PART 2 Bilingual Simplified Standard Format Column 1 Column 2 Item Figure in Directory of NFT Formats (Version) Condition of use 1 6.1(B) 2 6.2(B) 3 6.3(B) Colonne 1 Colonne 2

(2)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in (a) the bilingual aggregate format in accordance with Figure 15.5(B) or 15.6(B) of the Directory of NFT Formats; or (b) any of the versions listed in column 1 of the table to this section, even if the nutrition facts table is displayed in a version that does not satisfy the condition specified in column 2. (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.

Article Figure du Répertoire des modèles de TVN (version) Condition d’utilisation

2 5.2(F) et (A) (éléments nutritifs figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3 5.3(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4 5.4(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 5 5.5(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 6 5.6(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

(3)

For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each amount of the food for which separate information is set out in the table.

PARTIE 2

Modèle standard simplifié bilingue Colonne 1 Colonne 2

(4)

Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) (nutrients to be shown in a type size of not less than 7 points (condensed)) (nutrients to be shown in a type size of not less than 7 points (condensed)) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations (nutrients to be shown in a type size of not less than 6 points (condensed)) (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Aggregate Format — Different Amounts of Food (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) (nutrients to be shown in a type size of not less than 7 points (condensed)) (nutrients to be shown in a type size of not less than 6 points (condensed)) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Presentation of Additional Information B.01.460 (1) If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in English and a table in French or a table in English or French, that information shall be displayed (a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figures 18.1(E) and (F) of the Directory of NFT Formats; and (b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in the Directory of NFT Formats.

Article Figure du Répertoire des modèles de TVN (version) Condition d’utilisation

1 6.1(B) (éléments nutritifs figurant en caractères d’au moins 8 points) 2 6.2(B) (éléments nutritifs figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3 6.3(B) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART B Foods DIVISION 1 Nutrition Labelling Sections B.01.455-B.01.455.1 Column 1 | Column 2 Figure in Directory of NFT Formats (Version) | Condition of use Item 4 | 6.4(B) PART 3 Column 1 | Column 2 Figure in Directory of NFT Formats (Version) | Condition of use Item 1 | 7.1(B) 2 | 7.2(B) SOR/2003-11, s. 20; SOR/2016-305, ss. 28, 74. Règlement sur les aliments et drogues

(2)

If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in both English and French, that information shall be displayed (a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figure 19.1(B) of the Directory of NFT Formats; and (b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in the Directory of NFT Formats.

PARTIE B Aliments

(3)

Despite paragraph (1)(a), the use of indents illustrated in Figures 18.1(E) and (F) of the Directory of NFT Formats is not applicable if information referred to in column 1 of the table to section B.01.402 is set out in the linear format referred to in paragraph B.01.454(3)(c) or the simplified linear format referred to in paragraph B.01.455(3)(c). Standard and Horizontal Formats — Infants Six Months of Age or Older but Less Than One Year of Age B.01.461 (1) This section applies to a prepackaged product that is intended solely for infants six months of age or older but less than one year of age unless section B.01.462, B.01.463 or B.01.464 applies to the product.

TITRE 1

Étiquetage nutritionnel

(2)

Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

Articles B.01.455-B.01.455.1

Colonne 1 | Colonne 2

(3)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in (b) the bilingual horizontal format in accordance with Figure 23.3(B) or 23.4(B) of the Directory of NFT Formats; (c) the linear format in accordance with Figures 31.1(E) and (F) or 31.2(E) and (F) of the Directory of NFT Formats; (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or (e) a manner described in section B.01.466.

Article Figure du Répertoire des modèles de TVN (version) | Condition d’utilisation

(4)

For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included in that table. Standard Format — Infants Six Months of Age or Older but Less Than One Year of Age (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points)

Article

4 | 6.4(B) (éléments nutritifs figurant en caractères étroits d’au moins 6 points) | Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

1 The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PARTIE 3

Modèle horizontal simplifié bilingue Colonne 1 | Colonne 2

2 The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Food and Drug Regulations (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Narrow Standard Format — Infants Six Months of Age or Older but Less Than One Year of Age (nutrients to be shown in a type size of not less than 8 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations Bilingual Standard Format — Infants Six Months of Age or Older but Less Than One Year of Age (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Horizontal Format — Infants Six Months of Age or Older but Less Than One Year of Age (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in Parts 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in Parts 1 to 3 and an item in Part 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Simplified Formats — Infants Six Months of Age or Older but Less Than One Year of Age B.01.462 (1) This section applies to a prepackaged product that is intended solely for infants six months of age or older but less than one year of age if it satisfies the condition set out in subsection B.01.403(5) and its nutrition facts table includes only the information referred to in paragraphs B.01.403(5)(a) to (k).

Article Figure du Répertoire des modèles de TVN (version) | Condition d’utilisation

(2)

Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

Article

1 | 7.1(B) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) | Les versions des parties 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 2 | 7.2(B) (éléments nutritifs figurant en caractères étroits d’au moins 6 points) | Les versions des parties 1 et 2 de l’article 1 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. DORS/2003-11, art. 20; DORS/2016-305, art. 28 et 74. Modèles simplifiés — produits préemballés à portion individuelle B.01.455.1 (1) Le présent article s’applique à tout produit préemballé à portion individuelle autre qu’un repas préemballé dont le tableau de la valeur nutritive ne contient que les renseignements visés aux alinéas B.01.401(6.1)a) à j).

(3)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table containing only the information referred to in paragraphs B.01.403(5)(a) to (k) in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in (b) the bilingual simplified horizontal format in accordance with Figure 26.3(B) or 26.4(B) of the Directory of NFT Formats; (c) the simplified linear format in accordance with Figures 32.1(E) and (F) or 32.2(E) and (F) of the Directory of NFT Formats; (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or (e) a manner described in section B.01.466. Simplified Standard Format — Infants Six Months of Age or Older but Less Than One Year of Age (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Simplified Standard Format — Infants Six Months of Age or Older but Less Than One Year of Age Food and Drug Regulations (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points (condensed)) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Simplified Horizontal Format — Infants Six Months of Age or Older but Less Than One Year of Age (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in Parts 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in Parts 1 and 2 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Aggregate Format — Different Kinds of Foods — Infants Six Months of Age or Older but Less Than One Year of Age B.01.463 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product that is intended solely for infants six months of age or older but less than one year of age includes separate information for each food or ingredient as provided in subsection B.01.406(2), paragraph B.01.406(3)(a) or subsection B.01.406(4), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2)

Sous réserve du paragraphe (3), le tableau de la valeur nutritive du produit préemballé à portion individuelle est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(2)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out (a) in the case of a product described in subsection B.01.406(2) or (4), in (i) the bilingual aggregate format in accordance with Figure 28.5(B) or 28.6(B) of the Directory of NFT Formats, or (ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or (b) in the case of a product described in paragraph B.01.406(3)(a), in (i) the bilingual aggregate format in accordance with Figure 28.5(B) or 28.6(B) of the Directory of NFT Formats, (ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or (iii) a manner described in section B.01.466.

(3)

Si le tableau de la valeur nutritive qui ne contient que les renseignements visés aux alinéas B.01.401(6.1)a) à j) ne peut être présenté conformément au présent (a) the bilingual simplified standard format in accordance with Figure 6.5.1(B) or 6.6.1(B) of the Directory of NFT Formats; règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé à portion individuelle selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté de l’une des façons suivantes : a) selon le modèle standard simplifié bilingue prévu aux figures 6.5.1(B) ou 6.6.1(B) du Répertoire des modèles de TVN; b) selon le modèle horizontal simplifié bilingue prévu aux figures 7.3.1(B) ou 7.4.1(B) du Répertoire des modèles de TVN; c) selon le modèle linéaire simplifié prévu aux figures 17.1.1(F) et (A) ou 17.2.1(F) et (A) du Répertoire des modèles de TVN; d) selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible; e) d’une façon prévue à l’article B.01.466.

(3)

For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each food or ingredient for which separate information is set out in the table. Aggregate Format — Different Kinds of Foods — Infants Six Months of Age or Older but Less Than One Year of Age (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) (nutrients to be shown in a type size of not less than 7 points (condensed)) (nutrients to be shown in a type size of not less than 7 points (condensed)) (nutrients to be shown in a type size of not less than 6 points (condensed)) (nutrients to be shown in a type size of not less than 6 points (condensed)) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The version in item 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Aggregate Format — Different Kinds of Foods — Infants Six Months of Age or Older but Less Than One Year of Age (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Aggregate Format — Different Amounts of Food — Infants Six Months of Age or Older but Less Than One Year of Age B.01.464 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product that is intended solely for infants six months of age or older but less than one year of age includes separate information for different amounts of the food as provided in subsection B.01.406(8), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(4)

Malgré les paragraphes (2) et (3), si le produit préemballé à portion individuelle est vendu uniquement dans l’établissement de détail où il est emballé, le tableau de la valeur nutritive est présenté selon l’une des versions figurant à la colonne 1 des articles 1 à 3 de la partie 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2.

(2)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in... (a) the bilingual aggregate format in accordance with Figure 30.5(B) or 30.6(B) of the Directory of NFT Formats; or (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.

(5)

Malgré les paragraphes (2) et (3), si le tableau de la valeur nutritive du produit préemballé à portion individuelle est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues aux alinéas (3)a), b) et c) ou selon des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2. TABLE PART 1 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(3)

For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each amount of the food for which separate information is set out in the table. Aggregate Format — Different Amounts of Food — Infants Six Months of Age or Older but Less Than One Year of Age (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations (nutrients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Aggregate Format — Different Amounts of Food — Infants Six Months of Age or Older but Less Than One Year of Age (nutrients to be shown in a type size of not less than 8 points) (nutrients to be shown in a type size of not less than 7 points) (nutrients to be shown in a type size of not less than 7 points (condensed)) (nutrients to be shown in a type size of not less than 6 points (condensed)) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Presentation of Additional Information — Infants Six Months of Age or Older but Less Than One Year of Age B.01.465 (1) This section applies to a prepackaged product that is intended solely for infants six months of age or older but less than one year of age.

6.1.1(B)

2

(2)

If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in English and a table in French or a table in English or French, that information shall be displayed (a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figures 33.1(E) and (F) of the Directory of NFT Formats; and (b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in the Directory of NFT Formats.

6.2.1(B)

3

(3)

If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in both English and French, that information shall be displayed (a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figure 34.1(B) of the Directory of NFT Formats; and (b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in the Directory of NFT Formats.

6.3.1(B)

4

(4)

Despite paragraph (2)(a), the use of indents illustrated in Figures 33.1(E) and (F) of the Directory of NFT Formats is not applicable if information referred to in column 1 of the table to section B.01.402 is set out in the linear format referred to in paragraph B.01.461(3)(c) or the simplified linear format referred to in paragraph B.01.462(3)(c). Alternative Methods of Presentation

6.4.1(B)

PART 2 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(2)

If the nutrition facts table is set out in a manner described in paragraph (1)(b) or (c), the outer side of the label of the package shall indicate in a type size of not less than 8 points where the nutrition facts table is located.

7.1.1(B)

2

(3)

If the nutrition facts table is set out in a manner described in subsection (1), it shall be set out (a) in the case of a product described in subsection B.01.454(3), in a version that is described in paragraph B.01.454(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.454; (b) in the case of a product described in subsection B.01.455(3), in a version that is described in paragraph B.01.455(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.455; (c) in the case of a product described in paragraph B.01.457(2)(b), in a version that is described in subparagraph B.01.457(2)(b)(i) or that is listed in column 1 of the table to section B.01.457; (d) in the case of a product described in subsection B.01.461(3), in a version that is described in paragraph B.01.461(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.461; (e) in the case of a product described in subsection B.01.462(3), in a version that is described in paragraph B.01.462(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.462; and (f) in the case of a product described in paragraph B.01.463(2)(b), in a version that is described in subparagraph B.01.463(2)(b)(i) or that is listed in column 1 of the table to section B.01.463. B.01.467 (1) Despite section A.01.016 and subject to subsection (2), if the available display surface of a prepackaged product is less than 100 cm², the label of the product need not carry a nutrition facts table if the outer side of the label contains an indication of how a purchaser or consumer may obtain the nutrition information that would otherwise be required to be set out in a nutrition facts table on the label of the product.

7.2.1(B)

SOR/2016-305, s. 29. (a) the bilingual dual format in accordance with Figures 9.5(B) or 9.6(B) of the Directory of NFT Formats; or TABLE PART 1 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(2)

Subsection (1) does not apply to a prepackaged product that is (b) contained in a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase. (2.1) However, subsection (1) applies to a prepackaged product that is referred to in subparagraph B.01.401(3)(e)(ii) and that meets the conditions set out in item 37, column 2, of the Table of Permitted Nutrient Content Statements and Claims for the subject “Free of sugars” set out in column 1 if (a) the product does not contain an added vitamin or mineral nutrient; (b) the energy value expressed in Calories per serving of stated size and the amount of sugar alcohols expressed in grams per serving of stated size are shown immediately after whichever of the following elements appears last on the label: (ii) a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1), (c) any statement or claim that is set out in item 37, column 4, of the table for the subject “Free of sugars” set out in column 1 and that appears on the label is (i) legibly set out on the principal display panel, (ii) in lower case letters except for the first letter of each word of the statement or claim, which may be an upper case letter, (iii) of at least the same size and prominence as the letters used in the numerical portion of the declaration of net quantity as required under paragraph 229(1)(a) and subsections 229(2) and (3) of the Safe Food for Canadians Regulations, and (a) shall be set out in a type size of not less than 8 points; (b) shall include a postal address or a toll-free telephone number; and (i) in English and French, or (ii) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the product may be shown in that language only and is shown on the label in that language.

8.1(E) and (F)

2

(4)

The manufacturer of the prepackaged product shall provide the information referred to in subsection (1) to a purchaser or consumer on request (b) in the following manner, namely, (i) in the official language in which the information is requested or, if specified by the purchaser or consumer, in both official languages, or (ii) in one of the official languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the product may be shown in that language only and is shown on the label in that language; and (c) in the form of a nutrition facts table that is set out (i) in a format, other than a horizontal format, that is specified in any of sections B.01.454 to B.01.459 or B.01.461 to B.01.464 and that would otherwise be carried on the label of the product in accordance with these Regulations, and (ii) in a version of that format that is listed in column 1 of item 1 of any Part of the table to the applicable section referred to in subparagraph (i).

8.2(E) and (F)

3

(5)

In this section, official languages means the English language and the French language. B.01.468 (1) Subject to subsection (2), if a prepackaged product has an available display surface of less than 100 cm² and has a nutrition facts table on its label, the nutrition facts table need only include (a) the serving of stated size; (b) the energy value and, subject to subsection (2), the amount of nutrients referred to in column 1 of items 2 to 15 of the table to section B.01.401 if the amount shown in the nutrition facts table may not be expressed as “0” according to the manner set out in column 4; and (c) the amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product.

8.3(E) and (F)

4

(2)

If the label of a prepackaged product, or any advertisement for the product that is made or placed by or under the direction of the manufacturer of the product, contains a representation, express or implied, that includes information that is set out in column 1 of the table to section B.01.401 or B.01.402, that information shall also be in the nutrition facts table. B.01.469 Despite subsection B.01.401(1), the label of a prepackaged product that has an available display surface of less than 15 cm² need not carry a nutrition facts table. B.01.500 (1) The following definitions apply in this section and in the Table of Permitted Nutrient Content Statements and Claims. combination foods means the category of food to which belong foods that contain as ingredients foods from more than one food group, or foods from one or more food groups mixed with foods from the category of other foods, such as pizza or lasagna. (aliments composés) food group means one of the following categories of foods: (a) milk products, and milk product alternatives such as fortified plant-based beverages; (b) meat, poultry and fish, and alternatives such as legumes, eggs, tofu or peanut butter; (c) bread and grain products; or other foods means the category of food to which belong foods that are not part of any food group, including (a) foods that are mostly fats, such as butter, margarine, oil or lard; (b) foods that are mostly sugars, such as jam, honey, syrup or confectionery; (c) snack foods, such as potato chips or pretzels; (e) herbs, spices and condiments, such as pickles, mustard or ketchup. (autres aliments) reference food of the same food group means a food that can be substituted in the diet for the food to which it is compared and that belongs to (a) the same food group as the food to which it is compared, such as cheese as a reference food for milk, or chicken as a reference food for tofu; (b) the category of other foods, if the food to which it is compared also belongs to that category, such as pretzels as a reference food for potato chips; or similar reference food means a food of the same type as the food to which it is compared and that has not been processed, formulated, reformulated or otherwise modified in a manner that increases or decreases the energy value or the amount of a nutrient that is the subject of the comparison, such as whole milk as a similar reference food for partly skimmed milk or regular chocolate chip cookies as a similar reference food for fat-reduced chocolate chip cookies. (aliment de référence similaire)

8.4(E) and (F)

5

(2)

The similar reference food referred to in column 3 of item 45 of the Table of Permitted Nutrient Content Statements and Claims, with respect to the subject “light in energy or fat” set out in column 1, shall have a nutrient value that is representative of foods of that type that have not been processed, formulated, reformulated or otherwise modified in a manner that increases the energy value or the amount of fat. (a) in English and French; or (b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language. B.01.502 (1) No person shall, on the label of or in any advertisement for a food, make a representation, express or implied, that characterizes the energy value of the food or the amount of a nutrient contained in the food. (a) a representation otherwise provided for in these Regulations, including one that is in the form of a nutrition symbol; (b) a representation provided for by section 273 of the Safe Food for Canadians Regulations; (c) a representation provided for by column 1 of Table 2 to Volume 7 of the document entitled Canadian Standards of Identity, prepared by the Canadian Food Inspection Agency and published on its website, as amended from time to time. (e) a representation that characterizes the addition of salt to a food, other than any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims; (f) a representation that characterizes the addition of sugars to a food, other than any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims; (g) a representation that characterizes the amount of starch in a food, if the food is intended solely for infants six months of age or older but less than one year of age; (h) the representations “defatted (naming the food)”, “demineralized (naming the food)” and “high (naming the monosaccharide or disaccharide) (naming the syrup)”; (i) a representation that characterizes the amount of fatty acid in a vegetable oil and forms part of its common name; (j) a representation that characterizes the amount of alcohol in a beverage; (k) the representation “light salted” with respect to fish; or (l) the English representation “lean” with respect to a prepackaged meal represented for use in a weight reduction diet or a weight maintenance diet. B.01.503 (1) A person may, on the label of or in any advertisement for a food, make a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims, with respect to a subject set out in column 1, if (a) the food meets the applicable conditions set out in column 2; (b) the label or advertisement meets the conditions, if any, set out in column 3, in accordance with sections B.01.504 to B.01.506; and (c) in the case of a food that is not a prepackaged product, or a prepackaged product for which an advertisement is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement includes, per serving of stated size, and in accordance with section B.01.505 or B.01.506 if applicable, (i) the declaration of the energy value, if the energy value is the subject of the statement or claim, or (ii) the amount of the nutrient, if a nutrient is the subject of the statement or claim. (1.1) Despite subsection (1), no person shall, on the principal display panel of a prepackaged product, make a statement or claim that is set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims and that relates to a nutrient that is referred to in a nutrition symbol that appears on the panel unless it is a statement or claim respecting one of the following subjects set out in column 1: (b) “reduced in sodium or salt”, set out in item 33; or (c) “reduced in sugars”, set out in item 38.

8.5(E) and (F)

6

(2)

Despite subsection (1), no person shall, on the label of or in any advertisement for a food that is intended solely for children under four years of age, make a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims unless it is a statement or claim respecting one of the following subjects set out in column 1: (e) “no added sugars”, set out in item 40. (2.01) Despite subsections (1) and (2), it is prohibited, on the label of or in any advertisement for a human milk fortifier, to make a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims. (2.1) The information required by paragraph (1)(c) need not be included on the label or in any advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating, if a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims is made on the label or advertisement.

8.6(E) and (F)

Column 2 PART 2 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(3)

If a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims is made on the label of or in any advertisement for a food, all the words, numbers, signs or symbols that constitute the statement or claim shall be of the same size and prominence.

9.1(B)

PART B Foods DIVISION 1 Nutrition Labelling Sections B.01.406-B.01.457 Column 1 Figure in Directory of NFT Formats (Version) Item 2 9.2(B) 3 9.3(B) 4 9.4(B) Column 2 Condition of use SOR/2003-11, s. 20; SOR/2016-305, ss. 30, 74. Aggregate Format — Different Kinds of Foods Règlement sur les aliments et drogues

(4)

In the English version of the statements or claims, the word “fibre” may be spelled as “fiber”. B.01.504 If a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims is made on the label of a food, the information required under the conditions set out in column 3 shall be (a) adjacent to, without any intervening printed, written or graphic material, (i) the statement or claim, if the statement or claim is made only once, or (ii) the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once; and (b) shown in letters of at least the same size and prominence as (i) those of the statement or claim, if the statement or claim is made only once, or (ii) those of the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once. B.01.505 If a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims is made in an advertisement for a food, other than a radio or television advertisement, the information required under the conditions set out in column 3 and, if applicable, the information required by paragraph B.01.503(1)(c), shall be (a) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and (b) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once. B.01.506 (1) If a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims is made in a radio or television advertisement, the information required under the conditions set out in column 3 and, if applicable, the information required by paragraph B.01.503(1)(c), shall be provided in the advertisement, except for the information required under the condition set out in paragraph (a) of column 3, in respect of the following subjects set out in column 1, which may be on the label: (a) “reduced in energy”, set out in item 3; (b) “reduced in fat”, set out in item 13; (c) “reduced in saturated fatty acids”, set out in item 20; (e) “reduced in cholesterol”, set out in item 29; (h) “reduced in sugars”, set out in item 38; and (i) “light in energy or fat”, set out in item 45.

PARTIE B Aliments

(2)

Despite subsection (1), if the statement or claim is made in a radio or television advertisement that is not made or placed by or on the direction of the manufacturer of the food, the information required under the condition set out in paragraph (a) of column 3 of the Table of Permitted Nutrient Content Statements and Claims, in respect of the subjects set out in paragraphs (1)(a) to (i), shall be provided in the advertisement.

TITRE 1 Étiquetage nutritionnel

(3)

If the information required under the conditions set out in column 3 of the Table of Permitted Nutrient Content Statements and Claims and the information required by paragraph B.01.503(1)(c) is provided in a radio advertisement or in the audio portion of a television advertisement, that information shall immediately precede or follow the statement or claim.

Articles B.01.406-B.01.457

Colonne 1 Figure du Répertoire des modèles de TVN (version)

(4)

In the case of a television advertisement, the information required under the conditions set out in column 3 of the Table of Permitted Nutrient Content Statements and Claims and, if applicable, the information required by paragraph B.01.503(1)(c), shall be communicated (a) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions; or (b) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.

Article

2 9.2(B) (éléments nutritifs figurant en caractères d’au moins 8 points) 3 9.3(B) (éléments nutritifs figurant en caractères d’au moins 7 points) 4 9.4(B) (éléments nutritifs figurant en caractères d’au moins 6 points) Colonne 2 Condition d’utilisation La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. DORS/2003-11, art. 20; DORS/2016-305, art. 30 et 74. Modèle composé — différents types d’aliments B.01.457 (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive de tout produit préemballé qui inclut des renseignements distincts en fonction de chaque aliment ou ingrédient, tel qu’il est prévu au paragraphe B.01.406(2), à l’alinéa B.01.406(3)a) ou au paragraphe B.01.406(4), est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(5)

If the information required under the conditions set out in column 3 of the Table of Permitted Nutrient Content Statements and Claims and the information required by paragraph B.01.503(1)(c) is communicated in the visual mode of a television advertisement, it shall (a) appear concurrently with and for at least the same amount of time as the statement or claim; (b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and (c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once. B.01.507 A person may, on the label of or in any advertisement for a food, make a representation, express or implied, that the food is for use in an energy-reduced diet, if a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims, in respect of any of the following subjects set out in column 1, is made on the label of or in the advertisement for the food, in accordance with section B.01.503: (b) “low in energy”, set out in item 2; (c) “reduced in energy”, set out in item 3; B.01.508 (1) A person may, on the label of or in any advertisement for a food, make a representation, express or implied, that the food is for use in a sodium-restricted diet, if a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims, in respect of any of the following subjects set out in column 1, is made on the label of or in the advertisement for the food, in accordance with section B.01.503: (c) “reduced in sodium or salt”, set out in item 33; or

(2)

Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté : a) dans le cas de tout produit visé aux paragraphes B.01.406(2) ou (4) : (i) soit selon le modèle composé bilingue prévu aux figures 11.5(B) ou 11.6(B) du Répertoire des modèles de TVN, (ii) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible; TABLE PART 1 Aggregate Format — Different Kinds of Foods Column 1 Figure in Directory of NFT Formats (Version) 1

(2)

Despite subsection (1), no person shall, on the principal display panel of a prepackaged product, make a representation, express or implied, that the product is for use in a sodium-restricted diet if a nutrition symbol referring to sodium appears on the panel. B.01.509 (1) A person may, on the label of or in any advertisement for a food, make the statement or claim that the food is “unsweetened” if (a) the food meets the conditions set out in item 40, column 2, of the Table of Permitted Nutrient Content Statements and Claims for the subject “No added sugars” set out in column 1; and (b) the food does not contain a sweetener referred to in section 2 of the Marketing Authorization for Food Additives That May Be Used as Sweeteners.

10.1(E) and (F)

2

(2)

Despite subsection (1), no person shall, on the principal display panel of a prepackaged product, make a statement or claim that the product is “unsweetened” if a nutrition symbol referring to sugars appears on the panel. B.01.510 A statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims, respecting the following subjects set out in column 1, that is made on the label of or in an advertisement for a breakfast cereal with milk, shall be accompanied by an indication that it refers to 30 g of the breakfast cereal combined with 125 mL of milk: (b) “excellent source of protein”, set out in item 9; and B.01.511 (1) For greater certainty and subject to subsections (2) to (4), a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims that is made on the label of or in any advertisement for a food may be preceded or followed by other words, numbers, signs or symbols, but none of those shall be interposed between the words, numbers, signs or symbols of the statement or claim.

10.2(E) and (F)

Column 2 Condition of use b) dans le cas de tout produit visé à l’alinéa B.01.406(3)a) : (i) soit selon le modèle composé bilingue prévu aux figures 11.5(B) ou 11.6(B) du Répertoire des modèles de TVN, (ii) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible, (iii) soit d’une façon prévue à l’article B.01.466.

(2)

The words “very”, “ultra” and “extra”, and all other words, numbers, signs or symbols that modify the nature of a statement or claim, shall not precede or follow the statement or claim.

(3)

Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il est tenu compte, dans le tableau, de tous les renseignements exigés par le présent règlement pour chaque ingrédient ou aliment pour lequel des renseignements distincts y sont indiqués.

(3)

A statement or claim that is made on the label of or in any advertisement for a food that has not been processed, formulated, reformulated or otherwise modified to meet the conditions set out in column 2 of the Table of Permitted Nutrient Content Statements and Claims shall not be accompanied by the brand name of the food.

(4)

Malgré les paragraphes (1) et (2), si le tableau de la valeur nutritive du produit préemballé est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage auquel est fixé un contenant décoratif permanent et que l’étiquette est de façon que les renseignements ne peuvent être indiqués lisiblement et facilement visibles par l’acheteur ou le consommateur dans les conditions habituelles d’achat, il est présenté selon l’une des versions figurant au sous-alinéa (2)a)(i) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2. TABLEAU

(4)

Any words, numbers, signs or symbols preceding or following the statement or claim referred to in subsection (3) shall accompany the statement or claim in such a manner that the statement or claim characterizes all foods of that type, and not only the specific food. B.01.512 If a food meets the conditions set out in column 2 of the Table of Permitted Nutrient Content Statements and Claims for more than one of the subjects set out in column 1, it is not necessary to repeat the common element of the statements or claims set out in column 4 that are used on the label or in the advertisement for the food, and the remaining elements may be joined by means of a conjunction or punctuation, as appropriate. B.01.513 (1) No person shall, on the label of or in any advertisement for a food, make the statement or claim “light” or “léger” — including any phonetic rendering of that statement or claim — respecting a sensory characteristic of the food unless the following conditions are met: (a) if the statement or claim “light” or “léger” is made on the label of a food, the sensory characteristic shall be (i) adjacent to, without any intervening printed, written or graphic material, (A) the statement or claim, if the statement or claim is made only once, or (B) the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once, and (ii) shown in letters of at least the same size and prominence as (A) those of the statement or claim, if the statement or claim is made only once, or (B) those of the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once; (b) if the statement or claim “light” or “léger” is made in an advertisement for a food, other than a radio or television advertisement, the sensory characteristic shall be (i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and (ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; (c) if the statement or claim “light” or “léger” is made in a radio advertisement or in the audio portion of a television advertisement, the sensory characteristic shall immediately precede or follow the statement or claim; and (d) if the statement or claim “light” or “léger” is made in the visual portion of a television advertisement, the sensory characteristic shall (i) appear concurrently with and for the same amount of time as the statement or claim, (ii) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and (iii) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

PARTIE 1

Modèle composé — différents types d’aliments Colonne 1 Figure du Répertoire des modèles de TVN (version) 1

(2)

Subsection (1) does not apply to the statement or claim “light” or “léger” when it is used with respect to rum. B.01.600 A statement or claim set out in column 1 of the table following section B.01.603 that appears on the label of a food shall be (a) in English and French; or (b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language. B.01.601 (1) A food with a label or advertisement that carries a statement or claim set out in column 1 of the table following section B.01.603 is exempt from the provisions of the Act and its Regulations with respect to drugs, and from subsections 3(1) and (2) of the Act, if (a) the food meets the applicable conditions set out in column 2; (b) the label of or the advertisement for the food meets the applicable conditions set out in column 3; and (c) the food is not (i) intended solely for children under four years of age, or (ii) a food represented for use in a very low energy diet.

10.1(F) et (A)

(éléments nutritifs figurant en caractères d’au moins 8 points) 2

(2)

Subsection (1) does not apply to a food that comes within the definition of drug as defined in section 2 of the Act for a reason other than the fact that its label or advertisement carries a statement or claim referred to in that subsection.

10.2(F) et (A)

(éléments nutritifs figurant en caractères d’au moins 7 points) Colonne 2 Condition d’utilisation La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins. PART B Foods DIVISION 1 Nutrition Labelling

(3)

Subsection (1) applies even if the word “graisses” in the French version of the statement or claim is replaced by the word “lipides.” B.01.602 (1) The information required under the conditions set out in column 3 of the table following section B.01.603 that appears in an advertisement for a food that is not a prepackaged product, or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, shall, (a) in the case of an advertisement, other than a radio or television advertisement, be (i) adjacent to, without any intervening printed, written or graphic material, the statement or claim set out in column 1, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and (ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; (b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim set out in column 1; or (c) in the case of a television advertisement, be communicated (i) in the audio mode, if the statement or claim set out in column 1 is made only in the audio portion of the advertisement or in both the audio and visual portions, or (ii) in the audio or visual mode, if the statement or claim set out in column 1 is made only in the visual portion of the advertisement.

Section B.01.457

Column 1 | Column 2 Figure in Directory of NFT Formats (Version) | Condition of use Item 3 | 10.3(E) and (F) 4 | 10.4(E) and (F) 5 | 10.5(E) and (F) 6 | 10.6(E) and (F) --- PART 2 Bilingual Aggregate Format — Different Kinds of Foods Column 1 | Column 2 Figure in Directory of NFT Formats (Version) | Condition of use Item 1 | 11.1(B) 2 | 11.2(B) 3 | 11.3(B) --- Règlement sur les aliments et drogues

(2)

The information that is communicated in the visual mode of a television advertisement in accordance with subparagraph (1)(c)(ii) shall (a) appear concurrently with and for at least the same amount of time as the statement or claim; (b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and (c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once. B.01.603 (1) For greater certainty, a statement or claim set out in column 1 of the table following this section that is made on the label of or in any advertisement for a food may be preceded or followed by other words, numbers, signs or symbols, but none of those shall be interposed between the words, numbers, signs or symbols of the statement or claim.

PARTIE B Aliments

(2)

If a food meets the conditions set out in column 2 of the table following this section for more than one item of that table, it is not necessary to repeat the common element of the statements or claims set out in column 1 that are used on the label of or in the advertisement for the food, and the remaining elements may be joined by means of a conjunction or punctuation, as appropriate.

TITRE 1

Étiquetage nutritionnel

(1)

"A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is sodium-free."

Article B.01.457

Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TVN (version) | Condition d’utilisation

(2)

"A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is low in sodium."

Article

3 | 10.3(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4 | 10.4(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 5 | 10.5(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 6 | 10.6(F) et (A) (éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. ---

(3)

"A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is a good source of potassium and is sodium-free."

PARTIE 2

Modèle composé bilingue — différents types d’aliments Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TVN (version) | Condition d’utilisation

(4)

"A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is a good source of potassium and is low in sodium."

Article

1 | 11.1(B) (éléments nutritifs figurant en caractères d’au moins 8 points) 2 | 11.2(B) (éléments nutritifs figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3 | 11.3(B) (éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART B Foods DIVISION 1 Nutrition Labelling Sections B.01.457-B.01.458 Column 1 Item 4 Figure in Directory of NFT Formats (Version)

(5)

"A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is high in potassium and is sodium-free."

11.4(B)

Column 2 Condition of use SOR/2003-11, s. 20; SOR/2016-305, ss. 31, 74. Dual Format — Different Amounts of Food (a) the bilingual dual format in accordance with Figure 13.5(B) or 13.6(B) of the Directory of NFT Formats; or Règlement sur les aliments et drogues

(6)

"A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is high in potassium and is low in sodium." (a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of item 2 of the Table of Permitted Nutrient Content Statements and Claims for the subject "low in energy" set out in column 1; (b) contains at least 10% of the weighted recommended nutrient intake of a vitamin or a mineral nutrient (i) per reference amount and per serving of stated size, or (ii) per serving of stated size, if the food is a prepackaged meal; (c) meets the conditions set out in column 2 of item 19 of the Table of Permitted Nutrient Content Statements and Claims for the subject "low in saturated fatty acids" set out in column 1; (e) meets the conditions set out in column 2 of item 32 of the Table of Permitted Nutrient Content Statements and Claims for the subject "free of sodium or salt" set out in column 1, if the label of or advertisement for the food carries statement of claim (2), (4) or (6) set out in column 1 of this item; and (i) per reference amount and per serving of stated size, or (ii) per serving of stated size, if the food is a prepackaged meal. If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of sodium and potassium per serving of stated size, in accordance with section B.01.602, if applicable. However, this requirement does not apply if the statement or claim is made on the label of or in the advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, or an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petroleum or any other protective coating.

PARTIE B Aliments

(1)

"A healthy diet with adequate calcium and vitamin D, and regular physical activity, may help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is a good source of calcium."

TITRE 1

Étiquetage nutritionnel

(2)

"A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones (a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of item 2 of the Table of Permitted Nutrient Content Statements and Claims for the subject "low in energy" set out in column 1;

Articles B.01.457-B.01.458

Colonne 1

(1)

If the statement or claim is made on the label of a prepackaged product, or in any advertisement for the prepackaged product that is made or placed by or on the direction of the manufacturer of the product, the amount of vitamin D and phosphorus shall be included in, as the case may be, and may reduce the risk of osteoporosis. (Naming the food) is high in calcium."

Article

4 Figure du Répertoire des modèles de TVN (version)

(3)

"A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is an excellent source of calcium."

11.4(B)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Colonne 2 Condition d’utilisation Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. DORS/2003-11, art. 20; DORS/2016-305, art. 31 et 74. Modèle double — différentes quantités d’aliments B.01.458 (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive de tout produit préemballé qui indique des renseignements distincts en fonction de différentes quantités de l’aliment, tel qu’il est prévu à l’alinéa B.01.406(7)a), sans indiquer les renseignements visés sous-alinéa B.01.406(7)c), est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(4)

"A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is very high in calcium."

(2)

Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté : a) soit selon le modèle double bilingue prévu aux figures 13.5(B) ou 13.6(B) du Répertoire des modèles de TVN; b) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible.

(5)

"A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is an excellent source of calcium and vitamin D."

(3)

Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement pour chaque quantité d’aliment pour laquelle des renseignements distincts y sont indiqués.

(6)

"A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is very high in calcium and vitamin D." (b) contains no more phosphorus, excluding that provided by phytate, than calcium; (c) contains 0.5% or less alcohol; (i) 200 mg or more of calcium per reference amount and per serving of stated size, or (ii) 300 mg or more of calcium per serving of stated size, if the food is a prepackaged meal; (i) 275 mg or more of calcium per reference amount and per serving of stated size, or (ii) 275 mg or more of calcium per serving of stated size, if the food is a prepackaged meal; (f) contains 1.25 μg or more of vitamin D, if the label of or advertisement for the food carries statement or claim (5) or (6) set out in column 1 of this item, (i) per reference amount and per serving of stated size, or (ii) per serving of stated size, if the food is a prepackaged meal. (b) the supplemented food facts table in accordance with subsection B.29.002(1), in respect of the description referred to in column 2, the unit referred to in column 3 and the manner of expression referred to in column 4 of the table to section B.29.002, or with subsection B.29.003(3), or with both, as the case may be.

(4)

Malgré les paragraphes (1) et (2), si le tableau de la valeur nutritive du produit préemballé est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel TABLE PART 1 Dual Format — Different Amounts of Food Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(2)

If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or packaged by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of vitamin D, calcium and phosphorus per serving of stated size, in accordance with section B.01.602, if applicable. However, this requirement does not apply if the statement or claim is made on the label of or in the advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating.

12.1(E) and (F)

2

3 (1) "A healthy diet low in saturated and trans fats may reduce the risk of heart disease. (Naming the food) is free of saturated and trans fats."

12.2(E) and (F)

3

(2)

"A healthy diet low in saturated and trans fats may reduce the risk of heart disease. (Naming the food) is low in saturated and trans fats." (a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of item 2 of the Table of Permitted Nutrient Content Statements and Claims for the subject "low in energy" set out in column 1; (b) contains at least 10% of the weighted recommended nutrient intake of a vitamin or a mineral nutrient (i) per reference amount and per serving of stated size, or (ii) per serving of stated size, if the food is a prepackaged meal; (c) contains 100 mg or less of cholesterol per 100 g of food; (e) if it is a fat or an oil, meets the conditions set out in If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or packaged by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of saturated fatty acids and trans fatty acids per serving of stated size, in accordance with section B.01.602, if applicable. However, this requirement does not apply if the statement or claim is made on the label of or in the advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating. (f) contains (i) 480 mg or less of sodium per reference amount and per serving of stated size, and per 50 g if the reference amount is 30 g or 30 mL or less, or (ii) 960 mg or less of sodium per serving of stated size, if the food is a prepackaged meal; (g) meets the conditions set out in column 2 of item 18 of the Table of Permitted Nutrient Content Statements and Claims for the subject "free of saturated fatty acids" set out in column 1, if the label or advertisement for the food carries statement or claim (1) set out in column 1 of this item; and (h) meets the conditions set out in column 2 of item 19 of the Table of Permitted Nutrient Content Statements and Claims for the subject "low in saturated fatty acids" set out in column 1, if the label or advertisement for the food carries statement or claim (2) set out in column 1 of this item.

12.3(E) and (F)

4

4 "A healthy diet rich in a variety of vegetables and fruit may help reduce the risk of some types of cancer."

(a) is one of the following vegetables, fruits or juices and may contain only food additives that are referred to in section 2 of a marketing authorization, sweetening agents, salt, herbs, spices, seasonings and water: (iv) a combination of the foods set out in subparagraphs (i) to (iii); (b) is not one of the following: (i) potatoes, yams, cassava, plantain, corn, mushrooms, mature legumes and their juices, (ii) vegetables or fruit used as condiments, garnishes or "A healthy diet rich in a variety of vegetables and fruit may help reduce the risk of heart disease." (a) is one of the following vegetables or fruits and may contain only food additives that are referred to in section 2 of a marketing authorization, salt, herbs, spices, seasonings and water: (iv) a combination of the foods set out in any of subparagraphs (i) to (iii); (b) is not one of or does not contain any of the following: (i) potatoes, yams, cassava, plantain, mature legumes and their juices, (ii) vegetables or fruit used as condiments, garnishes or flavourings, including maraschino cherries, glacé fruit, candied fruit and onion flakes, (v) a fruit juice or fruit drink, (vii) the seed of a fruit known as a drupe, including almonds, cashews and coconuts; (c) contains 0.5% or less alcohol; and (d) contains less than 15% of the daily value of sodium per reference amount and per serving of stated size, and per 50 g if the reference amount is 30 g or 30 mL or less. The food is a chewing gum, hard candy or breath freshener product that If the statement or claim is made on the label of a prepackaged product, or in any advertisement for the prepackaged

12.4(E) and (F)

5

(3)

"Does not promote dental caries." (b) does not, if it contains more than 0.25% fermentable carbohydrates, lower plaque pH below 5.7 by bacterial fermentation during 30 minutes after consumption as measured by the indwelling plaque pH test, referred to in "Identification of Low Caries Risk Dietary Components" by T.N. Imfeld, Volume 11, Monographs in Oral Science, 1983. product that is made or placed by or on the direction of the manufacturer of the product, the amount of sugar alcohols, if present, shall be included in, as the case may be, (b) the supplemented food facts table, in accordance with subsection B.29.003(3). Food and Drug Regulations Food and Drug Regulations Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations Food and Drug Regulations Food and Drug Regulations B.02.001 The foods referred to in this Division are included in the term alcoholic beverage. age means the period during which an alcoholic beverage is kept under such conditions of storage as may be necessary to develop its characteristic flavour and bouquet; (âge) alcohol means ethyl alcohol; (alcool) flavouring means, in respect of a spirit, any other spirit or wine, domestic or imported, added as a flavouring to that spirit as authorized under the Excise Act; (substance aromatique) grain spirit means an alcoholic distillate, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or by other enzymes and fermented by the action of yeast or a mixture of yeast and other micro-organisms, from which all or nearly all of the naturally occurring substances other than alcohol and water have been removed; (esprit de grain) malt spirit means an alcoholic distillate, obtained by pot-still distillation from a mash of cereal grain or cereal grain products saccharified by the diastase of malt and fermented by the action of yeast or a mixture of yeast and other micro-organisms; (esprit de malt) molasses spirit means an alcoholic distillate, obtained from sugar-cane or sugar-cane products fermented by the action of yeast or a mixture of yeast and other micro-organisms, from which all or nearly all of the naturally occurring substances other than alcohol and water have been removed; (esprit de mélasse) sweetening agent means glucose-fructose, fructose syrup or any food for which a standard is provided in Division 18, or any combination thereof. (agent édulcorant) B.02.003 If an alcoholic beverage contains 1.1% or more alcohol by volume, the percentage by volume of alcohol present in the alcoholic beverage shall be shown on the principal display panel (a) followed by the words “alcohol by volume” or the abbreviation “alc./vol.” or “alc/vol”; or (b) preceded by the abbreviation “alc.” or “alc” and followed by the abbreviation “vol.” or “vol.” B.02.004 (1) No person shall sell flavoured purified alcohol in a container with a capacity of 1,000 mL or less unless it contains 25.6 mL or less of alcohol.

12.5(E) and (F)

6

(2)

Subsection (1) does not apply to flavoured purified alcohol that is sold in a glass container with a capacity of at least 750 mL.

12.6(E) and (F)

TABLEAU

(3)

For the purposes of this section, flavoured purified alcohol means an alcoholic beverage (a) that is obtained from an alcohol base that has been purified during the course of manufacture through a process other than distillation and from which most of the naturally occurring substances other than alcohol and water have been removed; and (b) to which has been added during the course of manufacture any substance or mixture of substances that imparts flavour. B.02.010 [S]. Whisky or Whiskey, other than Malt Whisky, Scotch Whisky, Irish Whisky, Canadian Whisky, Canadian Rye Whisky, Rye Whisky, Highland Whisky, Bourbon Whisky and Tennessee Whisky, (a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or by other enzymes and fermented by the action of yeast or a mixture of yeast and other micro-organisms; and (b) may contain caramel and flavouring. (a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of a mash of malted grain fermented by the action of yeast or a mixture of yeast and other micro-organisms; (b) shall possess the aroma, taste and character generally attributed to malt whisky; and (c) may contain caramel and flavouring. B.02.016 [S]. Scotch Whisky shall be whisky distilled in Scotland as Scotch whisky for domestic consumption in accordance with the laws of the United Kingdom. B.02.017 No person shall blend or modify in any manner any Scotch whisky that is imported in bulk for the purpose of bottling and sale in Canada as Scotch whisky except by (b) the addition of distilled or otherwise purified water to adjust to a required strength, or (c) the addition of caramel. B.02.018 [S]. Irish Whisky shall be whisky distilled in Northern Ireland or in the Republic of Ireland as Irish whisky for domestic consumption in accordance with the laws of Northern Ireland or the Republic of Ireland. B.02.019 No person shall blend or modify in any manner any Irish whisky that is imported in bulk for the purpose of bottling and sale in Canada as Irish whisky except by (i) be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or by other enzymes and fermented by the action of yeast or a mixture of yeast and other micro-organisms, (ii) be aged in small wood for not less than three years, (iii) possess the aroma, taste and character generally attributed to Canadian whisky, (iv) be manufactured in accordance with the requirements of the Excise Act and the regulations made thereunder, (v) be mashed, distilled and aged in Canada, and (vi) contain not less than 40 per cent alcohol by volume; and (b) may contain caramel and flavouring.

PARTIE 1

Modèle double — différentes quantités d’aliments Colonne 1 Figure du Répertoire des modèles de TVN (version) Colonne 2 Condition d’utilisation

(2)

Subject to subsection (3), no person shall make any claim with respect to the age of Canadian whisky, other than for the period during which the whisky has been held in small wood.

Article

1

(3)

Where Canadian whisky has been aged in small wood for a period of at least three years, any period not exceeding six months during which that whisky was held in other containers may be claimed as age. (a) shall be a potable alcoholic beverage blended in Canada from (i) not less than 25 per cent malt whisky calculated on an absolute alcohol basis, distilled in Canada or Scotland, and B.02.022 (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Bourbon Whisky, or in such a manner that it is likely to be mistaken for Bourbon whisky unless it is whisky manufactured in the United States as Bourbon whisky in accordance with the laws of the United States applicable in respect of Bourbon whisky for consumption in the United States.

12.1(F) et (A)

(éléments nutritifs figurant en caractères d’au moins 8 points) 2

(2)

A person may modify Bourbon whisky that is imported for the purpose of bottling and sale in Canada as Bourbon whisky by the addition of distilled or otherwise purified water to adjust the Bourbon whisky to a required strength. B.02.022.1 (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Tennessee Whisky, or in such a manner that it is likely to be mistaken for Tennessee whisky unless it is a straight Bourbon whisky produced in the State of Tennessee and manufactured in accordance with the laws of the United States applicable in respect of Tennessee whisky for consumption in the United States.

12.2(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3

(2)

A person may modify Tennessee whisky that is imported for the purpose of bottling and sale in Canada as Tennessee whisky by the addition of distilled or otherwise purified water to adjust the Tennessee whisky to a required strength. B.02.023 (1) Subject to sections B.02.022 and B.02.022.1, no person shall sell for consumption in Canada any whisky that has not been aged for a period of at least three years in small wood.

12.3(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4

(2)

Nothing in subsection (1) applies in respect of flavouring contained in whisky, but no person shall sell for consumption in Canada whisky containing any flavouring, other than wine, that has not been aged for a period of at least two years in small wood. (a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from sugar-cane or sugar-cane products fermented by the action of yeast or a mixture of yeast and other micro-organisms; (ii) fruit and other botanical substances, and (iii) flavouring and flavouring preparations; and (c) if it is imported in bulk for the purpose of bottling and sale in Canada as imported rum, may only be: (i) modified by adding distilled or otherwise purified water to adjust the rum to the strength stated on the label applied to the container, (ii) modified by adding caramel, or (iii) blended with other imported rum or, in the case of rum sold as Caribbean rum, with other rum. B.02.031 (1) No person shall sell for consumption in Canada any rum that has not been aged for a period of at least one year in small wood.

12.4(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 5

(2)

Nothing in subsection (1) applies in respect of flavouring contained in rum, but no person shall sell for consumption in Canada rum containing any flavouring, other than wine, that has not been aged for a period of at least one year in small wood. (i) by the redistillation of malt spirit with or over juniper berries, or by a mixture of the products of more than one such redistillation, (ii) by the redistillation of a combination of malt spirit and not more than four times its volume on an absolute alcohol basis of grain spirit with or over juniper berries, or by a mixture of the products of more than one such redistillation, or (iii) by the blending of malt spirit, redistilled with or over juniper berries, with not more than four times its volume on an absolute alcohol basis of grain spirit or molasses spirit, or by a mixture of the products of more than one such blending; (b) may contain (i) other aromatic botanical substances, added during the redistillation process, and (d) may be labelled or advertised as being distilled, where subparagraph (a)(i) or (ii) is complied with; and (e) shall be described on the principal display panel of its label and in any advertisements as blended gin, where subparagraph (a)(iii) is complied with. B.02.041 [S]. Gin, other than Hollands, Hollands Gin, Geneva, Geneva Gin, Genever, Genever Gin or Dutch-type Gin, (i) by the redistillation of alcohol from food sources with or over juniper berries, or by a mixture of the products of more than one such redistillation, or (ii) by the blending of alcohol from food sources, redistilled with or over juniper berries, with alcohol from food sources or by a mixture of the products of more than one such blending; (b) may contain (i) other aromatic botanical substances, added during the redistillation process, (c) may be labelled or advertised as Dry Gin or London Dry Gin if sweetening agents have not been added. B.02.043 No person shall make any claim for age for gin but gin that has been held in suitable containers may bear a label declaration to that effect. B.02.050 [S]. Brandy, other than Armagnac Brandy or Armagnac, Canadian Brandy, Cognac Brandy or Cognac, Dried Fruit Brandy, Fruit Brandy, Grappa, Lees Brandy and Pomace or Marc, (a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of wine; and (b) may contain (ii) fruit and other botanical substances, and B.02.051 [S]. Armagnac Brandy or Armagnac shall be brandy manufactured in the Armagnac district of France in accordance with the laws of the French Republic for consumption in that country. (a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of wine that has been fermented in Canada; and (b) may contain (ii) fruit and other botanical substances, and B.02.053 [S]. Cognac Brandy or Cognac shall be brandy manufactured in the Cognac district of France in accordance with the laws of the French Republic for consumption in that country. (a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from sound dried fruit; and (b) may contain (ii) fruit and other botanical substances, and (a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of (i) fruit wine or a mixture of fruit wines, or (ii) a fermented mash of sound ripe fruit other than grapes, or a mixture of sound ripe fruits other than grapes; (b) may contain (ii) fruit and other botanical substances, and (iii) flavouring and flavouring preparations; and (c) may be described on its label as "(naming the fruit) brandy" if all of the fruit or fruit wine used to make the brandy originates from the named fruit. (a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of the pomace from sound ripe grapes after the removal of the juice or wine; and (b) may contain (ii) fruit and other botanical substances, and (a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of the lees of wine or fruit wine; (b) may contain (ii) fruit and other botanical substances, and (iii) flavouring and flavouring preparations; and (c) may be described on its label as "(naming the fruit) Lees Brandy" if all of the lees used to make the brandy originate from the named fruit. (a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of the skin and pulp of sound ripe fruit after the removal of the fruit juice, wine or fruit wine; (b) may contain (ii) fruit and other botanical substances, and (iii) flavouring and flavouring preparations; and (c) may be described on its label as "(naming the fruit) Pomace" or "(naming the fruit) Marc" if all of the skin and pulp used to make the brandy originate from the named fruit. B.02.059 No person shall blend or modify in any manner any brandy that is imported in bulk for the purpose of bottling and sale in Canada as imported brandy, except by B.02.060 Where brandy is wholly distilled in a country other than Canada, the label shall indicate the country of origin. B.02.061 (1) No person shall sell any brandy that has not been aged for a period of at least one year in wooden containers or at least six months in small wood.

12.5(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 6

(2)

Nothing in subsection (1) applies in respect of flavouring contained in brandy, but no person shall sell brandy containing any flavouring, other than wine, that has not been aged for a period of at least one year in wooden containers or at least six months in small wood.

12.6(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART 2 Column 1 | Column 2 Item | Figure in Directory of NFT Formats (Version) | Condition of use 1 | 13.1(B) 2 | 13.2(B) 3 | 13.3(B) 4 | 13.4(B) SOR/2003-11, s. 20; SOR/2016-305, ss. 32, 74. Aggregate Format — Different Amounts of Food TABLE PART 1 Aggregate Format — Different Amounts of Food Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(3)

Nothing in subsection (1) or (2) applies in respect of brandy that meets the standards prescribed by any of sections B.02.051 to B.02.058.

14.1(E) and (F)

2

(4)

No person shall make any claim with respect to the age of brandy other than for the period during which the brandy has been held in wooden containers or in small wood. (a) shall be a product obtained by the mixing or distillation of alcohol from food sources with or over fruits, flowers, leaves or other botanical substances or their juices or with extracts derived by the infusion, percolation or maceration of those botanical substances; (b) shall have added, during the course of manufacture, a sweetening agent in an amount that is not less than 2.5 per cent of the finished product; (c) shall contain not less than 23 per cent absolute alcohol by volume; and (i) natural and artificial flavouring preparations, and B.02.080 (1) Vodka shall be a potable alcoholic distillate obtained from potatoes, cereal grain or any other material of agricultural origin fermented by the action of yeast or a mixture of yeast and other micro-organisms.

14.2(E) and (F)

3

(2)

The distillate shall be treated with charcoal or other means so that the vodka is without distinctive character, aroma or taste.

14.3(E) and (F)

4

(3)

Vodka produced, in whole or in part, from material of agricultural origin other than potatoes or cereal grain, shall carry in close proximity to the common name, the statement “produced from” followed by the name of all material of agricultural origin used. B.02.090 (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Tequila, or in such a manner that it is likely to be mistaken for Tequila unless it is Tequila manufactured in Mexico as Tequila in accordance with the laws of Mexico applicable in respect of Tequila for consumption in Mexico.

14.4(E) and (F)

Column 2 Condition of use ---

(2)

A person may modify Tequila that is imported for the purpose of bottling and sale in Canada as Tequila by the addition of distilled or otherwise purified water to adjust the Tequila to a required strength. B.02.091 (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Mezcal, or in such a manner that it is likely to be mistaken for Mezcal unless it is Mezcal manufactured in Mexico as Mezcal in accordance with the laws of Mexico applicable in respect of Mezcal for consumption in Mexico.

(3)

Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement pour chaque quantité d’aliment pour laquelle des renseignements distincts y sont indiqués.

(2)

A person may modify Mezcal that is imported for the purpose of bottling and sale in Canada as Mezcal by the addition of distilled or otherwise purified water to adjust the Mezcal to a required strength. (a) shall be an alcoholic beverage that is produced by the complete or partial alcoholic fermentation of fresh grapes, grape must, products derived solely from fresh grapes, or any combination of them; (b) may have added to it during the course of the manufacture (ii) concentrated grape juice, (iv) yeast foods, in accordance with Table XIV to section B.16.100, (v) calcium sulphate in such quantity that the content of soluble sulphates in the finished wine shall not exceed 0.2 per cent weight by volume calculated as potassium sulphate, (vi) calcium carbonate in such quantity that the content of tartaric acid in the finished wine shall not be less than 0.15 per cent weight by volume, (vii) sulphurous acid, including salts thereof, in such quantity that its content in the finished wine shall not exceed (A) 70 parts per million in the free state, or (B) 350 parts per million in the combined state, calculated as sulphur dioxide, (viii) any of the following substances: (ix) amylase and pectinase at a maximum level of use consistent with good manufacturing practice, (x) ascorbic acid or erythorbic acid, or their salts, at a maximum level of use consistent with good manufacturing practice, (xi) antifoaming agents, in accordance with Table VIII to section B.16.100, (xii) any of the following fining agents: (B) acacia gum, agar, gelatin and potassium ferrocyanide, at a maximum level of use consistent with good manufacturing practice, (C) tannic acid at a maximum level of use of 200 parts per million, and (D) polyvinylpolypyrrolidone in an amount that does not exceed 2 parts per million in the finished product, (xiii) caramel at a maximum level of use consistent with good manufacturing practice, (xiv) brandy, fruit spirit or alcohol derived from the alcoholic fermentation of a food source distilled to not less than 94 per cent alcohol by volume, (xv) any of the following substances: (A) carbon dioxide and ozone at a maximum level of use consistent with good manufacturing practice, and (xvi) sorbic acid or salts thereof, not exceeding 500 parts per million calculated as sorbic acid, (xvii) malolactic bacteria from the genera Lactobacillus, Leuconostoc and Pediococcus, (xviii) copper sulphate in such a quantity that the content of copper in the finished product shall not exceed 0.0001 per cent, (xx) oak chips and particles; and B.02.101 No person shall sell wine that contains more than 0.24 per cent weight by volume of volatile acidity calculated as acetic acid, as determined by official method FO-2, Determination of Volatile Acidity of Wine, Cider and Champagne Cider, October 15, 1981. B.02.102 [S]. Fruit spirit shall be an alcoholic distillate obtained from wine, fruit wine, grape pomace or fruit pomace. B.02.103 [S]. Fruit Wine, or (naming the fruit) Wine shall be the product of the alcoholic fermentation of the juice of sound ripe fruit other than grape, and in all other respects shall meet the requirements of the standard for wine as prescribed by section B.02.100. B.02.104 [S]. Vermouth shall be wine to which has been added bitters, aromatics or other botanical substances or a flavouring preparation, and shall contain not more than 20 per cent absolute alcohol by volume. B.02.105 [S]. Flavoured Wine, Wine Cocktail, Aperitif Wine shall be wine to which has been added herbs, spices, other botanical substances, fruit juices or a flavouring preparation, and shall contain not more than 20 per cent absolute alcohol by volume. B.02.105A [S]. Flavoured (naming the fruit) Wine, (naming the fruit) Wine Cocktail, or Aperitif (naming the fruit) Wine shall be fruit wine, a mixture of fruit wines, or a mixture of fruit wine and wine to which has been added herbs, spices, other botanical substances, fruit juices or a flavouring preparation, and shall (a) shall be the product of the alcoholic fermentation of an aqueous solution of honey; and (b) may have added to it during the course of manufacture any of the following substances: (iii) sulphurous acid, including salts thereof, in such quantity that its content in the finished wine shall not exceed (B) 350 p.p.m. in the combined state, calculated as sulphur dioxide; (vii) fruit spirit or alcohol derived from the alcoholic fermentation of a food source distilled to not less than 94 per cent alcohol by volume; (x) activated carbon, clay or tannic acid as fining agents; or (xi) sorbic acid, and any salts thereof, calculated as sorbic acid, in a quantity such that the content of sorbic acid and its salts in the finished wine does not exceed 500 parts per million. B.02.107 [S]. May Wine shall be wine to which has been added artificial woodruff flavouring preparation. B.02.108 A clear indication of the country of origin shall be shown on the principal display panel of a wine. (i) be the product of the alcoholic fermentation of apple juice, and (ii) contain not less than 2.5 per cent and not more than 13.0 per cent absolute alcohol by volume; and (b) may have added to it during the course of manufacture (v) sulphurous acid, including salts thereof, in such quantity that its content in the finished cider shall not exceed (A) 70 parts per million in the free state, or (B) 350 parts per million in the combined state, calculated as sulphur dioxide, (ix) pectinase and amylase, (xi) any of the following fining agents: Cidre (J) polyvinylpyrrolidone not exceeding two parts per million in the finished product, (xiii) brandy, fruit spirit or alcohol derived from the alcoholic fermentation of a food source distilled to not less than 94 per cent alcohol by volume, (xvii) sorbic acid or salts thereof, not exceeding 500 parts per million, calculated as sorbic acid. B.02.122 [S]. Champagne Cider shall be cider that is impregnated with carbon dioxide under pressure by (a) conducting the afterpart of the fermentation in closed vessels, or (b) secondary fermentation in closed vessels with or without the addition of sugar, dextrose, invert sugar, glucose or glucose solids or aqueous solutions thereof, and shall contain not less than seven per cent absolute alcohol by volume. B.02.123 No person shall sell cider or champagne cider that has more than 0.2 per cent weight by volume volatile acidity calculated as acetic acid, as determined by official method FO-2, Determination of Volatile Acidity of Wine, Cider and Champagne Cider, October 15, 1981. (a) shall be the product of the alcoholic fermentation by yeast, or a mixture of yeast and other micro-organisms, an infusion of barley or wheat malt and hops or hop extract in potable water; (b) shall contain at most 4% of residual sugars; and (c) may have added to it during the course of manufacture any of the following ingredients: (vi) pre-isomerized hop extract, (vii) reduced isomerized hop extract, and (viii) food additives to which a marketing authorization applies and that are set out in the Lists of Permitted Food Additives published on the Health Canada website.

(4)

Malgré les paragraphes (1) et (2), si le tableau de la valeur nutritive du produit préemballé est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée physiquement et où les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues à l’alinéa (2)a) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2. TABLEAU

(2)

The name of any flavouring preparation added to a beer shall form part of the common name of the beer. B.02.132 The qualified common name or common name set out in column II of the table to this section shall be used in any advertisement and on the label of a beer that contains the percentage of alcohol by volume set out in column I. Percentage Alcohol by Volume Qualified Common Name or Common Name

PARTIE 1

Modèle composé — différentes quantités d’aliments Colonne 1 Figure du Répertoire des modèles de TVN (Article (version)) Colonne 2 Condition d’utilisation

8.6 or more

B.02.133 [S]. In this Division, hop extract means an extract derived from hops by a process employing the solvent (a) hexane, methanol, or methylene chloride in such a manner that the hop extract does not contain more than 2.2 per cent of the solvent used; or (b) carbon dioxide or ethyl alcohol in an amount consistent with good manufacturing practice. B.02.134 [S]. (1) In this Division, pre-isomerized hop extract means an extract derived from hops by (a) the use of one of the following solvents: (b) the subsequent isolation of the alpha acids and their conversion to isomerized alpha acids by means of diluted alkali and heat. B.02.135 [S]. In this Division, reduced isomerized hop extract means (i) by isomerization and reduction of humulones (alpha-acids) by means of hydrogen and a catalyst, or (ii) by reduction of lupulones (beta-acids) by means of hydrogen and a catalyst, followed by oxidation and isomerization; (b) hexahydroisohumulones derived from hops by reduction of tetrahydroisohumulones by means of sodium borohydride; and (c) dihydroisohumulones derived from hops by reduction of isoalpha acids by means of sodium borohydride. B.03.001 In this Division, **acid-reacting material** means one or any combination of (a) lactic acid or its salts; (b) tartaric acid or its salts; (c) acid salts of phosphoric acid; and B.03.002 [S]. **Baking Powder** shall be a combination of sodium or potassium bicarbonate, an acid-reacting material, starch or other neutral material, may contain an anticaking agent and shall yield not less than 10 per cent of its weight of carbon dioxide, as determined by official method FO-3, *Determination of Carbon Dioxide in Baking Powder*, October 15, 1981. Cocoa and Chocolate Products B.04.001 The definitions in this section apply in this Division. **chocolate product** means a product derived from one or more cocoa products and includes chocolate, bittersweet chocolate, semi-sweet chocolate, dark chocolate, sweet chocolate, milk chocolate and white chocolate. *(produit de chocolat)* **milk ingredient** means one or any combination of (a) the following products for which a standard is prescribed in this Part, namely, (i) milk or whole milk, (iii) partly skimmed milk or partially skimmed milk, (v) condensed milk or sweetened condensed milk, (vii) evaporated skim milk or concentrated skim milk, (viii) evaporated partly skimmed milk or concentrated partly skimmed milk, (ix) milk powder or whole milk powder or dry whole milk or powdered whole milk, (x) skim milk powder or dry skim milk, (xi) skim milk with added milk solids, (xii) partly skimmed milk with added milk solids or partially skimmed milk with added milk solids, (xiii) malted milk or malted milk powder, (b) the following products for which a standard is not prescribed by this Part, namely (i) reconstituted milk or whole milk, (ii) reconstituted skim milk, (iii) reconstituted partly skimmed milk, (vi) butter oil, and B.04.002 [S]. Cocoa Beans shall be the seeds of Theobroma cacao L. or a closely related species. B.04.003 [S]. Cocoa Nibs shall be the product prepared by removing the shell from cleaned cocoa beans, of which the residual shell content may not exceed 1.75 per cent by mass, calculated on a nib alkali free basis if the nibs or the cocoa beans from which the nibs were prepared have been processed with alkali, as determined by the method prescribed in the Official Methods of Analysis of the Association of Official Analytical Chemists, 12th Ed. (1975), sections 13.010 to 13.014, under the heading “Shell in Cacao Nibs — Official Final Action”, published by the Association of Official Analytical Chemists, in Washington. (a) be the product obtained from the mechanical disintegration of the cocoa nib with or without removal or addition of any of its constituents; and B.04.005 (1) Cocoa products may be processed with one or more of the following pH-adjusting or alkalizing agents: (b) carbonates of magnesium or hydroxides of magnesium; and

Article

1

(3)

The total mass of the pH-adjusting agents referred to in paragraphs (1)(a) to (c) shall not be greater in neutralizing value, calculated from the respective masses of those agents, than the neutralizing value of five parts by mass of anhydrous potassium carbonate for each 100 parts by mass of cocoa product, calculated on a fat-free basis.

14.1(F) et (A)

(éléments nutritifs figurant en caractères d’au moins 8 points) 2

(4)

Cocoa products may be processed with one or more of the following pH-adjusting or neutralizing agents, added as such or in aqueous solution: (b) citric acid; and

14.2(F) et (A)

(éléments nutritifs figurant en caractères d’au moins 7 points) 3

(5)

The total mass of pH-adjusting agents referred to in subsection (4) shall not exceed in neutralizing value, calculated from the respective masses of those agents, the appropriate maximum levels of use set out in column III of Table X to section B.16.100. (a) the total quantity of phosphoric acid shall not be greater than 0.5 part by mass, expressed as P₂O₅, for each 100 parts by mass of cocoa product, calculated on a fat-free basis; and (b) the total quantity of citric acid and tartaric acid, singly or in combination, shall not be greater than 1.0 part by mass for each 100 parts by mass of cocoa product, calculated on a fat-free basis. (a) shall be one or more of the following combined with a sweetening ingredient, namely, (ii) cocoa liquor and cocoa butter, and (b) shall contain not less than 35 per cent total cocoa solids, of which (i) not less than 18 per cent is cocoa butter, and (ii) not less than 14 per cent is fat-free cocoa solids; and (c) may contain (i) less than 5 per cent total milk solids from milk ingredients, (iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour, (iv) salt, and (v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely, (A) mono-glycerides and mono- and diglycerides, (B) lecithin and hydroxylated lecithin, (a) shall be one or more of the following combined with a sweetening ingredient, namely, (ii) cocoa liquor and cocoa butter, and (b) shall contain not less than 30 per cent total cocoa solids, of which (i) 18 per cent is cocoa butter, and (ii) 12 per cent is fat-free cocoa solids; and (c) may contain (i) less than 12 per cent total milk solids from milk ingredients, (iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour, (iv) salt, and (v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely, (A) mono-glycerides and mono- and diglycerides, (B) lecithin and hydroxylated lecithin, (A) mono-glycerides and mono- and diglycerides, (B) lecithin and hydroxylated lecithin, (a) shall be one or more of the following combined with a sweetening ingredient, namely, (ii) cocoa liquor and cocoa butter, and (b) shall contain not less than (A) not less than 15 per cent is cocoa butter, and (B) not less than 2.5 per cent is fat-free cocoa solids, (c) may contain (i) less than 5 per cent whey or whey products, (iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour, (iv) salt, and (v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely, (A) mono-glycerides and mono- and diglycerides, (B) lecithin and hydroxylated lecithin, (a) shall contain the following combined together, namely, (ii) not less than 14 per cent total milk solids from milk ingredients, and (iii) not less than 3.5 per cent milk fat; and (b) may contain (i) less than 5 per cent whey or whey products, (iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour, (iv) salt, and (v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely, (A) mono-glycerides and mono- and diglycerides, (B) lecithin and hydroxylated lecithin, (a) shall be the product that (i) is obtained by pulverising the remaining material from partially defatted cocoa liquor by mechanical means, and (ii) contains not less than 10 per cent cocoa butter; and (b) may contain (ii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour, (iv) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of cocoa product, namely, (A) mono-glycerides and mono- and diglycerides, (B) lecithin and hydroxylated lecithin, and (a) shall be the product that: (i) is obtained by pulverising the remaining material from partially defatted cocoa liquor by mechanical means, and (ii) contains less than 10 per cent cocoa butter; and (b) may contain (ii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour, (iv) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of cocoa product, namely, (A) mono-glycerides and mono- and diglycerides, (B) lecithin and hydroxylated lecithin, and (ii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour, (iv) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of cocoa product, namely, (A) mono-glycerides and mono- and diglyc-erides, (B) lecithin and hydroxylated lecithin, and B.04.012 No person shall sell a cocoa product or a chocolate product unless it is free from bacteria of the genus Salmonella as determined by official method MFO-11, Microbiological Examination of Cocoa and Chocolate, November 30, 1981. B.05.001 [S]. Green Coffee, Raw Coffee or Un-roasted Coffee shall be the seed of Coffee arabica L., C. liberica Hiern, or C. robusta Chev., freed from all but a small portion of its spermoderm. B.05.002 [S]. Roasted Coffee or Coffee shall be roasted green coffee, and shall contain not less than 10 per cent fat, and may contain not more than six per cent total ash. (a) shall be coffee of the type indicated, from which caffeine has been removed and that, as a result of the removal, contains not more than (i) 0.1 per cent caffeine, in the case of decaffeinated raw coffee and decaffeinated coffee, or (b) may have been decaffeinated by means of extraction solvents set out in Table XV to Division 16. diluent means any substance other than a synthetic colour present in a colour mixture or preparation; (diluant) dye means the principal dye and associated subsidiary and isomeric dyes contained in a synthetic colour; (pigment) mixture means a mixture of two or more synthetic colours or a mixture of one or more synthetic colours with one or more diluents; (mélange) preparation means a preparation of one or more synthetic colours containing less than three per cent dye and sold for household use; (préparation) synthetic colour means any organic food colour, other than caramel, that is produced by chemical synthesis and that has no counterpart in nature. (colorant synthétique) B.06.002 No person shall sell a food, other than a synthetic colour, mixture, preparation or flavouring preparation, that contains, when prepared for consumption according to label directions, more than (b) 100 parts per million of Fast Green FCF or Brilliant Blue FCF or any combination of those colours; (c) 300 parts per million of any combination of the synthetic colours named in paragraphs (a) and (b) within the limits set by those paragraphs; or B.06.007 No person shall sell a preparation for use in or upon food unless (a) the label carries the words “Food Colour Preparation” on its principal display panel; and (b) in the case of a liquid preparation, the container has a capacity of 60 ml or less and will permit dropwise discharge only. B.06.053 [S]. Citrus Red No. 2 shall be 1-(2,5-dimethoxyphenylazo)-2-naphthol, shall contain not less than 98% dye and may contain not more than (b) 0.3% sulphated ash; (g) 1 part per million of arsenic; and (h) 10 parts per million of lead. B.06.061 The lake of any water soluble synthetic colour that is referred to in section 2 of the Marketing Authorization for Food Additives That May Be Used as Colouring Agents shall be the calcium or aluminum salt of the respective colour extended on alumina. Spices, Dressings and Seasonings (a) not more than (b) not less than 2.5 millilitres volatile oil per 100 grams of spice. B.07.002 [S]. Anise or Anise Seed, whole or ground, shall be the dried fruit of Pimpinella anisum L. and shall contain (a) not more than (a) not more than (a) not more than (b) not less than one millilitre volatile oil per 100 grams of spice. B.07.005 [S]. Caraway or Caraway Seed, whole or ground, shall be the dried fruit of the caraway plant, Carum carvi L. and shall contain (a) not more than (b) not less than two millilitres volatile oil per 100 grams of spice. ripe fruit of Elettaria cardamomum Maton and shall contain (a) not more than (b) not less than three millilitres volatile oil per 100 grams of spice. (b) may contain silicon dioxide as an anti-caking agent in an amount not exceeding 2.0 per cent. (i) ground celery seed or ground dehydrated celery, and (ii) salt in an amount not exceeding 75 per cent; and (b) may contain silicon dioxide as an anticaking agent in an amount not exceeding 0.5 per cent. B.07.009 [S]. Celery Seed, whole or ground, shall be the dried ripe fruit of Apium graveolens L. and shall contain (a) not more than Food and Drug Regulations (b) not less than 1.5 millilitres volatile oil per 100 grams of spice. (i) ground celery seed or ground dehydrated celery, and (ii) ground black pepper in an amount not exceeding 70 per cent; and (b) may contain silicon dioxide as an anticaking agent in an amount not exceeding 0.5 per cent. (a) not more than (b) not less than 1.2 millilitres volatile oil per 100 grams of spice. (a) not more than Food and Drug Regulations (b) not less than 13 millilitres volatile oil per 100 grams of spice. B.07.014 [S]. Coriander or Coriander Seed, whole or ground, shall be the dried fruit of Coriandrum sativum L. and shall contain (a) not more than B.07.015 [S]. Cumin or Cumin Seed, whole or ground, shall be the dried seeds of Cuminum cyminum L. and shall contain (a) not more than (b) not less than 2.5 millilitres volatile oil per 100 grams of spice. (a) turmeric with spices and seasoning; and (a) not more than Food and Drug Regulations (b) not less than two millilitres volatile oil per 100 grams of spice. (a) not more than (b) not less than one millilitre volatile oil per 100 grams of spice. B.07.019 [S]. Fenugreek, whole or ground, shall be the dried ripe fruit of Trigonella foenumgraecum L. and shall contain not more than (ii) salt in an amount not exceeding 75 per cent; and (b) may contain one or more of the following anticaking agents in a total amount not exceeding two per cent: B.07.021 [S]. Ginger whole or ground, shall be the washed and dried or decorticated rhizome of Zingiber officinale Roscoe and shall contain (a) not more than (b) not less than 1.5 millilitres volatile oil per 100 grams of spice. (a) not more than (b) not less than 11 millilitres volatile oil per 100 grams of spice, and the total non-volatile extracts obtainable therefrom by (c) ethyl ether, shall not be less than 20 per cent nor more than 35 per cent, and B.07.023 [S]. Marjoram, whole or ground, shall be the dried leaves, with or without a small proportion of the flowering tops, of Majorana hortensis Moench and shall contain (a) not more than (b) not less than 0.5 millilitres volatile oil per 100 grams of spice. Food and Drug Regulations (a) not more than (a) made from mustard seed from which (i) most of the hulls have been removed, and (ii) a portion of the fixed oil may have been removed; and (b) that contains not more than B.07.026 [S]. Nutmeg, whole or ground, shall be the dried seed of *Myristica fragrans Houttyn* and may, prior to grinding, have a thin coating of lime and shall contain (a) not more than Food and Drug Regulations (b) not less than (b) may contain one or more of the following anticaking agents in a total amount not exceeding two per cent: (a) not more than (b) not less than 2.5 millilitres volatile oil per 100 grams of spice. B.07.029 [S]. Paprika shall be the dried, ground ripe fruit of Capsicum annuum L. and (a) shall contain not more than (b) may contain silicon dioxide as an anti-caking agent in an amount not exceeding 2.0 per cent. (a) not more than (b) not less than (i) six per cent non-volatile methylene chloride extract, (c) when ground, all the parts of the berry in their normal proportions. B.07.031 [S]. White Pepper, whole or ground, shall be the dried, mature berry of Piper nigrum L., from which the outer coating is and the inner coating may be removed and shall contain (a) not more than (b) not less than (i) six per cent non-volatile methylene chloride extract, (a) not more than (a) not more than (b) not less than 1.2 millilitres volatile oil per 100 grams of spice. (a) not more than (b) not less than one millilitre volatile oil per 100 grams of spice. Food and Drug Regulations (a) not more than (a) not more than B.07.038 [S]. Thyme, whole or ground, shall be the dried leaves and flowering tops of the thyme plant Thymus vulgaris L. or Thymus zygis L. and shall contain (a) not more than (a) not more than (b) not less than 3.5 millilitres volatile oil per 100 grams of spice. (ii) whole egg or egg yolk, in liquid, frozen or dried form, and (b) may contain (i) vegetable oil, and (b) may contain Food and Drug Regulations (iv) spice, tomato or other seasoning, (b) may contain (iv) spice or other seasoning, B.07.043 No person shall sell a dressing that contains more than five per cent C22 Monoenoic Fatty Acids calculated as a proportion of the total fatty acids contained in the dressing. Dairy Products B.08.001 The foods referred to in this Division are dairy products. B.08.001.1 The following definitions apply in this Division. milk product means (a) with respect to butter or whey butter, any of the following products, namely, (i) partly skimmed milk, skim milk, cream, buttermilk and whey cream, and (ii) milk in concentrated, dried or reconstituted form and any product referred to in subparagraph (i) in concentrated, dried or reconstituted form; (b) with respect to cheese, any of the following products, namely, (i) partly skimmed milk, skim milk, cream, buttermilk, whey and whey cream, (ii) milk in concentrated, dried, frozen or reconstituted form and any product referred to in subparagraph (i) in concentrated, dried, frozen or reconstituted form, (iii) butter, butter oil and whey butter, (iv) any constituent of milk — other than water — singly or in combination with other constituents of milk, and (c) with respect to cold-pack cheese food, cold-pack cheese food with (naming the added ingredients), cream cheese spread, cream cheese spread with (naming the added ingredients), processed cheese food, processed cheese food with (naming the added ingredients), processed cheese spread or processed cheese spread with (naming the added ingredients), any of the following products, namely, (ii) whey protein concentrate, and (iii) any product referred to in subparagraph (i) in concentrated or dried form; and ultrafiltered, in relation to milk, partly skimmed milk or skim milk, means that the milk, partly skimmed milk or skim milk has been subjected to a process in which it is passed over one or more semi-permeable membranes to partially remove water, lactose, minerals and water-soluble vitamins without altering the whey protein to casein ratio and that results in a liquid product. (ultrafiltré) B.08.002 Except as provided in these Regulations, a dairy product that is obtained by the action of heat on milk fat is adulterated. B.08.002.1 Sections B.08.003 to B.08.028 do not apply to a lacteal secretion obtained from the mammary gland of any animal other than a cow, genus Bos, or a product or derivative of such secretion. B.08.002.2 (1) Subject to subsection (2), no person shall sell the normal lacteal secretion obtained from the mammary gland of the cow, genus Bos, or of any other animal, or sell a dairy product made with any such secretion, unless the secretion or dairy product has been pasteurized by being held at a temperature and for a period that ensure the reduction of the alkaline phosphatase activity so as to meet the tolerances specified in official method MFO-3, Determination of Phosphatase Activity in Dairy Products, dated November 30, 1981. (b) any food that is sold for further manufacturing or processing in order to pasteurize it in the manner described in subsection (1). (a) shall be the normal lacteal secretion obtained from the mammary gland of the cow, genus Bos; and (a) shall be milk that contains not more than 0.3 per cent milk fat; (b) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and (a) shall be derived from milk that has had its fat content reduced by mechanical separation or adjusted by the addition of cream, milk, partly skimmed milk or skim milk, either singly or in combination; (b) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and B.08.006 [S]. Milk Fat or Butter Fat shall be the fat of cow’s milk, and shall have (a) a specific gravity of not less than 0.905 at a temperature of 40°, (b) a tocopherol content not greater than 50 micrograms per gram, as determined by official method FO-16, Determination of Tocopherol in Milk Fat or Butter Fat, October 15, 1981, (c) a Reichert-Meissl number not less than 24, and where the tocopherol content is greater than 50 micrograms per gram or the Polenske number exceeds 10 per cent of the Reichert-Meissl number, there shall be deemed to have been an addition to the milk fat of fat other than that of cow’s milk. (c) shall contain not less than B.08.008 The percentage of milk fat contained in (a) partly skimmed milk or partially skimmed milk, (b) partly skimmed milk with added milk solids or partially skimmed milk with added milk solids, or (c) evaporated partly skimmed milk or concentrated partly skimmed milk shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”. B.08.009 [S]. Condensed Milk or Sweetened Condensed Milk shall be milk from which water has been evaporated and to which has been added sugar, dextrose, glucose, glucose solids or lactose, or any combination thereof, may contain added vitamin D and shall contain not less than (a) shall be milk from which water has been evaporated; (b) shall contain not less than Food and Drug Regulations (c) shall, notwithstanding sections D.01.009 to D.01.011, contain added vitamin C in such an amount that a reasonable daily intake of the milk contains not less than 60 milligrams and not more than 75 milligrams of vitamin C; B.08.011 [S]. Evaporated Skim Milk or Concentrated Skim Milk (a) shall be milk that has been concentrated to at least one-half of its original volume by the removal of water; (i) not more than 0.3 per cent milk fat, and (ii) not less than 17.0 per cent milk solids other than fat; (c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; (d) shall, notwithstanding sections D.01.009 to D.01.011, contain added vitamin C in such an amount that a reasonable daily intake of the milk contains not less than 60 milligrams and not more than 75 milligrams of vitamin C; (e) shall contain 2 µg of vitamin D per 100 mL when reconstituted to its original volume; and B.08.012 [S]. Evaporated Partly Skimmed Milk or Concentrated Partly Skimmed Milk (a) shall be milk from which part of the milk fat has been removed; (b) shall be concentrated to at least one-half its original volume by the removal of water; (c) shall contain not less than 17.0 per cent milk solids other than fat; and (d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; (e) shall, notwithstanding sections D.01.009 to D.01.011, contain added vitamin C in such an amount that a reasonable daily intake of the milk contains not less than 60 milligrams and not more than 75 milligrams of vitamin C; (f) shall contain 2 µg of vitamin D per 100 mL when reconstituted to its original volume; and (g) may contain (b) shall contain not less than (c) shall contain 2 µg of vitamin D per 100 mL when reconstituted according to directions for use; and (b) shall contain not less than 95 per cent milk solids; and (c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; B.08.014A No person shall sell milk powder, whole milk powder, dry whole milk, powdered whole milk, skim milk powder or dry skim milk unless it is free from bacteria of the genus Salmonella, as determined by official method MFO-12, Microbiological Examination of Milk Powder, November 30, 1981. B.08.015 No person shall sell milk, skim milk, partly skimmed milk, (naming the flavour) milk, (naming the flavour) skim milk, (naming the flavour) partly skimmed milk, skim milk with added milk solids, partly skimmed milk with added milk solids, (naming the flavour) skim milk with added milk solids, (naming the flavour) partly skimmed milk with added milk solids, condensed milk, evaporated milk, evaporated skim milk, evaporated partly skimmed milk, milk powder or skim milk powder, in which the vitamin content has been increased by either irradiation or addition unless (a) in the case of the addition of vitamin D, the menstruum containing the vitamin D contributes not more than 0.01 per cent fat foreign to milk; and (b) in cases where the vitamin D content is increased by irradiation, the principal display panel of the label carries the statement “Vitamin D Increased” immediately preceding or following the name of the food, without intervening written, printed or graphic matter. (a) shall be the product made from (i) milk, milk powder, skim milk, skim milk powder, partly skimmed milk, evaporated milk, evaporated partly skimmed milk, evaporated skim milk or cream or any combination thereof, (ii) a flavouring preparation, and (b) shall contain not less than three per cent milk fat; (e) may contain not more than 50,000 total aerobic bacteria per cubic centimetre, as determined by official method MFO-7, Microbiological Examination of Milk, November 30, 1981. (a) shall be the product made from (i) skim milk, skim milk powder or evaporated skim milk or any combination thereof, (ii) a flavouring preparation, and (c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; (e) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch. (a) shall be the product made from (i) milk, milk powder, skim milk, skim milk powder, partly skimmed milk, evaporated milk, evaporated partly skimmed milk, evaporated skim milk or cream or any combination thereof, (ii) a flavouring preparation, and (c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; (e) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch; and (f) may contain not more than 50,000 total aerobic bacteria per cubic centimetre, as determined by official method MF0-7, Microbiological Examination of Milk, November 30, 1981. B.08.019 [S]. Skim Milk with Added Milk Solids (a) shall be skim milk to which has been added skim milk powder or evaporated skim milk or both; (d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the dairy product contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and B.08.020 [S]. Partly Skimmed Milk with Added Milk Solids or Partially Skimmed Milk with Added Milk Solids (a) shall be partly skimmed milk to which has been added skim milk powder, milk powder, evaporated milk, evaporated partly skimmed milk or evaporated skim milk or any combination thereof; (b) shall contain not less than 10 per cent milk solids not including fat; and (c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and B.08.021 [S]. Malted Milk or Malted Milk Powder (a) shall be the product made by combining milk with the liquid separated from a mash of ground barley malt and meal; (b) may have added to it, in such manner as to secure the full enzyme action of the malt extract, salt and sodium bicarbonate or potassium bicarbonate; (c) may have water removed from it; and (i) not less than 7.5 per cent milk fat, and (a) shall be malted milk or malted milk powder containing a flavouring preparation; and (a) shall be the product made from (i) skim milk, skim milk powder, or evaporated skim milk or any combination thereof, (ii) a flavouring preparation, and (b) shall contain not less than 10 per cent milk solids not including fat; less than 1,200 International Units and not more than 2,500 International Units of vitamin A; B.08.024 No person shall sell milk for manufacture into dairy products if it contains more than (a) two million total aerobic bacteria per millilitre, as determined by official method MFO-7, Microbiological Examination of Milk, November 30, 1981; or (b) two milligrams of sediment per 16 fluid ounces, as determined by official method MFO-8, Determination of Sediment in Milk, November 30, 1981. B.08.025 No manufacturer shall purchase milk for manufacture or manufacture milk into other dairy products if he has reason to believe it does not meet the requirements of section B.08.024. B.08.026 [S]. (naming the flavour) Partly (Partially) Skimmed Milk with Added Milk Solids (a) shall be the product made from (i) milk, milk powder, skim milk, skim milk powder, partly skimmed milk, evaporated milk, evaporated partly skimmed milk, evaporated skim milk or cream or any combination thereof, (ii) a flavouring preparation, and (b) shall contain not less than 10 per cent milk solids not including fat; (d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; B.08.027 Notwithstanding anything contained in these Regulations, the following dairy products that are used in or sold for the manufacture of other foods are not required to contain added vitamins: milk; partly skimmed milk; partially skimmed milk; skim milk; sterilized milk; evaporated milk; evaporated skim milk; concentrated skim milk; evaporated partly skimmed milk; concentrated partly skimmed milk; milk powder; dry whole milk; powdered whole milk; skim milk powder; dry skim milk; partly skimmed milk powder; partially skimmed milk powder; skim milk with added milk solids; partly skimmed milk with added milk solids; and partially skimmed milk with added milk solids. (c) (naming the flavour) partly (partially) skimmed milk with added milk solids, shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.

14.3(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) 4

(2)

In addition to the statement referred to in subsection (1), a person may, on the label of a food referred to in that subsection, make a declaration of the fat content of the food, expressed in grams per serving of stated size. Goat's Milk B.08.028.1 A lacteal secretion obtained from the mammary gland of any animal other than a cow, genus Bos, and a product or derivative of such secretion shall be labelled so as to identify that animal. B.08.029 (1) No person shall sell goat’s milk or goat’s milk powder to which vitamin D has been added unless 100 mL of that food, when ready-to-serve, contains 2 µg of vitamin D.

14.4(F) et (A)

Colonne 2 Condition d’utilisation La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART B DIVISION 1 Nutrition Labelling

(2)

No person shall sell skimmed or partly skimmed goat’s milk or skimmed or partly skimmed goat’s milk powder to which vitamin A or D has been added unless 100 mL of that food, when ready-to-serve, contains both vitamin A and D in the following amounts: (a) not less than 140 I.U. and not more than 300 I.U. of vitamin A; and

Section B.01.459

Column 1 Item 5 6 Column 2 Figure in Directory of NFT Formats (Version)

(3)

No person shall sell evaporated goat’s milk to which any of the following vitamins have been added unless 100 mL of that food, when reconstituted to its original volume, contains each of the following vitamins in the following amounts: (a) not less than 7 mg and not more than 9 mg of vitamin C; (b) 2 µg of vitamin D; and (c) not less than 10 µg and not more than 20 µg of folic acid.

14.5(E) and (F)

(4)

No person shall sell evaporated partly skimmed goat’s milk or evaporated skimmed goat’s milk to which any of the following vitamins have been added unless 100 mL of that food, when reconstituted to its original volume, contains each of the following vitamins in the following amounts: (a) not less than 140 I.U. and not more than 300 I.U. of vitamin A; (b) not less than 7 mg and not more than 9 mg of vitamin C; (c) 2 µg of vitamin D; and Cheese B.08.030 (1) In this Division, when used with respect to cheese, pasteurized source means milk, skim milk, cream, reconstituted milk powder, reconstituted skim milk powder or any combination thereof that has been pasteurized by being held at a temperature of not less than 61.6°C for a period of not less than 30 minutes, or for a time and a temperature that is equivalent thereto in phosphatase destruction, as determined by official method MFO-3, Determination of Phosphatase Activity in Dairy Products, November 30, 1981; (matière première pasteurisée) pickles and relishes means foods that meet the standard prescribed in section B.11.051; (cornichons et achards) stored means to have been kept or held at a temperature of 2°C or more for a period of 60 days or more from the date of the beginning of the manufacturing process; (entreposé) whole means of the original size and shape as manufactured. (entier)

14.6(E) and (F)

Condition of use PART 2 Column 1 Item 1 2 3 4 Column 2 Figure in Directory of NFT Formats (Version)

(2)

The word “process” may be used in the place of the word “processed” in the following common names: processed (naming the variety) cheese, processed (naming the variety) cheese with (naming the added ingredients), processed cheese food, processed cheese food with (naming the added ingredients), processed cheese spread, and processed cheese spread with (naming the added ingredients). B.08.031 A cheese made from milk that is the normal lacteal secretion of the mammary gland of animals other than the cow, genus Bos, shall (a) conform to all requirements in this Division applicable to the variety; and (b) be labelled to show the source of the milk on the principal display panel. B.08.032 (1) Each of the following foods for which a standard is prescribed, namely, (b) cheddar cheese, (c) cream cheese, (h) cream cheese spread with (naming the added ingredients), (i) processed (naming the variety) cheese, (j) processed (naming the variety) cheese with (naming the added ingredients), (l) processed cheese food with (naming the added ingredients), (m) processed cheese spread, (n) processed cheese spread with (naming the added ingredients), (p) cold-pack (naming the variety) cheese with (naming the added ingredients), (q) cold-pack cheese food, and (r) cold-pack cheese food with (naming the added ingredients), shall be labelled to show on the principal display panel a statement of the percentage of milk fat in the food followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”, and the percentage of moisture in the food followed by the word “moisture” or “water”.

15.1(B)

(2)

Subject to subsection (3), no person shall make any direct or indirect reference on the label of a food referred to in subsection (1) to the milk fat content or moisture content of the food except as required by subsection (1).

15.2(B)

(3)

In addition to the statements referred to in subsection (1), a person may, on the label of a food referred to in that subsection, make a declaration of the fat content of the food, expressed in grams per serving of a stated size. B.08.033 (1) [S]. (Naming the variety) Cheese, other than cheddar cheese, cream cheese, whey cheese, cream cheese with (naming the added ingredients), cream cheese spread, cream cheese spread with (naming the added ingredients), processed (naming the variety) cheese, processed (naming the variety) cheese with (naming the added ingredients), processed cheese food, processed cheese food with (naming the added ingredients), processed cheese spread, processed cheese spread with (naming the added ingredients), cold-pack (naming the variety) cheese, cold-pack (naming the variety) cheese with (naming the added ingredients), cold-pack cheese food, cold-pack cheese food with (naming the added ingredients), cottage cheese and creamed cottage cheese, (i) be the product made by coagulating milk, milk products or a combination thereof with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, (i.1) except for feta cheese, have a casein content that is derived from milk or from ultrafiltered milk, partially skim milk, ultrafiltered partially skimmed milk, skim milk, ultrafiltered skim milk or cream, rather than from other milk products, that is at least the following percentage of the total protein content of the cheese, namely, (B) 83 per cent, in the case of Brick cheese, Canadian Style Brick cheese, Canadian Style Munster cheese, Colby cheese, Farmer’s cheese, Jack cheese, Monterey (Monterey Jack) cheese, Mozzarella (Scamorza) cheese, Part Skim Mozzarella (Part Skim Scamorza) cheese, Part Skim Pizza cheese, Pizza cheese, Skim milk cheese and any other variety of cheese not referred to in clause (A) or (C), and (C) 95 per cent, in the case of any other variety of cheese named in the table to this section, (i.2) have a whey protein to casein ratio that does not exceed the whey protein to casein ratio of milk, (ii) possess the physical, chemical and organoleptic properties typical for the variety, (iii) where it is a cheese of variety named in the table to this section, contain no more than the maximum percentage of moisture shown in Column II thereof for that variety, (iv) where it is a cheese of a variety named in Part I of the table to this section, contain no less than the minimum percentage of milk fat shown in Column III for that variety, and (v) where it is cheese of a variety named in Part II of the table to this section, contain no more than the maximum percentage of milk fat shown in Column III for that variety; and (b) may contain (ii) flavouring preparations other than cheese flavouring, (iii) micro-organisms to aid further ripening, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin or turmeric, (B) in an amount not exceeding 35 parts per million, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate or a combination thereof, and (v) calcium chloride as a firming agent in an amount not exceeding 0.02 per cent of the milk and milk products used, (vi) paraffin wax as a coating in an amount consistent with good manufacturing practice, (vii) where potassium nitrate, sodium nitrate or a combination thereof are used for the purpose and in the manner described in subsection (2), residues of potassium nitrate, sodium nitrate or a combination thereof in an amount not exceeding 50 parts per million, (viii) wood smoke as a preservative in an amount consistent with good manufacturing practice, (ix) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively, or (D) natamycin applied to the surface of the cheese in an amount that does not exceed 20 parts per million or, if the cheese is grated or shredded, 10 parts per million, (x) in the case of grated or shredded cheese, calcium silicate, microcrystalline cellulose or cellulose, or a combination of them, as an anticaking agent, the total amount not to exceed 2.0 per cent, and (xi) carbon dioxide as a pH adjusting agent in milk for cheese production, in an amount consistent with good manufacturing practice. (1.1) A cheese of a variety set out in column I of Part I of the table to this section may contain more than the maximum percentage of moisture set out in column II and less than the minimum percentage of milk fat set out in column III if (a) a statement or claim set out in column 4 of any of items 12 to 14, 16, 20, 21 and 45 of the Table of Permitted Nutrient Content Statements and Claims is shown on the label of the product as part of the common name; and (b) the cheese has the characteristic flavour and texture of the named variety of cheese. (1.2) The reference to “83 per cent” in clause (1)(a)(i.1)(B) shall be read as “78 per cent”, and the reference to “95 per cent” in clause (1)(a)(i.1)(C) shall be read as “90 per cent”, with respect to the named variety of cheese if (a) a statement or claim set out in column 4 of any of items 12 to 14, 16, 20, 21 and 45 of the Table of Permitted Nutrient Content Statements and Claims is shown on the label of the product as part of the common name; and (b) the cheese has the characteristic flavour and texture of the named variety of cheese.

15.3(B)

(2)

Potassium nitrate, sodium nitrate or a combination thereof may be used as a preservative in cheese providing the following requirements are met: (a) the amount of the salt or combination of salts does not exceed 200 parts per million of the milk and milk products used to make the cheese; (b) the cheese in which the preservative is used is (i) mold ripened cheese packed in a hermetically sealed container, or (A) that contains not more than 68 per cent moisture on a fat free basis, and (B) during the manufacture of which the lactic acid fermentation and salting was completed more than 12 hours after coagulation of the curd by enzymes; and (c) the salting is, in the case of the cheese described in subparagraph (b)(ii), applied externally as a dry salt or in the form of a brine.

15.4(B)

Condition of use SOR/2003-11, s. 20; SOR/2016-305, ss. 33, 74. Règlement sur les aliments et drogues

(3)

No person shall use an enzyme other than glandular layer of porcine stomach, phospholipase derived from *Aspergillus oryzae* (PfP1042), protease derived from *Micrococcus caseolyticus* var. or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of any cheese to which subsection (1) applies. (c) a milk coagulating enzyme derived from *Endothia parasitica* and enzymes described in paragraph (a), in the manufacture of Emmentaler (Emmental, Swiss) cheese, Mozzarella (Scamorza) cheese and Part Skim Mozzarella (Part Skim Scamorza) cheese; (d) a milk coagulating enzyme derived from *Endothia parasitica* and enzymes described in paragraph (a), in the manufacture of Parmesan cheese and Romano cheese; (3.1) No person shall use an enzyme referred to in subsection (3) at a level of use above that consistent with good manufacturing practice.

PARTIE B

(4)

Where a flavouring preparation, other than a flavouring preparation that has been traditionally used in the variety, is added to a cheese as permitted in subsection (1), the words “with (naming the flavouring preparation)” shall be added to the common name on any label.

TITRE 1

Étiquetage nutritionnel

(5)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

Article B.01.459

Colonne 1

(6)

Where a cheese is labelled as permitted in subsection (5), the word “smoked” shall be shown on the principal display panel. Item | Variety of Cheese | Maximum percentage of moisture | Minimum percentage of milk fat

Article

5 6 Colonne 2 Figure du Répertoire des modèles de TVN (version)

11 | Canadian Style Brick | 42.0 | 29.0

14.5(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points)

12 | Canadian Style Munster | 46.0 | 27.0

Food and Drug Regulations Division 8 Dairy Products Cheese Item | Variety of Cheese | Maximum percentage of moisture | Minimum percentage of milk fat Item | Variety of Cheese | Maximum percentage of moisture | Maximum percentage of milk fat (i.2) have a whey protein to casein ratio that does not exceed the whey protein to casein ratio of milk, and (b) may contain (ii) flavouring preparations other than cheese flavouring, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, (v) calcium chloride as a firming agent in an amount not exceeding 0.02 per cent of the milk and milk products used, (vi) wood smoke as a preservative in an amount consistent with good manufacturing practice, (vii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or a combination thereof in an amount not exceeding 2,000 parts per million calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate or a combination thereof in an amount not exceeding 3,000 parts per million calculated as sorbic acid, (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million calculated as propionic acid and sorbic acid respectively, or (D) natamycin applied to the surface of the cheese in an amount that does not exceed 20 parts per million or, if the cheese is grated or shredded, 10 parts per million, and (viii) in the case of grated or shredded cheddar cheese, calcium silicate, microcrystalline cellulose or cellulose, or a combination of them, as an anti-caking agent, the total amount not to exceed 2.0 per cent; and (c) shall not be labelled or advertised as cheddar cheese that has been aged unless (i) it is made solely with milk, ultrafiltered milk, partly skimmed milk, ultrafiltered partly skimmed milk, skim milk, ultrafiltered skim milk or cream or a combination of those things, and (ii) it has been aged for at least nine months and the period for which it has been aged is specified on the principal display panel of that label or in that advertising. (1.1) Cheddar cheese may contain more than the maximum percentage of moisture set out in clause (1)(a)(ii)(A) and less than the minimum percentage of milk fat set out in clause (1)(a)(ii)(B) if (a) a statement or claim set out in column 4 of any of items 12 to 14, 16, 20, 21 and 45 of the Table of Permitted Nutrient Content Statements and Claims is shown on the label of the product as part of the common name; and (b) the cheese has the characteristic flavour and texture of cheddar cheese. (a) a statement or claim set out in column 4 of any of items 12 to 14, 16, 20, 21 and 45 of the Table of Permitted Nutrient Content Statements and Claims is shown on the label of the product as part of the common name; and (b) the cheese has the characteristic flavour and texture of cheddar cheese.

14.6(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Condition d’utilisation Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

(2)

No person shall, in the manufacture of the cheddar cheese, use any enzyme other than (b) protease derived from Aspergillus oryzae; and (c) lysozyme derived from egg-white. (2.1) No person shall use an enzyme referred to in subsection (2) at a level of use above that consistent with good manufacturing practice.

PARTIE 2

Modèle composé bilingue — différentes quantités d’aliments Colonne 1

(3)

Where a flavouring preparation is added to a cheese as permitted in subsection (1), the words “with (naming the flavouring preparation)” shall be added to the common name in any label.

Article

1 2 3 4 Colonne 2 Figure du Répertoire des modèles de TVN (version)

(4)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

15.1(B)

(éléments nutritifs figurant en caractères d’au moins 8 points)

(5)

Where a cheese is labelled as permitted in subsection (4), the word “smoked” shall be shown on the principal display panel. (i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, and (B) not less than 30 per cent milk fat; and (b) may contain (i) cream added to adjust the milk fat content, (iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice, (iv) the following emulsifying, gelling, stabilizing and thickening agents: (v) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively. (a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (GAMpR) (b) at a level of use above that consistent with good manufacturing practice. (a) shall be the product made by coagulating whey or concentrated whey with the aid of heat to form a curd and shaping the curd; and (b) may contain (i) micro-organisms to aid further ripening, (ii) added milk and milk products, and (iii) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate, sodium hydroxide and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice.

15.2(B)

(éléments nutritifs figurant en caractères d’au moins 7 points)

(2)

No person shall use, to aid coagulation of whey in the manufacture of whey cheese, a substance other than vinegar or sour whey. (i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, and (ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cream cheese but not in amounts so large as to change the basic nature of the product: (A) cheese other than cream cheese, (C) fruits, nuts, pickles, relishes or vegetables, (D) prepared or preserved meat, or (E) prepared or preserved fish, and (B) not less than 26 per cent milk fat; and (b) may contain (i) cream added to adjust the milk fat content, (iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, (v) the following emulsifying, gelling, stabilizing and thickening agents: (vi) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively. (a) other than chymosin A derived from *Escherichia coli* K-12, GEB1 (pPFZ87A), chymosin B derived from *Aspergillus niger* var. *awamori*, GCC0349 (pGAMpR) or from *Kluyveromyces marxianus* var. *lactis*, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of a product to which subsection (1) applies; and (b) at a level of use above that consistent with good manufacturing practice. (i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, and (A) added milk and milk products, (D) not less than 24 per cent milk fat; and (b) may contain (i) cream added to adjust the milk fat content, (iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate, (v) the following emulsifying, gelling, stabilizing and thickening agents: (vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, and (vii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, Food and Drug Regulations Cheese (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively. (a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of a product to which subsection (1) applies; and (b) at a level of use above that consistent with good manufacturing practice. (i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, (ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cream cheese spread but not in amounts so large as to change the basic nature of the product: (A) cheese other than cream cheese, (C) fruits, nuts, pickles, relishes or vegetables, (D) prepared or preserved meat, or (E) prepared or preserved fish, and (A) added milk and milk products, (C) not less than 24 per cent milk fat; and (b) may contain (i) cream added to adjust the milk fat content, (iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, and (C) in an amount not exceeding 1.5%, caramel, (v) the following emulsifying, gelling, stabilizing and thickening agents: citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total, (vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, and (vii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively. (a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAM9P) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of a product to which subsection (1) applies; and (b) at a level of use above that consistent with good manufacturing practice. (i) subject to subparagraph (ii), be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat, (ii) in the case of processed cheddar cheese, be the product made by comminuting and mixing one or more of the following: (A) cheddar cheese, (D) washed curd cheese into a homogeneous mass with the aid of heat, (iii) have, where it is made from (A) one variety of cheese, in which the maximum amount of moisture permitted is less than 40 per cent, or (B) two or more varieties of cheese, in which the average maximum amount of moisture permitted is less than 40 per cent, a moisture content that does not exceed, by more than five per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than three per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be, (iv) subject to subparagraph (v), have, where it is made from (A) one variety of cheese, in which the maximum amount of moisture permitted is 40 per cent or more, or (B) more than one variety of cheese, in which the average maximum amount of moisture permitted is 40 per cent or more, a moisture content that does not exceed, by more than three per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than two per cent, (A) fromage cheddar, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be, and (v) in the case of processed skim milk cheese, contain not more than (b) may contain (ii) added milk fat, (iii) in the case of processed skim milk cheese, added skim milk powder, buttermilk powder and whey powder, (v) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, (vi) the following emulsifying, gelling, stabilizing and thickening agents: Food and Drug Regulations Cheese (vi.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent, (vii) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, (viii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and (ix) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

15.3(B)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points)

(2)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

15.4(B)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Condition d’utilisation La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. DORS/2003-11, art. 20; DORS/2016-305, art. 33 et 74. SOR/2003-11, s. 20; SOR/2016-305, s. 74. [SOR/2003-11, s. 20; err.(E), Vol. 137, No. 5; SOR/2016-305, s. 34] (a) the bilingual standard format in accordance with Figure 22.5(B), 22.6(B) or 22.7(B) of the Directory of NFT Formats; TABLE PART 1 Column 1 Figure in Directory of NFT Formats (Version) 1 20.1(E) and (F) 2 20.2(E) and (F) Column 2 Condition of use

(3)

Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel. B.08.041 (1) [S]. Processed (naming the variety) Cheese with (naming the added ingredients) (i) be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat, (ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from processed (naming the variety) cheese but not in amounts so large as to change the basic nature of the product: (A) flavouring preparations other than such preparations that resemble the flavour of the varieties of cheese used in the product, (C) fruits, nuts, pickles, relishes or vegetables, (D) prepared or preserved meat, or (E) prepared or preserved fish, (iii) have, where it is made from (A) one variety of cheese, in which the maximum amount of moisture permitted is less than 40 per cent, or (B) more than one variety of cheese, in which the average maximum amount of moisture permitted is less than 40 per cent, a moisture content that does not exceed by more than five per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than three per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be, and (iv) have, where it is made from (A) one variety of cheese, in which the maximum amount of moisture permitted is 40 per cent or more, or (B) more than one variety of cheese, in which the average maximum amount of moisture permitted is 40 per cent or more, a moisture content that does not exceed, by more than three per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than two per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be; and (b) may contain (ii) added milk fat, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, (v) the following emulsifying, gelling, stabilizing and thickening agents: (v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, (vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and (viii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(3)

Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté de l’une des façons suivantes : a) selon le modèle standard bilingue prévu aux figures 22.5(B), 22.6(B) ou 22.7(B) du Répertoire des modèles de TVN; b) selon le modèle horizontal bilingue prévu aux figures 23.3(B) ou 23.4(B) du Répertoire des modèles de TVN; c) selon le modèle linéaire prévu aux figures 31.1(F) et (A) ou 31.2(F) et (A) du Répertoire des modèles de TVN; d) selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible; e) d’une façon prévue à l’article B.01.466.

(2)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(4)

Pour l’application du présent article, afin de déterminer si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement. TABLEAU

(3)

Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel. (i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat, and (A) added milk or milk products, (D) not less than 23 per cent milk fat; and (b) may contain (ii) added milk fat, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, (v) the following emulsifying, gelling, stabilizing and thickening agents: (v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent, (vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, (vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and (viii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

PARTIE 1

Modèle standard — bébés âgés d’au moins six mois mais de moins d’un an Colonne 1 Figure du Répertoire des modèles de TVN

(2)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

Article (version)

1 20.1(F) et (A) (éléments nutritifs figurant en caractères d’au moins 8 points) 2 20.2(F) et (A) (éléments nutritifs figurant en caractères d’au moins 7 points) Colonne 2 Condition d’utilisation 1 La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 2 La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART B Foods DIVISION 1 Nutrition Labelling

(3)

Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel. B.08.041.2 (1) [S]. Processed Cheese Food with (naming the added ingredients) (i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat, (ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from processed cheese food but not in amounts so large as to change the basic nature of the product: (C) prepared or preserved meat, or (D) prepared or preserved fish, and (A) added milk or milk products, (C) not less than 22 per cent milk fat; and (b) may contain (ii) added milk fat, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, and (v) the following emulsifying, gelling, stabilizing and thickening agents: phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total, (v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent, (vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, and (vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and (viii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

Section B.01.461

Column 1 | Column 2 Figure in Directory of NFT Formats (Version) | Condition of use Item | 3 | 20.3(E) and (F) 4 | 20.4(E) and (F) 5 | 20.5(E) and (F) 6 | 20.6(E) and (F) PART 2 Column 1 | Column 2 Figure in Directory of NFT Formats (Version) | Condition of use Item | 1 | 21.1(E) and (F) 2 | 21.2(E) and (F) 3 | 21.3(E) and (F) 4 | 21.4(E) and (F) Règlement sur les aliments et drogues

(2)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

PARTIE B Aliments

(3)

Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel. (i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat, and (A) added milk or milk products, (b) may contain (ii) added milk fat, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate, (v) the following emulsifying, gelling, stabilizing and thickening agents: (v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent, (vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, (vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and (viii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid or, (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

TITRE 1

Étiquetage nutritionnel

(2)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

Article B.01.461

Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TVN (version) | Condition d’utilisation

(3)

Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel. B.08.041.4 (1) [S]. Processed Cheese Spread with (naming the added ingredients) (i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat, (ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from processed cheese spread but not in amounts so large as to change the basic nature of the product: (C) prepared or preserved meat, or (D) prepared or preserved fish, and (A) added milk or milk products, (C) not less than 20 per cent milk fat; and (b) may contain (ii) added milk fat, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, (v) the following emulsifying, gelling, stabilizing and thickening agents: (v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent, (vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, (vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and (viii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

Article |

3 | 20.3(F) et (A) (éléments nutritifs figurant en caractères d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4 | 20.4(F) et (A) (éléments nutritifs figurant en caractères d’au moins 7 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 5 | 20.5(F) et (A) (éléments nutritifs figurant en caractères d’au moins 6 points) Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 6 | 20.6(F) et (A) (éléments nutritifs figurant en caractères d’au moins 6 points) Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

(2)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

PARTIE 2

Modèle standard étroit — bébés âgés d’au moins six mois mais de moins d’un an Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TVN (version) | Condition d’utilisation

(3)

Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel. (i) subject to subparagraph (ii), be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat, (ii) in the case of cold-pack cheddar cheese, be the product made by comminuting and mixing one or more of the following: (A) cheddar cheese, (D) washed curd cheese into a homogeneous mass without the aid of heat, (iii) contain, where it is made from (A) one variety of cheese, not more moisture and not less milk fat than the maximum moisture content and minimum fat content permitted for that variety, or (B) more than one variety of cheese, not more moisture and not less milk fat than the average maximum moisture content and the average minimum fat content permitted for those varieties; and (b) may contain (ii) added milk fat, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, (v) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, (vi) wood smoke as a preservative in an amount consistent with good manufacturing practice, and (vii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

Article |

1 | 21.1(F) et (A) (éléments nutritifs figurant en caractères d’au moins 8 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 2 | 21.2(F) et (A) (éléments nutritifs figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3 | 21.3(F) et (A) (éléments nutritifs figurant en caractères d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4 | 21.4(F) et (A) (éléments nutritifs figurant en caractères d’au moins 6 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART B Foods DIVISION 1 Nutrition Labelling

(2)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

Section B.01.461

PART 3 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(3)

Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel. (i) be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat, (ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cold-pack (naming the variety) cheese but not in amounts so large as to change the basic nature of the product: (A) flavouring preparations other than such preparations that resemble the flavour of the varieties of cheese used in the product, (C) fruits, nuts, pickles, relishes or vegetables, (D) prepared or preserved meat, or (E) prepared or preserved fish, and (iii) contain, where it is made from (A) one variety of cheese, not more moisture and not less milk fat than the maximum moisture content and one per cent less than the minimum milk fat content permitted for that variety, or (B) more than one variety of cheese, not more moisture and not less milk fat than the average maximum moisture content and one per cent less than the average minimum milk fat content permitted for those varieties; and (b) may contain (ii) added milk fat, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, (v) the following emulsifying, gelling, stabilizing and thickening agents: (vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, (vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and (viii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

22.1(B)

2

(2)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

22.2(B)

3

(3)

Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel. (i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat, (A) added milk or milk products, (D) not less than 23 per cent milk fat; and (b) may contain (ii) added milk fat, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, (v) the following emulsifying, gelling, stabilizing and thickening agents: (vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, (vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and (viii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

22.3(B)

4

(2)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

22.4(B)

PART 4 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(3)

Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel. (i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat, (ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cold-pack cheese food but not in amounts so large as to change the basic nature of the product: (C) prepared or preserved meat, or (D) prepared or preserved fish, and (A) added milk or milk products, (C) not less than 22 per cent milk fat; and (b) may contain (ii) added milk fat, (iv) one or more of the following colouring agents: (A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and (B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8'-carotenal, ethyl beta-apo-8'-carotenoate, (v) the following emulsifying, gelling, stabilizing and thickening agents: (vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, (vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and (viii) the following preservatives: (A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or (C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

23.1(B)

Règlement sur les aliments et drogues

(2)

Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

PARTIE B Aliments

(3)

Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel. B.08.042 No manufacturer shall sell whole cheese that is not made from a pasteurized source unless the date of the beginning of the manufacturing process is (a) marked or branded thereon within three days thereof; or (b) marked on the label at the time of packaging, if the cheese is such that, because of its texture, consistency, or physical structure, such date cannot be effectively branded or marked on the cheese. B.08.043 No manufacturer shall sell any cheese that is not made from a pasteurized source if it has been cut into smaller portions, unless (a) it has been duly stored; or (b) each portion cut of cheese is marked, branded or labeled with the date of the beginning of the manufacturing process. B.08.044 (1) Subject to subsection (2), no person shall sell cheese, including cheese curd, that is not made from a pasteurized source unless it has been stored.

TITRE 1

Étiquetage nutritionnel

(2)

Cheese, including cheese curd, that is not made from a pasteurized source may be used as an ingredient in any food providing such food is manufactured or processed so as to pasteurize the cheese in the manner described in the definition pasteurized source in section B.08.030(1). B.08.045 Notwithstanding B.08.044, cheese that has not been manufactured from a pasteurized source and has not been stored but is marked or branded with the date of the beginning of the manufacturing process, may be sold to (c) in quantities of not less than 900 pounds, to a retailer. B.08.046 No person shall sell any whole cheese that has not been made from a pasteurized source unless there is stamped thereon the date of the beginning of the manufacturing process. B.08.047 Every manufacturer, wholesaler, or jobber who sells cheese not made from a pasteurized source and which has not been stored shall keep a record of (e) the weight sold from each vat, for each lot of cheese sold. B.08.048 (1) Subject to section B.08.054, no person shall sell cheese, including cheese curd, made from a pasteurized source if the cheese contains more than per gram, as determined by official method MFO-14, Microbiological Examination of Cheese, November 30, 1983.

Article B.01.461

(2)

No person shall sell cheese, made from an unpasteurized source if the cheese contains more than per gram, as determined by official method MFO-14, Microbiological Examination of Cheese, November 30, 1983. (a) shall be the product remaining after the curd has been removed from milk in the process of making cheese; and (b) may contain (i) catalase, in the case of liquid whey that has been treated with hydrogen peroxide, (iii) hydrogen peroxide, in the case of liquid whey destined for the manufacture of dried whey products, (iv) benzoyl peroxide, and calcium phosphate tribasic and calcium sulphate as carriers of the benzoyl peroxide, in the case of liquid whey destined for the manufacture of dried whey products other than those for use in infant formula, and (v) sodium hexametaphosphate, in the case of liquid whey destined for the manufacture of concentrated or dried whey products. (a) shall be the product, in the form of discrete curd particles, prepared from skim milk, evaporated skim milk or skim milk powder and harmless acid-producing bacterial cultures; (c) may contain not more than 0.5 per cent stabilizing agent; and (i) milk, (iv) rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, (v) a milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), in an amount consistent with good manufacturing practice, (vi.1) chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), in an amount consistent with good manufacturing practice, B.08.052 [S]. Creamed Cottage Cheese shall be cottage cheese containing cream or a mixture of cream with milk or skim milk, or both, in such quantity that the final product shall contain (a) not less than four per cent milk fat; and (b) not more than 80 per cent moisture and may contain emulsifying, gelling, stabilizing and thickening agents. B.08.053 All dairy products used in the preparation of cottage cheese shall be from a pasteurized source. B.08.054 No person shall sell cottage cheese or creamed cottage cheese that contains more than 10 coliform bacteria per gram, as determined by official method MF04, Microbiological Examination of Cottage Cheese, November 30, 1981. (i) be the food prepared in accordance with good manufacturing practices from milk or milk products, and (ii) contain not less than 80 per cent milk fat; and (b) may contain (i) milk solids, B.08.057 [S]. Whey Butter shall be butter made from whey cream. (a) shall be the unfrozen, pasteurized combination of cream, milk or other milk products, sweetened with sugar, liquid sugar, invert sugar, honey, dextrose, glucose, corn syrup, corn syrup solids or any combination of such sweeteners; (b) may contain (i) egg, (vi) microcrystalline cellulose or a stabilizing agent or both in an amount that will not exceed 0.5 per cent of the ice cream made from the mix, (x) propylene glycol mono fatty acid esters in an amount that will not exceed 0.35 per cent of the ice cream made from the mix and sorbitan tristearate in an amount that will not exceed 0.035 per cent of the ice cream made from the mix; and (c) shall contain not less than (ii) 10 per cent milk fat or, where cocoa or chocolate syrup has been added, eight per cent milk fat. (a) shall be the frozen food obtained by freezing an ice cream mix, with or without the incorporation of air; (b) may contain cocoa or chocolate syrup, fruit, nuts or confections; (c) shall contain not less than (ii) 10 per cent milk fat, or, where cocoa or chocolate syrup, fruit, nuts, or confections have been added, eight per cent milk fat, and (iii) 180 grams of solids per litre of which amount not less than 50 grams shall be milk fat, or, where cocoa or chocolate syrup, fruit, nuts or confections have been added, 180 grams of solids per litre of which amount not less than 40 grams shall be milk fat; and as determined by official method MFQ-2, Microbiological Examination of Ice Cream or Ice Milk, November 30, 1981. (a) shall be the frozen food, other than ice cream or ice milk, made from a milk product; (b) may contain (iii) fruit or fruit juice, (i) not more than five per cent milk solids, including milk fat, and (ii) not less than 0.35 per cent acid determined by titration and expressed as lactic acid. (a) shall be the unfrozen, pasteurized combination of cream, milk or other milk products, sweetened with sugar, liquid sugar, invert sugar, honey, dextrose, glucose, corn syrup, corn syrup solids or any combination of such sweeteners; (b) may contain (i) egg, (vi) a stabilizing agent, in an amount that will not result in more than 0.5 per cent stabilizing agent in the ice milk, (x) salt, and (a) shall be the frozen food obtained by freezing an ice milk mix, with or without the incorporation of air; (b) may contain cocoa or chocolate syrup, fruit, nuts or confections; (ii) not less than three per cent and not more than five per cent milk fat, and (iii) not less than 160 grams of solids per litre of which amount not less than 14 grams shall be milk fat; and as determined by official method MFQ-2, Microbiological Examination of Ice Cream or Ice Milk, November 30, 1981. (b) cottage cheese, and (c) creamed cottage cheese, shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.

PARTIE 3

Modèle standard bilingue — bébés âgés d’au moins six mois mais de moins d’un an Colonne 1 Figure du Répertoire des modèles de TVN (version) Colonne 2 Condition d’utilisation

(2)

In addition to the statement referred to in subsection (1), a person may, on the label of a food referred to in subsection (1), make a declaration of the fat content of the food, expressed in grams per serving of stated size. (a) shall be the fatty liquid prepared from milk by separating the milk constituents in such a manner as to increase the milk fat content; and (b) may contain (iii) in the case of cream for whipping that has been heat-treated above 100°C, the following ingredients and food additives: B.08.076 (1) The percentage of milk fat contained in canned cream shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.

Article

1

(2)

In addition to the statement referred to in subsection (1), a person may, on the label of canned cream, make a declaration of the fat content of the cream, expressed in grams per serving of stated size. (a) shall be the product prepared by the souring of pasteurized cream with acid-producing bacterial culture and shall contain not less than 14 per cent milk fat; and (b) may contain (i) milk solids, (iv) starch in an amount not exceeding one per cent, (vi) rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in an amount consistent with good manufacturing practice, (vii) the following emulsifying, gelling, stabilizing and thickening agents: (A) algin, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, pectin or propylene glycol alginate or any combination thereof in an amount not exceeding 0.5 per cent, (B) monoglycerides, mono- and diglycerides, or any combination thereof, in an amount not exceeding 0.3 per cent, and (ix) a milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), in an amount consistent with good manufacturing practice, (x) chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), in an amount consistent with good manufacturing practice, and Fats and Oils B.09.001 [S]. Vegetable fats and oils shall be fats and oils obtained entirely from the botanical source after which they are named, shall be dry and sweet in flavour and odour and, with the exception of olive oil, may contain emulsifying agents, Class IV preservatives, an antifoaming agent, and B-carotene in a quantity sufficient to replace that lost during processing, if such an addition is declared on the label. B.09.002 [S]. Animal fats and oils shall be fats and oils obtained entirely from animals healthy at the time of slaughter, shall be dry and sweet in flavour and odour and may contain (a) with the exception of milk fat and suet, Class IV preservatives; and (b) with the exception of lard, milk fat and suet, an antifoaming agent. (a) shall be the oil obtained from the fruit of the olive tree (Olea europaea L.); (b) shall have a fatty acid content that is (i) not less than 56.0 and not more than 83.0 per cent oleic acid, (ii) not less than 7.5 and not more than 20.0 per cent linoleic acid, (iii) not less than 3.5 and not more than 20.0 per cent linolenic acid, (iv) not less than 0.5 and not more than 3.5 per cent stearic acid, (v) not less than 0.3 and not more than 3.5 per cent palmitoleic acid, (vii) not more than 0.05 per cent myristic acid, calculated as methyl esters; (c) shall not contain more than minute amounts of arachidic acid, behenic acid, gadoleic acid or lignoceric acid; (i) a relative density of not less than 0.910 and not more than 0.916, calculated with the oil at 20°C and water at 20°C (20°C/20°C), (ii) a refractive index of not less than 1.4677 and not more than 1.4705, calculated using the sodium D-line as the light source and with the oil at 20°C (nD20°C), (iii) an iodine value of not less than 75 and not more than 94, calculated using the Wijs test, (iv) a saponification value of not less than 184 and not more than 196, expressed as milligrams of potassium hydroxide per gram of oil, (vi) a free acidity of not more than 3.3 per cent expressed as oleic acid, (ix) a Bellier index of not more than 17; (e) shall show negative results when tested for semi-siccative oil, olive-residue oil, cotton-seed oil, tea-seed oil or sesame seed oil; and (f) notwithstanding section B.09.001, may contain alpha-tocopherol in a quantity sufficient to replace that lost during refining, if such an addition is declared on the label. (b) shall have (i) a relative density (20°C/water at 20°C) of not less than 0.918 and not more than 0.926, (ii) a refractive index (nD40°C) of not less than 1.458 and not more than 1.466, (iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 189 and not more than 198, (iv) an iodine value (Wijs) of not less than 99 and not more than 119, Food and Drug Regulations (viii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil; and B.09.005 [S]. Cocoa Butter shall be the fat from cocoa nibs, obtained either before or after roasting, or cocoa liquor, and shall have (a) a refractive index (40°C) of not less than 1.453 and not more than 1.458; (b) a saponification value of not less than 188 and not more than 202; (c) an iodine value (Hanus) of not less than 32 and not more than 41; and (b) shall have (i) a relative density of (20°C/water at 20°C) of not less than 0.917 and not more than 0.925, (ii) a refractive index (nD40°C) of not less than 1.465 and not more than 1.468, (iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 187 and not more than 195, (iv) an iodine value (Wijs) of not less than 103 and not more than 128, (vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and (b) shall have (i) a relative density of (20°C/water at 20°C) of not less than 0.914 and not more than 0.917, (ii) a refractive index (nD40°C) of not less than 1.460 and not more than 1.465, (iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 187 and not more than 196, (iv) an iodine value (Wijs) of not less than 80 and not more than 106, (b) shall have (i) a relative density of (20°C/water at 20°C) of not less than 0.919 and not more than 0.925, (ii) a refractive index (nD40°C) of not less than 1.466 and not more than 1.470, (iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 189 and not more than 195, (iv) an iodine value (Wijs) of not less than 120 and not more than 143, Food and Drug Regulations (vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and (vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil; and B.09.009 [S]. Sunflowerseed Oil or Sunflower Oil (a) shall be the oil of the seeds of *Helianthus annuus* L.; and (b) shall have (i) a relative density (20°C/water at 20°C) of not less than 0.918 and not more than 0.923, (ii) a refractive index (nD40°C) of not less than 1.467 and not more than 1.469, (iii) an iodine value (Wijs) of not less than 110 and not more than 143, (iv) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 188 and not more than 194, (vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and (b) shall have (i) a relative density (20°C/water at 20°C) of not less than 0.922 and not more than 0.927, (ii) a refractive index (nD40°C) of not less than 1.467 and not more than 1.470, (iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 186 and not more than 198, (iv) an iodine value (Wijs) of not less than 135 and not more than 150, (vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and B.09.010 Despite the common name set out in the Common Names for Ingredients and Components Document, if a vegetable fat or oil is an ingredient of any cooking oil, salad oil or table oil, the fat or oil shall be shown in the list of ingredients by its common name. B.09.011 [S]. Shortening, other than butter or lard, shall be the semi-solid food prepared from fats, oils or a combination of fats and oils, may be processed by full hydrogenation and may contain (a) Class IV preservatives, (e) lactylated monoglycerides, or a combination of lactylated monoglycerides and diglycerides of fat forming fatty acids, the total weight being not more than eight per cent of the weight of the shortening, and (b) shall have (ii) a relative density of not less than 0.894 and not more than 0.906, calculated with the lard at 40°C and water at 20°C (40°C/water at 20°C), (ii) a refractive index of not less than 1.448 and not more than 1.461, calculated using the sodium D-line as the light source and with the lard at 40°C (nD40°C), (iv) a saponification value of not less than 192 and not more than 203, expressed as milligrams potassium hydroxide per gram of fat, (v) an iodine value of not less than 45 and not more than 70, calculated using the Wijs test, (c) may contain (i) lard stearine or fully hydrogenated lard, (ii) a Class IV preservative, and (iii) not more than one per cent of substances resulting from the rendering process, other than fatty acids and fat. B.09.014 [S]. Leaf Lard shall be lard that has been rendered at a moderately high temperature from the internal fat of the abdomen of the hog, excluding that adhering to the intestines, and shall have an iodine value (Hanus) of not more than 65. (a) shall be the fat taken from the region of the kidney or loin or caul fat of a beef carcass; (b) shall have (i) a relative density of not less than 0.893 and not more than 0.898, calculated with the suet at 40°C and water at 20°C (40°C/water at 20°C), (ii) a refractive index of not less than 1.448 and not more than 1.460, calculated using the sodium D-line as the light source and with the suet at 40°C (nD40°C), (iv) a saponification value of not less than 190 and not more than 200, expressed as milligrams of potassium hydroxide per gram of fat, (v) an iodine value of not less than 32 and not more than 47, calculated using the Wijs test, (c) where sold in comminuted form, shall contain not more than three per cent cereal and one per cent salt. (a) shall be a plastic or fluid emulsion of water in fats, oil or fats and oil that are not derived from milk and may have been subjected to full hydrogenation; (i) not less than 80% fat, oil or fat and oil calculated as fat, (ii) not less than 3,300 I.U. of vitamin A per 100 g, and (c) may contain (i) skim milk powder, buttermilk powder or liquid buttermilk, (v) vitamin E, if added in such an amount that will result in the finished product containing not less than 0.6 I.U. of alpha-tocopherol per gram of linoleic acid present in the margarine, (ix) the following colouring agents: annatto, β-apo-8′-carotenal, canthaxanthin, carotene, ethyl β-apo-8′-carotenoate and turmeric, as set out in Table III to section B.16.100, (x) the following emulsifying agents: lecithin, mono- and di-glycerides, mono-glycerides and sorbitan tristearate, as set out in Table IV to section B.16.100, (xii) the following Class II and Class IV preservatives: ascorbyl palmitate, ascorbyl stearate, benzoic acid, butylated hydroxyanisole, butylated hydroxytoluene, calcium sorbate, citric acid esters of mono- and di-glycerides, monoglyceride citrate, monoisopropyl citrate, potassium benzoate, potassium sorbate, propyl gallate, sodium benzoate, sodium sorbate and sorbic acid, as set out in Table XI to section B.16.100, and (xiii) the following sequestering agents: calcium disodium ethylenediaminetetraacetate and stearyl citrate, as set out in Table XII to section B.16.100. (a) shall conform to the standard for margarine except it shall contain not more than (i) 40 per cent fat, oil or fat and oil calculated as fat, and (ii) 50 per cent of the calories that would be normally present in the product if it were not calorie-reduced; (b) subject to paragraph (c), may contain, either singly or in combination, in an amount not exceeding 0.5 per cent, (c) may (ii) if it contains a combination of one or more of the ingredients mentioned in paragraph (b) and polyglycerol esters of fatty acids, contain such esters in an amount not exceeding 0.2 per cent, provided that the total combination of such esters and ingredients does not exceed an amount of 0.5 per cent; (ii) modified vegetable starch, and B.09.022 No person shall sell cooking oil, margarine, salad oil, simulated dairy product, shortening or food that resembles margarine or shortening, if the product contains more than five per cent C22 Monoenoic Fatty Acids calculated as a proportion of the total fatty acids contained in the product. Flavouring Preparations B.10.003 [S]. (naming the flavour) Extract or (naming the flavour) Essence shall be a solution in ethyl alcohol, glycerol, propylene glycol or any combination of these, of sapid or odorous principles, or both, derived from the plant after which the flavouring extract or essence is named, and may contain water, a sweetening agent, food colour and a Class II preservative or Class IV preservative. B.10.004 [S]. Artificial (naming the flavour) Extract, Artificial (naming the flavour) Essence, Imitation (naming the flavour) Extract or Imitation (naming the flavour) Essence shall be a flavouring extract or essence except that the flavouring principles shall be derived in whole, or in part, from sources other than the aromatic plant after which it is named, and if such extract or essence is defined in these Regulations, the flavouring strength of the artificial or imitation extract or essence shall be not less than that of the extract or essence. (a) shall be a preparation, other than a flavouring preparation described in section B.10.003, of sapid or odorous principles, or both, derived from the aromatic plant after which the flavour is named; (b) may contain a sweetening agent, food colour, Class II preservative, thaumatin, Class IV preservative or emulsifying agent; and (c) may have added to it the following liquids only: (ii) any of, or any combination of, the following: benzyl alcohol; 1, 3-butylene glycol, ethyl acetate, ethyl alcohol, glycerol, glyceryl diacetate, glyceryl triacetate, glyceryl tributyrate, isopropyl alcohol, monoglycerides and diglycerides; 1, 2-propylene glycol or triethylcitrate. B.10.005 [S]. Artificial (naming the flavour) Flavour or Imitation (naming the flavour) Flavour shall be a flavour except that the flavouring principles may be derived in whole or in part from sources other than the aromatic plant after which it is named, and if such flavour is defined in these Regulations, the flavouring strength of the artificial or imitation flavour shall be not less than that of the flavour. B.10.007 [S]. Notwithstanding sections B.10.003 and B.10.005, a (naming the fruit) Extract Naturally Fortified, (naming the fruit) Essence Naturally Fortified or (naming the fruit) Flavour Naturally Fortified shall be an extract, essence or flavour derived from the named fruit to which other natural extractives have been added and 51 per cent of the flavouring strength shall be derived from the named fruit. B.10.008 On any label of or in any advertisement for an artificial or imitation flavouring preparation, the word “artificial,” or “imitation” shall be an integral part of the name of such flavouring preparation and shall be set out in identical type and identically displayed with such name. B.10.009 [S]. Almond Essence, Almond Extract or Almond Flavour shall be the essence, extract or flavour derived from the kernels of the bitter almond, apricot or peach and shall contain not less than one per cent by volume of hydrocyanic acid-free volatile oil obtained therefrom. B.10.010 [S]. Anise Essence, Anise Extract or Anise Flavour shall be the essence, extract or flavour derived from natural or terpeneless oil of anise and shall represent in flavouring strength to an alcoholic solution containing not less than three per cent by volume of oil of anise, the volatile oil obtained from the fruit of Pimpinella anisum L. or Illicium verum Hook. B.10.011 [S]. Celery Seed Essence, Celery Seed Extract or Celery Seed Flavour shall be the essence, extract or flavour derived from celery seed, or oil of celery seed, or terpeneless oil of celery seed and shall correspond in flavouring strength to an alcoholic solution containing not less than 0.3 per cent by volume of volatile oil of celery seed. B.10.012 [S]. Cassia Essence, Cassia Extract, Cassia Cinnamon Essence, Cassia Cinnamon Extract, Cassia Flavour or Cassia Cinnamon Flavour shall be the essence, extract or flavour derived from natural or terpeneless oil, obtained from leaves and twigs of Cinnamomum cassia L. containing not less than 80 per cent cinnamic aldehyde, and shall correspond in flavouring strength to an alcoholic solution containing not less than two per cent by volume of volatile oil of cassia cinnamon. B.10.013 [S]. Ceylon Cinnamon Essence, Ceylon Cinnamon Extract or Ceylon Cinnamon Flavour shall be the essence, extract or flavour derived from the volatile oil obtained from the bark of Cinnamomum zeylanicum Nees, and shall contain (a) not less than two per cent by volume of oil of Ceylon cinnamon; (b) not less than 65 per cent cinnamic aldehyde; and B.10.014 [S]. Clove Essence, Clove Extract or Clove Flavour shall be the essence, extract or flavour derived from the volatile oil obtained from clove buds, and shall contain not less than two per cent by volume of oil of clove. B.10.015 [S]. Ginger Essence, Ginger Extract or Ginger Flavour shall be the essence, extract or flavour derived from ginger and shall contain in 100 millilitres the alcohol-soluble matter from not less than 20 grams of ginger. B.10.016 [S]. Lemon Essence, Lemon Extract or Lemon Flavour shall be the essence, extract or flavour prepared from natural or terpeneless oil of lemon or from lemon peel and shall contain not less than 0.2 per cent citral derived from oil of lemon. B.10.017 [S]. Nutmeg Essence, Nutmeg Extract or Nutmeg Flavour shall be the essence, extract or flavour prepared from natural or terpeneless oil of nutmeg and shall correspond in flavouring strength to an alcoholic solution containing not less than two per cent by volume of oil of nutmeg. B.10.018 [S]. Orange Essence, Orange Extract or Orange Flavour shall be the essence, extract or flavour prepared from sweet orange peel, oil of sweet orange or terpeneless oil of sweet orange, and shall correspond in flavouring strength to an alcoholic solution containing five per cent by volume of oil of sweet orange, the volatile oil obtained from the fresh peel of Citrus aurantium L., that shall have an optical rotation, at a temperature of 25°C, of not less than +95° using a tube 100 millimetres in length. B.10.019 [S]. Peppermint Essence, Peppermint Extract or Peppermint Flavour shall be the essence, extract or flavour prepared from peppermint or oil of peppermint, obtained from the leaves and flowering tops of Mentha piperita L., or of Mentha arvensis De.C., var. piperascens Holmes, and shall correspond in flavouring strength to an alcoholic solution of not less than three per cent by volume of oil of peppermint, containing not less than 50 per cent free and combined menthol. B.10.020 [S]. Rose Essence, Rose Extract or Rose Flavour shall be the essence, extract or flavour prepared from the volatile oil obtained from the petals of Rosa damascena Mill., R. centifolia L., or R. moschata Herrm., and shall contain not less than 0.4 per cent by volume of attar of rose. B.10.021 [S]. Savory Essence, Savory Extract or Savory Flavour shall be the essence, extract or flavour prepared from savory or oil of savory and shall contain not less than 0.35 per cent by volume oil of savory. B.10.022 [S]. Spearmint Essence, Spearmint Extract or Spearmint Flavour shall be the essence, extract or flavour prepared from spearmint or from oil of spearmint, obtained from the leaves and flowering tops of Mentha spicata L. and shall contain not less than three per cent by volume of oil of spearmint. B.10.023 [S]. Sweet Basil Essence, Sweet Basil Extract or Sweet Basil Flavour shall be the essence, extract or flavour prepared from sweet basil or from oil of sweet basil, obtained from the leaves and tops of Ocymum basilicum L. and shall contain not less than 0.1 per cent by volume of oil of sweet basil. B.10.024 [S]. Sweet Marjoram Essence, Sweet Marjoram Extract, Marjoram Essence, Marjoram Extract, Sweet Marjoram Flavour or Marjoram Flavour shall be the essence, extract or flavour prepared from marjoram or from oil of marjoram and shall contain not less than one per cent by volume of oil of marjoram. B.10.025 [S]. Thyme Essence, Thyme Extract or Thyme Flavour shall be the essence, extract or flavour prepared from thyme or from oil of thyme and shall contain not less than 0.2 per cent by volume of oil of thyme. B.10.026 [S]. Vanilla Extract, Vanilla Essence or Vanilla Flavour (b) shall contain in 100 ml, regardless of the method of extraction, at least the quantity of soluble substances in their natural proportions that are extractable, according to official method FO-17, Extraction of Soluble Substances from Vanilla Beans, dated September 15, 1989, from B.10.027 [S]. Wintergreen Essence, Wintergreen Extract or Wintergreen Flavour shall be the essence, extract or flavour prepared from oil of wintergreen, the volatile oil distilled from the leaves of Gaultheria procumbens L. or from Betula lenta L. and shall contain not less than three per cent by volume of oil of wintergreen. Food and Drug Regulations Fruits, Vegetables, Their Products and Substitutes fruit juice means the unfermented liquid expressed from sound ripe fresh fruit, and includes any such liquid that is heat treated and chilled; (jus de fruit) B.11.001.1 No person shall sell any fresh fruit or vegetable that is intended to be consumed raw, except grapes, if sulphurous acid or any salt thereof has been added thereto. (a) shall be the product obtained by heat processing the named fresh vegetable after it has been properly prepared; (b) shall be packed in hermetically sealed containers; (c) may contain (i) in the case of canned green beans and canned wax beans, pieces of green peppers, red peppers and tomato in an amount not exceeding 15 per cent of the final product, and dill seasonings and vinegar, (ii) in the case of canned peas, garnishes composed of one or more of lettuce, onions, carrots, and pieces of green or red peppers in an amount not exceeding 15 per cent of the total drained vegetable ingredient, aromatic herbs, spices and seasonings, stock or juice of vegetables and aromatic herbs, calcium hydroxide in an amount not exceeding 0.01 per cent of the final product and magnesium hydroxide in an amount not exceeding 0.05 per cent of the final product, (A) canned asparagus, acetic acid, malic acid and tartaric acid in an amount consistent with good manufacturing practice, and (B) canned white asparagus, acetic acid, ascorbic acid, malic acid and tartaric acid in an amount consistent with good manufacturing practice, (iv) in the case of asparagus packed in glass containers or fully lined (lacquered) cans, stannous chloride in an amount not exceeding 25 parts per million, calculated as tin, (A) butter or other edible animal or vegetable fats or oils, but if butter is added it shall be not less than three per cent of the final product, (B) natural or enzymatically or physically modified starches when used with butter or other edible animal or vegetable fats and oils, (C) acacia gum, algin, carrageenan, furcelleran, guar gum and propylene glycol alginate used with butter or other edible animal or vegetable fats or oils in an amount not exceeding one per cent, singly or in any combination, of the final product, and (D) characterizing sauces, seasonings or flavouring agents if it is included in the common name of the product. (a) shall be the product obtained by heat-processing properly prepared mushrooms of the cultivated type; (b) shall be packed in hermetically sealed containers; and (c) may contain ascorbic acid, citric acid and salt. (a) shall be the product obtained by freezing properly prepared mushrooms of the cultivated type; and B.11.004 [S]. Frozen (naming the vegetable) shall be the product obtained by freezing the named fresh vegetable after it has been prepared and subjected to a blanching treatment and may contain citric acid and added salt. (a) shall be the product made by heat processing properly prepared fresh ripe tomatoes; (b) may contain (iv) citric acid, and (v) spice or other seasoning; and (c) shall contain not less than 50 per cent drained tomato solids, as determined by official method FO-18, Determination of Drained Tomato Solids, October 15, 1981. B.11.007 [S]. Tomato Juice shall be the unconcentrated, pasteurized liquid containing a substantial portion of fine tomato pulp extracted from sound, ripe, whole tomatoes from which all stems and other portions unfit for consumption have been removed by any method that does not add water to the liquid and may contain citric acid, salt and a sweetening ingredient in dry form. B.11.009 [S]. Tomato Paste shall be the product made by evaporating a portion of the water from tomatoes or sound tomato trimmings, may contain citric acid, salt and a Class II preservative and shall contain not less than 20 per cent tomato solids as determined by official method FO-19, Determination of Tomato Solids, October 15, 1981. B.11.010 [S]. Concentrated Tomato Paste shall be tomato paste containing not less than 30 per cent tomato solids, as determined by official method FO-19, Determination of Tomato Solids, October 15, 1981. B.11.011 [S]. Tomato Pulp shall be the heat-processed product made from sound, whole and ripe tomatoes or sound tomato trimmings, concentrated to yield a product with a specific gravity of not less than 1.050 (20°C/20°C) and may contain citric acid, salt and a Class II preservative. B.11.012 [S]. Tomato Puree shall be the heat-processed product made from sound, whole and ripe tomatoes with the skins and seeds removed, concentrated to yield a product with a specific gravity of not less than 1.050 (20°C/20°C) and may contain citric acid, salt and a Class II preservative. B.11.014 [S]. Tomato Catsup, Catsup or products whose common names are variants of the word Catsup (a) shall be the heat processed product made from the juice of red-ripe tomatoes or sound tomato trimmings from which skins and seeds have been removed; (iii) seasoning, and (c) may contain (i) a Class II preservative, and B.11.016 No person shall sell canned tomatoes, tomato juice or vegetable juice that contains mould filaments in more than 25 per cent of the microscopic fields, when examined by official method MFO-5, Examination of Canned Tomatoes, Tomato Juice and Vegetable Juice, Tomato Puree, Tomato Paste, Tomato Pulp and Tomato Catsup for Mould Filaments, November 30, 1981. B.11.017 No person shall sell tomato puree, tomato paste, tomato pulp or tomato catsup that contains mould filaments in more than 50 per cent of the microscopic fields, when examined by official method MFO-5, Examination of Canned Tomatoes, Tomato Juice and Vegetable Juice, Tomato Puree, Tomato Paste, Tomato Pulp and Tomato Catsup for Mould Filaments, November 30, 1981. B.11.025 No person shall sell potatoes, sweet potatoes or yams that have been artificially coloured. B.11.040 [S]. Beans with Pork or Beans and Pork shall be the food prepared from dried beans and pork, may contain calcium disodium ethylenediaminetetraacetate, citric acid, disodium ethylenediaminetetraacetate, sauce, seasoning, spices or a sweetening agent and shall contain not less than 60 per cent drained solids as determined by official method FO-20, Determination of Drained Solids of Beans with Pork or Beans and Pork and Beans or Vegetarian Beans, October 15, 1981. B.11.041 [S]. Beans or Vegetarian Beans shall be the food prepared from dried beans, may contain calcium disodium ethylenediaminetetraacetate, citric acid, disodium ethylenediaminetetraacetate, sauce, seasoning, spices or a sweetening agent and shall contain not less than 60 per cent drained solids as determined by official method FO-20, Determination of Drained Solids of Beans with Pork or Beans and Pork and Beans or Vegetarian Beans, October 15, 1981. B.11.050 [S]. Olives shall be the plain or stuffed fruit of the olive tree, and may contain (g) sorbic acid or its potassium or sodium salt; (i) citric acid; and B.11.051 [S]. Pickles and relishes shall be the product prepared from vegetables or fruits with salt and vinegar, and may contain (e) a Class II preservative; (i) vegetable oils; and (j) in the case of relishes and mustard pickles, a thickening agent. (a) shall be the product prepared by heat processing the named fresh fruit after it has been properly prepared; (b) shall be packed in hermetically sealed containers; (c) may contain (iii) concentrated (naming the fruit) juice, (naming the fruit) juice, (naming the fruits) juice, (naming the fruit) juice from concentrate or any combination thereof, Food and Drug Regulations DIVISION 11 Fruits, Vegetables, Their Products and Substitutes (i) in the case of canned pears, lactic acid, lemon juice, malic acid, mint, spice oils, spices, tartaric acid and a flavouring preparation other than that which simulates the flavour of canned pears, (iii) in the case of canned applesauce, ascorbic acid, isoascorbic acid, malic acid, salt, spices and a flavouring preparation other than that which simulates the flavour of canned applesauce, (iv) in the case of canned grapefruit, calcium chloride, calcium lactate, lemon juice, spices and a flavouring preparation other than that which simulates the flavour of canned grapefruit, (vi) in the case of canned peaches, peach kernels, peach pits and spices intended for flavour development, spice oil and a flavouring preparation other than that which simulates the flavour of canned peaches, (vii) in the case of canned pineapple, dimethylpolysiloxane when pineapple juice is used as a packing medium, mint, spice oils, spices and a flavouring preparation other than that which simulates the flavour of canned pineapple, (viii) in the case of canned plums, a flavouring preparation other than that which simulates the flavour of canned plums, (ix) in the case of canned strawberries, lactic acid, malic acid or tartaric acid, and B.11.102 [S]. Frozen (naming the fruit) shall be the product obtained by freezing the named fresh fruit after it has been properly prepared and may contain (c) fruit juice, fruit juice from concentrate, concentrated fruit juice or any combination thereof; (e) in the case of frozen sliced apples, (a) shall be the juice obtained from the named fruit; and (b) may contain a sweetening ingredient in any form, a Class II preservative, amylase, cellulase and pectinase. B.11.121 Notwithstanding section B.11.120, the fruit juice prepared from any fruit named in any of sections B.11.123 to B.11.128A shall conform to the standard prescribed for that fruit juice in that section. (a) shall be the fruit juice obtained from apples; (b) may contain a Class II preservative, vitamin C, amylase, cellulase and pectinase; (c) shall have a specific gravity of not less than 1.041 and not more than 1.065 (20°C/20°C); and (d) shall contain, in 100 millilitres measured at a temperature of 20°C, not less than 0.24 gram and not more than 0.60 gram of ash of which not less than 50 per cent shall be potassium carbonate. (a) shall be the fruit juice obtained from grapes; (b) shall have a specific gravity of not less than 1.040 and not more than 1.124 (20°C/20°C); (c) shall contain, before the addition of a sweetening ingredient, in 100 millilitres measured at a temperature of 20°C, (i) not less than 0.20 gram and not more than 0.55 gram of ash, and (ii) not less than 0.015 gram and not more than 0.070 gram of phosphoric acid calculated as phosphorus pentoxide; and (a) shall be fruit juice obtained from clean, sound, mature grapefruit; (i) contain not less than 1.15 milliequivalents of free amino acid per 100 millilitres, as determined by official method FO-21, Determination of Amino Acids in Grapefruit Juice and Orange Juice, October 15, 1981, (ii) contain not less than 70 milligrams of potassium per 100 millilitres, as determined by official method FO-22, Determination of Potassium in Grapefruit Juice and Orange Juice, October 15, 1981, and (iii) have an absorbance value for total polyphenolics of not less than 0.310, as determined by official method FO-23, Determination of Absorbance Value for Total Polyphenolics in Grapefruit Juice and Orange Juice, October 15, 1981; (c) shall, before the addition of sugar, invert sugar, dextrose or glucose solids, (i) have a Brix reading of not less than 9.3°, as determined by official method FO-24, Determination of Brix Reading for Grapefruit Juice and Orange Juice, October 15, 1981, and (a) shall be the fruit juice obtained from lemons; (b) shall contain, before the addition of a sweetening ingredient, in 100 millilitres measured at a temperature of 20°C, not less than (i) 8.0 grams of soluble solids, as determined by official method FO-2

22.1(B)

(éléments nutritifs figurant en caractères d’au moins 8 points) 2

(2)

No person shall manufacture prepackaged ice for sale if the water from which it is made contains (a) any coliform bacteria, as determined by official method MF0-15, Microbiological Examination of Water in Sealed Containers (Excluding Mineral and Spring Water) and of Prepackaged Ice, November 30, 1981; (b) naturally occurring fluoride ion in an amount that exceeds its naturally occurring amount; or (c) added fluoride in such an amount that the total amount therein of added and naturally occurring fluoride ion exceeds one part per million. B.12.007 Notwithstanding section B.01.008, when chlorine or any compounds of chlorine have been (a) used in the treatment of water in sealed containers, other than water represented as mineral water or spring water, and (b) subsequently removed from the water together with any chlorine and compounds of chlorine produced in the water, chlorine or any compounds of chlorine need not be shown as ingredients on any part of the label on a sealed container of that water. B.12.008 A statement of the total fluoride ion content expressed in parts per million shall appear on the principal display panel of the label on a sealed container of water, other than water represented as mineral water or spring water and on the label on a container of prepackaged ice. Grain and Bakery Products B.13.001 [S]. Flour, White Flour, Enriched Flour or Enriched White Flour (a) shall be the food prepared by the grinding and bolting through cloth having openings not larger than those of woven wire cloth designated "149 microns (No. 100)", of cleaned milling grades of wheat; (b) shall be free from bran coat and germ to such an extent that the percentage of ash therein, before the addition of any other material permitted by this section, calculated on a moisture-free basis, does not exceed 1.20 per cent; (c) shall have a moisture content of not more than 15 per cent; (i) malted wheat flour, (vi) benzoyl peroxide in an amount not exceeding 150 parts by weight for each one million parts of flour, with or without not more than 900 parts by weight for each one million parts of flour of one or a mixture of two or more of calcium carbonate, calcium sulphate, dicalcium phosphate, magnesium carbonate, potassium aluminum sulphate, sodium aluminum sulphate, starch and tricalcium phosphate as carriers of the benzoyl peroxide, (viii) ammonium persulphate in an amount not exceeding 250 parts by weight for each one million parts of flour, (ix) ammonium chloride in an amount not exceeding 2,000 parts by weight for each one million parts of flour, (xi) azodicarbonamide in an amount not exceeding 45 parts by weight for each one million parts of flour, (xii) ascorbic acid in an amount not exceeding 200 parts by weight for each one million parts of flour, (xiii) L-cysteine (hydrochloride) in an amount not exceeding 90 parts by weight for each one million parts of flour, (xiv) monocalcium phosphate in an amount not exceeding 7,500 parts by weight for each one million parts of flour, and B.13.002 Notwithstanding section B.13.001, flour, white flour, enriched flour or enriched white flour, used in or sold for the manufacture of gluten or starch is not required to contain added thiamine, riboflavin, niacin, folic acid or iron. B.13.003 [S]. Vitamin B White Flour (Canada Approved) (a) shall be flour that has been milled in such a way as to retain a high proportion of the vitamins naturally occurring in the original wheat berry; (b) shall constitute not less than 70 per cent of the wheat from which it is milled; (c) shall be bolted through at least one cloth having openings not larger than those of woven wire cloth designated “149 microns (No. 100)”; and (i) in one pound an amount of the vitamin B complex that will contribute not less than 1.2 milligrams of thiamine, and (a) shall be the food prepared by the grinding and bolting of cleaned, milling grades of wheat from which a part of the outer bran or epidermis layer may have been separated; (b) shall contain the natural constituents of the wheat berry to the extent of not less than 95 per cent of the total weight of the wheat from which it is milled; (c) shall have (i) an ash content, calculated on a moisture-free basis, of not less than 1.25 per cent and not more than 2.25 per cent, (iii) such a degree of fineness that not less than 90 per cent bolts freely through a No. 8 (2 380 micron) sieve, and not less than 50 per cent through a No. 20 (840 micron) sieve; and (i) malted wheat flour, (vi) benzoyl peroxide in an amount not exceeding 150 parts by weight for each one million parts of flour, with or without not more than 900 parts by weight for each one million parts of flour of one or a mixture of two or more of calcium carbonate, calcium sulphate, dicalcium phosphate, magnesium carbonate, potassium aluminum sulphate, sodium aluminum sulphate, starch and tricalcium phosphate as carriers of the benzoyl peroxide, (viii) ammonium persulphate in an amount not exceeding 250 parts by weight for each one million parts of flour, (ix) ammonium chloride in an amount not exceeding 2,000 parts by weight for each one million parts of flour, (x) azodicarbonamide in an amount not exceeding 45 parts by weight for each one million parts of flour, (xii) ascorbic acid in an amount not exceeding 200 parts by weight for each one million parts of flour, and (xiii) L-cysteine (hydrochloride) in an amount not exceeding 90 parts by weight for each one million parts of flour. B.13.006 [S]. Graham Flour shall be flour to which has been added part of the bran and other constituents of the wheat, bran shall have an ash content, calculated on a moisture-free basis, of not less than 1.20 per cent and not more than 2.25 per cent. B.13.007 [S]. Gluten Flour shall be the food obtained by removing from flour a part of the starch and shall not contain more than (b) 44 per cent Starch, calculated on a moisture-free basis, as determined by official method FO-28, Determination of Starch in Gluten Flour, October 15, 1981. B.13.008 [S]. Crushed Wheat or Coarse Ground Wheat shall be the food prepared by so crushing cleaned wheat that 40 per cent or more passes through a No. 8 (2 380 micron) sieve and less than 50 per cent through a No. 20 (840 micron) sieve, the proportions of the other constituents of such wheat, other than moisture, remaining unaltered and shall have (a) an ash content, calculated on a moisture-free basis, of not less than 1.50 per cent and not more than 2.25 per cent; and B.13.009 [S]. Cracked Wheat shall be the food prepared by so cracking or cutting cleaned wheat into angular fragments that not less than 90 per cent passes through a No. 8 (2 380 micron) sieve and not more than 20 per cent through a No. 20 (840 micron) sieve, the proportions of the natural constituents of such wheat, other than moisture, remaining unaltered and shall have (a) an ash content, calculated on a moisture-free basis, of not less than 1.50 per cent and not more than 2.25 per cent; and B.13.010 [S]. Rice shall be the hulled or hulled and polished seed of the rice plant and, in the case of hulled and polished seeds, may be coated with magnesium silicate, talc and glucose. B.13.010.1 (1) For the purposes of this Division, pre-cooked rice means polished rice that has been cooked in water or steam and dried in such a manner as to retain the rice grains in a porous and open-structured condition.

22.2(B)

(éléments nutritifs figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3

(2)

Notwithstanding sections D.01.009, D.01.011 and D.02.009, no person shall sell pre-cooked rice to which a vitamin or mineral nutrient set out in Column I of an item of the table to this section has been added, either singly or in any combination, unless each 100 g of the pre-cooked rice sold contains the added vitamin or mineral nutrient in the amount set out in Column II of that item. Amount per 100 g of Pre-cooked Rice

22.3(B)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4

(3)

No person shall represent pre-cooked rice as “enriched” unless the food contains added thiamine, niacin and iron. B.13.011 [S]. Corn starch shall be starch made from maize and shall contain not less than 84% starch. B.13.014 For the purpose of this Division, moisture, ash, and fineness shall be determined by the following applicable official methods: a) FO-29, Determination of Moisture in Grain, October 15, 1981; b) FO-30, Determination of Ash in Grain, October 15, 1981; and c) FO-31, Determination of Degree of Fineness of Grain, October 15, 1981. B.13.015 [S]. Cottonseed Flour or similar products from cottonseed shall be derived from decorticated, defatted or partially defatted, cooked, ground cottonseed kernels and contain not more than 450 parts per million of free gossypol. B.13.020 In this Division, milk solids means the entire solids content from milk, partly skimmed milk or skim milk or their concentrated, dried or reconstituted form, singly or in any combination. B.13.021 [S]. Bread or White Bread shall be the food made by baking a yeast-leavened dough prepared with flour and water and may contain d) whole egg, egg-white; egg-yolk, (fresh, dried, or frozen); g) inactive dried yeast of the genus Saccharomyces cerevisiae in an amount not greater than two parts by weight for each 100 parts of flour used; (i) subject to section B.13.029, one or more of the following in a total amount not exceeding five parts by weight per 100 parts of flour used, namely, whole wheat flour, entire wheat flour, graham flour, gluten flour, wheat meal, wheat starch, non-wheat flour, non-wheat meal or non-wheat starch, any of which may be wholly or partially dextrinized; (m) ammonium chloride, ammonium sulphate, calcium carbonate, calcium lactate, diammonium phosphate, dicalcium phosphate, monoammonium phosphate or any combination thereof in an amount not greater than 0.25 parts by weight of all such additives for each 100 parts of flour used; (n) monocalcium phosphate in an amount not greater than 0.75 parts by weight for each 100 parts of flour used; (o) calcium peroxide, ammonium persulphate, potassium persulphate or any combination thereof in an amount not greater than 0.01 part by weight of all such additives for each 100 parts of flour used; (r) Class III preservative; (t) calcium stearoyl-2-lactylate or sodium stearoyl-2-lactylate in an amount not greater than 0.375 parts by weight for each 100 parts of flour used; (v) calcium sulphate in an amount not greater than 0.5 parts by weight for each 100 parts of flour used; (w) sodium stearyl fumarate in an amount not greater than 0.5 parts by weight for each 100 parts of flour used; (x) ascorbic acid in an amount not greater than 0.02 parts by weight for each 100 parts of flour used; B.13.022 [S]. Enriched Bread or Enriched White Bread (a) shall be bread that is baked from a dough in which enriched flour is the only wheat flour used; (i) for each 100 parts of flour used, not less than (A) two parts by weight of skim milk solids, (B) four parts by weight of dried whey powder, or (C) such amount of the protein product made from peas (Pisum sativum) or soybeans (Glycine max) as will provide 0.5 parts by weight of protein, and (c) may contain, in 100 grams of bread, (d) where it contains not less than six parts by weight of milk solids per 100 parts of enriched flour used, may be described by the common name “milk bread”. B.13.025 [S]. Raisin Bread shall be bread that contains for each 100 parts by weight of flour used not less than 50 parts by weight of seeded or seedless raisins, or raisins and currants of which not less than 35 parts shall be raisins and may contain spices or peel. (i) be bread in the making of which the named percentage of the flour used shall be whole wheat flour, and (ii) contain not less than 60 per cent whole wheat flour in relation to the total flour used; and (b) may (i) contain caramel, and (ii) where it contains not less than six parts by weight of milk solids per 100 parts of the total enriched flour and whole wheat flour used, be described by the common name “(naming the percentage) whole wheat milk bread”. B.13.027 [S]. Brown Bread shall be bread coloured by the use of whole wheat flour, graham flour, bran, molasses or caramel. B.13.029 A specialty bread may contain (b) fruit, nuts, seeds and flavouring. Alimentary Paste B.13.051 No person shall sell macaroni, spaghetti, noodles or similar alimentary pastes, as egg macaroni, egg spaghetti, egg noodles or egg alimentary pastes, respectively, unless they contain, on the dry basis, not less than four per cent, egg-yolk solids derived from whole egg, dried egg, frozen egg or frozen egg-yolk. B.13.052 (1) Notwithstanding sections D.01.009, D.01.011 and D.02.009, no person shall sell an alimentary paste to which a vitamin or a mineral nutrient set out in column I of any item of the table to this section has been added unless each 100 g of the alimentary paste contains the added vitamin or mineral nutrient in an amount not less than the minimum amount set out in column II of that item and not more than the maximum amount set out in column III of that item.

22.4(B)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

(2)

No person shall represent an alimentary paste as “enriched” unless the alimentary paste contains added thiamine, riboflavin, niacin, folic acid and iron, in accordance with the table to this section. | Alimentary | Alimentary Food and Drug Regulations DIVISION 13 Grain and Bakery Products Alimentary Paste B.13.060 Notwithstanding sections D.01.009, D.01.011 and D.02.009, no person shall sell a breakfast cereal to which a vitamin or mineral nutrient set out in Column I of the table to this section has been added, either singly or in any combination, unless each 100 g of the breakfast cereal contains the added vitamin or mineral nutrient in the amount set out in Column II of that item. Meat, Its Preparations and Products B.14.001 In this Division, animal means any animal used as food, but does not include marine and fresh water animals; (animal) filler means any vegetable material (except tomato or beetroot), milk, egg, yeast or any derivative or combination thereof that is acceptable as food. (agent de remplissage) B.14.002 [S]. Meat shall be the edible part of the skeletal muscle of an animal that was healthy at the time of slaughter, or muscle that is found in the tongue, diaphragm, heart or oesophagus, and may contain accompanying and overlaying fat together with the portions of bone, skin, sinew, nerve and blood vessels that normally accompany the muscle tissue and are not separated from it in the process of dressing, but does not include muscle found in the lips, snout, scalp or ears. B.14.003 [S]. Meat by-product shall be any edible part of an animal, other than meat, that has been derived from one or more animals that were healthy at the time of slaughter. B.14.004 Meat, meat by-products or preparations thereof are adulterated if any of the following substances or class of substances are present therein or have been added thereto: (a) mucous membranes, any organ or portions of the genital system, black gut, spleens, udders, lungs or any other organ or portion of animal that is not commonly sold as an article of food; (b) preservatives other than those provided for in this Division; (c) colour other than annatto, allura red and sunset yellow FCF, where provided for in this Division, and caramel. B.14.005 [S]. Prepared meat or a prepared meat by-product shall be any meat or any meat by-product, respectively, whether comminuted or not, to which has been added any ingredient permitted by these Regulations, or which has been preserved, placed in a hermetically-sealed container or cooked, and may contain (a) a Class II preservative; (b) in the case of partially defatted pork fatty tissue and partially defatted beef fatty tissue, a Class IV preservative; (c) where a minimum total protein content or a minimum meat protein content is prescribed in this Division, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely, B.14.006 Powdered fully hydrogenated cottonseed oil may be applied as a release agent to the surface of meat, meat by-product, prepared meat, prepared meat by-product, extended meat product and simulated meat product in an amount not greater than 0.25% of the product. (a) where sold for use in preserved meat or preserved meat by-product, may contain any of ascorbic acid, calcium ascorbate, erythorbic acid, iso-ascorbic acid, potassium nitrate, potassium nitrite, sodium ascorbate, sodium carbonate, sodium erythorbate, sodium iso-ascorbate, sodium nitrate and sodium nitrite, provided that these nitrates and nitrites, if any, are packaged separately from any spice or seasoning. (b) where sold for use in prepared meat or meat by-product in which a gelling agent is a permitted ingredient, may contain a gelling agent; (c) where sold for use in fresh, uncooked sausage, may contain artificial maple flavour; and B.14.008 No person shall sell a meat binder, filler or preparations for pumping pickle, cover pickle or dry cure represented for use in meat products unless the label therefor carries directions for use that when followed will produce a food that will comply with the requirements of section B.14.030 insofar as the filler is concerned and the food will not contain food additives in excess of the maximum levels of use prescribed by these Regulations. B.14.009 [S]. Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product may contain (a) Class I preservatives if the nitrate or nitrite salts or both are packaged separately from any spice or seasoning; (c) sweetening agents, including maple sugar and maple syrup; (f) in the case of pumping pickle for cured pork, beef and lamb cuts, disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate in such amount calculated as disodium phosphate, as will result in the finished product containing not more than 0.5 per cent added phosphate; (g) in the case of pumping pickle for cured beef cuts, enzymes, if the principal display panel of the label of the cured beef carries, immediately preceding or following the common name, the statement “Tenderized with (naming the proteolytic enzyme or enzymes)”; (h) in the case of dry cure, an anticaking agent or a humectant; and (i) in the case of pumping pickle (i) for cured pork hams, shoulders and backs, artificial maple flavour, and (ii) for cured pork bellies, artificial maple flavour and an orange flavour that meets the standard prescribed in section B.10.005. B.14.010 No person shall sell as food a dead animal or any part thereof. B.14.011 No person shall sell as food, meat, meat by-products, preparations containing meat or meat derivatives obtained, prepared or manufactured from a dead animal. B.14.012 For the purpose of Sections B.14.010 and B.14.011, dead animal means a dead animal that (a) was not killed for the purpose of food in accordance with commonly accepted practice of killing animals for the purpose of food, which shall include exsanguination; or (b) was affected with disease at the time it was killed. Meat, Meat By-Products B.14.015 [S]. Regular Ground Beef shall be beef meat processed by grinding and shall contain not more than 30 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981. B.14.015A [S]. Medium Ground Beef shall be beef meat processed by grinding and shall contain not more than 23 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981. B.14.015B [S]. Lean Ground Beef shall be beef meat processed by grinding and shall contain not more than 17 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981. B.14.015C No person shall sell ground beef that contains more than 30 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981. (a) it is labelled as such when offered or exposed for sale; and (b) when in package form, the principal display panel of the label carries a declaration of the presence of horse-meat or of horse-meat by-product in type at least as legible and conspicuous as any other type upon such principal display panel. B.14.018 (1) Subject to subsection (2), if a carcass of beef or veal, or a portion of a carcass of beef or veal that weighs 7 kg or more, is advertised for sale, the advertisement shall indicate (a) in the case of a carcass other than an imported carcass, the grade that was assigned to the carcass under the Safe Food for Canadians Act or a provincial law; (b) in the case of an imported beef carcass, the grade that was assigned to the carcass under the Safe Food for Canadians Act or a provincial law or the grade that was assigned to the carcass by a grading authority established under the laws of the country from which the carcass was imported; (c) in the case of an imported veal carcass, the grade that was assigned to the carcass by a grading authority established under the laws of the country from which the carcass was imported; and (d) in the case of a beef carcass, the yield class, if any, that was assigned to the carcass under the Safe Food for Canadians Act.

PARTIE 4

Modèle horizontal bilingue — bébés âgés d’au moins six mois mais de moins d’un an Colonne 1 Figure du Répertoire des modèles de TVN (version) Colonne 2 Condition d’utilisation

(2)

Where, in the case of a carcass referred to in subsection (1), no grade has been assigned thereto as described in that subsection and the carcass or portion thereof that weighs 7 kg or more is advertised for sale, the advertisement shall clearly indicate that the carcass has not been graded. B.14.019 (1) Where a carcass of beef, veal, pork or lamb or a portion thereof that weighs 7 kg or more is advertised for sale and a selling price is stated in the advertisement, the advertisement shall (a) contain the words “price per kilogram is based on carcass weight before cutting, boning and trimming” or the words “price per kilogram is based on the weight of the meat after cutting, boning and trimming”, whichever words are applicable; and (b) where in addition to the selling price a charge is payable for cutting, boning, trimming, wrapping or freezing the carcass or portion thereof, indicate (i) the amount of the additional charge, and (ii) where the additional charge is payable on a price per unit weight basis, whether the additional charge is based on the weight of the carcass or portion thereof before or after the carcass has been cut, boned and trimmed.

Article

1

(2)

Any information required by subsection (1) to appear in an advertisement shall be located therein immediately adjacent to the selling price stated therein, without any intervening written, printed or graphic matter. B.14.020 [S]. Solid cut meat shall be (b) a product consisting of pieces of meat of which at least 80 per cent weigh at least 25 g each. B.14.021 (1) No person shall sell solid cut meat to which phosphate salts or water has been added unless (a) in the case of meat, other than side bacon, Wiltshire bacon, pork jowls, salt pork and salt beef, the meat (i) where cooked, contains a meat protein content of not less than 12 per cent, and (ii) where uncooked, contains a meat protein content of not less than 10 per cent; and (b) that meat contains, phosphate salts that do not, when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely,

23.1(B)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des parties 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART B Foods DIVISION 1 Nutrition Labelling Sections B.01.461-B.01.462 Column 1 Item 2 Figure in Directory of NFT Formats (Version)

(2)

A bone or a visible fat layer shall not be included in any calculation used to determine meat protein content for the purposes of paragraph (1)(a). B.14.022 No person shall sell mechanically tenderized beef unless (a) the beef is identified as mechanically tenderized when it is offered or exposed for sale; and (b) the beef has a label on it with a principal display panel that, subject to section B.01.012, includes all of the following information: (i) in type at least as legible and prominent as that of the common name, (A) the expression “mechanically tenderized” in the English version of the label, and (ii) in type at least as legible and prominent as that of any other information other than the common name, (A) in the English version of the label, (II) in the case of steak, the additional message "Turn steak over at least twice during cooking.", and (B) in the French version of the label, Prepared Meats, Prepared Meat By-Products B.14.030 (1) Subject to subsections (2) and (3) and section B.14.034, no person shall sell a prepared meat or prepared meat by-product with a meat protein content of less than 1.5 percentage points below the total protein requirement for that food.

23.2(B)

Column 2 Condition of use SOR/2003-11, s. 20; SOR/2016-305, ss. 35, 74. [SOR/2016-305, s. 36] (a) the bilingual simplified standard format in accordance with Figure 25.5(B) or 25.6(B) of the Directory of NFT Formats; --- Règlement sur les aliments et drogues

(2)

Subsection (1) does not apply to an extended meat product.

PARTIE B Aliments

(3)

Where gelatin is an ingredient of a prepared meat or prepared meat by-product, that gelatin shall not be included when calculating the total protein content of the prepared meat or prepared meat by-product. B.14.030A For the purposes of sections B.14.030, B.14.032, B.14.033, B.14.035, B.14.074, B.14.075, B.14.076 and B.14.077, where any of the non-meat ingredients listed in paragraphs B.14.032A(a) to (g) are present in a prepared meat or prepared meat by-product in separate identifiable pieces or chunks in any amount sufficient to B.14.031 [S]. Preserved Meat or Preserved Meat By-product shall be cooked or uncooked meat or meat by-product that is salted, dried, pickled, corned, cured or smoked, may be glazed and may contain (a) a Class I preservative; (a.1) a Class II preservative; (c) spices and seasonings, except tomato; (g) in the case of cured pork hams, shoulders, backs and bellies, artificial maple flavour; (gg) in the case of cured pork bellies, an added orange flavour that meets the standard prescribed in section B.10.005; (h) in the case of cured pork, beef and lamb cuts prepared with the aid of pumping pickle, disodium phosphate, monosodium phosphate, sodium hexam-etaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate in such amount calculated as disodium phosphate, as will result in the finished product containing not more than 0.5 per cent added phosphate; (i) in the case of tocino, annatto in such amount as will result in the finished product containing not more than 0.1% annatto; and B.14.032 [S]. Sausage or Sausage Meat (a) shall be fresh or preserved comminuted meat; (b) may be enclosed in a casing or have an edible coating; (c) may be dipped in vinegar, smoked, cooked or dried; (viii) seasoning, other than tomato, (xii) in a Class II preservative, (xiii) in the case of preserved comminuted meat, smoke flavouring or artificial smoke flavouring, (xiv) in the case of fresh uncooked sausage, artificial maple flavour or apple powder as a flavouring ingredient, (xv) in the case of dry sausage or dry sausage meat, glucono delta lactone, (A) annatto in such amount as will result in the finished product containing not more than 0.1% annatto, B.14.032A [S]. (naming the prepared meat or prepared meat by-product) with (naming the non-meat ingredients) shall be prepared meat to which has been added other non-meat ingredients including B.14.032AA Where the non-meat ingredients referred to in section B.14.032A are added to prepared meat in such a manner that they are not present in the final product in separate identifiable pieces or chunks, the final product shall meet the total protein content requirement established for (naming the prepared meat or prepared meat by-product) referred to in section B.14.032A. B.14.033 [S]. Potted Meat, Meat Paste or Meat Spread shall be fresh or preserved meat that is comminuted and cooked, and may contain meat binder, salt, sweetening agents, spices, other seasonings, a gelling agent, sodium acetate and sodium diacetate and shall have a total protein content of not less than 9%. B.14.034 [S]. Potted Meat By-product, Meat By-product Paste or Meat By-product Spread shall be a food that (a) consists, wholly or in part, of meat by-products and conforms to the standard prescribed for potted meat; and B.14.035 [S]. Meat Loaf, Meat Roll, Meat Lunch or Luncheon Meat shall be fresh or preserved meat that is comminuted, cooked and pressed into shape, and may contain a dried skim milk product obtained from skim milk by the reduction of its calcium content and a corresponding increase in its sodium content, in an amount not exceeding 3% of the finished food, as well as filler, meat binder, salt, sweetening agents, glucono delta lactone, spices, other seasonings, milk, eggs, a gelling agent, sodium acetate, sodium diacetate and partially defatted beef fatty tissue or partially defatted pork fatty tissue, and shall have a total protein content of not less than 11%. B.14.036 [S]. Meat By-product Loaf or Meat and Meat By-product Loaf shall be the food consisting, wholly or in part, of meat by-products and shall otherwise conform to the standard prescribed for meat loaf. (a) shall be comminuted cooked meat or comminuted cooked preserved meat, (i) less than 50 per cent head meat, or (ii) skin, other than that naturally adherent to any pork meat used, (c) may contain scalps, snouts, beef tripe, salt, spices, seasoning or an added gelling agent, and (i) a Class I preservative, and (ii) a Class II preservative.

SECTION I

Étiquetage nutritionnel

(2)

For the purpose of subsection (1), scalps and snouts are considered to be head meat. B.14.038 [S]. Brawn shall be headcheese, except that it need not contain 50 per cent head meat. B.14.040 Subject to section B.14.032 and sections B.14.033 to B.14.036, no person shall sell a food that consists of a mixture of ground meat and filler, ground meat by-product and filler or ground meat, ground meat by-product and filler, unless that food (a) has a total protein content of not less than 13 per cent; (b) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of a mixture containing pork meat or pork meat by-product or both; and (c) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of any other meat mixture. B.14.041 Subject to section B.14.032 and sections B.14.033 to B.14.036, no person shall sell a food that consists of a mixture of ground meat and spices and seasonings, ground meat by-product and spices and seasonings, ground meat, ground meat by-product and spices and seasonings or ground meat and ground meat by-product, unless that food (a) has a total protein content of not less than 16 per cent; (b) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of a mixture containing pork meat or pork meat by-product or both; and (c) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of any other meat mixture. Meat Derivatives B.14.061 [S]. Edible Bone Meal or Edible Bone Flour shall be the food prepared by grinding dry, defatted bones, obtained from animals healthy at the time of slaughter and shall contain (a) not less than 85 per cent ash, as determined by official method FO-34, Determination of Ash in Edible Bone Meal or Edible Bone Flour, October 15, 1981. (a) shall be the purified food obtained by the processing of skin, ligaments or bones of animals; (b) shall contain not less than 82 per cent ash-free solids, when tested by official method FO-35, Determination of Ash-Free Solids in Gelatin, October 15, 1981. (e) shall be free from objectionable taste and offensive odour when 2.5 grams thereof are dissolved in 100 millilitres of warm water; (e) shall not contain any residues of hydrogen peroxide where it has been used in the course of manufacture; and (ii) not more than 500 parts per million of sulphurous acid, including the salts thereof, calculated as sulphur dioxide, and (b) filtering and clarifying agents other than activated carbon, alumina, aluminum sulphate, calcium phosphate, dibasic, cellulose, diatomaceous earth, perlite, strongly acidic cation exchange resin in the hydrogen ion form or basic anion exchange resins in the chloride ion or free base ion forms. B.14.063 For the purposes of sections B.14.064 to B.14.068, stew meat means meat that contains when raw not more than (a) 25 per cent fat, in the case of meat in meat ball stews; and (b) 20 per cent fat, in the case of meat in other stews. B.14.064 [S]. Vegetable Stew with (naming the meat) (a) shall contain vegetables and the named meat in the following amounts, calculated as raw ingredients: (b) may contain gravy, salt, seasoning and spices. (a) shall contain vegetables and the named meat in the following amounts, calculated as raw ingredients: (b) may contain gravy, salt, seasoning and spices. (a) shall contain mutton, lamb or beef, singly or in any combination, and vegetables, in the following amounts, calculated as raw ingredients: (b) may contain gravy, salt, seasoning and spices. (a) shall contain vegetables and meat balls in the following amounts, calculated as raw ingredients: (b) may contain gravy, salt, seasoning and spices. (a) shall contain meat and vegetables in the following amounts, calculated as raw ingredients: (b) may contain gravy, salt, seasoning and spices. B.14.070 [S]. Wieners and Beans or Wieners with Beans shall be the food prepared from dried beans and wieners, may contain sauce, seasoning, spices and a sweetening agent and shall contain not less than 25 per cent wieners, as determined by official method FO-36, Determination of Wiener Content of Meat Specialties, October 15, 1981. B.14.071 [S]. Beans and Wieners or Beans with Wieners shall be the food prepared from dried beans and wieners, may contain sauce, seasoning, spices and a sweetening agent and shall contain not less than 10 per cent wieners, as determined by official method FO-36, Determination of Wiener Content of Meat Specialties, October 15, 1981. Sale of Barbecued, Roasted or Broiled Meat or Meat By-Products B.14.072 No person shall sell meat or a meat by-product that has been barbecued, roasted or broiled and is ready for consumption unless the cooked meat or meat by-product (i) has a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher, Food and Drug Regulations DIVISION 14 Meat, Its Preparations and Products Sale of Barbecued, Roasted or Broiled Meat or Meat By-Products (iii) has been stored at an ambient temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher; and (b) carries on the principal display panel of the label a statement to the effect that the food must be stored at a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher. B.14.073 No person shall sell a meat product extender intended to be used in a food consisting of a mixture described in section B.14.074, B.14.075, B.14.076, B.14.077 or B.14.078, unless that extender (a) has, in the rehydrated state, (i) a total protein content of not less than 16 per cent, and (ii) a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981; (b) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and (c) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein. Extended Meat Products B.14.074 Subject to sections B.14.075 to B.14.079, no person shall sell a food that consists of a mixture of meat product and meat product extender, unless that food (a) has a total protein content of not less than 16 per cent; (b) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and (c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c). B.14.075 No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles fresh sausage, unless that food (a) has a total protein content of not less than nine per cent; (b) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and (c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c). B.14.076 No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles cooked sausage, meat loaf, meat by-product loaf, meat roll, meat lunch, or luncheon meat, unless that food (a) has a total protein content of not less than 11 per cent; (b) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and (c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c). B.14.077 No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles potted meat, potted meat by-product, meat paste, meat by-product paste, meat spread, or meat by-product spread, unless that food (a) has a total protein content of not less than nine per cent; (b) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and (c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c). B.14.078 No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles regular ground beef, medium ground beef or lean ground beef, unless that food (a) has a total protein content of not less than 16 per cent; (b) has a fat content of (i) not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being regular, (ii) not more than 23 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being medium, or (iii) not more than 17 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being lean; and (c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c). B.14.079 No person shall sell a food that consists of a mixture of meat product, filler and meat product extender, unless that food (a) has a total protein content of not less than 13 per cent; (b) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and (c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c). Simulated Meat Products B.14.085 Subject to sections B.14.086 to B.14.090 no person shall sell a simulated meat product unless that product (a) has, in the rehydrated state, (i) a total protein content of not less than 16 per cent, (ii) a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981, and (iii) a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; (b) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and (c) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein. B.14.086 No person shall sell a simulated meat product that resembles fresh sausage, unless that product (a) has a total protein content of not less than nine per cent; (b) has a protein rating of not less than 23, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981; (c) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981. (d) has, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and (e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein. B.14.087 No person shall sell a simulated meat product that resembles cooked sausage, meat loaf, meat by-product loaf, meat roll, meat lunch, or luncheon meat, unless that product (a) has a total protein content of not less than 11 per cent; (b) has a protein rating of not less than 28, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981; (c) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; (d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and (e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein. B.14.088 No person shall sell a simulated meat product that resembles potted meat, potted meat by-product, meat paste, meat by-product paste, meat spread, or meat by-product spread, unless that product (a) has a total protein content of not less than nine per cent; (b) has a protein rating of not less than 23, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981; (c) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; (d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each vitamin and mineral nutrient respectively; and (e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein. B.14.089 No person shall sell a simulated meat product that resembles regular ground beef, medium ground beef or lean ground beef, unless that product (a) has a total protein content of not less than 16 per cent; (b) has a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981; (c) has a fat content of (i) not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being regular, (ii) not more than 23 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being medium, or (iii) not more than 17 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being lean; Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient, respectively; and (e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein. B.14.090 No person shall sell a simulated meat product that resembles side bacon, unless that product (a) has a total protein content of not less than 25 per cent; (b) has a protein rating of not less than 20, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981; (c) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient, respectively; and (d) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein. Amount per gram of protein Item No. Food and Drug Regulations DIVISION 15 Meat, Its Preparations and Products Simulated Meat Products Item No. Amount per gram of protein B.15.001 (1) A food referred to in column 2 of Part 1 of the List of Contaminants and Other Adulterating Substances in Foods is adulterated if the corresponding substance referred to, by name or class, in column 1 is present in or on the food.

Articles B.01.461-B.01.462

Colonne 1

(2)

A food referred to in column 2 of Part 2 of the List of Contaminants and Other Adulterating Substances in Foods is adulterated if the corresponding substance referred to, by name or class, in column 1 is present in or on the food in an amount that exceeds the maximum level set out in column 3.

Article

2 Figure du Répertoire des modèles de TVN (version)

(3)

If a substance referred to, by name or class, in column 1 in Part 2 the List of Contaminants and Other Adulterating Substances in Foods is present in or on the corresponding food referred to in column 2, the food is, in respect of the presence of the substance, exempt from the application of paragraph 4(1)(a) of the Act if the amount of the substance does not exceed the maximum level set out in column 3.

23.2(B)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Colonne 2 Condition d’utilisation Les versions des parties 1 à 3 et de l’article 1 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. DORS/2003-11, art. 20; DORS/2016-305, art. 35 et 74. Modèles simplifiés — bébés âgés d’au moins six mois mais de moins d’un an [DORS/2016-305, art. 36] B.01.462 (1) Le présent article s’applique à tout produit préemballé destiné exclusivement aux bébés âgés d’au moins six mois mais de moins d’un an qui remplit la condition du paragraphe B.01.403(5) et dont le tableau de la valeur nutritive ne contient que les renseignements visés aux alinéas B.01.403(5)a) à k).

(4)

Subsections (1) to (3) do not apply to a substance that is present in or on a food as (b) a pest control product as defined in subsection 2(1) of the Pest Control Products Act or its components or derivatives; or (c) a veterinary drug or its metabolites. B.15.002 (1) Subject to subsection (2), a food is adulterated if (a) a pest control product as defined in subsection 2(1) of the Pest Control Products Act or its components or derivatives, for which no maximum residue limit has been specified under sections 9 or 10 of that Act for that food, are present in or on the food, singly or in any combination, in an amount exceeding 0.1 part per million; or (b) an agricultural chemical or its components or derivatives, other than a pest control product as defined in subsection 2(1) of the Pest Control Products Act or its components or derivatives, are present in or on the food, singly or in any combination, in an amount exceeding 0.1 part per million.

(2)

Sous réserve du paragraphe (3), le tableau de la valeur nutritive du produit préemballé est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(2)

A food is exempt from paragraph 4(1)(d) of the Act if the following agricultural chemicals, or their components or derivatives, are the only agricultural chemicals, or components or derivatives of agricultural chemicals, that are present in or on the food, singly or in any combination:

(3)

Si le tableau de la valeur nutritive qui ne contient que les renseignements visés aux alinéas B.01.403(5)a) à k) ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une ou l’autre des versions figurant à la colonne 1 du tableau du présent article, il est présenté de l’une ou l’autre des façons suivantes : a) selon le modèle standard simplifié bilingue prévu aux figures 25.5(B) ou 25.6(B) du Répertoire des modèles de TVN; b) selon le modèle horizontal simplifié bilingue prévu aux figures 26.3(B) ou 26.4(B) du Répertoire des modèles de TVN; c) selon le modèle linéaire simplifié prévu aux figures 32.1(F) et (F) ou 32.2(E) et (F) du Répertoire des modèles de TVN; d) selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible; e) d’une façon prévue à l’article B.01.466. TABLE PART 1 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(3)

Subsection (2) does not apply to a food if there is present in or on the food an agricultural chemical, or a component or derivative of that agricultural chemical, referred to in that subsection that is a pest control product as defined in subsection 2(1) of the Pest Control Products Act, or a component or derivative of that product, in respect of which a maximum residue limit has been specified under sections 9 or 10 of that Act for that food. Food Additives B.16.001 A quantitative statement of the amount of each additive present or directions for use that, if followed, will produce a food that will not contain such additives in excess of the maximum levels of use prescribed by these Regulations shall be shown, grouped together with the list of ingredients, of any substance or mixture of substances for use as a food additive. B.16.002 A request that a food additive be added to or a change made in the Tables following section B.16.100 shall be accompanied by a submission to the Minister in a form, manner and content satisfactory to him and shall include (a) a description of the food additive, including its chemical name and the name under which it is proposed to be sold, its method of manufacture, its chemical and physical properties, its composition and its specifications and, where that information is not available, a detailed explanation; (b) a statement of the amount of the food additive proposed for use, and the purpose for which it is proposed, together with all directions, recommendations and suggestions for use; (c) where necessary, in the opinion of the Minister, an acceptable method of analysis suitable for regulatory purposes that will determine the amount of the food additive and of any substance resulting from the use of the food additive in the finished food; (e) detailed reports of tests made to establish the safety of the food additive under the conditions of use recommended; (f) data to indicate the residues that may remain in or upon the finished food when the food additive is used in accordance with good manufacturing practice; (g) a proposed maximum limit for residues of the food additive in or upon the finished food; (h) specimens of the labelling proposed for the food additive; and B.16.003 The Minister shall, within 90 days after the filing of a submission in accordance with section B.16.002, notify the person filing the submission whether or not it is his intention to recommend to the Governor-in-Council that the said food additive be so listed and the detail of any listing to be recommended. B.16.007 No person shall sell a food containing a food additive if food from a food additive provided for in sections B.01.042, B.01.043 and B.25.062. B.16.100 No person shall sell any substance as a food additive unless the food additive is listed in one or more of the following Tables: Food Additives That May Be Used as Anticaking Agents | Item No. | Additive | Permitted in or Upon | Maximum Level of Use | Item No. Additive Permitted in or Upon

24.1(E) and (F)

2

(1)

1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)

24.2(E) and (F)

3

(6)

If used either singly or in combination with Calcium Silicate, Magnesium Carbonate, Magnesium Silicate, Magnesium Stearate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5%

24.3(E) and (F)

4

(8)

Grated or shredded (naming the variety) cheese; Grated or shredded cheddar cheese; Unstandardized grated or shredded cheese preparations

24.4(E) and (F)

5

(8)

If used singly or in combination with microcrystalline cellulose or cellulose, the total amount not to exceed 2.0%

24.5(E) and (F)

6

(1)

1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a) Grated or shredded (naming the variety) cheese; Grated or shredded cheddar cheese; Unstandardized grated or shredded cheese preparations If used singly or in combination with calcium silicate or microcrystalline cellulose, the total amount not to exceed 2.0%

24.6(E) and (F)

PART 2 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(1)

Salt (except when used in preparations of Meat and Meat By-products of Division 14)

25.1(B)

TABLEAU

(1)

1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)

PARTIE 1

Modèle standard simplifié — bébés âgés d’au moins six mois mais de moins d’un an Colonne 1 Figure du Répertoire des modèles de TVN (version) Colonne 2 Condition d’utilisation

(2)

Garlic salt, Onion salt (except when used in preparations of Meat and Meat By-products of Division 14) Item No. | Additive Permitted in or Upon Unstandardized dry mixes (Except when used in preparations of Meat and Meat by-products of Division 14)

Article

1

(1)

1.0%, except in the case of fine-grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)

24.1(F) et (A)

(éléments nutritifs figurant en caractères d’au moins 8 points) 2

(4)

If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Carbonate, Magnesium Stearate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5%

24.2(F) et (A)

(éléments nutritifs figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3

(1)

1.0%, except in the case of fine-grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)

24.3(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4

(4)

If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Carbonate, Magnesium Silicate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5% Grated or shredded (naming the variety) cheese; Grated or shredded cheddar cheese; Unstandardized grated or shredded cheese preparations If used singly or in combination with microcrystalline cellulose or cellulose, the total amount not to exceed 2.0%

24.4(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 5

(4)

If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Carbonate, Magnesium Silicate, Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

24.5(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 6

(2)

Icing sugar | (2) If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Carbonate, Magnesium Silicate, Magnesium Stearate or Silicon Dioxide the total must not exceed 1.5% Salt | 13 p.p.m. calculated as anhydrous sodium ferrocyanide Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Bleaching, Maturing and Dough Conditioning Agents Item No. Additive Permitted in or Upon Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use S.3 | Sodium Sulphite | Biscuit dough | 500 p.p.m. calculated as Sulphur Dioxide Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Colouring Agents Item No. | Additive | Permitted in or Upon | Maximum Level of Use

24.6(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

1 | Aluminum Metal | (1) Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Packaged fish and meat products that are marinated or otherwise cold-processed (Division 21); Pickles; Pineapple marmalade with pectin; Relishes; Sherbet; Smoked fish; Tomato catsup | (1) Good Manufacturing Practice

PARTIE 2

Modèle standard simplifié bilingue — bébés âgés d’au moins six mois mais de moins d’un an Colonne 1 Figure du Répertoire des modèles de TVN (version) Colonne 2 Condition d’utilisation

4 | Anthocyanins | (4) Vegetable fats and oils | (4) Good Manufacturing Practice in accordance with section B.09.001

Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

Article

1

(1)

Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; Margarine; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Pickles; Pineapple marmalade with pectin; Relishes; Sherbet; Smoked fish; Tomato catsup | (1) 35 p.p.m. (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Pickles; Pineapple marmalade with pectin; Porter; Relishes; Rum; Sherbet; Smoked fish; Stout; Tomato catsup; Whisky; Wine; Wine vinegar

25.1(B)

PART B Foods DIVISION 1 Nutrition Labelling

(3)

A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)

Section B.01.462

Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 2

(1)

Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Pickles; Pineapple marmalade with pectin; Relishes; Sherbet; Smoked fish; Tomato catsup

25.2(B)

3

(3)

A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)

25.3(B)

4

(4)

Salted anchovy, salted scad and salted shrimp

25.4(B)

PART 3 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(4)

15% (Residues of caramel in sausage prepared with such casings not to exceed 0.15%)

26.1(B)

2

(2)

300 p.p.m. singly or in combination in accordance with section B.26.002 Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

26.2(B)

SOR/2003-11, s. 20; SOR/2016-305, ss. 37, 74. [SOR/2016-305, s. 38] TABLE PART 1 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

4 | Brilliant Blue FCF | (1) Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Pickles; Pineapple marmalade with pectin; Relishes; Sherbet; Smoked fish; Tomato catsup | (1) 100 p.p.m. singly or in combination in accordance with section B.06.002

| (3) A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n) | (3) 100 p.p.m. singly or in combination in accordance with section B.06.002 Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Emulsifying, Gelling, Stabilizing and Thickening Agents Item No. | Additive | Permitted in or Upon | Maximum Level of Use A.1 | Acacia Gum | (1) Cream; French dressing; (naming the flavour) Milk; Mustard pickles; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids;

27.1(E) and (F)

2

(2)

Ice cream; Ice cream mix; Ice milk; Ice milk mix

27.2(E) and (F)

3

(5)

0.5% in accordance with the requirements of section B.09.017 A.2 | Acetylated Mono-glycerides | Unstandardized foods | Good Manufacturing Practice

27.3(E) and (F)

4

(3)

0.024% as consumed A.4 | Agar | (1) Brawn; Canned (naming the poultry); Cream; Headcheese; Meat binder or (naming the meat product) binder where sold for use in prepared meat or prepared meat by-product in which a gelling agent is a permitted ingredient; Meat by-product loaf; Meat loaf; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jelly with pectin; Potted meat; Potted meat by-product; Prepared fish or prepared meat (Division 21); Relishes

27.4(E) and (F)

5

(2)

Ice cream; Ice cream mix; Ice milk; Ice milk mix Item No. Additive Permitted in or Upon

27.5(E) and (F)

6

(1)

Ale; Beer; Cream; French dressing; Malt liquor; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Porter; Relishes; Salad dressing; Stout

27.6(E) and (F)

Condition of use PART 2 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(3)

Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix

28.1(B)

2

(9)

Infant formula based on isolated amino acids or protein hydrolysates, or both

28.2(B)

3

(10)

Lactose-free infant formula based on milk protein

28.3(B)

4

(5)

0.5% in accordance with the requirements of section B.09.017

28.4(B)

SOR/2003-11, s. 20; SOR/2016-305, ss. 39, 74. [SOR/2016-305, s. 40] ---

(6)

0.5% in accordance with the requirements of section B.09.017

PARTIE 2

Modèle composé bilingue — différents types d’aliments — bébés âgés d’au moins six mois mais de moins d’un an Colonne 1 Figure du Répertoire des modèles de TVN (Article (version)) Colonne 2 Condition d’utilisation

(10)

0.05% as consumed. If used in combination with carrageenan or guar gum or both, the total not to exceed 0.05% Same foods as listed for Algin Same foods as listed for Algin Same foods as listed for Carrageenan Same foods as listed for Furcelleran Permitted in or Upon

Article

1

(1)

Bread; Cream; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Relishes

28.1(B)

(éléments nutritifs figurant en caractères d’au moins 8 points) 2

(2)

Ice Cream; Ice cream mix; Ice milk; Ice milk mix Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use C.1 | Calcium Alginate | Same foods as listed for Algin | Same levels as prescribed for Algin C.4 | Calcium Citrate | (1) Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) | (1) 0.4%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4 C.5 | Calcium Furcelleran | Same foods as listed for Furcelleran | Same levels as prescribed for Furcelleran C.9 | Calcium Phosphate, dibasic | (1) Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) | (1) 3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4 Current to November 11, 2024 Last amended on June 17, 2024 Item No. | Additive Permitted in or Upon

28.2(B)

(éléments nutritifs figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3

(6)

A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n) Same foods as listed for Sodium Carboxymethyl Cellulose

28.3(B)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4

(1)

Cream; French dressing; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Relishes; Salad dressing

28.4(B)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. [DORS/2003-11, art. 20; DORS/2016-305, art. 39 et 74.] Modèle composé — différentes quantités d’aliments — bébés âgés d’au moins six mois mais de moins d’un an [DORS/2016-305, art. 40] B.01.464 (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive de tout produit préemballé destiné exclusivement aux bébés âgés d’au moins six mois mais de moins d’un an qui indique des renseignements distincts en fonction de différentes quantités de l’aliment, tel qu’il est prévu au paragraphe B.01.406(8), est présenté en l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(2)

Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix

(2)

Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté :... TABLE PART 1 Column 1 Figure in Directory of NFT Formats (Version) Column 2 Condition of use Item 1

(7)

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients)

29.1(E) and (F)

2

(1)

Ale; Beer; Brawn; Canned (naming the poultry); Cream; French dressing; Headcheese; (naming the fruit) Jelly with pectin; Light beer; Malt liquor; Meat binder (when sold for use in prepared meat or prepared meat by-products in which a gelling agent is a permitted ingredient); Meat by-product loaf; Meat loaf; (naming the flavour) Milk; Mustard pickles; Porter; Potted meat; Potted meat by-product; Prepared fish or prepared meat (Division 21); Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids; Stout Same levels as prescribed for Sodium Carboxymethyl Cellulose

29.2(E) and (F)

3

(3)

0.5% in accordance with the requirements of paragraph B.09.017(b) Item No. Additive Permitted in or Upon Same foods as listed for Sodium Carboxymethyl Cellulose

29.3(E) and (F)

4

(1)

Infant formula based on crystalline amino acids or protein hydrolysates, or both Same levels as prescribed for Sodium Carboxymethyl Cellulose

29.4(E) and (F)

5

(1)

0.155% as consumed

29.5(E) and (F)

a) soit selon le modèle composé bilingue prévu aux figures 30.5(B) ou 30.6(B) du Répertoire des modèles de TVN; b) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible.

(3)

0.5% in accordance with the requirements of section B.09.017 Item No. Additive Permitted in or Upon

(3)

Pour l’application du présent article, afin d’établir si une version d’un tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement pour chaque quantité d’aliment pour laquelle des renseignements distincts y sont indiqués. TABLEAU

(2)

Aspics; Unstandardized fruit spreads; Unstandardized processed fruit products

PARTIE 1

Modèle composé — différentes quantités d’aliments — bébés âgés d’au moins six mois mais de moins d’un an Colonne 1 Figure du Répertoire des modèles de TVN (version) Colonne 2 Condition d’utilisation

(3)

Calorie-reduced margarine; Reduced fat spreads Item No. Additive Permitted in or Upon

Article

1

(1)

Bread; Cream; French dressing; Mince­meat; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Relishes; Salad dressing

29.1(F) et (A)

(éléments nutritifs figurant en caractères d’au moins 8 points) 2

(2)

Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix

29.2(F) et (A)

(éléments nutritifs figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3

(9)

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients)

29.3(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4

(10)

Infant formula based on isolated amino acids or protein hydrolysates, or both

29.4(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 5

(11)

Lactose-free infant formula based on milk protein

29.5(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins PART B Foods DIVISION 1 Nutrition Labelling

(3)

0.03% as consumed. If used in combination with algin or carrageenan or both, the total not to exceed 0.03%

Section B.01.464

Column 1 Item Figure in Directory of NFT Formats (Version) 6

(6)

0.5% in accordance with the requirements of section B.09.017

29.6(E) and (F)

Column 2 Condition of use PART 2 Column 1 Item Figure in Directory of NFT Formats (Version) 1

(10)

0.1% as consumed. If used in combination with algin or carrageenan or both, the total not to exceed 0.05%

30.1(B)

2

(11)

0.05% as consumed. If used in combination with algin or carrageenan or both, the total not to exceed 0.05% Permitted in or Upon Same foods as listed for Acacia Gum Same level as prescribed for Acacia Gum H.1 Hydroxylated Lecithin Permitted in or Upon Permitted in or Upon Permitted in or Upon

30.2(B)

3

(1)

French dressing; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids; Salad dressing Item No. | Additive Permitted in or Upon Same foods as listed for Carrageenan

30.3(B)

4

(1)

French dressing; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids; Salad dressing

30.4(B)

Column 2 Condition of use SOR/2003-11, s. 20; SOR/2016-305, ss. 41, 74. [SOR/2016-305, s. 42] Règlement sur les aliments et drogues

(2)

Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix

PARTIE B Aliments

(5)

0.5% in accordance with the requirements of section B.09.017 L.1 | Lactylated Mono- and Di-glycerides

TITRE 1

Étiquetage nutritionnel

(1)

0.8% (except that the total combined mono- and di-glycerides and lactylated mono- and di-glycerides must not exceed 20.0% of the shortening)

Article B.01.464

Colonne 1

(1)

Bread; Cream; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids

Article

Figure du Répertoire des modèles de TVN (version) 6

(2)

Ice Cream; Ice cream mix; Ice milk; Ice milk mix

29.6(F) et (A)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Colonne 2 Condition d’utilisation Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

(8)

Processed (naming the variety) cheese; Processed (naming the added ingredients) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

PARTIE 2

Modèle composé bilingue — différentes quantités d’aliments — bébés âgés d’au moins six mois mais de moins d’un an Colonne 1

(10)

Chocolate products; Cocoa products

Article

Figure du Répertoire des modèles de TVN (version) 1

(2)

0.5%, singly or in combination with other emulsifiers

30.1(B)

(éléments nutritifs figurant en caractères d’au moins 8 points) 2

(3)

0.03% as consumed Item No. | Additive M.5 | Mono- and Di-glycerides Permitted in or Upon L.3 | Same foods as listed for Carob Bean Gum

30.2(B)

(éléments nutritifs figurant en caractères d’au moins 7 points) 3

(2)

Chocolate products; Cocoa products

30.3(B)

(éléments nutritifs figurant en caractères étroits d’au moins 7 points) 4

(12)

Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

30.4(B)

(éléments nutritifs figurant en caractères étroits d’au moins 6 points) Colonne 2 Condition d’utilisation La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. DORS/2003-11, art. 20; DORS/2016-305, art. 41 et 74. Présentation des renseignements complémentaires — bébés âgés d’au moins six mois mais de moins d’un an [DORS/2016-305, art. 42] SOR/2003-11, s. 20; SOR/2016-305, ss. 43, 74. B.01.466 (1) Despite section A.01.016, the nutrition facts table of a prepackaged product that meets the condition specified in subsection B.01.454(3) or B.01.455(3), paragraph B.01.457(2)(b), subsection B.01.461(3) or B.01.462(3) or paragraph B.01.463(2)(b) may be set out on (a) a tag attached to the package; (b) a package insert; B.01.465 (1) Le présent article s’applique à tout produit préemballé destiné exclusivement aux bébés âgés d’au moins six mois mais de moins d’un an.

(2)

Chocolate products; Cocoa products L.3 | Same levels as prescribed for Carob Bean Gum M.1 | 0.3%, calculated as the anhydrous salt

(2)

Les renseignements visés à la colonne 1 du tableau de l’article B.01.402 qui sont inclus dans une version du tableau de la valeur nutritive se composant d’un tableau en anglais et d’un tableau en français ou d’un tableau en anglais ou en français, sont présentés : a) selon l’ordre de présentation, les retraits et les notes complémentaires indiqués aux figures 33.1(F) et (A) du Répertoire des modèles de TVN; b) quant aux autres caractéristiques de présentation, selon le modèle prévu à la figure applicable du Répertoire des modèles de TVN.

(5)

0.25% as consumed

(3)

Les renseignements visés à la colonne 1 du tableau de l’article B.01.402 qui sont inclus dans une version du tableau de la valeur nutritive se composant d’un tableau en anglais et en français sont présentés : a) selon l’ordre de présentation, les retraits et les notes complémentaires indiqués à la figure 34.1(B) du Répertoire des modèles de TVN; b) quant aux autres caractéristiques de présentation, selon le modèle prévu à la figure applicable du Répertoire des modèles de TVN.

(9)

10.0% (except that the total combined mono and diglycerides and lactylated mono and diglycerides must not exceed 20.0% of the shortening)

(4)

Malgré l’alinéa (2)a), les retraits indiqués aux figures 33.1(F) et (A) du Répertoire des modèles de TVN ne s’appliquent pas si les renseignements visés à la colonne 1 du tableau de l’article B.01.402 sont présentés selon le modèle linéaire visé à l’alinéa B.01.461(3)c) ou le modèle linéaire simplifié visé à l’alinéa B.01.462(3)c). DORS/2003-11, art. 20; DORS/2016-305, art. 43 et 74. Autres modes de présentation B.01.466 (1) Malgré l’article A.01.016, le tableau de la valeur nutritive d’un produit préemballé qui répond aux critères mentionnés aux paragraphes B.01.454(3) ou B.01.455(3), à l’alinéa B.01.457(2)b), aux paragraphes B.01.461(3) ou à l’alinéa B.01.462(3)b) peut être placé sur, selon le cas : a) une étiquette mobile attachée à l’emballage; b) une notice d’accompagnement; (c) the inner side of a label; (d) a fold-out label; or (e) an outer sleeve, overwrap or collar. SOR/2003-11, s. 20; SOR/2018-69, s. 3(F). Small Packages (a) described in paragraph B.01.401(3)(a), (b) or (e); or (i) the list of ingredients, (iii) a declaration referred to in subsection B.01.010.4(1), or (iv) any statement referred to in subsection B.01.014(1); and (iv) displayed in a colour contrasting with the background of the label.

(5)

0.25% as consumed

(3)

An indication referred to in subsection (1) (c) shall be (a) without charge; (iv) est d’une couleur faisant contraste avec le fond de l’étiquette.

(9)

10.0% (except that the total combined mono and diglycerides and lactylated mono and diglycerides must not exceed 20.0% of the shortening) Item No. Additive Permitted in or Upon

(3)

Les indications visées au paragraphe (1) répondent aux critères suivants : a) elles sont présentées en caractères d’au moins 8 points; b) elles comportent une adresse postale ou un numéro de téléphone sans frais; c) elles figurent : (i) soit en français et en anglais, (ii) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette du produit aux termes du présent règlement peuvent l’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci.

(12)

Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

(4)

Le fabricant du produit préemballé fournit les renseignements visés au paragraphe (1) à l’acheteur ou au consommateur sur demande : a) sans frais; b) de la façon suivante : (i) soit dans la langue officielle dans laquelle les renseignements sont demandés ou, à la demande de l’acheteur ou du consommateur, dans les deux langues officielles, (ii) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette du produit aux termes du présent règlement peuvent l’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci; c) sous forme d’un tableau de la valeur nutritive qui est présenté, à la fois : (i) selon un modèle — autre qu’un modèle horizontal — qui est prévu à l’un des articles B.01.454 à B.01.459 et B.01.461 à B.01.464 et qui, autrement, figurerait sur l’étiquette du produit conformément au présent règlement, (ii) selon l’une des versions de ce modèle figurant à la colonne 1 de l’article 1 de toute partie du tableau de l’article applicable visé au sous-alinéa (i). SOR/2003-11, s. 20; SOR/2016-305, s. 45; SOR/2018-108, s. 400; SOR/2022-168, s. 15. SOR/2016-305, s. 45. SOR/2016-305, s. 45. [B.01.470 to B.01.499 reserved] Nutrient Content Claims Interpretation

(1)

Edible vegetable oil-based cookware coating emulsions

(5)

Dans le présent article, langues officielles s’entend du français et de l’anglais. DORS/2003-11, art. 20; DORS/2016-305, art. 45; DORS/2018-108, art. 400; DORS/2022-168, art. 15. B.01.468 (1) Sous réserve du paragraphe (2), si un produit préemballé a une surface exposée disponible de moins de 100 cm² et porte un tableau de la valeur nutritive sur son étiquette, ce tableau peut ne contenir que les renseignements suivants : a) la portion indiquée; b) la valeur énergétique et, sous réserve du paragraphe (2), la teneur en tout élément nutritif visé à la colonne 1 des articles 2 à 15 du tableau de l’article B.01.401 qui ne peut être exprimée par « 0 » au tableau de la valeur nutritive selon les règles d’écriture indiquées dans la colonne 4; c) la teneur en un polyalcool, en une vitamine ou en un minéral nutritif ajoutés au produit.

(1)

Apple (or rhubarb) and (naming the fruit) Jam; Cream; Fig marmalade; Fig marmalade with pectin; French dressing; Mince-meat; Mustard pickles; (naming the citrus fruit) Marmalade with pectin; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Pineapple marmalade; Pineapple marmalade with pectin; Relishes; Salad dressing

(2)

Lorsqu’une déclaration expresse ou implicite contenant les renseignements visés à la colonne 1 des tableaux des articles B.01.401 ou B.01.402 est faite sur l’étiquette d’un produit préemballé ou dans une publicité de ce produit faite par le fabricant du produit ou sous ses ordres, ces renseignements sont aussi mentionnés dans le tableau de la valeur nutritive. DORS/2016-305, art. 45. B.01.469 Malgré le paragraphe B.01.401(1), l’étiquette d’un produit préemballé dont la surface exposée disponible est de moins de 15 cm² peut ne pas porter de tableau de la valeur nutritive. DORS/2016-305, art. 45. [B.01.470 à B.01.499 réservés] Allégations relatives à la teneur nutritive Définitions B.01.500 (1) Les définitions qui suivent s’appliquent au présent article et au Tableau des mentions et des allégations autorisées concernant la teneur nutritive. aliment de référence du même groupe alimentaire Aliment qui peut être substitué, dans l’alimentation, à l’aliment auquel il est comparé et qui appartiennent, selon le cas : a) au même groupe alimentaire que l’aliment auquel il est comparé, tel que le fromage comme aliment de (d) vegetables and fruit. (groupe alimentaire) (d) beverages, such as water, tea, coffee or soft drinks; and (c) the category of combination foods, if the food to which it is compared also belongs to that category, such as pizza as a reference food for lasagna. (aliment de référence du même groupe alimentaire) SOR/2003-11, s. 20; SOR/2007-302, s. 4(F); SOR/2022-168, s. 52. Languages B.01.501 The representations provided for in sections B.01.503 to B.01.513 that appear on the label of a food shall be SOR/2003-11, s. 20. Statements or Claims

(2)

Ice cream; Ice cream mix; Ice milk; Ice milk mix

(2)

Subsection (1) does not apply to (d) a representation that characterizes the amount of lactose in a food; SOR/2003-11, s. 20; SOR/2008-108, s. 396; SOR/2022-143, s. 19; SOR/2022-168, s. 16; SOR/2022-168, s. 52. (a) “reduced in saturated fatty acids”, set out in item 20; (a) “source of protein”, set out in item 8; (b) “excellent source of protein”, set out in item 9; (c) “more protein”, set out in item 10; (d) “no added sodium or salt”, set out in item 35; or --- annonce est faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres, l’étiquette ou l’annonce indique, par portion indiquée, le cas échéant, conformément aux articles B.01.505 ou B.01.506 : (i) soit la valeur énergétique, si l’objet de la mention ou de l’allégation est la valeur énergétique, (ii) soit la teneur en l’élément nutritif en cause, si l’objet de la mention ou de l’allégation est un élément nutritif. (1.1) Malgré le paragraphe (1), est interdite, dans l’espace principal du produit préemballé, toute mention ou toute allégation figurant dans la colonne 4 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive liée à un élément nutritif visé par le symbole nutritionnel figurant dans cet espace, sauf si la mention ou l’allégation est faite à l’égard de l’un des sujets ci-après figurant dans la colonne 1 : a) « teneur réduite en acides gras saturés » visé à l’article 20; b) « teneur réduite en sodium ou en sel » visé à l’article 33; c) « teneur réduite en sucres » visé à l’article 38.

(3)

Edible vegetable oil-based pan coating emulsions for use on baking pans

(2)

Malgré le paragraphe (1), est interdite, sur l’étiquette ou dans l’annonce d’un aliment destiné exclusivement aux enfants âgés de moins de quatre ans, toute mention ou toute allégation figurant dans la colonne 4 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive, sauf si la mention ou l’allégation est faite à l’égard de l’un des sujets ci-après figurant dans la colonne 1 : a) « source de protéines » visé à l’article 8; b) « excellente source de protéines » visé à l’article 9; c) « plus de protéines » visé à l’article 10; d) « non additionné de sel ou de sodium » visé à l’article 35; e) « non additionné de sucres » visé à l’article 40. (2.01) Malgré les paragraphes (1) et (2), est interdite, sur l’étiquette ou dans l’annonce d’un fortifiant pour lait humain, toute mention ou toute allégation figurant à la colonne 4 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive. SOR/2003-11, s. 20; SOR/2016-305, ss. 46, 76(F); SOR/2021-57, s. 10; SOR/2022-168, s. 52. SOR/2003-11, s. 20; SOR/2022-168, s. 52. SOR/2003-11, s. 20; SOR/2022-168, s. 52. (d) “reduced in trans fatty acids”, set out in item 23; (f) “reduced in sodium or salt”, set out in item 33; (g) “lightly salted”, set out in item 36; SOR/2003-11, s. 20; SOR/2022-168, s. 52. une personne agissant sous ses ordres, les renseignements requis en vertu des critères mentionnés à l’alinéa a) de la colonne 3 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive à l’égard des sujets visés aux alinéas (1)a) à i) sont mentionnés dans l’annonce.

(3)

Pickles and relishes

(3)

Si les renseignements requis en vertu des critères mentionnés à la colonne 3 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive et les renseignements requis par l’alinéa B.01.503(1)c) sont mentionnés dans une annonce radiophonique ou dans la composante audio d’une annonce télévisée, ces renseignements doivent suivre immédiatement la mention ou l’allégation.

(3)

2.0% in accordance with the requirements of paragraph B.09.017(c)

(4)

Dans le cas d’une annonce télévisée, les renseignements requis en vertu des critères mentionnés à la colonne 3 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive et, le cas échéant, les renseignements requis par l’alinéa B.01.503(1)c) sont communiqués, selon le cas : a) en mode audio, si la mention ou l’allégation fait partie uniquement de la composante audio de l’annonce ou à la fois des composantes audio et visuelle de l’annonce; b) en mode audio ou en mode visuel, si la mention ou l’allégation fait partie uniquement de la composante visuelle de l’annonce.

(1)

0.1%. If Polyoxyethylene (20) sorbitan tristearate is also used, the total must not exceed 0.1%

(5)

Les renseignements requis en vertu des critères mentionnés à la colonne 3 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive et les renseignements requis par l’alinéa B.01.503(1)c) qui sont communiqués en mode visuel dans une annonce télévisée, le sont de la façon suivante : a) paraissent en même temps et pendant au moins la même durée que la mention ou l’allégation; b) précèdent ou suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence; c) figurent en caractères d’une taille au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence. DORS/2003-11, art. 20; DORS/2022-168, art. 52. B.01.507 Est permise, sur l’étiquette ou dans l’annonce d’un aliment, toute déclaration, expresse ou implicite, (a) “free of energy”, set out in item 1; (d) “lower in energy”, set out in item 4; or (e) “free of sugars”, set out in item 37. SOR/2003-11, s. 20; SOR/2022-168, s. 52. (a) “free of sodium or salt”, set out in item 31; (b) “low in sodium or salt”, set out in item 32; (d) “lower in sodium or salt”, set out in item 34. SOR/2003-11, s. 20; SOR/2022-168, s. 18; SOR/2022-168, s. 52. selon laquelle l’aliment est conçu pour un régime à teneur réduite en énergie si une mention ou une allégation figurant à la colonne 4 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard de l’un des sujets ci-après figurant à la colonne 1 est faite sur l’étiquette ou dans l’annonce conformément à l’article B.01.503 : a) « sans énergie » visé à l’article 1; b) « peu d’énergie » visé à l’article 2; c) « énergie réduite » visé à l’article 3; d) « moins d’énergie » visé à l’article 4; e) « sans sucres » visé à l’article 37. DORS/2003-11, art. 20; DORS/2022-168, art. 52. B.01.508 (1) Est permise, sur l’étiquette ou dans l’annonce d’un aliment, toute déclaration, expresse ou implicite, selon laquelle l’aliment est conçu pour un régime à teneur réduite en sodium si une mention ou une allégation figurant à la colonne 4 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard de l’un des sujets ci-après figurant à la colonne 1 est faite sur l’étiquette ou dans l’annonce conformément à l’article B.01.503 : a) « sans sodium ou sans sel » visé à l’article 31; b) « faible teneur en sodium ou en sel » visé à l’article 32; c) « teneur réduite en sodium ou en sel » visé à l’article 33; d) « moins de sodium ou de sel » visé à l’article 34.

(4)

0.4% of the beverage. If sorbitan monostearate is also used the total Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

(2)

Malgré le paragraphe (1), est interdite, dans l’espace principal d’un produit préemballé, toute déclaration, expresse ou implicite, selon laquelle le produit est conçu pour un régime à teneur réduite en sodium si un symbole nutritionnel à l’égard du sodium paraît dans cet espace. DORS/2003-11, art. 20; DORS/2022-168, art. 18; DORS/2022-168, art. 52. B.01.509 (1) Est permise, sur l’étiquette ou dans l’annonce d’un aliment, la mention ou l’allégation « non sucré » si les conditions ci-après sont réunies : a) l’aliment répond aux critères mentionnés à l’article 40 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive relatifs, dans la colonne 2, au sujet « Non additionné de sucres » figurant dans la colonne 1; SOR/2003-11, s. 20; SOR/2022-168, s. 19. (a) “source of protein”, set out in item 8; (c) “more protein”, set out in item 10. SOR/2003-11, s. 20; SOR/2022-168, s. 52. SOR/2003-11, s. 20; SOR/2022-168, s. 52. SOR/2003-11, s. 20; SOR/2022-168, s. 52. Sensory Characteristic SOR/2003-11, s. 20; err. (F), Vol. 137, No. 5; SOR/2007-176, s. 6; SOR/2016-305, ss. 75(F), 80(F); SOR/2018-108, s. 39; SOR/2022-185, s. 20. [B.01.514 to B.01.599 reserved] Health Claims Languages SOR/2003-11, s. 20. (ii) figure en caractères d’une taille qui est au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence; c) si la mention ou l’allégation « léger » ou « light » est faite dans une annonce radiophonique ou dans la composante audio d’une annonce télévisée, la caractéristique organoleptique doit se suivre immédiatement la mention ou l’allégation; d) si la mention ou l’allégation « léger » ou « light » est faite dans la composante visuelle d’une annonce télévisée, la caractéristique organoleptique doit (i) paraître en même temps et pendant la même durée que la mention ou l’allégation, (ii) précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence, (iii) figure en caractères d’une taille au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence.

(5)

0.1%. If Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristearate or Sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.4%.

(2)

Le paragraphe (1) ne s’applique pas à la mention ou l’allégation « léger » ou « light » faite à l’égard du rhum. DORS/2003-11, art. 20; err. (F), vol. 137, no 5; DORS/2007-176, art. 6; DORS/2016-305, art. 75(F), 80(F); DORS/2018-108, art. 39; DORS/2022-185, art. 20. [B.01.514 à B.01.599 réservés] Allégations relatives à la santé Langues B.01.600 Toute mention ou allégation mentionnée à la colonne 1 du tableau suivant l’article B.01.603 faite sur l’étiquette d’un aliment figure : a) soit en français et en anglais; b) soit dans l’une de ces langues si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette de l’aliment aux termes du présent règlement peuvent être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci. DORS/2003-11, art. 20. Statements or Claims SOR/2003-11, s. 20; SOR/2022-168, s. 21. SOR/2003-11, s. 20. b) dans le cas d’une annonce radiophonique ou de la composante audio d’une annonce télévisée, ils précèdent ou suivent immédiatement la mention ou l’allégation figurant à la colonne 1; c) dans le cas d’une annonce télévisée, ils sont communiqués : (i) en mode audio, si la mention ou l’allégation figurant à la colonne 1 fait partie uniquement de la composante audio de l’annonce ou, à la fois, des composantes audio et visuelle de celle-ci, (ii) en mode audio ou en mode visuel, si la mention ou l’allégation figurant à la colonne 1 fait partie uniquement de la composante visuelle de l’annonce.

(6)

0.05%. If Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristearate or Sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.4%.

(2)

Les renseignements qui sont communiqués en mode visuel dans une annonce télévisée conformément au sous-alinéa (1)c)(ii), à la fois : a) paraissent en même temps et pendant au moins le même laps de temps que la mention ou l’allégation; b) précèdent ou suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence; c) figurent en caractères d’une taille au moins égale et aussi bien en vue que ceux de la mention ou allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence. DORS/2003-11, art. 20. B.01.603 (1) Il est entendu que toute mention ou allégation figurant à la colonne 1 du tableau suivant le présent article, faite sur l’étiquette ou dans l’annonce d’un aliment, ne peut être entrecoupée d’autres mots, chiffres, signes ou symboles, mais peut en être précédée ou suivie.

(7)

0.5% of the finished cake icing. If Polyoxyethylene (20) sorbitan monostearate, or Sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.5% of the finished cake icing.

(2)

Si un aliment répond aux critères mentionnés à la colonne 2 du tableau suivant le présent article pour plus d’un article de ce tableau, la répétition de l’élément commun, dans les mentions ou les allégations figurant à la colonne 1 faites sur l’étiquette ou dans l’annonce de l’aliment, n’est pas nécessaire et les éléments dissemblables peuvent être unis au moyen d’une conjonction ou d’un signe de ponctuation, selon le cas. TABLE Column 1 Item Statement or Claim Column 2 Conditions — Food Column 3 Conditions — Label or Advertisement 1 The food (d) meets the conditions set out in column 2 of item 32 of the Table of Permitted Nutrient Content Statements and Claims for the subject "low in sodium or salt" set out in column 1, if the label of or advertisement for the food carries statement of claim (1), (3) or (5) set out in column 1 of this item; (g) contains 350 mg or more of potassium, if the label of or advertisement for the food carries statement of claim (3), (4), (5) or (6) set out in column 1 of this item. 2 The food (d) contains, if the label of or advertisement for the food carries statement or claim (1) or (2) set out in column 1 of this item, (e) contains, if the label of or advertisement for the food carries statement or claim (3), (4), (5) or (6) set out in column 1 of this item, (a) the nutrition facts table in accordance with subsection B.01.402(2); or The food (d) contains 0.5% or less alcohol; (i) column 2 of item 25 of the Table of Permitted Nutrient Content Statements and Claims for the subject "source of omega-3 polyunsaturated fatty acids" set out in column 1, (ii) column 2 of item 26 of the Table of Permitted Nutrient Content Statements and Claims for the subject "source of omega-6 polyunsaturated fatty acids" set out in column 1, or (iii) subparagraphs (i) and (ii); The food (i) a fresh, frozen, canned or dried vegetable, (ii) a fresh, frozen, canned or dried fruit, (iii) a vegetable or fruit juice, or Column 1 Item Statement or Claim

(12)

Spice oils and spice oleoresins for use in pumping pickle employed in the curing of preserved meat or preserved meat by-product (Division 14)

4.1

5

(18)

Good Manufacturing Practice. Residues of Polysorbate 80 must not exceed 0.3% in the finished food

(1)

"Won’t cause cavities."

(1)

0.4%. If Polyoxyethylene (20) sorbitan tristearate, Sorbitan monostearate or Polyoxyethylene (20) sorbitan mono-oleate, either singly or in combination is also used, the total must not exceed 0.4%, except that in the case of whipped vegetable oil topping a combination of Polysorbate 60 and Sorbitan monostearate may be used in excess of 0.4%, if the amount of the Polysorbate 60 does not exceed Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

(2)

"Does not promote tooth decay." Column 2 Conditions — Food The food (i) a fresh, frozen, canned or dried vegetable, (ii) a fresh, frozen, canned or dried fruit, (iii) a vegetable juice or vegetable drink, or (iii) jams or jam-type spreads, marmalades, preserves and jellies, (iv) olives, (vi) powdered vegetables or fruit, or Column 3 Conditions — Label or Advertisement Column 1 Item Statement or Claim

0.77% and the amount of Sorbitan monostearate does not exceed 0.27% of the whipped vegetable oil topping

(4)

"Non-cariogenic." Column 2 Conditions — Food (a) contains 0.25% or less starch, dextrins, mono-, di- and oligosaccharides or other fermentable carbohydrates or other fermentable carbohydrates combined; or Column 3 Conditions — Label or Advertisement (a) the nutrition facts table, in accordance with subsection B.01.402(2); or TABLEAU Colonne 1

(2)

Cakes | (2) 0.5% on a dry weight basis. If Polyoxyethylene (20) sorbitan tristearate is also used, the total must not exceed 0.5% on a dry weight basis

Article

Mention ou allégation 1

(3)

Cakes; Cake mixes | (3) 0.5% on a dry weight basis. If Sorbitan monostearate is also used, the total must not exceed 0.7% on a dry weight basis

(1)

« Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de maladie du cœur. (Nom de l’aliment) ne contient pas de sodium. »

(4)

Unstandardized confectionery coatings and unstandardized moulded confectionery products for use as confectionery or in baking | (4) 0.5%. If any combination of Polyoxyethylene (20) sorbitan tristearate, Sorbitan monostearate or Sorbitan tristearate are all used the total must not exceed 1.0%

(2)

« Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de maladie du cœur. (Nom de l’aliment) est pauvre en sodium. »

(5)

Cake icing; Cake icing mix | (5) 0.5% of the finished cake icing. If Sorbitan monostearate or Polyoxyethylene (20) sorbitan monooleate either singly or in combination is also used, the total must not exceed 0.5% of the finished cake icing

(3)

« Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de maladie du cœur. (Nom de l’aliment) est une bonne source de potassium et ne contient pas de sodium. »

(7)

Unstandardized beverage bases; Unstandardized beverage mixes | (7) 0.05% of the flavour. If Sorbitan monostearate is also used the total must not exceed 0.05% of the beverage

(4)

« Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de maladie du cœur. (Nom de l’aliment) est une bonne source de potassium et est pauvre en sodium. »

(1)

(Naming the flavour) Milk; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids | (1) 0.5%

(5)

« Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de maladie du cœur. (Nom de l’aliment) est une excellente source de potassium et ne contient pas de sodium. »

(2)

Ice cream; Ice cream mix; Ice milk; Ice milk mix; Sherbet | (2) 0.1%. If Polyoxyethylene (20) sorbitan mono-oleate is also used, the total must not exceed 0.1%

(6)

« Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de maladie du cœur. (Nom de l’aliment) est une excellente source de potassium et est pauvre en sodium. » Colonne 2 Critères — aliments L’aliment : a) autre qu’un légume ou un fruit, ne répond pas aux critères mentionnés à la colonne 2 de l’article 2 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « peu d’énergie » visé à la colonne 1; b) contient au moins 10 % de l’apport nutritionnel recommandé pondéré d’une vitamine ou d’un minéral nutritif, selon le cas : (i) par portion indiquée, si l’aliment est un repas préemballé, (ii) par quantité de référence et portion indiquée, si l’aliment n’est pas un repas préemballé; c) répond aux critères mentionnés à la colonne 2 de l’article 19 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « faible teneur en acides gras saturés » visé à la colonne 1; d) contient au plus 0,5 % d’alcool; e) l’étiquette ou l’annonce comporte les mentions ou allégations (1), (3) ou (5) figurant à la colonne 1 du présent article, répond aux critères mentionnés à la colonne 2 de l’article 31 du Tableau des mentions et des allégations autorisées concernant la teneur en sodium visé à la colonne 1; f) dont l’étiquette ou l’annonce comporte les mentions ou allégations (2), (4) ou (6) figurant à la colonne 1 du présent article, répond aux critères mentionnés à la colonne 2 de l’article 31. Colonne 3 Critères — étiquette ou annonce Si la mention ou l’allégation est faite sur l’étiquette ou dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé par une personne autre que le fabricant ou une personne agissant sous ses ordres, l’étiquette ou l’annonce indique que l’aliment est une bonne source de potassium par portion indiquée et, le cas échéant, conformément à l’article B.01.602. Toutefois, cette exigence ne s’applique pas si la mention ou l’allégation est faite sur l’étiquette ou dans l’annonce d’un légume, d’un fruit frais ou d’un mélange quelconque de fruits frais ou de fruits frais sans ajout d’ingrédient, d’une orange à laquelle un colorant alimentaire a été ajouté et d’un légume frais enduit d’une couche d’huile minérale, de paraffine, de cire ou d’un mélange de ces substances. PART B Foods DIVISION 1 Health Claims

(4)

Cakes | (4) 0.3% on a dry weight basis. If Polyoxyethylene (20) sorbitan monostearate is also used, the total must not exceed 0.5% on a dry weight basis Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

Section B.01.603

Règlement sur les aliments et drogues

(5)

Unstandardized confectionery coatings | (5) 0.5%. If any combination of Polyoxyethylene (20) sorbitan monostearate, Sorbitan monostearate, or Sorbitan tristearate are also used, the total must not exceed 1.0%.

PARTIE B Aliments

(6)

Unstandardized beverage bases; Unstandardized beverage mixes | (6) 0.05% of the beverage. If Sorbitan monostearate is also used, the total must not exceed 0.05% of the beverage.

TITRE 1

Allégations relatives à la santé

(7)

Imitation dry cream mix; Vegetable oil creaming agent; Whipped vegetable oil topping; Vegetable oil topping mix | (7) 0.4%. If Polyoxyethylene (20) sorbitan monostearate, Sorbitan monostearate or Polyoxyethylene (20) sorbitan mono-oleate, either singly or in combination is also used, the total must not exceed 0.4%. P.6 | Potassium Alginate | Same foods as listed for Algin | Same levels as prescribed for Algin. P.9 | Potassium Citrate | (1) Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) | (1) 4.0%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4. P.10 | Potassium Furcellaran | Same foods as listed for Furcellaran | Same levels as prescribed for Furcellaran. P.11 | Potassium Phosphate, dibasic | (1) Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) | (1) 3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4. | (2) Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix | (2) Good Manufacturing Practice. | (5) Calorie-reduced margarine | (5) 0.5% in accordance with the requirements of section B.09.017. Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use P.13 | Propylene Glycol Ether of Methylcellulose | Same foods as listed for Hydroxypropyl Methylcellulose | Same levels as prescribed for Hydroxypropyl Methylcellulose S.1 | Sodium Acid Pyrophosphate | (1) Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) | (1) 3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4 S.2 | Sodium Alginate | (1) Same foods as listed for Algin | (1) Same levels as prescribed for Algin S.2A | Sodium Aluminum Phosphate | (1) Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) | (1) 3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4 S.3 | Sodium Carboxymethyl Cellulose | (1) Cream; French dressing; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Relishes; Salad dressing | (1) Good Manufacturing Practice Current to November 11, 2024 Last amended on June 17, 2024 Item No. Additive Permitted in or Upon Same foods as listed for Carrageenan Same foods as listed for Sodium Carboxymethyl Cellulose Same levels as prescribed for Sodium Carboxymethyl Cellulose

Article B.01.603

Colonne 1

(1)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

Article

Mention ou allégation Colonne 2 Critères — aliments Colonne 3 Critères — étiquette ou annonce 2

(2)

Evaporated milk; evaporated skim milk or concentrated skim milk; evaporated partly skimmed milk or concentrated partly skimmed milk

(1)

« Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une bonne source de calcium. »

(3)

Ice cream; Ice cream mix; Ice milk; Ice milk mix Same foods as listed for Furcelleran Same levels as prescribed for Furcelleran

(2)

« Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une source élevée de calcium. »

(1)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use S.9 | Sodium Hexameta- phosphate | cheese spread; Processed cheese spread with (naming the added ingredients)

(3)

« Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une excellente source de calcium. »

(3)

Infant formula | (3) 0.05% as consumed

(4)

« Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une bonne source de vitamine D. »

(6)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) | (6) 3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4 S.11 | Sodium Phosphate, dibasic | (1) Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Relishes | (1) Good Manufacturing Practice

(5)

« Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une excellente source de vitamine D. »

(3)

Evaporated milk; evaporated skim milk or concentrated skim milk; evaporated partly skimmed milk or concentrated partly skimmed milk | (3) 0.1% singly or in combination with sodium citrate

(6)

« Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une source élevée de calcium et de vitamine D. » 32 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « faible teneur en sodium ou en sel » visé à la colonne 1; g) dont l’étiquette ou l’annonce comporte les mentions ou allégations (3), (4), (5) ou (6) figurant à la colonne 1 du présent article, contient 350 mg ou plus de potassium, selon le cas : (i) par quantité de référence et portion indiquée, (ii) par portion indiquée, si l’aliment est un repas prémélangé. L’aliment : a) autre qu’un légume ou un fruit, ne répond pas aux critères mentionnés à la colonne 2 de l’article 2 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « source de calcium » visé à la colonne 1, b) est une source de phosphore, autre que le phosphore lié par le phytate, que de calcium; c) contient au plus 0,5 % d’alcool; d) dont l’étiquette ou l’annonce comporte les mentions ou allégations (1) ou (2) figurant à la colonne 1 du présent article, contient, selon le cas : (i) 200 mg ou plus de calcium par quantité de référence et par portion indiquée, (ii) 300 mg ou plus de calcium par portion indiquée, si l’aliment est un repas prémélangé; e) dont l’étiquette ou l’annonce comporte les mentions ou allégations (3), (4), (5) ou (6) figurant à la colonne 1 du présent article, contient, selon le cas : (i) 275 mg ou plus de calcium par quantité de référence et par portion indiquée, (ii) 400 mg ou plus de calcium par portion indiquée, si l’aliment est un repas prémélangé; f) dont l’étiquette ou l’annonce comporte les mentions ou allégations (1), (2), (3), (4), (5) ou (6) figurant à la colonne 1 du présent article, contient 1,5 µg ou plus de vitamine D, selon le cas : (i) par quantité de référence et portion indiquée, (ii) par portion indiquée, si l’aliment est un repas prémélangé.

(6)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) | (6) 3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4 S.12 | Sodium Phosphate, monobasic | (1) Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the | (1) 3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041 Item No. Additive Permitted in or Upon

(1)

Si la mention ou l’allégation figure sur l’étiquette d’un produit prémélangé ou dans l’annonce d’un tel produit faite par le fabricant du produit ou sous ses ordres, la teneur en vitamine D et en phosphore indiquée, selon le cas : a) est conforme aux valeurs nutritives conformément au paragraphe B.02.002(1), en ce qui a trait à la norme prévue à la colonne 3 de l’article 2 du Tableau des normes de composition visées à la colonne 3 de l’article B.29.002, ou au paragraphe B.29.003(3), au besoin, selon le cas.

(1)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

(2)

Si la mention ou l’allégation est faite sur l’étiquette d’un produit prémélangé ou dans l’annonce d’un tel produit faite par le fabricant du produit ou sous ses ordres, la teneur en vitamine D et en phosphore indiquée, selon le cas, est conforme aux valeurs nutritives conformément au paragraphe B.01.402(2). PART B Foods DIVISION 1 Health Claims

(1)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

Section B.01.603

Règlement sur les aliments et drogues

(1)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

PARTIE B Aliments

(3)

A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)

TITRE 1

Allégations relatives à la santé

(3)

0.2% of the finished product

Article B.01.603

Colonne 1

(7)

0.35% of the finished product

Article

Mention ou allégation Colonne 2 Critères — aliments Colonne 3 Critères — étiquette ou annonce l’aliment) et une source très élevée de calcium et de vitamine D. » 3

(1)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

(1)

« Une alimentation saine pauvre en graisses saturées et en graisses trans peut réduire le risque de maladie du cœur. (Nom de l’aliment) ne contient pas de graisses saturées ni de graisses trans. »

(8)

0.4% of the finished product

(2)

« Une alimentation saine pauvre en graisses saturées et en graisses trans peut réduire le risque de maladie du cœur. (Nom de l’aliment) est pauvre en graisses saturées et en graisses trans. » L’aliment : a) autre qu’un légume ou un fruit, ne répond pas aux critères mentionnés à la colonne 2 de l’article 2 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « et qui répondent au sujet » à la colonne 1 ; b) contient moins de 10 % de l’apport nutritionnel recommandé pondéré d’une vitamine ou d’un minéral nutritif, selon le cas : (i) par quantité de référence et de portion indiquée, (ii) par portion indiquée, si l’aliment est un repas préemballé ; c) contient moins de 100 mg de cholestérol par 100 g de l’aliment ; d) ne contient pas d’acides gras trans ; e) contient des acides gras saturés en une quantité qui ne dépasse pas l’une des limites suivantes : (i) ceux mentionnés à la colonne 2 de l’article 25 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « source d’acides gras polyinsaturés oméga-3 » visé à la colonne 1, (ii) ceux mentionnés à la colonne 2 de l’article 26 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « source d’acides gras polyinsaturés oméga-6 » visé à la colonne 1, (iii) ceux prévus aux sous-alinéas (i) et (ii) ; f) contient, selon le cas : (i) au plus 480 mg de sodium par quantité de référence et de portion indiquée, si la quantité de référence est de plus de 30 g ou 30 mL, (ii) au plus 960 mg de sodium par portion indiquée, si l’aliment est un repas préemballé ; g) dont l’étiquette ou l’annonce comporte la mention ou l’allégation (1) figurant à la colonne 1 du présent article, selon les critères mentionnés à la colonne 2 de l’article 18 du Tableau des mentions et des allégations Si la mention ou l’allégation est faite sur l’étiquette ou dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres, l’étiquette ou l’annonce indique la teneur en acides gras saturés et en acides gras trans par portion indiquée et par 100 g de l’aliment, conformément à l’article B.01.602. Toutefois, cette exigence ne s’applique pas si la mention ou l’allégation est faite sur l’étiquette ou dans l’annonce d’un légume frais, d’un fruit frais ou d’une viande maigre fraîche sans ingrédient ajouté, d’une volaille à laquelle la couche cornée alimentaire a été retirée, d’un légume ou d’un fruit frais enduit d’une huile d’olive, de margarine, de beurre, de persil ou de tout autre produit protecteur. PART B Foods DIVISION 1 Health Claims

(9)

0.2% of the finished product A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)

Section B.01.603

Règlement sur les aliments et drogues

(3)

Unstandardized confectionery coatings and unstandardized moulded confectionery products for use as confectionery or in baking

PARTIE B Aliments

(1)

0.4%. If Polyoxyethylene (20) sorbitan tristearate, Polysorbate 60 or Polyoxyethylene (20) sorbitan monooleate, either singly or in combination is also used, the total must not exceed 0.4%, except that in whipped vegetable oil topping a combination of Sorbitan monostearate and Polysorbate 60 may be used in excess of 0.4% if the amount of Sorbitan monostearate does not exceed 0.27% and the amount of Polysorbate 60 does not exceed 0.77% of the weight of the whipped vegetable oil topping

TITRE 1

Allégations relatives à la santé

(2)

0.6% on a dry weight basis. If Polyoxyethylene (20) sorbitan monostearate is also used, the total must not exceed 0.7% on a dry weight basis

Article B.01.603

Colonne 1

(3)

1.0%. If any combination of Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristearate or Sorbitan tristearate are also used, the total must not exceed 1.0%

Article

Mention ou allégation Colonne 2 Critères — aliments Colonne 3 Critères — étiquette ou annonce autorisées concernant la teneur nutritive en regard du sujet « sans acides gras saturés » visé à la colonne 1; h) dont l’étiquette ou l’annonce comportant la mention ou l’allégation (2) figurant à la colonne 1 du présent article, répond aux critères mentionnés à la colonne 2 de l’article 19 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « faible teneur en acides gras saturés » visé à la colonne 1. 4 « Une alimentation saine comportant une grande variété de légumes et de fruits peut aider à réduire le risque de certains types de cancer. » L’aliment : a) est un des légumes, fruits ou jus ci-après et ne peut contenir que les additifs alimentaires visés à l’article 2 d’une autorisation de mise en marché, des agents édulcorants, du sel, des fines herbes, des épices, des assaisonnements ou de l’eau : (i) un légume frais, congelé ou en conserve ou déshydraté, (ii) un fruit frais, congelé ou en conserve ou sec, (iii) un jus de légume ou de fruit, (iv) une combinaison des aliments mentionnés aux sous-alinéas (i) à (iii); b) n’est pas : (i) une pomme de terre, une igname, du manioc, une banane plantain, du maïs, un champignon, une légumineuse mature ou leur jus, (ii) un légume ou un fruit utilisé comme condiment, garniture ou aromatisant, notamment une cerise au marasquin, un fruit glacé ou confit ou de l’oignon en flocons, (iii) une confiture ou une tartinade de type confiture, une marmelade, une conserve de fruit ou une gelée, (iv) une olive; (v) un légume ou fruit en poudre; c) contient au plus 0,5 % d’alcool.

(4)

0.5% of the finished cake icing. If Polyoxyethylene (20) sorbitan monooleate or Polyoxyethylene (20) sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.5% of the finished cake icing

4.1

« Une alimentation saine comportant une grande variété de légumes et de fruits peut aider à réduire le risque de maladie du cœur. » L’aliment : a) est l’un des légumes ou fruits ci-après et ne peut contenir que les additifs alimentaires visés à l’article 2 d’une autorisation de mise en marché, du sel, des fines herbes, des épices, des assaisonnements ou de l’eau : PART B Foods DIVISION 1 Health Claims

(5)

0.05% of the beverage. If Polyoxyethylene (20) sorbitan monooleate is also used, the total must not exceed 0.05% of the beverage. If Polyoxyethylene (20) sorbitan monostearate is also used, the total must not exceed 0.05% of the beverage. If Polyoxyethylene (20) Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use S.18A | Sorbitan trioleate | Sausage casings | 0.35% of the casing

Section B.01.603

Règlement sur les aliments et drogues

(2)

Unstandardized confectionery coatings and unstandardized moulded confectionery products for use as a confectionery or in baking | (2) 1.0% If any combination of Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristearate or Sorbitan monostearate are also used, the total must not exceed 1.0%

PARTIE B Aliments

(3)

Ice cream mix | (3) 0.035% of the ice cream made from the mix

TITRE 1

Allégations relatives à la santé

(2)

Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix | (2) 0.5% in accordance with the requirements of section B.09.017

Article B.01.603

Colonne 1

(8)

Comminuted prepared fish or prepared meat, other than lumpfish caviar; Comminuted preserved fish or preserved meat (Division 21) | (8) 0.75% Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

Article

Mention ou allégation Colonne 2 Critères — aliments Colonne 3 Critères — étiquette ou annonce (i) un légume frais, congelé, en conserve ou déshydraté, (ii) un fruit frais, congelé, en conserve ou sec, (iii) un jus de légumes ou une boisson aux légumes, (iv) une combinaison quelconque des aliments mentionnés aux sous-alinéas (i) à (iii); b) n’est pas ou ne contient pas l’un des aliments suivants : (i) une pomme de terre, une igname, du manioc, une banane plantain, une légumineuse mature ou leur jus, (ii) un légume ou un fruit utilisé comme condiment, garniture ou aromatisant, notamment une cerise au marasquin, un fruit glacé ou confit ou de l’oignon en flocons, (iii) une confiture ou une tartinade de type confiture, une marmelade, une gelée ou une gelée de fruits, (iv) une olive, (v) un jus de fruits ou une boisson aux fruits, (vi) un légume ou fruit en poudre, (vii) une graine d’un fruit connu comme un drupe, notamment une amande, une noix de cajou et de la noix de coco; c) contient au plus 0,5 % d’alcool; d) contient moins de 15 % de la valeur quotidienne de sodium par quantité de référence, par portion indiquée et, si la quantité de référence est d’au plus 30 g ou 30 ml, par 50 g. 5

(4)

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients)

(1)

« Ne cause pas la carie dentaire. »

(9)

Cream for whipping, heat-treated above 100°C

(2)

« Ne favorise pas la carie dentaire. »

(2)

0.5% or, if used in combination with other stabilizing agents, the total amount of the combined stabilizers shall not exceed 0.5%

(3)

« Ne favorise pas les caries dentaires. »

(3)

0.5% in accordance with the requirements of section B.09.017

(4)

« Non cariogène. » L’aliment est une gomme à mâcher, un bonbon ou un autre rafraîchisseur d’haleine qui répond à l’un ou l’autre des critères suivants : a) il ne contient, au total, pas plus de 0,25 % d’amidon, de dextrines, de monosaccharides, de disaccharides, d’oligosaccharides ou d’autres glucides fermentescibles; b) il contient moins de 0,25 % de glucides fermentescibles et il ne réduit pas le pH de la plaque à moins de 5,7 par fermentation bactérienne pendant 30 minutes après avoir été consommé, le pH étant mesuré selon le test « individual plaque pH » décrit dans « Identification of Low Caries Risk Dietary Components », Monographs in Si la mention ou l’allégation figure sur l’étiquette d’un produit préemballé ou encore dans l’annonce d’un tel produit faite par le fabricant du produit ou sous ses ordres, le produit ne peut porter la mention ou l’allégation, selon le cas : a) si la teneur de la valeur nutritive conformément au paragraphe B.01.402(2); b) dans le tableau des renseignements sur les aliments supplémentaires mentionné au paragraphe B.29.003(3). PART B Foods DIVISION 1 Health Claims Sections B.01.603-B.02.002 DIVISION 2 Alcoholic Beverages B.02.002 In this Division, absolute alcohol means alcohol of a strength of 100 per cent; (alcool absolu) Règlement sur les aliments et drogues

(6)

0.1% or, if used in combination with microcrystalline cellulose and other stabilizers, the total amount of combined stabilizers shall not exceed 0.5%

PARTIE B Aliments

(7)

0.1% or, if used in combination with other stabilizers, the total amount of combined stabilizers shall not exceed 0.5%

TITRE 1

Allégations relatives à la santé

(8)

0.1% or, if used in combination with other stabilizers, the total amount of combined stabilizers shall not exceed 0.75% Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Food Enzymes Item No. Additive Permitted Source Permitted in or Upon

Articles B.01.603-B.02.002

(2)

Dairy based flavouring preparations

TITRE 2

Boissons alcooliques B.02.001 L’expression boissons alcooliques vise notamment les aliments mentionnés dans le présent titre. B.02.002 Les définitions qui suivent s’appliquent au présent titre. âge Période durant laquelle une boisson alcoolique est conservée dans les conditions d’emmagasinage nécessaires pour développer sa saveur et son bouquet caractéristiques. (âge) agent édulcorant Le glucose-fructose, le sirop de fructose ou tout aliment qui fait l’objet d’une norme énoncée au titre 18, ou une combinaison de ces produits. (sweetening agent) alcool Alcool éthylique. (alcool) alcool absolu Alcool à 100 pour cent. (absolute alcohol) esprit de grain Distillat alcoolique obtenu à partir d’un moût de céréales ou de produits de céréales saccharifié par la diastase du malt ou par d’autres enzymes et fermenté au moyen de levure ou d’un mélange de levure et d’autres micro-organismes, et dont les substances naturellement présentes, autres que l’alcool et l’eau, ont été complètement ou presque complètement éliminées. (grain spirit) esprit de malt Distillat alcoolique obtenu, par distillation à l’alambic chauffé à feu nu, d’un moût de céréales ou de produits de céréales saccharifié par la diastase du malt et fermenté au moyen de levure ou d’un mélange de levure et d’autres micro-organismes. (esprit de malt) esprit de mélasse Distillat alcoolique obtenu à partir de la canne à sucre ou de produits de la canne à sucre fermentés au moyen de levure ou d’un mélange de levure et d’autres micro-organismes, et dont les substances small wood means wood casks or barrels of not greater than 700 L capacity; (petit fût) SOR/84-300, s. 10; SOR/93-145, s. 4. SOR/88-418, s. 1; SOR/93-145, s. 5(F); SOR/2019-147, s. 1. SOR/2019-147, s. 1. Whisky SOR/93-145, s. 6; SOR/93-603, s. 2. B.02.011 and B.02.012 [Repealed, SOR/93-145, s. 7] B.02.013 [S]. Malt Whisky SOR/93-145, s. 8. B.02.014 and B.02.015 [Repealed, SOR/93-145, s. 9] (a) blending with other Scotch whisky, (a) blending with other Irish whisky, d’un moût de céréales ou de produits de céréales saccharifié par la diastase du malt ou par d’autres enzymes et fermenté au moyen de levure ou d’un mélange de levure et d’autres micro-organismes; b) peut contenir du caramel et des substances aromatiques. DORS/93-145, art. 6; DORS/93-603, art. 2. B.02.011 et B.02.012 [Abrogés, DORS/93-145, art. 7] B.02.013 [N]. Le whisky de malt: a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu par la distillation d’un moût de grain malté qui a été fermenté au moyen de levure ou d’un mélange de levure et d’autres micro-organismes; b) doit posséder l’arôme, le goût et les caractéristiques communément attribués au whisky de malt; c) peut contenir du caramel et des substances aromatiques. DORS/93-145, art. 8. B.02.014 et B.02.015 [Abrogés, DORS/93-145, art. 9] B.02.016 [N]. Le whisky écossais doit être du whisky qui a été distillé en Écosse comme whisky écossais pour la consommation domestique, conformément aux lois du Royaume-Uni. B.02.017 Est interdit tout mélange ou toute modification de whisky écossais importé en vrac aux fins d’embouteillage et de vente au Canada comme whisky écossais, sauf a) le mélange avec d’autre whisky écossais; b) l’addition d’eau distillée ou autrement purifiée pour porter le whisky au degré alcoolique requis; ou c) l’addition de caramel. B.02.018 [N]. Le whisky irlandais doit être du whisky distillé en Irlande du Nord ou dans la République d’Irlande pour la consommation domestique, conformément aux lois de l’Irlande du Nord ou de la République d’Irlande. B.02.019 Est interdit tout mélange ou toute modification de whisky irlandais importé en vrac aux fins d’embouteillage et de vente au Canada comme whisky irlandais, sauf a) le mélange avec d’autre whisky irlandais; B.02.020 [S]. (1) Canadian Whisky, Canadian Rye Whisky or Rye Whisky (a) shall SOR/93-145, s. 10; SOR/2000-51, s. 1. B.02.021 [S]. Highland Whisky (ii) whisky; and SOR/89-59, s. 2; SOR/93-145, s. 11(F). SOR/93-603, s. 3. SOR/93-145, art. 12; SOR/93-603, s. 4. Rum B.02.030 [S]. Rum (b) may contain: (i) caramel, SOR/93-145, s. 13; SOR/2012-292, s. 1. SOR/84-657, s. 1; SOR/93-145, s. 13. B.02.032 [Repealed, SOR/93-145, s. 14] B.02.033 [Repealed, SOR/2012-292, s. 2] B.02.034 [Repealed, SOR/2012-292, s. 2] Gin B.02.040 [S]. Hollands, Hollands Gin, Geneva, Geneva Gin, Genever, Genever Gin or Dutch-type Gin (a) shall be a potable alcoholic beverage obtained (ii) caramel; (c) shall not contain more than two per cent sweetening agent; SOR/93-145, s. 15. (a) shall be a potable alcoholic beverage obtained (ii) a sweetening agent, and (iii) a flavouring preparation for the purpose of maintaining a uniform flavour profile; (i) soit par la redistillation de l’esprit de malt avec ou sur des baies de genévrier ou par le mélange des produits de plus d’une telle redistillation, (ii) soit par la redistillation d’un mélange d’esprit de malt et d’au plus quatre fois le même volume d’esprit de grain en alcool absolu avec ou sur des baies de genévrier, ou par le mélange des produits de plus d’une telle redistillation, (iii) soit par le mélange d’esprit de malt redistillé avec ou sur des baies de genévrier et d’au plus quatre fois le même volume d’esprit de grain ou d’esprit de mélasse en alcool absolu, ou par une combinaison de plus d’un tel mélange; b) peut contenir : (i) d’autres substances végétales aromatiques ajoutées pendant la redistillation, (ii) du caramel; c) ne peut contenir plus de deux pour cent d’agent édulcorant; d) peut être étiqueté ou annoncé comme étant distillé lorsque l’un des sous-alinéas a)(i) ou (ii) est respecté; e) doit être désigné comme génévrier mélangé sur l’espace principal de l’étiquette et dans la publicité lorsque le sous-alinéa a)(iii) est respecté. DORS/93-145, art. 15. B.02.041 [N]. Le gin, à l’exclusion du genièvre Hollands, genièvre, gin type hollandais ou gros gin : a) doit être une boisson alcoolique potable obtenue : (i) soit par la redistillation d’alcool dérivé de matières premières alimentaires avec ou sur des baies de genévrier, ou par le mélange des produits de plus d’une telle redistillation, (ii) soit par le mélange d’alcool dérivé de matières premières alimentaires redistillé avec ou sur des baies de genévrier et d’alcool dérivé de matières premières alimentaires, ou par une combinaison de plus d’un tel mélange; b) peut contenir : (i) d’autres substances végétales aromatiques ajoutées pendant la redistillation, (ii) un agent édulcorant, (iii) un agent aromatisant pour maintenir un profil aromatique uniforme; SOR/93-145, s. 15. B.02.042 [Repealed, SOR/93-145, s. 15] Brandy (i) caramel, (iii) flavouring and flavouring preparations. SOR/84-300, s. 12; SOR/93-145, s. 16. SOR/93-145, s. 16. B.02.052 [S]. Canadian Brandy (i) caramel, (iii) flavouring and flavouring preparations. SOR/93-145, s. 16. (iii) des préparations aromatisantes pour assurer un profil aromatique uniforme; c) peut être étiqueté et annoncé comme Dry Gin ou London Dry Gin lorsqu’aucun agent édulcorant n’y a été ajouté. DORS/93-145, art. 15. B.02.042 [Abrogé, DORS/93-145, art. 15] B.02.043 Est interdite toute déclaration sur l’âge du genièvre, mais dans le cas du genièvre qui a été conservé dans des récipients appropriés, l’étiquette peut porter une déclaration à cet effet. Eau-de-vie B.02.050 [N]. L’eau-de-vie de vin (brandy), à l’exclusion de l’armagnac, du brandy canadien, du brandy de fruits, du brandy de fruits secs, du brandy de lies, du cognac, de la grappa et du marc : a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu par la distillation du vin; b) peut contenir : (i) du caramel, (ii) des fruits et d’autres substances végétales, (iii) des substances aromatiques et des préparations aromatisantes. DORS/84-300, art. 12; DORS/93-145, art. 16. B.02.051 [N]. L’armagnac doit être de l’eau-de-vie de vin (brandy) fabriquée dans la région d’Armagnac, en France, conformément aux lois de la République française pour la consommation en France. DORS/93-145, art. 16. B.02.052 [N]. Le brandy canadien : a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu par la distillation du vin qui a été fermenté au Canada; b) peut contenir : (i) du caramel, (ii) des fruits et d’autres substances végétales, (iii) des substances aromatiques et des préparations aromatisantes. DORS/93-145, art. 16. SOR/93-145, s. 16. B.02.054 [S]. Dried Fruit Brandy (i) caramel, (iii) flavouring and flavouring preparations. SOR/93-145, s. 16. B.02.055 [S]. Fruit Brandy (i) caramel, SOR/93-145, s. 16. B.02.056 [S]. Grappa (i) caramel, (iii) flavouring and flavouring preparations. SOR/93-145, s. 16. B.02.057 [S]. Lees Brandy (i) caramel, SOR/93-145, s. 16. B.02.058 [S]. Pomace or Marc (i) caramel, SOR/93-145, s. 16. (a) blending with other imported brandy; SOR/84-300, s. 13(F); SOR/93-145, s. 16. SOR/93-145, s. 16. Liqueurs and Spirituous Cordials B.02.070 [S]. Liqueur or Spirituous Cordial (d) may contain (ii) colour. SOR/93-145, s. 16. Vodka SOR/93-145, s. 16; SOR/2019-217, s. 1. Tequila SOR/93-603, s. 5. Mezcal Wine B.02.100 [S]. Wine (i) yeast, (iii) dextrose, fructose, glucose or glucose solids, invert sugar, sugar, or aqueous solutions of any of them, (A) citric acid, fumaric acid, lactic acid, malic acid, potassium bicarbonate, potassium carbonate, potassium citrate and tartaric acid, at a maximum level of use consistent with good manufacturing practice, (B) metatartaric acid at a maximum level of use of 0.01 per cent, and (C) potassium acid tartrate at a maximum level of use of 0.42 per cent, (A) activated carbon, albumen, casein, clay, diatomaceous earth, egg-white, isinglass, polyvinylpolypyrrolidone and silicon dioxide, (B) oxygen, (xix) nitrogen, and (C) tartrate acide de potassium, selon une limite de tolérance de 0,42 pour cent, (ix) d’amylase et de pectinase, selon les limites de tolérance conformes aux bonnes pratiques industrielles, (x) d’acide ascorbique ou de ses sels ou d’acide érythorbique ou de ses sels, selon les limites de tolérance conformes aux bonnes pratiques industrielles, (xi) d’agent antimousse, en conformité avec le tableau VIII de l’article B.16.100, (xii) de l’un ou plusieurs des agents de collage suivants : (A) albumine, argile, bioxyde de silicium, blanc d’œuf, caséine, charbon activé, colle de poisson, polyvinylpolypyrrolidone et terre de diatomées, (B) agar-agar, ferrocyanure de potassium, gélatine et gomme arabique, selon les limites de tolérance conformes aux bonnes pratiques industrielles, (C) acide tannique, selon une limite de tolérance de 200 parties par million, (D) polyvinylpyrrolidone, en une quantité ne dépassant pas 2 parties par million dans le produit fini, (xiii) de caramel, selon une limite de tolérance conforme aux bonnes pratiques industrielles, (xiv) d’eau-de-vie de vin (brandy), d’eau-de-vie de fruits, ou d’alcool obtenu par fermentation alcoolique de substances alimentaires puis par distillation jusqu’à produire d’alcool titrant au moins 94 pour cent en volume, (xv) de l’une ou plusieurs des substances suivantes : (A) anhydride carbonique et ozone, selon les limites de tolérance conformes aux bonnes pratiques industrielles, (B) oxygène, (xvi) d’acide sorbique ou de ses sels, n’excédant pas 500 parties par million, calculé en acide sorbique, SOR/82-768, s. 2; SOR/2006-91, s. 2. SOR/93-146, s. 17(F). B.02.106 [S]. Honey Wine (i) yeast; (ii) yeast foods; (A) 70 p.p.m. in the free state, or (iv) tartaric or citric acid; (v) potassium acid tartrate; (vi) natural botanical flavours; (viii) caramel; (ix) carbon dioxide; SOR/86-241, s. 1; SOR/2010-94, s. 9(E). SOR/84-300, s. 16(E). Cider B.02.120 [S]. Cider (a) shall (i) yeast, (ii) concentrated apple juice, (iii) sugar, dextrose, invert sugar, glucose, glucose solids, or aqueous solutions thereof, (iv) yeast foods, (vi) tartaric acid and potassium tartrate, (vii) citric acid, (viii) lactic acid, (x) ascorbic or erythorbic acid, or salts thereof, (A) activated carbon, (B) clay, (C) diatomaceous earth, (D) gelatin, (E) albumen, (F) sodium chloride, (G) silica gel. B.02.120 [N]. Le cidre a) doit (i) être le produit de la fermentation alcoolique du jus de pomme, et (ii) renfermer au moins 2,5 pour cent et au plus 13,0 pour cent d’alcool absolu en volume; et b) peut, en cours de fabrication, être additionné (i) de levure, (ii) de jus de pomme concentré, (iii) de sucre, de dextrose, de sucre inverti, de glucose, de solides de glucose ou de solutions aqueuses de n’importe lequel de ces sucres, (iv) de nourriture pour les levures, (v) d’acide sulfureux, y compris ses sels, en quantité telle que leur concentration dans le cidre fini ne dépasse pas (A) 70 parties par million à l’état libre, ou (B) 350 parties par million à l’état combiné, calculée en anhydride sulfureux, (vi) d’acide tartrique et de tartrate de potassium, (vii) d’acide citrique, (viii) d’acide lactique, (ix) de pectinase et amylase, (x) d’acide ascorbique ou érythorbique ou leurs sels, (xi) de n’importe lequel des agents de clarification suivants : (A) le charbon activé, (B) l’argile, (C) la terre d’infusoires, (D) la gélatine, (E) l’albumine, (F) le chlorure de sodium, (G) le gel de silice. (H) casein, (I) tannic acid not exceeding 200 parts per million, or (xii) caramel, (xiv) carbon dioxide, (xv) oxygen, (xvi) ozone, or SOR/81-565, s. 2; SOR/84-300, s. 17(E). SOR/84-300, s. 18. SOR/82-768, s. 3. Beer B.02.130 [S]. (1) Beer (i) cereal grain, (ii) honey, maple syrup, fruit, fruit juice or any other source of carbohydrates, (iii) herbs and spices, (iv) salt, (v) flavouring preparations, SOR/88-418, s. 2; SOR/92-92, s. 1; SOR/96-483, s. 1; SOR/2006-91, s. 3; SOR/2019-98, s. 3. B.02.131 [Repealed, SOR/2019-98, s. 4] TABLE Column I Column II Item 1

(3)

Hydrolyzed animal, milk and vegetable protein Food and Drug Regulations DIVISION 16 Food Additives Item No. Additive Permitted Source Permitted in or Upon Aqueous extracts from the fourth stomach of adult Cheddar cheese; Cottage cheese; Cream cheese; Food and Drug Regulations DIVISION 16 Food Additives Item No. Additive Permitted Source Bovine animals, sheep and goats Permitted in or Upon Cream cheese spread; Cream cheese spread with (naming the added ingredients); Cream cheese with (naming the added ingredients); (naming the variety) Cheese

1.1 to 2.5

Extra Light Beer 2

(4)

Hydrolyzed animal, milk and vegetable protein

2.6 to 4.0

Light Beer 3

(7)

Pumping pickle for the curing of beef cuts

4.1 to 5.5

Beer 4

(3)

Liquid whey treated with hydrogen peroxide in accordance with item H.1, Table VIII

5.6 to 8.5

Strong Beer 5 Extra Strong Beer SOR/88-418, s. 2; SOR/2019-98, s. 5. SOR/88-418, s. 3; SOR/88-418, s. 3. (i) hexane, (ii) carbon dioxide, or (iii) ethanol; and

(1)

Cheddar cheese; (naming the variety) cheese; Cottage cheese; Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream

(2)

For the purposes of paragraph (1)(b), the residues of hexane shall not exceed 1.5 parts per million per per cent iso-alpha acid content of the pre-isomerized hop extract. SOR/88-418, s. 4. (a) tetrahydroisohumulones derived from hops SOR/96-483, s. 2; SOR/2000-352, s. 1. DIVISION 3 Baking Powder (d) acid compounds of aluminum. SOR/82-768, s. 4; SOR/92-626, s. 12. DIVISION 4 **cocoa product** means a product derived from cocoa beans and includes cocoa nibs, cocoa liquor, cocoa mass, unsweetened chocolate, bitter chocolate, chocolate liquor, cocoa, low fat cocoa, cocoa powder and low fat cocoa powder. *(produit du cacao)* (ii) skim milk, (iv) sterilized milk, (vi) evaporated milk, (xiv) butter, and (xv) cream; and (iv) partly skimmed milk powder, (v) buttermilk, (vii) reconstituted cream. (ingrédient laitier) sweetening ingredient means any one or any combination of sweetening agents, except for icing sugar. (ingrédient édulcorant) SOR/97-263, s. 2. SOR/97-263, s. 2. (vii) lait écrémé évaporé ou écrémé concentré, (viii) lait évaporé partiellement écrémé ou lait concentré partiellement écrémé, (ix) poudre de lait, poudre de lait entier, lait entier desséché ou lait entier en poudre, (x) lait écrémé en poudre, poudre de lait écrémé desséché, (xi) lait écrémé additionné de solides du lait, (xii) lait partiellement écrémé additionné de solides du lait ou lait en partie écrémé additionné de solides du lait, (xiii) lait malté, lait malté en poudre, (xiv) beurre, (xv) crème; b) les produits suivants ne faisant pas l’objet d’une norme établie dans la présente partie : (i) lait ou lait entier reconstitué, (ii) lait écrémé reconstitué, (iii) lait partiellement écrémé reconstitué, (iv) lait partiellement écrémé en poudre, (v) babeurre, (vi) huile de beurre, (vii) crème reconstituée. (milk ingredient) produit de chocolat Produit dérivé d’un ou de plusieurs produits du cacao, y compris le chocolat, le chocolat mi-amer, le chocolat mi-sucré, le chocolat noir, le chocolat noir sucré, le chocolat au lait et le chocolat blanc. (chocolate product) produit du cacao Produit dérivé des fèves de cacao, y compris les fèves de cacao décortiquées, la liqueur de cacao, la pâte de cacao, le chocolat non sucré, le chocolat amer, la liqueur de chocolat, le cacao, le cacao faible en gras, la poudre de cacao et la poudre de cacao faible en gras. (cocoa product) DORS/97-263, art. 2. B.04.002 [N]. Les fèves de cacao sont les graines de Theobroma cacao L. ou d’une espèce très proche. DORS/97-263, art. 2. SOR/89-283, s. 2. B.04.004 [S]. Cocoa Liquor, Cocoa Mass, Unsweetened Chocolate, Bitter Chocolate or Chocolate Liquor shall (b) contain not less than 50 per cent cocoa butter. SOR/89-283, s. 2. (a) hydroxides of ammonia, carbonates of ammonia, bicarbonates of ammonia, hydroxides of sodium, carbonates of sodium, bicarbonates of sodium, hydroxides of potassium, carbonates of potassium or bicarbonates of potassium; (c) carbonates of calcium.

(7)

Good Manufacturing Practice in accordance with paragraph B.14.009(g) Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted Source | Permitted in or Upon | Maximum Level of Use | | | (3) Hydrolyzed animal, milk and vegetable protein | (3) Good Manufacturing Practice | | | (6) Pumping pickle for the curing of beef cuts | (6) Good Manufacturing Practice in accordance with paragraph B.14.009(g) Item No. Additive Permitted Source Permitted in or Upon

(2)

The quantity of any one pH-adjusting agent referred to in paragraphs (1)(a) to (c) shall not exceed the maximum level of use for that agent set out in column III of an item of Table X to section B.16.100. (a) phosphoric acid; (c) tartaric acid.

(2)

Good Manufacturing Practice in accordance with paragraphs B.22.034(b), B.22.035(b) and B.22.036(b)

(6)

For the purpose of subsection (5), SOR/89-263, s. 2; SOR/2012-43, s. 1. B.04.006 [S]. Chocolate, Bittersweet Chocolate, Semi-sweet Chocolate or Dark Chocolate (i) cocoa liquor, (iii) cocoa butter and cocoa powder; (ii) spices, (C) ammonium salts of phosphorylated glycerides, (D) polyglycerol esters of interesterified castor oil fatty acids, and (E) sorbitan monostearate. SOR/79-664, s. 2; SOR/97-263, s. 2. B.04.007 [S]. Sweet Chocolate (i) cocoa liquor, (iii) cocoa butter and cocoa powder; (ii) spices, (C) ammonium salts of phosphorylated glycerides, (D) polyglycerol esters of interesterified castor oil fatty acids, and (E) sorbitan monostearate. DORS/79-664, art. 2; DORS/97-263, art. 2. B.04.007 [N]. Le chocolat sucré : a) est constitué d’un ou plusieurs des éléments suivants, en combinaison avec un ingrédient édulcorant : (i) liqueur de cacao, (ii) liqueur de cacao et beurre de cacao, (iii) beurre de cacao et poudre de cacao; b) contient au moins 30 pour cent de solides du cacao totaux dont : (i) 18 pour cent sont du beurre de cacao, (ii) 12 pour cent sont des solides du cacao dégraissés; c) peut contenir : (i) moins de 12 pour cent de solides du lait totaux provenant d’ingrédients laitiers, (ii) des épices, (iii) des préparations aromatisantes pour équilibrer la saveur, sauf celles qui imitent la saveur du chocolat ou du lait, (iv) du sel, (v) les agents émulsifiants suivants, en quantité n’excédant pas, pour chacun de ces agents, les limites de tolérance prévues à la colonne III du tableau IV de l’article B.16.100 et, pour toute combinaison de ces agents, 1,5 pour cent en masse du produit de chocolat : (A) monoglycérides et mono- et diglycérides, (B) lécithine et lécithine hydroxylée, (C) sels d’ammonium de glycérides phosphorylés, (D) esters polyglycérides d’acides gras d’huile de ricin transestérifiée, (E) monostéarate de sorbitan. (C) ammonium salts of phosphorylated glycerides, (D) polyglycerol esters of interesterified castor oil fatty acids, and (E) sorbitan monostearate. SOR/97-263, s. 2. B.04.008 [S]. Milk Chocolate (i) cocoa liquor, (iii) cocoa butter and cocoa powder; (i) 25 per cent total cocoa solids, of which (ii) 12 per cent total milk solids from milk ingredients, and (iii) 3.39 per cent milk fat; and (ii) spices, (A) monoglycérides et mono- et diglycérides, (B) lécithine et lécithine hydroxylée, (C) sels d’ammonium de glycérides phosphorylés, (D) esters polyglycériques d’acides gras d’huile de ricin transestérifiée, (E) monostéarate de sorbitan. DORS/97-263, art. 2. B.04.008 [N]. Le chocolat au lait : a) est constitué d’un ou de plusieurs des éléments suivants, en combinaison avec un ingrédient édulcorant : (i) liqueur de cacao, (ii) liqueur de cacao et beurre de cacao, (iii) beurre de cacao et poudre de cacao; b) contient au moins : (i) 25 pour cent de solides du cacao totaux dont : (A) au moins 15 pour cent sont du beurre de cacao, (B) au moins 2,5 pour cent sont des solides du cacao dégraissés, (ii) 12 pour cent de solides du lait totaux provenant d’ingrédients laitiers, (iii) 3,39 pour cent de matières grasses du lait; c) peut contenir : (i) moins de 5 pour cent de petit-lait ou de produits du petit-lait, (ii) des épices, (iii) des préparations aromatisantes pour équilibrer la saveur, sauf celles qui imitent la saveur du chocolat ou du lait, (iv) du sel, (C) ammonium salts of phosphorylated glycerides, (D) polyglycerol esters of interesterified castor oil fatty acids, and (E) sorbitan monostearate. SOR/97-263, s. 2. B.04.009 [S]. White Chocolate (i) not less than 20 per cent cocoa butter, (ii) spices, (C) ammonium salts of phosphorylated glycerides, (D) polyglycerol esters of interesterified castor oil fatty acids, and (E) sorbitan monostearate. DORS/97-263, art. 2. B.04.009 [N]. Le chocolat blanc : a) est constitué des éléments suivants : (i) au moins 20 pour cent de beurre de cacao, (ii) au moins 14 pour cent de solides du lait total provenant d’ingrédients laitiers, (iii) au moins 3,5 pour cent de matières grasses du lait; b) peut contenir : (i) moins de 5 pour cent de petit-lait ou de produits du petit-lait, (ii) des épices, (iii) des préparations aromatisantes pour équilibrer la saveur, sauf celles qui imitent la saveur du chocolat ou du lait, (iv) du sel, (v) les agents émulsifiants suivants, en quantité n’excédant pas, pour chacun de ces agents, les limites de tolérance prévues à la colonne III du tableau IV de l’article B.16.100 et, pour toute combinaison de ces agents, 1,5 pour cent en masse du produit de chocolat : (A) monoglycérides et mono- et diglycérides, (B) lécithine et lécithine hydroxylée, (C) sels d’ammonium de glycéride phosphorylés, (D) esters polyglycérides d’acides gras d’huile de ricin transestérifiée, (E) monostéarate de sorbitan. (D) polyglycerol esters of interesterified castor oil fatty acids, and (E) sorbitan monostearate. SOR/97-263, s. 2. B.04.010 [S]. Cocoa or Cocoa Powder (i) spices, (iii) salt, and (C) ammonium salts of phosphorylated glycerides. SOR/82-768, s. 5; SOR/97-263, s. 2. B.04.011 [S]. Low Fat Cocoa or Low Fat Cocoa Powder (i) spices, (iii) salt, and (C) ammonium salts of phosphorylated glycerides. SOR/82-768, s. 5; SOR/97-263, s. 2. (iii) salt, and (C) ammonium salts of phosphorylated glyc-erides. SOR/82-768, s. 6; SOR/97-263, s. 2. SOR/97-263, s. 2. DIVISION 5 Coffee B.05.003 [S]. Decaffeinated (indicating the type of coffee) (ii) 0.3 per cent caffeine, in the case of decaffein-ated instant coffee; SOR/90-443, s. 1. DIVISION 6 Food Colours B.06.001 In this Division, official method FO-7 [Repealed, SOR/2016-305, s. 49] official method FO-8 [Repealed, SOR/2016-305, s. 49] official method FO-9 [Repealed, SOR/2016-305, s. 49] official method FO-10 [Repealed, SOR/2016-305, s. 49] official method FO-11 [Repealed, SOR/2016-305, s. 49] official method FO-12 [Repealed, SOR/2016-305, s. 49] official method FO-13 [Repealed, SOR/2016-305, s. 49] official method FO-14 [Repealed, SOR/2016-305, s. 49] official method FO-15 [Repealed, SOR/2016-305, s. 49] SOR/80-500, s. 2; SOR/84-440, s. 1; SOR/2016-305, s. 49. (a) 300 parts per million of Allura Red, Amaranth, Erythrosine, Indigotine, Sunset Yellow FCF or Tartrazine or any combination of those colours unless a higher maximum level of use is specified in column III of item 3 of Table III to section B.16.100; (d) 150 parts per million of Ponceau SX. SOR/80-500, s. 2; SOR/84-440, s. 2; SOR/86-178, s. 1(F); SOR/2007-75, s. 1. B.06.003 [Repealed, SOR/2016-305, s. 50] B.06.004 [Repealed, SOR/2016-305, s. 50] B.06.005 [Repealed, SOR/2016-305, s. 50] B.06.006 [Repealed, SOR/2016-305, s. 50] SOR/80-500, s. 2. B.06.008 [Repealed, SOR/2016-305, s. 51] B.06.009 to B.06.013 [Repealed, SOR/80-500, s. 2] B.06.021 [Repealed, SOR/2016-305, s. 52] B.06.022 [Repealed, SOR/2016-305, s. 52] B.06.023 [Repealed, SOR/2016-305, s. 52] B.06.024 [Repealed, SOR/2016-305, s. 52] B.06.025 [Repealed, SOR/2016-305, s. 52] B.06.031 [Repealed, SOR/2016-305, s. 52] B.06.032 [Repealed, SOR/2016-305, s. 52] B.06.033 [Repealed, SOR/2016-305, s. 52] B.06.041 [Repealed, SOR/2016-305, s. 53] B.06.042 [Repealed, SOR/2016-305, s. 53] B.06.043 [S]. Ponceau SX shall be the disodium salt of 2-(5-sulpho-2,4-xylylazo)-1-naphthol-4-sulphonic acid, shall contain not less than 85% dye and may contain not more than (a) 0.2% water insoluble matter; (b) 0.2% combined ether extracts; (c) 1.0% subsidiary dyes; (d) 0.5% intermediates; (e) 3 parts per million of arsenic; and (f) 10 parts per million of lead. SOR/82-768, s. 9; SOR/84-440, s. 3; SOR/2016-305, s. 54. B.06.044 [Repealed, SOR/2016-305, s. 54] B.06.045 [Repealed, SOR/2016-305, s. 54] B.06.046 [Repealed, SOR/2016-305, s. 54] B.06.049 [Repealed, SOR/2016-305, s. 54] B.06.050 [Repealed, SOR/2016-305, s. 54] B.06.051 [Repealed, SOR/2016-305, s. 54] (a) 0.5% volatile matter (at 100°C); (c) 0.3% water soluble matter; (d) 0.5% carbon tetrachloride insoluble matter; (e) 0.05% uncombined intermediates. (f) 2.0% subsidiary dyes; SOR/82-768, s. 12; SOR/84-440, s. 3; SOR/2016-305, s. 55. SOR/82-107, s. 3; SOR/84-440, s. 20; SOR/87-640, s. 2; SOR/2016-305, s. 56. B.06.062 [Repealed, SOR/82-768, s. 13] DIVISION 7 B.07.001 [S]. Allspice or Pimento, whole or ground, shall be the dried, full but unripe whole berries of Pimenta dioica (L) Merr. and shall contain (i) 25 per cent crude fibre, (ii) 5.5 per cent total ash, (iii) 0.4 per cent ash insoluble in hydrochloric acid, and (iv) 12 per cent moisture; and SOR/79-659, s. 1. (i) nine per cent total ash, (ii) one per cent ash insoluble in hydrochloric acid, and (iii) 10 per cent moisture; and B.07.003 [S]. Basil or Sweet Basil, whole or ground, shall be the dried leaves of Ocimum basilicum L. and shall contain (i) 15 per cent total ash, (ii) two per cent ash insoluble in hydrochloric acid, and (iii) nine per cent moisture; and (b) not less than 0.2 millilitre volatile oil per 100 grams of spice. SOR/79-659, s. 1. B.07.004 [S]. Bay Leaves or Laurel Leaves, whole or ground, shall be the dried leaves of Laurus nobilis L. and shall contain (i) 4.5 per cent total ash, (ii) 0.5 per cent ash insoluble in hydrochloric acid, and (iii) seven per cent moisture; and SOR/79-659, s. 1. (i) eight per cent total ash, (ii) one per cent ash insoluble in hydrochloric acid, and (iii) 11.5 per cent moisture; and SOR/79-659, s. 1. B.07.006 [S]. Cardamom or Cardamom Seed, bleached or green, whole or ground, shall be the dried (i) eight per cent total ash, (ii) three per cent ash insoluble in hydrochloric acid, and (iii) 13 per cent moisture; and SOR/79-659, s. 1. B.07.007 [S]. Cayenne Pepper or Cayenne, whole or ground, (a) shall be the dried ripe fruit of Capsicum frutescens L., Capsicum baccatum L., or other small-fruited species of Capsicum and shall contain not more than (i) 1.5 per cent starch, (ii) 28 per cent crude fibre, (iii) 10 per cent total ash, (iv) 1.5 per cent ash insoluble in hydrochloric acid, and (v) 10 per cent moisture; and SOR/79-659, s. 1; SOR/84-17, s. 2. B.07.008 [S]. Celery Salt (a) shall be a combination of SOR/79-659, s. 1. être le fruit mûr et desséché de l’Elettaria cardamomum Maton et doit renfermer a) au plus (i) huit pour cent de cendres totales, (ii) trois pour cent de cendres insolubles dans l’acide chlorhydrique, et (iii) 13 pour cent d’humidité; et b) au moins trois millilitres d’huile volatile par 100 grammes d’épice. DORS/79-659, art. 1. B.07.007 [N]. Le poivre de cayenne ou le cayenne, entier ou moulu, a) est le fruit mûr et desséché du Capsicum frutescens L., du Capsicum baccatum L., ou d’autres espèces de Capsicum portant de petits fruits et doit renfermer au plus (i) 1,5 pour cent d’amidon, (ii) 28 pour cent de cellulose brute, (iii) 10 pour cent de cendres totales, (iv) 1,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et (v) 10 pour cent d’humidité; et b) peut renfermer au plus deux pour cent de bioxyde de silicium en tant qu’agent anti-agglomérant. DORS/79-659, art. 1; DORS/84-17, art. 2. B.07.008 [N]. Le sel de céleri a) doit être un mélange (i) de graines de céleri moulu ou de céleri déshydraté moulu, et (ii) de sel en une quantité n’excédant pas 75 pour cent; et b) peut renfermer au plus 0,5 pour cent de bioxyde de silicium comme agent anti-agglomérant. DORS/79-659, art. 1. B.07.009 [N]. La graine de céleri, entière ou moulue, doit être la graine mûre et desséchée de l’Apium graveolens L. et doit renfermer a) au plus PART B Foods DIVISION 7 Spices, Dressings and Seasonings Sections B.07.008-B.07.013 (i) 12 per cent total ash, (ii) two per cent ash insoluble in hydrochloric acid, and (iii) 10 per cent moisture; and SOR/79-659, s. 1. B.07.010 [S]. Celery Pepper (a) shall be a combination of SOR/79-659, s. 1. B.07.011 [S]. Cinnamon or Cassia, whole or ground, shall be the dried bark of trees of the genus Cinnamomum of Species C. burmannii Blume, C. loureirii Nees or C. Cassia Blume and shall contain (i) six per cent total ash, (ii) two per cent ash insoluble in hydrochloric acid, and (iii) 13 per cent moisture; and SOR/79-659, s. 1. B.07.012 [S]. Ceylon Cinnamon, whole or ground, shall be cinnamon obtained exclusively from Cinnamomum zeylanicum Nees. SOR/79-659, s. 1. B.07.013 [S]. Cloves, whole or ground, shall be the dried unopened flower buds of Eugenia caryophyllus (Spreng) and shall contain (i) five per cent clove stems, (ii) six per cent total ash, PART B Foods DIVISION 7 Spices, Dressings and Seasonings Sections B.07.013-B.07.017 (iii) 0.5 per cent ash insoluble in hydrochloric acid, (iv) 10 per cent crude fibre, and (v) eight per cent moisture; and SOR/79-659, s. 1. (i) seven per cent total ash, (ii) one per cent ash insoluble in hydrochloric acid, and (iii) nine per cent moisture; and (b) not less than 0.3 millilitre volatile oil per 100 grams of spice. SOR/79-659, s. 1. (i) 9.5 per cent total ash, (ii) 1.5 per cent ash insoluble in hydrochloric acid, and (iii) nine per cent moisture; and SOR/79-659, s. 1. B.07.016 [S]. Curry Powder shall be any combination of (b) salt in an amount not exceeding five per cent. SOR/79-659, s. 1. B.07.017 [S]. Dill Seed, whole or ground, shall be the dried fruit of Anethum graveolens L., or Anethum sowa D.C. and shall contain Règlement sur les aliments et drogues

(1)

Glucose (glucose syrup) to be partially or completely isomerized to fructose Food and Drug Regulations DIVISION 16 Food Additives Item No. | Column I Additive | Column II Permitted Source | Column III Permitted in or Upon | Column IV Maximum Level of Use | | | (4) (naming the flavour) milk; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) malted milk; (naming the flavour) skimmed milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids | (4) Good Manufacturing Practice | | | (4) (naming the flavour) milk; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) malted milk; (naming the flavour) skim milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids | (4) Good Manufacturing Practice Food and Drug Regulations DIVISION 16 Food Additives Item No. | Column I Additive | Column II Permitted Source | Column III Permitted in or Upon | Column IV Maximum Level of Use | | | (3) Cheddar cheese; (naming the variety) Cheese; Processed cheddar cheese | (3) Good Manufacturing Practice | | | (6) Hydrolyzed animal, milk and vegetable protein | (6) Good Manufacturing Practice | | | (3) Dairy based flavouring preparations | (3) Good Manufacturing Practice | | | (4) Hydrolyzed animal, milk and vegetable protein | (4) Good Manufacturing Practice | | | (2) Dairy based flavouring preparations | (2) Good Manufacturing Practice Food and Drug Regulations DIVISION 16 Food Additives Item No. | Column I Additive | Column II Permitted Source | Column III Permitted in or Upon | Column IV Maximum Level of Use | | | (4) Hydrolyzed animal, milk and vegetable protein | (4) Good Manufacturing Practice Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Column II Permitted Source | Column III Permitted in or Upon | Column IV Maximum Level of Use | | | (3) Unstandardized fruit and vegetable products | (3) Good Manufacturing Practice | | | (2) Cheddar cheese; Cottage cheese; Cream cheese; Cream cheese spread; Cream cheese spread with (naming the added ingredients); Cream cheese with (naming the added ingredients); (naming the variety) Cheese | (2) Good Manufacturing Practice Food and Drug Regulations DIVISION 16 Food Additives Item No. | Column I Additive | Column II Permitted Source | Column III Permitted in or Upon | Column IV Maximum Level of Use Cheddar cheese; (naming the variety) Cheese P.6 Protease

PARTIE B Aliments

(3)

Dairy based flavouring preparations

TITRE 7 Épices, condiments et assaisonnements

(6)

Hydrolyzed animal, milk and vegetable protein

Articles B.07.013-B.07.017

(iii) 0,5 pour cent de cendres insolubles dans l’acide chlorhydrique, (iv) 10 pour cent de cellulose, et (v) huit pour cent d’humidité; et b) au moins 13 millilitres d’huile volatile par 100 grammes d’épice. DORS/79-659, art. 1. B.07.014 [N]. La coriandre ou la graine de coriandre, entière ou moulue, doit être la graine desséchée du Coriandrum sativum L. et doit renfermer a) au plus (i) sept pour cent de cendres totales, (ii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et (iii) neuf pour cent d’humidité; et b) au moins 0,3 millilitre d’huile volatile par 100 grammes d’épice. DORS/79-659, art. 1. B.07.015 [N]. Le cumin ou la graine de cumin, entier ou moulu, doit être la graine desséchée du Cuminum cyminum L. et doit renfermer a) au plus (i) 9,5 pour cent de cendres totales, (ii) 1,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et (iii) neuf pour cent d’humidité; et b) au moins 2,5 millilitres d’huile volatile par 100 grammes d’épice. DORS/79-659, art. 1. B.07.016 [N]. La poudre de cari doit être un mélange a) de curcuma avec des épices et des condiments; et b) de sel en une quantité n’excédant pas cinq pour cent. DORS/79-659, art. 1. B.07.017 [N]. La graine d’aneth, entière ou moulue, doit être la graine desséchée de l’Anethum graveolens L., ou de l’Anethum sowa D.C. et doit renfermer a) au plus PART B Foods DIVISION 7 Spices, Dressings and Seasonings Sections B.07.017-B.07.020 (i) 10 per cent total ash, (ii) two per cent ash insoluble in hydrochloric acid, and (iii) nine per cent moisture; and SOR/79-659, s. 1. B.07.018 [S]. Fennel or Fennel Seed, whole or ground, shall be the dried ripe fruit of Foeniculum vulgare Mill. and shall contain (i) 10 per cent total ash, (ii) one per cent ash insoluble in hydrochloric acid, and (iii) 10 per cent moisture; and SOR/79-659, s. 1. (a) five per cent total ash; (b) one per cent ash insoluble in hydrochloric acid; and (c) 10 per cent moisture. SOR/79-659, s. 1. B.07.020 [S]. Garlic Salt (a) shall be a combination of (i) powdered dehydrated garlic, and calcium aluminum silicate, calcium phosphate tribasic, calcium silicate, calcium stearate, magnesium carbonate, magnesium silicate, magnesium stearate, silicone dioxide in an amount not exceeding one per cent and sodium aluminum silicate. SOR/79-659, s. 1. (i) seven per cent total ash, (ii) one per cent ash insoluble in hydrochloric acid, and (iii) 12.5 per cent moisture; and SOR/79-659, s. 1. B.07.022 [S]. Mace, whole or ground, shall be the dried arillus of Myristica fragrans Houttyn and shall contain (i) 3.5 per cent total ash, (ii) 0.5 per cent ash insoluble in hydrochloric acid, and (iii) eight per cent moisture, and (d) ethyl ether, after preliminary extraction with petroleum ether, shall not exceed five per cent. SOR/79-659, s. 1. (i) eight per cent total ash, (ii) one per cent ash insoluble in hydrochloric acid, and (iii) 10 per cent moisture; and SOR/79-659, s. 1. PART B Foods DIVISION 7 Spices, Dressings and Seasonings Sections B.07.023-B.07.026 (i) 10 per cent stems and foreign material of plant origin, (ii) 13.5 per cent total ash, (iii) 4.5 per cent ash insoluble in hydrochloric acid, and (iv) 10 per cent moisture; and (b) not less than 0.7 millilitre volatile oil per 100 grams of spice. SOR/79-659, s. 1. B.07.024 [S]. Mustard Seed shall be the seed of *Sinapis alba, Brassica hirta Moench, Brassica juncea (L.) Cosson or Brassica nigra* and shall contain (i) seven per cent total ash, (ii) one per cent ash insoluble in hydrochloric acid, and (iii) 11 per cent moisture; and (b) not less than 25 per cent non-volatile ether extract. SOR/79-659, s. 1. B.07.025 [S]. Mustard, Mustard Flour or Ground Mustard shall be powdered mustard seed (i) 1.5 per cent starch, and (ii) eight per cent total ash, on an oil-free basis. SOR/79-659, s. 1; SOR/2010-142, s. 3[F]. (i) three per cent total ash, PART B Foods DIVISION 7 Spices, Dressings and Seasonings Sections B.07.026-B.07.029 (ii) 0.5 per cent ash insoluble in hydrochloric acid, and (iii) eight per cent moisture; and (i) 25 per cent non-volatile ether extract, and (ii) 6.5 millilitres volatile oil per 100 grams of spice. SOR/79-659, s. 1. B.07.027 [S]. Onion Salt (a) shall be a combination of (i) powdered dehydrated onion, and (ii) salt in an amount not exceeding 75 per cent; and calcium aluminum silicate, calcium phosphate tribasic, calcium silicate, calcium stearate, magnesium carbonate, magnesium silicate, magnesium stearate, silicon dioxide in an amount not exceeding one per cent and sodium aluminum silicate. SOR/79-659, s. 1. B.07.028 [S]. Oregano, whole or ground, shall be the dried leaves of Origanum vulgare L. or Origanum Spp. and shall contain (i) 10 per cent total ash, (ii) two per cent ash insoluble in hydrochloric acid, and (iii) 10 per cent moisture; and SOR/79-659, s. 1. (i) 23 per cent crude fibre, (ii) 8.5 per cent total ash, Règlement sur les aliments et drogues

(12)

Cheddar cheese; Cheddar cheese for processing (granular curd cheese; Stirred curd cheese; Washed curd cheese); Colby cheese

PARTIE B Aliments

(1)

Hydrolyzed animal, milk and vegetable protein Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Column II Permitted Source | Column III Permitted in or Upon | Column IV Maximum Level of Use Aqueous extracts from the fourth stomach of calves, kids or lambs

TITRE 7 Épices, condiments et assaisonnements

(1)

Cheddar cheese; Cottage cheese; Cream cheese; Cream cheese spread; Cream cheese spread with (naming the added ingredients); Cream cheese with (naming the added ingredients); Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted Source | Permitted in or Upon | Maximum Level of Use | | | (4) Unstandardized processed cheese products | (4) Good Manufacturing Practice | | | (2) Unstandardized milk based dessert preparations | Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Lipoxydase Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Firming Agents Item No. Additive Permitted in or Upon

Articles B.07.026-B.07.029

(ii) 0,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et (iii) huit pour cent d’humidité; et b) au moins (i) 25 pour cent d’extrait d’éther non volatil, et (ii) 6,5 millilitres d’huile volatile par 100 grammes d’épice. DORS/79-659, art. 1. B.07.027 [N]. Le sel d’oignon a) doit être un mélange (i) d’oignons déshydratés en poudre, et (ii) de sel en une quantité n’excédant pas 75 pour cent; et b) peut renfermer les agents anti-agglomérants suivants pour une quantité totale n’excédant pas deux pour cent : silicate double d’aluminium et de calcium, phosphate tricalcique, silicate de calcium, stéarate de calcium, carbonate de magnésium, silicate de magnésium, stéarate de magnésium, bioxyde de silicium en une quantité n’excédant pas un pour cent et silicate double de sodium et d’aluminium. DORS/79-659, art. 1. B.07.028 [N]. L’origan, entier ou moulu, doit être la feuille desséchée de l’Origanum vulgare L. ou de l’Origanum Spp. et doit renfermer a) au plus (i) 10 pour cent de cendres totales, (ii) deux pour cent de cendres insolubles dans l’acide chlorhydrique, et (iii) 10 pour cent d’humidité; et b) au moins 2,5 millilitres d’huile volatile par 100 grammes d’épice. DORS/79-659, art. 1. B.07.029 [N]. Le paprika est le fruit mûr desséché et moulu du Capsicum annuum L. et a) doit renfermer au plus (i) 23 pour cent de cellulose, (ii) 8,5 pour cent de cendres totales, (iii) one per cent ash insoluble in hydrochloric acid, and (iv) 12 per cent moisture; and SOR/79-659, s. 1; SOR/84-17, s. 3. B.07.030 [S]. Black Pepper or Peppercorn, whole or ground, shall be the dried, immature berry of Piper nigrum L. and shall contain (i) seven per cent total ash, (ii) one per cent ash insoluble in hydrochloric acid, and (iii) 12 per cent moisture; (ii) 30 per cent pepper starch, and (iii) 2.0 millilitres volatile oil per 100 grams of spice; and SOR/79-659, s. 1. (i) five per cent crude fibre, (ii) 2.5 per cent total ash, (iii) 0.3 per cent ash insoluble in hydrochloric acid, and (iv) 15 per cent moisture; and (ii) 52 per cent pepper starch, and (iii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et (iv) 12 pour cent d’humidité; et b) peut renfermer au plus deux pour cent de bioxyde de silicium en tant qu’agent anti-agglomérant. DORS/79-659, art. 1; DORS/84-17, art. 3. B.07.030 [N]. Le poivre noir ou le poivre en grain, entier ou moulu, doit être la baie non mûrie et desséchée du Piper nigrum L. et doit renfermer a) au plus (i) sept pour cent de cendres totales, (ii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et (iii) 12 pour cent d’humidité; b) au moins (i) six pour cent d’extrait de chlorure de méthylène non volatil, (ii) 30 pour cent d’amidon de poivre, et (iii) 2,0 millilitres d’huile volatile par 100 grammes d’épice; et c) une fois moulu, les diverses parties de la baie dans leurs proportions normales. DORS/79-659, art. 1. B.07.031 [N]. Le poivre blanc, entier ou moulu, doit être la baie mûre et desséchée du Piper nigrum L. débarrassée de son enveloppe extérieure et dont l’enveloppe intérieure peut être enlevée, il doit renfermer a) au plus (i) cinq pour cent de cellulose, (ii) 2,5 pour cent de cendres totales, (iii) 0,3 pour cent de cendres insolubles dans l’acide chlorhydrique, et (iv) 15 pour cent d’humidité; et b) au moins (i) six pour cent d’extrait de chlorure de méthylène non volatil, (ii) 52 pour cent d’amidon de poivre, et B.07.032 [S]. Poppy seed shall be the dried seed of Papaver somniferum L. and shall contain (i) seven per cent total ash, and (ii) one per cent ash insoluble in hydrochloric acid; and (b) not less than 40 per cent non-volatile ether extract. SOR/79-659, s. 1. B.07.033 [S]. Rosemary, whole or ground, shall be the dried leaves of Rosmarinus officinalis L. and shall contain (i) 7.5 per cent total ash, (ii) one per cent ash insoluble in hydrochloric acid, and (iii) nine per cent moisture; and SOR/78-637, s. 1; SOR/79-659, s. 1. B.07.034 [S]. Sage, whole or ground, shall be the dried leaves of the sage plant Salvia officinalis L., Salvia triloba L. or Salvia lavandulaefolia Vahl. and shall contain (i) 12 per cent stems excluding petioles and foreign material of plant origin, (ii) 10 per cent total ash, (iii) one per cent ash insoluble in hydrochloric acid, and (iv) 10 per cent moisture; and SOR/78-637, s. 1; SOR/79-659, s. 1. B.07.035 [S]. Savory, whole or ground, shall be the dried leaves and flowering tops of Satureja hortensis L. or Satureja montana L. and shall contain PART B Foods DIVISION 7 Spices, Dressings and Seasonings Sections B.07.035-B.07.038 (i) 11 per cent total ash, (ii) two per cent ash insoluble in hydrochloric acid, and (iii) 14 per cent moisture; and (b) not less than 0.8 millilitre volatile oil per 100 grams of spice. SOR/79-659, s. 1. B.07.036 [S]. Sesame Seed shall be the dried hulled seed of Sesamum indicum L. and shall contain (a) not more than eight per cent moisture; and (b) not less than 50 per cent non-volatile ether extract. SOR/79-659, s. 1; SOR/2010-142, s. 4(F). B.07.037 [S]. Tarragon, whole or ground, shall be the dried leaves and flowering tops of Artemisia dracunculus L. and shall contain (i) 15 per cent total ash, (ii) 1.5 per cent ash insoluble in hydrochloric acid, and (iii) 10 per cent moisture; and (b) not less than 0.3 millilitre volatile oil per 100 grams of spice. SOR/79-659, s. 1. (i) 12 per cent total ash, (ii) five per cent ash insoluble in hydrochloric acid, and (iii) nine per cent moisture; and (b) not less than 0.9 millilitre volatile oil per 100 grams of spice. SOR/79-659, s. 1. B.07.039 [S]. Turmeric, whole or ground, shall be the dried rhizome of *Curcuma longa L.* and shall contain (i) seven per cent total ash, (ii) 1.5 per cent ash insoluble in hydrochloric acid, and (iii) 10 per cent moisture; and SOR/79-659, s. 1. B.07.040 [S]. Mayonnaise, Mayonnaise Dressing or Mayonnaise Salad Dressing (a) shall be a combination of (i) vegetable oil, (iii) vinegar or lemon juice; (i) water, (ii) salt, (iii) a sweetening agent, (iv) spice or other seasoning except turmeric or saffron, (v) citric, tartaric or lactic acid, and (vi) a sequestering agent; and (c) shall contain not less than 65 per cent vegetable oil. SOR/79-659, s. 1. B.07.041 [S]. French Dressing (a) shall be a combination of (ii) vinegar or lemon juice; (i) water, PART B Foods DIVISION 7 Spices, Dressings and Seasonings Sections B.07.041-B.07.042 (ii) salt, (iii) a sweetening agent, (v) an emulsifying agent, (vi) whole egg or egg yolk, in liquid, frozen or dried form, (vii) citric, tartaric or lactic acid, and (viii) a sequestering agent; and (c) shall contain not less than 35 per cent vegetable oil. SOR/79-659, s. 1. B.07.042 [S]. Salad Dressing (a) shall be a combination of (i) vegetable oil, (ii) whole egg or egg yolk, in liquid, frozen or dried form, (iii) vinegar or lemon juice, and (iv) starch, flour, rye flour or tapioca flour or any combination thereof; (i) water, (ii) salt, (iii) a sweetening agent, (v) an emulsifying agent, (vi) citric, tartaric or lactic acid, and (vii) a sequestering agent; and (c) shall contain not less than 35 per cent vegetable oil. SOR/79-659, s. 1. Règlement sur les aliments et drogues

(1)

Canned crabmeat, lobster, salmon, shrimp and tuna; Pickles and relishes

PARTIE B Aliments

(1)

Pickles and relishes

TITRE 7 Épices, condiments et assaisonnements

(7)

Pickles and relishes

Articles B.07.041-B.07.042

(i) de l’eau, (ii) du sel, (iii) un agent édulcorant, (iv) des épices, des tomates ou d’autres condiments, (v) un émulsif, (vi) des œufs entiers ou des jaunes d’œufs, à l’état liquide, congelés ou desséchés, (vii) de l’acide citrique, tartrique ou lactique, et (viii) un agent séquestrant; et c) doit renfermer au moins 35 pour cent d’huile végétale. DORS/79-659, art. 1. B.07.042 [N]. La sauce à salade ou sauce genre mayonnaise a) doit être un mélange (i) d’huile végétale, (ii) d’œufs entiers ou de jaunes d’œufs, à l’état liquide, congelés ou desséchés, (iii) de vinaigre ou de jus de citron, et (iv) d’amidon, de farine, de farine de seigle ou de tapioca, ou un mélange de ces produits; b) peut renfermer (i) de l’eau, (ii) du sel, (iii) un agent édulcorant, (iv) des épices ou autres condiments, (v) un émulsif, (vi) de l’acide citrique, tartrique ou lactique, et (vii) un agent séquestrant; et c) doit renfermer au moins 35 pour cent d’huile végétale. DORS/79-659, art. 1. SOR/79-659, s. 1. DIVISION 8 (v) whey protein concentrate; B.07.043 Est interdite la vente d’une sauce d’assaisonnement qui contient plus de cinq pour cent d’acide gras monoénoïques en C22 par rapport aux acides gras totaux qu’elle renferme. DORS/79-659, art. 1.

(1)

0.026% calculated as calcium

TITRE 8

Produits laitiers B.08.001 Les aliments mentionnés dans le présent Titre sont des produits laitiers. B.08.001.1 Les définitions qui suivent s’appliquent au présent titre. produit du lait a) Dans le cas du beurre ou du beurre de petit-lait, l’un ou l’autre des produits suivants : (i) le lait partiellement écrémé, le lait écrémé, la crème, le babeurre ou la crème de petit-lait, (ii) le lait sous forme concentrée, desséchée ou reconstituée ou tout produit visé au sous-alinéa (i) sous forme concentrée, desséchée ou reconstituée; b) dans le cas du fromage, l’un ou l’autre des produits suivants : (i) le lait partiellement écrémé, le lait écrémé, la crème, le babeurre, le petit-lait ou la crème de petit-lait, (ii) le lait sous forme concentrée, desséchée, congelée ou reconstituée ou tout produit visé au sous-alinéa (i) sous forme concentrée, desséchée, congelée ou reconstituée, (iii) le beurre, l’huile de beurre et le beurre de petit-lait, (iv) tout composant du lait — sauf l’eau —, pris seul ou en combinaison avec d’autres, (v) le concentré protéique de petit-lait; c) dans le cas du fromage à la crème à tartiner, du fromage à la crème à tartiner (avec indication des ingrédients ajoutés), du fromage fondu à tartiner, du fromage fondu à tartiner (avec indication des ingrédients ajoutés), d’une préparation de fromage conditionné à froid, d’une préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés), d’une préparation de fromage fondu ou d’une préparation de (i) butter, whey butter and whey, (d) with respect to ice milk mix, ice cream mix or sherbet, any of the products referred to in subparagraph (a)(i) or (ii) or (c)(i), (ii) or (iii). (produit du lait) SOR/94-8, s. 1; SOR/95-543, s. 1(F); SOR/98-580, s. 1; SOR/2007-302, s. 1; SOR/2010-94, s. 2; SOR/2011-205, s. 41. SOR/85-623, s. 1.

(2)

0.035% of the total calcium content, whether added or otherwise present

(2)

Subsection (1) does not apply to (a) cheese; or SOR/91-549, s. 1; SOR/95-499, s. 1. fromage fondu (avec indication des ingrédients ajoutés), l’un ou l’autre des produits suivants : (i) le beurre, le beurre de petit-lait et le petit-lait, (ii) le concentré protéique de petit-lait, (iii) tout produit visé au sous-alinéa (i) sous forme concentrée ou desséchée; d) dans le cas d’un mélange à lait glacé, d’un mélange à crème glacée et du sorbet laitier, les produits visés aux sous-alinéas a)(i) ou (ii) ou c)(i), (ii) ou (iii). (milk product) ultrafiltré Se dit du lait, du lait partiellement écrémé ou du lait écrémé qu’on fait passer à travers une ou plusieurs membranes semi-perméables permettant de soustraire l’eau, le lactose, les minéraux et les vitamines hydrosolubles sans en altérer le rapport protéine de petit-lait à la caséine et qui résulte en un produit liquide. (ultrafiltered) DORS/94-8, art. 1; DORS/95-543, art. 1(F); DORS/98-580, art. 1; DORS/2007-302, art. 1; DORS/2010-94, art. 2; DORS/2011-205, art. 41. B.08.002 Sauf exception prévue dans le présent règlement, un produit laitier obtenu par l’action de la chaleur sur du gras de lait est falsifié. B.08.002.1 Les articles B.08.003 à B.08.028 ne s’appliquent pas à la sécrétion lactée des glandes mammaires d’un animal autre qu’une vache, genre Bos, ni aux produits ou dérivés de cette sécrétion. DORS/85-623, art. 1. B.08.002.2 (1) Il est interdit de vendre la sécrétion lactée normale provenant des glandes mammaires d’une vache, genre Bos, ou d’un autre animal, ou tout produit laitier fabriqué à partir de cette sécrétion, à moins que la sécrétion ou le produit laitier n’aient été pasteurisés à une température et pendant une période permettant de réduire l’activité de la phosphatase alcaline de façon que la limite de tolérance spécifiée dans la méthode officielle MFO-3, Détermination de l’activité phosphatasique des produits laitiers, en date du 30 novembre 1981, soit respectée.

(3)

0.02% of the milk and milk products used

(2)

Le paragraphe (1) ne s’applique pas : a) aux fromages; b) aux aliments vendus pour être soumis à d’autres étapes de fabrication ou de transformation en vue de leur pasteurisation de la façon prévue au paragraphe (1). DORS/91-549, art. 1; DORS/95-499, art. 1. Milk B.08.003 [S]. Milk or Whole Milk (b) shall contain 2 µg of vitamin D per 100 mL. SOR/85-499, s. 2; SOR/2022-168, s. 22. B.08.004 [S]. Skim Milk (c) shall contain 2 µg of vitamin D per 100 mL. SOR/78-656, s. 1; SOR/2022-168, s. 23. B.08.005 [S]. Partly Skimmed Milk or Partially Skimmed Milk (c) shall contain 2 µg of vitamin D per 100 mL. SOR/78-656, s. 1; SOR/2022-168, s. 24. (d) a Polenske number not exceeding 10 per cent of the Reichert-Meissl number and in no case shall the Polenske number exceed 3.5, and SOR/82-768, s. 14. B.08.007 [S]. Sterilized Milk (a) and (b) [Repealed, SOR/97-148, s. 1] (i) 11.75 per cent milk solids, and (ii) 3.25 per cent milk fat; and (d) shall contain 2 µg of vitamin D per 100 mL. SOR/97-148, s. 1; SOR/2022-168, s. 25. (a) 28 per cent milk solids; and (b) eight per cent milk fat. B.08.010 [S]. Evaporated Milk (i) 25.0 per cent milk solids, and d) un indice de Polenske ne dépassant pas 10 pour cent de l’indice de Reichert-Meissl et ne dépassant 3,5 en aucun cas, et si la teneur en tocophérols dépasse 50 microgrammes par gramme ou si l’indice de Polenske dépasse 10 pour cent de l’indice de Reichert-Meissl, le gras de lait sera censé avoir été additionné d’une matière grasse autre que celle du lait de vache. DORS/82-768, art. 14. B.08.007 [N]. Le lait stérilisé a) et b) [Abrogés, DORS/97-148, art. 1] c) doit renfermer au moins (i) 11,75 pour cent de solides du lait, et (ii) 3,25 pour cent de gras de lait; et d) doit contenir 2 µg de vitamine D par 100 mL. DORS/97-148, art. 1; DORS/2022-168, art. 25. B.08.008 Le pourcentage de matière grasse du lait contenu dans a) du lait partiellement écrémé ou en partie écrémé, b) du lait partiellement écrémé additionné de solides du lait ou du lait en partie écrémé additionné de solides du lait, ou c) du lait évaporé partiellement écrémé ou du lait concentré partiellement écrémé doit être indiqué sur l’espace principal suivi de l’expression « matière grasse du lait » ou de l’abréviation « M.G. ». B.08.009 [N]. Le lait condensé ou lait condensé sucré doit être du lait dont l’eau a été évaporée et auquel on a ajouté du sucre, du dextrose, du glucose, des solides de glucose ou du lactose, ou une combinaison de ces substances; il peut renfermer de la vitamine D ajoutée et doit renfermer au moins a) 28 pour cent de solides du lait, et b) huit pour cent de gras de lait. B.08.010 [N]. Le lait évaporé a) doit être du lait dont de l’eau a été évaporée; b) doit contenir au moins (i) 25,0 pour cent de solides du lait, PART B Foods DIVISION 8 Dairy Products Milk Sections B.08.010-B.08.012 (ii) 7.5 per cent milk fat; (d) shall contain 2 µg of vitamin D per 100 mL when reconstituted to its original volume; and (e) may contain (i) added disodium phosphate or sodium citrate, or both, and (ii) an emulsifying agent. SOR/86-686, s. 3; SOR/92-400, s. 2; SOR/2022-168, s. 26. (b) shall contain (f) may contain added disodium phosphate or sodium citrate, or both. SOR/2022-168, s. 27. Règlement sur les aliments et drogues

(8)

0.026% calculated as calcium, and in the case of canned peas 0.035% calculated as calcium

PARTIE B Aliments

(10)

0.022% calculated as calcium

TITRE 8 Produits laitiers

Lait

(1)

0.026% calculated as calcium

Articles B.08.010-B.08.012

(ii) 7,5 pour cent de matière grasse du lait; c) doit, nonobstant les articles D.01.009 à D.01.011, contenir de la vitamine C ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 60 milligrammes et au plus 75 milligrammes de vitamine C; d) une fois reconstitué à son volume original, doit contenir 2 µg de vitamine D par 100 mL; e) peut renfermer (i) du phosphate disodique ou du citrate de sodium ajoutés, ou les deux, et (ii) un agent émulsifiant. DORS/86-686, art. 3; DORS/92-400, art. 2; DORS/2022-168, art. 26. B.08.011 [N]. Le lait écrémé évaporé ou écrémé concentré a) doit être un lait qui a été concentré à la moitié au moins de son volume primitif par déshydratation; b) doit contenir (i) au plus 0,3 pour cent de gras de lait, et (ii) au moins 17,0 pour cent de solides du lait autres que le gras; c) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A; d) doit, nonobstant les articles D.01.009 à D.01.011, contenir de la vitamine C en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne 60 milligrammes et au plus 75 milligrammes de vitamine C; e) une fois reconstitué à son volume original, doit contenir 2 µg de vitamine D par 100 mL; f) peut contenir du phosphate disodique ou du citrate de sodium ajoutés, ou les deux. DORS/2022-168, art. 27. B.08.012 [N]. Le lait évaporé partiellement écrémé ou lait concentré partiellement écrémé a) doit être un lait dont une partie du gras a été enlevé; (i) an emulsifying agent, and (ii) added disodium phosphate or sodium citrate, or both. SOR/2022-168, s. 28. B.08.013 [S]. Milk Powder, Whole Milk Powder, Dry Whole Milk, or Powdered Whole Milk (a) shall be dried milk; (i) 95 per cent milk solids, and (ii) 26 per cent milk fat; (d) may contain the emulsifying agent lecithin in an amount not exceeding 0.5 per cent. SOR/78-656, s. 4; SOR/83-932, s. 2; SOR/2022-168, s. 29. B.08.014 [S]. Skim Milk Powder or Dry Skim Milk (a) shall be dried skim milk; (d) shall contain 2 µg of vitamin D per 100 mL when reconstituted according to directions for use; and (e) may contain an anti-foaming agent. SOR/78-686, s. 6; SOR/80-501, s. 2(F); SOR/2022-168, s. 30. SOR/78-686, s. 6; SOR/82-768, s. 15. SOR/88-336, s. 3. B.08.016 [S]. (naming the flavour) Milk (iii) a sweetening agent; (c) shall contain 2 µg of vitamin D per 100 mL; (d) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch; and SOR/78-686, s. 7; SOR/82-768, s. 16; SOR/84-762, s. 1; SOR/2022-168, s. 31. B.08.017 [S]. (naming the flavour) Skim Milk (iii) a sweetening agent; (b) shall contain not more than 0.3 per cent milk fat; (d) shall contain 2 µg of vitamin D per 100 mL; and SOR/78-686, s. 8; SOR/84-762, s. 2; SOR/2022-168, s. 32. B.08.018 [S]. (naming the flavour) Partly (Partially) Skimmed Milk (iii) a sweetening agent; (iii) a sweetening agent; (b) shall contain more than 0.3 per cent and less than 3.0 per cent milk fat; (d) shall contain 2 µg of vitamin D per 100 mL; SOR/78-686, s. 9; SOR/82-768, s. 17; SOR/84-762, s. 32; SOR/2022-168, s. 33. (b) shall contain not less than 10 per cent milk solids; (c) shall contain not more than 0.3 per cent milk fat; (e) shall contain 2 µg of vitamin D per 100 mL. SOR/78-686, s. 10; SOR/2022-168, s. 34. (d) shall contain 2 µg of vitamin D per 100 mL. SOR/2022-168, s. 35. (d) shall contain (ii) not more than 3.5 per cent moisture. B.08.022 [S]. (naming the flavour) Malted Milk or (naming the flavour) Malted Milk Powder (b) may contain lactase. SOR/84-762, s. 4. B.08.023 [S]. (naming the flavour) Skim Milk with Added Milk Solids (iii) a sweetening agent; (c) shall contain not more than 0.3 per cent milk fat; (d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not (e) shall contain 2 µg of vitamin D per 100 mL; and (f) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch. SOR/78-665, s. 11; SOR/84-762, s. 5; SOR/2022-168, s. 36. SOR/78-765, s. 18. (iii) a sweetening agent; (c) shall contain more than 0.3 per cent and less than 3.0 per cent milk fat; (e) shall contain 2 µg of vitamin D per 100 mL; SOR/78-166, s. 12; SOR/82-768, ss. 19; SOR/84-300, s. 21(F); SOR/84-762, s. 6; SOR/2022-168, s. 37. B.08.028 (1) The percentage of milk fat contained in (a) (naming the flavour) milk, (b) (naming the flavour) partly (partially) skimmed milk, (d) cream, and (e) sour cream, SOR/79-23, s. 10; SOR/88-559, s. 16; SOR/2010-94, s. 3(F); SOR/2016-305, s. 75(F). SOR/85-623, s. 2. (b) 2 µg of vitamin D. (d) not less than 10 µg and not more than 20 µg of folic acid. SOR/85-623, s. 2; SOR/2022-168, s. 38. SOR/79-752, s. 2; SOR/82-768, s. 20; SOR/92-400, s. 3. SOR/79-752, s. 2. (a) (naming the variety) cheese, (d) whey cheese, (e) (naming the variety) whey cheese, (f) cream cheese with (naming the added ingredients), (g) cream cheese spread, (k) processed cheese food, (o) cold-pack (naming the variety) cheese, SOR/79-752, s. 2; SOR/88-559, s. 17; SOR/94-688, s. 21(E); SOR/2010-94, s. 8(E); SOR/2016-305, s. 7(F). (a) shall (A) 63 per cent in the case of Pizza Mozzarella cheese and Part Skim Pizza Mozzarella cheese, (i) salt, seasonings, condiments and spices, (C) in an amount not exceeding 0.10 parts per million, brilliant blue FCF in feta cheese only, (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof. (ix) les agents de conservation suivants : (A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique, (B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium, ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée en acide propionique et en acide sorbique, (D) la natamycine appliquée à la surface du fromage, en une quantité n’excédant pas 20 parties par million ou, si le fromage est râpé fin ou en filaments, 10 parties par million, (x) s’il est râpé fin ou en filaments, du silicate de calcium, de la cellulose microcristalline, de la cellulose ou un mélange de ces produits, utilisé comme agent anti-agglomérant, en quantité totale n’excédant pas 2,0 pour cent, (xi) du dioxyde de carbone comme rajusteur du pH dans le lait pour la fabrication du fromage, en quantité conforme aux bonnes pratiques industrielles. (1.1) Le fromage d’une variété visée à la colonne I de la partie I du tableau du présent article peut contenir plus que le pourcentage maximal d’humidité indiqué dans la colonne II et moins que le pourcentage minimal de matière grasse du lait indiqué dans la colonne III, si les conditions suivantes sont réunies : a) la mention ou l’allégation figurant à la colonne 4 de l’un des articles 12 à 14, 16, 20, 21 et 45 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive est indiquée sur l’étiquette du produit dans le nom usuel de celui-ci; b) le fromage a la saveur et la texture caractéristiques de la variété de fromage visée. (1.2) La mention « 83 % » dans la division (1)a)(i.1)(B) vaut mention de « 78 % » et la mention « 95 % » dans la division (1)a)(i.1)(C) vaut mention de « 90 % », dans le cas des variétés de fromage visées, si les conditions suivantes sont réunies : (ii) ripened cheese (a) aminopeptidase derived from Lactococcus lactis, bovine rennet derived from aqueous extracts from the fourth stomach of adult bovine animals, sheep and goats, chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), lipase derived from Animal pancreatic tissue; Aspergillus niger var.; Aspergillus oryzae var.; Edible fore-stomach tissue of calves, kids or lambs; Rhizopus oryzae var. or from Aspergillus oryzae (MILT-2) (pRML 87) (p35R); Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)); Rhizopus niveus, milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), pepsin derived from a) la mention ou l’allégation figurant à la colonne 4 de l’un des articles 12 à 14, 16, 20, 21 et 45 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive est indiquée sur l’étiquette du produit dans le nom usuel de celui-ci; b) le fromage a la saveur et la texture caractéristiques de la variété de fromage visée.

(2)

0.026% calculated as calcium Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use | | (2) Canned peas | (2) 0.035% calculated as calcium C.5 | Calcium Phosphate, monobasic | (1) Tomatoes; Canned vegetables; Frozen apples | (1) 0.026% calculated as calcium | | (2) Canned apples | (2) 0.026% calculated as calcium C.6 | Calcium Sulphate | (1) Tomatoes; Canned vegetables; Frozen apples | (1) 0.026% calculated as calcium | | (2) Canned apples | (2) 0.026% calculated as calcium Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Glazing and Polishing Agents Item No. Additive Permitted in or Upon Current to November 11, 2024 Last amended on June 17, 2024 Miscellaneous Food Additives Item No. | Additive | Permitted in or Upon | Purpose of Use | Maximum Level of Use B.2.1 | Benzoyl Peroxide | Liquid whey destined for the manufacture of dried whey products other than those for use in infant formula | To decolourize | 100 p.p.m. Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Purpose of Use | Maximum Level of Use B.3 | Brominated vegetable oil | (Naming the flavour) Flavour for use in beverages containing citrus or spruce oils | Density adjusting agent | 15 p.p.m. in beverages containing citrus or spruce oils as consumed B.4 | n-Butane | Edible vegetable oil-based or lecithin-based pan coatings or a mixture of both | Propellant | Good Manufacturing Practice C.1 | Caffeine | Cola type beverages | To characterize the product | 200 p.p.m. in the finished product C.2 | Caffeine Citrate | Cola type beverages | To characterize the product | 200 p.p.m. calculated as caffeine, in the finished product C.3.01 | Calcium Chloride | Sausage having an edible coating | To stabilize the edible coating | Good Manufacturing Practice | (3) Sausage having an edible coating | (3) To stabilize the edible coating | (3) Good Manufacturing Practice C.4 | Calcium Oxide | (1) Frozen crustaceans and molluscs | (1) To facilitate the removal of extraneous matter and to reduce moisture loss during cooking | (1) When used in combination with sodium chloride (salt) and sodium hydroxide in solution, calcium oxide not to exceed 30 p.p.m. Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Purpose of Use | Maximum Level of Use

(2)

Le nitrate de potassium, le nitrate de sodium ou un mélange de ces produits peuvent être utilisés comme agents de conservation dans le fromage, pourvu que: a) la quantité de sel ou le mélange de sels ne dépasse pas 200 parties par million du lait et des produits laitiers utilisés; b) le fromage dans lequel l’agent de conservation est utilisé est (i) du fromage affiné aux moisissures conservé dans un contenant hermétique, ou (ii) du fromage affiné (A) qui contient au plus 68 pour cent d’humidité à l’état dégraissé, et (B) dont la fermentation lactique et la salaison ont été faites plus de 12 heures après la coagulation du caillé par enzymes; et c) la salaison soit, dans le cas du fromage visé au sous-alinéa b)(ii), appliquée à l’extérieur du fromage sous forme de sel ou de saumure.

(1)

Ale; Beer; Carbonated (naming the fruit) juice; Cider; Light beer; Malt liquor; Porter; Stout; Wines; Water represented as mineral water or spring water | (1) Carbonation | (1) Good Manufacturing Practice

(3)

Il est interdit d’utiliser un enzyme qui n’est pas compris parmi les suivants: a) l’aminopeptidase provenant de Lactococcus lactis, la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAMpR) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS105), l’enzyme coagulant le lait provenant de Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)), de Mucor pusillus Lindt par un procédé de fermentation pure ou de Aspergillus oryzae RET-1 (pBoel777), la lipase provenant de Aspergillus niger var.; Aspergillus oryzae var.; Rhizopus oryzae var.; Tissus comestibles des préestomacs d’agneaux, de chevreaux ou de veaux; Tissus pancréatiques d’animaux ou de Aspergillus oryzae (MILT-2) (pRML 87) (p35R); Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)); Rhizopus niveus, la pepsine provenant de la muqueuse (b) [Repealed, SOR/2010-143, s. 1] (e) protease derived from *Aspergillus oryzae* var., *Aspergillus niger* var. or *Bacillus subtilis* var., in the manufacture of Colby cheese; and (f) lysozyme derived from egg-white. TABLE PART I Column I | Column II | Column III 1 | Asiago | 40.0 | 30.0 2 | Baby Edam | 47.0 | 21.0 3 | Baby Gouda | 45.0 | 26.0 4 | Blue | 47.0 | 27.0 5 | Butter (Butterkäse) | 46.0 | 27.0 6 | Bra | 36.0 | 26.0 7 | Brick | 42.0 | 29.0 8 | Brie | 54.0 | 23.0 9 | Caciocavallo | 46.0 | 24.0 10 | Camembert (Carré de l’est) | 56.0 | 22.0 13 | Colby | 42.0 | 29.0 14 | Danbo | 46.0 | 25.0 15 | Edam | 46.0 | 22.0 16 | Elbo | 46.0 | 25.0 17 | Emmentaler (Emmental, Swiss) | 40.0 | 27.0 18 | Esrom | 50.0 | 23.0 19 | Farmer’s | 44.0 | 27.0 20 | Feta | 55.0 | 22.0 21 | Fontina | 46.0 | 27.0 22 | Fynbo | 46.0 | 25.0 23 | Gouda | 43.0 | 28.0 24 | Gournay | 55.0 | 33.0 25 | Gruyère | 38.0 | 28.0 26 | Havarti | 50.0 | 23.0 27 | Jack | 50.0 | 25.0 28 | Kasseri | 44.0 | 25.0 29 | Limburger | 50.0 | 25.0 30 | Maribo | 43.0 | 26.0 31 | Montasio | 40.0 | 28.0 32 | Monterey (Monterey Jack) | 44.0 | 28.0 33 | Mozzarella (Scamorza) | 52.0 | 20.0 34 | Muenster (Munster) | 50.0 | 25.0 35 | Neufchâtel | 32.0 | 20.0 36 | Parmesan | 32.0 | 22.0 37 | Part Skim Mozzarella (Part Skim Scamorza) | 52.0 | 15.0 38 | Part Skim Pizza | 48.0 | 15.0

(3)

Liquid whey destined for the manufacture of dried whey products other than those for use in infant formula | (3) Carrier of benzoyl peroxide | (3) 0.04% of dried whey product

38.1 | Part Skim Pizza Mozzarella | 61.0 | 11.0

PART B Foods Sections B.08.033-B.08.034 Column I | Column II | Column III 39 | Pizza | 48.0 | 20.0

(4)

Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredient); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) | (4) To improve colour, texture, consistency and spreadability | (4) 1.0%

39.1 | Pizza Mozzarella | 58.0 | 15.0

40 | Provolone | 45.0 | 24.0 41 | Romano (Sardo) | 34.0 | 25.0 42 | St. Jorge | 40.0 | 27.0 43 | Saint-Paulin | 50.0 | 25.0 44 | Samsö | 40.0 | 26.0 45 | Tilsiter (Tilsit) | 45.0 | 25.0 46 | Tybo | 46.0 | 25.0 PART II Column I | Column II | Column III 1 | Harzkase (Harzer Käse, Mainzer Käse) | 55.0 | 3.0 2 | Skim Milk | 55.0 | 7.0 SOR/79-752, s. 2; SOR/80-632, s. 2; SOR/82-383, ss. 2, 23; SOR/82-566, s. 1; SOR/84-302, s. 1; SOR/88-88, s. 2; SOR/89-167, s. 3; SOR/89-544, s. 2; SOR/93-161, s. 2; SOR/94-683, s. 1; SOR/95-548, s. 1; SOR/97-513, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; 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SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1; SOR/99-169, s. 1 (ii) contain (A) not more than 39 per cent moisture, and (B) not less than 31 per cent milk fat; (i) salt, (iii) bacterial cultures to aid further ripening, (1.2) The reference to “83 per cent” in subparagraph (1)(a)(i.1) shall be read as “78 per cent” if (a) aminopeptidase derived from Lactococcus lactis, chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMrP) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), lipase derived from Animal pancreatic tissue; Aspergillus niger var.; Aspergillus oryzae var.; Edible proteolytic tissue of calves, kids or lambs; Rhizopus oryzae var. or from Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney and Emerson)) (previous name: Mucor miehei (Cooney and Emerson)); Rhizopus niveus, milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoE777), pepsin derived from glandular layer of porcine stomach, phospholipase derived from Aspergillus oryzae (pPFJo142) or renin derived from aqueous extracts from the fourth stomach of calves, kids or lambs; B.08.035 (1) [S]. Cream Cheese (a) shall (ii) contain (A) not more than 55 per cent moisture, and (ii) salt, ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or any combination thereof in an amount not exceeding 0.5 per cent, and

(4)

Liquid whey destined for the manufacture of dried whey products, other than those for use in infant formula | (4) Carrier of benzoyl peroxide | (4) 0.3% of the dried whey product Current to November 11, 2024 Last amended on June 17, 2024 Item No. | Additive Permitted in or Upon

(2)

No person shall use any enzyme or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of cream cheese; and SOR/79-752, s. 2; SOR/92-197, s. 3; SOR/94-212, s. 3; SOR/95-183, s. 3; SOR/2010-143, s. 3. B.08.036 (1) [S]. Whey Cheese or (naming the variety) Whey Cheese SOR/79-752, s. 2; SOR/2007-302, s. 4(F); SOR/2010-142, s. 5. B.08.037 (1) [S]. Cream Cheese with (naming the added ingredients) (a) shall (pGAMPr) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), la pepsine provenant de la muqueuse glandulaire de l’estomac de porc ou la présure provenant de l’extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux, dans la fabrication du fromage à la crème; b) en quantité supérieure à ce qui est conforme aux bonnes pratiques industrielles. DORS/79-752, art. 2; DORS/92-197, art. 3; DORS/94-212, art. 3; DORS/95-183, art. 3; DORS/2010-143, art. 3. B.08.036 (1) [N]. Le fromage de petit-lait ou le fromage de petit-lait (indication de la variété) a) doit être le produit de la coagulation, à l’aide d’une source de chaleur, du petit-lait ou du petit-lait concentré en vue de former un caillé auquel une forme est donnée; et b) peut contenir (i) des micro-organismes favorisant l’affinage, (ii) du lait et des produits du lait ajoutés, et (iii) de l’acide acétique, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’hydroxyde de sodium comme rajusteurs du pH.

(3)

Unstandardized confectionery that meet the conditions set out in column 2 of item 3 of the table following section B.01.513 for the subject “Reduced in energy” set out in column 1 Breath freshener products

(2)

Il est interdit d’utiliser, pour favoriser la coagulation du petit-lait dans la fabrication du fromage de petit-lait, une substance autre que du vinaigre ou du petit-lait sûr. DORS/79-752, art. 2; DORS/2007-302, art. 4(F); DORS/2010-142, art. 5. B.08.037 (1) [N]. Le fromage à la crème (avec indication des ingrédients ajoutés) a) doit (i) être le produit de la coagulation de la crème à l’aide de bactéries, en vue de former, après égouttement du petit-lait, une masse homogène de caillé, (ii) contenir, en quantité suffisante pour pouvoir se distinguer du fromage à la crème, tout en conservant sa nature fondamentale, les ingrédients suivants : (A) du fromage autre que du fromage à la crème, (B) chocolate, condiments, flavouring preparations, seasonings or spices, (iii) contain (A) not more than 60 per cent moisture, and (ii) salt, ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycoate), sodium carrageenan, tragacanth gum, xanthan gum or any combination thereof in an amount not exceeding 0.5 per cent, and (B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination

(1)

Apple (or rhubarb) and (naming the fruit) Jam; Fats and oils; Fig marmalade; Fig marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade; Pineapple marmalade with pectin; Reconstituted lemon juice; Reconstituted lime Purpose of Use Pressure dispensing and aerating agent To characterize the product

(2)

No person shall use any enzyme SOR/79-752, s. 2; SOR/92-197, s. 4; SOR/94-212, s. 4; SOR/95-183, s. 4; SOR/2010-143, s. 4; SOR/2011-278, s. 2. B.08.038 (1) [S]. Cream Cheese Spread (a) shall (ii) contain (B) not less than 51 per cent cream cheese, (C) not more than 60 per cent moisture, and (ii) salt, vinegar and sweetening agents, (A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, and (B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total, PART B: Foods DIVISION 8: Dairy Products Sections B.08.038-B.08.039

0.0001%, calculated as copper, in the finished product

Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Purpose of Use | Maximum Level of Use

(2)

No person shall use any enzyme SOR/79-752, s. 2; SOR/92-197, s. 5; SOR/94-212, s. 5; SOR/95-183, s. 5; SOR/2007-302, s. 4(F); SOR/2010-143, s. 5. B.08.039 (1) [S]. Cream Cheese Spread with (naming the added ingredients) (a) shall (B) chocolate, condiments, flavouring preparations, seasonings or spices, Règlement sur les aliments et drogues

(2)

Pineapple juice; Blends of pineapple juice with other fruit juices; canned pineapple (when pineapple juice is used as the packing medium)

PARTIE B: Aliments

(3)

Surfaces that come in contact with food

TITRE 8: Produits laitiers

Fromages

(5)

Wort used in the manufacture of Ale, Beer, Light beer, Malt liquor, Porter and Stout I | Isobutane | Edible vegetable oil-based or lecithin-based pan coatings or a mixture of both | Propellant | Good Manufacturing Practice Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Purpose of Use | Maximum Level of Use L.1 | Lactylic Esters of Fatty Acids | Unstandardized foods | Plasticizing agent | Good Manufacturing Practice L.2 | Lanolin | Chewing gum | Plasticizing agent | Good Manufacturing Practice M.2A | Magnesium Chloride | Egg albumen (delysozymized) | Restoration of functional properties | Good Manufacturing Practice (Quantity of magnesium added not to exceed that lost during processing) M.4A | Magnesium Sulphate | Egg albumen (delysozymized) | Restoration of functional properties | Good Manufacturing Practice (Quantity of magnesium added not to exceed that lost during processing) | | (3) Unstandardized foods that meet the conditions set out in column 2 of item 3 of the table following section | (3) Filler | (3) Good Manufacturing Practice Item No. Additive Permitted in or Upon Purpose of Use B.01.513 for the subject "Reduced in energy" set out in column 1

Articles B.08.038-B.08.039

(vii) les agents de conservation suivants : (A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique, (B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(7)

Unstandardized foods other than those unstandardized foods referred to in this item

(2)

Il est interdit d’utiliser un enzyme a) autre que la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAMpR) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), la pepsine provenant de la couche glandulaire de l’estomac de porc ou la présure provenant de l’extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux, dans la fabrication d’un produit visé au paragraphe (1); b) en quantité supérieure à ce qui est conforme aux bonnes pratiques industrielles. DORS/79-752, art. 2; DORS/92-197, art. 5; DORS/94-212, art. 5; DORS/95-183, art. 5; DORS/2007-302, art. 4(F); DORS/2010-143, art. 5. B.08.039 (1) [N]. Le fromage à la crème à tartiner (avec indication des ingrédients ajoutés) a) doit (i) être le produit de la coagulation de la crème à l’aide de bactéries, en vue de former une masse homogène de caillé après égouttement du petit-lait, (ii) contenir, en quantité suffisante pour pouvoir se distinguer du fromage à la crème à tartiner, tout en conservant sa nature fondamentale, les ingrédients ajoutés suivants : (A) du fromage autre que du fromage à la crème, (B) des assaisonnements, du chocolat, des condiments, des épices ou des préparations aromatisantes, (iii) contain (B) not more than 60 per cent moisture, and (ii) salt, vinegar and sweetening agents, (A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycoate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, and (B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium (C) des achards, des cornichons, des fruits, des légumes ou des noix, (D) de la viande préparée ou conservée, ou (E) du poisson préparé ou conservé, et (iii) contenir (A) du lait et des produits du lait ajoutés, (B) au plus 60 pour cent d’humidité, et (C) au moins 24 pour cent de matière grasse de lait; et b) peut contenir (i) de la crème ajoutée pour modifier la teneur en matière grasse de lait, (ii) du sel, du vinaigre et des agents édulcorants, (iii) de l’azote pour améliorer la tartinabilité, en une quantité conforme aux bonnes pratiques industrielles, (iv) les colorants suivants : (A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, (B) en quantité n’excédant pas 35 parties par million, le ß-apo-8'-caroténal, l’ester éthylique de l’acide ß-apo-8'-caroténoïque ou un mélange de ces produits, (C) en quantité n’excédant pas 1,5 %, le caramel, (v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent : (A) en quantité n’excédant pas 0,5 pour cent, la carraghénine d’ammonium, la carraghénine de calcium, la gomme de caroube (gomme de l’acacia vulgaire ou faux acacia), la carraghénine, la gélatine, la gomme de guar, la gelose de l’Irlande, la carraghénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycoate sodique de cellulose), la carraghénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits, (B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de

(8)

0.5% or, if used in combination with stabilizing agents, the combined amount shall not exceed 0.5% of the ice cream made from the mix

(2)

No person shall use any enzyme sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate de sodium ou de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas de sels de phosphate, et 4,0 pour cent en tout, (vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’acide tartrique comme rajusteurs du pH, et (vii) les agents de conservation suivants : (A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique, (B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(1)

0.3% in accordance with section B.01.047. If petrolatum is also used as a release agent in bakery products the total of any combination of petrolatum and mineral oil must not exceed 0.15%

(2)

Il est interdit d’utiliser un enzyme (a) autre que la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAM9P) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), la pepsine provenant de la muqueuse glandulaire de l’estomac de porc ou la présure provenant de l’extrait aqueux du 4e estomac de veaux, de chevreaux ou d’agneaux, dans la fabrication d’un produit visé au paragraphe (1); (b) en quantité supérieure à ce qui est conforme aux bonnes pratiques industrielles. B.08.040 (1) [S]. Processed (naming the variety) Cheese (a) shall (B) stirred curd cheese, (C) granular curd cheese, or --- B.08.040 (1) [N]. Le fromage fondu (indication de la variété) a) doit (i) sous réserve du sous-alinéa (ii), être le produit du broyage et du mélange, à l’aide d’une source de chaleur, des variétés de fromages nommées, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène, (ii) dans le cas du fromage cheddar fondu, être le produit du broyage et du mélange, à l’aide d’une source de chaleur, des fromages suivants en vue de former une masse homogène : (B) fromage à caillé brassé, (C) fromage à caillé granuleux, ou (D) fromage à caillé lavé, (iii) s’il est fait (A) d’une seule variété de fromage dont le pourcentage maximal d’humidité permise est inférieur à 40 pour cent, ou (B) de plusieurs variétés de fromage dont la moyenne des pourcentages maximum d’humidité permise est inférieure à 40 pour cent, contenir un pourcentage d’humidité non supérieur de plus de cinq pour cent au pourcentage maximal visé à la disposition (A) ou (B), selon le cas, et un pourcentage de matière grasse de lait non inférieur de plus de trois pour cent au pourcentage minimal ou à la moyenne des pourcentages minimaux permis pour cette ou ces variétés, (iv) sous réserve du sous-alinéa (v), s’il est fait (A) d’une seule variété de fromage dont le pourcentage maximal d’humidité permise est d’au moins 40 pour cent, ou (B) de plusieurs variétés de fromage dont la moyenne des pourcentages maximum d’humidité permise est d’au moins 40 pour cent, contenir un pourcentage d’humidité non supérieur de plus de trois pour cent au pourcentage maximal visé à la disposition (A) ou (B), selon le cas, et un pourcentage de matière grasse de lait non inférieur (A) 55 per cent moisture, and (B) seven per cent milk fat; and (i) water added to adjust the moisture content, (iv) salt, vinegar and sweetening agents, (A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent, (B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total, (C) lecithin in an amount not exceeding 0.2 per cent, and de plus de deux pour cent au pourcentage minimal ou à la moyenne des pourcentages minimaux permis pour cette ou ces variétés, et (v) dans le cas du fromage de lait écrémé fondu, contenir au plus (A) 55 pour cent d’humidité, et (B) sept pour cent de matière grasse de lait; et b) peut contenir (i) de l’eau ajoutée pour modifier la teneur en humidité, (ii) de la matière grasse de lait ajoutée, (iii) s’il s’agit de fromage de lait écrémé fondu, du lait écrémé en poudre, du lait de beurre en poudre et du petit-lait en poudre ajoutés, (iv) du sel, du vinaigre et des agents édulcorants, (v) les colorants suivants : (A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et (B) en quantité n’excédant pas 35 parties par million, le ß-apo-8'-caroténal, l’ester éthylique de l’acide ß-apo-8'-caroténoïque ou un mélange de ces produits, (vi) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent : (A) en quantité n’excédant pas 0,5 pour cent, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), (B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas des sels de phosphate, et 4,0 pour cent en tout, PART B Foods DIVISION 8 Dairy Products Sections B.08.040-B.08.041 (D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent, SOR/79-752, s. 2; SOR/91-409, s. 1; SOR/2017-18, s. 18(F); SOR/2018-69, s. 28(F). (a) shall Règlement sur les aliments et drogues

(2)

0.3% in accordance with section B.01.047 Unstandardized bakery products

PARTIE B Aliments

(4)

Binding agent and protective coating Plasticizer M.9 Mono- and di-glycerides

TITRE 8 Produits laitiers

Fromage

(1)

Apple (or rhubarb) and (naming the fruit) Jam; Fats and oils; Fig marmalade; Fig marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Purpose of Use | Maximum Level of Use O.1 | Octafluorocyclobutane | Unstandardized foods | Pressure dispensing and aerating agent | Good Manufacturing Practice | | (2) Water represented as mineral water or spring water | (2) Chemosterilant | (2) Good Manufacturing Practice | | (2) Cheese and turnips | (2) Coating | (2) Good Manufacturing Practice in accordance with section B.01.047 P.2 | Petrolatum | (1) Bakery products | (1) Release agent | (1) 0.15% in accordance with section B.01.047. If mineral oil is also used as a release agent the total of any combination of petrolatum and mineral oil must not exceed 0.15% Item No. | Additive Permitted in or Upon Purpose of Use Bodying and texturizing agent

Articles B.08.040-B.08.041

(C) de la lécithine en quantité n’excédant pas 0,2 pour cent, (D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits, (vi.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n’excédant pas 1 pour cent, (vii) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium, et de l’acide tartrique comme rajusteurs de pH, (viii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et (ix) les agents de conservation suivants : (A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique, (B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(1)

2 p.p.m. in the finished product

(2)

L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3)

Viscosity reduction agent and stabilizer in colour lake dispersions Carrier of benzoyl peroxide Pressure dispensing and aerating agent Beverage bases; Beverage mixes; Soft drinks Beverage bases; Beverage mixes; Soft drinks Edible vegetable oil-based cookware coating emulsions Frozen fish fillets; frozen minced fish; frozen lobster; frozen crab; frozen clams; frozen shrimp To reduce processing losses and to reduce the drip Used in combination with sodium tripolyphosphate and sodium pyrophosphate tetrabasic, total added pyrophosphate not to exceed 0.5% calculated as sodium phosphate, dibasic Carrier of benzoyl peroxide Item No. | Additive Permitted in or Upon In combination with sodium hexametaphosphate for use on frozen fish fillets, frozen lobster, frozen crabs, frozen clams and frozen shrimp Sausage casings

(3)

Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette. DORS/79-752, art. 2; DORS/91-409, art. 1; DORS/2017-18, art. 18(F); DORS/2018-69, art. 28(F). B.08.041 (1) [N]. Le fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés) (B) chocolate, condiments, seasonings or spices, a) doit (i) être le produit du broyage et du mélange, à l’aide d’une source de chaleur, des variétés de fromage nommées, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène, (ii) contenir, en quantité suffisante pour pouvoir se distinguer du fromage fondu (indication de la variété), tout en conservant la nature fondamentale, les ingrédients suivants : (A) des préparations aromatisantes autres que celles qui ressemblent à l’arôme des variétés de fromage utilisées, (B) des assaisonnements, du chocolat, des condiments ou des épices, (C) des achards, des cornichons, des fruits, des légumes ou des noix, (D) de la viande préparée ou conservée, ou (E) du poisson préparé ou conservé, (iii) s’il est fait (A) d’une seule variété de fromage dont le pourcentage maximal d’humidité permise est inférieur à 40 pour cent, ou (B) de plusieurs variétés de fromage dont la moyenne des pourcentages maximum d’humidité permise est inférieure à 40 pour cent, contenir un pourcentage d’humidité non supérieur de plus de cinq pour cent au pourcentage maximal visé à la disposition (A) ou (B), selon le cas, et un pourcentage de matière grasse du lait non inférieur de plus de trois pour cent au pourcentage minimal permis pour cette ou ces variétés, et (iv) s’il est fait (A) d’une seule variété de fromage dont le pourcentage maximal d’humidité permise est d’au moins 40 pour cent, ou (B) de plusieurs variétés de fromage dont la moyenne des pourcentages maximum d’humidité permise est d’au moins 40 pour cent, contenir un pourcentage d’humidité non supérieur de plus de trois pour cent au pourcentage maximal (i) water added to adjust moisture content, (iii) salt, vinegar and sweetening agents, (A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent, (B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, tartaric acid, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total, (C) lecithin in an amount not exceeding 0.2 per cent, and (D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent, (vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, visé à la disposition (A) ou (B), selon le cas, et un pourcentage de matière grasse de lait non inférieur de plus de deux pour cent au pourcentage minimal ou à la moyenne des pourcentages minimaux permis pour cette ou ces variétés; et b) peut contenir (i) de l’eau ajoutée pour modifier la teneur en humidité, (ii) de la matière grasse de lait ajoutée, (iii) du sel, du vinaigre et des agents édulcorants, (iv) les colorants suivants : (A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le β-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et (B) en quantité n’excédant pas 35 parties par million, le β-apo-8'-caroténal, l’ester éthylique de l’acide β-apo-8'-caroténoïque ou un mélange de ces produits, (v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent : (A) en quantité n’excédant pas 0,5 pour cent, la carboxyméthylcellulose sodique (carboxyméthyl-cellulose, gomme de cellulose, glycolate sodique de cellulose), (B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas des sels de phosphate, et 4,0 pour cent en tout, (C) de la lécithine en quantité n’excédant pas 0,2 pour cent, et (D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits, B.08.041.1 (1) [S]. Processed Cheese Food (a) shall (ii) contain (v.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n’excédant pas 1 pour cent, (vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du bicarbonate de sodium, du carbonate de sodium, et de l’acide tartrique comme rajusteurs du pH, (vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et (viii) les agents de conservation suivants : (A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique, (B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(3)

A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)

(2)

L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(2)

Frozen fish fillets; frozen lobsters; frozen crab; frozen clams and frozen shrimp Frozen crustaceans and molluscs Breath freshener products Frozen fish fillets; frozen minced fish; frozen lobster; frozen crab; frozen clams; frozen shrimp Canned drinking water Purpose of Use To reduce thaw drip To facilitate the removal of the crustacean shell and to reduce moisture loss during cooking To characterize the product To reduce processing losses and to reduce thaw drip Corrosion inhibitor Plasticizing agent

(3)

Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette. B.08.041.1 (1) [N]. Une préparation de fromage fondu a) doit (i) être le produit du broyage et du mélange, à l’aide d’une source de chaleur, d’une ou de plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène, et (B) not less than 51 per cent cheese, (C) not more than 46 per cent moisture, and (i) water added to adjust the moisture content, (iii) salt, vinegar and sweetening agents, (A) sodium carboxymethyl cellulose (carboxymethylcellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent, (B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total, (C) lecithin in an amount not exceeding 0.2 per cent, and (D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent, (ii) contenir (A) du lait ou des produits du lait ajoutés, (B) au moins 51 pour cent de fromage, (C) au plus 46 pour cent d’humidité, et (D) au moins 23 pour cent de matière grasse de lait; et b) peut contenir (i) de l’eau ajoutée pour modifier la teneur en humidité, (ii) de la matière grasse de lait ajoutée, (iii) du sel, du vinaigre et des agents édulcorants, (iv) les colorants suivants : (A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et (B) en quantité n’excédant pas 35 parties par million, le ß-apo-8’-caroténal, l’ester éthylique de l’acide ß-apo-8’-caroténoïque ou d’un mélange de ces produits. (v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent : (A) en quantité n’excédant pas 0,5 pour cent, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), (B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans les cas des sels de phosphate, et 4,0 pour cent en tous, (C) de la lécithine, en quantité n’excédant pas 0,2 pour cent, et (a) shall (D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits, (v.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n’excédant pas 1 pour cent, (vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’acide tartrique comme rajusteurs du pH, (vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et (viii) les agents de conservation suivants : (A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique, (B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

13 p.p.m. calculated as anhydrous sodium ferrocyanide

(2)

L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(2)

0.5% total added phosphate calculated as sodium phosphate, dibasic When used in combination with sodium oxide in solution, sodium hydroxide not to exceed 70 p.p.m. Used in combination with sodium tripolyphosphate and sodium acid pyrophosphate, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Purpose of Use | Maximum Level of Use S.11 | Sodium Tripolyphosphate | Frozen fish fillets; frozen minced fish; frozen comminuted fish; frozen lobster; frozen crab; frozen clams and frozen shrimp | To reduce processing losses and to reduce thaw drip | Used singly or in combination with sodium acid pyrophosphate and sodium pyrophosphate tetrabasic, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic S.13 | Stannous Chloride | (1) Asparagus packed in glass containers or fully lined (lacquered) cans | (1) Flavour and colour stabilizer | (1) 25 p.p.m. calculated as tin | | (2) Canned carbonated soft drinks; concentrated fruit juices except frozen concentrated orange juice; lemon juice; lime juice | (2) Flavour and colour stabilizer | (2) Good Manufacturing Practice S.15 | Sodium Methyl Sulphate | Pectin | A processing aid, the result of methylation of pectin by sulfuric acid and methyl alcohol and neutralized by sodium bicarbonate | 0.1% of pectin S.16 | Sucrose Acetate Isobutyrate | (Naming the flavour) Flavour for use in beverages containing citrus or spruce oils | Density adjusting agent | 300 p.p.m. in beverages containing citrus or spruce oils as consumed Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Purpose of Use | Maximum Level of Use Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Sweeteners Item No. Additive Permitted in or on

(3)

Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette. B.08.041.2 (1) [N]. Une préparation de fromage fondu (avec indication des ingrédients ajoutés) a) doit (i) être le produit du broyage et du mélange, à l’aide d’une source de chaleur, d’une ou de (A) chocolate, condiments, flavouring preparations, seasonings or spices, (B) fruits, nuts, pickles, relishes or vegetables, (iii) contain (B) not more than 46 per cent moisture, and (i) water added to adjust the moisture content, (iii) salt, vinegar and sweetening agents, (A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent, (B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium (C) lecithin in an amount not exceeding 0.2 per cent, (D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent, SOR/79-752, s. 2; SOR/91-409, s. 4; SOR/92-400, s. 7; SOR/2007-302, s. 4(F); SOR/2011-278, s. 5; SOR/2017-18, s. 18(F); SOR/2018-69, s. 28(F). B.08.041.3 (1) [S]. Processed Cheese Spread (a) shall (ii) contain (B) not less than 51 per cent cheese, (C) not more than 60 per cent moisture, and (D) not less than 20 per cent milk fat; (i) water added to adjust the moisture content, (iii) salt, vinegar and sweetening agents, (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(3)

0.1% in beverages as consumed

(2)

L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(4)

0.3% in products as consumed Current to November 11, 2024 Last amended on June 17, 2024 Item No. | Additive | Permitted in or on | Maximum Level of Use A.2 | Aspartame, encapsulated to prevent degradation during baking | Baking mixes; Unstandardized bakery products | 0.4% in product as consumed H.1 | Hydrogenated starch hydrolysates | Unstandardized foods | Good Manufacturing Practice Item No. | Additive Permitted in or on

(3)

Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette. DORS/79-752, art. 2; DORS/91-409, art. 4; DORS/92-400, art. 7; DORS/2007-302, art. 4(F); DORS/2011-278, art. 5; DORS/2017-18, art. 18(F); DORS/2018-69, art. 28(F). B.08.041.3 (1) [N]. Le fromage fondu à tartiner a) doit (i) être le produit du broyage et du mélange, à l’aide d’une source de chaleur, d’une ou de plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène, et (ii) contenir (A) du lait ou des produits du lait ajoutés, (B) au moins 51 pour cent de fromage, (C) au plus 60 pour cent d’humidité, et (D) au moins 20 pour cent de matière grasse de lait; et b) peut contenir (i) de l’eau ajoutée pour modifier la teneur en humidité, (ii) de la matière grasse de lait ajoutée, (iii) du sel, du vinaigre et des agents édulcorants, (iv) les colorants suivants : (A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et (B) en quantité n’excédant pas 35 parties par million, le ß-apo-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-caroténoïque ou un mélange de ces produits, (A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethylcellulose), cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, (B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total, (C) lecithin in an amount not exceeding 0.2 per cent, and (D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent, (v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent : (A) en quantité n’excédant pas 0,5 pour cent, la carraghénine d’ammonium, la carraghénine de calcium, la gomme de caroube (gomme de caroubier), la carraghénine, la gélatine, la gomme de guar, la gélose de mousse d’Irlande, la carraghénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carraghénine de sodium, la gomme adragante, la gomme xanthane ou un mélange de ces produits, (B) le phosphate de calcium diacide, le phosphate de potassium diacide, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité, calculée en sels anhydres, ne dépassant pas 3,5 pour cent, dans le cas des sels de phosphate, et 4,0 pour cent en tout, (C) de la lécithine, en quantité n’excédant pas 0,2 pour cent, et (D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits, (v.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n’excédant pas 1 pour cent, (vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’acide tartrique comme rajusteurs du pH, (vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et (viii) les agents de conservation suivants : (a) shall (A) chocolate, condiments, flavouring preparations, seasonings or spices, (B) fruits, nuts, pickles, relishes or vegetables, (iii) contain (B) not more than 60 per cent moisture, and (A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique, (B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculées respectivement en acide propionique et en acide sorbique.

(9)

Confectionery glazes for snack foods; Sweetened seasonings or coating mixes for snack foods

(2)

L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(1)

A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)

(3)

Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette. B.08.041.4 (1) [N]. Le fromage fondu à tartiner (avec indication des ingrédients ajoutés) a) doit (i) être le produit du broyage et du mélange, à l’aide d’une source de chaleur, d’une ou de plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène, (ii) contenir, en quantité suffisante pour pouvoir se distinguer du fromage fondu à tartiner, tout en conservant sa nature fondamentale, les ingrédients suivants : (A) des assaisonnements, du chocolat, des condiments, des épices ou des préparations aromatisantes, (B) des achets, des cornichons, des fruits, des légumes ou des noix, (C) de la viande préparée ou conservée, ou (D) du poisson préparé ou conservé, et (iii) contenir (A) du lait ou des produits du lait ajoutés, (i) water added to adjust the moisture content, (iii) salt, vinegar and sweetening agents, (A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, (B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total, (C) lecithin in an amount not exceeding 0.2 per cent, (D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent, b) au plus 60 pour cent d’humidité, et (C) au moins 20 pour cent de matière grasse de lait; et b) peut contenir (i) de l’eau ajoutée pour modifier la teneur en humidité, (ii) de la matière grasse de lait ajoutée, (iii) du sel, du vinaigre et des agents édulcorants, (iv) les colorants suivants : (A) en quantité conformant aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et (B) en quantité n’excédant pas 35 parties par million, le ß-apo-8’-caroténal, l’ester éthylique de l’acide ß-apo-8’-caroténoïque ou un mélange de ces produits, (v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent : (A) en quantité n’excédant pas 0,5 pour cent, la carraghénine d’ammonium, la carraghénine de calcium, la gomme de caroube (gomme de caroubier), la carraghénine, la gélatine, la gomme de guar, la gélose de mousse d’Irlande, la carraghénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carraghénine de sodium, la gomme adragante, la gomme xanthane ou un mélange de ces produits, (B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité calculée en sels anhydres, ne dépassant pas 3,5 pour cent dans le cas des sels de phosphate, et 4,0 pour cent en tout, (C) la lécithine en quantité n’excédant pas 0,2 pour cent, (D) les monoglycérides, les mono- et diglycérides ou un mélange de ces produits, en quantité n’excédant pas 0,5 pour cent, (v.1) le phosphate tribasique de calcium comme agent destiné à améliorer la couleur, la texture, la consistance et l’aptitude à tartiner, en quantité n’excédant pas 1 pour cent, SOR/79-752, s. 2; SOR/82-1071, s. 5; SOR/91-490, s. 6; SOR/2007-302, s. 4(F); SOR/2011-278, s. 6; SOR/2017-18, s. 18(F); SOR/2018-69, s. 28(F). B.08.041.5 (1) [S]. Cold-Pack (naming the variety) Cheese (a) shall (C) de la lécithine, en quantité n’excédant pas 0,2 pour cent, et (D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits. (v.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n’excédant pas 1 pour cent, (vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium, et de l’acide tartrique comme rajusteurs de pH, (vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et (viii) les agents de conservation suivants : (A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique, (B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(6)

Unstandardized fruit spreads

(2)

L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(10)

Unstandardized processed fruit and vegetable products, except unstandardized canned fruit

(3)

Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette. DORS/79-752, art. 2; DORS/82-1071, art. 5; DORS/91-490, art. 6; DORS/2007-302, art. 4(F); DORS/2011-278, art. 6; DORS/2017-18, art. 18(F); DORS/2018-69, art. 28(F). B.08.041.5 (1) [N]. Le fromage conditionné à froid (indication de la variété) a) doit (B) stirred curd cheese, (C) granular curd cheese, or (i) water added to adjust the moisture content, (iii) salt, vinegar and sweetening agents, SOR/79-755, s. 2; SOR/92-440, s. 8; SOR/2017-18, s. 18(F); SOR/2018-69, s. 28(F). B.08.041.6 (1) [S]. Cold-Pack (naming the variety) Cheese with (naming the added ingredients) (a) shall (B) chocolate, condiments, seasonings or spices, (i) water added to adjust the moisture content, (iii) salt, vinegar and sweetening agents, ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycollate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, SOR/79-752, s. 2; SOR/92-490, s. 9; SOR/2010-94, s. 5(E); SOR/2011-278, s. 7; SOR/2017-18, s. 18(F); SOR/2018-98, s. 28(F). B.08.041.7 (1) [S]. Cold-Pack Cheese Food (a) shall la gomme du guar, la gélose de mousse d’Irlande, la carraghénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carraghénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits, (vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’acide tartrique comme rajusteurs du pH, (vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et (viii) les agents de conservation suivants : (A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique, (B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(11)

0.013% in products as consumed

(2)

L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3)

0.025% in beverages as consumed

(3)

Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette. DORS/79-752, art. 2; DORS/92-490, art. 9; DORS/2010-94, art. 5(A); DORS/2011-278, art. 7; DORS/2017-18, art. 18(F); DORS/2018-98, art. 28(F). B.08.041.7 (1) [N]. Une préparation de fromage conditionné à froid a) doit (i) être le produit du broyage et du mélange, sans l’aide d’une source de chaleur, d’une ou de (ii) contain (B) not less than 51 per cent cheese, (C) not more than 46 per cent moisture, and (i) water added to adjust the moisture content, (iii) salt, vinegar and sweetening agents, ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène, (ii) contenir (A) du lait ou des produits du lait ajoutés, (B) au moins 51 pour cent de fromage, (C) au plus 46 pour cent d’humidité, et (D) au moins 23 pour cent de matière grasse de lait; et b) peut contenir (i) de l’eau ajoutée pour modifier la teneur en humidité, (ii) de la matière grasse de lait ajoutée, (iii) du sel, du vinaigre et des agents édulcorants, (iv) les colorants suivants : (A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et (B) en quantité n’excédant pas 35 parties par million, le ß-apo-8'-caroténal, l’ester éthylique de l’acide ß-apo-8'-caroténoïque ou un mélange de ces produits, (v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent : en quantité ne dépassant pas 0,5 pour cent, la carraghénine d’ammonium, la carraghénine de calcium, la gomme de caroube (fève de l’acacia à gomme ou fève acacia), la carraghénine, la gélatine, la gomme de guar, la gélose de mousse d’Irlande, la carraghénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carraghénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits, (vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’acide tartrique comme rajusteurs du pH, SOR/79-752, s. 2; SOR/2007-302, s. 4(F); SOR/2017-18, s. 18(F); SOR/2018-69, s. 28(F). B.08.041.8 (1) [S]. Cold-Pack Cheese Food with (naming the added ingredients) (a) shall (A) chocolate, condiments, flavouring preparations, seasonings or spices, (B) fruits, nuts, pickles, relishes or vegetables, (vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et (viii) les agents de conservation suivants : (A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique, (B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou (C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(4)

0.025% in products as consumed

(2)

L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(9)

0.065% in products as consumed

(3)

Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette. DORS/79-752, art. 2; DORS/2007-302, art. 4(F); DORS/2017-18, art. 18(F); DORS/2018-69, art. 28(F). B.08.041.8 (1) [N]. Une préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés) a) doit (i) être le produit du broyage et du mélange, sans l’aide d’une source de chaleur, d’une ou de plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de lactosérum, en vue de former une masse homogène, (ii) contenir, en quantité suffisante pour pouvoir se distinguer de la préparation de fromage conditionné à froid, tout en conservant sa nature fondamentale, les ingrédients suivants : (A) des assaisonnements, du chocolat, des condiments, des épices ou des préparations aromatisantes, (B) des achards, des cornichons, des fruits, des légumes ou des noix, (iii) contain (B) not more than 46 per cent moisture, and (i) water added to adjust moisture content, (iii) sweetening agents, salt and vinegar, ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycoate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, (C) de la viande préparée ou conservée, ou (D) du poisson préparé ou conservé, et (iii) contenir (A) du lait ou des produits du lait ajoutés, (B) au plus 46 pour cent d’humidité, et (C) au moins 22 pour cent de matière grasse de lait; et b) peut contenir (i) de l’eau ajoutée pour modifier la teneur en humidité, (ii) de la matière grasse de lait ajoutée, (iii) des agents édulcorants, du sel et du vinaigre, (iv) les colorants suivants : (A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et (B) en quantité n’excédant pas 35 parties par million, le ß-apo-8’-caroténal, l’ester éthylique de l’acide ß-apo-8’-caroténoïque ou un mélange de ces produits, (v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent : en quantité ne dépassant pas 0,5 pour cent, la carraghénine d’ammonium, la carraghénine de calcium, la gomme de caroube (fève de l’acacia vulgaire ou faux acacia), la carraghénine, la gélatine, la gomme de guar, la gélose de mousse d’Irlande, la carraghénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycoate sodique de cellulose), la carraghénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits, (vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’acide tartrique comme rajusteurs du pH, SOR/79-752, s. 2; SOR/2007-302, s. 4(F); SOR/2011-278, s. 8; SOR/2017-18, s. 18(F); SOR/2018-69, s. 28(F). SOR/78-405, s. 1; SOR/79-752, s. 3. (a) a wholesaler; (b) a jobber; or (a) the registered number of the cheese factory, (b) the date of manufacture of the cheese, (c) the vat number or vat numbers, (d) the name and address of the person to whom the cheese is sold, and (a) 100 Escherichia coli, or (b) 100 Staphylococcus aureus (a) 500 Escherichia coli, or (b) 1,000 Staphylococcus aureus SOR/78-405, s. 2; SOR/82-768, s. 21; SOR/84-17, s. 4. B.08.049 [S]. Whey (ii) lactase, SOR/79-752, s. 4; SOR/89-655, s. 1; SOR/2010-40, s. 1; SOR/2011-282, s. 1. B.08.050 [Repealed, SOR/95-281, s. 1] B.08.051 [S]. Cottage Cheese (b) shall contain not more than 80 per cent moisture; (d) may contain (ii) cream, (iii) milk powder, (vi.2) chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), in an amount consistent with good manufacturing practice, (vi.2) pepsin derived from glandular layer of porcine stomach, (vii) salt, (viii) calcium chloride, (ix) added lactose, (x) pH adjusting agents, (xi) relishes, (xii) fruits, (xiii) vegetables, and (xiv) carbon dioxide. SOR/82-768, s. 22. Butter B.08.056 [S]. Butter (a) shall (ii) bacterial culture, (iii) salt, and (iv) food colour. SOR/92-400, s. 10. SOR/92-400, s. 10. Ice Cream B.08.061 [S]. Ice Cream Mix (ii) a flavouring preparation, (iii) cocoa or chocolate syrup, (iv) a food colour, (v) pH adjusting agents, (vii) a sequestering agent, (viii) salt, (ix) not more than one per cent added edible casein or edible caseinates; and (i) 36 per cent solids, and SOR/93-400, a. 11; SOR/97-543, a. 2; SOR/2007-75, a. 2; SOR/2007-302, s. 4(F); SOR/2010-142, s. 6(F). B.08.062 [S]. Ice Cream (i) 36 per cent solids, (d) shall contain not more than (i) 100,000 bacteria per gram, and (ii) 10 coliform organisms per gram, SOR/82-768, s. 23; SOR/92-490, s. 12. Sherbet [SOR/98-580, s. 1(F)] B.08.063 [S]. Sherbet (i) water, (ii) a sweetening agent, (iv) citric or tartaric acid, (v) a flavouring preparation, (vi) a food colour, (vii) not more than 0.75 per cent stabilizing agent, (viii) a sequestering agent, (ix) lactose, (x) not more than 0.5 per cent microcrystalline cellulose, and (xi) not more than one per cent added edible casein or edible caseinates; and (c) shall contain SOR/92-490, s. 13; SOR/97-543, s. 3(F); SOR/98-580, s. 1(F); SOR/2007-302, s. 4(F). fruits, des noix ou des confiseries ont été ajoutés, 180 grammes de solides au litre, dont au moins 40 grammes doivent être de la matière grasse du lait; d) doit renfermer au plus (i) 100 000 bactéries par gramme, et (ii) 10 organismes coliformes par gramme, déterminés selon la méthode officielle MFQ-2, Examen microbiologique de la crème glacée ou du lait glacé, 30 novembre 1981. DORS/82-768, art. 23; DORS/92-490, art. 12. Sorbet laitier [DORS/98-580, art. 1(F)] B.08.063 [N]. Le sorbet laitier a) doit être l’aliment congelé, autre que la crème glacée ou le lait glacé, fabriqué à partir d’un produit du lait; b) peut renfermer (i) de l’eau, (ii) un agent édulcorant, (iii) des fruits ou jus de fruits, (iv) de l’acide citrique ou tartrique, (v) une préparation aromatisante, (vi) un colorant pour aliments, (vii) au plus 0,75 pour cent d’agent stabilisant, (viii) un chélateur ou agent séquestrant, (ix) du lactose, (x) au plus 0,5 pour cent de cellulose microcristalline, (xi) au plus un pour cent de caséine comestible ou de caséinates comestibles ajoutés; c) doit renfermer (i) au plus cinq pour cent de solides du lait, y compris le gras de lait, et (ii) au moins 0,35 pour cent d’acide déterminé par titrage et exprimé en acide lactique. Ice Milk B.08.071 [S]. Ice Milk Mix (ii) a flavouring preparation, (iii) cocoa or chocolate syrup, (iv) a food colour, (v) a pH adjusting agent, (vii) a sequestering agent, (viii) added lactose, and (ix) not more than 1.5 per cent microcrystalline cellulose, (xi) not more than one per cent added edible casein or edible caseinates; and (c) shall contain (i) not less than 33 per cent solids, and (ii) not less than three per cent and not more than five per cent milk fat. SOR/92-400, s. 14; SOR/97-543, s. 4(F); SOR/2007-302, s. 4(F). B.08.072 [S]. Ice Milk (c) shall contain (i) not less than 33 per cent solids, (d) shall contain not more than (i) 100,000 bacteria per gram, and (ii) 10 coliform organisms per gram, SOR/82-768, s. 24; SOR/92-400, s. 15. B.08.073 [Repealed, SOR/92-626, s. 13] B.08.074 (1) The percentage of milk fat contained in (a) yogurt, SOR/88-559, s. 18; SOR/2016-305, s. 75(F). Cream B.08.075 [S]. Cream (i) a pH adjusting agent, (ii) a stabilizing agent, (A) skim milk powder in an amount not exceeding 0.25 per cent, (B) glucose solids in an amount not exceeding 0.1 per cent, (C) calcium sulphate in an amount not exceeding 0.005 per cent, and (D) xanthan gum in an amount not exceeding 0.02 per cent, and (E) [Repealed, SOR/2010-142, s. 7] (iv) in the case of cream for whipping, microcrystalline cellulose in an amount not exceeding 0.2 per cent. SOR/79-662, s. 2; SOR/82-107, s. 6; SOR/88-419, s. 1; SOR/2010-142, s. 7. SOR/88-559, s. 19; SOR/2016-305, s. 75(F). B.08.077 [S]. Sour Cream (ii) whey solids, (iii) buttermilk, (v) salt, (C) sodium phosphate dibasic in an amount not exceeding 0.05 per cent, (viii) sodium citrate as a flavour precursor in an amount not exceeding 0.1 per cent, (xi) chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), in an amount consistent with good manufacturing practice. SOR/87-616, s. 1; SOR/90-500, s. 6; SOR/91-60, s. 5; SOR/92-197, s. 8; SOR/94-212, s. 8; SOR/95-189, s. 8; SOR/98-456, s. 5; SOR/2005-98, s. 7; SOR/2010-143, ss. 38, 39(E). DIVISION 9 SOR/85-179, s. 1. B.09.003 [S]. Olive Oil or Sweet Oil (vi) not more than 1.5 per cent linolenic acid, and (d) shall have (v) an acid value of not more than 6.6 milligrams potassium hydroxide per gram of oil, (vii) a peroxide value of not more than 20 milliequivalents peroxide oxygen per kilogram of oil, (viii) an unsaponifiable matter content of not more than 15 grams per kilogram, and SOR/78-665, s. 1. B.09.004 [S]. Cotton Seed Oil (a) shall be the oil of seeds of cultivated Gossypium spp.; (v) an unsaponifiable matter content of not more than 15 grams per kilogram, (vi) a positive Halphen test, PART B Foods DIVISION 8 Fats and Oils Sections B.09.004-B.09.007 (vii) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and (c) may contain oxystearin. (d) an acid value of not more than five. SOR/97-263, s. 3. B.09.006 [S]. Corn Oil or Maize Oil (a) shall be the oil of the germ or embryo of Zea mays L.; and (v) an unsaponifiable matter content of not more than 28 grams per kilogram, (vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil. B.09.007 [S]. Peanut Oil or Arachis Oil Règlement sur les aliments et drogues

(12)

0.04% in products as consumed Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives

PARTIE B Aliments

(15)

Achards (relish); cornichons Food Additives That May Be Used as pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents Item No. Additive | Permitted in or Upon | Maximum Level of Use

TITRE 8 Graisses et huiles

(1)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

Articles B.09.004-B.09.007

(vii) un indice d’acidité d’au plus 0,6 milligramme d’hydroxyde de potassium par gramme d’huile, et (viii) un indice de peroxyde d’au plus 10 milléquivalents d’oxygène dégagé par kilogramme d’huile; et c) peut renfermer de l’oxystéarine. B.09.005 [N]. Le beurre de cacao est la matière grasse extraite de fèves de cacao décortiquées, avant ou après torréfaction, ou de la liqueur de cacao et possède les caractéristiques suivantes : a) un indice de réfraction (à 40 °C) d’au moins 1,453 et d’au plus 1,458; b) un indice de saponification d’au moins 188 et d’au plus 202; c) un indice d’iode (Hanus) d’au moins 32 et d’au plus 41; et d) un indice d’acidité d’au plus cinq. DORS/97-263, art. 3. B.09.006 [N]. L’huile de maïs ou huile de blé d’inde a) est l’huile du germe ou de l’embryon de Zea mays L.; et b) doit avoir (i) une densité relative (20 °C/eau à 20 °C) d’au moins 0,917 et d’au plus 0,925, (ii) un indice de réfraction (nD40°C) d’au moins 1,465 et d’au plus 1,468, (iii) un indice de saponification (milligrammes d’hydroxyde de potassium par gramme d’huile) d’au moins 187 et d’au plus 195, (iv) un indice d’iode (Wijs) d’au moins 103 et d’au plus 128, (v) une teneur en substances insaponifiables d’au plus 28 grammes par kilogramme, (vi) un indice d’acidité d’au plus 0,6 milligramme d’hydroxyde de potassium par gramme d’huile, et (vii) un indice de peroxyde d’au plus 10 milléquivalents d’oxygène dégagé par kilogramme d’huile. B.09.007 [N]. L’huile d’arachide (a) shall be the oil of the seeds of *Arachis hypogaea L.*; (v) an unsaponifiable matter content of not more than 10 grams per kilogram, (vi) an arachidic and higher fatty acids content of not less than 48 grams per kilogram, (vii) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and (viii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil; and (c) not contain oxystearin. SOR/84-300, s. 22(E). **B.09.008 [S]. Soybean Oil, Soya Bean Oil, Soja Oil or Soya Oil** (a) shall be the oil of the seeds of *Glycine max (L.) Merr.*; (v) an unsaponifiable matter content of not more than 15 grams per kilogram, PART B Foods DIVISION 8 Fats and Oils Sections B.09.008-B.09.009A (c) may contain oxystearin. SOR/84-300, s. 23(E). (v) an unsaponifiable matter content of not more than 15 grams per kilogram, (vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil. B.09.009A [S]. Safflowerseed Oil or Safflower Oil (a) shall be the oil of the seeds of *Carthamus tinctorius* L.; (v) an unsaponifiable matter content of not more than 15 grams per kilogram, (vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil. SOR/88-456, s. 7(F); SOR/2022-143, s. 20. (b) an antifoaming agent, (c) stearyl monoglyceridyl citrate, (d) monoglycerides or a combination of monoglycerides and diglycerides of fat forming fatty acids, the weight of the monoglycerides being not more than 10 per cent and the total weight of monoglycerides and diglycerides being not more than 20 per cent of the weight of the shortening, (f) sorbitan tristearate, except that the total weight of the ingredients permitted under paragraphs (d) and (e) shall not be greater than 20 per cent of the weight of the shortening. SOR/2022-168, s. 39. B.09.012 [Repealed, SOR/97-148, s. 2] B.09.013 [S]. Lard (a) shall be the rendered fat from hogs; (iii) a titre of not less than 32°C and not more than 45°C, (vi) an unsaponifiable matter content of not more than 12 grams per kilogram, (vii) an acid value of not more than 2.5 milligrams potassium hydroxide per gram of fat, and (viii) a peroxide value of not more than 16 milliequivalents peroxide oxygen per kilogram of fat; and SOR/78-401, s. 1(F); SOR/84-300, s. 25(F); SOR/2022-168, s. 40. B.09.015 [S]. Suet (iii) a titre of not less than 42.5°C and not more than 47°C, (vi) an unsaponifiable matter content of not more than 10 grams per kilogram, (vii) an acid value of not more than 2.0 milligrams potassium hydroxide per gram of fat, and (viii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of fat; and SOR/78-665, s. 2(F). B.09.016 [S]. Margarine (b) shall contain (iii) 26 µg of vitamin D per 100 g; and (ii) whey solids or modified whey solids, (iii) protein, (iv) water, (vi) a flavouring agent, (vii) a sweetening agent, (viii) potassium chloride and sodium chloride, (xi) the following pH adjusting agents: citric acid, lactic acid, potassium bicarbonate, sodium bicarbonate, potassium carbonate, sodium carbonate, sodium citrate, sodium lactate, potassium citrate, potassium hydroxide, sodium hydroxide, potassium lactate, sodium potassium tartrate and tartaric acid, as set out in Table X to section B.16.100, B.09.017 [S]. Calorie-Reduced Margarine (i) acacia gum, (ii) agar, (iii) algin, (iv) carob bean gum, (v) carrageenan, (vi) furcelleran, (vii) gellan gum, (viii) guar gum, (ix) karaya gum, (x) propylene glycol alginate, (xi) tragacanth gum, and (xii) xanthan gum; (i) if it contains none of the ingredients mentioned in paragraph (b), contain polyglycerol esters of fatty acids in an amount not exceeding 0.2 per cent, or (d) notwithstanding subparagraph B.09.016(c)(x), may contain lecithin in an amount not exceeding 0.5 per cent; and (e) may contain (i) vegetable starch, (iii) maltodextrin. SOR/94-38, s. 1; SOR/95-350, s. 1; SOR/96-160, s. 1. B.09.020 and B.09.021 [Repealed, SOR/88-559, s. 20] DIVISION 10 B.10.005 [S]. (naming the flavour) Flavour (i) water, SOR/84-300, s. 27(E); SOR/86-1112, s. 1; SOR/2010-142, s. 8. B.10.006 [N]. Une préparation aromatisante artificielle (de nom de l’arôme) ou une préparation aromatisante imitation de (nom de l’arôme) doit être une préparation aromatisante, sauf que les principes aromatiques peuvent provenir en tout ou en partie de sources autres que la plante aromatique dont il porte le nom, et, si ladite préparation aromatisante est définie dans le présent règlement, le pouvoir aromatisant de ladite préparation aromatisante artificielle ou imitation doit être au moins égal à celui de ladite préparation aromatisante. DORS/84-300, art. 27(A); DORS/86-1112, art. 1; DORS/2010-142, art. 8. B.10.007 [N]. Nonobstant les articles B.10.003 et B.10.005, un extrait (de nom du fruit) naturellement fortifié, une essence (de nom du fruit) naturellement fortifiée ou une préparation aromatisante (de nom du fruit) naturellement fortifiée doivent être un extrait, une essence ou une préparation aromatisante obtenus du fruit nommé, auxquels ont été ajoutés d’autres extraits naturels et dont 51 pour cent du pouvoir aromatisant doit provenir du fruit nommé. SOR/84-300, s. 28. B.10.008 Sur toute étiquette ou dans toute réclame d’une préparation aromatisante artificielle ou d’une imitation d’une préparation aromatisante, le mot « artificielle » ou « imitation » doit faire partie intégrante du nom de ladite préparation aromatisante, être imprimé en caractères identiques à ceux du nom et être disposé de façon identique. DORS/84-300, art. 28. B.10.009 [N]. L’essence d’amande, l’extrait d’amande et la préparation aromatisante à l’amande, doivent être extraits ou nommés de l’amande amère, de l’abricot ou de la pêche, et doivent renfermer au moins un pour cent en volume de l’huile volatile ainsi obtenue, exempte d’acide cyanhydrique. B.10.010 [N]. L’essence d’anis, l’extrait d’anis et la préparation aromatisante à l’anis, doivent être l’essence, l’extrait ou la préparation aromatisante, préparés à partir d’huile d’anis, naturelle ou dépourvue de terpènes, et doivent représenter un pouvoir aromatisant correspondant à celui d’une solution alcoolique qui renferme au moins trois pour cent en volume d’huile d’anis, huile volatile extraite du fruit de Pimpinella anisum L. ou d’Illicium Verum Hook. (c) not more than 10 per cent eugenol. (a) shall be the essence, extract or flavour prepared from the vanilla bean, the dried, cured fruit of Vanilla planifolia, Andrews, or Vanilla tahitensis, J. W. Moore; (i) not less than 10 g of vanilla beans, where the beans contain 25 per cent or less moisture, and (ii) not less than 7.5 g of vanilla beans on the moisture-free basis, where the beans contain more than 25 per cent moisture; and (c) notwithstanding sections B.10.003 and B.10.005, shall not contain added colour. SOR/82-768, s. 25; SOR/84-300, s. 29(F); SOR/91-149, s. 1. PART B Foods DIVISION 11 Flavouring Preparations Sections B.11.001–B.11.002 DIVISION 11 [SOR/78-478, s. 1] B.11.001 In this Division, acid ingredient means (a) citric, malic or tartaric acid, (b) lemon or lime juice, or (c) vinegar; (ingrédient acide) sweetening ingredient means sugar, invert sugar, honey, dextrose, glucose or glucose solids or any combination thereof in dry or liquid form. (ingrédient édulcorant) SOR/87-374, s. 1. Vegetables B.11.002 [S]. Canned (naming the vegetable) (i) a sweetening ingredient, (ii) salt, (iii) water, (iv) a firming agent, and (v) citric acid; and Règlement sur les aliments et drogues

(1)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005

PARTIE B Aliments

(1)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005

TITRE 11 Préparations aromatisantes

(1)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005

Articles B.10.027–B.11.002

(3)

Uncultured buttermilk Item No. Additive Permitted in or Upon

TITRE 11

Fruits, légumes, leurs produits et succédanés [DORS/78-478, art. 1] B.11.001 Dans le présent titre, ingrédient acide désigne a) l’acide citrique, malique ou tartrique, b) le jus de citron ou de limette, ou c) le vinaigre; (acid ingredient) ingrédient édulcorant désigne le sucre, le sucre inverti, le miel, le dextrose, le glucose ou les solides du glucose, ou un mélange quelconque de ces produits, à l’état sec ou liquide; (sweetening ingredient) jus de fruit désigne le liquide non fermenté, exprimé de fruits mûrs, sains et frais qui peut être traité par la chaleur et refroidi. (fruit juice) B.11.001.1 Est interdite la vente de fruits ou de légumes frais destinés à être consommés crus, à l’exception de raisins frais, s’ils sont additionnés d’anhydride sulfureux ou de ses sels. DORS/87-374, art. 1. Légumes B.11.002 [N]. Le ou les (nom du légume) en conserve a) doivent être le produit obtenu par traitement thermique du légume frais qui est nommé, après préparation appropriée; b) doivent être conditionnés en récipients hermétiquement scellés; c) peuvent renfermer (i) un ingrédient édulcorant, (ii) du sel, (iii) de l’eau, (iv) un agent raffermissant, (d) may contain (iii) in the case of (C) [Repealed, SOR/2012-43, s. 4] (v) in the case of canned legumes, other than canned green beans, canned peas and canned wax beans, calcium disodium ethylenediaminetetraacetate in an amount not exceeding 365 parts per million calculated as the anhydrous form, or disodium ethylenediaminetetraacetate in an amount not exceeding 165 parts per million, (vi) to (vii) [Repealed, SOR/2012-43, s. 4] (viii) in the case of canned asparagus, canned green beans, canned wax beans and canned peas (v) de l’acide citrique; d) peuvent contenir (i) pour les haricots verts en conserve et les haricots jaunes en conserve, une quantité de morceaux de poivron vert, de poivron rouge et de tomate représentant au plus 15 pour cent du produit final, ainsi que des assaisonnements à l’aneth et du vinaigre, (ii) pour les pois en conserve, des garnitures composées d’un ou de plusieurs des éléments suivants : laitue, oignons, carottes, morceaux de poivron vert ou rouge, dont la quantité représente au plus 15 pour cent de l’ensemble de l’ingrédient végétal égoutté, des herbes aromatiques, des épices et des assaisonnements, du bouillon ou du jus de légumes et des herbes aromatiques, une quantité d’hydroxyde de calcium d’au plus 0,01 pour cent du produit final et une quantité d’hydroxyde de magnésium d’au plus 0,05 pour cent du produit final, (iii) pour (A) les asperges en conserve, une quantité d’acide acétique, d’acide malique et d’acide tartrique conforme aux bonnes pratiques industrielles, (B) les asperges blanches en conserve, une quantité d’acide acétique, d’acide ascorbique, d’acide malique et d’acide tartrique conforme aux bonnes pratiques industrielles, (C) [Abrogé, DORS/2012-43, art. 4] (iv) pour les asperges conservées dans des contenants en verre ou des contenants métalliques vernis sur toute leur surface intérieure, une quantité de chlorure stanneux d’au plus 2,5 [25] parties par million, calculée en étain, (v) pour les légumineuses en conserve, à l’exception des haricots jaunes en conserve, des haricots verts en conserve et des pois en conserve, une quantité d’éthylènediaminetétraacétate de calcium disodique d’au plus 365 parties par million, calculée sous forme anhydre, ou une quantité d’éthylènediaminetétraacétate disodique d’au plus 165 parties par million, (vi) à (vii) [Abrogés, DORS/2012-43, art. 4] (viii) pour les asperges en conserve, les haricots verts en conserve, les haricots jaunes en conserve et les pois en conserve, SOR/79-660, s. 1; SOR/84-300, s. 30; SOR/95-435, s. 1; SOR/97-561, s. 1; SOR/2012-43, s. 4. B.11.003 [S]. Canned Mushrooms SOR/84-300, s. 31. B.11.003A [S]. Frozen Mushrooms (b) may contain citric acid, sodium metabisulphite, sodium phosphate, dibasic, sodium sulphate and salt. SOR/2012-43, s. 5. SOR/2012-43, s. 6. B.11.005 [S]. Tomatoes or Canned Tomatoes (i) a sweetening ingredient in dry form, (ii) salt, (iii) a firming agent, SOR/82-768, s. 26. SOR/2012-43, s. 7. SOR/82-768, s. 27; SOR/2012-43, s. 8. SOR/82-768, s. 27. SOR/2012-43, s. 9. SOR/2012-43, s. 10. (b) shall contain (i) vinegar, (ii) salt, (iv) a sweetening ingredient; and (ii) food colour. B.11.015 [Repealed, SOR/97-151, s. 19] SOR/82-768, s. 28. SOR/82-768, s. 28. B.11.012 [N]. La purée de tomates doit être le produit obtenu par traitement thermique et fait de tomates saines, mûres et entières, débarrassées des pelures et des graines et concentrée jusqu’à l’obtention d’un produit d’une densité d’au moins 1,050 (à 20 °C/20 °C); elle peut renfermer de l’acide citrique, du sel et un agent de conservation de la catégorie II. DORS/2012-43, art. 10. B.11.014 [N]. Le catsup de tomates, le catsup et les produits dont le nom usuel est une variante du mot catsup a) doivent être le produit obtenu par traitement thermique du jus de tomates rouges à maturité, ou de parures saines de tomates débarrassées des pelures et des graines; b) doivent renfermer (i) du vinaigre, (ii) du sel, (iii) des condiments, et (iv) un ingrédient édulcorant; et c) peuvent renfermer (i) un agent de conservation de la catégorie II, et (ii) un colorant pour aliments. B.11.015 [Abrogé, DORS/97-151, art. 19] B.11.016 Est interdite la vente de tomates en conserve, de jus de tomates ou d’un jus de légume qui renferme des filaments de moisissures dans plus de 25 pour cent du champ microscopique, à l’examen selon la méthode officielle MFO-5, Examen de tomates en conserve, de jus de tomates et de jus de légumes, de purée de tomates, de pâte de tomates, de pulpe de tomates et de catsup de tomates pour la détermination des filaments de moisissures, 30 novembre 1981. DORS/82-768, art. 28. B.11.017 Est interdite la vente de purée de tomates, de pâte de tomates, de pulpe de tomates ou de catsup de tomates qui renferme des filaments de moisissures dans plus de 50 pour cent du champ microscopique, à l’examen selon la méthode officielle MFO-5, Examen de tomates en conserve, de jus de tomates et de jus de légumes, de purée de tomates, de pâte de tomates, de SOR/82-768, s. 29; SOR/2012-43, s. 11. SOR/82-768, s. 29; SOR/2012-43, s. 12. (a) vinegar; (b) salt; (c) a sweetening ingredient; (d) spices; (e) seasonings; (f) lactic acid; (h) calcium chloride; (j) in the case of ripe olives, ferrous gluconate. SOR/97-561, s. 2. (a) spices; (b) seasonings; (c) sugar, invert sugar, dextrose or glucose, in dry or liquid form; (d) food colour; (f) a firming agent; (g) polyoxyethylene (20) sorbitan monooleate in an amount not exceeding 0.05 per cent; (h) lactic acid; (h.1) citric acid; (h.2) sucralose; SOR/84-300, s. 32; SOR/2012-43, s. 13; SOR/2012-104, s. 1. Fruits B.11.101 [S]. Canned (naming the fruit) (i) a sweetening ingredient, (ii) water, (iv) citric acid, (v) acesulfame-potassium, and PART B Foods Fruits Sections B.11.101-B.11.102 (vi) sucralose; and (d) may contain (ii) in the case of canned apples, a firming agent, (v) in the case of canned mandarin oranges, ascorbic acid, (x) in the case of canned apricots, calcium chloride. SOR/84-300, s. 33; SOR/2012-43, s. 14; SOR/2012-104, s. 2. (a) a sweetening ingredient; Règlement sur les aliments et drogues

(2)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese Item No. Additive Permitted in or Upon (Naming the variety) Cheese

PARTIE B Aliments

(2)

Apple (or rhubarb) and (naming the fruit) jam; Apricot nectar; Beans; Beans with pork; Canned mushrooms; Canned (naming the fruit); Canned (naming the vegetable); Canned tomatoes; Concentrated tomato paste; Fig marmalade; Fig marmalade with pectin; Frozen mushrooms; Frozen (naming the fruit); Frozen (naming the vegetable); Grape juice; Mincemeat; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Olives; Peach nectar; Pear nectar; Pickles; Pineapple marmalade; Pineapple marmalade with pectin; Relishes; Tomato juice; Tomato paste; Tomato pulp; Tomato puree

TITRE 11 Fruits, légumes, leurs produits et succédanés

Fruits

(5)

Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cottage cheese; Cream cheese spread; Cream cheese spread with (naming the added ingredients); Creamed cottage cheese; Ice cream mix; Ice milk mix; (naming the variety) Whey cheese; Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Sherbet

Articles B.11.101-B.11.102

(vi) du sucralose; d) peuvent renfermer : (i) dans le cas des poires en conserve, de l’acide lactique, de l’acide malique, de l’acide tartrique, des épices, des huiles d’épices, du jus de citron, de la menthe et une préparation aromatisante autre que celle qui simule l’arôme des poires en conserve, (ii) dans le cas des pommes en conserve, un agent raffermissant, (iii) dans le cas de la compote de pommes en conserve, de l’acide ascorbique, de l’acide isoascorbique, de l’acide malique, des épices, du sel et une préparation aromatisante autre que celle qui simule l’arôme de la compote de pommes en conserve, (iv) dans le cas des pamplemousses en conserve, du chlorure de calcium, des épices, du jus de citron, du lactate de calcium et une préparation aromatisante autre que celle qui simule l’arôme des pamplemousses en conserve, (v) dans le cas des mandarines en conserve, de l’acide ascorbique, (vi) dans le cas des pêches en conserve, des épices, des graines de pêches et des noyaux de pêches pour rehausser la saveur, des huiles d’épices et une préparation aromatisante autre que celle qui simule l’arôme des pêches en conserve, (vii) dans le cas de l’ananas en conserve, du diméthylpolysiloxane lorsque du jus d’ananas est utilisé comme véhicule de conditionnement, des épices, des huiles d’épices, de la menthe, et une préparation aromatisante autre que celle qui simule l’arôme de l’ananas en conserve, (viii) dans le cas des prunes en conserve, une préparation aromatisante autre que celle qui simule l’arôme des prunes en conserve, (ix) dans le cas des fraises en conserve, de l’acide lactique, de l’acide malique ou de l’acide tartrique, et (x) dans le cas des abricots en conserve, du chlorure de calcium. DORS/84-300, art. 33; DORS/2012-43, art. 14; DORS/2012-104, art. 2. B.11.102 [N]. Le (nom du fruit) congelés doivent être le produit obtenu par congélation du fruit frais qui est nommé, après qu’il ait été convenablement préparé, et ils peuvent renfermer (b) water; (d) ascorbic acid, citric acid, erythorbic acid or malic acid to prevent discolouration; and (i) a firming agent, and (ii) sulphurous acid. SOR/84-300, s. 34; SOR/95-436, s. 1. B.11.103 and B.11.104 [Repealed, SOR/79-252, s. 1] B.11.105 [Repealed, SOR/97-151, s. 20] Fruit Juices B.11.120 [S]. (Naming the fruit) Juice SOR/78-402, s. 2; SOR/84-300, s. 35; SOR/89-87, s. 1; SOR/92-591, s. 2. B.11.123 [S]. Apple Juice SOR/89-87, s. 2. B.11.124 [S]. Grape Juice (d) may contain a pH-adjusting agent, a sweetening ingredient in dry form, a Class II preservative, vitamin C, amylase, cellulase and pectinase. SOR/84-300, s. 36(E); SOR/86-111, s. 2; SOR/98-87, s. 3. B.11.125 [S]. Grapefruit Juice (b) shall B.11.126 [S]. Lemon Juice (d) may contain a sweetening ingredient in a dry form, a Class II preservative, amylase, cellulase and pectinase. SOR/82-768, s. 31; SOR/90-87, s. 5. B.11.127 [S]. Lime Juice or Lime Fruit Juice (d) may contain stannous chloride; and (e) may contain a sweetening ingredient in a dry form, a Class II preservative, amylase, cellulase and pectinase. SOR/82-768, s. 32; SOR/90-87, s. 6. B.11.128 [S]. Orange Juice (b) shall (d) may contain orange essences, orange oils and orange pulp adjusted in accordance with good manufacturing practice; and SOR/82-768, s. 33; SOR/90-87, s. 7. B.11.128A [S]. Pineapple Juice (b) may contain a sweetening ingredient in dry form, a Class II preservative, vitamin C, amylase, cellulase, pectinase and an antifoaming agent. SOR/90-87, s. 8; SOR/91-90, s. 1. (i) vitamin C, (ii) food colour, (iii) stannous chloride, (iv) a sweetening ingredient, and

(4)

1.0%, singly or in combination with tartaric acid, calculated on a fat-free basis Item No. Additive Permitted in or Upon Same foods as listed for Potassium Acid Tartrate

(2)

Subparagraphs (1)(b)(i), (ii), (iii) and (v) do not apply in respect of frozen concentrated orange juice. SOR/89-198, s. 2; SOR/91-124, s. 3. (d) may contain, in the case of reconstituted lemon or lime juice, not more than 10 parts per million of dimethylpolysiloxane. SOR/78-637, s. 2. B.11.134 [S]. Apricot Nectar, Peach Nectar or Pear Nectar (b) shall contain PART B Foods Fruit Juices Sections B.11.134-B.11.150 (d) shall not contain more than 3 g/kg (3000 p.p.m.) of ethanol and 10 mg/kg (10 p.p.m.) of hydroxymethyl furfural; and (e) may contain (iii) lemon juice, and (iv) vitamin C. SOR/79-660, s. 2; SOR/2010-94, s. 9(E). (i) a soft drink, or (d) notwithstanding sections D.01.009, D.01.011 and D.02.009, Règlement sur les aliments et drogues

(4)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese Soft drinks Same levels as prescribed for Potassium Acid Tartrate

PARTIE B Aliments

(1)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005 Item No. | Additive Permitted in or Upon Ice cream mix; Ice milk mix

TITRE 11 Fruits, légumes, leurs produits et succédanés

Jus de fruits

(1)

Apple (or rhubarb) and (naming the fruit) jam; Apricot nectar; Canned asparagus; Fig marmalade; Fig marmalade with pectin; Frozen (naming the fruit); (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Peach nectar; Pear nectar; Pineapple marmalade; Pineapple marmalade with pectin

Articles B.11.134-B.11.150

d) doit comprendre au plus 3 g/kg (3000 p.p.m.) d’éthanol et 10 mg/kg (10 p.p.m.) de furfural hydroxyméthylique; et e) peut comprendre (i) du miel si aucun autre ingrédient édulcorant n’est utilisé, (ii) une quantité d’acide citrique et d’acide malique conforme aux bonnes pratiques industrielles, (iii) du jus de citron, et (iv) de la vitamine C. DORS/79-660, art. 2; DORS/2010-94, art. 9(A). Boissons à arôme de fruit B.11.150 Il est interdit d’étiqueter, d’empaqueter, de vendre ou d’annoncer une boisson à arôme de fruit de façon à créer l’impression qu’elle contient des vitamines ou présente toute autre valeur nutritive normalement attribuée à un jus de fruits à moins que les exigences suivantes ne soient respectées : a) qu’elle soit vendue comme succédané d’un jus de fruits ou comme boisson pour le petit déjeuner; b) qu’elle ne soit pas gazeuse; c) qu’elle ne soit pas offerte ni habituellement connue comme (i) une boisson gazeuse, ou (ii) une boisson désaltérante ou rafraîchissante; et d) qu’elle contienne, nonobstant les articles D.01.009, D.01.011 et D.02.009, lorsque la boisson est prête à servir, par 100 ml, (i) de la vitamine C en quantité d’au moins 24 mg et d’au plus 48 mg, et (ii) (A) de l’acide folique, si ajouté, en quantité d’au moins 40 μg et d’au plus 80 μg, (B) de la thiamine, si ajoutée, en quantité d’au moins 0,08 mg et d’au plus 0,11 mg, (C) du fer, si ajouté, en quantité d’au moins 0,56 mg et d’au plus 0,80 mg, ou SOR/78-478, s. 2. (a) the base, concentrate or mix SOR/78-478, s. 2. Jams B.11.201 [S]. (Naming the fruit) Jam PART B Foods JAMS Sections B.11.201-B.11.203 (iii) a pH adjusting agent, and (iv) an antifoaming agent; and (d) shall not contain apple or rhubarb. SOR/92-400, s. 16. (b) shall contain (iii) pectin or pectinous preparations; (ii) food colour, (iv) a pH adjusting agent, and (v) an antifoaming agent; and (d) shall not contain apple or rhubarb. SOR/92-400, s. 17. (ii) 20 per cent apple or rhubarb pulp, and Règlement sur les aliments et drogues

(3)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

PARTIE B Aliments

(2)

Cream cheese spread; Cream cheese spread with (naming the added

TITRE 11 Fruits, légumes, leurs produits et succédanés

Confitures

(2)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005 Item No. Additive Permitted in or Upon

Articles B.11.201-B.11.203

(iii) un agent rajusteur du pH, et (iv) un agent anti-mousse; et d) ne doit renfermer ni pommes ni rhubarbe. DORS/92-400, art. 16. B.11.202 [N]. La confiture de (nom du fruit) avec pectine a) doit être le produit obtenu en traitant des fruits, de la pulpe de fruits ou des fruits en conserve, par ébullition jusqu’à une consistance convenable, avec de l’eau et un agent édulcorant; b) doit renfermer (i) au moins 27 pour cent du fruit nommé, (ii) au moins 66 pour cent de solides solubles dans l’eau, déterminés au réfractomètre, et (iii) de la pectine ou une préparation pectique; c) peut renfermer (i) la quantité d’ingrédient acide requise pour compenser raisonnablement toute déficience en acidité naturelle du fruit nommé, (ii) un colorant pour aliments, (iii) un agent de conservation de la catégorie II, (iv) un agent rajusteur du pH, et (v) un agent anti-mousse; et d) ne doit renfermer ni pommes ni rhubarbe. DORS/92-400, art. 17. B.11.203 [N]. La confiture de pommes (ou de rhubarbe) et de (nom du fruit) a) doit être le produit obtenu en traitant des fruits, de la pulpe de fruits ou des fruits en conserve, par ébullition jusqu’à une consistance convenable, avec de l’eau et un agent édulcorant; b) doit renfermer au moins (i) 12,5 pour cent du fruit nommé, sauf que si le fruit nommé est la fraise, elle doit renfermer au moins 15 pour cent de fraises, (ii) 20 pour cent de pulpe de pommes ou de rhubarbe, et (iii) 66 pour cent de solides solubles dans l’eau, déterminés au réfractomètre; et (iii) food colour, (v) a pH adjusting agent, and (vi) an antifoaming agent. B.11.204 [Repealed, SOR/2022-143, s. 21] Marmalade (b) a pH adjusting agent; and (c) an antifoaming agent. (b) shall contain (iii) food colour, (v) a pH adjusting agent, and (vi) an antifoaming agent. (iii) a pH adjusting agent, and (iv) an antifoaming agent. B.11.222 [S]. Pineapple Marmalade or Fig Marmalade (d) a pH adjusting agent; and (e) an antifoaming agent. (b) shall contain (iii) pectin or pectinous preparation; (ii) food colour, Jelly (b) a pH adjusting agent; and (c) an antifoaming agent. (b) shall contain (ii) juice of another fruit, (iii) a gelling agent, (iv) food colour, (vi) a pH adjusting agent, and (vii) an antifoaming agent. B.11.242 The standards prescribed in these Regulations for jam and jelly do not apply to cranberry sauce, jellied cranberry, cranberry jelly, mint jelly and jellied mint. Mincemeat B.11.250 [S]. Mincemeat, Mince Meat, Mince or Fruit Mince (a) shall be the food prepared from (ii) suet, (iii) salt, (v) a sweetening agent; and (i) vinegar, (iii) spirituous liquor, (iv) nuts, (vii) a thickening agent, (viii) citric acid, and DIVISION 12 [SOR/80-633, s. 1] (d) notwithstanding paragraph (c), may contain SOR/80-633, s. 2; SOR/82-768, s. 34. (d) [Repealed, SOR/2022-143, s. 22] SOR/84-300, s. 39(F); SOR/88-336, s. 3; SOR/92-626, s. 14(F); SOR/2022-143, s. 22. B.12.003 [Repealed, SOR/2022-143, s. 23] SOR/80-633, s. 3; SOR/82-768, s. 35. SOR/80-633, s. 3; SOR/82-768, s. 36. B.12.006 [Repealed, SOR/2022-143, s. 24] SOR/80-633, s. 3. SOR/80-633, s. 3; SOR/2000-353, s. 51(E). B.12.009 [Repealed, SOR/2022-143, s. 25] DIVISION 13 (d) shall contain in 100 grams of flour (i) 0.64 milligram of thiamine, (ii) 0.40 milligram of riboflavin, (iii) 5.30 milligrams of niacin or niacinamide, (iv) 0.15 milligram of folic acid, and (v) 4.4 milligrams of iron; (e) may contain (ii) malted barley flour in an amount not exceeding 0.50 per cent of the weight of the flour, (iii) amylase, amylase (maltogenic), asparaginase, bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, phospholipase, protease, pullulanase or xylanase, (iv) chlorine, (v) chlorine dioxide, (vii) [Repealed, SOR/94-227, s. 1] (x) acetone peroxide, (xv) in 100 grams of flour (iv) 0,15 milligramme d’acide folique, (v) 4,4 milligrammes de fer; e) peut renfermer (i) de la farine de blé malté, (ii) de la farine d’orge malté, en quantité d’au plus 0,50 pour cent du poids de la farine, (iii) de l’amylase, de l’amylase maltogène, de l’asparaginase, de la broméline, de la glucoamylase, de la glucose-oxydase, de la lactase, de la lipase, de la lipoxydase, de la pentosanase, de la phospholipase, de la protéase, de la pullulanase ou de la xylanase, (iv) du chlore, (v) du bioxyde de chlore, (vi) du peroxyde de benzoyle, en quantité d’au plus 150 parties en poids par million de parties de farine, avec ou sans véhicule constitué d’au plus 900 parties en poids par million de parties de farine d’une ou de plusieurs des substances suivantes : carbonate de calcium, sulfate de calcium, phosphate bicalcique, carbonate de magnésium, sulfate double d’aluminium et de potassium, sulfate double d’aluminium et de sodium, amidon et phosphate tricalcique, (vii) [Abrogé, DORS/94-227, art. 1] (viii) du persulfate d’ammonium, en quantité d’au plus 250 parties en poids par million de parties de farine, (ix) du chlorure d’ammonium, en quantité d’au plus 2 000 parties en poids par million de parties de farine, (x) du peroxyde d’acétone, (xi) de l’azodicarbonamide, en quantité d’au plus 45 parties en poids par million de parties de farine, (xii) de l’acide ascorbique, en quantité d’au plus 200 parties en poids par million de parties de farine, (xiii) du L-cystéine (chlorhydrate), en quantité d’au plus 90 parties en poids par million de parties de farine, (xiv) du phosphate monocalcique en quantité d’au plus 7 500 parties en poids par million de parties de farine, et (xv) dans 100 grammes de farine SOR/98-550, s. 42. (d) shall contain, on a moisture-free basis, (ii) not more than 0.70 per cent and not less than 0.61 per cent ash. B.13.004 [Repealed, SOR/79-252, s. 2] B.13.005 [S]. Whole Wheat Flour or Entire Wheat Flour (ii) a moisture content of not more than 15 per cent, and (d) may contain (ii) malted barley flour in an amount not exceeding 0.50 per cent of the weight of the flour, (iii) amylase, amylase (maltogenic), asparaginase, bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, phospholipase, protease, pullulanase or xylanase, (iv) chlorine, (v) chlorine dioxide, (vii) [Repealed, SOR/94-227, s. 2] (xi) acetone peroxide, (e) [Repealed, SOR/97-151, s. 22] SOR/88-402, s. 4; SOR/89-83, s. 5; SOR/89-233, s. 6; SOR/92-94, s. 2; SOR/94-202, s. 2; SOR/94-689, s. 2; SOR/97-122, s. 2; SOR/97-151, s. 22; SOR/98-156, s. 2; SOR/2000-184, s. 6.3(F); SOR/2003-130, s. 2; SOR/2012-26, s. 2; SOR/2012-46, s. 2. (a) 10 per cent moisture, and SOR/88-702, s. 37. (b) a moisture content of not more than 15.5 per cent. (b) a moisture content of not more than 15.5 per cent. SOR/78-403, s. 3. TABLE Column I Vitamin or Mineral Nutrient 1 Thiamine 2 Niacin 3 Vitamin B6 4 Folic acid 5 Pantothenic acid 6 Iron Column II

(1)

Baking powder; Malted milk; Malted milk powder

0.45 mg

(3)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

4.2 mg

(2)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005 Item No. | Additive Permitted in or Upon

0.6 mg

(2)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

0.016 mg

(5)

A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)

1.2 mg

(1)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005 Item No. | Additive Permitted in or Upon

1.6 mg

SOR/86-320, s. 1; SOR/98-485, s. 7(F). SOR/84-300, s. 42; SOR/2011-28, s. 5. SOR/82-768, s. 38. SOR/89-170, s. 1. Bread a) salt; b) shortening, lard, butter or margarine; c) milk or milk product; e) a sweetening agent; f) malt syrup, malt extract or malt flour; h) amylase, amylase (maltogenic), asparaginase, bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, phospholipase, protease, pullulanase or xylanase; (j) other parts of the wheat berry; (k) lecithin or ammonium salt of phosphorylated glyceride; (l) monoglycerides and diglycerides of fat-forming fatty acids, (p) acetone peroxide; (q) vinegar; (s) food colour; (u) l-cysteine (hydrochloride) in an amount not greater than 0.009 parts by weight for each 100 parts of flour used; h) de l’amylase, de l’amylase maltogène, de l’asparaginase, de la broméline, de la glucamylase, de la glucose-oxydase, de la lactase, de la lipase, de la lipoxygénase, de la pentosanase, de la phospholipase, de la protéase, de la pullulanase ou de la xylanase; i) sous réserve de l’article B.13.029, un ou plusieurs des ingrédients suivants, en quantité d’au plus cinq parties en poids par 100 parties de farine employée : farine de blé complet, farine de blé entier, farine Graham, farine de gluten, farine de blé, amidon de blé, farine autre que le blé ou amidon autre que le blé, chacun pouvant être entièrement ou partiellement dextrinisé; j) d’autres parties du grain de blé; k) de la lécithine ou du sel d’ammonium de glycéride phosphorylé; l) des monoglycérides et des diglycérides des acides gras qui entrent dans la composition des matières grasses; m) du chlorure d’ammonium, du sulfate d’ammonium, du carbonate de calcium, du lactate de calcium, du phosphate diammonique, du phosphate dicalcique, du phosphate monoammonique ou d’un mélange quelconque desdits, en quantité n’excédant pas, pour l’ensemble des additifs, 0,25 partie en poids par 100 parties de farine employée; n) du phosphate monocalcique en quantité d’au plus 0,75 parties en poids par 100 parties de farine employée; o) du peroxyde de calcium, du persulfate d’ammonium, du persulfate de potassium ou une combinaison de ces additifs, en quantité n’excédant pas, pour l’ensemble des additifs, 0,01 partie en poids par 100 parties de farine employée; p) du peroxyde d’acétone; q) du vinaigre; r) un agent de conservation de la catégorie III; s) un colorant pour aliments; t) du stéaroyl-2-lactylate de calcium ou stéaroyl-2-lactylate de sodium en quantité d’au plus 0,375 partie, en poids, par 100 parties de farine employée; u) du l-cystéine (chlorhydrate), en quantité d’au plus 0,009 partie en poids par 100 parties de farine employée; (b) shall contain (ii) in 100 grams of bread, (A) 0.40 milligram of thiamine, (B) 0.24 milligram of riboflavin, (C) 3.3 milligrams of niacin or niacinamide, (D) 0.10 milligram of folic acid, and B.13.022 [N]. Le pain enrichi ou le pain blanc enrichi: a) doit être du pain fabriqué à partir d’une pâte dans laquelle la farine de blé enrichi est la seule farine de blé utilisée; b) doit contenir : (i) par 100 parties de farine employée, au moins : (A) soit deux parties en poids de solides de lait écrémé, (B) soit quatre parties en poids de poudre de petit-lait, (C) soit la quantité d’un produit protéique à base de pois (Pisum sativum) ou de fèves de soya (Glycine max) qui donnera 0,5 partie en poids de protéine, (ii) par 100 grammes de pain, au moins : (A) 0,40 milligramme de thiamine, (B) 0,24 milligramme de riboflavine, (E) 2.76 milligrams of iron; (i) 0.14 milligram of vitamin B₆, (ii) 0.6 milligram of d-pantothenic acid, (iii) 90 milligrams of magnesium, and (iv) 66 milligrams of calcium; and SOR/78-688, s. 3; SOR/87-704, s. 1; SOR/89-170, s. 2; SOR/98-188, s. 3; SOR/98-550, s. 3. B.13.023 and B.13.024 [Repealed, SOR/79-252, s. 3] B.13.026 [S]. (naming the percentage) Whole Wheat Bread (a) shall SOR/89-170, s. 3. (C) 3,3 milligrammes de niacine ou de niacinamide, (D) 0,10 milligramme d’acide folique, (E) 2,76 milligrammes de fer; c) peut contenir par 100 grammes de pain au moins : (i) 0,14 milligramme de vitamine B₆, (ii) 0,6 milligramme d’acide d-pantothénique, (iii) 90 milligrammes de magnésium, (iv) 66 milligrammes de calcium; d) peut être désigné par le nom usuel « pain au lait » s’il contient au moins six parties en poids de solides de lait par 100 parties de farine enrichie employée. DORS/78-688, art. 3; DORS/87-704, art. 1; DORS/89-170, art. 2; DORS/98-188, art. 3; DORS/98-550, art. 3. B.13.023 et B.13.024 [Abrogés, DORS/79-252, art. 1] B.13.025 [N]. Le pain aux raisins ou pain de raisin doit être du pain qui renferme, par 100 parties de farine employée, au moins 50 parties en poids de raisins secs épépinés, ou sans pépins, ou de raisin sec et de raisin de Corinthe, dont au moins 35 parties doivent être du raisin, et il peut renfermer des épices et des écorces ou zeste de fruits. B.13.026 [N]. Le pain à (indication du pourcentage) de blé entier : a) doit : (i) être du pain pour lequel le pourcentage indiqué de farine représente le pourcentage de farine de blé entier employée, (ii) contenir au moins 60 pour cent de farine de blé entier par rapport à la quantité totale de farine employée; b) peut : (i) contenir du caramel, (ii) être désigné par le nom usuel « pain au lait à (indication du pourcentage) de blé entier » s’il contient au moins six parties en poids de solides de lait par 100 parties de la quantité totale de farine enrichie et de farine de blé entier employées. DORS/89-170, art. 3. B.13.028 [Repealed, SOR/97-151, s. 23] (a) one or more of the ingredients specified in paragraph B.13.021(i) in a total amount greater than the total amount specified in that paragraph; and SOR/79-251, s. 3. TABLE Column I | Column II | Column III Added Vitamin or | Minimum | Maximum Mineral Nutrient | Amount per | Amount per | 100 g of | 100 g of | Paste | Paste 1 Thiamine | 0.63 mg | 1.50 mg 2 Riboflavin | 0.11 mg | 0.60 mg 3 Niacin | 5.90 mg | 7.50 mg 4 Folic Acid | 0.20 mg | 0.27 mg PART B Foods Sections B.13.052-B.14.001 Column I | Column II | Column III Added Vitamin or Mineral Nutrient | Minimum Amount per 100 g of Alimentary Paste | Maximum Amount per 100 g of Alimentary Paste 5 | Pantothenic Acid | 1.00 mg | 2.00 mg 6 | Vitamin B6 | 0.40 mg | 0.80 mg 7 | Iron | 2.90 mg | 4.30 mg 8 | Magnesium | 150.00 mg | 300.00 mg SOR/94-37, s. 1; SOR/94-689, s. 2; SOR/96-527, s. 2; SOR/98-550, ss. 4, 5. Breakfast Cereal TABLE Column I | Column II Vitamin or Mineral Nutrient | Amount per 100 g of Breakfast Cereal 1 | Thiamine | 2.0 mg 2 | Niacin | 4.8 mg 3 | Vitamin B6 | 0.6 mg 4 | Folic Acid | 0.06 mg 5 | Pantothenic Acid | 1.6 mg 6 | Magnesium | 160.0 mg 7 | Iron | 13.3 mg 8 | Zinc | 3.5 mg SOR/83-858, s. 1; SOR/89-145, s. 2; SOR/98-458, s. 7(F). DIVISION 14 Règlement sur les aliments et drogues

(3)

Ice cream mix; Ice milk mix; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product

PARTIE B Aliments

(2)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005 Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use S.6 | Sodium Bicarbonate | (1) Apple (or rhubarb) and (naming the fruit) jam; Baking powder; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Fig marmalade; Fig marmalade with pectin; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Ice cream mix; Ice milk mix; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk; Malted milk powder; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Oil-soluble annatto; Pineapple marmalade; Pineapple marmalade with pectin; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product | (1) Good Manufacturing Practice | | (2) Cocoa products | (2) Sufficient to process the cocoa products in accordance with the requirements of section B.04.005 | | (3) Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese | (3) Good Manufacturing Practice Item No. Additive Permitted in or Upon

TITRE 13 Céréales et produits de boulangerie

Pâtes alimentaires

(1)

Apple (or rhubarb) and (naming the fruit) jam; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Fig marmalade; Fig marmalade with pectin; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Gelatin; Ice cream mix; Ice milk mix; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk; Meat binder or (naming the meat product) binder where sold for use in preserved meat or preserved meat by-product; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Pineapple marmalade; Pineapple marmalade with pectin

Articles B.13.052-B.14.001

Colonne I | Colonne II | Colonne III Vitamine ou minéral nutritif ajouté | Quantité minimale par 100 g de la pâte alimentaire | Quantité maximale par 100 g de la pâte alimentaire 5 | Acide pantothénique | 1,00 mg | 2,00 mg 6 | Vitamine B6 | 0,40 mg | 0,80 mg 7 | Fer | 2,90 mg | 4,30 mg 8 | Magnésium | 150,00 mg | 300,00 mg DORS/94-37, art. 1; DORS/94-689, art. 2; DORS/96-527, art. 2; DORS/98-550, art. 4, 5. Céréales à déjeuner B.13.060 Nonobstant les articles D.01.009, D.01.011 et D.02.009, il est interdit de vendre une céréale à déjeuner à laquelle ont été ajoutés un ou plusieurs des vitamines ou minéraux nutritifs énumérés à la colonne I du tableau du présent article, à moins que chaque portion de 100 g de la céréale ne renferme la quantité de vitamines ou de minéraux nutritifs ajoutés qui est prévue à la colonne II de ce tableau. TABLEAU Colonne I | Colonne II Vitamine ou minéral nutritif | Quantité par 100 g de la céréale à déjeuner 1 | Thiamine | 2,0 mg 2 | Niacine | 4,8 mg 3 | Vitamine B6 | 0,6 mg 4 | Acide folique | 0,06 mg 5 | Acide pantothénique | 1,6 mg 6 | Magnésium | 160,0 mg 7 | Fer | 13,3 mg 8 | Zinc | 3,5 mg DORS/83-858, art. 1; DORS/89-145, art. 2; DORS/98-458, art. 7(F).

(3)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

TITRE 14

Viande, préparations et produits de la viande B.14.001 Dans le présent titre, agent de remplissage désigne toute substance végétale, (à l’exception de la tomate et de la pulpe de betterave), le lait, les œufs, la levure, ou tout dérivé ou combinaison de ces produits qui serait acceptable comme aliment; (filler) SOR/82-768, s. 39; SOR/86-875, s. 1. SOR/92-725, s. 2; SOR/97-516, s. 2; SOR/2016-74, s. 6(F). (a.1) in the case of prepared hams, shoulders, butts, picnics and backs, gelatin; (i) sodium acid pyrophosphate, (ii) sodium hexametaphosphate, (iii) sodium phosphate, dibasic, (iv) sodium phosphate, monobasic, (v) sodium pyrophosphate, tetrabasic, (vi) sodium tripolyphosphate, (vii) potassium phosphate, monobasic, (viii) potassium phosphate, dibasic, and (ix) potassium pyrophosphate, tetrabasic; and (d) in the case of vacuum-packed sliced roast beef and vacuum-packed sliced cooked ham, Carnobacterium maltaromaticum CB1. SOR/96-422, s. 2; SOR/2010-264, s. 1; SOR/2011-280, s. 1. SOR/2010-142, s. 59(F); SOR/2022-168, s. 42. B.14.007 [S]. Meat Binder or (naming the meat product) Binder shall be a filler with any combination of salt, sweetening agents, spices or other seasonings (except tomato), egg, egg albumen, and b) dans le cas des tissus gras de porc ou de bœuf partiellement dégraissés : un agent de conservation de la catégorie IV; c) lorsque le présent titre prescrit une teneur totale minimale en protéines ou une teneur minimale en protéines de viande, un ou plusieurs des sels de phosphate suivants, en une proportion n’excédant pas la limite de tolérance calculée en phosphate disodique conformément au tableau XII de l’article B.16.100 : (i) du pyrophosphate acide de sodium, (ii) de l’hexamétaphosphate de sodium, (iii) du phosphate disodique, (iv) du phosphate monosodique, (v) du pyrophosphate tétrasodique, (vi) du tripolyphosphate de sodium, (vii) du phosphate monopotassique, (viii) du phosphate dipotassique, (ix) du pyrophosphate tétrapotassique; d) dans le cas de rôtis de bœuf tranchés emballés sous vide et de jambons cuits tranchés emballés sous vide : du Carnobacterium maltaromaticum CB1. DORS/96-422, art. 2; DORS/2010-264, art. 1; DORS/2011-280, art. 1. B.14.006 L’huile de coton entièrement hydrogénée en poudre peut être appliquée comme agent de démoulage sur la surface de la viande, des sous-produits de viande, des viandes préparées, des sous-produits de viande préparés, des produits de viande avec allongeur et des simili-produits de viande dans une quantité n’excédant pas 0,25 % du produit. DORS/2010-142, art. 59(F); DORS/2022-168, art. 42. B.14.007 [N]. Le liant à viande ou le liant à (désignation du produit de viande) est un agent de remplissage contenant une combinaison quelconque de sel, d’agents édulcorants, d’épices ou d’autres condiments (sauf la tomate), d’œufs, de blanc d’œufs, et a) lorsqu’il est vendu pour servir dans les viandes conservées et dans les sous-produits de viande conservés, il peut renfermer de l’acide ascorbique, de l’ascorbate de calcium, de l’acide érythorbique, de l’acide iso-ascorbique, du nitrate de potassium, du nitrite de potassium, de l’ascorbate de sodium, du carbonate de sodium, de l’érythorbate de sodium, de l’iso-ascorbate de sodium, du nitrate de sodium ou du nitrite de sodium, (d) may contain an anticaking agent. SOR/80-313, s. 1; SOR/82-913, s. 1; SOR/86-875, s. 2(F); SOR/2010-143, s. 9; SOR/2017-18, s. 3(F). SOR/84-300, s. 4(F). (b) citric acid, sodium citrate or vinegar; (d) liquid smoke flavour, liquid smoke flavour concentrate, salt, seasonings, spices, spice extracts, spice oils or spice oleoresins; (e) sodium bicarbonate, sodium hydroxide or potassium hydroxide; SOR/79-251, s. 4; SOR/88-13, s. 2; SOR/92-466, s. 1; SOR/98-338, s. 3; SOR/94-567, s. 1; SOR/2010-143, s. 16(F); SOR/2017-18, s. 4(F); SOR/2018-69, s. 4(F). B.14.013 and B.14.014 [Repealed, SOR/97-148, s. 3] SOR/82-768, s. 40. SOR/82-768, s. 40. SOR/82-768, s. 40. SOR/82-768, s. 40. B.14.016 No person shall sell horse-meat or horse-meat by-product, or any food containing horse-meat or horse-meat by-product unless SOR/88-336, s. 3. B.14.017 [Repealed, SOR/2003-292, s. 2] SOR/92-626, s. 15; SOR/2003-6, s. 79; SOR/2018-108, s. 398. SOR/92-626, s. 15; SOR/95-548, s. 5(F). (a) a whole cut of meat; or SOR/94-262, s. 3. c) s’il s’agit d’une carcasse de veau importée, la catégorie qui a été attribuée à la carcasse par l’autorité responsable constituée en vertu des lois du pays d’origine; d) s’il s’agit d’une carcasse de bœuf, la catégorie de rendement qui a été attribuée à la carcasse, le cas échéant, en application de la Loi sur la salubrité des aliments au Canada.

(2)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005 Item No. Additive Permitted in or Upon

(2)

Si la carcasse visée au paragraphe (1) n’a fait l’objet d’aucune classification et que toute la carcasse ou une partie de celle-ci pesant au moins 7 kilogrammes est annoncée pour la vente, l’annonce doit indiquer clairement que la carcasse n’a pas été classée. DORS/92-626, art. 15; DORS/2003-6, art. 79; DORS/2018-108, art. 398. B.14.019 (1) L’annonce, pour la vente, d’une carcasse de bœuf, de veau, de porc ou d’agneau ou d’une partie de celle-ci pesant au moins 7 kilogrammes qui indique le prix de vente doit : a) contenir la mention « le prix au kilogramme est établi en fonction du poids de la carcasse avant le débitage, le désossage et le parage » ou la mention « le prix au kilogramme est établi en fonction du poids de la viande après le débitage, le désossage et le parage », selon le cas; b) si, en sus du prix de vente, des frais sont exigibles pour le débitage, le désossage, le parage, l’emballage ou la congélation de la carcasse ou de la partie de carcasse : (i) préciser le montant de ces frais, (ii) lorsque ces frais sont établis d’après un prix unitaire au poids, préciser s’ils sont calculés selon le poids avant ou après le débitage, le désossage et le parage de la carcasse.

(1)

Apple (or rhubarb) and (naming the fruit) jam; Cottage cheese; Cream; Creamed cottage cheese; Ice cream mix; Ice milk mix; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade or Fig marmalade; Pineapple marmalade with pectin or Fig marmalade with pectin; Sherbet Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use S.15 Sodium Hydroxide | (1) Cocoa products | (1) Sufficient to process the cocoa products in accordance with the requirements of section B.04.005 | (2) Gelatin; Ice cream mix; Ice milk mix; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product | (2) Good Manufacturing Practice S.20 Sodium Potassium Tartrate | (1) Apple (or rhubarb) and (naming the fruit) jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade or Fig marmalade; Pineapple marmalade with pectin or Fig marmalade with pectin | (1) Good Manufacturing Practice S.24 Sulphurous Acid | Gelatin | Good Manufacturing Practice provided the finished product does not contain more than 500 p.p.m. calculated as sulphur dioxide Item No. Additive Permitted in or Upon

(2)

Les renseignements exigés au paragraphe (1) doivent figurer juste à côté du prix de vente, sans qu’aucun texte imprimé ou écrit ni aucune image graphique soient intercalés entre les deux. DORS/92-626, art. 15; DORS/95-548, art. 5(F). B.14.020 [N]. La viande coupée solide doit consister : a) soit en une pièce de viande entière; b) soit en un produit constitué de morceaux de viande dont plus de 80 pour cent pèsent au moins 25 g chacun. DORS/94-262, art. 3. (i) sodium acid pyrophosphate, (ii) sodium hexametaphosphate, (iii) sodium phosphate, dibasic, (iv) sodium phosphate, monobasic, (v) sodium pyrophosphate, tetrabasic, (vi) sodium tripolyphosphate, (vii) potassium phosphate, monobasic, (viii) potassium phosphate, dibasic, and (ix) potassium pyrophosphate, tetrabasic. SOR/94-262, s. 3. (B) the expression "attendri mécaniquement", with any necessary grammatical modifications, in the French version of the label, and (I) the message "Cook to a minimum internal temperature of 63°C (145°F).", and (I) the message "Faire cuire jusqu’à ce que la température interne atteigne au moins 63 °C (145 °F).", and (II) in the case of steak, the additional message "Retourner le bifteck au moins deux fois durant la cuisson.". SOR/2014-99, s. 2. SOR/78-637, s. 3; SOR/82-785, s. 5(F); SOR/80-13, s. 41; SOR/86-875, s. 6. (A) pour ce qui est de la version française de l’étiquette, les mots « attendri mécaniquement », avec les adaptations nécessaires, le cas échéant, (B) pour ce qui est de la version anglaise de l’étiquette, les mots « mechanically tenderized », (ii) en caractères au moins aussi lisibles et en évidence que ceux de tout autre renseignement autre que le nom usuel : (A) pour ce qui est de la version française de l’étiquette, les mentions ci-après : (I) « Faire cuire jusqu’à ce que la température interne atteigne au moins 63 °C (145 °F). », (II) en outre, s’agissant de bifteck, « Retourner le bifteck au moins deux fois durant la cuisson. », (B) pour ce qui est de la version anglaise de l’étiquette, les mentions ci-après : (I) « Cook to a minimum internal temperature of 63°C (145°F). », (II) en outre, s’agissant de bifteck, « Turn steak over at least twice during cooking. ». DORS/2014-99, art. 2. Viandes préparées, sous-produits de viande préparés B.14.030 (1) Sous réserve des paragraphes (2) et (3) et de l’article B.14.034, il est interdit de vendre de la viande préparée ou un sous-produit de viande préparée dont la teneur en protéines est de moins de 1,5 point de pourcentage inférieure à la teneur totale en protéines exigée pour cet aliment.

(1)

Ale; Apple (or rhubarb) and (naming the fruit) jam; Baking powder; Beer; Cider; Canned asparagus; Fig marmalade; Fig marmalade with pectin; French dressing; Honey wine; Ice cream mix; Ice milk mix; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Light beer; Malt liquor; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Mayonnaise; Pineapple marmalade; Pineapple marmalade with pectin; Porter; Salad dressing; Sherbet; Stout; Wine

(2)

Le paragraphe (1) ne s’applique pas à un produit de viande avec allongeur.

(3)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(3)

Dans le cas où le gélatine est un des sous-produits de viande préparée contient de la gélatine, cet ingrédient ne doit pas être pris en compte dans le calcul de la teneur totale en protéines de cet aliment. DORS/78-637, art. 3; DORS/82-785, art. 5(F); DORS/80-13, art. 41; DORS/86-875, art. 6. B.14.030A Pour l’application des articles B.14.030, B.14.032, B.14.033, B.14.035, B.14.074, B.14.075, B.14.076 et B.14.077, dans le cas où l’un ou l’autre des ingrédients non carnés énumérés aux sous-alinéas B.14.032A(a) à (g) est présent dans une viande préparée ou un sous-produit de viande préparée, en morceaux identifiables en (b) sweetening agents; (d) vinegar; (e) alcohol; (f) smoke flavouring or artificial smoke flavouring; (j) in the case of vacuum-packed sliced cooked ham, Carnobacterium maltaromaticum CB1. SOR/78-231, s. 6; SOR/80-75, s. 4; SOR/82-968, s. 2; SOR/84-300, ss. 4, 45(E); SOR/88-338, ss. 2, 3; SOR/92-725, s. 3; SOR/97-151, s. 24; SOR/2010-264, s. 2; SOR/2011-20, s. 2; SOR/2016-305, s. 57; SOR/2017-18, s. 5(F); SOR/2018-68, s. 5(F). (d) may contain (i) animal fat, (ii) filler, (iii) beef tripe, (iv) liver, (v) fresh or frozen beef and pork blood, (vi) sweetening agents, (vii) salt and spices, (ix) lactic acid producing starter culture, (x) meat binder, (xi) beef and pork blood plasma, (xvi) in the case of longaniza, b) peut être renfermée dans des boyaux ou avoir un enrobage comestible; c) peut être mouillée de vinaigre, fumée, cuite ou asséchée; d) peut renfermer (i) de la graisse animale, (ii) un agent de remplissage, (iii) de la tripe de bœuf, (iv) du foie, (v) du sang de bœuf ou de porc, frais ou congelé, (vi) des agents édulcorants, (vii) du sel et des épices, (viii) des condiments autres que le tomate, (ix) un pied-de-cuve produisant de l’acide lactique, (x) du liant à viande, (xi) du plasma sanguin de bœuf et de porc, (xi.1) un agent de conservation de la catégorie II, (xii) dans le cas de la viande hachée, en conserve : de l’arôme de fumée ou de l’arôme artificiel de fumée, (xiii) si elle est cuite, (A) de glucono-delta-lactone, (B) des tissus gras de bœuf ou de porc partiellement dégraissés, et (C) un produit de lait écrémé desséché obtenu du lait écrémé par la réduction de sa teneur en calcium et une augmentation correspondante de sa teneur en sodium, dans une proportion ne dépassant pas trois pour cent du produit fini, (xiv) dans le cas de la saucisse fraîche, crue : de l’arôme artificiel d’érable, et de la poudre de pomme comme aromatisant, (xv) dans le cas de la saucisse sèche ou de la chair à saucisse sèche, de la glucono-delta-lactone, (xvi) dans le cas du longaniza : (A) du rocou en une quantité telle que le produit fini n’en contienne pas plus de 0,1 %. (a) fruit; (b) vegetables; (c) nuts; (d) cheese or processed cheese; (e) macaroni; (f) pickles; or (g) olives. SOR/84-300, s. 46. SOR/86-875, s. 4. SOR/80-13, s. 6; SOR/2011-280, s. 5; SOR/2017-18, s. 19(F). (b) in the case of liver paste or liverwurst spread, may contain wheat germ and yeast. SOR/86-875, s. 4; SOR/80-13, s. 7; SOR/86-875, s. 5. SOR/80-13, s. 8; SOR/2011-280, s. 5; SOR/2017-18, s. 19(F). B.14.037 (1) [S]. Headcheese (b) shall not contain (d) may contain SOR/80-500, s. 5; SOR/2011-280, s. 6; SOR/2017-18, s. 19(F). B.14.039 [Repealed, SOR/2022-143, s. 26] SOR/79-251, s. 7(F); SOR/82-788, s. 43. SOR/79-251, s. 7(F); SOR/82-768, s. 44. (b) and (c) [Repealed, SOR/97-148, s. 4] SOR/82-768, s. 45; SOR/97-148, s. 4. B.14.062 [S]. (1) Gelatin or Edible Gelatin (d) [Repealed, SOR/97-148, s. 5] (f) may contain (i) not more than 2.6 per cent ash on a dry basis, (iii) where intended for use in the manufacture of marshmallow, sodium hexametaphosphate or sodium lauryl sulphate.

(6)

1%, singly or in combination with citric acid, calculated on a fat-free basis Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Class I Preservatives Item No. Additive | Permitted in or Upon | Maximum Level of Use

(2)

No person shall use, in the course of manufacturing gelatin or edible gelatin, (a) acidic or basic compounds other than acetic acid, ammonium hydroxide, citric acid, formic acid, hydrochloric acid, lime, magnesium hydroxide, phosphoric acid, sodium carbonate, sodium hydroxide, sodium sulphide, sulphuric acid, sulphurous acid or tartaric acid; or SOR/78-501, s. 21; SOR/78-874, s. 1; SOR/80-501, s. 3; SOR/82-768, s. 46; SOR/97-148, s. 5. Meat Stews SOR/78-874, s. 2. (i) 12 per cent or more stew meat, and (ii) 38 per cent or more vegetables; and SOR/78-874, s. 2. B.14.065 [S]. (naming the meat) Stew (i) 20 per cent or more stew meat, and (ii) 30 per cent or more vegetables; and SOR/78-874, s. 2. B.14.066 [S]. Irish Stew (i) 20 per cent or more stew meat, (ii) 30 per cent or more vegetables; and SOR/78-874, s. 2. B.14.067 [S]. Meat Ball Stew (i) 22 per cent or more meat balls, (ii) 30 per cent or more vegetables; and SOR/78-874, s. 2. B.14.068 [S]. Specialty Meat Stews (i) 25 per cent or more stewy meat, (ii) 30 per cent or more vegetables; and SOR/78-874, s. 2. Meat Specialties SOR/82-768, s. 47. SOR/82-768, s. 47. (a) at all times PART B Foods Sections B.14.072-B.14.074 SOR/78-403, s. 4; SOR/88-336, s. 3. Meat Product Extender SOR/82-788, s. 48. SOR/82-768, s. 49. SOR/82-768, s. 50; SOR/84-300, s. 47(F). SOR/82-768, s. 51. SOR/82-768, s. 52; SOR/84-300, s. 48(E). SOR/82-768, s. 53. SOR/82-768, s. 54. SOR/82-768, s. 55. SOR/82-768, s. 56. SOR/82-768, s. 57. SOR/82-768, s. 58. (d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in SOR/82-768, s. 59. SOR/82-768, art. 60. TABLE Column I Vitamin or Mineral Nutrient Column II

(1)

Preserved fish; Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product

C

1 ........ Copper ......................... 4.4 micrograms F.1 ........ Folic Acid .................... 0.45 microgram

(1)

Ale; Beer; Canned mushrooms; Canned tuna; Canned white asparagus; Cider; Frozen fruit; Glaze of frozen fish; Headcheese; Light beer; Malt liquor; Meat binder for preserved meat and preserved meat by-product (Division 14 only); Porter; Preserved fish; Frozen minced fish; Frozen comminuted fish; Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product; Pumping pickle; Cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product; Stout; Wine Same foods as listed for Ascorbic Acid Same levels as prescribed for Ascorbic Acid

I

1 ........ Iron ............................... 0.25 milligram

(1)

Ale; Beer; Cider; Frozen fruit; Headcheese; Light beer; Malt liquor; Meat binder for preserved meat and preserved meat by-product (Division 14 only); Porter; Preserved fish; Frozen minced fish; Frozen comminuted fish; Glaze of frozen fish; Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product; Pumping pickle; Cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product; Stout; Wine Same foods as listed for Erythorbic Acid Same levels as prescribed for Erythorbic Acid Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use P.1 | Potassium Nitrate | (1) Meat binder for dry sausage, semi-dry sausage, preserved meat and preserved meat by-products prepared by slow cure processes (Division 14) | (1) When the meat binder is used in accordance with label instructions, whether potassium nitrate is added alone or in combination with sodium nitrate, the total amount of such nitrates thereby added to each batch of dry sausage, semi-dry sausage, preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation | | (2) Cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products prepared by slow cure processes (Division 14) | (2) When the cover pickle or dry cure is used in accordance with label instructions, whether potassium nitrate is added alone or in combination with sodium nitrate, the total amount of such nitrates thereby added to each batch of preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation | | (3) Dry sausage, semi-dry sausage, preserved meat and preserved meat by-products prepared by slow cure processes (Division 14) | (3) Where potassium nitrate is added alone or in combination with sodium nitrate, the total amount of such nitrates added to each batch of dry sausage, semi-dry sausage, preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation | | (4) Ripened cheese, containing not more than 68% moisture on a fat free basis during manufacture of which the lactic acid fermentation and salting is completed later than 12 hours after coagulation of the curd by food enzymes and where the added salt is applied externally to the cheese as dry salt or in the form of brine | (4) If used singly or in combination with sodium nitrate, the total not to exceed 200 p.p.m. (based in milk). Residue in the finished cheese not to exceed 50 p.p.m. | | (5) Mold ripened cheese packed in hermetically sealed containers | (5) If used singly or in combination with sodium nitrate, the total not to exceed 200 p.p.m. (based in milk). Residue in the finished cheese not to exceed 50 p.p.m. P.2 | Potassium Nitrite | (1) Meat binder, pumping pickle, cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products (Division 14) | (1) When the meat binder, pumping pickle, cover pickle or dry cure is used in accordance with label instructions, whether potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites thereby added to each batch of preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

M

1 ........ Magnesium .................. 1.1 milligrams N.1 ........ Niacin .......................... 0.34 milligram P.1 ........ Pantothenic Acid .......... 0.04 milligram P.2 ........ Potassium .................... 20 milligrams P.3 ........ Pyridoxine .................... 0.02 milligram R.1 ........ Riboflavin .................... 0.01 milligram T.1 ........ Thiamine ..................... 0.02 milligram

(2)

Preserved meat except side bacon and preserved meat by-products (Division 14)

V

1 ........ Vitamin B12 ................. 0.08 microgram PART B Foods Sections B.14.090-B.15.002 Column I Vitamin or Mineral Nutrient Z.1 .......... Zinc Column II

(2)

Where potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites added to each batch of preserved meat, except side bacon or preserved meat by-products, shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation

0.20 milligram

SOR/88-468, s. 7(F). DIVISION 15 Adulteration of Food (a) a food additive; (a.1) a supplemental ingredient; SOR/78-404, s. 1; SOR/79-249, s. 1; SOR/2016-74, s. 7; SOR/2022-169, s. 19. Règlement sur les aliments et drogues

(3)

Where potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites added to each batch of side bacon shall not exceed 0.19 ounce per 100 pounds or 120 parts per million, calculated prior to any smoking, cooking or fermentation

PARTIE B Aliments

(4)

Preserved poultry meat and preserved poultry meat by-products (Division 22)

TITRE 15 Viande, préparations et produits de la viande

Simulacres de viande

(4)

Where potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites added to each batch of preserved poultry meat or preserved poultry meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation S.1 | Sodium Ascorbate | Same foods as listed for Ascorbic Acid | Same levels as prescribed for Ascorbic Acid S.2 | Sodium Erythorbate | (1) Same foods as listed for Erythorbic Acid S.3 | Sodium Iso-Ascorbate | Same foods as listed for Erythorbic Acid | Same levels as prescribed for Erythorbic Acid S.4 | Sodium Nitrate | (1) Meat binder for dry sausage, semi-dry sausage, preserved meat and preserved meat by-products prepared by slow cure processes (Division 14)

Articles B.14.090-B.15.002

Colonne I Vitamines ou minéraux nutritifs

(2)

Cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products prepared by slow cure processes (Division 14) | (1) Where the meat binder is used in accordance with label instructions, whether sodium nitrate is added alone or in combination with potassium nitrate, the total amount of such nitrates thereby added to each batch of dry sausage, semi-dry sausage, preserved meat or preserved meat by-products shall not exceed 0.2 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation

Article

(2)

Where the cover pickle or dry cure is used in accordance with label instructions, whether sodium nitrate is added alone or in combination with potassium nitrate, the total amount of such nitrates thereby added to each batch of preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

V

1 .......... Vitamine B12 Z.1 .......... Zinc Colonne II Quantité par gramme de protéines 0,08 microgramme 0,20 milligramme DORS/88-468, art. 7(F).

(3)

Dry sausage, semi-dry sausage, preserved meat and preserved meat by-products prepared by the slow cure processes (Division 14)

TITRE 15

Falsification des produits alimentaires B.15.001 (1) Un aliment visé à la colonne 2 de la partie 1 de la Liste de contaminants et d'autres substances adultérantes dans les aliments est falsifié si est présent dans l’aliment ou sur sa surface une substance dont le nom ou la catégorie figure à la colonne 1.

(3)

Where sodium nitrate is added alone or in combination with potassium nitrate, the total amount of such nitrates added to each batch of dry sausage, semi-dry sausage, preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation

(2)

Un aliment visé à la colonne 2 de la partie 2 de la Liste de contaminants et d'autres substances adultérantes dans les aliments est falsifié si est présente dans l’aliment ou sur sa surface une substance dont le nom ou la catégorie figure à la colonne 1 en une quantité dépassant la limite maximale prévue à la colonne 3.

(4)

Ripened cheese, containing not more than 68% moisture on a fat free basis during manufacture of which the lactic acid fermentation and salting is completed later than 12 hours after coagulation of the curd by food enzymes and where the added salt is applied externally to the cheese as dry salt or in the form of brine

(3)

Un aliment visé à la colonne 2 de la partie 2 de la Liste de contaminants et d'autres substances adultérantes dans les aliments est soustrait à l’application de l’alinéa 4(1)a) de la Loi, en ce qui concerne une substance dont le nom ou la catégorie figure à la colonne 1, si la quantité de cette substance ne dépasse pas la limite maximale prévue à la colonne 3.

(4)

If used singly or in combination with potassium nitrate, the total not to exceed 200 p.p.m. (based in milk). Residue in the finished cheese not to exceed 50 p.p.m.

(4)

Les paragraphes (1) à (3) ne s’appliquent pas à une substance présente dans l’aliment ou sur sa surface, si elle est : a) d’additif alimentaire; a.1) d’ingrédient supplémentaire; b) de produit antiparasitaire au sens du paragraphe 2(1) de la Loi sur les produits antiparasitaires, ou de ses composants ou dérivés; c) d’une drogue pour usage vétérinaire ou d’un de ses métabolites. DORS/78-404, art. 1; DORS/79-249, art. 1; DORS/2016-74, art. 7; DORS/2022-169, art. 19. B.15.002 (1) Sous réserve du paragraphe (2), un aliment est falsifié dans l’un ou l’autre des cas suivants : a) des produits antiparasitaires au sens du paragraphe 2(1) de la Loi sur les produits antiparasitaires (a) a fertilizer; (b) an adjuvant or a carrier of an agricultural chemical; (c) an inorganic bromide salt; (d) silicon dioxide; (e) sulphur; (f) viable spores of Bacillus thuringiensis Berliner; or (g) Kaolin.

(5)

Mold ripened cheese packed in hermetically sealed containers

(4)

[Repealed, SOR/2008-181, s. 3] SOR/2004-8, s. 1; SOR/79-218, s. 1; SOR/81-83, s. 2; SOR/97-513, s. 2; SOR/98-98, s. 1; SOR/2005-60, s. 1; SOR/2008-181, s. 3; SOR/2008-182, s. 2. B.15.003 [Repealed, SOR/2016-74, s. 8] DIVISION 16 (d) data establishing that the food additive will have the intended physical or other technical effect; B.16.004 [Repealed, SOR/97-148, s. 6] B.16.006 Paragraph B.01.042(c) and paragraph B.01.043(a) do not apply to spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extracts. B.16.008 [Repealed, SOR/88-418, s. 5] TABLE I | Column I | Column II | Column III | |----------|-----------|------------| | C.1 | Calcium Aluminum Silicate | (1) Salt | (1) 1.0%, except in the case of fine-grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a) | | | | (2) Garlic salt; Onion salt | (2) 2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively | | | | (3) Unstandardized dry mixes | (3) Good Manufacturing Practice | | C.2 | Calcium Phosphate tribasic | (1) Salt | (1) 1.0%, except in the case of fine-grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a) | | | | (2) Garlic salt; Onion salt | (2) 2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively | | | | (3) Dry cure | (3) Good Manufacturing Practice | | | | (4) Unstandardized dry mixes | (4) Good Manufacturing Practice | Column I Column II Column III Maximum Level of Use

(5)

If used singly or in combination with potassium nitrate, the total not to exceed 200 p.p.m. (based in milk). Residue in the finished cheese not to exceed 50 p.p.m.

C

3 Calcium Silicate

(1)

Meat binder, pumping pickle, cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products (Division 14)

(1)

Salt

(1)

When the meat binder, pumping pickle, cover pickle or dry cure is used in accordance with label instructions, whether sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites thereby added to each batch of preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation

(2)

Garlic salt; Onion salt

(2)

Preserved meat, except side bacon, and preserved meat by-products (Division 14)

(2)

2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively

(2)

Where sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites added to each batch of preserved meat, except side bacon or preserved meat by-products, shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation

(3)

Baking Powder

(3)

Where sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites added to each batch of side bacon shall not exceed 0.19 ounce per 100 pounds or 120 parts per million, calculated prior to any smoking, cooking or fermentation Current to November 11, 2024 Last amended on June 17, 2024 Item No. Additive Permitted in or Upon

(3)

5.0%

(4)

Preserved poultry meat and preserved poultry meat by-products (Division 22)

(4)

Dry cure

(4)

Where sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites added to each batch of preserved poultry meat or preserved poultry meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation

(4)

Good Manufacturing Practice

(1)

(naming the variety) Cheese; Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients)

(5)

Unstandardized dry mixes

(2)

Preserved fish; Preserved meat (Divisions 14 and 21); Preserved meat by-product (Divisions 14 and 21); Preserved poultry meat; Preserved poultry meat by-product; Sausage Article Additifs Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Class II Preservatives Item No. Additive Permitted in or Upon

(5)

Good Manufacturing Practice

(1)

Apple (or rhubarb) and (naming the fruit) jam; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Mincemeat; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jelly with pectin; (naming the fruit) Juice; (naming the fruits) Juice; Packaged fish and meat products that are marinated or otherwise cold-processed (Division 21); Pickles; Pineapple marmalade with pectin; Relishes; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree (a) meat and meat by-product (Divisions 14 and 21)]; Item No. Additive Permitted in or Upon (b) fish; and (c) poultry meat and poultry meat by-product Same foods as listed for sorbic acid Same levels as prescribed for Sorbic Acid

(6)

Icing sugar

(2)

Vacuum-packed sliced roast beef in accordance with section B.14.005

(7)

Meat Binder or (naming the meat product) Binder

(3)

Vacuum-packed sliced cooked ham in accordance with section B.14.005 or B.14.031

(7)

1.0%

(4)

Vacuum-packed sliced cooked turkey in accordance with section B.22.006 or B.22.021 Good Manufacturing Practice. Residues in the edible portion of the uncooked product not to exceed 1.0 p.p.m.

(9)

Dried egg-white (dried albumen); Dried whole egg; Dried whole egg mix; Dried yolk; Dried yolk mix

(1)

Apple (or rhubarb) and (naming the fruit) jam; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Mincemeat; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; (naming the fruit) Juice; (naming the fruits) Juice; Packaged fish and meat products that are marinated or otherwise cold-processed (Division 21); Pickles; Pineapple marmalade with pectin; Relishes; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product] Same foods as listed for Methyl-p-hydroxy Benzoate Same levels as prescribed for Methyl-p-hydroxy Benzoate Same foods as listed for Benzoic Acid 1,000 p.p.m. calculated as Benzoic Acid Same foods as listed for Sulphurous Acid Same levels as prescribed for Sulphurous Acid Same foods as listed for Sulphurous Acid Same levels as prescribed for Sulphurous Acid Same foods as listed for Sorbic Acid Same levels as prescribed for Sorbic Acid Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use P.5 | Propyl-p-hydroxy Benzoate | (1) Apple (or rhubarb) and (naming the fruit) jam; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Mincemeat; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; (naming the fruit) Juice; (naming the fruits) Juice; Packaged fish and meat products that are marinated or otherwise cold-processed (Division 21); Pickles; Pineapple marmalade with pectin; Relishes; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and P.6 | Propyl Paraben | Same foods as listed for Propyl-p-hydroxy Benzoate | Same levels as prescribed for Propyl-p-hydroxy Benzoate S.01 | Sodium Acetate | (1) Brawn; Headcheese; Meat by-product loaf; Meat loaf; Potted meat; Potted meat by-product; Prepared meat; Prepared meat by-product; Prepared poultry meat; Prepared poultry meat by-product; Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product; Sausage (a) meat and meat by-product (Division 14); and S.1 | Sodium Benzoate | Same foods as listed for Benzoic Acid | 1,000 p.p.m. calculated as Benzoic Acid S.2 | Sodium Bisulphite | Same foods as listed for Sulphurous Acid | Same levels as prescribed for Sulphurous Acid S.21 | Sodium Diacetate | (1) Brawn; Headcheese; Meat by-product loaf; Meat loaf; Potted meat; Potted meat by-product; Prepared meat; Prepared meat by-product; Prepared poultry meat; Prepared poultry meat by-product; Preserved fish or preserved meat (Division 21); Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product; Sausage Item No. | Additive | Permitted in or Upon | Maximum Level of Use S.3 | Sodium Metabisulphite | Same foods as listed for Sulphurous Acid | Same levels as prescribed for Sulphurous Acid S.4 | Sodium Salt of Methyl-p-hydroxy Benzoic Acid | Same foods as listed for Methyl-p-hydroxy Benzoate | 1,000 p.p.m. calculated as Methyl-p-hydroxy Benzoate S.5 | Sodium Salt of Propyl-p-hydroxy Benzoic Acid | Same foods as listed for Propyl-p-hydroxy Benzoate | 1,000 p.p.m. calculated as Propyl-p-hydroxy Benzoate S.6 | Sodium Sorbate | Same foods as listed for Sorbic Acid | Same levels as prescribed for Sorbic Acid S.7 | Sodium Sulphite | Same foods as listed for Sulphurous Acid | Same levels as prescribed for Sulphurous Acid S.8 | Sodium Dithionite | Same foods as listed for Sulphurous Acid | Same levels as prescribed for Sulphurous Acid S.9 | Sorbic Acid | (1) Apple (or rhubarb) and (naming the fruit) jam; Cold-processed smoked and salted fish paste; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Mince-meat; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; (naming the fruit) Juice; (naming the fruits) Juice; (naming the source of the glucose) Syrup; Pickles; Pineapple marmalade with pectin; Relishes; Smoked or salted dried fish; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree | (1) 1,000 p.p.m. (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and | (1) Cider; Honey wine; Wine | (1) 70 p.p.m. in the free state or 350 p.p.m. in the combined state calculated as sulphur dioxide | (2) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (2) 15 p.p.m. calculated as sulphur dioxide | (3) Apple (or rhubarb) and (naming the fruit) jam; Concentrated (naming the | (3) 500 p.p.m. calculated as sulphur dioxide Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use fruit) juice except frozen concentrated orange juice; Fancy molasses; Fig marmalade with pectin; Frozen sliced apples; Gelatin; Mincemeat; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; (naming the fruit) Juice; (naming the fruits) Juice; (naming the source of the glucose) Syrup; Pickles; Pineapple marmalade with pectin; Refiners’ molasses; Relishes; Table molasses; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

(9)

2.0%

(4)

Unstandardized beverages | (4) 100 p.p.m. calculated as sulphur dioxide

C

4 Calcium Stearate

(5)

Dried fruits and vegetables | (5) 2,500 p.p.m. calculated as sulphur dioxide

(1)

Salt

(6)

Unstandardized foods [except in food recognized as a source of thiamine and except unstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

(2)

Garlic salt; Onion salt

(7)

Frozen mushrooms | (7) 90 p.p.m. calculated as sulphur dioxide

(2)

2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively

(8)

Dextrose Anhydrous; Dextrose Monohydrate | (8) 20 p.p.m. calculated as sulphur dioxide

(3)

Unstandardized dry mixes

(9)

Glucose or glucose syrup | (9) 40 p.p.m. except glucose or glucose syrup for the manufacture of sugar confectionery not more than 400 p.p.m. calculated as sulphur dioxide

(3)

Good Manufacturing Practice

(10)

Glucose solids or dried glucose syrup | (10) 40 p.p.m. except glucose solids or dried glucose syrup for the manufacture of sugar confectionery not more than 150 p.p.m. calculated as sulphur dioxide

C

5 Cellulose

(11)

Crustaceans | (11) Good Manufacturing Practice. Residues in the edible portion of the uncooked product not to exceed 100 p.p.m., calculated as sulphur dioxide. Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Class III Preservatives Item No. Additive Permitted in or Upon

M

1 Magnesium Carbonate

(1)

Same foods as listed for Propionic Acid

(2)

2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively Column I Column II Column III Maximum Level of Use

(1)

2,000 p.p.m. calculated as Propionic Acid Same foods as listed for Sorbic Acid Same maximum levels of use as listed for Sorbic Acid

M

2 Magnesium Oxide

(1)

The surface of (naming the variety) cheese and cheddar cheese

(3)

Good Manufacturing Practice

(2)

The surface of grated or shredded (naming the variety) cheese and grated or shredded cheddar cheese

M

3 Magnesium Silicate

(1)

Same foods as listed for Sorbic Acid

(1)

Salt

(1)

Same maximum levels of use as listed for Sorbic Acid

(2)

Garlic salt; Onion salt

(2)

(Naming the variety) Cheese; Cheddar cheese; Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with Item No. Additive Permitted in or Upon Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients) (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product] Same foods as listed for Propionic Acid Same foods as listed for Sorbic Acid

(2)

2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively

(2)

(naming the variety) Cheese; Cheddar cheese; Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients) (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and 2,000 p.p.m. calculated as Propionic Acid Same maximum levels of use as listed for Sorbic Acid Item No. Additive Permitted in or Upon Maximum Level of Use (c) poultry meat and poultry meat by-products Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food Additives That May Be Used as Class IV Preservatives Item No. | Additive | Permitted in or Upon | Maximum Level of Use | | (a) meat and meat by-product (Divisions 14 and 21); | | (b) fish; and | | (3) Margarine | (3) 0.02% of the fat content. If ascorbyl stearate is also used the total must not exceed 0.02% of the fat content | | (4) Infant formula | (4) 0.001% as consumed | | (2) Margarine | (2) 0.02% of the fat content. If ascorbyl palmitate is also used the total must not exceed 0.02% of the fat content B.1 | Butylated Hydroxyanisole (a mixture of 2-tertiarybutyl-4-hydroxyanisole and 3-tertiarybutyl-4-hydroxyanisole) | (1) Fats and oils, lard, shortening | (1) 0.02%. If butylated hydroxytoluene, propyl gallate or tertiary butyl hydroquinone, singly or in combination, is also used, the total must not exceed 0.02% | | (2) Dried breakfast cereals; Dehydrated potato products | (2) 0.005%. If butylated hydroxytoluene or propyl gallate or both are also used, the total must not exceed 0.005% | | (3) Chewing gum | (3) 0.02%. If butylated hydroxytoluene or propyl gallate or both are also used, the total must not exceed 0.02% | | (4) Essential oils; Citrus oil flavours; Dry flavours | (4) 0.125%. If butylated hydroxytoluene or propyl gallate or both are also used, the total must not exceed 0.125% | | (5) Citrus oils | (5) 0.5%. If butylated hydroxytoluene or propyl gallate or both are also used, the total must not exceed 0.5% | | (6) Partially defatted pork fatty tissue; Partially defatted beef fatty tissue | (6) 0.0056%. If butylated hydroxytoluene is also used the total must not exceed 0.0056% Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product

(3)

Unstandardized dry mixes

(11)

Dry Vitamin D preparations for addition to food

(3)

Good Manufacturing Practice

(12)

0.01% of the fat content. If butylated hydroxytoluene or propyl gallate or both are also used the total must not exceed 0.01% of the fat content

(4)

Icing sugar

(13)

0.015% of the fat content. If propyl gallate or citric acid or both are also used, the total must not exceed 0.015% of the fat content

M

4 Magnesium Stearate

(1)

0.02%. If butylated hydroxyanisole, propyl gallate or tertiary butyl hydroquinone, singly or in combination, is also used, the total must not exceed 0.02%

(1)

Salt

(2)

0.005%. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.005%

(2)

Garlic salt; Onion salt

(3)

0.02%. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.02%

(2)

2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively

(4)

0.125%. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.125%

(3)

Unstandardized dry mixes

(5)

0.5%. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.5%

(3)

Good Manufacturing Practice

(6)

Partially defatted pork fatty tissue; Partially defatted beef fatty tissue

(4)

Icing sugar

(6)

0.0065%. If butylated hydroxyanisole is also used the total must not exceed 0.0065%

M

5 Microcrystalline Cellulose P.1 Propylene Glycol Salt

(8)

Parboiled rice (a) meat and meat by-products (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

0.035%

S.1 Silicon Dioxide

(9)

0.02% of the fat or the oil content of the food. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.02% of the fat or the oil content of the food

(1)

Garlic salt; Onion salt

(10)

Dry Vitamin D preparations for addition to food

(1)

1.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively

(11)

0.01% of the fat content. If butylated hydroxyanisole or propyl gallate or both are also used the total must not exceed 0.01% of the fat content Item No. | Additive Permitted in or Upon (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

(2)

Celery Salt; Celery Pepper

(3)

0.015% of the fat content. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.015% of the fat content. Permitted in or Upon (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

(2)

0.5%

(3)

0.01% of the fat content. If monoglyceride citrate, monoisopropyl citrate or stearyl citrate, singly or in combination, is also used, the total must not exceed 0.01% of the fat content. Permitted in or Upon Permitted in or Upon Sulphite replacement formulations for prepared fruits and vegetables Permitted in or Upon (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product] Permitted in or Upon (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product] Item No. Additive Permitted in or Upon (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product] (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

(3)

Unstandardized dry mixes

(3)

0.01% of the fat content. If citric acid esters of mono- and di-glycerides, monoiso­propyl citrate or stearyl citrate, singly or in combination, is also used, the total must not exceed 0.01% of the fat content (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

(3)

Good Manufacturing Practice

(3)

0.01% of the fat content. If citric acid esters of mono- and di-glycerides, monoglyceride citrate or stearyl citrate, singly or in combination, is also used, the total must not exceed 0.01% of the fat content

(4)

Icing sugar PART B Foods

(1)

0.02%. If butylated hydroxyanisole, butylated hydroxytoluene or tertiary butyl hydroquinone, singly or in combination, is also used, the total must not exceed 0.02%

Section B.16.100

Column I | Column II | Column III S.2 Sodium Aluminum Silicate

(2)

0.005%. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used, the total must not exceed 0.005%

(1)

Salt | (1) 1.0%, except in the case of fine-grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)

(3)

0.02%. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used, the total must not exceed 0.02% Item No. Additive Permitted in or Upon

(3)

Dried egg-white (dried albumen); Dried whole egg; Dried whole egg mix; Dried yolk; Dried yolk mix | (3) 2.0%

(4)

0.125%. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used, the total must not exceed 0.125%

(4)

Garlic salt; Onion salt | (4) 2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively

(5)

0.5%. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used, the total must not exceed 0.5% (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

(5)

Unstandardized dry mixes | (5) Good Manufacturing Practice S.3 Sodium Ferrocyanide, decahydrate TABLEAU I Additifs alimentaires autorisés comme agents anti-agglomérants Colonne I | Colonne II | Colonne III

(6)

0.02% of the fat or oil content of the food. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used, the total must not exceed 0.02% of the fat or the oil content of the food

Article | Additifs | Permis dans ou sur | Limites de tolérance

(7)

0.01% of the fat content. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used the total must not exceed 0.01% of the fat content

C

1 Silicate double d’aluminium et de calcium

(8)

0.015% of the fat content. If butylated hydroxyanisole or citric acid or both are also used the total must not exceed 0.015% of the fat content (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product] Fats and oils, lard, shortening

(1)

Sel | (1) 1,0 %, sauf pour le sel à fins 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a)

0.02%. If butylated hydroxyanisole, butylated hydroxytoluene or propyl gallate, singly or in combination, is also used, the total must not exceed 0.02%

T.2 Tocopherols (alpha-tocopherol; tocopherols concentrate, mixed) (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

(2)

Sel d’ail, sel d’oignon | (2) 2,0 % conformément aux exigences des alinéas B.07.020(b) et B.07.027(b) respectivement

(3)

0.001% as consumed Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Sequestering Agents Item No. | Additive | Permitted in or Upon | Maximum Level of Use

(3)

Mélanges secs non normalisés | (3) Bonnes pratiques industrielles

(2)

French dressing; Mayonnaise; Salad dressing; Unstandardized dressings; Unstandardized sauces | (1) 25 p.p.m. calculated as the anhydrous form

C

2 Phosphate tricalcique

(2)

75 p.p.m. calculated as the anhydrous form Item No. Additive Permitted in or Upon

(1)

Sel | (1) 1,0 %, sauf pour le sel à fins 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a)

(3)

100 p.p.m. calculated as the anhydrous form

(2)

Sel d’ail, sel d’oignon | (2) 2,0 % conformément aux exigences des alinéas B.07.020(b) et B.07.027(b) respectivement

(4)

250 p.p.m. calculated as the anhydrous form

(3)

Mélanges de salaison à sec | (3) Bonnes pratiques industrielles

(5)

275 p.p.m. calculated as the anhydrous form

(4)

Mélanges secs non normalisés | (4) Bonnes pratiques industrielles

(6)

75 p.p.m. calculated as the anhydrous form

(5)

Rocou soluble dans l’huile | (5) Bonnes pratiques industrielles PART B Foods

(7)

340 p.p.m. calculated as the anhydrous form

Section B.16.100

Règlement sur les aliments et drogues

(8)

365 p.p.m. calculated as the anhydrous form

PARTIE B Aliments

(9)

Canned sea snails; Canned snails

TITRE 16 Additifs alimentaires

(9)

300 p.p.m. calculated as the anhydrous form

Article B.16.100

Colonne I

(10)

33 p.p.m. calculated as the anhydrous form Ice cream mix; Ice milk mix Glazed fruit

Article

Additifs

(1)

Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product

C

3 Silicate de calcium

(3)

Frozen fish fillets; frozen minced fish; frozen comminuted fish

C

4 Stéarate de calcium

(5)

Aqueous suspensions of colour lake preparations for use in coating confectionery tablets

C

5 Cellulose

(7)

Edible coating for sausages

M

1 Carbonate de magnésium Colonne II Permis dans ou sur

(7)

80 p.p.m. in the edible coating, calculated on the basis of the whole sausage Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use | (3) Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product | (3) 0.5% total added phosphate, calculated as sodium phosphate, dibasic | (2) Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product | (2) 0.5% total added phosphate, calculated as sodium phosphate, dibasic P.4 | Potassium Phosphate, dibasic | Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product | 0.5% total added phosphate, calculated as sodium phosphate, dibasic S.1 | Sodium Acid Pyrophosphate | (1) Canned seafoods | (1) Used singly or in combination with sodium hexametaphosphate or sodium tripolyphosphate, or both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic | (3) Injection or cover solution for the curing of poultry or poultry meat | (3) Good Manufacturing Practice, and in accordance with B.22.021(e) | (4) Pumping pickle for the curing of pork, beef and lamb cuts | (4) Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h) | (6) Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product | (6) 0.5% total added phosphate, calculated as sodium phosphate, dibasic S.2 | Sodium Citrate | (1) Ice cream mix; Ice milk mix; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product; Sherbet | (1) Good Manufacturing Practice S.3 | Sodium Hexametaphosphate | (1) Canned seafoods | (1) Used singly or in combination with sodium acid pyrophosphate or sodium tripolyphosphate, or both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic | (3) Injection or cover solution for the curing of poultry or poultry meat | (3) Good Manufacturing Practice, and in accordance with B.22.021(e) | (4) Pumping pickle for the curing of pork, beef and lamb cuts | (4) Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h) Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

(1)

Sel

(6)

Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product

(2)

Sel d’ail, sel d’oignon

(7)

Liquid whey destined for the manufacture of concentrated or dried whey products

(3)

Poudre à pâte

(3)

Pumping pickle for the curing of pork, beef and lamb cuts

(4)

Mélange de salaison à sec

(5)

Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product

(5)

Mélanges secs non normalisés

(6)

0.5% total added phosphate, calculated as sodium phosphate, dibasic

(6)

Sucre à glacer

(2)

Good Manufacturing Practice, and in accordance with B.22.021(e)

(7)

Liant à viande ou liant à (désignation du produit de viande)

(3)

Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)

(8)

Fromage râpé fin ou en filaments (indication de la variété); fromage cheddar râpé fin ou en filaments; préparations de fromage râpé fin ou en filaments non normalisées

(5)

0.5% total added phosphate, calculated as sodium phosphate, dibasic S.5 Sodium Phosphate, monobasic

(9)

Mélange de poudre de jaunes d’œufs; mélange de poudre d’œufs entiers; poudre de blanc d’œuf (poudre d’albumen); poudre de jaune d’œuf; poudre d’œuf entier

(3)

Pumping pickle for the curing of pork, beef and lamb cuts

(1)

Sel

(5)

Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product

(2)

Sel d’ail, sel d’oignon

(2)

Good Manufacturing Practice, and in accordance with B.22.021(e)

(3)

Mélanges secs non normalisés Fromage râpé fin ou en filaments (indication de la variété); fromage cheddar râpé fin ou en filaments; préparations de fromage râpé fin ou en filaments non normalisées

(3)

Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)

(1)

Sel (sauf si employé dans les préparations de viande et de sous-produits de viande du Titre 14)

(5)

0.5% total added phosphate, calculated as sodium phosphate, dibasic

(2)

Sel d’ail, sel d’oignon (sauf si employé dans les préparations de viande et de sous-produits de viande du Titre 14) Colonne III Limites de tolérance

(4)

Pumping pickle for the curing of pork, beef and lamb cuts

(6)

Si on l’emploie seul ou avec du silicate de calcium, du carbonate de magnésium, du silicate de magnésium, du stéarate de magnésium, du dioxyde de silicium ou du silicate double d’aluminium et de sodium, le total ne doit pas dépasser 1,5 %

(6)

Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product

(1)

1,0 %, pour le sel à grains fins, 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a).

(3)

Good Manufacturing Practice, and in accordance with B.22.021(e)

(2)

2,0 % conformément aux exigences des alinéas B.07.020b) et B.07.027b) respectivement.

(4)

Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)

(3)

5,0 %

(6)

0.5% total added phosphate, calculated as sodium phosphate, dibasic

(4)

Bonnes pratiques industrielles

(3)

Pumping pickle for the curing of pork, beef and lamb cuts

(5)

Bonnes pratiques industrielles

(5)

Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product

(7)

1,0 %

(1)

Good Manufacturing Practice, and in accordance with B.22.021(e)

(8)

Si on l’emploie seul ou avec la cellulose microcristalline ou la cellulose, la quantité totale n’excédant pas 2,0 %

(3)

Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)

(9)

2,0 %

(5)

0.5% total added phosphate, calculated as sodium phosphate, dibasic Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use

(1)

1,0 %, sauf pour le sel à grains fins 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a).

(6)

Canned seafoods | (6) Used singly or in combination with sodium acid pyrophosphate or sodium hexametaphosphate, or both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic S.8 | Stearyl Citrate | Margarine | 0.01% of the fat content. If citric acid esters of mono- and di-glycerides, monoglyceride citrate or monoisopropyl citrate, singly or in combination, is also used, the total must not exceed 0.01% of the fat content Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Starch Modifying Agents Item No. | Additive | Permitted in or Upon | Maximum Level of Use Current to November 11, 2024 Last amended on June 17, 2024 Item No. Additive Permitted in or Upon Maximum Level of Use P.3 Potassium Permanganate Starch 50 p.p.m. of Manganese Sulphate calculated as Manganese S.7 Sodium Trimetaphosphate Starch 400 p.p.m. calculated as Phosphorus S.7A Sodium Tripolyphosphate Starch Total residual phosphate not to exceed 0.4% (calculated as Phosphorus) Food and Drug Regulations DIVISION 16 Food Additives Food Additives That May Be Used as Yeast Foods Item No. | Additive | Permitted in or Upon | Maximum Level of Use Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Level of Use Food and Drug Regulations DIVISION 16 Food Additives Current to November 11, 2024 Last amended on June 17, 2024 Food Additives That May Be Used as Carrier or Extraction Solvents Item No. | Additive | Permitted in or Upon | Maximum Residue | Maximum Level of Use

(2)

2,0 %, conformément aux exigences des alinéas B.07.020b) et B.07.027b) respectivement.

3.1 | Carbon Dioxide | (1) Green coffee beans and tea leaves for decaffeination purposes | | (1) Good Manufacturing Practice

| | (3) Green coffee beans for decaffeination purposes | (3) 10 p.p.m. in both roasted and decaffeinated soluble (instant) coffee | Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Residue | Maximum Level of Use Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Residue | Maximum Level of Use

(3)

Bonnes pratiques industrielles

(5)

Meat and Egg Marking Inks | the pre-isomerized hop extract

(8)

Si on l’emploie seul ou avec le silicate de calcium, le silicate de magnésium ou le silicate double d’aluminium et de sodium, la quantité totale n’excédant pas 1,5 %

(3)

10 p.p.m. in decaffeinated roasted coffee, decaffeinated soluble (instant) coffee, decaffeinated tea leaves and decaffeinated instant tea | Food and Drug Regulations DIVISION 16 Food Additives Item No. | Additive | Permitted in or Upon | Maximum Residue | Maximum Level of Use Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives Food and Drug Regulations DIVISION 16 Food Additives B.17.001 (1) [S]. Salt, other than crude rock salt, shall be crystalline sodium chloride and may contain (a) one or more of the following anti-caking agents, (iii) sodium ferrocyanide decahydrate in an amount not exceeding 13 parts per million calculated as anhydrous sodium ferrocyanide; (b) not more than (ii) 13 parts per million anhydrous sodium ferrocyanide when added as sodium ferrocyanide decahydrate in the production of dendritic crystals of salt, (iv) 15 parts per million of sodium alginate when used in the production of coarse crystal salt, and (c) notwithstanding paragraphs (a) and (b), the total level of sodium ferrocyanide decahydrate, whether added as an anti-caking agent or as an adjuvant in the production of dendritic salt, shall not exceed 13 parts per million, calculated as anhydrous sodium ferrocyanide. B.17.003 Notwithstanding section B.17.001, salt for table or general household use shall contain 0.01 per cent potassium iodide, with or without dextrose, sodium thiosulphate or sodium bicarbonate as a stabilizer of the iodide and the presence of iodide shall be shown on the principal display panel. (a) shall be the food chemically known as sucrose; and B.18.002 [S]. Liquid Sugar shall be the food obtained by dissolving sugar in water. B.18.003 [S]. Invert Sugar shall be the food obtained by the partial or complete hydrolysis of sugar. B.18.004 [S]. Liquid Invert Sugar shall be the food consisting of a solution of invert sugar in water. B.18.005 [S]. No person shall sell liquid sugar or liquid invert sugar unless the label carries a statement of the percentage of sugar or invert sugar contained therein. (b) may contain (i) food colour, and (a) shall be the food obtained from the syrups originating in the sugar refining process; (b) may contain not more than (c) shall not contain less than 90 per cent sugar and invert sugar. (a) shall be the food made from syrup originating in the sugar refining process; (b) may be hydrolyzed; and (c) shall not contain more than (a) shall be the syrupy food obtained by the evaporation and partial inversion of the clarified or unclarified sugar cane juice from which sugar has not been previously extracted; (b) may contain sulphurous acid or its salts; and (c) shall not contain more than (b) may contain sulphurous acid or its salts; (c) shall not contain more than (b) may contain sulphurous acid or its salts; (c) shall not contain more than B.18.015 [S]. (1) Dextrose Anhydrous, for the purpose of Part B of these Regulations (a) shall be the food chemically known as dextrose; (c) shall contain not more than 0.25 per cent sulphated ash on a dry basis; (e) may contain sulphurous acid or its salts.

(1)

1,0 %, sauf pour le sel à grains fins 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a).

(2)

Dextrose Monohydrate, for the purpose of Part B of these Regulations (a) shall be the food chemically known as dextrose; (c) shall contain not more than 0.25 per cent sulphated ash on a dry basis; (a) shall be the purified concentrated solution of nutritive saccharides obtained from the incomplete hydrolysis, by means of acid or enzymes, of starch or of a starch-containing substance; (b) shall have a total solids content of not less than 70 per cent; (c) shall have a sulphated ash content of not more than 1.0 per cent on a dry basis; (d) shall have a reducing sugar content (dextrose equivalent) of not less than 20 per cent expressed as D-glucose on a dry basis; and (e) may contain sulphurous acid or its salts. (a) shall be glucose or glucose syrup from which the water has been partially removed; (b) shall have a total solids content of not less than 93 per cent; (c) shall have a sulphated ash content of not more than 1.0 per cent on a dry basis; (d) shall have a reducing sugar content (dextrose equivalent) of not less than 20 per cent expressed as D-glucose, on a dry basis; and (e) may contain sulphurous acid or its salts. (b) may contain (iv) sulphurous acid or its salts. (c) shall not contain more than (a) shall be the carbohydrate normally obtained from whey and may (ii) contain one molecule of water of crystallization, or (iii) be a mixture of both subparagraphs (i) and (ii); (e) shall have, in a 10 per cent solution, a pH of not less than 4.5 and not more than 7.0. B.18.025 [S]. Honey shall be the food produced by honey bees and derived from (c) secretions on living plants, and shall have (e) a diastase activity, determined after processing and blending, as represented by a diastase figure on the Gothe scale of not less than eight where the hydroxy-methyl-furfural content is not more than 0.004 per cent; or (f) a diastase activity, determined after processing and blending, as represented by a diastase figure on the Gothe scale of not less than three where the hydroxymethyl-furfural content is not more than 0.0015 per cent. B.18.026 (1) Subject to subsection (2), honey derived mainly from nectar of blossoms shall not contain (a) less than 65 per cent apparent reducing sugar, calculated as invert sugar; B.18.027 Honey derived from secretions of living plants or from secretions on living plants shall not contain (a) less than 60 per cent apparent reducing sugar, calculated as invert sugar; B.19.001 Vinegar shall be the liquid obtained by the acetous fermentation of an alcoholic liquid and shall contain not less than 4.1 per cent and not more than 12.3 per cent acetic acid. B.19.002 The percentage of acetic acid by volume contained in any vinegar described in Division 19 shall be shown on the principal display panel followed by the words “acetic acid”. B.19.003 [S]. Wine Vinegar shall be vinegar made from wine and may contain caramel. B.19.004 [S]. Spirit Vinegar, Alcohol Vinegar, White Vinegar or Grain Vinegar shall be vinegar made from diluted distilled alcohol. B.19.005 [S]. Malt Vinegar shall be vinegar made from an infusion of malt undistilled prior to acetous fermentation, may contain other cereals or caramel, shall be dextro-rotary, and shall contain, in 100 millilitres measured at a temperature of 20°C, not less than B.19.006 [S]. Cider Vinegar or Apple Vinegar shall be vinegar made from the liquid expressed from whole apples, apple parts or apple culls and may contain caramel. B.19.007 [S]. Blended Vinegar shall be a combination of two or more varieties of vinegar of which spirit vinegar shall contribute not more than 55 per cent of the total acetic acid. B.19.008 No person shall name any of the varieties of vinegar forming a blended vinegar unless the label of such blended vinegar carries a complete list of all the varieties of vinegar present, in descending order of proportionate content, based on acetic acid. B.19.009 The maximum limits for the acetic acid content of a vinegar described in section B.19.001 do not apply to vinegar sold only for manufacturing use if the words “For Manufacturing Use Only” are shown on the principal display panel and upon all documents pertaining to such vinegar. B.20.001 [S]. Tea shall be the dried leaves and buds of *Thea sinensis* (L.) Sims prepared by the usual trade processes. B.20.002 [S]. Black Tea shall be black tea or a blend of two or more black teas and shall contain, on the dry basis, not less than 30 per cent water-soluble extractive, as determined by official method FO-37, Determination of Water-Soluble Extractive in Tea, October 15, 1981, and not less than four per cent and not more than seven per cent total ash. B.20.003 The provisions of B.20.002 do not apply to original unblended black tea that contains, on the dry basis, not less than 25 per cent water-soluble extractive, as determined by official method FO-37, Determination of Water-Soluble Extractive in Tea, October 15, 1981, and not less than four per cent and not more than seven per cent total ash, and is packaged according to good commercial practice in the country of origin. B.20.004 [S]. Green Tea shall contain, on the dry basis, not less than 33 per cent water-soluble extractive, as determined by official method FO-37, Determination of Water-Soluble Extractive in Tea, October 15, 1981, and not less than four per cent and not more than seven per cent total ash. (a) shall be tea of the type indicated, from which caffeine has been removed and that, as a result of the removal, contains not more than 0.4 per cent caffeine; and (b) may have been decaffeinated by means of extraction solvents set out in Table XV to Division 16. Marine and Fresh Water Animal Products B.21.001 The foods referred to in this Division are included in the term marine and fresh water animal products. B.21.002 In this Division, filler means (a) flour or meal prepared from grain or potato, but not from a legume, (b) processed wheat flour containing not less than the equivalent of 80 per cent dextrose, as determined by official method FO-32, Determination of Fillers, Binders and Dextrose Equivalent, October 15, 1981, (c) bread, biscuit or bakery products, but not those containing or made with a legume, marine and fresh water animal includes (b) crustaceans, molluscs, other marine invertebrates, (c) marine mammals, and B.21.003 [S]. Fish shall be the clean, dressed edible portion of fish, with or without salt or seasoning, and may (a) in the case of frozen fillets, contain ascorbic acid or its sodium salt, citric acid, or erythorbic acid or its sodium salt, and B.21.004 [S]. In this Division, meat shall be the clean, dressed flesh of crustaceans, molluscs, other marine invertebrates and marine mammals, whether minced or not, with or without salt or seasoning, and in the case of frozen lobster, frozen crab, frozen shrimp and frozen prawns, may contain a combination of sodium tripolyphosphate and sodium hexametaphosphate or a combination of sodium hexametaphosphate and sodium carbonate or a combination of sodium tripolyphosphate, sodium acid pyrophosphate and sodium pyrophosphate tetrabasic. B.21.005 Fish, except fish protein, and meat products or preparations thereof are adulterated if any of the following substances or any substance in one of the following classes is present therein or has been added thereto: (a) mucous membranes, any organ or portion of the genital system, or any organ or portion of a marine or fresh water animal that is not commonly sold as an article of food; (b) preservatives, other than those provided for in this Division, except (i) sorbic acid or its salts in dried fish that has been smoked or salted, and in cold processed smoked and salted fish paste, and (ii) benzoic acid or its salts, methyl-p-hydroxy benzoate and propyl-p-hydroxy benzoate in marinated or similar cold-processed, packaged fish and meat products; B.21.006 [S]. Prepared fish or prepared meat shall be the whole or minced food prepared from fresh or preserved fish or meat respectively, may be canned or cooked, and may, (a) in the case of lobster paste and fish roe (caviar), contain food colour; (b) in the case of canned shellfish, canned spring mackerel and frozen cooked shrimp, contain citric acid or lemon juice; (f) in the case of canned seafoods, contain sodium acid pyrophosphate, sodium hexametaphosphate or sodium tripolyphosphate, singly, or in combination, at a maximum level of total added phosphate not to exceed 0.5%, calculated as sodium phosphate, dibasic; (h) contain edible oil, vegetable broth and tomato sauce or puree; (i) contain a gelling agent if the principal display panel carries the word “jellied” as an integral part of the common name; (n) in the case of a blend of prepared fish and prepared meat that has the appearance and taste of the flesh of a marine or freshwater animal, contain filler, fish binder, whole egg, egg-white, egg-yolk, food colour, gelling or stabilizing agents, texture-modifying agents, natural and artificial flavouring preparations, pH-adjusting agents, sweetener and, in a proportion not exceeding two per cent of the blend, a legume; (p) in the case of frozen crustaceans and molluscs, contain calcium oxide and sodium hydroxide; (q) in the case of frozen pre-cooked battered or breaded fish products, contain citric acid at a level of use not exceeding 0.1 per cent; (s) in the case of minced products, other than lumpfish caviar, contain tragacanth gum at a level of use not exceeding 0.75 per cent; and (t) contain a Class II preservative. B.21.007 [S]. Fish binder for use in or upon prepared fish or prepared meat shall be filler with any combination of salt, sugar, dextrose, glucose, spices and other seasonings. B.21.008 No person shall sell filler or a fish binder represented for use in fish products either by label or in any advertisement unless the label carries adequate directions for use in accordance with the limits provided in section B.21.020. B.21.009 Powdered fully hydrogenated cottonseed oil may be applied as a release agent to the surface of marine and fresh water animal products in an amount not greater than 0.25% of the product. B.21.020 No person shall sell prepared fish or prepared meat that contains more than (a) that amount of filler, fish binder or other ingredients that is represented by four per cent reducing sugars, calculated as dextrose, as determined by official method FO-32, Determination of Fillers, Binders and Dextrose Equivalent, October 15, 1981; and B.21.021 [S]. Preserved fish or preserved meat shall be cooked or uncooked fish or meat that is dried, salted, pickled, cured or smoked and may contain a Class I preservative, a Class II preservative, dextrose, glucose, spices, sugar and vinegar, and (a) dried fish that has been smoked or salted, and cold-processed smoked and salted fish paste may contain sorbic acid or its salts; (b) smoked fish may contain food colour; (c) packaged fish and meat products that are marinated or otherwise cold-processed may contain saunderswood (sandalwood), benzoic acid or its salts, methyl-p-hydroxy benzoate and propyl-p-hydroxy benzoate; (d) salted anchovy, salted scad and salted shrimp may contain erythrosine in such amount as will result in the finished product containing not more than 125 parts per million of erythrosine; and (e) minced products may contain tragacanth gum at a level of use not exceeding 0.75 per cent. B.21.024 Notwithstanding section B.21.020 lobster paste shall not contain more than two per cent filler or fish binder. B.21.025 No person shall sell marine and fresh water animals, or marine and fresh water animal products, that are packed in a container that has been sealed to exclude air and that are smoked or to which liquid smoke flavour or liquid smoke flavour concentrate has been added, unless (a) the container has been heat-processed after sealing at a temperature and for a time sufficient to destroy all spores of the species Clostridium botulinum; (b) the contents of the container contain not less than nine per cent salt, as determined by official method FO-38, Determination of Salt in Smoked Fish, dated March 15, 1985; (c) the contents of the container are customarily cooked before eating; or (d) the contents of the container are frozen and the principal display panel of the label of the container carries the statement “Keep Frozen Prior to Use” in the same size type used for the common name of the contents of the container. (a) shall be the food prepared by (i) extracting water, fat and other soluble components through the use of isopropyl alcohol from fresh whole edible fish of the order Clupeiformes, families Clupeidae and Osmeridae and of the order Gadiformes, family Gadidae, or from trimmings resulting from the filleting of such fish when eviscerated, and (ii) drying and grinding the protein concentrate resulting from the operation described in subparagraph (i); (b) may contain a pH adjusting agent; and (i) less than 75 per cent protein, which protein shall be at least equivalent to casein in protein quality, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981. B.21.031 No person shall sell fresh or frozen frogslegs unless they are free from bacteria of the genus Salmonella, as determined by official method MFO-10, Microbiological Examination of Frogslegs, November 30, 1981. Poultry, Poultry Meat, Their Preparations and Products B.22.001 [S]. Poultry shall be any bird that is commonly used as food. B.22.002 [S]. Poultry meat shall be the clean, dressed flesh including the heart and gizzard of eviscerated poultry that is healthy at the time of slaughter. B.22.003 [S]. Poultry meat by-product shall be the clean parts of poultry other than poultry meat commonly used as food and includes liver and skin but excludes the oesophagus, feet and head. B.22.004 [S]. Giblets shall be the heart, liver and gizzard of poultry. B.22.005 Poultry meat, poultry meat by-products or preparations thereof are adultered if any of the following substances or any substance in the following classes is present therein or has been added thereto: (a) any organ or portion of poultry that is not commonly sold as food; (b) preservatives, other than those provided for in this Division; and (c) colour, other than caramel. B.22.006 [S]. Prepared poultry meat or a prepared poultry meat by-product shall be any poultry meat or any poultry meat by-product, respectively, whether comminuted or not, to which has been added any ingredient permitted by these Regulations or that has been preserved, placed in a hermetically-sealed container or cooked, and may contain (a) where a minimum total protein content or minimum meat protein requirement is prescribed in this Division, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely, (a.1) a Class II preservative; (b) in the case of dried, cooked poultry meat, a Class IV preservative; and (c) in the case of vacuum-packed sliced cooked turkey, Carnobacterium maltaromaticum CB1. B.22.008 In this Division, filler means any vegetable material (except tomato or beetroot), milk, egg, yeast, or any derivative or combination thereof that is acceptable as food. B.22.009 No person shall sell (a) any poultry intended for consumption as food if any preparation having oestrogenic activity has been administered to the poultry; or B.22.010 Powered fully hydrogenated cottonseed oil may be applied as a release agent to the surface of poultry meat, poultry meat by-product, prepared poultry meat, prepared poultry meat by-product, extended poultry product and simulated poultry product in an amount not greater than 0.25% of the product. B.22.011 [S]. Solid cut poultry meat shall be (b) a product consisting of pieces of poultry meat of which at least 80 per cent weigh at least 25 g each. B.22.012 (1) No person shall sell solid cut poultry meat to which phosphate salts or water has been added unless (a) that meat (i) where cooked, contains a meat protein content of not less than 12 per cent, and (ii) where uncooked, contains a meat protein content of not less than 10 per cent; and (b) that meat contains, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely,

(2)

2,0 %, conformément aux exigences des alinéas B.07.020b) et B.07.027b) respectivement. PART B Foods

(2)

A bone or a visible fat layer shall not be included in any calculation used to determine meat protein content for the purposes of paragraph (1)(a). B.22.013 No person shall sell the whole or any part of a dressed poultry carcass that has been placed in a chilling tank containing fluids to which phosphate salts have been added. B.22.016 For the purposes of sections B.22.017 to B.22.019, stew poultry meat means cooked or uncooked poultry meat containing not more than 15 per cent fat, calculated on the weight of uncooked stew poultry meat. B.22.017 [S]. Vegetable Stew with (naming the poultry meat) (a) shall contain vegetables and the named poultry meat in the following amounts: (b) may contain gravy, salt, seasoning and spices. (a) shall contain vegetables and the named poultry meat in the following amounts: (b) may contain gravy, salt, seasoning and spices. (a) shall contain poultry meat and vegetables in the following amounts: (b) may contain gravy, salt, seasoning and spices. Prepared Poultry Meats, Prepared Poultry Meat By-Products B.22.021 [S]. Preserved poultry meat or poultry meat by-product shall be cooked or uncooked poultry meat or poultry meat by-product that is cured or smoked and may contain (a) a Class I preservative; (a.1) a Class II preservative; (e) in the case of cured poultry or poultry meat prepared by means of injection or cover solution, disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate, in such amount calculated as disodium phosphate, as will result in the finished product containing not more than 0.5 per cent added phosphate; and B.22.022 [S]. Canned (naming the poultry) shall be prepared from poultry meat and may contain (a) those bones or pieces of bones attached to the portion of the poultry meat that is being canned; B.22.023 [S]. Broth that is used in canned (naming the poultry) shall be the liquid in which the poultry meat has been cooked. B.22.025 [S]. Boneless (naming the poultry) shall be canned poultry meat from which the bones and skin have been removed, shall contain not less than 50 per cent of the named poultry meat, as determined by official method FO-39, Determination of Meat in Boneless Poultry, October 15, 1981, and may contain broth having a specific gravity of not less than 1.000 at a temperature of 50°C. B.22.026 No person shall sell poultry, poultry meat or poultry meat by-product that has been barbecued, roasted or broiled and is ready for consumption unless the cooked poultry, poultry meat or poultry meat by-product (i) has a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher, or (ii) has been stored at an ambient temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher; and (b) carries on the principal display panel of the label a statement to the effect that the food must be stored at a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher. B.22.027 No person shall sell a poultry product extender unless that extender (a) has, in the rehydrated state, (i) a total protein content of not less than 16 per cent; and (ii) a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981; (b) has, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to Division 14 in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and (c) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein. Extended Poultry Products B.22.028 No person shall sell a food that consists of a mixture of poultry product and poultry product extender, unless that food (a) has a total protein content of not less than 16 per cent, and (b) has a protein rating of not less than 40, as determined by official method, and unless Simulated Poultry Products B.22.029 No person shall sell a simulated poultry product unless that product (a) has a total protein content of not less than 16 per cent; (b) has a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981; (c) has a fat content of not more than 15 per cent; (d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to Division 14 in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and (e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein. Egg Products B.22.032 No person shall sell any product simulating whole egg unless that product (a) is made from liquid, dried or frozen egg albumen or mixtures thereof; (b) has a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981; (i) not less than (ii) not more than 3 milligrams cholesterol; (e) contains in the total fat of any fat or oil used not less than 40 per cent cis-cis methylene interrupted polyunsaturated fatty acids and not more than 20 per cent saturated fatty acids. B.22.033 No person shall sell any egg product referred to in sections B.22.032, B.22.034, B.22.035, B.22.036 and B.22.037 for use as food unless it is free from bacteria of the genus Salmonella, as determined by official method MFO-6, Microbiological Examination of Egg Products and Liquid Eggs, November 30, 1981. (a) shall be the product obtained by removing the shell from wholesome fresh eggs or wholesome stored eggs; and (i) in the case of dried whole egg, drying the product, or (ii) in the case of frozen whole egg, freezing the product; and (b) may (ii) in the case of liquid whole egg destined for drying, contain yeast autolysate and may be treated with hydrogen peroxide and catalase, glucose oxidase and catalase or yeast and suitable glucose fermenting bacterial culture, or (iii) in the case of dried whole egg, contain anti-caking agents. (a) shall be the product obtained by removing the shell and egg-white from wholesome fresh eggs or wholesome stored eggs, and (i) in the case of dried yolk, drying the product, or (ii) in the case of frozen yolk, freezing the product, and (b) may (ii) in the case of liquid yolk destined for drying, contain yeast autolysate and may be treated with hydrogen peroxide and catalase, glucose oxidase and catalase or yeast and suitable glucose fermenting bacterial culture, or (iii) in the case of dried yolk, contain anti-caking agents. (a) shall be the product obtained by removing the shell and yolk from wholesome fresh eggs or wholesome stored eggs, and (i) in the case of dried egg-white, drying the product, or (ii) in the case of frozen egg-white, freezing the product; and (b) may (ii) in the case of liquid egg-white destined for drying, contain yeast autolysate and may be treated with hydrogen peroxide and catalase, glucose oxidase and catalase or yeast and suitable glucose fermenting bacterial culture, (iii) in the case of liquid egg-white and dried egg-white, contain lipase or pancreatin, or (iv) in the case of dried egg-white, contain anti-caking agents. (a) shall be the product obtained by adding salt, sweetening agent or both to Liquid Whole Egg, Dried Whole Egg, Frozen Whole Egg, Liquid Yolk, Dried Yolk or Frozen Yolk; and (b) may, in the case of dried whole egg mix or dried yolk mix, contain anti-caking agents. B.22.038 (1) No person shall use a common name referred to in sections B.22.034 to B.22.037 for an egg product that has been subjected to a process, other than a process referred to in those sections, if that process results in a decrease in the amount of a vitamin or mineral nutrient that before processing was present in 100 g of the egg product in an amount equal to at least 10 per cent of the weighted recommended nutrient intake, unless the amount of the vitamin or mineral nutrient is restored to the amount that was present before processing.

Section B.16.100

Règlement sur les aliments et drogues

(2)

Notwithstanding sections D.01.009, D.01.011 and D.02.009, a person may add any vitamin or mineral nutrient referred to in column II of item 27 of the table to section D.03.002 to any egg product referred to in sections B.22.034 to B.22.037 to restore the vitamin or mineral nutrient to the amount that was present in the egg product before processing.

PARTIE B Aliments

(3)

In this section, weighted recommended nutrient intake has the same meaning as in subsection D.01.001(1). B.23.001 No person shall sell any food in a package that may yield to its contents any substance that may be injurious to the health of a consumer of the food. B.23.002 Subject to section B.23.003 no person shall sell any food in a package that has been manufactured from a polyvinyl chloride formulation containing an octyltin chemical. B.23.003 A person may sell food, other than milk, skim milk, partly skimmed milk, sterilized milk, malt beverages and carbonated non-alcoholic beverage products, in a package that has been manufactured from a polyvinyl chloride formulation containing any or all of the octyltin chemicals, namely, di(n-octyl)tin S,S′,S″-tris(isooctylmercaptoacetate), di(n-octyl)tin maleate polymer and (n-octyl)tin S,S′,S″-tris(isooctylmercaptoacetate) if the proportion of such chemicals, either singly or in combination, does not exceed a total of three per cent of the resin, and the food in contact with the package contains not more than one part per million total octyltin. B.23.005 Di(n-octyl)tin maleate polymer shall be the octyltin chemical made from di(n-octyl)tin dichloride and shall have the formula ((C8H17)2 SnC4H2O4)n (where n is between 2 and 4 inclusive), and a saponification number of 225 to 255, and shall contain 25.2 to 26.6 per cent of tin.

TITRE 16 Additifs alimentaires

(2)

For the purposes of this Division, (n-octyl)tin trichloride shall be the chemical having an organotin composition of not less than 95 per cent (n-octyl)tin trichloride and shall contain not more than: B.23.007 No person shall sell a food in a package than may yield to its contents any amount of vinyl chloride, as determined by official method, FO-40, Determination of Vinyl Chloride in Food, October 15, 1981, in respect of that food. B.23.008 No person shall sell a food in a package that may yield to its contents any amount of acrylonitrile as determined by official method FO-41, Determination of Acrylonitrile in Food, February 16, 1982, in respect of that food. Foods for Special Dietary Use B.24.001 In this Division, expiration date means, in respect of a formulated liquid diet, a food represented for use in a very low-energy diet, a meal replacement or a nutritional supplement, the date (a) after which the manufacturer does not recommend that it be consumed, and (b) up to which it maintains its microbiological and physical stability and the nutrient content declared on the label; (date limite d’utilisation) food for special dietary use means food that has been specially processed or formulated to meet the particular requirements of a person (a) in whom a physical or physiological condition exists as a result of a disease, disorder or injury, or formulated liquid diet means a food that (a) is sold for consumption in liquid form, and (b) is sold or represented as a nutritionally complete diet for oral or tube feeding of a person described in paragraph (a) of the definition “food for special dietary use”; (préparation pour régime liquide) hospital means a facility (a) that is licensed, approved or designated as a hospital by a province, in accordance with the laws of the province, to provide care or treatment to persons suffering from any form of disease or illness, or (b) that is owned or operated by the government of Canada or of a province and that provides health services; (hôpital) major change means, in respect of a food that is represented for use in a very low energy diet, any change in any of the following, where the manufacturer’s experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, the microbiological or chemical safety of or the safe use of the food: (b) the manufacturing process or the packaging of the food, or pharmacist means a person who is registered and entitled under the laws of a province to practise pharmacy and who is practising pharmacy under those laws in that province; (pharmacien) physician means a person who is registered and entitled under the laws of a province to practise medicine and who is practising medicine under those laws in that province; (médecin) target body weight means the anticipated body weight at the end of the weight reduction diet, as determined by the physician before the weight reduction diet begins; (poids corporel cible) B.24.003 (1) No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is a food for special dietary use unless the food is (f) a formulated liquid diet that meets the requirements contained in sections B.24.101 and B.24.102; (f.1) a meal replacement for special dietary use that meets the requirements contained in section B.24.200; (g) a gluten-free food that meets the requirements contained in section B.24.018; (h) represented for protein-restricted diets; (i) represented for low (naming the amino acid) diets; or (j) a food represented for use in a very low energy diet, where the food meets the requirements contained in section B.24.303. (1.1) Despite subsection (1), a person may label, package, sell or advertise a food in a manner likely to create an impression that it is a food for special dietary use if its label carries a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1: (b) “low in energy”, set out in item 2;

Article B.16.100

Colonne I | Colonne II | Colonne III

(2)

Subsection (1) does not apply to a human milk fortifier or human milk substitute as defined in section B.25.001.

Article | Additifs | Permis dans ou sur | Limites de tolérance

(3)

No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is for use in a weight reduction diet unless that food is (a) a meal replacement that meets the compositional requirements contained in section B.24.200; (b) a prepackaged meal; (c) a food sold by a weight reduction clinic to clients of the clinic for use in a weight reduction program supervised by the staff of the clinic; or (d) a food represented for use in a very low-energy diet that meets the compositional requirements contained in section B.24.303.

M

2 | Oxyde de magnésium | Mélanges secs non normalisés (sauf lorsqu’il est utilisé dans les préparations de viande et de sous-produits de la viande du Titre 14) | (3) Bonnes pratiques industrielles

(4)

Except as otherwise permitted by these Regulations, no person shall label, package, sell or advertise a food as “dietetic” or “diet”, or use those words as part of the brand name of the food, unless its label carries a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1: (b) “low in energy”, set out in item 2; (c) “reduced in energy”, set out in item 3; B.24.017 (1) Where the manufacturer of a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet is requested in writing by the Minister to submit, on or before a specified day, evidence with respect to that product, the manufacturer shall make no further sales of that product after that day unless the manufacturer has submitted the evidence requested.

M

3 | Silicate de magnésium | (1) Sel | (1) 1,0 %, sauf pour le sel à grains fins 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a). | | (2) Sel d’ail et d’oignon | (2) 2,0 % conformément aux exigences des alinéas B.07.020b) et B.07.027b) respectivement. | | (3) Mélanges secs non normalisés | (3) Bonnes pratiques industrielles. | | (4) Sucre à glacer | (4) Si on l’emploie seul ou avec du phosphate tricalcique, du silicate de calcium, du carbonate de magnésium, du stéarate de magnésium, du dioxyde de silicium ou du silicate double d’aluminium et de sodium, le total ne doit pas dépasser 1,5 %.

(2)

If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing.

M

4 | Stéarate de magnésium | (1) Sel | (1) 1,0 %, sauf pour le sel à grains fins 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a). | | (2) Sel d’ail, sel d’oignon | (2) 2,0 % conformément aux exigences des alinéas B.07.020b) et B.07.027b) respectivement. | | (3) Mélanges secs non normalisés | (3) Bonnes pratiques industrielles. | | (4) Sucre à glacer | (4) Si on l’emploie seul ou avec du phosphate tricalcique, du carbonate de magnésium, du silicate de calcium, du dioxyde de silicium ou du silicate double d’aluminium et de sodium, la quantité totale n’excédant pas 2,0 %.

(3)

Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet is not sufficient, the manufacturer shall make no further sales of that product unless the manufacturer submits further evidence and is notified in writing by the Minister that the further evidence is sufficient.

M

5 | Cellulose microcristalline | Fromage râpé fin ou en filaments (indication de la variété); fromage cheddar râpé fin ou en filaments; préparations de fromage râpé fin ou en filaments non normalisées | Si on l’emploie seul ou avec le silicate de calcium ou le carbonate de calcium, la quantité totale n’excédant pas 2,0 %. P.1 | Propylèneglycol | Sel | 0,035 %. S.1 | Bioxyde de silicium | (1) Sel d’ail; sel d’oignon | (1) 1,0 % conformément aux exigences des alinéas B.07.020b) et B.07.027b). | | (2) Sel de céleri; poivre de céleri | (2) 0,5 %. | | (3) Mélanges secs non normalisés | (3) Bonnes pratiques industrielles. PART B Foods

(4)

A reference in this section to evidence with respect to a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet means evidence to establish that the food is nutritionally adequate to be used as the sole source of nutrition in meeting the nutritional needs of a person for whom it is intended, when the food is consumed in accordance with the directions for use. B.24.018 It is prohibited to label, package, sell or advertise a food in a manner likely to create an impression that it is a gluten-free food if the food contains any gluten protein or modified gluten protein, including any gluten protein fraction, referred to in the definition gluten in subsection B.01.010.1(1). B.24.100 No person shall advertise a formulated liquid diet to the general public. B.24.101 No person shall sell a formulated liquid diet unless the food (b) if not sold ready to serve, when diluted with water, milk, or water and milk, (i) not less than 20 grams of protein of nutritional quality equivalent to casein, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981, or (ii) such an amount and quality of protein, including those proteins to which amino acids are added, that, when the quality of the protein is expressed as a fraction of the quality of casein, (A) the fraction will not be less than 85/100, and (B) the result obtained by multiplying the fraction by the gram weight of the protein will not be less than 20; and (b) not less than one gram linoleic acid in the form of a glyceride.

Section B.16.100

Règlement sur les aliments et drogues

(2)

Notwithstanding sections D.01.009, D.01.011 and D.02.009, a formulated liquid diet shall contain, when ready to serve, the vitamins and minerals named in Column I of the table to this section in amounts, (a) where the recommended intake of the food is 2,500 kilocalories per day or less, not less than the amounts set out in Column II and not more than the amounts, if any, set out in Column III of that table opposite those vitamins and minerals; and (b) where the recommended intake of the food is greater than 2,500 kilocalories per day, not less than the amounts set out in Column IV and not more than the amounts, if any, set out in Column V of the table opposite those vitamins and minerals. (a) per 1,000 available kilocalories, where the recommended intake of the food is 2,500 kilocalories per day or less; and (b) per 1,500 available kilocalories, where recommended intake of the food is greater than 2,500 kilocalories per day.

PARTIE B Aliments

(4)

Paragraph (1)(a) does not apply to a formulated liquid diet represented as being for a protein restricted diet or a low (named amino acid) diet. Food and Drug Regulations B.24.103 The label of a formulated liquid diet shall carry the following information: (a) a statement that the food is intended to be consumed orally or by tube feeding; (b) a statement of the energy value of the food, expressed in Calories (i) per 100 grams or per 100 millilitres of the food as offered for sale, and (i) per 100 grams or per 100 millilitres of the food as offered for sale, and (d) a statement of the content of vitamins and mineral nutrients that are listed in the table to section B.24.102, expressed in International Units, milligrams or micrograms (i) per 100 grams or per 100 millilitres of the food as offered for sale, and (e) a statement of the content of any vitamin or mineral nutrient that is not listed in the table to section B.24.102, expressed in milligrams or micrograms (i) per 100 grams or per 100 millilitres of the food as offered for sale, and (f) complete directions for the preparation and use of the food and for its storage after the container has been opened; and Meal Replacements, Nutritional Supplements, Prepackaged Meals and Foods Sold by Weight Reduction Clinics B.24.200 (1) No person shall sell or advertise a meal replacement unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk or skim milk, or a combination thereof, it meets the following requirements: (b) not less than 15 per cent and not more than 40 per cent of the energy available from the meal replacement is derived from its protein content, except that a meal replacement for use in a weight reduction diet shall derive not less than 20 per cent of its available energy from its protein content; (c) subject to subsection (2), not more than 35 per cent of the energy available from the meal replacement is derived from its fat content; (d) not less than 3.0 per cent of the energy available from the meal replacement is derived from linoleic acid in the form of a glyceride and not less than 0.5 per cent of the energy available from the meal replacement is derived from n-3 linolenic acid in the form of a glyceride, and the ratio of linoleic acid to n-3 linolenic acid is not less than 4 to 1 and not more than 10 to 1; (e) the proteins present in the meal replacement are (ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent, or not less than 20 per cent in the case of a meal replacement for use in a weight reduction diet, when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the meal replacement; and (f) each serving of the meal replacement contains each vitamin and mineral nutrient listed in column I of the table to this section (i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and (ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.

TITRE 16 Additifs alimentaires

(2)

No person shall sell or advertise a meal replacement that is represented as a replacement for all daily meals unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk or skim milk, or a combination thereof, it meets the following requirements: (a) not more than 30 per cent of the energy available from the meal replacement is derived from its fat content; and (b) not more than 10 per cent of the energy available from the meal replacement is derived from its saturated fatty acid content.

Article B.16.100

Colonne I

(3)

The minimum amount required under subparagraph (1)(f)(i) for selenium, chromium or molybdenum does not apply in respect of a meal replacement that is not represented as a replacement for all daily meals and that does not contain added selenium, chromium or molybdenum, as the case may be.

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

(4)

A vitamin or mineral nutrient that is not an added ingredient in the meal replacement shall not be taken into account for the purposes of subparagraph (1)(f)(ii).

(4)

Sucre à glacer

(5)

The maximum amount shown for vitamin C in column III of the table to this section does not include overage. Food and Drug Regulations Meal Replacements, Nutritional Supplements, Prepackaged Meals and Foods Sold by Weight Reduction Clinics B.24.201 (1) No person shall sell or advertise a nutritional supplement that contains less than 225 kcal or 945 kJ per serving, unless it meets the following requirements: (b) not less than 15 per cent and no more than 40 per cent of the energy available from the nutritional supplement is derived from its protein content; (c) the proteins present in the nutritional supplement are (ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the nutritional supplement; and (i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and (ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.

(4)

Si on l’emploie seul ou avec du phosphate tricalcique, du silicate de calcium, du carbonate de magnésium, du silicate de magnésium, du stéarate de magnésium ou du silicate double d’aluminium et de sodium, le total ne doit pas dépasser 1,5 %.

(2)

No person shall sell or advertise a nutritional supplement that provides 225 kcal or 945 kJ, or more, per serving unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk, skim milk, or a combination thereof, it meets the following requirements: (b) not more than 35 per cent of the energy available from the nutritional supplement is derived from its fat content; (c) not less than 3.0 per cent of the energy available from the nutritional supplement is derived from linoleic acid in the form of a glyceride and not less than 0.5 per cent of the energy available from the nutritional supplement is derived from n-3 linolenic acid in the form of a glyceride, and the ratio of linoleic acid to n-3 linolenic acid is not less than 4 to 1 and not more than 10 to 1; (d) not less than 15 per cent and not more than 40 per cent of the energy available from the nutritional supplement is derived from its protein content; (e) the proteins present in the nutritional supplement are (ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the nutritional supplement; and (f) it contains, per 100 Kcal or 420 kJ, each of the vitamins and each of the mineral nutrients listed in column I of the table to this section, in an amount (i) subject to subsection (3), not less than the minimum amount shown in column II, (ii) subject to subsections (4) and (5), not more than the maximum amount shown in column III. (f) the nutritional supplement contains, per 100 kcal or 420 kJ, each vitamin and mineral nutrient listed in column I of the table to this section (i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and (ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.

(5)

Aliments vendus sous forme de comprimés

(3)

The minimum amount required under subparagraph (1)(d)(i) or (2)(f)(i) for selenium, chromium or molybdenum does not apply in respect of a nutritional supplement that does not contain added selenium, chromium or molybdenum, as the case may be.

(5)

Bonnes pratiques industrielles.

(4)

A vitamin or mineral nutrient that is not an added ingredient in the nutritional supplement shall not be taken into account for the purposes of subparagraphs (1)(d)(ii) and (2)(f)(ii).

(6)

Poivre de cayenne; chili; assaisonnement au chili; paprika; poivre rouge

(5)

The maximum amount shown for vitamin C in column III of the table to this section does not include overage. Food and Drug Regulations Meal Replacements, Nutritional Supplements, Prepackaged Meals and Foods Sold by Weight Reduction Clinics (a) show the following information per serving of stated size and per stated quantity of food, when prepared according to the directions for use: (ii) the protein, fat, linoleic acid, n-3 linolenic acid, saturated fatty acid and carbohydrate contents of the food, expressed in grams, (iii) the vitamin A, vitamin D, vitamin E, vitamin C, thiamin or vitamin B₁, riboflavin or vitamin B₂, niacin, vitamin B₆, vitamin B₁₂, folate and pantothenic acid or pantothenate contents of the food, expressed (A) in the case of a meal replacement, as a percentage of the daily value specified in column 4 of Part 2 of the Table of Daily Values for that vitamin, and (B) in the case of a nutritional supplement, in the applicable unit referred to in subsection D.01.003(1), (A) in the case of a meal replacement, as a percentage of the daily value specified in column 4 of (A) in the case of a meal replacement, as a percentage of the daily value specified in column 4 of Part 2 of the Table of Daily Values, and (B) in the case of a nutritional supplement, in milligrams for calcium, phosphorus, iron, magnesium and zinc and in micrograms for iodide, (v) the copper, potassium, sodium and manganese contents of the food, expressed in milligrams, and (vi) the biotin, selenium, chromium and molybdenum contents of the food, expressed in micrograms; (b) in the case of a meal replacement or a nutritional supplement to which milk, partially skim milk or skim milk is to be added, carry a statement that the nutrient content of the food has been determined taking into consideration the milk, partially skim milk or skim milk that will be added according to the directions for use; (c) in the case of a meal replacement that is sold or advertised as a replacement for all daily meals in a weight reduction diet, include directions for use that would result in a daily energy intake of at least 900 kcal or 3 780 kJ; (f) in the case of a meal replacement for use in a weight reduction diet that is not represented as a replacement for all daily meals in a diet, include the information required under section B.24.204. B.24.203 The label of a prepackaged meal for use in a weight reduction diet or of a food to be sold in a weight reduction clinic shall (c) include the information required under section B.24.204. B.24.204 The label of a prepackaged meal, or of a meal replacement other than a meal replacement represented as a replacement for all daily meals in a diet, that is packaged, sold or advertised for use in a weight reduction diet, or of a food to be sold in a weight reduction clinic, shall include, in the directions for use, a sample seven-day menu in which the prepackaged meal, meal replacement or food is used and which meets the following requirements: (a) each daily meal includes at least one serving, as described in Canada's Food Guide to Healthy Eating, published in 1992 by the Department of Supply and Services by authority of the Minister of National Health and Welfare, of food from each of the following groups: (i) milk, milk products or their alternatives, (ii) meat and meat alternatives, (iii) bread and grain products, and (iv) vegetables and fruit; (b) the daily energy intake provided for is not less than 1 200 kcal or 5 040 kJ; (c) not more than 30 per cent of the total daily energy intake of the seven-day menu is derived from its fat content and not more than 10 per cent of the total daily energy intake of the menu is derived from its saturated fatty acid content; (d) the mean daily intake of each nutrient listed in column I of the table to this section is not less than the amount shown in column II, in the case of a menu recommended for men, or in column III, in the case of a menu recommended for women; and (e) the menu does not include any reference to vitamin or mineral supplements. Mean Daily Intake B.24.205 (1) No person shall label, package, sell or advertise a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, in a manner likely to create an impression that consumption of a vitamin or mineral supplement must be part of a weight reduction diet.

(6)

2,0 %.

(2)

No person shall, on a label of or in an advertisement for a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, make any direct or indirect reference to a vitamin or mineral supplement.

(7)

Sel

(3)

Every person who advertises a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, shall include in the advertisement the statement “USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN Foods Represented for Use in Very Low Energy Diets B.24.300 No person shall advertise to the general public a food represented for use in a very low energy diet. B.24.301 (1) No person shall sell, without a written order from a physician, a food represented for use in a very low energy diet.

(7)

1,0 % (sauf pour le sel à grains fins : 2,0 %) conformément aux exigences de l’alinéa B.17.001(1)a). S.2 Silicate double d’aluminium et de sodium

(2)

Notwithstanding subsection (1), a person may sell, without a written order from a physician, a food represented for use in a very low energy diet to

(1)

Sel

(3)

No person other than a pharmacist shall sell to the general public a food represented for use in a very low energy diet. B.24.302 A pharmacist shall retain the written order of a physician for a food represented for use in a very low energy diet for at least two years after the date on which the order is filled. B.24.303 (1) A food represented for use in a very low energy diet, whether ready to serve or diluted with water according to the manufacturer’s directions, shall provide, per daily allowance recommended by the manufacturer (i) not less than 60 g of protein of a nutritional quality equivalent to that of casein, or (ii) such an amount and quality of protein that, when the quality of the protein is expressed as a fraction of the quality of casein, (A) the fraction is not less than 85/100, and (B) the product obtained by multiplying the fraction by the gram weight of the protein is not less than 60; (b) each vitamin or mineral nutrient named in column I of an item of the table to this subsection, in an amount not less than the minimum amount per day set out in column II of that item; and (c) any nutritive substance added to the food other than those referred to in paragraph (a) or (b), in an amount that is appropriate for the purpose of the substance in the food as determined from clinical trials.

(1)

1,0 %, sauf pour le sel à grains fins 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a).

(2)

Notwithstanding paragraph (1)(a), a food represented for use in a very low energy diet shall be accompanied by directions for use that when followed would result in B.24.304 The label of a food represented for use in a very low energy diet shall carry the following information: (b) a statement of the content in the food of protein, fat, carbohydrate and, where present, fibre expressed in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food; (c) a statement of the content in the food of all those vitamins and mineral nutrients that are listed in the table to subsection B.24.303(1) expressed in milligrams, or in the case of vitamin A expressed in retinol equivalents (RE), per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food; (d) a statement of the content in the food of any other nutrient added to the food in an amount described in paragraph B.24.303(1)(c), expressed in milligrams or in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food; (f) directions for use of the food, including (i) a statement of the rationale for the use of the food, (ii) criteria to be used for the selection of the persons to whom the food may be prescribed, (iii) instructions for consultation with and evaluation of the patient and patient follow-up, and (iv) a statement concerning adequate precautions and contra-indications; (g) directions for the preparation of the food, and storage instructions for the food before and after the container has been opened; and (h) the expiration date of the food. B.24.305 (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Minister in writing of the intention to sell the food or advertise the food for sale.

(2)

Sucre à glacer

(2)

The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a low energy diet, the following information: (a) the name under which the food is to be sold or advertised for sale; (b) the name and address of the principal place of business of the manufacturer; (c) the name and address of each establishment in which the food is manufactured; (e) the specifications for nutrient, microbiological and physical quality for each ingredient and for the food; (f) details of quality control procedures respecting the testing of the ingredients and of the food; (g) details of the manufacturing process and quality control procedures used throughout the process; (h) the results of tests carried out to determine the expiration date of the food; (i) the evidence relied on to establish that the food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is consumed in accordance with the directions for use; (l) the written text of all labels, including package inserts, to be used in connection with the food; and (m) the name and title of the person who signed the notification and the date of signature.

(2)

Si on l’emploie seul ou avec du phosphate tricalcique, du silicate de calcium, du carbonate de magnésium, du silicate de magnésium, du stéarate de magnésium ou du dioxyde de silicium, le total ne doit pas dépasser 1,5 %.

(3)

Notwithstanding subsection (1), a person may sell or advertise for sale a food represented for use in a very low energy diet, if the Minister, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2). B.24.306 (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet that has undergone a major change, unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Minister in writing of the intention to sell or advertise for sale the food that has undergone the major change.

(3)

Mélange de poudre de jaunes d’œufs; mélange de poudre d’œufs entiers; poudre de blanc d’œuf (poudre d’albumen); poudre de jaune d’œuf; poudre d’œuf entier

(2)

The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a very low energy diet that has undergone a major change, the following information: (a) the name under which the food is to be sold or advertised for sale; (b) the name and address of the principal place of business of the manufacturer; (c) a description of the major change; (d) the evidence relied on to establish that the food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is consumed in accordance with the directions for use; (e) the evidence relied on to establish that the major change has no adverse effect on the food or its use; (f) the written text of all labels, including package inserts, to be used in connection with the food; and (g) the name and title of the person who signed the notification and the date of signature.

(3)

2,0 %.

(3)

Notwithstanding subsection (1), a person may sell or advertise for sale a food represented for use in a very low energy diet that has undergone a major change if the Minister, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2). B.25.001 In this Division, expiration date means, in respect of a human milk fortifier or human milk substitute, the date (a) after which the manufacturer does not recommend that it be consumed, and (b) up to which it maintains its microbiological and physical stability and the nutrient content declared on the label; (date limite d’utilisation) human milk fortifier means a food that (a) includes at least one added vitamin, mineral nutrient or amino acid, and (b) is labelled or advertised as intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state; (fortifiant pour lait humain) human milk substitute means any food that is labelled or advertised (a) for use as a partial or total replacement for human milk and as intended for consumption by infants, or infant means an individual who is under the age of one year; (bébé) major change means, in respect of a human milk fortifier or human milk substitute, any change of an ingredient, the amount of an ingredient or the processing or packaging of the human milk fortifier or human milk substitute where the manufacturer’s experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, or the microbiological or new human milk substitute means a human milk substitute that is (a) manufactured for the first time, (b) sold in Canada for the first time, or strained (naming a food) means the named food where it is of a generally uniform particle size that does not require and does not encourage chewing by infants before being swallowed. (nom d’un aliment) en purée ou tamisé) B.25.002 No person shall sell or advertise for sale an infant food that is set out in Column I of an item of Table I to this Division and contains more than the amount of sodium set out in Column II of that item. B.25.003 (1) Subject to subsection (2), no person shall sell infant food that contains (b) fruit juice, (c) fruit drink, or if sodium chloride has been added to that food. B.25.010 Subject to section B.25.013, it is prohibited to sell or advertise for sale a human milk fortifier unless the Minister has notified the manufacturer under paragraph B.25.011(1)(a) or (3)(a) that those activities are authorized. B.25.011 An application to sell or advertise for sale a human milk fortifier shall be submitted by the manufacturer and signed by the manufacturer or an individual authorized to sign on their behalf and shall include the following information: (a) the brand name and product name under which the human milk fortifier will be sold or advertised for sale; (c) the name and address of each establishment in which the human milk fortifier is manufactured; (e) the scientific rationale for the formulation of the human milk fortifier; (f) the specifications for nutrient, microbiological and other quality criteria for the human milk fortifier and its ingredients; (g) details of the quality control procedures respecting the testing of the human milk fortifier and its ingredients; (h) details of the human milk fortifier’s manufacturing process and the quality control procedures used throughout the process; (i) the results of the tests carried out to determine the expiration date of the human milk fortifier; (j) the evidence that establishes that the human milk fortifier is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; (l) directions for use for the human milk fortifier; (m) the written text of all labels, including package inserts, to be used in connection with the human milk fortifier; and (n) the name and title of the individual who signed the application and the date of signature. B.25.012 (1) After having conducted an assessment of the information submitted under section B.25.011 and any other information related to the assessment of the application, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier that is the subject of the application (a) is authorized if (i) the application meets the requirements set out in section B.25.011, and (ii) the information is sufficient to establish the safety of the human milk fortifier; or (b) is not authorized, in any other case.

(4)

Sel d’ail, sel d’oignon

(2)

If the conditions set out in paragraph (1)(a) are not satisfied, the Minister may request the manufacturer to submit in writing the additional information that is necessary to satisfy the conditions.

(4)

2,0 %, conformément aux exigences des alinéas B.07.020b) et B.07.027b) respectivement.

(3)

After having conducted an assessment of any additional information that is submitted by the manufacturer, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier (a) is authorized, if the conditions set out in paragraph (1)(a) are satisfied; or (b) is not authorized, in any other case.

(5)

Mélanges secs non normalisés

(4)

Despite paragraphs (1)(a) and (3)(a), the Minister shall not authorize the sale or advertisement for sale of the human milk fortifier if the Minister has reasonable grounds to believe that any of the information that the manufacturer has submitted is false, misleading or deceptive. B.25.013 The prohibition set out in section B.25.010 does not apply in respect of a human milk fortifier that is set out in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 that is published on a Government of Canada website if, on or before April 30, 2022, (a) the manufacturer of the human milk fortifier submits to the Minister (i) an attestation signed and dated by the manufacturer, or by an individual authorized to sign on their behalf, confirming that the human milk fortifier has not undergone a major change since the date set out in the List in connection with the human milk fortifier, and (ii) the written text of all labels, including package inserts, that will be required to be used in connection with the human milk fortifier after the second anniversary of the day on which section B.25.020 comes into force; and (b) the Minister notifies the manufacturer under subsection B.25.014(1) or paragraph B.25.014(3)(a) that they are authorized to continue to sell or advertise for sale the human milk fortifier. B.25.014 (1) The Minister shall notify the manufacturer in writing that they are authorized to continue to sell or advertise for sale the human milk fortifier if (a) the manufacturer has submitted the information referred to in paragraph B.25.013(a) in sufficient time for the Minister to assess the information before April 30, 2022; and (b) the written text of the labels submitted under subparagraph B.25.013(a)(ii) satisfies the relevant requirements of these Regulations.

(5)

Bonnes pratiques industrielles. S.3 Decahydrate ferrocyanure de sodium Sel 13 p.p.m. calculé en ferrocyanure de sodium anhydre SOR/79-662, ss. 3 to 13; SOR/82-913, s. 4; SOR/83-410, s. 2; SOR/84-17, s. 5; SOR/84-901, s. 2; SOR/86-1125, s. 1; SOR/88-534, s. 3; SOR/94-81, ss. 3, 5; SOR/94-688, s. 2(F); SOR/97-191, s. 3; SOR/2001-94, ss. 11, 12. DORS/79-662, art. 3 à 13; DORS/82-913, art. 4; DORS/83-410, art. 2; DORS/84-17, art. 5; DORS/84-901, art. 2; DORS/86-1125, art. 1; DORS/88-534, art. 3; DORS/94-81, art. 3, 5; DORS/94-688, art. 2(F); DORS/97-191, art. 3; DORS/2001-94, art. 8(A); DORS/2001-143, art. 11 et 12. TABLE II Column I Column II Column III Maximum Level of Use A.1 Acetone Peroxide

(2)

If the information that is submitted is insufficient to satisfy the conditions set out in subsection (1), the Minister may request the manufacturer to submit in writing the additional information that is necessary to satisfy the conditions.

(1)

Bread; Flour; Whole wheat flour

(3)

After having conducted an assessment of any additional information that is submitted by the manufacturer, the Minister shall notify the manufacturer in writing that (a) they are authorized to continue to sell or advertise for sale the human milk fortifier, if the conditions set out in subsection (1) are satisfied; or (b) they are not authorized to continue to sell or advertise for sale the human milk fortifier, in any other case. B.25.015 (1) It is prohibited to sell or advertise for sale a human milk fortifier that has undergone a major change unless (a) the manufacturer of the human milk fortifier submits to the Minister an application in accordance with subsection (2) that reflects the major change; and (b) the Minister notifies the manufacturer under paragraph B.25.016(1)(a) or (3)(a) that the sale or advertisement for sale of the human milk fortifier is authorized.

(1)

Good Manufacturing Practice

(2)

The application shall be signed by the manufacturer or an individual authorized to sign on their behalf and shall include the following information: (a) the brand name and product name under which the human milk fortifier will be sold or advertised for sale; (c) a description of, and the rationale for, the major change; (d) the evidence that establishes that the human milk fortifier is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; (e) the evidence that establishes that the major change has had no adverse effect on the human milk fortifier; (f) the written text of all labels, including package inserts, to be used in connection with the human milk fortifier; and (g) the name and title of the individual who signed the application and the date of signature. B.25.016 (1) After having conducted an assessment of the information submitted under subsection B.25.015(2) and any other information related to the assessment of the application, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier that is the subject of the application (a) is authorized if (i) the application meets the requirements set out in subsection B.25.015(2), and (ii) the information is sufficient to establish the safety of the human milk fortifier; or (b) is not authorized, in any other case.

(2)

Unstandardized bakery products

(2)

If the conditions set out in paragraph (1)(a) are not satisfied, the Minister may request the manufacturer to submit in writing the additional information that is necessary to satisfy the conditions.

(2)

Good Manufacturing Practice A.1A [Repealed, SOR/79-660, s. 3] A.2 Ammonium Persulphate

(3)

After having conducted an assessment of any additional information that is submitted by the manufacturer, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier (a) is authorized, if the conditions set out in paragraph (1)(a) are satisfied; or (b) is not authorized, in any other case.

(1)

Flour; Whole wheat flour

(4)

Despite paragraphs (1)(a) and (3)(a), the Minister shall not authorize the sale or advertisement for sale of the human milk fortifier if the Minister has reasonable grounds to believe that any of the information that the manufacturer has submitted is false, misleading or deceptive. B.25.017 A manufacturer named in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 referred to in section B.25.013 is not entitled to submit an application referred to in paragraph B.25.015(1)(a) in respect of a human milk fortifier set out in the list unless the Minister has (a) notified them under paragraph B.25.012(1)(a) or (3)(a) that the sale or advertisement for sale of the human milk fortifier is authorized; or (b) notified them under subsection B.25.014(1) or paragraph B.25.014(3)(a) that they are authorized to continue to sell or advertise for sale the human milk fortifier. B.25.018 (1) If the manufacturer of a human milk fortifier is requested in writing by the Minister to submit evidence with respect to the human milk fortifier within a time limit specified by the Minister, the manufacturer shall make no further sales of the human milk fortifier — and shall not advertise it for sale — after the expiry of the time limit unless they have submitted the requested evidence.

(1)

250 p.p.m.

(2)

The time limit cannot be less than 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

(2)

Bread

(3)

If the Minister determines that the evidence submitted by the manufacturer is insufficient, the Minister shall notify the manufacturer accordingly in writing.

(2)

100 p.p.m. of flour

(4)

If the manufacturer is notified that the evidence with respect to the human milk fortifier is insufficient, the manufacturer shall make no further sales of the human milk fortifier and shall not advertise it for sale — unless they submit additional evidence and are notified in writing by the Minister that the additional evidence is sufficient.

(3)

Unstandardized bakery products

(5)

In this section, evidence with respect to the human milk fortifier means (a) evidence that establishes that the human milk fortifier is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; and (b) the results of tests carried out to determine the expiration date of the human milk fortifier. B.25.019 (1) Even if the Minister has notified the manufacturer of a human milk fortifier that the sale or advertisement for sale of the human milk fortifier is authorized, it may only be sold in the following situations: (a) it is sold by the manufacturer to (A) the individual has received a written order for a human milk fortifier from a physician or from a nurse practitioner or dietitian who is authorized to write the order under the laws of a province, and (B) the manufacturer has received a written request from a hospital that specifies the product name and quantity of the human milk fortifier that needs to be provided to the individual; or (b) it is sold by a hospital to an individual who has received a written order for a human milk fortifier from a physician or from a nurse practitioner or dietitian who is authorized to write the order under the laws of a province.

(3)

Good Manufacturing Practice A.2A Ascorbic Acid

(2)

The following definitions apply in this section. dietitian means a person who is registered and entitled under the laws of a province to practise as a dietitian and who is practising as a dietitian under those laws in that province. (diététiste) hospital has the same meaning as in section B.24.001. (hôpital) nurse practitioner has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (infirmier praticien) physician has the same meaning as in section B.24.001. (médecin) (c) a statement of the quantity, expressed in milligrams, micrograms or International Units, of all vitamins, mineral nutrients and amino acids set out in item 6, Column II, of the table to section D.03.002 that are present in a quantity of human milk fortifier specified in the directions for use; (e) directions for the storage of the human milk fortifier before and after the package has been opened; (f) the directions for use for the human milk fortifier, including directions for the preparation, use and storage of the mixture of human milk fortifier and human milk; (g) a statement indicating that the human milk fortifier is to be used only under medical supervision; (h) the expiration date of the human milk fortifier; and (i) the lot number of the human milk fortifier.

(1)

Bread; Flour; Whole wheat flour

(2)

If the human milk fortifier does not have an outer label, (a) the information referred to in subsection (1) is required to be displayed on the inner label, except as otherwise provided in paragraph (b); and (b) the information referred to in paragraphs (1)(e) and (f) may, despite section A.01.016, be displayed on a leaflet that is affixed or attached to the container that is in direct contact with the human milk fortifier.

(1)

200 p.p.m. of flour PART B Foods

(3)

If the human milk fortifier has an outer label, the information referred to in paragraphs (1)(h) and (i) is also required to be displayed on the inner label. B.25.021 It is prohibited, on the label of or in any advertisement for a human milk fortifier, to make any statement or claim relating to the content in the human milk fortifier of (b) the number of Calories from (ii) saturated fatty acids and trans fatty acids. Human Milk Substitutes and Food Containing Human Milk Substitutes B.25.046 (1) No person shall sell or advertise for sale a new human milk substitute unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Minister in writing of the intention to sell or advertise for sale the new human milk substitute.

Section B.16.100

Column I | Column II | Column III A.3 | [Repealed, SOR/79-660, s. 4] A.3A | [Repealed, SOR/79-660, s. 4] A.4 | Azodicarbonamide | Bread; Flour; Whole wheat flour | 45 p.p.m. of flour B.1 | Benzoyl Peroxide | Flour; Whole wheat flour | 150 p.p.m.

(2)

The notification referred to in subsection (1) shall be signed and shall include, in respect of the new human milk substitute, the following information: (a) the name under which it will be sold or advertised for sale; (b) the name and the address of the principal place of business of the manufacturer; (c) the names and addresses of each establishment in which it is manufactured; (e) the specifications for nutrient, microbiological and physical quality for the ingredients and for the new human milk substitute; (f) details of quality control procedures respecting the testing of the ingredients and of the new human milk substitute; (g) details of the manufacturing process and quality control procedures used throughout the process; (h) the results of tests carried out to determine the expiration date of the new human milk substitute; (i) the evidence relied on to establish that the new human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; (l) the written text of all labels, including package inserts, to be used in connection with the new human milk substitute; and (m) the name and title of the person who signed the notification and the date of signature.

C

1 | Calcium Iodate | (1) Bread | (1) 45 p.p.m. of flour | | (2) Unstandardized bakery products | (2) 45 p.p.m. of flour

(3)

Notwithstanding subsection (1), a person may sell or advertise for sale a new human milk substitute if the manufacturer has notified the Minister pursuant to subsection (1) and is informed in writing by the Minister that the notification is satisfactory. B.25.047 Sections B.25.051 to B.25.059 apply in respect of new human milk substitutes. B.25.048 (1) No person shall sell or advertise for sale a human milk substitute that has undergone a major change unless the manufacturer of the human milk substitute, at least 90 days before the sale or advertisement, notifies the Minister in writing of the intention to sell or advertise for sale the human milk substitute.

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2 | Calcium Peroxide | (1) Bread | (1) 100 p.p.m. of flour | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice

(2)

The notification referred to in subsection (1) shall be signed and shall include, in respect of the human milk substitute, the following information: (a) the name under which it will be sold or advertised for sale; (b) the name and the address of the principal place of business of the manufacturer; (c) a description of the major change; (d) the evidence relied on to establish that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; (e) the evidence relied on to establish that the major change has had no adverse effect on the human milk substitute; (f) the written text of all labels, including package inserts, to be used in connection with the human milk substitute; and (g) the name and title of the person who signed the notification and the date of signature.

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3 | Calcium Stearoyl-2-Lactylate | (1) Bread | (1) 3,750 p.p.m. of flour | | (2) Unstandardized bakery products | (2) 3,750 p.p.m. of flour | | (3) Cake mixes | (3) 0.5% of dry weight of mix

(3)

Notwithstanding subsection (1), a person may sell or advertise for sale a human milk substitute that has undergone a major change if the manufacturer has notified the Minister pursuant to subsection (1) and is informed in writing by the Minister that the notification is satisfactory. B.25.051 (1) No person shall sell or advertise for sale a human milk substitute unless, when prepared according to directions for use, it complies with the provisions of this Division respecting human milk substitutes.

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4 | Chlorine | Flour; Whole wheat flour | Good Manufacturing Practice

(2)

No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food complies with the nutritional requirements set out in this Division for human milk substitutes. B.25.052 (1) No person shall sell or advertise for sale a human milk substitute unless it meets the nutritional requirements of infants with normal or special dietary needs and it is of such a consistency that, when ready-to-serve, it passes freely through a nursing bottle nipple.

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5 | Chlorine Dioxide | Flour; Whole wheat flour | Good Manufacturing Practice

(2)

No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food meets the nutritional requirements of infants with normal or special dietary needs. B.25.053 (1) No person shall sell or advertise for sale a human milk substitute that requires, when prepared according to directions for use, the addition of a nutritive substance, other than water or a source of carbohydrate or both.

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6 | L-Cysteine Hydrochloride | (1) Bread; Flour; Whole wheat flour | (1) 90 p.p.m. | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice P.1 | [Repealed, SOR/94-227, s. 4] P.2 | Potassium Iodate | (1) Bread | (1) 45 p.p.m. of flour | | (2) Unstandardized bakery products | (2) 45 p.p.m. of flour P.3 | Potassium Persulphate | (1) Bread | (1) 100 p.p.m. of flour | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice S.1 | Sodium Stearoyl-2-Lactylate | (1) Bread | (1) 3,750 p.p.m. of flour | | (2) Unstandardized bakery products | (2) 3,750 p.p.m. of flour | | (3) Pancakes and pancake mixes | (3) 0.3% of dry ingredient weight | | (4) Waffles and waffle mixes | (4) 0.3% of dry ingredient weight | | (5) Cake mixes | (5) 0.5% of dry weight of mix S.2 | Sodium Stearyl Fumarate | (1) Bread | (1) 5,000 p.p.m. of flour | | (2) Unstandardized bakery products | (2) 5,000 p.p.m. of flour TABLEAU II Additifs alimentaires autorisés comme agents de blanchiment, de maturation, ou pour conditionner les pâtes Colonne I | Colonne II | Colonne III

(2)

No person shall sell or advertise for sale a food represented as containing a human milk substitute that requires, when prepared according to directions for use, the addition of a nutritive substance other than water. B.25.054 (1) Except as otherwise provided in this Division, no person shall sell or advertise for sale a human milk substitute unless it contains, when prepared according to directions for use, (i) not less than 3.3 and not more than 6.0 grams of fat, (ii) not less than 500 milligrams of linoleic acid in the form of a glyceride, (iii) not more than 1 kilocalorie from C22 Monoenoic Fatty Acids, (iv) not less than 1.8 and not more than 4.0 grams of protein, (v) not less than 1.8 grams of protein of nutritional quality equivalent to casein, or such an amount and quality of protein, including those proteins to which amino acids are added, that, when the quality of the protein is expressed as a fraction of the quality of casein, (A) the fraction will not be less than 85/100, and (B) the product obtained by multiplying the fraction by the gram weight of the protein will not be less than 1.8, (vi) notwithstanding sections D.01.010, D.01.011 and D.02.009, the vitamin and mineral nutrient set out in Column I of an item of Table II to this Division in an amount not less than the amount set out in Column II of that item and not more than the amount set out in Column III of that item, and (vii) not less than 12 milligrams of choline; and (i) alpha-tocopherol to linoleic acid of not less than 0.6 International Units to one gram, (ii) calcium to phosphorus of not less than 1.2 grams to one gram and not more than 2.0 grams to one gram, and (iii) vitamin B6 to protein of not less than 15 micrograms to one gram.

Article | Additifs | Permis dans ou sur | Limites de tolérance

A.1 | Peroxyde d’acétone | (1) Farine; farine de blé entier; pain | (1) Bonnes pratiques industrielles | | (2) Produits de boulangerie non normalisés | (2) Bonnes pratiques industrielles A.1A | [Abrogé, DORS/79-660, art. 3] A.2 | Persulfate d’ammonium | (1) Farine; farine de blé entier | (1) 250 p.p.m. | | (2) Pain | (2) 100 p.p.m. de farine | | (3) Produits de boulangerie non normalisés | (3) Bonnes pratiques industrielles A.2A | Acide ascorbique | (1) Farine; farine de blé entier; pain | (1) 200 p.p.m. de farine PART B Foods

(2)

No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food complies with subsection (1). B.25.055 (1) Subparagraph B.25.054(1)(a)(i) does not apply to a human milk substitute represented as being for a fat-modified diet.

Section B.16.100

Règlement sur les aliments et drogues

(2)

Subparagraph B.25.054(1)(a)(iv), except that portion thereof that prescribes the maximum amount of protein, and subparagraph B.25.054(1)(a)(v) do not apply to a human milk substitute represented as being for a low (naming the amino acid) diet.

PARTIE B Aliments

(3)

All that portion of subparagraph B.25.054(1)(a)(vi) that prescribes the minimum amounts of vitamin D, calcium and phosphorus and subparagraph B.25.054(1)(b)(ii) do not apply to a human milk substitute represented as being for a low (naming the mineral) diet or a low vitamin D diet or both. B.25.056 No person shall sell a human milk substitute or a food that is represented as containing a human milk substitute (a) that contains an added nutritive substance that is (i) normally contained in human milk, and unless the amount of that substance present per 100 available kilocalories of the human milk substitute or human milk substitute portion of the food, when prepared according to directions for use, is equal to the amount thereof present per 100 available kilocalories of human milk; or (b) that contains added amino acids unless (i) the amino acids are required to improve the quality of the protein in the human milk substitute or human milk substitute portion of the food and are present in an amount not exceeding the minimum required for that purpose, or (ii) the protein content of the human milk substitute or human milk substitute portion of the food is supplied by isolated amino acids or by protein hydrolysate, or both and only the L forms of the amino acids have been added. B.25.057 (1) The label of a human milk substitute shall carry the following information: (i) in grams per 100 grams or in grams per 100 millilitres of the human milk substitute as offered for sale, and (ii) in grams in a stated quantity of the human milk substitute when ready-to-serve; (b) a statement of the energy value expressed in Food and Drug Regulations Human Milk Substitutes and Food Containing Human Milk Substitutes (i) calories per 100 grams or calories per 100 millilitres of the human milk substitute as offered for sale, and (ii) calories in a stated quantity of the human milk substitute when ready-to-serve; (c) a statement of the quantity of all vitamins and mineral nutrients listed in Table II to this Division (i) in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the human milk substitute as offered for sale, and (ii) in International Units or milligrams in a stated quantity of the human milk substitute when ready-to-serve; (i) in milligrams or grams per 100 grams, or in milligrams or grams per 100 millilitres, of the human milk substitute as offered for sale, and (ii) in milligrams or grams in a stated quantity of the human milk substitute when ready-to-serve; (e) adequate directions for the preparation, use and storage of the human milk substitute after the container has been opened; and

TITRE 16 Additifs alimentaires

(2)

The label of a food that is represented as containing human milk substitute shall carry the following information: (a) a statement on the principal display panel of the proportion of the human milk substitute contained in the food as offered for sale in close proximity to any claim regarding the presence of the human milk substitute and given equal prominence to such a claim; (b) the common name of the human milk substitute in the list of ingredients to be followed by a statement of all the components contained in the human milk substitute; (i) the content of protein, fat, available carbohydrate, ash and, where present, crude fibre contained in the human milk substitute portion of the food, expressed in grams per 100 grams or per 100 millilitres of the human milk substitute portion of the food as offered for sale, (ii) the energy value of the human milk substitute portion of the food expressed in calories per 100 grams or in calories per 100 millilitres of the human milk substitute portion of the food as offered for sale, (iii) the quantity of all the vitamins and mineral nutrients set out in Table II to this Division that are contained in the human milk substitute portion of the food in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the human milk substitute portion of the food as offered for sale, and (iv) the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a) contained in the human milk substitute portion of the food in milligrams or grams per 100 grams or in milligrams or grams per 100 millilitres of the human milk substitute portion of the food as offered for sale; (i) the content of protein, fat, available carbohydrate, ash and, where present, crude fibre in grams per 100 grams or per 100 millilitres of the food as offered for sale and in grams per stated quantity of ready-to-serve food, (ii) the energy value expressed in calories per 100 grams or in calories per 100 millilitres of the food as offered for sale and in grams per a stated quantity of the food when ready-to-serve, (iii) the quantity of all vitamins and mineral nutrients set out in Table II to this Division in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the food as offered for sale and in International Units or milligrams in a stated quantity of the food when ready-to-serve, and (iv) the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a) in milligrams or grams per 100 grams or in milligrams or grams per 100 millilitres of the food as offered for sale; for sale and in milligrams or grams in a stated quantity of the food when ready-to-serve; (e) adequate directions for the preparation, use and storage of the food after the container has been opened; and B.25.058 Notwithstanding section D.02.005, no person shall make any claim with respect to the iron content of a human milk substitute except as required by paragraph B.25.057(1)(c), unless the human milk substitute contains at least one milligram of iron per 100 available kilocalories. B.25.059 No person shall, on the label of or in any advertisement for a human milk substitute or a food represented as containing a human milk substitute, make any statement or claim relating to the content in the food of (b) the number of Calories from (ii) saturated fatty acids and trans fatty acids. B.25.060 (1) Where the manufacturer of a human milk substitute or of a food that is represented as containing a human milk substitute is requested in writing by the Minister to submit on or before a specified day evidence with respect to the human milk substitute, the manufacturer shall make no further sales of that human milk substitute or food that is represented as containing human milk substitute after that day unless he has submitted the evidence requested.

Article B.16.100

Colonne I | Colonne II | Colonne III

(2)

If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing.

Article | Additifs | Permis dans ou sur | Limites de tolérance

A.3 | [Abrogé, DORS/79-660, art. 4] A.3A | [Abrogé, DORS/79-660, art. 4] A.4 | Azodicarbonamide | Farine; farine de blé entier; pain | 45 p.p.m. de farine B.1 | Peroxyde de benzoyle | Farine; farine de blé entier | 150 p.p.m. de farine

(3)

Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to the human milk substitute is not sufficient, he shall make no further sales of that human milk substitute or of that food that is represented as containing the human milk substitute unless he submits further evidence and is notified in writing by the Minister that the further evidence is sufficient.

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1 | Iodate de calcium | (1) Pain | (1) 45 p.p.m. de farine | | (2) Produits de boulangerie non normalisés | (2) 45 p.p.m. de farine

(4)

In this section, evidence with respect to the human milk substitute means (a) evidence that establishes that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; and (b) the results of tests carried out to determine the expiration date of the human milk substitute. Additional Rules B.25.061 (1) Subject to subsection (2), no person shall include on the label of a food any representation respecting the consumption of the food by an infant who is less than six months of age.

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2 | Peroxyde de calcium | (1) Pain | (1) 100 p.p.m. de farine | | (2) Produits de boulangerie non normalisés | (2) Bonnes pratiques industrielles

(2)

Subsection (1) does not apply in respect of a human milk fortifier, human milk substitute or new human milk substitute. B.25.062 (1) Subject to subsection (2), it is prohibited to sell an infant food if the food contains a food additive. (a) bakery products that are labelled or advertised for consumption by infants; (b) the following foods that are labelled or advertised for consumption by infants and that contain ascorbic acid: (c) infant cereal products that contain lecithin; (d) foods that are labelled or advertised for consumption by infants and that contain citric acid; (e) infant formula that contains the food additives set out in Tables IV and X to section B.16.100 for use in infant formula; (f) infant formula that contains ingredients manufactured with food additives set out in Table V to section B.16.100; (g) infant formula that contains concentrated or dried whey products manufactured with liquid whey to which sodium hexametaphosphate has been added; (h) infant cereal products that contain amylase in accordance with Table V to section B.16.100; (i) infant formula that contains ascorbyl palmitate or tocopherols; or (j) infant formula that contains oils to which ascorbyl palmitate or tocopherols have been added.

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3 | Stéaroyl-2-lactylate de calcium | (1) Pain | (1) 3 750 p.p.m. de farine | | (2) Produits de boulangerie non normalisés | (2) 3 750 p.p.m. de farine | | (3) Mélanges à gâteaux | (3) 0,5 % du poids sec du mélange

2 Junior Meat, Junior Meat Dinners, Junior Dinners, Junior Breakfasts

Food and Drug Regulations Additional Rules Item No. Food and Drug Regulations Additional Rules Item No. B.26.001 In this Division, irradiation means treatment with ionizing radiation. B.26.002 This Division does not apply to foods exposed to ionizing radiation from a measuring instrument used to determine weight, estimate bulk solids, measure the total solids in liquids or perform other inspection procedures. General B.26.003 (1) Subject to subsection (2), no person shall sell a food that has been irradiated.

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4 | Chlore | Farine; farine de blé entier | Bonnes pratiques industrielles

(2)

A food that is set out in column 1 of the table to this Division that has been irradiated may be sold if both of the following requirements are met: (a) the ionizing radiation is of a type and from a source set out in column 2 for the purpose of irradiation set out in column 3; and (b) the ionizing radiation that is absorbed by the food is either within the range set out in columns 4 and 5 or, if there is no minimum absorbed dose set out in column 4, is not more than the maximum absorbed dose set out in column 5. B.26.004 (1) A manufacturer who sells a food that has been irradiated shall keep on their premises, for at least two years after the date of the irradiation, a record that contains all of the following information: (a) the name of the food that was irradiated and the quantity and lot numbers of the food; (b) the purpose of the irradiation; (c) the date of the irradiation; (d) the dose of ionizing radiation that was absorbed by the food; (f) a statement that indicates whether the food was previously irradiated and, if it was previously irradiated, the information referred to in paragraphs (a) to (e) in respect of that previous irradiation.

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5 | Bioxyde de chlore | Farine; farine de blé entier | Bonnes pratiques industrielles

(2)

A person who imports a food for sale in Canada that has been irradiated shall keep on their premises, for at least two years after the date of importation, a record of the information required by subsection (1). B.26.005 A request that a food be added or a change made to the table to this Division shall be accompanied by a submission to the Minister containing the following information: (a) the purpose and details of the proposed irradiation — including the type and source of the ionizing radiation — and the proposed number of treatments and the minimum and maximum absorbed doses of the ionizing radiation; (b) data indicating that the minimum dose of ionizing radiation proposed to be used accomplishes the intended purpose of the irradiation and the maximum dose of ionizing radiation proposed does not exceed the amount required to accomplish the purpose of the irradiation; (c) information on the nature of the dosimeter used, the frequency of the dosimetry on the food and data pertaining to the dosimetry and phantoms used to assure that the dosimetry readings reflect the dose absorbed by the food during irradiation; (d) data on the effects, if any, of the irradiation under the proposed conditions and of the storage of the food on the chemical composition of the food, including the content of nutrients, and on the microbiological and organoleptic characteristics of the food; (e) data on the potential toxicity of the food, including data on the toxicological effects of the irradiation under the proposed conditions and of the storage of the food on the toxicological safety of the food; (f) data on the microbiological safety of the food, including data on the ability of the irradiation under the proposed conditions to reduce or limit the growth of pathogenic microorganisms in the food; (g) data on the capability of the irradiation under the proposed conditions to achieve the intended purpose of the irradiation; (h) data on the effects of the irradiation under the proposed conditions on the packaging materials intended for use during the irradiation of the food; (i) a description of the facility where the irradiation is to be conducted, including the type of radiation source, the energy level of the radiation source, the maximum capacity of the radiation source, the type of dosimeter to be used and the frequency of the dosimetry; (j) the proposed labelling of the food; and (k) any other information requested by the Minister. (d) data indicating the effects, if any, on the nutritional quality of the food, raw and ready-to-serve, under the proposed conditions of irradiation and any other processes that are combined with the irradiation; (e) data establishing that the irradiated food has not been significantly altered in chemical, physical or microbiological characteristics to render the food unfit for human consumption; (f) where the Minister so requests, data establishing that the proposed irradiation is safe under the conditions proposed for the irradiation; (g) the recommended conditions of storage and shipment of the irradiated food including the time, temperature and packaging and a comparison of the recommended conditions for the same food that has not been irradiated; (h) details of any other processes to be applied to the food prior to or after the proposed irradiation; and (i) such other data as the Minister may require to establish that consumers and purchasers of the irradiated food will not be deceived or misled as to the character, value, composition, merit or safety of the irradiated food. | 1 | Potatoes (Solanum tuberosum L.) | Gamma radiation from cobalt-60 | To inhibit sprouting during storage | - | 0.15 | | 2 | Onions (Allium cepa) | Gamma radiation from cobalt-60 | To inhibit sprouting during storage | - | 0.15 | | 4 | Whole or ground spices and dehydrated seasoning preparations | (1) Gamma radiation from cobalt-60 | (1) To reduce microbial load | (1) 10.0 (total overall average dose) | | | | (3) Electrons from machine sources operated at or below 3 MeV | (3) To reduce microbial load | (3) 10.0 (total overall average dose) | | 5 | Fresh raw ground beef | (1) Gamma radiation from cobalt-60 | (1) To reduce microbial load, including pathogens | (1) 1.0 | (1) 4.5 | Type and Source of Ionizing Radiation Frozen raw ground beef

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6 | Chlorhydrate de L-cystéine | (1) Farine; farine de blé entier; pain | (1) 90 p.p.m. de farine | | (2) Produits de boulangerie non normalisés | (2) Bonnes pratiques industrielles P.1 | [Abrogé, DORS/94-227, art. 4] P.2 | Iodate de potassium | (1) Pain | (1) 45 p.p.m. de farine | | (2) Produits de boulangerie non normalisés | (2) 45 p.p.m. de farine P.3 | Persulfate de potassium | (1) Pain | (1) 100 p.p.m. de farine | | (2) Produits de boulangerie non normalisés | (2) Bonnes pratiques industrielles S.1 | Stéaroyl-2-lactylate de sodium | (1) Pain | (1) 3 750 p.p.m. de farine | | (2) Produits de boulangerie non normalisés | (2) 3 750 p.p.m. de farine | | (3) Crêpes et mélanges à crêpes | (3) 0,3 % du poids des ingrédients secs | | (4) Gaufres et mélanges à gaufres | (4) 0,3 % du poids des ingrédients secs | | (5) Mélanges à gâteaux | (5) 0,5 % du poids sec du mélange S.2 | Stéaryl-fumarate de sodium | (1) Pain | (1) 5 000 p.p.m. de farine | | (2) Produits de boulangerie non normalisés | (2) 5 000 p.p.m. de farine S.3 | Sulfite de sodium | Pâte à biscuit | 500 p.p.m., calculé en bioxyde de soufre SOR/79-660, s. 3, 4; SOR/87-640, s. 6; SOR/92-591, s. 2; SOR/94-227, s. 4; SOR/94-689, s. 2(F); SOR/2005-98, ss. 3, 8(F); SOR/2010-41, s. 9(E). DORS/79-660, art. 3 et 4; DORS/87-640, art. 6; DORS/92-591, art. 2; DORS/94-227, art. 4; DORS/94-689, art. 2(F); DORS/2005-98, art. 3 et 8(F); DORS/2010-41, art. 9(A). TABLE III Column I | Column II | Column III 2 | Alkanet | (2) Dried whole egg; Dried yolk; Frozen whole egg; Frozen yolk; Liquid whole egg; Liquid yolk | (2) Good Manufacturing Practice in accordance with paragraphs B.22.034(b) and B.22.035(b) 3 | Annatto | (3) Unstandardized foods | (3) Good Manufacturing Practice 5 | Beet Red | (5) Margarine | (5) Good Manufacturing Practice 6 | Canthaxanthin | (6) (naming the variety) Cheese; Cheddar cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients) | (6) Good Manufacturing Practice in accordance with the requirements of sections B.08.033, B.08.034, B.08.037, B.08.038, B.08.038.1, B.08.038.2, B.08.041, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 and B.08.041.8 7 | Carbon Black | (7) A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n) | (7) Good Manufacturing Practice 8 | Carotene | (8) Longaniza; Tocino | (8) 0.1% in accordance with the requirements of paragraph B.14.031(i) or subparagraph B.14.032(d)(xvi) 9 | Charcoal | (9) Edible collagen film (iron oxide only) | (9) Good Manufacturing Practice PART B Foods

(1)

To reduce microbial load, including pathogens

Section B.16.100

Column I | Column II | Column III 1A | ß-apo- 8'-carotenal Ethyl ß-apo-8'-carotenoate

(2)

To reduce microbial load, including pathogens

(10)

Sausage casings (annatto only) | (10) 1.0% (Residues of annatto in sausage prepared with such casings not to exceed 100 p.p.m.)

(3)

Electrons from machine sources operated at or below 10 MeV

(11)

Sausage casings (cochineal only) | (11) 0.75% (Residues of cochineal in sausage prepared with such casings not to exceed 75 p.p.m.)

(3)

To reduce microbial load, including pathogens

(2)

Unstandardized foods | (2) 35 p.p.m.

(4)

X-rays from machine sources operated at or below one of the following: (a) 7.5 MeV when the target material is tantalum or gold; (a) To reduce microbial load, including pathogens; (b) 5 MeV in any other case. (b) To reduce microbial load, including pathogens. Food and Drug Regulations Food and Drug Regulations Low-Acid Foods Packaged in Hermetically Sealed Containers B.27.001 In this Division, commercially sterile means the condition obtained in a food that has been processed by the application of heat, alone or in combination with other treatments, to render the food free from viable forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage; (stérilité commerciale) hermetically sealed container means a container designed and intended to be secure against the entry of microorganisms, including spores; (récipient hermétiquement fermé) low-acid food means a food, other than an alcoholic beverage, where any component of the food has a pH greater than 4.6 and a water activity greater than 0.85; (aliment peu acide) refrigeration means exposure to a temperature of 4°C or less but does not mean frozen; (réfrigéré) shipping container means a receptacle, package or wrapper in which containers of food are placed for transportation; (contenant d’expédition) B.27.002 (1) No person shall sell a low-acid food packaged in a hermetically sealed container unless the food is commercially sterile.

(3)

(naming the variety) Cheese; Cheddar cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients) | (3) 35 p.p.m., in accordance with the requirements of sections B.08.033, B.08.034, B.08.037, B.08.038, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 and B.08.041.8

(2)

Subsection (1) does not apply in respect of a low-acid food packaged in a hermetically sealed container where (a) the low-acid food is kept under refrigeration and the statement "Keep Refrigerated" and "Garder réfrigéré" is carried on the principal display panel of the label of its container, as well as on the label of its shipping container; or (b) the low-acid food is kept frozen and the statement "Keep Frozen" and "Garder congelé" is carried on the principal display panel of the label of its container, as well as on the label of its shipping container.

(4)

A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n) | (4) 35 p.p.m. 2 | Caramel

(3)

Subsection (1) does not apply in respect of tomatoes or tomato products packaged in hermetically sealed containers where the tomatoes or tomato products have a pH of 4.7 or less after heat processing. B.27.003 No person shall sell a low-acid food packaged in a hermetically sealed container where the food (a) is swollen; (b) is not properly sealed; or (c) has any defect that may adversely affect its hermetic seal. B.27.004 (1) Where, in the opinion of the Minister, the sale of a low-acid food packaged in a hermetically sealed container may contravene section B.27.002 or B.27.003, the Minister may, by notice in writing, request that the manufacturer or importer of the food submit, on or before the date specified in the notice, evidence that establishes that the processes used to manufacture, process and package the food rendered and maintained the food commercially sterile.

(1)

Ale; Apple (or rhubarb) and (naming the fruit) jam; Beer; Brandy; Bread; Brown bread; Butter; Cider; Cider vinegar; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Hollands gin; Honey wine; Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; Malt liquor; Malt vinegar; Mincemeat; (naming the flavour) Milk; | (1) Good Manufacturing Practice

(2)

Where a manufacturer or an importer receives a notice issued pursuant to subsection (1), the manufacturer or importer shall make no further sales of the food on or after the day specified in the notice until he has submitted the evidence requested in that notice.

(2)

Unstandardized foods

(3)

Where the Minister is of the opinion that the evidence submitted by a manufacturer or importer pursuant to subsection (1) is not sufficient, the Minister shall notify the manufacturer or importer in writing that the evidence is not sufficient.

(4)

Sausage casings

(4)

Where, pursuant to subsection (3), a manufacturer or importer is notified that the evidence he has submitted is not sufficient, the manufacturer or importer shall make Food and Drug Regulations DIVISION 27 Low-Acid Foods Packaged in Hermetically Sealed Containers no further sales of the food until he submits further evidence and is notified in writing by the Minister that the further evidence is sufficient. B.27.005 No person shall sell a commercially sterile low-acid food packaged in a hermetically sealed container unless (a) the label or container of the food bears a code or lot number that identifies, in a legible and permanent manner, (i) the establishment in which the product was rendered commercially sterile, and (ii) the day, month and year on which the food was rendered commercially sterile; and (b) the exact meaning of each item in any code or lot number referred to in paragraph (a) is available to an inspector at the establishment or, where the food is imported, from the importer. B.28.001 The definitions in this section apply in this Division. major change means, in respect of a food, a change in the food that, based on the manufacturer’s experience or generally accepted nutritional or food science theory, places the modified food outside the accepted limits of natural variations for that food with regard to (a) the composition, structure or nutritional quality of the food or its generally recognized physiological effects; (b) the manner in which the food is metabolized in the body; or novel food means any of the following substances and foods, other than a supplemental ingredient or supplemented food: (a) a substance, including a microorganism, that does not have a history of safe use as a food; (b) a food that has been manufactured, prepared, preserved or packaged by a process that (i) has not been previously applied to that food, and (ii) causes the food to undergo a major change; and (c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that (i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism, (ii) the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or (iii) one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism. (aliment nouveau) Pre-Market Notification B.28.002 (1) No person shall sell or advertise for sale a novel food unless the manufacturer or importer of the novel food (a) has notified the Minister in writing of their intention to sell or advertise for sale the novel food; and (b) has received a written notice from the Minister under paragraph B.28.003(1)(a) or subsection B.28.003(2).

(5)

Cream cheese spread with (naming the added ingredients) 3 Allura Red Amaranth Erythrosine Indigotine Sunset Yellow FCF Tartrazine

(2)

A notification referred to in paragraph (1)(a) shall be signed by the manufacturer or importer, or a person authorized to sign on behalf of the manufacturer or importer, and shall include the following information: (a) the common name under which the novel food will be sold; (b) the name and address of the principal place of business of the manufacturer and, if the address is outside Canada, the name and address of the principal place of business of the importer; (c) a description of the novel food, together with (i) information respecting its development, (ii) details of the method by which it is manufactured, prepared, preserved, packaged and stored, (iii) details of the major change, if any, (iv) information respecting its intended use and directions for its preparation, (v) information respecting its history of use as a food in a country other than Canada, if applicable, and (vi) information relied on to establish that the novel food is safe for consumption; (e) the text of all labels to be used in connection with the novel food; and (f) the name and title of the person who signed the notification and the date of signing. B.28.003 (1) Within 45 days after receiving a notification referred to in paragraph B.28.002(1)(a), the Minister shall review the information included in the notification and (a) if the information establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient; or (b) if additional information of a scientific nature is necessary in order to assess the safety of the novel food, request in writing that the manufacturer or importer submit that information.

(2)

Unstandardized foods

(2)

Within 90 days after receiving the additional information requested under paragraph (1)(b) the Minister shall assess it and, if it establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient. Supplemented Foods B.29.001 (1) The following definitions apply in this Division. Directory of SFFT Formats means the document entitled Directory of Supplemented Food Facts Table Formats, published by the Government of Canada on its website, as amended from time to time. (Répertoire des modèles de TRAS) fat means all fatty acids expressed as triglycerides. (lipides)

(5)

Longaniza

(2)

For the purposes of this Division and subject to subsection (3), the amount of vitamins must be determined in accordance with section D.01.003.

(6)

Sausage casings (sunset yellow FCF only) Column III Maximum Level of Use

(3)

For the purposes of this Division, the amount in metric units of the following vitamins must be determined in terms of their amount in the supplemented food in accordance with column 5 of the List of Permitted Supplemented Food Ingredients, as applicable, and expressed in the applicable unit set out in column 3 of the List of Permitted Supplemented Ingredients: (a) beta-carotene as a form of vitamin A or retinol, including its derivatives, as a form of vitamin A, or both, if either is a supplemental ingredient; and B.29.002 (1) Except as otherwise provided in this section and sections B.29.003 to B.29.005, B.29.018 and B.29.019, the label of a supplemented food must carry a supplemented food facts table that contains only the information set out in column 1 of the table to this section, expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4.

(2)

Good Manufacturing Practice

(2)

For the purposes of subsection (1), the serving of stated size set out in the supplemented food facts table, as expressed in a metric unit, must be used as the basis for determining the information appearing in the supplemented food facts table in respect of the energy value of, and the content of nutrients and supplemental ingredients in, the supplemented food.

(3)

Good Manufacturing Practice

(3)

Subject to subsection (8), the percentage of the daily value for a vitamin or mineral nutrient shown in the supplemented food facts table in accordance with subsection (1) must be established on the basis of the amount, by weight, of the vitamin or mineral nutrient per serving of stated size of the supplemented food, rounded off in the applicable manner set out in column 4 of the table to this section.

(5)

1.5%

(4)

If the information in respect of six or more of the energy value and nutrients referred to in column 1 of items 2 to 5 and 7 to 15 of the table to this section may be expressed as “0” in the supplemented food facts table in accordance with this section, the supplemented food facts table need only include the following information: (a) the serving of stated size; (c) the amount of fat; (f) the amount of any nutrient that is the subject of a representation on the label of the supplemented food, or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food, if the representation expressly or implicitly indicates that the supplemented food has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004; (g) the amount of any added sugar alcohol; (i) the amount of any vitamin or mineral nutrient that is declared as a component of an ingredient, other than flour, of the supplemented food; (j) the amount of any nutrient referred to in column 1 of any of items 4, 5, 7, 8, 10, 11 and 13 to 15 of the table to this section that may not be expressed as “0” in the supplemented food facts table; (k) the statement “Not a significant source of (naming each nutrient that is omitted from the supplemented food facts table in accordance with this subsection)” or, if the supplemented food meets the condition specified in subsection B.29.010(3), the statement “Not a significant source of other nutrients”;

(1)

300 p.p.m. singly or in combination in accordance with section B.06.002

(5)

The supplemented food facts table of a supplemented food that is a single-serving prepackaged product need only include the following information: (a) the serving of stated size; (c) the amount of fat; (f) the amount of any nutrient that is the subject of a representation on the label of the supplemented food, or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food, if the representation expressly or implicitly indicates that the supplemented food has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004; (g) the amount of any added sugar alcohol; (i) the amounts of saturated fatty acids and trans fatty acids and the sum of saturated fatty acids and trans fatty acids, if any of the amounts or the sum may not Food and Drug Regulations (i) the amount of any nutrient referred to in column 1 of item 8 or 11 of the table to this section that may not be expressed as “0” in the supplemented food facts table;

(4)

125 p.p.m. in accordance with the requirements of paragraph B.21.021(d)

(6)

Subsection (1) does not apply to a supplemented food intended solely for use as an ingredient in the manufacture of other supplemented foods intended for sale to a consumer at the retail level.

(5)

80 p.p.m. aurea in accordance with the requirements of clause B.14.032(d)(xvii)(B) and 20 p.p.m. sunset yellow FCF in accordance with the requirements of clause B.14.032(d)(xvii)(C)

(8)

Subject to subsection (10), if a substance has been added as a supplemental ingredient, the amount referred to in item 18 of the table to this section includes the total amount of the substance in the supplemented food, unless otherwise provided in column 3 or 5 of the List of Permitted Supplemental Ingredients.

(6)

0.15% (Residues of sunset yellow FCF in sausage prepared with such casings not to exceed 15 p.p.m.) PART B Foods

(9)

If any amount of a nutrient referred to in column 1 of the table to this section has been added as a supplemental ingredient, the amount of the nutrient may only be expressed in the supplemented food facts table in accordance with item 18 of the table to this section.

Section B.16.100

Column I | Column II | Column III Fast Green FCF | (2) Unstandardized foods | (2) 100 p.p.m. singly or in combination in accordance with section B.06.002 | (4) Feta cheese (brilliant blue FCF only) | (4) 0.10 p.p.m. 5 | Citrus Red No. 2 | Skins of whole oranges | 2 p.p.m. 6 | Ponceau SX | Fruit Peel; Glacé fruits; Maraschino Cherries | 150 p.p.m. 7 | Gold | Alcoholic beverages | Good Manufacturing Practice TABLEAU III Additifs alimentaires autorisés comme colorants pour aliments

(10)

If a substance other than a nutrient has been added as a supplemental ingredient and the substance has one or more constituents for which a maximum amount is specified in column 3 of the List of Permitted Supplemental Ingredients, the amount of each constituent set out in the supplemented food facts table must include the total amount of the constituent in the supplemented food, unless otherwise provided in column 3 or 5 of the List of Permitted Supplemental Ingredients.

Article | Additif | Permis dans ou sur | Limites de tolérance

1 | Aluminium métallique | (1) Achards (relish); beurre; catsup de tomates; confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); cornichons; gelée de (nom du fruit) avec pectine; jus de (nom du fruit) concentré sauf le jus d’orange concentré congelé; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé additionné de solides du lait; liqueur; marmelade d’ananas avec | (1) Bonnes pratiques industrielles PART B Foods

1 Serving of stated size

“Serving Size (naming the serving size)”, “Serving (naming the serving size)” or “Per (naming the serving size)” The size is expressed (a) in the case of a supplemented food that is a single-serving prepackaged product, (b) in the case of a supplemented food that is a multiple-serving prepackaged product, in the following units set out in column 3B of the Table of Reference Amounts: (i) the household measure that applies to the supplemented food, and (ii) the metric measure that applies to the supplemented food.

Section B.16.100

Règlement sur les aliments et drogues

(1)

The size if expressed in a metric unit is rounded off (a) if it is less than 10 g or 10 mL, to the nearest multiple of 0.1 g or 0.1 mL; and (b) if it is 10 g or more or 10 mL or more, to the nearest multiple of 1 g or 1 mL.

PARTIE B Aliments

(2)

The size if expressed as a fraction is represented by a numerator and a denominator separated by a line.

TITRE 16 Additifs alimentaires

(3)

The size must include the word “assorted” if the information in the supplemented food facts table of a prepackaged product containing an assortment of supplemented foods is set out as a composite value. The value is expressed in Calories per serving of stated size. The value is rounded off (a) if it is less than 5 Calories, (i) if the supplemented food meets the conditions set out in column 2 of item 1 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of energy” set out in column 1, to “0” Calorie, and (b) if it is 5 Calories or more but not more than 50 Calories, to the nearest multiple of 5 Calories; and (c) if it is more than 50 Calories, to the nearest multiple of 10 Calories.

Article B.16.100

Colonne I

3 Amount of fat

The amount is expressed (a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

Article

Colonne II Additifs Permis dans ou sur Colonne III Limites de tolérance Oxyde de fer Orseille Paprika Riboflavine Safran Bois de santal Argent métallique Bioxyde de titane Curcuma Xanthophylle pectine; marmelade de figues avec pectine; mélange pour crème glacée; mélange pour lait glacé; œufs de poisson (caviar); pain; pâte de homard; poisson fumé; produits de poisson ou de chair de poisson emballés, marinés ou conditionnés à froid par une autre méthode (Titre 21); sorbet laitier; sucre à glacer

(1)

The amount is rounded off (a) if it is less than 0.5 g, (i) if the supplemented food meets the conditions set out in column 2 of item 11 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of fat” set out in column 1 and the amounts of saturated fatty acids and trans fatty acids are declared as “0 g” in the supplemented food facts table or are omitted from that table in accordance with subsection B.29.002(4) and no other fatty acids are declared in an Food and Drug Regulations

(2)

Jaune d’œuf congelé; jaune d’œuf liquide; œuf entier congelé; œuf entier liquide; poudre de jaune d’œuf; poudre d’œuf entier

4 | Amount of saturated fatty acids | "Saturated Fat", "Saturated Fatty Acids", "Saturated" or "Saturates" | The amount is expressed in grams per serving of stated size. | The amount is rounded off

(a) if it is less than 0.5 g, (i) if the supplemented food meets the conditions set out in column 2 of item 18 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of saturated fatty acids” set out in column 1, to “0 g”, and (b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.

(3)

Aliments non normalisés

5 | Amount of trans fatty acids | "Trans Fat", "Trans Fatty Acids" or "Trans" | The amount is expressed in grams per serving of stated size. | The amount is rounded off

(a) if it is less than 0.5 g, (i) if the supplemented food meets the conditions set out in column 2 of item 22 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of trans fatty acids” set out in column 1, to “0 g”, and (b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.

(4)

Les graisses et huiles végétales

6 | The sum of saturated fatty acids and trans fatty acids | "Saturated Fat + Trans Fat", "Saturated Fatty Acids + Trans Fatty Acids", "Saturated + Trans" or "Saturates + Trans" | The sum is expressed as a percentage of the daily value per serving of stated size. | The percentage is rounded off

(a) if the amounts of saturated fatty acids and trans fatty acids are declared as “0 g”, to 0%; and (b) in all other cases, to the nearest multiple of 1%. Food and Drug Regulations

(5)

Margarine

7 | Amount of cholesterol | “Cholesterol” | The amount

(a) is expressed in milligrams per serving of stated size; and (b) may also be expressed as a percentage of the daily value per serving of stated size.

(6)

Fromage (indication de la variété); fromage cheddar; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner, fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

(1)

The amount is rounded off (a) if the supplemented food meets the conditions set out in column 2 of item 27 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of cholesterol” set out in column 1, to “0 mg”; and (b) in all other cases, to the nearest multiple of 5 mg.

(7)

Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n)

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(8)

Longanzia; Tocino

8 | Amount of sodium | “Sodium” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(9)

Pellicule de collagène comestible (oxyde de fer seulement)

(1)

The amount is rounded off (a) if it is less than 5 mg, (i) if the supplemented food meets the conditions set out in column 2 of item 31 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of sodium or salt” set out in column 1, to “0 mg”; and (ii) in all other cases, to the nearest multiple of 1 mg; (b) if it is 5 mg or more but not more than 140 mg, to the nearest multiple of 5 mg; and (c) if it is more than 140 mg, to the nearest multiple of 10 mg.

(10)

Boyaux de saucisse (rocou seulement)

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(11)

Boyaux de saucisse (cochenille seulement)

9 | Amount of carbohydrate | “Carbohydrate”, “Total Carbohydrate” or “Carbohydrate, Total” | The amount is expressed in grams per serving of stated size.

The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and

(2)

Bonnes pratiques industrielles selon les alinéas B.22.034b) et B.22.035b)

10 | Amount of fibre | “Fibre”, “Fiber”, “Dietary Fibre” or “Dietary Fiber” | The amount is expressed

(a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(3)

Bonnes pratiques industrielles

(1)

The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and

(4)

Bonnes pratiques industrielles selon l’article B.09.001

(2)

The percentage is rounded off (a) if the amount is declared as “0 g”, to 0%; and (b) in all other cases, to the nearest multiple of 1%. Food and Drug Regulations

(5)

Bonnes pratiques industrielles

11 | Amount of sugars | “Sugars” | The amount is expressed

(a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and

(6)

Bonnes pratiques industrielles conformément aux exigences des articles B.08.003, B.08.008, B.08.038, B.08.040, B.08.041, B.08.042.1, B.08.042.2, B.08.042.3, B.08.042.4, B.08.041.5, B.08.041.6 et B.08.041.8

(2)

The percentage is rounded off (a) if the amount is declared as “0 g”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(7)

Bonnes pratiques industrielles

12 | Amount of protein | “Protein” | The amount is expressed in grams per serving of stated size. | The amount is rounded off

(a) if it is less than 0.5 g, to the nearest multiple of 0.1 g; and

(8)

0,1 % conformément aux exigences de l’alinéa B.14.031u) ou sous-alinéa B.14.032d)(vii)

13 | Amount of potassium | “Potassium” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 5 mg, to “0 mg”; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and

(9)

Bonnes pratiques industrielles

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(10)

1,0 % Les résidus de rocou dans les saucisses préparées avec des boyaux ne doivent pas dépasser 100 p.p.m.

14 | Amount of calcium | “Calcium” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 5 mg, to “0 mg”; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and

(11)

0,75 % Les résidus de cochenille dans les saucisses préparées avec des boyaux ne doivent pas dépasser 75 p.p.m. PART B Foods

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

Section B.16.100

Règlement sur les aliments et drogues

15 | Amount of iron | “Iron” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 0.05 mg, to “0 mg”; Food and Drug Regulations

PARTIE B Aliments

16 | % Daily Value interpretative statement | "**5% or less is a little, 15% or more is a lot**" | [not applicable] | The "% Daily Value" or "% DV" subheading is followed by an asterisk in order to reference the % Daily Value interpretative statement shown in the supplemented food facts table.

TITRE 16 Additifs alimentaires

17 | "Supplemented with" interpretative statement | "† Includes naturally occurring and supplemental amounts" | [not applicable] | The "Supplemented with" subheading is followed by a dagger in order to reference the "Supplemented with" interpretative statement shown in the supplemented food facts table.

Article B.16.100

Colonne I

18 | Amount of supplemental ingredient | The supplemental ingredient is described in accordance with column 1 of the List of Permitted Supplemental Ingredients. | The amount is expressed in

(a) the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients, per serving of stated size; and (b) in the case of a nutrient with a daily value, as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off to the nearest whole number and expressed in the manner set out in column 3 and, if applicable, column 5 of the List of Permitted Supplemental Ingredients.

Article

1A Additifs ß-apo-8'- Caroténal Ester éthylique de l'acide ß-apo-8'-caroténoïque Colonne II Permis dans ou sur

(2)

Unless otherwise provided in column 5 of the List of Permitted Supplemental Ingredients, the percentage is rounded off (a) if the amount declared in the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients is "0", to 0%; and (b) in all other cases, to the nearest multiple of 1%. Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations Food and Drug Regulations Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations Additional Information B.29.003 (1) Subject to subsection (2), the supplemented food facts table may also contain information set out in column 1 of the table to this section.

(1)

Achards (relish); beurre; catsup de tomates; confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); cornichons; gelée de (nom du fruit) avec pectine; jus de (nom du fruit) concentré sauf le jus d'orange concentré congelé; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; liqueur; margarine; marmelade d’ananas avec pectine; marmelade d’agrumes avec pectine; mélange pour lait glacé; mélange pour lait glacé; mélange de poisson (caviar); pain; pâte de rôti; poisson fumé; tarte; tarte à glacer

(2)

This section does not apply in respect of a vitamin or mineral nutrient that is set out in the supplemented food facts table in accordance with subsection B.29.002(1) if any amount of that vitamin or mineral nutrient has been added as a supplemental ingredient.

(2)

Aliments non normalisés

(3)

If information set out in column 1 of the table to this section is included in the supplemented food facts table, it must be expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4.

(3)

Fromage (indication de la variété); fromage cheddar; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

(4)

For the purposes of subsection (3), the serving of stated size set out in the supplemented food facts table, as expressed in a metric unit, must be used as the basis for declaring the information in respect of the supplemented food facts table in respect of the energy value and nutrient content of the supplemented food.

(4)

Mélange de poisson et de viande préparées visé à l’alinéa B.21.006n) Colonne III Limites de tolérance

(5)

The percentage of the daily value for a vitamin or mineral nutrient shown in the supplemented food facts table in accordance with subsection (3) must be established on the basis of the amount, by weight, of the vitamin or mineral nutrient per serving of stated size for the supplemented food, rounded off in the applicable manner set out in column 4 of the table to this section.

(1)

35 p.p.m.

(6)

The amount of omega-6 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids and monounsaturated fatty acids must be shown in the supplemented food facts table if (a) the amount of any of those groups of fatty acids or the amount of polyunsaturated fatty acids is shown in the supplemented food facts table or on the label of the supplemented food or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food; or (b) the amount of any specific fatty acid is shown on the label of the supplemented food or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food.

(2)

35 p.p.m.

(7)

If the label of the supplemented food, or any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer, contains a representation, express or implied, that includes information that is set out in column 1 of the table to this section, that information must also be shown in the supplemented food facts table.

(3)

35 p.p.m., conformément aux exigences des articles B.08.033, B.08.034, B.08.037, B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 et B.08.041.8

(8)

The supplemented food facts table must show the amount of any added sugar alcohol.

(4)

35 p.p.m. 2 Caramel Colonne II Permis dans ou sur

(9)

The supplemented food facts table must show the amount of any vitamin or mineral nutrient that is declared as a component of an ingredient, other than flour.

(1)

Achards (relish); ale; beurre; bière; catsup de tomates; cidre; confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); cornichons; eau-de-vie de vin (brandy); gelée de (nom du fruit) avec pectine; gelée renversée Hollandaise; jus de (nom du fruit) concentré sauf le jus d’orange concentré congelé; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) Colonne III Limites de tolérance

(10)

If information set out in column 1 of the table to this section is included in the supplemented food facts table, it must be shown (a) in English and French; or (b) in one of those languages, if, in accordance with subsection B.01.012(3), the information that is required by these Regulations to be shown on the label may be shown in that language only and is shown on the label in that language. Additional Information (a) if it is less than 2, to the nearest multiple of 1; (b) if it is between 2 and 5, to the nearest multiple of 0.5; and (c) if it is more than 5, to the nearest multiple of 1.

(1)

Bonnes pratiques industrielles PART B Foods

(2)

If a quantity is rounded off, it must be preceded by the word "about".

Section B.16.100

Règlement sur les aliments et drogues

(3)

If the product is of a random weight, the quantity may be declared as "varied". | | 3 | Amount of polyunsaturated fatty acids | "Polyunsaturated Fat", "Polyunsaturated Fatty Acids", "Polyunsaturated" or "Polyunsaturates" | The amount is expressed in grams per serving of stated size. | The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. |

PARTIE B Aliments

(1)

If the supplemented food facts table includes the amount of polyunsaturated fatty acids:

TITRE 16 Additifs alimentaires

(1)

If the supplemented food facts table includes the amount of polyunsaturated fatty acids: The amount is expressed in grams per serving of stated size. The amount is expressed in grams per serving of stated size. The amount is expressed in grams per serving of stated size. The amount is expressed in grams per serving of stated size. The amount is expressed in grams per serving of stated size. The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and Food and Drug Regulations

Article B.16.100

Colonne I

9 | Amount of sugar alcohol | (1) If the supplemented food contains only one type of sugar alcohol: “Sugar Alcohol”, “Polyol” or “(naming the sugar alcohol)”

Article

Colonne II Additifs Permis dans ou sur Colonne III Limites de tolérance additionné de solides du lait; lait (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; liqueur de malt; liqueur; marmelade d’ananas avec pectine; marmelade de figues avec pectine; mélange pour crème glacée; mélange pour lait glacé; mincemeat; œufs de poisson (caviar); pain; pain brun; pâte de homard; poisson fumé; porter; rhum; sorbet laitier; stout; sucre à glacer; vin; vinaigre de cidre; vinaigre de malt; vinaigre de vin; vin de miel; whisky

(2)

In all other cases: “Sugar Alcohols” or “Polyols” | The amount is expressed as grams per serving of stated size. | The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and

(2)

Aliments non normalisés

10 | Amount of starch | “Starch” | The amount is expressed as grams per serving of stated size. | The amount is rounded off

(a) if it is less than 0.5 g, to “0 g”; and

(3)

Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n)

11 | Amount of vitamin A | “Vitamin A” or “Vit A” | The amount is expressed

(a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 5 µg, to “0 µg”; (b) if it is 5 µg or more but less than 50 µg, to the nearest multiple of 10 µg; (c) if it is 50 µg or more but less than 250 µg, to the nearest multiple of 50 µg; and

(4)

Boyaux de saucisse

(2)

The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(2)

Bonnes pratiques industrielles

12 | Amount of vitamin C | “Vitamin C” or “Vit C” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 0.1 mg, to “0 mg”; (b) if it is 0.1 mg or more but less than 1 mg, to the nearest multiple of 0.2 mg; (c) if it is 1 mg or more but less than 5 mg, to the nearest multiple of 0.5 mg; and

(3)

Bonnes pratiques industrielles

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(4)

15 % (les résidus de caramel dans les saucisses préparées avec ces boyaux ne doivent pas dépasser 0,15 %) 3 Rouge allura Amaranthe Érythrosine Indigotine Jaune soleil FCF Tartrazine

13 | Amount of vitamin D | “Vitamin D” or “Vit D” | The amount is expressed

(a) in micrograms per serving of stated size; and | (1) The amount is rounded off (a) if it is less than 0.1 µg, to “0 µg”; Food and Drug Regulations Amount of vitamin K The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(1)

Achards (relish); beurre; catsup de tomates; confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); cornichons; gelée de (nom du fruit) avec pectine; jus de (nom du fruit) concentré sauf le jus d’orange concentré congelé; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; liqueur; marmelade d’ananas avec pectine; marmelade de figues avec pectine; mélange pour crème glacée; mélange pour lait glacé; œufs de poisson (caviar); pain; pâte de homard; poisson fumé; sorbet laitier; sucre à glacer

(1)

The amount is rounded off (a) if it is less than 0.05 mg, to "0 mg"; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and

(2)

Aliments non normalisés

(2)

The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(3)

Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n)

(1)

The amount is rounded off (a) if it is less than 0.05 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and

(4)

Anchois salé, chinchard salé et crevette salée

(2)

The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(5)

Longanzia

(1)

The amount is rounded off (a) if it is less than 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations

(1)

300 p.p.m., isolément ou en mélange, en conformité de l’article B.06.002

17 | Amount of riboflavin | “Riboflavin”, “Riboflavin (Vitamin B2)” or “Riboflavin (Vit B2)” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(2)

300 p.p.m., isolément ou en mélange, en conformité de l’article B.06.002

(1)

The amount is rounded off (a) if it is less than 0.005 mg, to “0 mg”; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and

(3)

300 p.p.m., isolément ou en mélange, en conformité de l’article B.06.002

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(4)

25 p.p.m. conformément aux exigences de l’alinéa B.21.021d)

18 | Amount of niacin | “Niacin” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(5)

200 p.p.m. conformément aux exigences de la PART B Foods

(1)

The amount is rounded off (a) if it is less than 0.05 mg, to “0 mg”; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and

Section B.16.100

Règlement sur les aliments et drogues

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

PARTIE B Aliments

19 | Amount of vitamin B6 | “Vitamin B6” or “Vit B6” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

TITRE 16 Additifs alimentaires

(1)

The amount is rounded off (a) if it is less than 0.005 mg, to “0 mg”; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and

Article B.16.100

Colonne I

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%. Food and Drug Regulations Amount of folate Amount of vitamin B12 Amount of biotin The amount is expressed (a) in micrograms of dietary folate equivalents (DFE) per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

(1)

The amount is rounded off (a) if it is less than 1 µg DFE, to “0 µg DFE”; (b) if it is 1 µg DFE or more but less than 10 µg DFE, to the nearest multiple of 2 µg DFE; (c) if it is 10 µg DFE or more but less than 50 µg DFE, to the nearest multiple of 5 µg DFE; and

(6)

Boyaux de saucisse (jaune soleil FCF seulement)

(2)

The percentage is rounded off (a) if the amount is declared as “0 µg DFE”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(7)

Grignotines de maïs à saveur de fromage (jaune soleil FCF seulement) division B.14.032d)(xvi)(B) et 20 p.p.m. de jaune soleil FCF conformément aux exigences de la division B.14.032d)(xvi)(C)

(1)

The amount is rounded off (a) if it is less than 0.005 µg, to “0 µg”; (b) if it is 0.005 µg or more but less than 0.05 µg, to the nearest multiple of 0.005 µg; (c) if it is 0.05 µg or more but less than 0.25 µg, to the nearest multiple of 0.025 µg; and

(6)

0,15 % (les résidus de jaune soleil FCF dans les saucisses préparées avec ces boyaux ne doivent pas dépasser 15 p.p.m.)

(2)

The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(7)

600 p.p.m. isolément. Si combiné avec d’autres colorants nommés à la colonne I du présent article et de l’article 4 du présent tableau, la limite de tolérance est de 300 p.p.m. conformément à l’alinéa B.06.002c) 4 Bleu brillant FCF Vert solide FCF

(1)

The amount is rounded off (a) if it is less than 0.05 µg, to “0 µg”; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and

(1)

Achards (relish); beurre; catsup de tomates; confiture de (nom du fruit) avec pectine; confiture de pommes (de rhubarbe) et de (nom du fruit); cornichons; gelée de (nom du fruit) avec pectine; jus de (nom du fruit) concentré sauf le jus d’orange concentré congelé; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; liqueur; marmelade d’ananas avec pectine; marmelade de figues avec pectine; mélange pour crème glacée; mélange pour lait glacé; œufs de poisson (caviar); pain; pâte de homard; poisson fumé; sorbet laitier; sucre à glacer

(2)

The percentage is rounded off Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations

(2)

Aliments non normalisés

23 | Amount of pantothenic acid | “Pantothenic Acid” or “Pantothenate” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(3)

Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n)

(1)

The amount is rounded off (a) if it is less than 0.01 mg, to “0 mg”; (b) if it is 0.01 mg or more but less than 0.1 mg, to the nearest multiple of 0.02 mg; (c) if it is 0.1 mg or more but less than 0.5 mg, to the nearest multiple of 0.05 mg; and

(4)

Feta (bleu brillant FCF seulement)

(2)

The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(1)

100 p.p.m., isolément ou en mélange, en conformité de l’article B.06.002

24 | Amount of choline | “Choline” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(2)

100 p.p.m., isolément ou en mélange, en conformité avec l’article B.06.002

(1)

The amount is rounded off (a) if it is less than 1 mg, to “0 mg”; (b) if it is 1 mg or more but less than 10 mg, to the nearest multiple of 2 mg; (c) if it is 10 mg or more but less than 50 mg, to the nearest multiple of 5 mg; and

(3)

100 p.p.m., isolément ou en mélange, en conformité avec l’article B.06.002

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(4)

0,1 p.p.m. 5 Rouge citrin no 2 Écorce des oranges entières 150 p.p.m. 6 Ponceau SX Écorce de fruits; fruits glacés; cerises glacées; marrasques 150 p.p.m. 7 — Boissons alcooliques Bonnes pratiques industrielles SOR/79-752, s. 6; SOR/80-66, s. 6; SOR/82-966, s. 3; SOR/84-440, s. 4; SOR/86-622, s. 6; SOR/89-195, s. 16 to 19; SOR/90-272, s. 5; SOR/94-686, s. 42; SOR/95-548, s. 4; SOR/97-513, s. 9; 96-434, ss. 5, 6; SOR/99-535, s. 10; SOR/99-516, s. 5; SOR/2000-217, s. 5; SOR/2000-411, s. 5; SOR/2004-100, s. 11; SOR/2004-146, ss. 1 to 3; SOR/2007-150, ss. 1 to 3; SOR/2010-143, s. 13; SOR/2010-143, s. 13; SOR/2011-231, s. 2; SOR/2011-231, s. 2; SOR/2012-43, ss. 16 to 20. DORS/79-752, art. 5; DORS/80-66, art. 5; DORS/82-966, art. 3; DORS/84-440, art. 4; DORS/86-622, art. 6; DORS/89-195, art. 16 à 19; DORS/90-272, art. 5; DORS/94-686, art. 42; DORS/95-548, art. 4; DORS/97-513, art. 9; DORS/96-434, art. 5, 6; DORS/99-535, art. 10; DORS/99-516, art. 5; DORS/2000-217, art. 5; DORS/2000-411, art. 5; DORS/2004-100, art. 11; DORS/2004-146, art. 1 à 3; DORS/2007-150, art. 1 à 3; DORS/2010-143, art. 13; DORS/2011-231, art. 2; DORS/2012-43, art. 16 à 20. TABLE IV Column I | Column II | Column III

25 | Amount of phosphorous | “Phosphorus” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(3)

Sherbet

(1)

The amount is rounded off (a) if it is less than 5 mg, to “0 mg”; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and

(4)

Unstandardized foods

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%. Food and Drug Regulations

(5)

Calorie-reduced margarine

26 | Amount of iodide | “Iodide” or “Iodine” | The amount is expressed

(a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 1 µg, to “0 µg”; (b) if it is 1 µg or more but less than 10 µg, to the nearest multiple of 2 µg; (c) if it is 10 µg or more but less than 50 µg, to the nearest multiple of 5 µg; and

(6)

Canned asparagus; Canned green beans; Canned wax beans; Canned peas | (1) Good Manufacturing Practice

(2)

The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(2)

0.5%

27 | Amount of magnesium | “Magnesium” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 1 mg, to “0 mg”; (b) if it is 1 mg or more but less than 10 mg, to the nearest multiple of 2 mg; (c) if it is 10 mg or more but less than 50 mg, to the nearest multiple of 5 mg; and

(3)

0.75%

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(4)

Good Manufacturing Practice

28 | Amount of zinc | “Zinc” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 0.05 mg, to “0 mg”; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and

(6)

1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C) A.1A | Acacia Gum modified with octenyl succinic anhydride (OSA) | (1) French dressing; Icings; Salad dressings; Unstandardized dressings; Unstandardized sauces

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(2)

Unstandardized beverages

29 | Amount of selenium | “Selenium” | The amount is expressed

(a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. | (1) The amount is rounded off (a) if it is less than 0.1 µg, to “0 µg”; (b) if it is 0.1 µg or more but less than 1 µg, to the nearest multiple of 0.2 µg; Food and Drug Regulations

(3)

Unstandardized flavouring preparations | (1) 1%

30 | Amount of copper | “Copper” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(2)

0.1%

(1)

The amount is rounded off (a) if it is less than 0.0015 mg, to “0 mg”; (b) if it is 0.0015 mg or more but less than 0.025 mg, to the nearest multiple of 0.002 mg; (c) if it is 0.025 mg or more but less than 0.05 mg, to the nearest multiple of 0.005 mg; and

(3)

0.05% A.3 | Acetylated Tartaric Acid Esters of Mono- and Di-glycerides | (1) Bread

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(2)

Unstandardized foods

31 | Amount of manganese | “Manganese” | The amount is expressed

(a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(3)

Infant formulas based on crystalline amino acids | (1) 6,000 p.p.m. of flour

(1)

The amount is rounded off (a) if it is less than 0.005 mg, to “0 mg”; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and

(2)

Good Manufacturing Practice

(2)

The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(3)

Sherbet

32 | Amount of chromium | “Chromium” | The amount is expressed

(a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(4)

Unstandardized foods | (1) Good Manufacturing Practice

(1)

The amount is rounded off (a) if it is less than 0.05 µg, to “0 µg”; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and Food and Drug Regulations Amount of chloride The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size. The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

(2)

0.5%

(1)

The amount is rounded off (a) if it is less than 0.05 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and

(3)

0.75%

(2)

The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.

(4)

Good Manufacturing Practice Column I A.5 Algin Column II

(1)

The amount is rounded off (a) if it is less than 5 mg, to "0 mg"; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and

(5)

Calorie-reduced margarine

(2)

The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%. Food and Drug Regulations Food and Drug Regulations Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations Food and Drug Regulations Food and Drug Regulations Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations Food and Drug Regulations Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations Food and Drug Regulations Supplemented Foods for Use in Manufacturing Other Supplemented Foods B.29.004 (1) This section applies to a supplemented food intended solely for use as an ingredient in the manufacture of other supplemented foods intended for sale to a consumer at the retail level.

(2)

Infant formula

(2)

It is prohibited to sell the supplemented food unless the information referred to in subsection (3) in respect of the supplemented food is provided in writing and accompanies the supplemented food when it is delivered to the purchaser. (a) must include the information that would, but for subsection B.29.002(6), be required by sections B.29.002 and B.29.003 to be included in a supplemented food facts table; (b) may include other information that is permitted by section B.29.003 to be included in that supplemented food facts table; and (c) must be expressed in accordance with sections B.29.002 and B.29.003, subject to the following modifications, namely, (i) information in respect of supplemental ingredients must be expressed according to the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients, (A) per gram or 100 g of the supplemented food, if the net quantity of the supplemented food is declared on the label by weight or by count, or (B) per millilitre or 100 mL of the supplemented food, if the net quantity of the supplemented food is declared on the label by volume, (A) per gram or 100 g of the supplemented food, if the net quantity of the supplemented food is declared on the label by weight or by count, or (B) per millilitre or 100 mL of the supplemented food, if the net quantity of the supplemented food is declared on the label by volume, (iii) information for other nutrients and the energy value set out in column 1 of the table to section B.29.002 or the table to section B.29.003 must be expressed in the units referred to in column 3, (A) per gram or 100 g of the supplemented food, if the net quantity of the supplemented food is declared on the label by weight or by count, or (B) per millilitre or 100 mL of the supplemented food, if the net quantity of the supplemented food is declared on the label by volume, (iv) percentages of daily values and information on servings of stated size may be omitted, and (v) the information must be stated with a degree of precision that corresponds to the accuracy of the analytical methodology used to produce the information. B.29.005 (1) Subject to subsections (2) to (5), the information in the supplemented food facts table must be set out only on the basis of the supplemented food as offered for sale.

(4)

Sherbet

(2)

If a prepackaged product contains an assortment of supplemented foods of the same type and the typical serving consists of only one of those supplemented foods, the information in the supplemented food facts table must be set out (a) on the basis of each of the supplemented foods contained in the prepackaged product, if the information set out in column 1 of the table to section B.29.002 for each of those supplemented foods is different; or (b) on the basis of one of the supplemented foods contained in the prepackaged product, if the information set out in column 1 of the table to section B.29.002 for each of those supplemented foods is the same.

(5)

Unstandardized foods

(3)

If a prepackaged product contains an assortment of supplemented foods of the same type and the typical serving consists of more than one of those supplemented foods, the information in the supplemented food facts table must be set out for each of the supplemented foods contained in the prepackaged product or as a composite value.

(6)

Calorie-reduced margarine

(4)

If a supplemented food is to be prepared in accordance with directions provided in or on the package or is commonly combined with other ingredients or another food or cooked before being consumed, the supplemented food facts table may also set out information for the supplemented food as prepared, in which case (a) the supplemented food facts table must set out the following information for the supplemented food as prepared, namely, (i) except in the case described in subparagraph (ii), the amount of the supplemented food expressed using the unit referred to in column 3 of subparagraph 1(b)(i) of the table to section B.29.002 as “about (naming the serving size)” or “about (naming the serving size) prepared” and, if applicable, in the manner specified in column 4 of subitems 1(c)(1) and (2), (ii) if the supplemented food is commonly served combined with another food, the amount of the other food expressed using the unit referred to in column 3 of subparagraph 1(b)(ii) of the table to section B.29.002, (iii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.29.002, in the unit set out in column 3 and in the manner set out in column 4, (iv) the information set out in column 1 of items 3, 6 to 8, 10, 11 and 13 to 15 of the table to section B.29.002 and in column 1 of items 11 to 34 of the table to section B.29.003 that is declared as a percentage of the daily value in the supplemented food facts table for the supplemented food as sold, expressed using a description set out in column 2 of those tables, as a percentage of the daily value per serving of stated size and in the manner specified in column 4 of those tables, and the description referred to in column 2, in the unit referred to in column 3 and in the manner referred to in column 4; and (b) the supplemented food facts table may also set out the following information for the added ingredients or the other food, if it is declared in the supplemented food facts table for the supplemented food as sold, namely, (i) the information set out in column 1 of items 3 to 5 and 7 to 12 of the table to section B.29.002, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7 and 8 and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4, (iii) the information set out in column 1 of item 2 of the table to section B.29.002, expressed using a description set out in column 2, in the unit set out in column 3 per serving or stated size of the supplemented food as prepared, and in the manner specified in column 4.

(7)

Sour cream

(5)

The information in the supplemented food facts table may also be set out on the basis of other amounts of the supplemented food that reflect different uses or different units of measurement of the supplemented food, in which case (a) the supplemented food facts table must set out the following information for each of the other amounts of the supplemented food, namely, (i) the amount of the supplemented food expressed in a household measure and a metric measure and in the manner specified in column 4 of subitems 1(1) and (2) of the table to section B.29.002, (ii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.29.002, in the unit set out in column 3 and in the manner set out in column 4, B.29.002 and in column 1 of items 11 to 34 of the table to section B.29.003 that is declared as a percentage of the daily value in the supplemented food facts table for the first amount of the supplemented food for which information is declared, expressed using a description set out in column 2 of those tables, as a percentage of the daily value per serving of stated size and in the manner specified in column 4 of those tables, and (iv) the information referred to in column 1 of item 18 of the table to section B.29.002, expressed using the description referred to in column 2, the unit referred to in column 3 and in the manner referred to in column 4; and (b) if the supplemented food facts table is set out in a version of the aggregate format specified in section B.29.015, it must also set out the following information for each of the other amounts of the supplemented food, if that information is declared in the supplemented food facts table for the first amount of the supplemented food for which information is declared, namely, (i) the information set out in column 1 of items 3 to 7 and 9 to 15 of the table to section B.29.002, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7, 8 and 13 to 15, and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4, and (ii) the information set out in column 1 of items 3 to 34 of the table to section B.29.003, expressed using a description set out in column 2, in micrograms for the information set out in column 1 of items 11, 13, 15, 21, 22, 26, 29, 32 and 33, in micrograms of dietary folate equivalents for the information set out in column 1 of item 20, in milligrams for the information set out in column 1 of items 12, 14, 16 to 19, 23 to 25, 27, 28, 30, 31 and 34, and in grams for the information set out in column 1 of items 3 to 10 and in the manner specified in column 4. B.29.006 (1) Subject to subsections (2) to (7), the supplemented food facts table must be presented in accordance with the format specified in the applicable figure in the Directory of SFFT Formats, having regard to matters such as order of presentation, dimensions, spacing and the use of upper and lower case letters and bold type.

(8)

Canned asparagus; Canned green beans; Canned wax beans; Canned peas Column III Maximum Level of Use

(2)

The characters and rules in the supplemented food facts table must be displayed in a single colour that is a visual equivalent of 100% solid black type on a white background or on a uniform neutral background with a maximum 5% tint of colour. (a) must be displayed in a single standard sans serif font that is not decorative and in such a manner that the characters never touch each other or the rules; and (b) may be displayed with larger dimensions than those specified in the applicable figure in the Directory of SFFT Formats if all the characters in the table are enlarged in a uniform manner.

(1)

Good Manufacturing Practice

(4)

The type size shown in parentheses for a version referred to in table to sections B.29.009 to B.29.015 is the minimum type size that may be used in a supplemented food facts table to show nutrients and supplemental ingredients set out in the tables to sections B.29.002 and B.29.003 in accordance with that version.

(2)

0.03% as consumed. If used in combination with carrageenan or guar gum or both, the total not to exceed 0.03%

(5)

A rule that is specified in the applicable figure in the Directory of SFFT Formats as being a 1 point rule or a 2 point rule may be displayed with larger dimensions in the supplemented food facts table.

(3)

0.5%

(6)

The information in the supplemented food facts table must be in accordance with subsections B.29.001(2) and (3) and sections B.29.002, B.29.003 and B.29.005.

(4)

0.75%

(7)

In a supplemented food facts table consisting of a table in both English and French, the order of languages may be reversed from the order shown in the applicable figure in the Directory of SFFT Formats. Location of Supplemented Food Facts Table (a) in a table in English and a table in French on the same continuous surface of the available display surface; (b) in a table in both English and French on a continuous surface of the available display surface; or (c) in a table in English on a continuous surface of the available display surface and a table in French on another continuous surface of the available display surface that is of the same size and prominence as the first surface.

(5)

Good Manufacturing Practice

(2)

If, in accordance with subsection B.01.012(3), the information required by these Regulations may be shown on the label of a supplemented food in English only or in French only and is shown in that language, the supplemented food facts table may be displayed on the label in a table in that language only on a continuous surface of the available display surface. Orientation of Supplemented Food Facts Table B.29.008 (1) Subject to subsection (2), the supplemented food facts table must be oriented in the same manner as other information appearing on the label of a supplemented food.

(7)

0.5% in accordance with the requirements of clause B.08.077(b)(vii)(A)

(2)

If a version of a supplemented food facts table cannot be oriented in the same manner as other information appearing on the label, it must be oriented in another manner if there is sufficient space to do so and the food contained in the package does not leak out and is not damaged when the package is turned over.

(8)

1.0% in accordance with the requirements of clause B.11.002(1)(viii)(C)

(3)

Subsection (1) does not apply in respect of a supplemented food facts table that is set out on the top or bottom of a package. Standard and Horizontal Formats B.29.009 (1) This section applies to a supplemented food unless any of sections B.29.010 to B.29.015 applies to it.

(9)

0.1% as consumed. If used in combination with carrageenan or guar gum or both, the total not to exceed 0.1% A.6 Alginic Acid A.7 Ammonium Alginate A.8 Ammonium Carrageenan A.9 Ammonium Furcelleran A.9A Ammonium Salt of Phosphorylated Glyceride Column II

(2)

Subject to subsection (3), the supplemented food facts table must be set out in a version listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3)

Sherbet

(3)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in (b) the bilingual horizontal format in accordance with Figure 4.3(B), 4.4(B) or 4.5(B) of the Directory of SFFT Formats; (c) the linear format in accordance with Figures 16.1(E) and (F) or 16.2(E) and (F) of the Directory of SFFT Formats; (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table; or (e) a manner described in section B.29.017.

(4)

Unstandardized foods Column III Maximum Level of Use

(4)

For the purposes of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table must include only the information that is required by these Regulations to be included in that table.

(1)

Good Manufacturing Practice

(5)

Despite subsections (2) and (3), if the supplemented food facts table is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in Parts 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in Parts 1 to 3 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. B.29.010 (1) This section applies to a supplemented food if it satisfies the condition set out in subsection B.29.002(4) and its supplemented food facts table includes only the information referred to in paragraphs B.29.002(4)(a) to (m).

(2)

0.5%

(2)

Subject to subsection (3), the supplemented food facts table must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3)

0.75%

(3)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table containing only the information referred to in paragraphs B.29.002(4)(a) to (m) in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in (b) the bilingual simplified horizontal format in accordance with Figure 7.3(B) or 7.4(B) of the Directory of SFFT Formats; (c) the simplified linear format in accordance with Figures 17.1(E) and (F) or 17.2(E) and (F) of the Directory of SFFT Formats; (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table; or (e) a manner described in section B.29.017.

(4)

Good Manufacturing Practice PART B Foods

(4)

Despite subsections (2) and (3), if the supplemented food facts table is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Simplified Horizontal Format The versions in Parts 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in Parts 1 and 2 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Simplified Formats — Supplemented Foods that are Single-serving Prepackaged Products B.29.011 (1) This section applies to a supplemented food that is a single-serving prepackaged product, whose supplemented food facts table includes only the information referred to in paragraphs B.29.002(5)(a) to (l).

Section B.16.100

Column I | Column II | Column III A.10 | Arabino-galactan | (5) Chocolate products; Cocoa products | (5) 0.7% | | Essential oils; Pie filling mixes; Pudding mixes; Unstandardized beverage bases; Unstandardized beverage mixes; Unstandardized dressings | Good Manufacturing Practice B.1 | Baker’s yeast Glycan | Unstandardized foods | Good Manufacturing Practice

(2)

Subject to subsection (3), the supplemented food facts table of the supplemented food that is a single-serving prepackaged product must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

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2 | Calcium Carbonate | (1) Unstandardized Foods | (1) Good Manufacturing Practice | | (2) A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n) | (2) Good Manufacturing Practice

(3)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food that is a single-serving prepackaged product, a supplemented food facts table containing only the information referred to in paragraphs B.29.002(5)(a) to (l) in any of the versions that are listed in column 1 of the table to this section, the supplemented food facts table must be set out in (b) the bilingual simplified horizontal format in accordance with Figure 7.3.1(B) or 7.4.1(B) of the Directory of SFFT Formats; (c) the simplified linear format in accordance with Figures 17.1.1(E) and (F) or 17.2.1(E) and (F) of the Directory of SFFT Formats; (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table; or (e) a manner described in section B.29.017.

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3 | Calcium Carrageenan | Same foods as listed for Carrageenan | Same levels as prescribed for Carrageenan | | (2) Unstandardized foods | (2) Good Manufacturing Practice

(4)

Despite subsections (2) and (3), if the supplemented food facts table of the supplemented food that is a single-serving prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in Food and Drug Regulations Bilingual Simplified Standard Format — Supplemented Foods that are Single-serving Prepackaged Products (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Simplified Horizontal Format — Supplemented Foods that are Single-serving Prepackaged Products (nutrients and supplemented ingredients to be shown in a type size of not less than 7 points (condensed)) The versions in Part 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemented ingredients to be shown in a type size of not less than 6 points (condensed)) The versions in Part 1 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Dual Format — Supplemented Foods Requiring Preparation B.29.012 (1) Subject to subsection (2), if the supplemented food facts table includes information referred to in subsection B.29.005(4), the supplemented food facts table must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

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6 | Calcium Gluconate | Unstandardized foods | Good Manufacturing Practice

(2)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

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7 | Calcium Glycerophosphate | Unstandardized dessert mixes | Good Manufacturing Practice

(3)

For the purposes of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table must include only the information that is required by these Regulations to be included in the table, together with the information referred to in subsection B.29.005(4).

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8 | Calcium Hypophosphite | Unstandardized dessert mixes | Good Manufacturing Practice | | (2) Unstandardized foods | (2) Good Manufacturing Practice

(4)

Despite subsections (1) and (2), if the supplemented food facts table is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. Dual Format — Supplemented Foods Requiring Preparation (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Dual Format — Supplemented Foods Requiring Preparation (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. B.29.013 (1) Subject to subsection (2), if the supplemented food facts table of a prepackaged product containing an assortment of supplemented foods includes separate information for each supplemented food as provided in paragraph B.29.005(2)(a) or subsection B.29.005(3), the supplemented food facts table must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

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10 | Calcium Phosphate, tribasic | Unstandardized foods | Good Manufacturing Practice

(2)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out (a) in the case of a prepackaged product described in paragraph B.29.005(2)(a), in (i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of the Directory of Supplemented Foods Formats, or (ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table, or (iii) a manner described in section B.29.017; or (b) in the case of a prepackaged product described in subsection B.29.005(3), in (i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of the Directory of SFFT Formats, or (ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

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11 | Calcium Sulphate | (1) Ice cream; Ice cream mix; Ice milk; Ice milk mix | (1) 0.5% | | (2) Sherbet | (2) 0.75% | | (3) Unstandardized foods | (3) Good Manufacturing Practice | | (4) Creamed cottage cheese | (4) 0.05% | | (5) Cream for whipping, heat-treated above 100°C | (5) 0.005% Column I

(3)

For the purposes of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the supplemented food facts table must include only the information that is required by these Regulations to be included for each supplemented food for which separate information is set out in the table.

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12 | Calcium Tartrate

(4)

Despite subsections (1) and (2), if the supplemented food facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in subparagraph 2(b)(i) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. | 1 | 10.1(E) and (F) | (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) | | 2 | 10.2(E) and (F) | The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. | | 3 | 10.3(E) and (F) | The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. | | 4 | 10.4(E) and (F) | The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. | | 5 | 10.5(E) and (F) | The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. | Food and Drug Regulations (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) | The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) | The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) | The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) | The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Dual Format — Different Amounts of Supplemented Food B.29.014 (1) Subject to subsection (2), if the supplemented food facts table includes separate information for different amounts of the supplemented food as provided in paragraph B.29.005(5)(a) without including the information referred to in paragraph B.29.005(5)(b), the supplemented food facts table must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

C

13 | Carboxymethyl Cellulose

(2)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

C

14 | Carob Bean Gum

(3)

For the purposes of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table must include only the information that is required by these Regulations to be included for each amount of the supplemented food for which separate information is set out in the table.

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15 | Carrageenan Column II Unstandardized foods

(4)

Despite subsections (1) and (2), if the supplemented food facts table is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. Dual Format — Different Amounts of Supplemented Food (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Dual Format — Different Amounts of Supplemented Food (nutrients and supplemented food ingredients to be shown in a type size of not less than 8 points) (nutrients and supplemented food ingredients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemented food ingredients to be shown in a type size of not less than 7 points (condensed)) The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemented food ingredients to be shown in a type size of not less than 6 points (condensed)) The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Aggregate Format — Different Amounts of Supplemented Food B.29.015 (1) Subject to subsection (2), if the supplemented food facts table includes separate information for different amounts of the supplemented food as provided in paragraphs B.29.005(5)(a) and (b), the supplemented food facts table must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3)

Calorie-reduced margarine

(2)

If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in (a) the bilingual aggregate format in accordance with Figure 15.5(B) or 15.6(B) of the Directory of SFFT Formats; or (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

(4)

Sherbet

(3)

For the purposes of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table must include only the information that is required by these Regulations to be included for each amount of the supplemented food for which separate information is set out in the table.

(5)

Sour cream

(4)

Despite subsections (1) and (2), if the supplemented food facts table of the supplemented food is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2. Aggregate Format — Different Amounts of Supplemented Food (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) Food and Drug Regulations The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Bilingual Aggregate Format — Different Amounts of Supplemented Food (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points) The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Food and Drug Regulations The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface. Presentation of Additional Information B.29.016 (1) If information referred to in column 1 of the table to section B.29.003 is included in a supplemented food facts table that is set out in a version consisting of a table in English and a table in French or a table in English or French, that information must be displayed (a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figures 18.1(E) and (F) of the Directory of SFFT Formats; and (b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in the Directory of SFFT Formats.

(6)

Unstandardized Foods Column III Maximum Level of Use

(2)

If information referred to in column 1 of the table to section B.29.003 is included in a supplemented food facts table that is set out in a version consisting of a table in both English and French, that information must be displayed (a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figure 19.1(B) of the Directory of SFFT Formats; and (b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in the Directory of SFFT Formats. Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations specified in the applicable figure in the Directory of SFFT Formats.

(6)

0.06% Good Manufacturing Practice

(3)

Despite paragraph (1)(a), the use of indents illustrated in Figures 18.1(E) and (F) of the Directory of SFFT Formats is not applicable if information referred to in column 1 of the table to section B.29.003 is set out in the linear format referred to in paragraph B.29.009(3)(c) or the simplified linear format referred to in paragraph B.29.010(3)(c). Alternative Methods of Presentation

(1)

Good Manufacturing Practice

(2)

The supplemented food facts table must not be set out in a manner described in paragraph (1)(b) or (c) if the label of the supplemented food is required to show a list of cautionary statements.

(2)

0.5%

(3)

If the supplemented food facts table is set out in a manner described in paragraph (1)(b) or (c), the outer side of the label of the package must indicate in a type size of not less than 8 points where the supplemented food facts table is located.

(4)

0.75%

(4)

If the supplemented food facts table is set out in a manner described in subsection (1), it must be set out (a) in the case of a supplemented food described in subsection B.29.009(3), in a version that is described in paragraph B.29.009(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.29.009; (b) in the case of a supplemented food described in subsection B.29.010(3), in a version that is described in paragraph B.29.010(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.29.010; (c) in the case of a supplemented food described in subsection B.29.011(3), in a version that is described in paragraph B.29.011(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.29.011; and (d) in the case of a prepackaged product containing an assortment of supplemented foods described in paragraph B.29.013(2)(a), in a version that is described in subparagraph B.29.013(2)(a)(i) or that is listed in column 1 of the table to section B.29.013. B.29.018 (1) Despite section A.01.016 and subject to subsection (2), if the available display surface of a supplemented food is less than 100 cm², the label of the supplemented food need not carry a supplemented foods facts table if the outer side of the label contains an indication of how a purchaser or consumer may obtain the information that would otherwise be required to be set out in a supplemented foods facts table on the label of the supplemented food.

(5)

0.5% in accordance with the requirements of clause B.08.077(b)(vii)(A)

(2)

Subsection (1) does not apply to a supplemented food (a) if the label of the supplemented food is required to show a list of cautionary statements; or (b) that is the subject of any of the following representations on the label of the supplemented food or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food: (ii) any representation that expressly or implicitly indicates that the supplemented food or any substance it contains has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004, and (iii) any health-related statement, name, logo, symbol, seal of approval or mark.

(6)

Good Manufacturing Practice

(3)

Despite paragraph (2)(b), subsection (1) applies to a supplemented food that meets the conditions set out in column 2 of item 37 of the Table of Permitted Nutrient Content Statements and Claims for the subject “Free of sugars” set out in column 1 if (a) the supplemented food is not the subject of any representation referred to in paragraph (2)(b) other than (i) a statement or claim set out in column 4 of item 37 of the Table of Permitted Nutrient Content Statements and Claims for the subject “Free of sugars” set out in column 1, (ii) the energy value of the supplemented food expressed in Calories per serving of stated size, and (iii) the amount of sugar alcohols expressed in grams per serving of stated size; (b) the statement or claim set out in column 4 of item 37 of the Table of Permitted Nutrient Content Statements and Claims for the subject “Free of sugars” set out in column 1 and that appears on the label is (i) legibly set out on the principal display panel, (ii) in lower case letters except for the first letter of each word of the statement or claim, which may be an upper case letter, (iii) of at least the same size and prominence as the letters used in the numerical portion of the declaration of net quantity as required under paragraph 229(1)(a) and subsections 229(2) and (3) of the Safe Food for Canadians Regulations, and (c) the energy value of the supplemented food expressed in Calories per serving of stated size and the amount of sugar alcohols expressed in grams per serving of stated size are shown immediately after whichever of the following elements appears last on the label: (ii) a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1), (a) must be set out in a type size of not less than 8 points; (b) must include a postal address, website address or toll-free telephone number; and (c) must be (i) in English and French, or (ii) in one of those languages, if, in accordance with subsection B.01.012(3), the information that is required by these Regulations to be shown on the label of the supplemented food may be shown in that language only and is shown on the label in that language.

(7)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

(5)

The manufacturer of the supplemented food must provide the information referred to in subsection (1) to a purchaser or consumer on request (b) in the following manner, namely, (i) in the official language in which the information is requested or, if specified by the purchaser or consumer, in both official languages, or (ii) in one of the official languages, if, in accordance with subsection B.01.012(3), the information that is required by these Regulations to be shown on the label of the supplemented food may be shown in that language only and is shown on the label in that language; and (c) in the form of a supplemented food facts table that is set out (i) in a format, other than a horizontal format, that is specified in any of sections B.29.009 to B.29.015 and that would otherwise be carried on the label of the supplemented food in accordance with these Regulations, and (ii) in a version of that format that is listed in column 1 of item 1 of any Part of the table to the applicable section referred to in subparagraph (i). B.29.019 If a supplemented food has an available display surface of less than 100 cm² and has a supplemented food facts table on its label, the supplemented food facts table need only include (a) the serving of stated size; (b) the information referred to in column 1 of the table to section B.29.002 or the table to section B.29.003 in respect of the energy value of the supplemented food and the amount of any nutrient or supplemental ingredient that is the subject of a representation on the label of the supplemented food, or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food, if the representation expressly or implicitly indicates that the supplemented food has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004; (c) the amount of any added sugar alcohol; (e) the amount of any supplemental ingredient for which a cautionary statement set out in the list of cautionary statements is applicable. B.29.020 (1) Every applicable cautionary statement set out in column 4 of the List of Permitted Supplemental Ingredients in respect of the supplemental ingredients contained in a supplemented food must be shown (a) in a list on the label of the supplemented food; (b) grouped together and introduced by the title, in bold type, (i) “Caution”, “Caution:” or “Caution:” in the English version, and (c) without any intervening printed, written or graphic material appearing between the title and the first cautionary statement; (e) in lower case letters, except that upper case letters must be used to show the first letter of each cautionary statement; and

(1)

Good Manufacturing Practice Column I

(2)

The list of cautionary statements must be shown in a manner that clearly differentiates it on the label by means of one or both of (a) graphics in the form of a solid-line border around the list or one or more solid lines appearing immediately above, below or at the sides of the list that are the same colour as that of the type used to show the information referred to in subsection B.01.008.1(1); and (b) a background colour that creates a contrast between the background colour of the list and the background colour used on the adjacent surface of the label, other than the surface used to display (ii) a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1),

C

17 Cellulose Gum

(3)

The list of cautionary statements must be shown on the label without any intervening printed, written or graphic material, (a) in English and French, adjacent to each linguistic version of the supplemented food facts table appearing in the same language, if there are separate English and French versions of the table; (b) in English and French, adjacent to a bilingual version of the supplemented food facts table, with one linguistic version of the list following the other linguistic version; or (c) in English or French, adjacent to the supplemented food facts table in the same language, if, in accordance with subsection B.01.012(3), the information required by these Regulations to be shown on the label may be shown in that language only and is shown on the label in that language.

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18 Citric Acid Esters of Mono- and Di-glycerides F.1 Furcelleran G.1 Gelatin Column II

(4)

If the English and French versions of a list of cautionary statements appear on the label, they must be displayed on a continuous surface of the label’s available display surface, but need not be on the same continuous surface of the label’s available display surface.

(2)

Unstandardized foods

(5)

If the English and French versions of a list of cautionary statements appear on the same continuous surface of the label, the version that follows the other version must not begin on the same line as that on which the other version ends, unless the available display surface is less than 100 cm². Supplemented Food Caution Identifier B.29.021 (1) The principal display panel of a supplemented food must carry the supplemented food caution identifier that is set out in Schedule K.2 if a list of cautionary statements is shown on the label of the supplemented food.

(1)

Ale; Beer; Light beer; Malt liquor; Porter; Stout

(2)

The supplemented food caution identifier must be displayed in black and white and be in accordance with the identifier set out in Schedule K.2.

(2)

Unstandardized foods

(3)

Subject to subsection (4), the supplemented food caution identifier must be presented in one of the following formats: (a) the unilingual standard format, where two separate versions of the identifier are shown, one in English (ES) and one in French (FS); or (b) the bilingual standard format (BS), where the identifier is shown in both official languages.

(3)

Calorie-reduced margarine

(4)

If the principal display surface is less than or equal to 450 cm² and the width of each of the versions of the supplemented food caution identifier in the unilingual standard format or the width of the identifier in the bilingual standard format exceeds the width of the principal display panel, the identifier must be presented in the bilingual compact format (BC) in which the identifier is shown in both official languages.

(4)

Canned asparagus; Canned green beans; Canned wax beans; Canned peas

(5)

The supplemented food caution identifier must be displayed in accordance with the applicable specifications set out in the Directory of Supplemented Food Caution Identifier Specifications.

(1)

Brawn; Canned (naming the poultry); Cream; Headcheese; Meat binder or (naming the meat product) Column III Maximum Level of Use

(6)

Despite subsection (5), the supplemented food caution identifier may be displayed with larger dimensions than those set out in column 3 of the applicable table in the Directory of Supplemented Food Caution Identifier Specifications if the identifier is enlarged in a proportional manner vertically and horizontally.

(1)

Good Manufacturing Practice

(7)

If, in accordance with subsection B.01.012(3), the information required by these Regulations may be shown on the label of a supplemented food in English only or in French only and is shown in that language, the supplemented food caution identifier may be displayed on the principal display panel of the supplemented food in that language only on a continuous surface of the available display surface.

(2)

Good Manufacturing Practice

(8)

If the supplemented food caution identifier is presented in a bilingual format, the order in which the languages appear may be reversed from the order shown in the applicable identifier set out in Schedule K.2.

(4)

1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)

(9)

The characters and other elements of the supplemented food caution identifier must not touch each other. (a) in the case of a supplemented food with a principal display panel whose height is less than its width, on the right half of the principal display panel; and (b) in the case of any other supplemented food, on the upper half of the principal display panel.

(1)

Good Manufacturing Practice Column I G.2 Gellan Gum Column II

(2)

The supplemented food caution identifier must be surrounded by a buffer that (a) has a width that is equal to or greater than that set out in column 4 of the applicable table in the Directory of Supplemented Food Caution Identifier Specifications, and (b) does not contain any text or other graphic material.

(1)

Frostings; Unstandardized confectionery

(3)

If a supplemented food is cylindrical in shape, the outer edge of the buffer must be a minimum distance of 10% of the width of the principal display surface from the edge of the left or right side of that surface.

(4)

Unstandardized dairy products

(4)

If it is impossible to comply with both paragraph (1)(a) and subsection (3), the supplemented food caution identifier may be displayed partially in the left half of the principal display panel but only to the extent necessary to comply with that subsection. B.29.023 The supplemented food caution identifier must be oriented in the same manner as most of the other information that appears on the principal display panel unless the panel is displayed in the vertical plane and most of the other information is not displayed parallel with the base of the package, in which case the identifier must be oriented in such a manner that the words appearing in it are parallel with the base. Prohibitions B.29.024 It is prohibited to label a prepackaged product with a supplemented food caution identifier or sell a product that is so labelled, unless a list of cautionary statements is shown on the label. B.29.025 (1) It is prohibited to label a prepackaged product with any representation, including a word, phrase, illustration, sign, mark, symbol or design, that is likely to be mistaken for a supplemented food caution identifier, or sell a prepackaged product that is so labelled.

(5)

Filling mixes; Fillings; French dressing; Pudding mixes; Puddings; Salad dressing; Unstandardized dressings; Unstandardized gelatins

(2)

For the purposes of subsection (1), a representation does not include a nutrition symbol. Representations B.29.026 (1) Despite anything in these Regulations, it is prohibited, on the label of or in any advertisement for a supplemented food, to make a statement or claim to the effect that a supplemental ingredient is a nutrient contained in the supplemented food is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health, if the supplemented ingredient is one for which a cautionary statement set out in the list of cautionary statements is applicable.

(6)

Baking mixes; Unstandardized bakery products

(2)

However, the label of or advertisement for a supplemented food may carry such a statement or claim if it is accompanied by a statement or claim about the specific action or effect of the supplemented ingredient in maintaining the functions of the body necessary to the maintenance of good health.

(7)

Topping mixes; Toppings; Unstandardized sauces; Unstandardized table syrups

(3)

If the label of or any advertisement for the supplemented food carries a statement or claim referred to in subsection (1), that statement or claim and the statement or claim referred to in subsection (2) must, (a) if made on the label of or in an advertisement, other than a radio or television advertisement, for the supplemented food, (i) be adjacent to one another without any intervening printed, written or graphic material, and (ii) be shown in letters of the same size and prominence; (b) if made in a radio advertisement or in the audio portion of a television advertisement for the supplemented food, immediately follow one another; or (c) if made in the visual portion of a television advertisement for the supplemented food, (i) appear concurrently and for the same amount of time, (ii) be adjacent to one another without any intervening printed, written or graphic material, and (iii) be shown in letters of the same size and prominence. B.29.027 Despite anything in these Regulations, if a supplemented food is required to show a cautionary statement that is set out in the list of cautionary statements and recommends against consumption by any individual less than 18 years of age that is part of a group identified in the cautionary statement, it is prohibited, on the label of or in any advertisement for the supplemented food, to make a statement or claim to the effect that a nutrient contained in the supplemented food is generally recognized as an aid in maintaining the functions of the body necessary to normal growth and development. B.29.028 (1) Despite anything in these Regulations, if the label of a supplemented food is required to carry the statement “high caffeine content” in accordance with column 5 of the List of Permitted Supplemental Ingredients, it is prohibited to make a representation, express or implied, on the label of or any advertisement for the supplemented food with respect to any vitamin or mineral nutrient contained in the supplemented food. B.29.029 (1) If a list of cautionary statements is shown on the label of a supplemented food, the representations set out in subsection (2) must meet the following requirements: (i) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the supplemented food caution identifier, other than in the words “Health Canada” and “Santé Canada”, and (ii) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the supplemented food caution identifier, other than in the words “Health Canada” and “Santé Canada”; and (b) if the representation is displayed on any continuous surface, other than on the principal display panel, (i) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the cautionary statements, and (ii) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the cautionary statements.

(8)

Unstandardized beverages

(2)

For the purposes of subsection (1), the representations are the following: (b) any representation that expressly or implicitly indicates that the supplemented food or any substance it contains has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004; and (c) any health-related statement, logo, symbol, seal of approval or mark.

(9)

Snack foods Column III Maximum Level of Use

(3)

This section does not apply to the brand name or product name of a supplemented food. B.29.030 A prepackaged product, other than a supplemented food, is adulterated if it contains a supplemented food as an ingredient. B.29.031 A prepackaged product, other than a supplemented food, is adulterated if a substance listed in column 1 of the List of Permitted Supplemental Ingredients has been added to it other than in accordance with these Regulations. B.29.032 A supplemented food does not have a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act — or is not adulterated for the purposes of paragraph 4(1)(d) of the Act — by reason only that a supplemental ingredient has been added to it. General antibiotic means any drug or combination of drugs such as those named in C.01.410 to C.01.592 which is prepared from certain micro-organisms, or which formerly was prepared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms; (antibiotique) brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French, (a) that is assigned to the drug by its manufacturer, (b) under which the drug is sold or advertised, and (c) that is used to distinguish the drug; (marque nominative) case report means a detailed record of all relevant data associated with the use of a drug in a subject; (fiche d’observation) child resistant package means a package that meets the requirements of subsection (2); (emballage protège-enfants) common name means, with reference to a drug, the name in English or French by which the drug is (a) commonly known, and (b) designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act; (nom usuel) COVID-19 drug means a drug, other than a veterinary health product, that is manufactured, sold or represented for use in relation to COVID-19; (drogue contre la COVID-19) discontinue means, in respect of the sale of a drug by the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug, to permanently cease the sale of the drug; (cesser) expiration date means (a) in the case of a drug in dosage form, the earlier of the following dates, expressed at minimum as a year and month: (i) the date up to and including which the drug maintains its labelled potency, purity and physical characteristics, and (ii) the date after which the manufacturer recommends that the drug not be used; and (b) in the case of an active ingredient, whichever of the following dates is applicable, expressed at minimum as a year and month: immediate container means the receptacle that is in direct contact with a drug; (récipient immédiat) internal use means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane; (usage interne) ISAD Interim Order means the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 made by the Minister on September 16, 2020 and published in Part I of the Canada Gazette on October 3, 2020; (arrêté d’urgence IVPD) List A means the document, entitled List of Certain Antimicrobial Active Pharmaceutical Ingredients, that is published by the Government of Canada on its website, as amended from time to time; (Liste A) List B means the document, entitled List of Certain Veterinary Drugs Which May Be Imported But Not Sold, that is published by the Government of Canada on its website, as amended from time to time; (Liste B) List C means the document, entitled List of Veterinary Health Products, that is published by the Government of Canada on its website, as amended from time to time; (Liste C) List D means the document entitled List of Certain Non-prescription Drugs for Distribution as Samples that is published by the Government of Canada on its website, as amended from time to time; (Liste D) non-medicinal ingredient means a substance — other than the pharmacologically active drug — that is added during the manufacturing process and that is present in the finished drug product; (ingrédient non médicinal) official drug means any drug (a) for which a standard is provided in these Regulations, or (b) for which no standard is provided in these Regulations but for which a standard is provided in any of the publications mentioned in Schedule B to the Act; (drogue officielle) parenteral use means administration of a drug by means of a hypodermic syringe, needle or other instrument through or into the skin or mucous membrane; (usage parentéral) pharmacist means a person who (a) is registered or otherwise entitled under the laws of a province to practise pharmacy, and pharmacy technician means a person who (a) is registered or otherwise entitled under the laws of a province to practise as a pharmacy technician; and practitioner means a person who (a) is entitled under the laws of a province to treat patients with a prescription drug, and (b) is practising their profession in that province; (praticien) prescription means an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order; (ordonnance) proper name means, with reference to a drug, the name in English or French (b) that appears in bold-face type for the drug in these Regulations and where, the drug is dispensed in a form other than that described in this Part, the name of the dispensing form, (c) specified in the Canadian licence in the case of drugs included in Schedule C or Schedule D to the Act, or (d) assigned in any of the publications mentioned in Schedule B to the Act in the case of drugs not included in paragraph (a), (b) or (c); (nom propre) salicylate product has the same meaning as in Division 9; (produit de salicylate) serious adverse drug reaction means a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death; (réaction indésirable grave à une drogue) veterinary health product means any of the following drugs that is in dosage form and that is not manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms: (a) a substance set out in Column I of Part 1 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of substances in which all the medicinal ingredients are substances set out in Column I of Part 1 of that list if that combination is, in respect of each of those substances, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those substances; (b) a homeopathic medicine set out in Column I of Part 2 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of homeopathic medicines set out in Column I of Part 2 of that list if that combination is, in respect of each of those homeopathic medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those homeopathic medicines; and (c) a traditional medicine set out in Column I of Part 3 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of traditional medicines set out in Column I of Part 3 of that list if that combination is, in respect of each of those traditional medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those traditional medicines. of that list if that combination is, in respect of each of those traditional medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those traditional medicines; (produit de santé animale) withdrawal period means the length of time between the last administration of a drug to an animal and the time when tissues or products collected from the treated animal for consumption as food contain a level of residue of the drug that would not likely cause risk to human health. (délai d’attente) (1.1) For the purposes of the Act, serious adverse drug reaction has the same meaning as in subsection (1).

(1)

0.5%

(2)

A child resistant package is a package that (a) when tested in accordance with an acceptable method, (i) in the case of a test group comprising children, cannot be opened (A) by at least 85 per cent of those children prior to a demonstration to them of the proper means of opening the package, and (B) by at least 80 per cent of those children after the demonstration, and (ii) in the case of a test group comprising adults (A) can be opened by at least 90 per cent of those adults, and (B) where the package is designed so that, once opened and reclosed, it continues to meet the requirements of subparagraph (i), can be so reclosed by at least 90 per cent of those adults; or (b) complies with the requirements of one of the following standards, namely, (i) Canadian Standards Association Standard CAN/CSA-Z76.1-M90, entitled Reclosable Child-Resistant Packages, published January 1990, as amended from time to time, (ii) European Standard EN 28317:1992, entitled Child-resistant packaging — Requirements and testing procedures for reclosable packages, as adopted by the European Committee for Standardization on October 30, 1992, recognized by the British Standards Institution, and effective February 15, 1993 and by the Association française de normalisation, and effective December 20, 1992, and which reiterates fully the international standard ISO 8317:1989, as amended from time to time, and (iii) Code of Federal Regulations (United States), Title 16, Section 1700.15, entitled Poison prevention packaging standards, as amended from time to time.

(2)

0.3%

(3)

For the purposes of this section, test group means (a) in relation to children, a group of at least 200 children who (i) are healthy and have no obvious physical or mental disability, (ii) are between 42 and 51 months of age, and (iii) represent evenly, within plus or minus 10 per cent, each monthly age between 42 and 51 months calculated to the nearest month; and (b) in relation to adults, a group of at least 100 adults who (i) are healthy and have no obvious physical or mental disability, (ii) are between 18 and 45 years of age, and (iii) represent evenly, within plus or minus 10 per cent, each yearly age between 18 and 45 years calculated to the nearest year.

(3)

0.25%

(4)

For the purpose of this section, an amendment from time to time to a standard referred to in paragraph (2)(b) becomes effective 18 months after the date designated by the competent authority as the effective date for the amendment. C.01.002 The Proper Name of a drug shown opposite an item number in the following Table in the column headed “Chemical Names and Synonyms” shall be the name shown opposite that item number in the column headed “Proper Names”. Item No. | Proper Names | Chemical Names and Synonyms A.9 | Aminopyrine: Amidopyrine | 1,5-dimethyl-2-phenyl-4-dimethylamino-3-pyrazolone: Dimethylaminophenazone B.4 | Betahistine | 2-[2-(Methylamino)ethyl] pyridine C.5 | Cephaloridine | 7-[2-Thienyl] acetaminocarbonyl-3-[1-pyridylmethyl]-3-cephem-4-carboxylic acid betaine Item No. Proper Names Chemical Names and Synonyms E.8 Ethyl Trichloramate Ethyl n-[1-(2,2,2, trichloro-1-hydroxyethyl)] carbamate Item No. Proper Names Chemical Names and Synonyms M.3 Mepazine ................................................................. 10-[1-methyl-3-piperidyl] methyl phenothiazine M.5 Mephenoxalone ....................................................... 5-(o-Methoxyphenoxymethyl)-2-oxazolidinone O.1 Oxanilide ................................................................. 2-ethyl-3-propyl-glycidamide Item No. Proper Names .................................................... Chemical Names and Synonyms P.11 Phendimetrazine .................................................... 3,4-Dimethyl-2 Phenylmorpholine P.14 Pheniprazine ......................................................... α-Methylphenethylhydrazine P.15 Phendimetrazine .................................................... Tetrahydro-3-methyl-2-phenyl-1,4-oxazine: 3-methyl-2-phenylmorpholine P.18 Phenyltoloxamine .................................................. N,N-dimethyl-2-[α-phenyl-o-tolyloxy] ethylamine R.1 Rifampin ................................................................. 3-({[4-methyl-1-piperazinyl]imino]methyl} rifamycin SV: Rifampicin (I.N.N.) (Rifamycin SV is an antibiotic produced by Streptomyces mediterraneae) Item No. Proper Names ................................................. Chemical Names and Synonyms T.5 Thioridazine ....................................................... 10-[2-(1-methylpiperidyl)] ethyl α-2-methylthiopheno-thiazine T.9 Trimeprazine .................................................... 10-(3-dimethylamino-2-methylpropyl) phenothiazine V.1 Vinblastine ....................................................... An alkaloid derived from Vinca rosea V.2 Vincristine ......................................................... An alkaloid derived from Vinca rosea C.01.003 No person shall sell a drug that is not labelled as required by these Regulations. (i) the proper name, if any, of the drug which, if there is a brand name for the drug, shall immediately precede or follow the brand name in type not less than one-half of the size of that of the brand name, (ii) if there is no proper name, the common name of the drug, (iii) where a standard for the drug is prescribed in Division 6 of this Part, a statement that the drug is a Canadian Standard Drug, for which the abbreviation C.S.D. may be used, (iv) where a standard for the drug is not prescribed in Division 6 of this Part but is contained in a publication mentioned in Schedule B to the Act, the name of the publication containing the standard used or its abbreviation as provided in Schedule B or, if a manufacturer's standard is used, a statement setting forth the fact that such a standard is used, and (v) in both official languages, the notation “sterile” “stérile” if the drug is required to be sterile by these Regulations; (i) the symbol “Pr” in the case of a prescription drug, but the symbol “Pr” shall not appear on the label of any other drug, (ii) the symbol “C” in a clear manner and a conspicuous colour and size, in the case of a controlled drug, other than a controlled drug contained in an agricultural implant and set out in Part III of the schedule to Part G, (iii) the symbol “N” in a colour contrasting with the rest of the label or in type not less than half the size of any letters used thereon, in the case of a narcotic as defined in the Narcotic Control Regulations, and (iv) in the case of a targeted substance as defined in section 1 of the Benzodiazepines and Other Targeted Substances Regulations, the following symbol in a colour contrasting with the rest of the label and in type not less than half the size of any other letter used on the main panel, namely, (c) on any panel (i) the name and address of the manufacturer of the drug, (ii) the lot number of the drug, (iii) adequate directions for use of the drug, except in the case of a drug to which section C.01.004.02 applies, (iv) a quantitative list of the medicinal ingredients of the drug by their proper names or, if they have no proper names, by their common names, except in the case of a drug to which section C.01.004.02 applies, (v) the expiration date of the drug, and (vi) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:

(4)

0.15%

(2)

In addition to the requirements of subsection (1), the outer label of a drug shall display the following information: (a) the net amount of the drug in the container in terms of weight, measure or number; (b) in the case of a drug intended for parenteral use, a quantitative list of any preservatives present therein by their proper names or, if they have no proper names, by their common names; and (c) in the case of a drug for human use that contains mercury or a salt or derivative thereof as a preservative, a quantitative list of all mercurial preservatives present therein by their proper names or, if they have no proper names, by their common names.

(5)

0.5%

(3)

Where the container of a drug is too small to accommodate an inner label that conforms to the requirements of these Regulations, the inner label requirements of these Regulations do not apply to the drug in that container if (a) there is an outer label that complies with the labeling requirements of these Regulations; and HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS. » (i) the proper name of the drug, the common name of the drug if there is no proper name or, in the case of a drug with more than one medicinal ingredient, the brand name of the drug, (ii) the potency of the drug except where, in the case of a drug with more than one medicinal ingredient, the name used pursuant to subparagraph (i) for that drug is unique for a particular potency of the drug, (iii) the net contents of the drug if it is not in a discrete dosage form, (iv) the route of administration of the drug if other than oral, (v) the lot number of the drug, (viii) the identification of special characteristics of the dosage form if they are not evident from the name of the drug under subparagraphs (i) or (ii).

(6)

0.1% of the dry mix

(5)

This section does not apply to (b) a drug dispensed pursuant to a prescription, if its label carries adequate directions for use and complies with the requirements of section C.01.005. (a) a telephone number, email address, website address, postal address or any other information that enables communication with a contact person in Canada; and (b) a statement to the effect that any injury to a person’s health that is suspected of being associated with the use of the drug may be reported to the contact person. (a) the labels of a drug that is listed in Schedule C or D to the Act and that is in dosage form; or (b) the inner and outer labels of a drug to which section C.01.004.02 applies. C.01.004.02 (1) In addition to the requirements of section C.01.004, the outer label of a drug for human use in dosage form shall display, either one bilingual table, placed on any panel, that contains only the following information in both English and French or one table in English and one table in French, each of which is placed on any panel, that contains only the following information: (b) a quantitative list of the drug’s medicinal ingredients by their proper names or, if they have no proper names, by their common names; (c) the drug’s non-medicinal ingredients listed in alphabetical order or in descending order of predominance by their proportion in the drug, preceded by words that clearly distinguish them from the medicinal ingredients; and

(7)

0.05%

(2)

If a package is too small to accommodate an outer label that displays one bilingual table that lists all of the drug’s non-medicinal ingredients or two unilingual tables, each of which lists all of the drug’s non-medicinal ingredients, the list of non-medicinal ingredients shall be displayed in both English and French on a tag, tape or card that is attached to the package.

(8)

0.08%

(3)

If pharmaceutical ink, a fragrance or a flavour has been added to the drug, the following expressions may be included in the list of non-medicinal ingredients to indicate that those ingredients have been added to the drug, instead of listing them individually: (b) in the case where two unilingual tables referred to in subsection (1) are displayed, the expressions (ii) “flavour”, “fragrance” and “pharmaceutical ink” in the table in English.

(9)

0.1% Column I G.3 Guar Gum Column II

(4)

If the composition of the drug varies from one lot to another with respect to its non-medicinal ingredients, (a) in the case where a bilingual table referred to in subsection (1) is displayed, the table shall include a reference to all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/-” or “±” or the expression “or/ou” or “may contain/peut contenir”; or (b) in the case where two unilingual tables referred to in subsection (1) are displayed, (i) the table in French shall list all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/-” or “±” or the expression “ou” or “peut contenir”, and (ii) the table in English shall list all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/-” or “±” or the expression “or” or “may contain”.

(3)

Infant formula

(5)

For the purposes of paragraphs (3)(a) and (4)(a), the French terms in the expressions may appear first. (b) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner; and (c) drugs that are represented as being solely for use as a disinfectant on hard non-porous surfaces. (b) a quantitative list of the drug’s medicinal ingredients by their proper names or, if they have no proper names, by their common names; and C.01.004.1 (1) No person shall import a drug in dosage form into Canada for the purpose of sale unless they have in Canada a person who is responsible for the sale of the drug.

(4)

Sherbet

(2)

No person who imports a drug in dosage form into Canada shall sell any lot or batch of the drug unless the name of the person who imports it, and the address of the principal place of business in Canada of the person responsible for its sale, appears on the inner and outer labels of the drug. C.01.005 (1) The principal display panel of both the inner label and outer label of a drug in dosage form shall show the drug identification number assigned for that drug, preceded by the expression “Drug Identification Number” or “Drug Identification numérique”, or both, or the abbreviation “DIN”. (a) a drug in dosage form that is compounded by a pharmacist under a prescription or by a practitioner; or (b) a drug in dosage form that is sold under a prescription if the following information appears on the drug’s label: (i) the drug’s proper name, common name or brand name, (ii) the drug’s potency, and

(5)

Unstandardized foods

(3)

In this section and in sections C.01.005.1 and C.01.014, drug in dosage form means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing. C.01.005.1 (1) No pharmacist or practitioner shall sell a Class A opioid — including one that is compounded by a pharmacist under a prescription or by a practitioner — unless (a) the drug’s package has applied to it a warning sticker that meets the specifications set out in the source document; and (b) the drug is accompanied by a patient information handout that meets the specifications set out in the source document.

(6)

Calorie-reduced margarine

(2)

Subsection (1) does not apply in respect of the sale of a Class A opioid by a pharmacist or practitioner if (b) the sale is to a pharmacist or practitioner.

(7)

Sour cream

(3)

The following definitions apply in this section. Class A opioid means a drug in dosage form set out in Part A of the List of Opioids, published by the Government of Canada on its website, as amended from time to time. (opioïde de catégorie A) source document means the document entitled *Information for Patients Concerning Opioids*, published by the Government of Canada on its website, as amended from time to time. (document source) C.01.006 Where a package of a drug has only one label, that label shall contain all the information required by these Regulations to be shown on both the inner and the outer labels. C.01.007 No reference, direct or indirect, to the Act or to these Regulations shall be made upon any label of or in any advertisement for a drug unless such reference is a specific requirement of the Act or these Regulations. C.01.009 If any Act of Parliament or any of its regulations prescribes a standard or grade for a drug and that standard or grade is given a name or designation in the Act or regulation, no person shall, on a label of or in any advertisement for that drug, use that name or designation unless the drug conforms with the standard or grade. C.01.010 If it is necessary to provide adequate directions for the safe use of a parenteral drug or prescription drug that is used in the treatment or prevention of any disease, disorder or abnormal physical state mentioned in Schedule A.1 to the Act, the disease, disorder or abnormal physical state may be mentioned on the drug’s labels, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug, and, in that respect, the drug is exempt from subsections 3(1) and (2) of the Act. C.01.011 (1) A drug referred to in subsection 10(2) of the Act shall be exempt from the standard for any drug contained in any publication mentioned in Schedule B to the Act to the extent that such drug differs from that standard with respect to colour, flavour, shape and size, if such difference does not interfere with any method of assay prescribed in any such publication.

(8)

Canned asparagus; Canned green beans; Canned waxed beans; Canned peas Column III Maximum Level of Use

(3)

Where a manufacturer’s standard is used for a drug, the manufacturer shall make available to the Minister, on request, details of that standard and of a method of analysis for the drug acceptable to the Minister.

(1)

Good Manufacturing Practice

(4)

No person shall use a manufacturer’s standard for a drug that provides (a) a lesser degree of purity than the highest degree of purity, or (b) a greater variation in potency than the least variation in potency, provided for that drug in any publication mentioned in Schedule B to the Act. C.01.012 A manufacturer who makes representations on a label of a drug in oral dosage form, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of the drug, or the availability to the body of a medicinal ingredient of the drug, shall (a) before making the representations, conduct such investigations, using an acceptable method, as may be necessary to demonstrate that the site, rate or extent of release to the body of the medicinal ingredient of the drug and the availability to the body of the medicinal ingredient of the drug, correspond to the representations; and (b) on request submit the record of such investigations to the Minister. C.01.013 (1) Where the manufacturer of a drug is requested in writing by the Minister to submit on or before a specified day evidence with respect to a drug, the manufacturer shall make no further sales of that drug after that day unless he has submitted the evidence requested.

(2)

0.5%

(2)

If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing.

(4)

0.75%

(3)

Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to a drug is not sufficient, he shall make no further sales of that drug unless he submits further evidence and is notified in writing by the Minister that that further evidence is sufficient.

(5)

Good Manufacturing Practice

(4)

A reference in this section to evidence with respect to a drug means evidence to establish the safety of the drug under the conditions of use recommended and the effectiveness of the drug for the purposes recommended. C.01.013.1 Section C.01.013 does not apply in respect of a veterinary health product. Assignment and Cancellation of Drug Identification Numbers C.01.014 (1) No manufacturer shall sell a drug in dosage form unless a drug identification number has been assigned for that drug and the assignment of the number has not been cancelled under section C.01.014.6.

(7)

0.5% in accordance with the requirements of clause B.08.077(b)(viii)(A)

(2)

Subsection (1) does not apply in respect of a veterinary health product, a study drug as defined in section C.03.301 or a medicated feed as defined in subsection 1(1) of the Feeds Regulations, 2024. C.01.014.1 (1) A manufacturer of a drug may make an application for a drug identification number for that drug.

(8)

1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)

(2)

An application under subsection (1) shall be made to the Minister in writing and shall include the following information and material: (a) the name of the manufacturer of the drug as it will appear on the label; (b) the pharmaceutical form in which the drug is to be sold; (c) in the case of any drug other than a drug described in paragraph (d), the recommended route of administration; (d) in the case of a drug for disinfection in premises, the types of premises for which its use is recommended; (e) a quantitative list of the medicinal ingredients contained in the drug by their proper names or, if they have no proper names, by their common names; (f) the brand name under which the drug is to be sold; (g) an indication of whether the drug is for human use or veterinary use; (i) the use or purpose for which the drug is recommended; (k) the address of the manufacturer referred to in paragraph (a) and, where the address is outside the country, the name and address of the importer of the drug; (l) the name and address of any individual, firm, partnership or corporation, other than the names and addresses referred to in paragraphs (a) and (k), that will appear on the label of the drug; (m) in the case of a drug for veterinary use, the written text of every label to be used in connection with the drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug; (m.1) in the case of a drug for human use, mock-ups of every label to be used in connection with the drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug — and mock-ups of the drug’s packages; (n) the name and title of the person who signed the application and the date of signature; and (o) in the case of a drug for human use, an assessment as to whether there is a likelihood that the drug will be mistaken for another drug for which a drug identification number has been assigned due to a resemblance between the brand name that is proposed to be used in respect of the drug and the brand name, common name or proper name of the other drug.

(9)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8 G.4 Gum Arabic Column II Column III Maximum Level of Use Column II

(3)

In the case of a new drug, a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission filed under section C.08.002, C.08.002.01 or C.08.002.1 shall be regarded as an application for a drug identification number. C.01.014.2 (1) Subject to subsection (2), if a manufacturer has provided all the information and material described in subsection C.01.014.1(2) or section C.08.002, C.08.002.01 or C.08.002.1, as the case may be, in respect of a drug, the Minister shall issue to the manufacturer a document that (i) the drug identification number assigned for the drug, preceded by the abbreviation “DIN”, or (ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Minister for the drug, each of which pertains to one of the brand names and is preceded by the abbreviation “DIN”; and (b) contains the information referred to in paragraphs C.01.014.1(2)(a) to (f).

(1)

Chocolate products; Cocoa products

(2)

The Minister may refuse to issue the document referred to in subsection (1) if he or she has reasonable grounds to believe that the product in respect of which an application referred to in section C.01.014.1 has been made (a) is not a drug, or (b) is a drug but its sale would cause injury to the health of the purchaser or consumer or would be a contravention of the Act or these Regulations.

(2)

Unstandardized foods Column III Maximum Level of Use

(3)

If the Minister refuses to issue the document under subsection (2), the manufacturer may submit additional document that (i) the drug identification number assigned for the drug, preceded by the abbreviation “DIN”, or (ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Minister for the drug, each of which pertains to one of the brand names and is preceded by the abbreviation “DIN”; and (b) contains the information referred to in paragraphs C.01.014.1(2)(a) to (f).

(1)

1.0%

(2)

The Minister may refuse to issue the document referred to in subsection (1) if he or she has reasonable grounds to believe that the product in respect of which an application referred to in section C.01.014.1 has been made (a) is not a drug, or (b) is a drug but its sale would cause injury to the health of the purchaser or consumer or would be a contravention of the Act or these Regulations.

(2)

Good Manufacturing Practice H.1A Hydroxypropyl Cellulose Column II Unstandardized foods Column III Maximum Level of Use Good Manufacturing Practice H.2 Hydroxypropyl Methylcellulose Column II Column III Maximum Level of Use

(3)

If the Minister refuses to issue the document under subsection (2), the manufacturer may submit additional information or material and request the Minister to reconsider his or her decision.

(1)

Good Manufacturing Practice Column I Column II Column III Maximum Level of Use

(4)

On the basis of the additional information or material submitted under subsection (3), the Minister shall reconsider the grounds on which the refusal to issue the document was made. C.01.014.21 (1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a Class B opioid or amend those terms and conditions. (1.1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a designated COVID-19 drug, or amend those terms and conditions, if (a) a notice of compliance was issued under section C.08.004 in respect of (i) a new drug submission that was filed under section C.08.002 for the designated COVID-19 drug that contains the statement referred to in paragraph C.08.002.1(2)(a), or (ii) a supplement to a new drug submission referred to in subparagraph (i) that was filed under section C.08.003 for the designated COVID-19 drug; (b) a notice of compliance was issued under section C.08.004 in respect of one of the following that was filed for the designated COVID-19 drug on the basis of a direct or indirect comparison to another designated COVID-19 drug referred to in paragraph (a):

I

1 | Irish Moss Gelose

(2)

The Minister shall notify, in writing, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number of any terms and conditions imposed on the drug identification number and of any amendment to those terms and conditions.

(2)

Unstandardized foods Same levels as prescribed for Carrageenan

(3)

The following definitions apply in this section. Class B opioid means a drug set out in Part B of the List of Opioids, published by the Government of Canada on its website, as amended from time to time. (opiode de catégorie B) C.01.014.3 The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, within 30 days after the day on which the drug is first sold following the issuance by the Minister of the document, date and sign the document and return it to the Minister with a statement set out on it that the information it contains is correct and with an indication of the date that first sale. C.01.014.4 If the information referred to in subsection C.01.014.1(2) in respect of a drug is no longer correct owing to a change in the subject matter of the information, (i) that occurs prior to the sale of the drug, a new application shall be made, or (ii) that occurs after the sale of the drug, no further sale of the drug shall be made until a new application for a drug identification number in respect of that drug is made and a number is assigned; and (i) that occurs prior to the sale of the drug, the particulars of the change shall be submitted with the return of the document referred to in section C.01.014.3, or (ii) that occurs after the sale of the drug, the person to whom the drug identification number in respect of that drug was issued shall, within 30 days of the change, inform the Minister of the change. C.01.014.5 (1) The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, annually before the first day of October and in a form established by the Minister, provide the Minister with a notification that is signed by them and that (a) indicates whether any of the following circumstances apply in respect of the drug: (i) as of the day on which the notification is sent, (A) the manufacturer sells the drug in Canada, or (B) the manufacturer has discontinued the sale of the drug in Canada, or (ii) the manufacturer has not sold the drug in Canada for a period that is greater than 12 months and a portion of that period is covered by the notification; and (b) subject to subsection (2), confirms that the information that the manufacturer previously submitted with respect to the drug under subsection C.01.014.1(2), paragraph C.01.014.4(b) or section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, is correct as of the day on which the notification is sent.

(2)

Good Manufacturing Practice K.1 | Karaya Gum

(2)

If any of the information that the manufacturer submitted under a provision referred to in paragraph (1)(b) is not correct as of the day on which the notification is sent, the manufacturer must update that information in the notification. C.01.014.6 (1) The Minister shall cancel the assignment of a drug identification number for a drug if (a) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number advises under section C.01.014.7 that they discontinued the sale of the drug; or (b) the Minister determines that the product for which the drug identification number has been assigned is not a drug.

(3)

Sherbet

(2)

The Minister may cancel the assignment of a drug identification number for a drug if (a) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number contravenes section C.01.014.5; (b) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number has been notified under section C.01.013 that the evidence that they submitted with respect to the drug is not sufficient; or (c) the drug is a new drug in respect of which the notice of compliance has been suspended under section C.08.006.

(4)

Unstandardized foods

(3)

The Minister may cancel the assignment of a drug identification number for a drug if, after he or she has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(a)(i) or (iii) to conduct an assessment of the drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health, (a) the holder fails to comply with the order; or (b) the holder complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the drug outweigh the risks of injury to health. (a) under paragraph (2)(b) is not affected by his or her power to cancel the assignment of such a number under subsection (3); and (b) under subsection (3) is not affected by his or her power to cancel the assignment of such a number under paragraph (2)(b). Shortages of Drugs and Interruption and Discontinuation of Sale of Drugs C.01.014.7 The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, within 30 days after the day on which they discontinue the sale of the drug, submit the following information to the Minister: (a) the drug identification number assigned for the drug; (b) the date on which they discontinued the sale of the drug; (b) the date on which the manufacturer discontinued the sale of the drug; and (c) the latest expiration date of the drug that the manufacturer sold and the lot number of that drug. C.01.014.71 If a period of 12 months has elapsed since the day on which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug as defined in section C.01.014.8 last sold the drug, the manufacturer shall notify the Minister in writing within 30 days after the day on which that period ends. C.01.014.72 If the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug resumes the sale of the drug after a period of 12 months has elapsed since the day on which they last sold the drug, the manufacturer shall so notify the Minister in writing within 30 days after the day on which they resume the sale of the drug. C.01.014.8 The following definitions apply in this section and in sections C.01.014.9 to C.01.014.14. drug means any of the following drugs for human use for which a drug identification number has been assigned: (a) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act; (c) drugs that are listed in Schedule C or D to the Act; and (d) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner. (drogue) shortage, in respect of a drug, means a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug in Canada. (pénurie) C.01.014.9 (1) If a shortage of a drug exists or is likely to occur, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug shall post the following information in English and French on a website that is operated by a party for that purpose with whom Her Majesty in right of Canada has entered into a contract to make that information available to the public: (a) the manufacturer’s name and their telephone number, email address, website address, postal address or any other information that enables communication with them; (b) the drug identification number assigned for the drug; (c) the drug’s brand name and proper name or, if it does not have a proper name, its common name; (d) the proper names of the drug’s medicinal ingredients or, if they do not have proper names, their common names; (e) the drug’s therapeutic classification according to the Anatomical Therapeutic Chemical classification system (ATC), established by the World Health Organization Collaborating Centre for Drug Statistics Methodology — namely the level 3 description of, and level 4 code for, the drug; (h) the quantity of the drug contained in its package; (j) the date when the shortage began or is anticipated to begin; (k) the anticipated date when the manufacturer will be able to meet the demand for the drug, if they can anticipate that date; and (a) if they anticipate that a shortage will begin in more than six months, at least six months before the day on which they anticipate it to begin; (b) if they anticipate that a shortage will begin in six months or less, within five days after the day on which they anticipate it; or (c) if they did not anticipate the shortage, within five days after the day on which they become aware of it.

(5)

Calorie-reduced margarine

(3)

If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change.

(1)

Good Manufacturing Practice

(4)

Within two days after the day on which the manufacturer is able to meet the demand for the drug, they shall post information on the website to that effect.

(2)

0.5%

(5)

This section does not apply in respect of a shortage of a drug that results from a decision by the manufacturer to discontinue its sale. C.01.014.10 (1) If the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug decides to discontinue the sale of the drug, they shall post the following information in English and French on the website referred to in subsection C.01.014.9(1): (a) the manufacturer’s name and their telephone number, email address, website address, postal address or any other information that enables communication with them; (b) the drug identification number assigned for the drug; (c) the drug’s brand name and proper name or, if it does not have a proper name, its common name; (d) the proper names of the drug’s medicinal ingredients or, if they do not have proper names, their common names; (e) the drug’s therapeutic classification according to the Anatomical Therapeutic Chemical classification system (ATC), established by the World Health Organization Collaborating Centre for Drug Statistics Methodology — namely the level 3 description of, and level 4 code for, the drug; (h) the quantity of the drug contained in its package; (j) the date on which the manufacturer will discontinue the sale of the drug; and (a) if they decide to discontinue the sale of the drug in more than six months, at least six months before the day on which they will discontinue its sale; and (b) if they decide to discontinue the sale of the drug in six months or less, within five days after the day on which that decision is made.

(3)

0.75%

(3)

If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change. C.01.014.11 The Minister shall ensure that a hyperlink to the website referred to in subsection C.01.014.9(1) is on the Government of Canada website. C.01.014.12 (1) The Minister may request that the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug — or any person who holds an establishment licence in respect of a drug — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that (a) there is a shortage or risk of shortage of the drug; (b) the information is necessary to establish or assess (i) the existence of a shortage or risk of shortage of the drug, (ii) the reason for a shortage or risk of shortage of the drug, (iii) the effects or potential effects on human health of a shortage of the drug, or (iv) measures that could be taken to prevent or alleviate a shortage of the drug; and (c) the manufacturer or licensee will not provide the information without a legal obligation to do so. C.01.014.13 No person who holds an establishment licence shall distribute a drug for consumption or use outside Canada unless the licensee has reasonable grounds C.01.014.14 (1) If a person who holds an establishment licence distributes a drug for consumption or use outside Canada, the licensee shall immediately create a detailed record of the information that they relied on to determine that the distribution of the drug is not prohibited by section C.01.014.13.

(4)

Good Manufacturing Practice

(2)

The licensee shall retain the record for at least one year after the latest expiration date of the drug that they distributed. C.01.015 (1) Subject to subsection (2), no person shall sell for human use a drug in the form of a tablet that is intended to be swallowed whole unless, when tested by the official method DO-25, Determination of the Disintegration Time of Tablets, dated July 5, 1989, (a) in the case of an uncoated tablet, the tablet disintegrates in not more than 45 minutes; (b) in the case of a plain coated tablet, the tablet disintegrates in not more than 60 minutes; and (c) in the case where the label of the drug indicates that the tablet carries an enteric coating or a coating designed to serve a purpose similar to that of an enteric coating, the tablet does not disintegrate when exposed for 60 minutes to simulated gastric fluid, but when it is subsequently exposed for a continuous period to simulated intestinal fluid, the tablet disintegrates in not more than 60 minutes.

(1)

Shortening

(2)

Subsection (1) does not apply in respect of a drug in the form of a tablet where (a) a notice of compliance in respect of the drug in the form of a tablet has been issued under section C.08.004 or C.08.004.01; (c) a dissolution or disintegration test for the drug in the form of a tablet is prescribed in Division 6 of this Part; (d) the drug is labelled as complying with a standard contained in a publication referred to in Schedule B to the Act; (e) the drug has been demonstrated by an acceptable method to be available to the body; or (f) representations regarding the drug are made on its label, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of that drug, or the availability to the body of a medicinal ingredient of that drug. Prohibition C.01.016 No manufacturer shall sell a drug unless the manufacturer complies with the conditions set out in sections C.01.017 to C.01.019. Serious Adverse Drug Reaction Reporting — Manufacturers C.01.017 The manufacturer shall submit to the Minister a report of all information relating to the following serious adverse drug reactions within 15 days after receiving or becoming aware of the information, whichever occurs first: (a) any serious adverse drug reaction that has occurred in Canada with respect to the drug; and (b) any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug. Annual Summary Report and Case Reports C.01.018 (1) The manufacturer shall prepare an annual summary report of all information relating to adverse drug reactions and serious adverse drug reactions to the drug that it received or became aware of during the previous 12 months.

(2)

Unstandardized foods

(2)

The annual summary report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug.

(2)

0.8% of the fat content

(3)

In preparing the annual summary report, the manufacturer shall determine, on the basis of the analysis referred to in subsection (2), whether there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report and shall include its conclusions in this regard in the summary report.

L

1A | Lactylate Esters of Fatty Acids Unstandardized foods Good Manufacturing Practice

(4)

If, in preparing the annual summary report, the manufacturer concludes that there has been a significant change, it shall notify the Minister without delay, in writing, unless this has already been done.

L

2 | Lecithin

(5)

The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister one or both of the following: (b) the case reports relating to the adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer.

(3)

Infant formula

(6)

The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the annual summary reports or the case reports, or both, that is reasonable in the circumstances, and the manufacturer shall submit the reports within that period. C.01.018.1 Section C.01.018 does not apply in respect of a veterinary health product. Issue-Related Summary Report C.01.019 (1) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister an issue-related summary report.

(4)

Sherbet

(2)

The report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug, as well as case reports of all or specified adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer in respect of the issue that the Minister directs the manufacturer to analyze in the report. C.01.019.1 Section C.01.019 does not apply in respect of a veterinary health product.

(5)

Unstandardized foods

(2)

The manufacturer shall retain the records for 25 years after the day on which they were created. C.01.020.1 (1) For the purposes of section 21.8 of the Act, hospitals are the prescribed health care institutions that shall provide information that is in their control to the Minister about a serious adverse drug reaction.

(6)

Margarine

(2)

The following prescribed information about a serious adverse drug reaction that is in a hospital’s control shall be provided to the Minister in writing within 30 days after the day on which the serious adverse drug reaction is first documented within the hospital: (a) the name of the hospital and the contact information of a representative of that hospital; (b) the drug’s brand name, proper name or common name; (c) in the case of a drug imported under subsection C.10.001(2) or section C.10.006, the identifying code or number of the drug, if any, assigned in the country in which the drug was authorized for sale; (c.1) in the case of a drug whose sale has been authorized under subsection C.11.003(1), its identifying name, code, number or mark; (g) the date on which the serious adverse drug reaction was first documented; (h) the date on which the patient first used the drug and, if applicable, the date on which the patient stopped using the drug; (i) the date on which the serious adverse drug reaction first occurred and, if applicable, the date on which the patient’s health was restored to its state prior to the reaction; (j) any medical condition of the patient that directly relates to the serious adverse drug reaction; (k) any concomitant therapeutic products used by the patient; and (l) the effect of the serious adverse drug reaction on the patient’s health.

(7)

Calorie-reduced margarine

(3)

A hospital is exempt from section 21.8 of the Act in respect of the reporting of information referred to in subsection (2) if (a) the hospital does not have in its control all of the information referred to in paragraphs (2)(b), (c), (e) and (f) in respect of the serious adverse drug reaction; or (b) the serious adverse drug reaction relates only to any of the following drugs: (i) a vaccine that was administered under a routine immunization program of a province, (ii) a drug that is authorized for sale under Division 5 of this Part, or (iii) a drug that was sold under subsection C.08.011(1).

(9)

Milk powder

(4)

In this section, hospital means a facility (a) that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or C.01.021 Except as provided in these Regulations, no person shall sell a drug for human use listed in the following table unless both the inner and the outer labels other than the inner label of a single dose container carry a statement of (b) the recommended single and daily adult dose designated as such, except for (i) preparations solely for external use, or (c) adequate directions for use when the drug is recommended for children which shall be either (i) the statement “CHILDREN: As directed by the physician”, or (ii) a suitable reduced maximum single and daily dose which shall not exceed the following: Age in years

(1)

Good Manufacturing Practice

5 - 9 one-fourth

(4)

0.75%

2 - 4 one-sixth

under 2 years as directed by physician | Item | External Use | Internal Use | | | Maximum Limit | Maximum Dosage Unless otherwise stated, doses are in milligrams | Food and Drug Regulations External Use | Internal Use Maximum Dosage Unless otherwise stated, doses are in milligrams Aconitine, its preparations and derivatives | 0.2 | 0.1 | 0.1 Amylocaine, its salts and derivatives when sold or recommended for ophthalmic use | 0.0 | 0.0 | 0.0 Antimony, compounds of | — | 3.3 | 13 Atropine, Methyltropine, and their salts | 1.0 | 0.13 | 0.44 Belladonna and its preparations, on the basis of belladonna alkaloids | 0.375 | 0.13 | 0.44 Butacaine, its salts and derivatives when sold or recommended for ophthalmic use | 0.0 | 0.0 | 0.0 Cantharides, cantharidin, and their preparations, on the basis of cantharidin, except blisters | 0.03 | 0.0 | 0.0 Chlorbutol (not more often than every 4 hours) | — | 325 | 975 Colchicine and its salts | — | 0.55 | 1.65 Colchicum and its preparations, on the basis of colchicine | — | 0.27 | 0.81 Cyproheptadine and its salts — when sold or recommended for the promotion of weight gain | — | 0.0 | 0.0 Ephedrine and its salts | — | 11 | 32.5 Ephedrine and its salts, sprays | 1.0 | — | — Epinephrine and its salts, sprays | 1.0 | — | — Gelsemine (Gelsemine) and its salts (not to be repeated within 4 hours) | — | 0.55 | 1.65 Gelsemium and its preparations, on the basis of the crude drug | — | 16.2 | 48.6 Hydrocyanic (Prussic) Acid as 2 per cent solution | — | 0.062 ml | 0.31 ml Hyoscine (Scopolamine) and its salts | 0.5 | 0.325 | 0.975 Hyoscyamine and its salts | — | 0.325 | 0.975 Hyoscyamus and its preparations, on the basis of hyoscyamus alkaloids | — | 0.073 | 0.22 Lobelia and its preparations, on the basis of the crude drug | — | 130 | 390 Current to November 11, 2024 Last amended on June 17, 2024 Food and Drug Regulations External Use | Internal Use Item | Maximum Dosage Unless otherwise stated, doses are in milligrams Lobeline and its salts ................................................................. — | 2.0 | 6.0 Phenazone and compounds thereof ......................................... — | 325 | 975 Phenylpropanolamine when sold or recommended as an appetite depressant ........................................................................ — | 0.0 | 0.0 Procaine and its salts ................................................................. — | — | — Proxymetacaine, its salts and derivatives when sold or recommended for ophthalmic use .................................................. 0.0 | 0.0 | 0.0 Selenium and its compounds .................................................... 2.5 | 0.0 | 0.0 Squill and its preparations, on the basis of crude drug ............ — | 32.5 | 97.5 Stramonium and its preparations, on the basis of stramonium alkaloids ...................................................................................... — | 0.16 | 0.65 Strychnine and its salts ............................................................. — | 0.0 | 0.0 Tetracaine, its salts and derivatives when sold or recommended for ophthalmic use .................................................. 0.0 | 0.0 | 0.0 Food and Drug Regulations Food and Drug Regulations Where drugs having similar physiological actions occur in combination, the dosage of each shall be proportionately reduced. Accurate dosages may be expressed in either metric units or imperial units. If the dosage is expressed in both systems, then an approximation may be used for one expression, but such approximation must precede or follow the accurate statement by which the product will be judged and must be in brackets. Current to November 11, 2024 Last amended on June 17, 2024 (a) intended to be burned and the smoke inhaled may be increased to 10 times the oral dose, and (b) intended for use as suppositories may be increased to 33 1/3 per cent in excess of the oral dose.

(5)

Good Manufacturing Practice

(3)

Where a drug mentioned in any of paragraphs (2)(a) to (d) is recommended for children, no person shall sell the drug for human use unless both the inner and the outer labels carry a statement that it is recommended (a) that the drug be used as directed by a physician; or (b) that the maximum doses of the drug not exceed the amounts set out in the following table and that single doses not be administered more frequently than every four hours. | 1 | 11 to under 12 years | 6 | 3 | 1.5 | 480 | 2 400 | Food and Drug Regulations Item | Age | Maximum Children's Dose (80 mg units) Acetaminophen Drops | Maximum Children's Dose (80 mg units) | Maximum Children's Dose (160 mg units) Acetaminophen | Maximum Adult's Dose (325 mg units) | Maximum Single Dose (mg) | Maximum Daily Dose (mg)

(6)

0.2%

6 | 1 to under 2 years | 1.5 or as directed by a physician | — | — | — | 120 | 600

(7)

0.5%

7 | 4 months to under 1 year | 1 or as directed by a physician | — | — | — | 80 | 400

(8)

0.2%

8 | 0 to under 4 months | 0.5 or as directed by a physician | — | — | — | 40 | 200

Food and Drug Regulations

(9)

0.5%

(4)

Where choline salicylate is recommended for children, no person shall sell the drug for human use unless both the inner and the outer labels carry a statement that it is recommended (a) that the drug be used as directed by physician; or (b) that the maximum doses of the drug not exceed the amounts set out in the following table and that single doses not be administered more frequently than every four hours.

(10)

1.0% Column I

11 to under 12

L

3 | Locust Bean Gum

9 to under 11

M

1 | Magnesium Chloride

6 to under 9

M

2 | Methylcellulose

4 to under 6

M

3 | Methyl Ethyl Cellulose

2 to under 4

As directed by physician C.01.025 Both the inner and the outer labels of a drug that carry a recommended single or daily dosage or a statement of concentration in excess of the limits provided by section C.01.021 shall carry a caution that the product is to be used only on the advice of a physician. C.01.027 (1) Where a person advertises to the general public a drug for human use, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug if it (a) contains a drug set out in the table to section C.01.021; and (b) carries on its label (i) a statement of the recommended single or daily adult dosage that results in a single or daily adult dosage of the drug referred to in paragraph (a) in excess of the maximum dosage set out in the table to section C.01.021 for that drug, or (ii) a statement that shows a concentration of the drug referred to in paragraph (a) in excess of the maximum limit set out in the table to section C.01.021 for that drug.

M

4 | Mono-glycerides Column II

(2)

Subsection (1) does not apply to products containing

M

1 | Tofu

(4)

Where a person advertises to the general public a drug for human use that contains acetylsalicylic acid, the person shall not make any representation with respect to its administration to or use by children or teenagers. Cautionary Statements and Child Resistant Packages C.01.028 (1) Subject to subsection (2), the inner and outer labels of a drug that contains (a) acetylsalicylic acid or any of its salts or derivatives, salicylic acid or a salt thereof, or salicylamide, where the drug is recommended for children, shall carry a cautionary statement to the effect that the drug should not be administered to a child under two years of age except on the advice of a physician; (b) boric acid or sodium borate as a medicinal ingredient shall carry a cautionary statement to the effect that the drug should not be administered to a child under three years of age; (c) hyoscine (scopolamine) or a salt thereof shall carry a cautionary statement to the effect that the drug should not be used by persons suffering from glaucoma or where it causes blurring of the vision or pressure pain within the eye; "CAUTION: May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician."; or (e) acetylsalicylic acid for internal use shall carry a cautionary statement to the effect that the drug should not be administered to or used by children or teenagers who have chicken pox or manifest flu symptoms before a physician or pharmacist is consulted about Reye’s syndrome, which statement shall also refer to the fact that Reye’s syndrome is a rare and serious illness.

M

2 | (1) Ale; Beer; French dressing; Light beer; Malt liquor; Porter; Salad dressing; Stout

(2)

Subsection (1) does not apply to a drug that is (b) dispensed pursuant to a prescription; or (c) a prescription drug or a drug that is required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations. (a) that contains (ii) acetylsalicylic acid, or any of its salts or derivatives, (a.1) that contains nicotine or any of its salts and is a vaping product as defined in section 2 of the Tobacco and Vaping Products Act but that is not referred to in paragraph 2(b) or (c) or section 3 of the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act, or (b) that is in a package that contains (i) more than the equivalent of 250 mg of elemental iron, or (ii) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices, shall carry a cautionary statement to the effect that the drug should be kept out of the reach of children.

(2)

Unstandardized foods

(2)

Subject to subsections C.01.031.2(1) and (2), the inner label and outer label of a drug that is in a package shall carry a cautionary statement, to the effect that there is enough drug in the package to seriously harm a child, if the package contains (a) more than 1.5 g of salicylic acid or the equivalent quantity of any of its salts or salicylamide, (b) more than 2 g of acetylsalicylic acid or the equivalent quantity of any of its salts or derivatives, (c) more than 3.2 g of acetaminophen, (e) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices, or (f) in the case where the drug is a vaping product as defined in section 2 of the Tobacco and Vaping Products Act but is not referred to in paragraph 2(b) or (c) or section 3 of the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act, 0.1 mg/ml or more of nicotine or the equivalent quantity of any of its salts.

M

3 | Unstandardized foods

(3)

The cautionary statements required under subsections (1) and (2) shall be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour. (a) no person shall sell a drug described in subsection C.01.029(1) unless (i) where the drug is recommended solely for children, it is packaged in a child resistant package, (ii) where the drug is not recommended solely for children, other than a drug referred to in subparagraph (iii), at least one of the sizes of packages available for sale is packaged in a child resistant package, and (iii) where the drug is a vaping product referred to in paragraph C.01.029(1)(a.1), it is packaged in a child resistant package; and (b) where a drug described in subsection C.01.029(1) is packaged in a package that is not a child resistant package, the outer label shall carry a statement that the drug is available in a child resistant package. (a) a prescription drug or a drug that is required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations; (e) intended for topical use, unless it is a liquid preparation containing more than five per cent alkyl salicylates; (f) packaged in a non-reclosable package containing not more than two adult standard dosage units per package; or (g) in toothpaste form.

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4 | (1) Bread; Cream; Fish paste

(2)

Sections C.01.029 to C.01.031 do not apply to a drug that is repackaged by a pharmacist or practitioner at the time of sale.

(3)

Ice cream mix; Ice milk mix

(3)

Section C.01.031 does not apply to a drug that is (a) sold only in containers that have roll-on or spray applicators or permanently installed wick applicators; (b) sold for exclusive use in animals other than household pets; or (c) intended solely for use in dentists’ offices, or packaged for hospital use only. (a) the outer label or the package insert carries, as part of the directions for use, the following statements: “Contraindications Tuberculosis of the eye; Fungal diseases of the eye; Acute purulent untreated infections of the eye, which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid. Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur.”; (b) the inner label carries the statements required by paragraph (a) or instructions to see the outer label or package insert for information about contraindications and side effects. C.01.033 Section C.01.032 does not apply to a corticosteroid drug that is sold by a pharmacist under a prescription. C.01.034 No person shall disseminate to a practitioner promotional literature about corticosteroid drugs for ophthalmic use unless the statements required by paragraph C.01.032(a) are included in that literature. Miscellaneous (a) a drug that contains phenacetin in combination with any salt or derivative of salicylic acid; (b) a drug for human use that contains (c) a drug for human use that contains mercury or a salt or derivative thereof, unless the drug is (i) a drug described in Schedule C or D to the Act, or (ii) one of the following drugs, namely, (A) an ophthalmic drug or other drug to be used in the area of the eye, (B) a drug for nasal administration, (C) a drug for otic administration, or (D) a drug for parenteral administration that is packaged in a multi-dose container, in which the mercury or the salt or derivative thereof is present as a preservative and the manufacturer or importer has submitted evidence to the Minister demonstrating that the only satisfactory way to maintain the sterility or stability of the drug is to use that preservative.

(4)

Creamed cottage cheese

(2)

For the purpose of clause (1)(c)(ii)(A), area of the eye means the area bounded by the supraorbital and infraorbital ridges and includes the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge. C.01.036.1 No person shall sell, or advertise for sale, nitrous oxide to the general public. C.01.037 (1) No person shall sell to the general public a drug that is recommended solely for children if the package in which the drug is sold contains (b) more than 1.92 g of acetylsalicylic acid or the equivalent quantity of a salt or derivative thereof; (c) more than 3.2 g of acetaminophen in 160 mg dosage units; or

(5)

Infant formula

(2)

Subsection (1) does not apply to a drug dispensed pursuant to a prescription. C.01.038 A drug for human use is adulterated if it contains (a) Strychnine or any of its salts; (iii) a Strychnos species containing strychnine, other than those species mentioned in subparagraphs (i) and (ii); (c) Methapyrilene or any of its salts; (e) any of the following plant species or extracts or tinctures thereof: C.01.039 In vitro diagnostic products that are or contain drugs other than drugs listed in Schedule E to the Act, and drugs listed in Schedule D to the Act that are labelled for veterinary use only, are exempt from the application of this Part. C.01.040 No manufacturer or importer shall sell a drug for human use that contains as an ingredient (b) arsenic or any of its salts or derivatives, other than arsenic trioxide. C.01.040.1 No manufacturer shall use methyl salicylate as a medicinal ingredient in a drug for internal use in humans. C.01.040.2 (1) No manufacturer shall use a colouring agent in a drug other than a colouring agent listed in subsections (3) and (4).

(6)

Sausage casings

(2)

No person shall import for sale a drug that contains a colouring agent other than a colouring agent listed in subsections (3) and (4). (2.1) The following definitions apply in subsections (3) to (4.1): C.I. (indication of the number) means the designation used to identify a colouring agent in the Colour Index published by The Society of Dyers and Colourists, as amended from time to time; (C.I. (indication du numéro))

(7)

Margarine

(3)

The following colouring agents are permitted in drugs for internal and external use, namely, ALIZARIN CYANINE GREEN F (D & C Green No. 5; C.I. No. 61570), ALLURA RED AC (FD & C Red No. 40; C.I. No. 16035), AMARANTH (Delisted FD & C Red No. 2; C.I. No. 16185), BRILLIANT BLUE FCF SODIUM SALT (FD & C Blue No. 1; C.I. No. 42090), CARBON BLACK (C.I. No. 77266), CARMOISINE (Delisted Ext. D & C Red No. 10; C.I. No. 14720), EOSIN YS ACID FORM (D & C Red No. 21; C.I. No. 45380:2), EOSIN YS SODIUM SALT (D & C Red No. 22; C.I. No. 45380), ERYTHROSINE (FD & C Red No. 3; C.I. No. 45430), FAST GREEN FCF (FD & C Green No. 3; C.I. No. 42053), FLAMING RED (D & C Red No. 36; C.I. No. 12085), HELLINDONE PINK CN (D & C Red No. 30; C.I. No. 73360), INDIGO (D & C Blue No. 6; C.I. No. 73000), INDIGOTINE (FD & C Blue No. 2; C.I. No. 73015), LITHOL RUBIN B SODIUM SALT (D & C Red No. 6; C.I. No. 15850), LITHOL RUBIN B CALCIUM SALT (D & C Red No. 7; C.I. No. 15850:1), PHLOXINE B ACID FORM (D & C Red No. 27; C.I. No. 45410:1), PHLOXINE B SODIUM SALT (D & C Red No. 28; C.I. No. 45410), QUINOLINE YELLOW WS (D & C Yellow No. 10; C.I. No. 47005), SUNSET YELLOW FCF (FD & C Yellow No. 6; C.I. No. 15985), TARTRAZINE (FD & C Yellow No. 5; C.I. No. 19140), (b) preparations made by extending any of the colour­ing agents listed in paragraph (a) on a substratum of (x) any combination of the substances listed in sub­paragraphs (i) to (ix); and

(8)

Sherbet

(4)

The following colouring agents are permitted in drugs for external use, namely, ALIZAROL PURPLE SS (D&C Violet No. 2; C.I. No. 60725), DEEP MAROON (D&C Red No. 34; C.I. No. 15880:1), MANGANESE VIOLET (C.I. No. 77742), PYRANINE CONCENTRATED (D&C Green No. 8; C.I. No. 59040), QUINIZARIN GREEN SS (D&C Green No. 6; C.I. No. 61565), TONEY RED (D&C Red No. 17; C.I. No. 26100), URANINE ACID FORM (D&C Yellow No. 7; C.I. No. 45350:1), URANINE SODIUM SALT (D&C Yellow No. 8; C.I. No. 45350), (b) preparations made by extending any of the colouring agents listed in paragraph (a) on a substratum of (x) any combination of the substances listed in subparagraphs (i) to (ix); and (4.1) Despite subsection (1), no manufacturer shall use a preparation made by extending any of the following substances on a substratum of mica in a drug unless the requirements in subsection (4.3) are met: (c) a mixed oxide made from substances referred to in both paragraphs (a) and (b). (4.2) Despite subsection (2), no person shall import for sale a drug that contains a preparation made by extending any of the substances referred to in paragraphs (4.1)(a) to (c) on a substratum of mica unless the requirements in subsection (4.3) are met. (4.3) The requirements referred to in subsections (4.1) and (4.2) are the following: (a) the drug shall be in a solid dosage form intended for oral administration or in a liquid dosage form intended for oral administration or it shall be a drug intended for external use; (b) in the case where the drug is in a solid dosage form intended for oral administration, the drug shall not contain more than 3% of the preparation; (c) in the case where the preparation was made using iron oxides, the preparation shall not contain more than 55% iron oxides.

(9)

Shortening

(5)

Subsections (1), (2), (4.1) and (4.2) do not apply in respect of a drug that is represented as being solely for use in the disinfection, for disease prevention, of (b) health care facilities; or (c) premises in which food is manufactured, prepared or kept. C.01.040.3 In deciding whether to amend the Prescription Drug List in respect of a drug, including by adding the drug to it or removing the drug from it, the Minister shall consider whether any of the following criteria apply with respect to the drug: (a) supervision by a practitioner is necessary (i) for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or (ii) to monitor a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or to monitor the use of the drug; (b) the level of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner; or (c) use of the drug can cause harm to human or animal health or a risk to public health and the harm or the risk can be mitigated by a practitioner’s supervision. C.01.040.4 The Minister shall consult the general public on any proposal by the Minister to remove a drug from the Prescription Drug List. C.01.040.5 Sections C.01.040.3 and C.01.040.4 apply, with any modifications that the circumstances require, in respect of classes of drugs. (a) they are entitled under the laws of a province to dispense a prescription drug and they sell it in that province under a verbal or written prescription that they received; or (b) they sell it under section C.01.043.

(10)

Sour Cream

(2)

In the case of a verbal prescription, the person referred to in paragraph (1)(a) or a pharmacy technician shall create a written record of the prescription that includes the following information: (a) the date on which the prescription was received and, if applicable, the number of the prescription; (b) the name and address of the person to whom the prescription was issued; (c) the proper name, common name or brand name of the drug and its quantity; (e) the directions for use provided with the prescription, whether or not the practitioner authorized it to be refilled and, if refills are authorized, the number of authorized refills.

(11)

Unstandardized Foods

(3)

The person referred to in paragraph (1)(a) shall retain the written prescription referred to in subsection (1) or the record referred to in subsection (2) for at least two years after the day on which the prescription is filled. C.01.041.2 (1) Before a pharmacist sells a drug under a prescription that was transferred under section C.01.041.1, the pharmacist or pharmacy technician shall (a) create a written record of the name and address of the pharmacist or pharmacy technician who transferred the prescription and, if applicable, the number of authorized refills remaining and the date of the last refill; and (b) obtain a copy of the written prescription or of the written record that was created under subsection C.01.041(2), as the case may be, or, in the case of a verbal prescription, create a written record that contains the information referred to in that subsection.

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5 | (1) Bread; Cream; Fish paste

(2)

The pharmacist shall retain the documents referred to in subsection (1) for at least two years after the day on which the prescription was filled. C.01.041.3 (1) A pharmacist or a pharmacy technician who transfers a prescription under section C.01.041.1 shall indicate the date of the transfer on the original of the written prescription or of the written record created under subsection C.01.041(2) or in a record kept under the name of the patient in question, as the case may be.

(3)

Ice cream mix; Ice milk mix

(2)

When the pharmacist or pharmacy technician has transferred the prescription, (a) the pharmacist shall not make any additional sales under the prescription; and (b) the pharmacist or pharmacy technician shall not transfer the prescription to another pharmacist or pharmacy technician. C.01.042 A person referred to in paragraph C.01.041(1)(a) shall not refill a prescription for a prescription drug unless authorized by the practitioner and, in the case of such an authorization, they shall not refill a C.01.042.1 A person referred to in paragraph C.01.041(1)(a) shall indicate on the original of or on the copy of the written prescription or the written record created under subsection C.01.041(2) or in a record kept under the name of the patient in question, as the case may be, (a) the date on which the prescription was filled; (c) the quantity of drug sold when the prescription was filled and, if applicable, for each refill; and (e) the Government of Canada or the government of a province, for the use of a department or agency of that government, on receipt of a written order signed by the minister responsible for the department or by the person in charge of the agency, or by their duly authorized representative.

(4)

Cottage Cheese; Creamed Cottage Cheese

(2)

If a person sells a prescription drug under paragraph (1)(e), they shall retain the written order for the drug for a period of at least two years after the day on which the drug is sold. C.01.044 If a person advertises a prescription drug to the general public, the person shall not make any representation other than with respect to the brand name, the proper name, the common name and the price and quantity of the drug. C.01.045 No person, other than one of the following, shall import a prescription drug: (d) a resident of a foreign country while a visitor in Canada, for their own use or for the use of a person under their care; (e) a drug manufacturer, for the purpose of conducting clinical testing in conformity with these Regulations; or (f) a person to whom an establishment licence has been issued under Division 1A. Distribution of Drugs as Samples C.01.048 (1) If a practitioner or pharmacist has signed an order specifying the proper name or common name, the brand name and the quantity of a drug, other than the following, the person who receives the order may distribute or cause to be distributed the drug, in dosage form, as a sample to that practitioner or pharmacist if the drug meets the requirements of these Regulations: (a) a narcotic as defined in the Narcotic Control Regulations; (b) a controlled drug as defined in section G.01.001; or (1.1) A person may distribute or cause to be distributed a prescription drug as a sample under subsection (1) only to a practitioner or pharmacist who is entitled, under the laws of the province in which they are practising, to prescribe or dispense that drug, as the case may be.

(5)

Infant formula

(2)

An order referred to in subsection (1) may provide that the order be repeated at specified intervals during any period not exceeding six months.

(6)

Sausage casings

(3)

Despite subsection (1), a person may distribute or cause to be distributed a drug, in dosage form, as a sample to a practitioner or pharmacist without a signed order if that drug is not a prescription drug and is part of a class of drugs that is set out in column 1 of List D, and if all of the following conditions are met: (a) the drug contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6; (b) the expiration date of the drug falls on a day that is (i) at least 30 days after the day on which it is distributed, if the expiration date consists of a day, month and year, or (ii) in a month that follows the month in which it is distributed, if the expiration date consists only of a month and year; (c) the drug meets the requirements of these Regulations. C.01.049 A person who, under subsection C.01.048(1), receives an order for and distributes or causes to be distributed a drug as a sample shall (i) the name, address and description of each person to whom the drug is distributed, (iii) the date upon which each such distribution was made; and (b) keep those records and all orders received for drugs in accordance with section C.01.048 for a period of not less than two years from the date upon which the distribution referred to in the records was made. C.01.049.1 A person may distribute or cause to be distributed a drug, in dosage form, as a sample to any consumer that is 18 years of age or older if that drug is not a prescription drug and is part of a class of drugs that is set out in column 1 of List D, and all of the following conditions are met: (a) the drug contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6; (b) the expiration date of the drug set is, (i) if it is indicated by day, month and year, at least 30 days after the date on which the drug is distributed, (ii) if it is indicated only by month and year, in a month that follows the month in which the drug is distributed; (c) the drug meets the requirements of these Regulations. (b) the expiration date of the drug falls on a day that is (i) at least 30 days after the day on which it is distributed, if the expiration date consists of a day, month and year, or (ii) in a month that follows the month in which it is distributed, if the expiration date consists only of a month and year; (c) the drug meets the requirements of these Regulations. C.01.050 (1) This section applies to a holder of one or more of the following therapeutic product authorizations: (a) a drug identification number that has been assigned under subsection C.01.014.2(1); and (b) a notice of compliance that has been issued under section C.08.004 or C.08.004.01.

(7)

Margarine

(2)

The holder of a therapeutic product authorization in respect of a drug that is part of a class of drugs set out in subsection (4) shall provide the Minister with information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the drug, regarding (a) risks that have been communicated by any foreign regulatory authority that is set out in Part A of the List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a drug within the jurisdiction of such an authority, and the manner of the communication; (b) changes that have been made to the labelling of any drug and that have been communicated to or requested by any foreign regulatory authority that is set out in Part B of the list referred to in paragraph (a); and (c) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any drug, that have taken place within the jurisdiction of any foreign regulatory authority that is set out in Part C of the list referred to in paragraph (a).

(8)

Sherbet

(3)

The information shall be provided to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.

(9)

Shortening

(4)

The classes of drugs are (b) drugs that are required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations; and (c) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner.

(10)

Sour Cream

(5)

Despite subsection (2), a holder of a therapeutic product authorization who provided information in accordance with (a) paragraph (2)(a) is not required to provide the same information again under that paragraph in the case where the holder receives or becomes aware of that information in respect of a foreign regulatory authority or person referred to in that paragraph; or (b) paragraph (2)(b) or (c) is not required to provide the same information again under that paragraph in the case where the holder receives or becomes aware of that information in respect of a foreign regulatory authority referred to in that paragraph.

(11)

Unstandardized Foods Column III Maximum Level of Use

(6)

In this section, foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. C.01.051 Where a manufacturer who sells a drug in dosage form or a person who imports into and sells in Canada a drug in dosage form commences a recall of the drug, the manufacturer or importer shall forthwith submit to the Minister the following information: (a) the proper name of the drug, the common name of the drug if there is no proper name, the brand name of the drug and the lot number; (b) in the case of an imported drug, the names of the manufacturer and importer; (f) the reasons for initiating the recall; and (g) a description of any other action taken by the manufacturer or importer with respect to the recall. Assessments Ordered Under Section 21.31 of the Act C.01.052 (1) The Minister’s power to make an order under section 21.31 of the Act in respect of a drug is subject to the following conditions: (a) the person to whom the order is made shall be the holder of one or more of the following therapeutic product authorizations in respect of the drug: (i) a drug identification number that has been assigned under subsection C.01.014.2(1), (ii) an establishment licence that has been issued under subsection C.01A.008(1), and (iii) a notice of compliance that has been issued under section C.08.004 or C.08.004.01; and (b) the Minister shall have reasonable grounds to believe that (i) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(i) or (iii), the benefits or risks of injury to health associated with the drug are significantly different than they were when the authorization was issued, (ii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(ii) who is an importer, the manner in which one or more of the following activities is conducted may present a risk of injury to health associated with the drug: (A) importation, as defined in subsection C.01A.001(1), of the drug, (B) fabrication or packaging/labelling, as defined in subsection C.01A.001(1), of the drug outside Canada, and (C) testing of the drug outside Canada, and (iii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(ii) who is not an importer, the manner in which an activity that is authorized under the authorization is conducted may present a risk of injury to health associated with the drug.

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2 | (1) Good Manufacturing Practice

(2)

The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act in respect of a drug, (a) provide the holder of the therapeutic product authorization with the results of the examination; and (b) ensure that a summary of the results of the examination, together with a description of any steps that the Minister has taken or may take as a consequence of the examination, is published on the Government of Canada website. Activities Ordered Under Section 21.32 of the Act C.01.053 The Minister’s power to make an order under section 21.32 of the Act in respect of a drug is subject to the following conditions: (a) the person to whom the order is made shall be the holder of one or more of the following therapeutic product authorizations in respect of the drug: (i) a drug identification number that has been assigned under subsection C.01.014.2(1), (ii) an establishment licence that has been issued under subsection C.01A.008(1), and (iii) a notice of compliance that has been issued under section C.08.004 or C.08.004.01; (b) the Minister shall have reasonable grounds to believe that (i) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(i) or (iii), there are significant uncertainties relating to the benefits or harms associated with the drug, (ii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(ii) who is an importer, the manner in which one or more of the following activities is conducted has introduced significant uncertainties relating to the benefits or harms associated with the drug: (A) importation, as defined in subsection C.01A.001(1), of the drug, (B) fabrication or packaging/labelling, as defined in subsection C.01A.001(1), of the drug outside Canada, or (C) testing of the drug outside Canada, (iii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(ii) who is not an importer, the manner in which an activity that is authorized under the authorization is conducted has introduced significant uncertainties relating to the benefits or harms associated with the drug, (iv) the holder of the therapeutic product authorization is unable to provide the Minister with information that is sufficient to manage those uncertainties, and (v) the applicable requirements of these Regulations, together with any terms and conditions that have been imposed on the authorization, do not allow for sufficient information to be obtained to manage those uncertainties; and (c) the Minister shall take into account the following matters: (i) whether the activities that the holder of the therapeutic product authorization will be ordered to undertake are feasible, and (ii) whether there are less burdensome ways of obtaining additional information about the drug’s effects on health or safety. Limits of Variability C.01.061 (1) Where the net amount of a drug in a package is not expressed on the label in terms of number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain an Food and Drug Regulations Limits of Variability amount of the drug such that, when determined by that official method, the average of the net amounts of the drug in the 10 packages is not less than the net amount of the drug shown on the label.

(2)

Good Manufacturing Practice

(2)

Where the net amount of a drug in a package is expressed on the label in terms of the number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, *Determination of Net Contents*, dated December 7, 1988, shall contain a number of units such that, when determined by that official method, (a) the average number of dosage units in the 10 packages is not less than the number of dosage units shown on the label; (b) no package contains less than the number of dosage units shown on the label except as provided in the table; and (c) where the drug is a controlled drug as defined in section G.01.001 or a narcotic as defined in the *Narcotic Control Regulations*, no package contains more than the number of dosage units shown on the label except as provided in the table to this section. Labelled Number of Dosage Units Per Package | Permitted Variation from the Labelled Number

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3 | Good Manufacturing Practice

1 | 50 or less | 0

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4 | (1) Good Manufacturing Practice

2 | More than 50, but less than 101 | 1

(2)

1.5%

(2)

Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a volatile substance of botanical origin or its synthetic equivalent, the amount of that ingredient, determined using an acceptable method, shall be

(3)

A total of 0.5% of stabilizing agents in accordance with subparagraphs B.08.061(b)(vi) and B.08.071(b)(vi)

(3)

Subject to subsection (5), where a drug in capsule form contains a medicinal ingredient that is a vitamin in a fish-liver oil, no variation from the amount of the medicinal ingredient as shown on the label, determined using an acceptable method, is permitted other than that which is in accordance with the variation for that fish-liver oil as stated in any publication whose name is referred to in Schedule B to the Act.

(4)

Good Manufacturing Practice

(4)

Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a vitamin, no variation from the amount of the medicinal ingredient shown on the label, determined using an acceptable method, is permitted other than that which is in accordance with the variation set out in column III or IV of an item of the table to this section opposite the vitamin set out in column I of that item for the amount of vitamin set out in column II of that item. (a) a drug for which a notice of compliance has been issued under section C.08.004 or C.08.004.01; (c) a drug for which a standard is contained in any publication whose name is referred to in Schedule B to the Act; (e) a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and in respect of which (i) the conditions of pharmaceutical production and quality control are suitable for controlling the identity, quality, purity, stability, safety, strength and potency of the drug, (ii) all labels to be used in connection with the drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug, make proper claims in respect of the drug, (iii) the drug can, without undue foreseeable risk to humans, be used for the purposes and under the conditions of use recommended by the manufacturer, and (iv) the drug is effective for the purposes and under the conditions of use recommended by the manufacturer. vitamin A (or as B-carotene) Limits of variation when the recommended daily dose shown on label is equal to or less than the amount set out in column II Limits of variation when the recommended daily dose shown on label is greater than the amount set out in column II Food and Drug Regulations Limits of Variability C.01.064 Where a drug is prepared for ophthalmic or parenteral use and contains a preservative ingredient, that ingredient (a) shall be present only in an amount necessary to obtain the intended action and that does not pose undue risk to humans or animals; and C.01.065 No person shall sell a drug that is prepared for ophthalmic or parenteral use unless a representative sample of each lot of the drug in its immediate container (a) is tested by an acceptable method for identity, and the drug is found to be true to its proper name, or to its common name if there is no proper name; (b) is tested by an acceptable method for sterility, except (ii) where the manufacturer has submitted evidence, satisfactory to the Minister to prove that processing controls ensure the sterility of the drug in its immediate container, and the drug is found to be sterile; and (c) is subjected to such further tests satisfactory to the Minister to ensure that the drug is safe to use according to directions. C.01.066 No person shall sell a drug in aqueous solution that is prepared for parenteral use unless it has been prepared with non-pyrogenic water produced by distillation or reverse osmosis. C.01.067 (1) Subject to subsection (2), no person shall sell a drug that is prepared for parenteral use unless a representative sample of each lot of the drug in its immediate container (a) is tested by an acceptable method for the presence of pyrogens; and (b) when so tested, is found to be non-pyrogenic.

(6)

0.35% of the casing

(2)

Subsection (1) does not apply in respect of a drug that cannot be tested for the presence of pyrogens or that is inherently pyrogenic. C.01.068 Detailed records of the tests required by sections C.01.065 and C.01.067 shall be retained by the manufacturer for a period of at least one year after the expiration date on the label of the drug. C.01.069 The packaging of a drug that is prepared for parenteral use shall meet the following requirements: (a) the immediate container shall be of such material and construction that (i) no deleterious substance is yielded to the drug, (ii) it is non-reactive with the drug, (iii) visual or electronic inspection of the drug is possible, (iv) protection against environmental factors that cause deterioration or contamination of the drug is provided or, where that protection cannot be provided by the immediate container, it is provided by the secondary packaging, and (v) a sufficient quantity of the drug is contained to allow withdrawal of the labelled amount of the drug; and (b) the immediate closures and any material coming into contact with the drug in its immediate container shall meet the requirements of subparagraphs (a)(i) and (ii). C.01.070 No person shall sell a drug that is a hypodermic tablet that does not completely dissolve in and form a clear solution within five minutes. C.01.071 No person shall sell mercuric chloride tablets for household use that are packaged in lots of 200 or less, unless (a) such tablets are (ii) coloured blue, and (iii) packed in an immediate container that is readily distinguishable by touch; and (b) the principal display panel of both the inner and the outer labels carries in prominent type and in a colour contrasting to that of such labels (i) the design of a skull and cross-bones, and Aminopyrine and Dipyrone “WARNING: Fatal agranulocytosis may be associated with the use of Aminopyrine and Dipyrone. It is essential that adequate blood studies be made. (See enclosed warnings and precautions)”; and (b) the outer label or the package insert carries the following statements: “WARNING: Serious and even fatal agranulocytosis is known to occur after the administration of Aminopyrine or Dipyrone. Fatal agranulocytosis has occurred after short term, intermittent and prolonged therapy with the drugs. Therefore, the use of these drugs should be as brief as possible. Bearing in mind the possibility that such reactions may occur, Aminopyrine or Dipyrone should be used only when other less potentially dangerous agents are ineffective. PRECAUTIONS: It is essential that frequent white blood cell counts and differential counts be made during treatment with these drugs. However, it is emphasized that agranulocytosis may occur suddenly without prior warning. The drug should be discontinued at the first evidence of any alteration of the blood count or sign of agranulocytosis, and the patient should be instructed to discontinue use of the drug at the first indication of sore throat or sign of other infection in the mouth or throat (pain, swelling, tenderness, ulceration).” C.01.132 No person shall disseminate to a practitioner promotional literature about Aminopyrine or Dipyrone unless the statements set out in section C.01.131 are included in such literature. C.01.133 The provisions of sections C.01.131 and C.01.132 do not apply to preparations containing Aminopyrine or Dipyrone that are (a) dispensed by a pharmacist pursuant to a prescription; or (b) sold for veterinary use only. C.01.134 No person shall sell coated tablets containing potassium salts, with or without thiazide diuretics, unless the inner label thereof or the package insert carries the following statement: "WARNING: A probable association exists between the use of coated tablets containing potassium salts, with or without thiazide diuretics, and the incidence of serious small bowel ulceration. Such preparations should be used only when adequate dietary supplementation is not practical, and should be discontinued if abdominal pain, distension, nausea, vomiting or gastro-intestinal bleeding occur." C.01.135 No person shall disseminate to a practitioner promotional literature about coated tablets containing potassium salts, with or without thiazide diuretics, unless the statement set out in section C.01.134 is included in such literature. (a) are sold for veterinary use only; (b) are dispensed by a pharmacist pursuant to a prescription; or C.01.401 Except as provided in these Regulations, an antibiotic for other than parenteral use shall, in addition to meeting the requirements of section C.01.004, carry on both the inner label and outer label the potency of the drug, expressed in terms of International Units where established or, if no International Unit has been established, in terms of units, milligrams, micrograms or fractions of a gram, (c) per individual dosage or dispensing form in the case of antibiotic preparations put up in individual dosage or dispensing form. C.01.433 No person shall sell chloramphenicol and its salts and derivatives, for oral or parenteral use, unless (i) bone marrow depression has been associated with the use of chloramphenicol, and (ii) the enclosed warnings and precautions should be read carefully; and (b) the outer label or the package insert carries the following: (i) a warning statement to the effect that chloramphenicol should not be used in the treatment or prophylaxis of minor infections or where it is not indicated, as in cold, influenza, or infections of the upper respiratory tract; that there are two types of bone marrow depression associated with the use of chloramphenicol; that some degree of depression of the bone marrow is commonly seen during therapy, is dose-related and is potentially reversible; that blood studies may detect early changes and; that the other type of bone marrow depression, a sudden, delayed and usually fatal bone marrow hypoplasia that may occur without warning, is very rare, and (ii) a statement of precautions to be taken to the effect that it is essential that appropriate blood studies be made during treatment with chloramphenicol and that while blood studies may detect early peripheral blood changes, such studies cannot be relied on to detect the rare and generally irreversible bone marrow depression prior to development of aplastic anemia. C.01.434 Section C.01.433 does not apply to chloramphenicol and its salts or derivatives that are sold by a pharmacist under a prescription. C.01.435 No person shall disseminate to a practitioner promotional literature about chloramphenicol and its salts or derivatives for oral or parenteral use unless the statements set out in paragraph C.01.433(b) are included in such literature. C.01.600 No person shall sell for veterinary use a drug listed in the Table of Limits of Drug Dosage for Adults, other than a drug in a form not suitable for human use, C.01.602 The provisions of sections C.01.401 and C.01.402 do not apply to an antibiotic in amounts less than 50 parts per million contained in an animal food. C.01.603 The provisions of paragraphs C.01.401 (b) and (c) and section C.01.402 do not apply to an antibiotic in amounts greater than 50 parts per million contained in an animal food. C.01.604 Both the inner and outer labels of a veterinary drug represented as containing a vitamin shall carry (a) a statement of the amount of each vitamin present in the drug, expressed in terms of the proper name and any of the vitamin in (iv) Oral Units for vitamin B12 with intrinsic factor concentrate, or (b) except for drugs in a form not suitable for human use, the statement “For Veterinary Use Only” or “Veterinary Use Only”. C.01.605 An antibiotic for parenteral use that is recommended for veterinary use only shall carry on both the inner and outer labels (a) the potency of the drug expressed in terms of International Units where established, or, if no International Unit has been established, in terms of units, milligrams or fractions of a gram, per gram in the case of solids or viscous liquids, per millilitre in the case of other liquids, or per individual dosage or dispensing form for antibiotic preparations put up in individual dosage or dispensing form; and (c) the statement “For Veterinary Use Only” or “Veterinary Use Only”. C.01.606 No person shall sell an antibiotic preparation for the treatment of animals, other than an antibiotic preparation that is a new drug sold pursuant to section C.08.013, unless, (a) where the preparation is not to be used for lactating animals providing milk to be consumed as food, the inner and outer labels of the preparation carry a statement to that effect; or (b) where the preparation may be used for lactating animals providing milk to be consumed as food, (i) there has been submitted, on request, to the Minister, acceptable evidence to show the period of time, not exceeding 96 hours, that must elapse after the last treatment with the preparation in order that the milk from treated lactating animals will contain no residue of antibiotics that would cause injury to human health, and (ii) the principal display panel of the outer label of the preparation, the inner label and the packaging insert, if any, describing the antibiotic preparation carry the warning “WARNING: MILK TAKEN FROM TREATED ANIMALS DURING TREATMENT AND WITHIN ... HOURS AFTER THE LATEST TREATMENT MUST NOT BE USED AS FOOD”, where the number of hours to be inserted is determined according to evidence submitted pursuant to subparagraph (i). C.01.606.1 No person shall sell a product intended for the prevention or treatment of foot rot of cattle if that product contains Ethylenediamine Dihydroiodide (ED-DI). C.01.609 Despite paragraph C.01.401(a), the potency of an antibiotic in amounts greater than 50 parts per million contained in a medicated feed registered under the Feeds Act may be declared in grams per tonne. C.01.610 No person shall sell any substance having oestrogenic activity for administration to poultry that may be consumed as food. C.01.610.1 No person shall sell a drug for administration to animals that produce food or that are intended for consumption as food if that drug contains (a) chloramphenicol or its salts or derivatives; (b) a 5-nitrofuran compound; (c) clenbuterol or its salts or derivatives; (e) diethylstilbestrol or other stilbene compounds. C.01.610.2 No person shall sell an antibiotic preparation containing chloramphenicol, its salts or derivatives, for administration to animals that do not produce food and that are not intended for consumption as food unless (a) both the inner label and outer label of the preparation carry the words “WARNING: FEDERAL LAW (b) where the preparation is for parenteral use, the preparation contains, in the form of chloramphenicol sodium succinate, not more than one gram of chloramphenicol per vial; (c) where the preparation is for ophthalmic use, the preparation contains not more than one per cent chloramphenicol; and (i) is in tablet or capsule form and contains not more than one gram of chloramphenicol per tablet or capsule, or (ii) is in the form of a chloramphenicol palmitate suspension and contains not more than three grams of chloramphenicol per container. C.01.611 (1) The Minister may, in writing, from time to time require the manufacturer of a drug recommended for administration to animals that may be consumed as food (a) to file with the Minister in respect of that drug a submission describing in detail tests carried out to verify that the administration of the drug to an animal does not result in a substance named in column II of the List referred to in the Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods being present in a food set out in column III of the List, except in an amount within the maximum residue limit set out in column IV of the List in respect of the food and the substance; and (b) to print on the principal display panel of the outer label, the inner label and the packaging insert, if any, that describes the drug, a warning that food derived from animals to which the drug has been administered must not be sold for human consumption unless there has elapsed since the administration of the drug a period of time specified by the Minister, based on a review of the available data with respect to drug residues.

(7)

0.5%

(2)

No manufacturer shall sell a drug in respect of which the Minister has required a warning to be printed pursuant to paragraph (1)(b) unless the manufacturer has complied with that request. C.01.612 (1) Every manufacturer or importer who sells a veterinary drug in dosage form that contains an active pharmaceutical ingredient that is set out in List A, or every person who compounds such a drug, shall, in a form established by the Minister, submit to the Minister an annual report identifying for each drug, the total quantity sold or compounded and an estimate of the quantity sold or compounded for each intended animal species.

(8)

0.75%

(2)

The annual report described in subsection (1) is for a period of one calendar year and shall be submitted on or before March 31 of the year following the calendar year covered by the report, beginning with the first full calendar year after the day on which this section comes into force. C.01.613 (1) No person shall import a drug into Canada for the purpose of administering it to an animal that produces food or an animal that is intended for consumption as food if the sale of the drug in Canada would constitute a violation of the Act or these Regulations.

(10)

0.3%

(2)

Subsection (1) does not apply to a drug that is described in List B. C.01.614 (1) Sections 43 to 58 of the Natural Health Products Regulations apply in relation to a veterinary health product, as if that product were a natural health product as defined in subsection 1(1) of those Regulations. C.01.615 (1) Every manufacturer or importer of a veterinary health product shall notify the Minister of the sale of that product in Canada at least 30 days before the day on which that sale is commenced.

(11)

Good Manufacturing Practice

(2)

The notification shall be in a form established by the Minister and contain the following information: (b) the brand name under which the veterinary health product is sold; (c) the pharmaceutical form in which the veterinary health product is sold; (g) the species of animal for which the veterinary health product is recommended; and (h) the use or purpose for which the veterinary health product is recommended.

(12)

5% in accordance with the requirements of sections B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(3)

A manufacturer or importer who has provided the Minister with a notification under subsection (1) shall provide the Minister with any changes to the information required under subsection (2), in a form established by the Minister, at least 30 days before the day on which the veterinary health product to which the changes relate is sold. C.01.616 If the Minister has reasonable grounds to believe that a veterinary health product may no longer be safe, the Minister may request that the manufacturer or importer of the veterinary health product provide the Minister, within 15 days after the day on which the request is received, with information and documents demonstrating that the veterinary health product is safe. C.01.617 (1) The Minister may direct the manufacturer or importer to stop the sale of a veterinary health product if (a) the manufacturer or importer does not comply with a request made under section C.01.616 within the specified time; (a) the manufacturer or importer does not, within the required period, provide the Minister with the information and documents requested under section C.01.616; (b) the information and documents provided by the manufacturer or importer in accordance with section C.01.616 do not demonstrate that the veterinary health product is safe; or (c) the Minister has reasonable grounds to believe that the sale of the veterinary health product would be a violation of the Act or these Regulations.

M

5 | (1) Good Manufacturing Practice

(2)

The Minister shall lift a direction to stop the sale of a veterinary health product if the manufacturer or importer provides the Minister with information and documents demonstrating that (a) in the case of a direction to stop a sale under either paragraph (1)(a) or (b), the veterinary health product is safe; (b) in the case of a direction to stop a sale under paragraph (1)(c), the sale of the veterinary health product would no longer be a violation of the Act or these Regulations; or (c) the situation giving rise to the direction to stop the sale of the veterinary health product did not exist. C.01.625 Contraceptive drugs that are manufactured, sold or represented for use in the prevention of conception and that are not prescription drugs may be advertised to the general public. Establishment Licences C.01A.001 (1) The definitions in this subsection apply in this Division and in Divisions 2 to 4. active ingredient means a drug that, when used as a raw material in the fabrication of a drug in dosage form, provides its intended effect. (ingrédient actif) antimicrobial agent means a drug that is capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, as defined in the Medical Devices Regulations, that (a) are not invasive devices as defined in those Regulations; and (b) are intended to come into contact with intact skin only. (agent antimicrobien) batch certificate means a certificate issued by the fabricator of a lot or batch of a drug that is either imported within the framework of a mutual recognition agreement or referred to on the List of Non-prescription Drugs Not Subject to Certain Testing Requirements, and in which the fabricator (a) identifies the master production document for the drug and certifies that the lot or batch has been fabricated, packaged/labelled and tested in accordance with the procedures described in that document; (b) provides a detailed description of the drug, including (i) a statement of all properties and qualities of the drug, including the identity, potency and purity of the drug, and (ii) a statement of tolerances for the properties and qualities of the drug; (c) identifies the analytical methods used in testing the lot or batch and provides details of the analytical results obtained; (d) sets out the addresses of the buildings at which the lot or batch was fabricated, packaged/labelled and tested; and (e) certifies that the lot or batch was fabricated, packaged/labelled and tested (i) in the case of a drug that is imported within the framework of a mutual recognition agreement, in accordance with the good manufacturing practices of the regulatory authority that has recognized those buildings as meeting its good manufacturing practices standards, or (ii) in the case of a drug that is not imported within the framework of a mutual recognition agreement and that is referred to on the List of Non-prescription Drugs Not Subject to Certain Testing Requirements, in accordance with the requirements of Division 2. (certificate of lot) bulk process intermediate means an active ingredient that is used in the fabrication of either a drug of biological origin that is listed in Schedule C to the Act or a drug that is listed in Schedule D to the Act. (produit intermédiaire en vrac) class monograph means a document prepared by the Department of Health that dilute drug premix means a drug for veterinary use that results from mixing a drug premix with a feed, as defined in section 2 of the Feeds Act, to such a level that at least 10 kg of the resulting mixture is required to medicate one tonne of complete feed, as defined in subsection 1(1) of the Feeds Regulations, 2024, with the lowest approved dosage level of the drug. (prémélange médicamenteux dilué) drug premix means a drug for veterinary use to which a drug identification number has been assigned, where the directions on its label specify that it is to be mixed with feed as defined in section 2 of the Feeds Act. (prémélange médicamenteux) fabricate means to prepare and preserve a drug for the purposes of sale. (manufacturer) import means to import into Canada a drug for the purpose of sale. (importer) List of Non-prescription Drugs Not Subject to Certain Testing Requirements means the document entitled List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019(1) and (2) of the Food and Drug Regulations Do Not Apply that is published by the Government of Canada on its website, Food and Drug Regulations DIVISION 1A Establishment Licences MRA country means a country that is a participant in a mutual recognition agreement with Canada. (pays participant) mutual recognition agreement means an international agreement that provides for the mutual recognition of compliance certification for good manufacturing practices for drugs. (accord de reconnaissance mutuelle) package/label means to put a drug in its immediate container or to affix the inner or outer label to the drug. (emballer-étiqueter) recognized building means, in respect of the fabrication, packaging/labelling or testing of a drug, a building that a regulatory authority that is designated under section C.01A.019(1) in respect of that activity for that drug has recognized as meeting its good manufacturing practices standards in respect of that activity for that drug. (bâtiment reconnu) recognized country or region means a country or region that is set out in the document entitled List of Foreign Countries or Regions and Their Regulatory Authorities for the Application of Subsection C.02.019(5) of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time. (pays ou régions reconnus) regulatory authority means a government agency or other entity in an MRA country that has a legal right to control the use or sale of drugs within that country and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with legal requirements. (autorité réglementaire) wholesaler means a person who is not a distributor described in section C.01A.003 and who sells any of the following drugs other than at retail sale: (a) a drug in dosage form that is listed in Schedule C or D to the Act, a drug that is a prescription drug or a controlled drug as defined in section G.01.001; (c) a narcotic as defined in the Narcotic Control Regulations; or

(2)

1.5%

(2)

In this Division and in Division 2, drug does not include any of the following: (b) a medicated feed as defined in subsection 1(1) of the Feeds Regulations, 2024; (c) an active ingredient that is for veterinary use and that is not an active pharmaceutical ingredient; (d) an active pharmaceutical ingredient for veterinary use that is not required to be sold pursuant to a prescription and that is also a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations; (e) a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015.

(3)

A total of 0.5% of stabilizing agents in accordance with subparagraphs B.08.061(b)(vi) and B.08.071(b)(vi)

(3)

Where the Minister designates additional dosage form classes, the Minister shall make a list of those classes available on request. C.01A.002 (1) This Division does not apply to (b) subject to subsection (3), importing or compounding, pursuant to a prescription, a drug that is not commercially available in Canada by one of the following persons: (iii) a person who compounds a drug under the supervision of a practitioner; (b.1) any activity with respect to a positron-emitting radiopharmaceutical that is used only for the purposes of a basic clinical research study described in section C.03.304; (c) any activity with respect to a drug that is used only for the purposes of clinical testing in accordance with subsection C.05.006(1) or section C.08.005; (d) fabricating, packaging/labelling, testing as required under Division 2, distributing as a distributor referred to in section C.01A.003, wholesaling or importing any of the following drugs for which prescriptions are not required and that are for human use in dosage form and not represented as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states set out in Schedule A.1 to the Act, namely, (ii) drugs that meet the requirements of a class monograph entitled “Vitamin Supplements”, “Mineral Supplements”, “Dietary Vitamin Supplements” or “Dietary Mineral Supplements”, as the case may be, and (iii) drugs that (A) contain a plant, mineral or animal substance in respect of which therapeutic activity or disease prevention activity is claimed, including traditional herbal medicines, traditional Chinese medicines, ayurvedic (East Indian) medicines and traditional aboriginal (North American) medicines, and (B) the medical use of which is based solely on historical and ethnological evidence from references relating to a medical system other than one based on conventional scientific standards; and (e) fabricating, packaging/labelling, testing, distributing, and importing of antimicrobial agents. (1.1) This Division and Division 2 do not apply to a veterinary health product or an active pharmaceutical ingredient that is used in the fabrication of a veterinary health product.

(4)

Good Manufacturing Practice

(2)

This Division and Divisions 2 to 4 do not apply to the affixing of a label to a previously labelled container.

(6)

0.35% of the casing

(3)

This Division applies to the importing, by a pharmacist, a veterinary practitioner or a person who compounds a drug under the supervision of a veterinary practitioner, of an active pharmaceutical ingredient or veterinary use that is for the purpose of compounding, pursuant to a prescription, a drug in dosage form that is not commercially available in Canada, if that ingredient is set out in List A. C.01A.003 This Division and Divisions 2 to 4 apply to the following distributors: (b) a distributor of a drug for which the distributor holds the drug identification number. C.01A.003.1 For the purposes of this Division and the provisions of Divisions 2 to 4 that are prescribed in paragraphs A.01.048(b) to (d), (a) a reference to a distributor referred to in section C.01A.003 or a distributor referred to in paragraph C.01A.003(a) includes a reference to a distributor of an active ingredient that is intended for use outside Canada; and (b) a reference to a distributor referred to in section C.01A.003 or a distributor referred to in paragraph C.01A.003(b) includes a reference to a distributor of a drug in dosage form that is intended for consumption or use outside Canada. Prohibition C.01A.004 (1) Subject to subsection (2), no person shall, except in accordance with an establishment licence, (b) perform the tests, including examinations, required under Division 2; (c) distribute as a distributor referred to in section C.01A.003 a drug other than (ii) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act; or (ii) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act.

(7)

0.5%

(2)

A person does not require an establishment licence to perform tests under Division 2 if the person holds an establishment licence as a fabricator, a packager/labeller, a distributor referred to in paragraph C.01A.003(b) or an importer.

(8)

0.75%

(3)

No person shall carry on an activity referred to in subsection (1) unless the person holds (a) in respect of a narcotic as defined in the Narcotic Control Regulations, a licence for that narcotic under those Regulations; (b) in respect of a controlled drug as defined in section G.01.001, a licence for that drug under Part G; or (c) in respect of a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act, a licence for that drug to conduct that activity under the Cannabis Regulations. C.01A.005 (1) A person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information and documents: (a) the applicant’s name, address and telephone number, and their facsimile number and electronic mail address, if any; (b) the name and telephone number, and the facsimile number and electronic mail address, if any, of a person to contact in case of an emergency; (c) each activity set out in Table I to section C.01A.008 for which the licence is requested; (e) each dosage form class in respect of which the applicant proposes to carry out a licensed activity, and whether it will be in a sterile dosage form; (f) whether the applicant proposes to carry out a licensed activity in respect of an active ingredient; (g) the address of each building in Canada in which the applicant proposes to fabricate, package/label, test as required under Division 2 or store drugs, specifying for each building the activities and the categories of drugs and, for each category, the dosage form classes, if any, and whether any drug will be in a sterile form; (h) the address of each building in Canada at which records will be maintained; (i) whether any building referred to in paragraphs (g) and (h) is a dwelling-house; (j) the drug identification number, if any, or a name that clearly identifies the drug, (i) for each narcotic as defined in the Narcotic Control Regulations, each controlled drug as defined in section G.01.001 or each drug containing cannabis as defined in subsection 2(1) of the Cannabis Act for which the licence is requested, (ii) for each other drug within a category of drugs for which the licence is requested, unless the licence is to perform tests required under Division 2, distribute as set out in paragraph C.01A.003(a), or wholesale; (k) if any of the buildings referred to in paragraph (g) have been inspected under the Act or these Regulations, the date of the last inspection; (l) evidence that the applicant’s buildings, equipment and proposed practices and procedures meet the applicable requirements of Divisions 2 to 4; (m) in the case of an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building, (i) the name and address of each fabricator, packager/labeller and tester of the drug and the address of each building in which the drug is fabricated, packaged/labelled or tested, specifying for each building the activities and the categories of drugs and, for each category, the dosage form classes, if any, and whether any drug will be in a sterile form, (ii) in respect of each activity done in an MRA country at a recognized building, the name of the regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug and that has recognized that building as meeting its good manufacturing practices standards in respect of that activity for that drug, and (iii) in respect of any other activities, (A) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or (B) other evidence establishing that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4; (n) in the case of any other importer, the name and address of each fabricator, packager/labeller and tester of the drugs proposed to be imported and the address of each building in which the drugs will be fabricated, packaged/labelled and tested, specifying for each building the activities and the categories of drugs and, for each category, the dosage form classes, if any, and whether any drug will be in a sterile form; and (i) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or (ii) other evidence establishing that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4.

(10)

0.3%

(2)

In addition to the information and documents referred to in subsection (1), a person who submits an application for an establishment licence that relates to one or more activities set out in Table I to section C.01A.008 to be carried out in respect of a category of drugs set out in Table II to that section that includes a COVID-19 drug may include a statement to that effect in the application. C.01A.006 (1) A person who wishes to amend an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the information and documents referred to in section C.01A.005 that relate to the amendment. (1.1) In addition to the information and documents referred to in subsection (1), a person who submits an application to amend an establishment licence that relates to one or more activities set out in Table I to section C.01A.008 to be carried out in respect of a category of drugs set out in Table II to that section that includes a COVID-19 drug may include a statement to that effect in the application.

(11)

Good Manufacturing Practice Column I

(2)

An establishment licence must be amended where the licensee proposes (a) to add an activity or category of drugs, as set out in the tables to section C.01A.008; (b) in respect of a category of drugs and activity indicated in the licence, to authorize sterile dosage forms of the category; (c) to add any building in Canada at which drugs are authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, or to add, for an existing building, an authorization to fabricate, package/label, test or store a category of drugs, or sterile dosage forms of the category; and (ii) to amend the name or address of a fabricator, packager/labeller or tester indicated in the licence, and (iii) if the address of the buildings at which drugs are authorized to be fabricated, packaged/labelled or tested is indicated in the licence, to add additional buildings or, for an existing building, to add an authorization to fabricate, package/label or test a category of drugs, or sterile dosage forms of the category. C.01A.007 (1) The Minister may, on receipt of an application for an establishment licence, an amendment to an establishment licence or the review of an establishment licence, require the applicant to submit further details pertaining to the information contained in the application that are necessary to enable the Minister to make a decision.

M

6 Monosodium Salts of Phosphorylated Mono- and Diglycerides O.1 Oat Gum P.1 Pectin P.1A Polyglycerol Esters of Fatty Acids P.1B Polyglycerol Esters of Interestesterified Castor Oil Fatty Acids P.2 Polyoxyethylene (20) Sorbitan Monooleate; Polysorbate 80 Column II

(2)

When considering an application, the Minister may require that (a) an inspection be made during normal business hours of any building referred to in paragraph C.01A.005(1)(g) or (h); and (b) the applicant, if a fabricator, a packager/labeller, a person who performs tests required under Division 2, a distributor referred to in paragraph C.01A.003(b) or an importer, supply samples of any material to be used in the fabrication, packaging/labelling or testing of a drug. C.01A.008 (1) Subject to subsection (1.1) and section C.01A.010, the Minister shall, on receipt of the information and material referred to in sections C.01A.005 to C.01A.007, issue or amend an establishment licence. (1.1) The Minister shall, in determining whether he or she has received the information and material referred to in sections C.01A.005 to C.01A.007 in relation to an application referred to in subsection C.01A.005(2) or C.01A.006(1.1) that contains the statement referred to in the applicable subsection, also take into consideration the public health need related to COVID-19. (a) each activity set out in Table I to this section that is authorized and the category of drugs set out in Table II to this section for which each activity is authorized, specifying for each activity and category whether sterile dosage forms are authorized; (b) the address of each building in Canada at which a category of drugs set out in Table II to this section is authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, specifying for each building which of those activities and for which category of drugs, and whether sterile dosage forms of the category are authorized; and (c) in addition to the matters referred to in paragraphs (a) and (b), in the case of an importer, (i) the name and address of each fabricator, packager/labeller and tester from whom the importer is authorized to obtain the drug for import, and (ii) the address of each building at which the drug is authorized to be fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drugs set out in Table II to this section that are authorized, and whether sterile dosage forms are authorized.

(1)

Unstandardized Foods

(3)

The Minister may indicate in an establishment licence a period for which records shall be retained under Division 2 that, based on the safety profile of the drug or materials, is sufficient to ensure the health of the consumer.

(3)

Sour cream

(4)

When issuing an establishment licence, the Minister may impose terms and conditions on the establishment licence respecting (a) the tests to be performed in respect of a drug, and the equipment to be used, to ensure that the drug is not unsafe for use; and (b) any other matters necessary to prevent risk to the health of consumers, including conditions under which drugs are fabricated, packaged/labelled or tested. Item Activities

(4)

Sherbet

3 Perform the tests, including any examinations, required under Division 2

Food and Drug Regulations DIVISION 1A Establishment Licences Item Activities

(5)

Unstandardized foods

4 Distribute as a distributor referred to in paragraph C.01A.003(a) an active ingredient other than

(b) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act

(1)

Unstandardized foods

5 Distribute as a distributor referred to in paragraph C.01A.003(b)

(2)

Vegetable oils

7 Wholesale a drug other than

(b) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act

(3)

Calorie-reduced margarine

4 Drugs that are listed in Schedule D to the Act other than vaccines

(1)

Chocolate products

5 Drugs listed in Schedule C to the Act

(2)

Unstandardized chocolate flavoured confectionery coatings

6 Drugs that are prescription drugs, controlled drugs as defined in section G.01.001, narcotics as defined in the Narcotic Control Regulations and drugs containing cannabis as defined in subsection 2(1) of the Cannabis Act

(1)

Ice cream; Ice cream mix; Ice milk; Ice milk mix; Sherbet

7 Active pharmaceutical ingredients set out in List A that are for veterinary use

Annual Licence Review C.01A.009 (1) The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referred to in section C.01A.005.

(2)

Unstandardized frozen desserts

(2)

The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession. Refusal to Issue C.01A.010 (1) The Minister may refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if (a) the applicant has made a false or misleading statement in relation to the application for the licence; or (b) the applicant has had an establishment licence suspended in respect of the matter.

(4)

Unstandardized beverage bases; Unstandardized beverage mixes Column III Maximum Level of Use

(2)

The Minister shall refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that issuing or amending an establishment licence in respect of the matter would constitute a risk to the health of the consumer.

(12)

0.5% in accordance with the requirements of sections B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(3)

Where the Minister refuses to issue or amend an establishment licence, the Minister shall (a) notify the applicant in writing of the reasons for the refusal; and (b) give the applicant an opportunity to be heard. Terms and Conditions C.01A.011 (1) Every person who holds an establishment licence shall comply with (a) the requirements of the establishment licence; and C.01A.012 (1) The Minister may amend the terms and conditions of an establishment licence that are imposed under subsection C.01A.008(4) if the Minister believes on reasonable grounds that an amendment is necessary to prevent risk to the health of the consumer.

(1)

4.0%

(2)

The Minister shall give at least 15 days notice in writing to the holder of the establishment licence of the proposed amendment, the reasons for it and its effective date. C.01A.012.1 (1) Despite subsection C.01A.008(4), the Minister may, at any time, including when issuing an establishment licence, impose terms and conditions on an establishment licence that is issued or amended under section C.01A.008 on the basis of an application referred to in subsection C.01A.005(2) or C.01A.006.1(1) that contains the statement referred to in the applicable subsection.

(1)

Good Manufacturing Practice

(2)

For greater certainty, terms and conditions that may be imposed under subsection (1) are not limited to those that may be imposed under subsection C.01A.008(4). C.01A.012.2 The Minister may, at any time, amend terms or conditions that are imposed on an establishment licence under subsection C.01A.012.1(1). Notification C.01A.013 Every person who holds an establishment licence shall notify the Minister in writing within 15 days after (a) there is any change to the information referred to in any of paragraphs C.01A.005(1)(a), (b) and (e) to (i); or (b) an event occurs that results in their being in contravention of any of the applicable requirements of Divisions 2 to 4, where it may affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested as required under Division 2 or stored by them. C.01A.014 (1) No licensee shall carry on a licensed activity in respect of any category of drugs if a change referred to in subsection (2) has occurred in respect of that category, unless (a) they have filed with the Minister a notice that contains sufficient information to enable the Minister to assess the safety of the drug, taking into account the change; and (b) the Minister has issued to them a letter indicating that the information will be reviewed and has not, within 90 days after issuing the letter, sent them a notice indicating that the change is not acceptable.

(1)

Good Manufacturing Practice

(2)

Notification is required in respect of the following changes where they may affect whether a drug can be fabricated, packaged/labelled, tested or stored in accordance with the applicable requirements of Divisions 2 to 4: (a) changes to the plans and specifications of a building where a drug is fabricated, packaged/labelled, tested or stored; (b) changes to the equipment that is used in the fabrication, packaging/labelling or testing of a drug; (c) changes to the practices or procedures; and (d) in the case of an importer, other than an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building, any change referred to in paragraphs (a) to (c) that relates to the fabricator, packager/labeller or tester of the drug being imported. C.01A.015 (1) An importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building shall immediately notify the Minister if the fabricator, packager/labeller or tester indicated in the importer’s establishment licence no longer holds a valid permit, licence or other authorization issued by the regulatory authority that recognized that building.

(2)

0.5%

(2)

The Minister shall, on receiving a notification under subsection (1), amend the importer’s establishment licence by removing the name and address of that fabricator, packager/labeller or tester. C.01A.016 (1) The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if he or she has reasonable grounds to believe that (a) the licensee has contravened any provision of the Act or these Regulations; or (b) the licensee has made a false or misleading statement in the application for the establishment licence.

(3)

0.5% in accordance with the requirement of clause B.08.077(b)(vii)(A)

(2)

Before suspending an establishment licence, the Minister shall consider (a) the licensee’s history of compliance with the Act and these Regulations; and (b) the risk that allowing the licence to continue in force would constitute for the health of the consumer.

(4)

Good Manufacturing Practice

(3)

The Minister shall not suspend an establishment licence until (a) the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken; (b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and (c) the licensee has been given an opportunity to be heard in respect of the suspension. C.01A.017 (1) The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if, after the Minister has, under section 21.31 of the Act, ordered the licensee to conduct an assessment in order to provide evidence establishing that the licensee’s buildings, equipment or practices and procedures, as the case may be, continue to meet the requirements referred to in paragraph C.01A.005(1)(l), subparagraph C.01A.005(1)(m)(ii) or (iii) or paragraph C.01A.005(1)(o), (a) the licensee fails to comply with the order; or (b) the licensee complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that those requirements continue to be met. C.01A.018 The Minister shall reinstate an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) that are the subject of the suspension if, within 12 months after the effective date of the suspension, the licensee provides the Minister with sufficient evidence demonstrating that (a) the situation on which the suspension was based has been corrected; or (b) the situation on which the suspension was based did not exist. Cancellation C.01A.018.1 The Minister shall cancel an establishment licence if the licensee has failed to submit an application for the review of the licence in accordance with subsection C.01A.009(1). C.01A.018.2 (1) If the Minister has suspended an establishment licence in respect of all matters indicated in subsection C.01A.008(2) and the suspension is still in effect 12 months after the effective date of the suspension, the Minister shall cancel the licence.

(5)

Good Manufacturing Practice

(2)

If the Minister has suspended an establishment licence in respect of one or more of the matters indicated in subsection C.01A.008(2) and the suspension is still in effect 12 months after the effective date of the suspension, the Minister shall cancel the licence only in respect of the matters that are the subject of the suspension. Designation C.01A.019 (1) For the purposes of this Division and Divisions 2 to 4, a regulatory authority that is set out in column 1 of the List of Regulatory Authorities for the Purposes of Section C.01A.019 of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time, is designated in respect of the activities set out in column 3 for the drugs or categories of drugs that are set out in column 2.

(1)

Good Manufacturing Practice

(2)

Whole blood and its components are excluded from the drugs and categories of drugs that are set out in column 2 of the List.

(2)

0.025%

(3)

The lot release of drugs listed in Schedule D to the Act is excluded from the activity of testing set out in column 3 of the List. medical gas means any gas or mixture of gases manufactured, sold or represented for use as a drug; (gaz médical) specifications means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes (a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material, (b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and (c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. (spécifications) C.02.002.1 This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents. (a) a reference to specifications is — in respect of a drug intended for consumption or use outside Canada, the raw material used in such a drug or the packaging material for such a drug—a reference to the specifications with which the drug, raw material or packaging material is required to comply in the country in which the drug is intended to be consumed or used; and (b) the definition expiration date in subsection C.01.001(1) does not apply in respect of a drug intended for consumption or use outside Canada. C.02.003 No distributor referred to in paragraph C.01A.003(b) and no importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division. C.02.003.1 No person shall sell a drug that they have fabricated, packaged/labelled, tested or stored unless they have fabricated, packaged/labelled, tested or stored it in accordance with the requirements of this Division. C.02.003.2 (1) No person shall import an active ingredient into Canada for the purpose of sale unless they have in Canada a person who is responsible for its sale.

(1)

0.5%

(2)

No person who imports an active ingredient into Canada shall sell any lot or batch of it unless the following appear on its label: (a) the name and civic address of the person who imports it; and (b) the name and address of the principal place of business in Canada of the person who is responsible for its sale. Use in Fabrication C.02.003.3 No person shall use an active ingredient in the fabrication of a drug unless it is fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division. C.02.004 The premises in which a lot or batch of a drug is fabricated, packaged/labelled or stored shall be designed, constructed and maintained in a manner that (a) permits the operations therein to be performed under clean, sanitary and orderly conditions; (b) permits the effective cleaning of all surfaces therein; and (c) prevents the contamination of the drug and the addition of extraneous material to the drug. Equipment C.02.005 The equipment with which a lot or batch of a drug is fabricated, packaged/labelled or tested shall be designed, constructed, maintained, operated and arranged in a manner that (a) permits the effective cleaning of its surfaces; (b) prevents the contamination of the drug and the addition of extraneous material to the drug; and (c) permits it to function in accordance with its intended use. C.02.006 Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic and other training as the Minister considers satisfactory in the interests of the health of the consumer or purchaser. C.02.007 (1) Every person who fabricates or packages/labels a drug shall have a written sanitation program that shall be implemented under the supervision of qualified personnel.

(2)

0.25%

(2)

The sanitation program referred to in subsection (1) shall include Food and Drug Regulations (a) cleaning procedures for the premises where the drug is fabricated or packaged/labelled and for the equipment used in the fabrication or packaging/ labelling; and (b) instructions on the sanitary fabrication and packaging/labelling of drugs and the handling of materials used in the fabrication and packaging/labelling of drugs. C.02.008 (1) Every person who fabricates or packages/ labels a drug shall have, in writing, minimum requirements for the health and the hygienic behaviour and clothing of personnel to ensure the clean and sanitary fabrication and packaging/labelling of the drug.

(3)

2.0%

(2)

No person shall have access to any area where a drug is exposed during its fabrication or packaging/labelling if the person (a) is affected with or is a carrier of a disease in a communicable form; or (b) has an open lesion on any exposed surface of the body. C.02.009 (1) Each lot or batch of raw material shall be tested against the specifications for that raw material prior to its use in the fabrication of a drug.

(2)

0.05%

(2)

No lot or batch of raw material shall be used in the fabrication of a drug unless that lot or batch of raw material complies with the specifications for that raw material.

(3)

0.05% PART B Foods

(3)

Notwithstanding subsection (1), water may, prior to the completion of its tests under that subsection, be used in the fabrication of a drug.

Section B.16.100

Règlement sur les aliments et drogues

(4)

Where any property of a raw material is subject to change on storage, no lot or batch of that raw material shall be used in the fabrication of a drug after its storage unless the raw material is retested after an appropriate interval and complies with its specifications for that property.

PARTIE B Aliments

(5)

Where the specifications referred to in subsections (1), (2) and (4) are not prescribed, they shall C.02.010 (1) The testing referred to in section C.02.009 shall be performed on a sample taken (a) after receipt of each lot or batch of raw material on the premises of the fabricator; or (b) subject to subsection (2), before receipt of each lot or batch of raw material on the premises of the fabricator, if (A) has evidence satisfactory to the Minister to demonstrate that raw materials sold to him by the vendor of that lot or batch of raw material are consistently manufactured in accordance with and consistently comply with the specifications for those raw materials, and (B) undertakes periodic complete confirmatory testing with a frequency satisfactory to the Minister, and (ii) the raw material has not been transported or stored under conditions that may affect its compliance with the specifications for that raw material.

TITRE 16 Additifs alimentaires

(2)

After a lot or batch of raw material is received on the premises of the fabricator, the lot or batch of raw material shall be tested for identity. C.02.011 (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall have written procedures prepared by qualified personnel in respect of the drug to ensure that the drug meets the specifications for that drug.

Article B.16.100

Column I | Column II | Column III

(2)

Every person required to have written procedures referred to in subsection (1) shall ensure that each lot or batch of the drug is fabricated, packaged/labelled and tested in compliance with those procedures. (a) a system of control that permits complete and rapid recall of any lot or batch of the drug that is on the market; and (b) a program of self-inspection.

(5)

Imitation dry cream mix

(2)

Every fabricator and packager/labeller and, subject to subsections (3) and (4), every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall maintain a system to ensure that any lot or batch of the drug fabricated and packaged/labelled on premises other than their own is fabricated and packaged/labelled in accordance with the requirements of this Division.

(6)

Whipped vegetable oil topping

(3)

Subsection (2) does not apply to a distributor if the drug is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities in respect of that drug.

(7)

Cake icing; cake icing mix

(4)

Subsection (2) does not apply to a distributor or importer if the drug is fabricated or packaged/labelled in an MRA country at a recognized building and both of the following requirements are met: (a) the address of the building is set out in their establishment licence; and (b) they retain a copy of the batch certificate for each lot or batch of the drug that they receive. C.02.013 (1) Every fabricator, packager/labeller, wholesaler, distributor referred to in section C.01A.003 and importer of a drug shall have on their premises in Canada a quality control department that is supervised by personnel described in section C.02.006.

(8)

Salt

(2)

Except in the case of a wholesaler or a distributor referred to in paragraph C.01A.003(a), the quality control department shall be a distinct organizational unit that functions and reports to management independently of any other functional unit, including the manufacturing, processing, packaging or sales unit. C.02.014 (1) Except in the case of a wholesaler or a distributor referred to in paragraph C.01A.003(a), no lot or batch of a drug shall be made available for further use in fabrication or for sale unless the person in charge of the quality control department approves the sale or the further use.

(8)

10 p.p.m.

(2)

A drug that is returned to its fabricator, packager/ labeller, wholesaler, distributor referred to in section C.01A.003 or importer shall not be made available for further use in fabrication or for further sale unless the person in charge of the quality control department approves the further sale or further use.

(9)

Whipped cream

(3)

No lot or batch of a raw material or packaging/ labelling material shall be used in the fabrication or packaging/labelling of a drug unless the person in charge of the quality control department approves the use.

(9)

0.1%

(4)

No lot or batch of a drug shall be reprocessed unless the person in charge of the quality control department approves the reprocessing. C.02.015 (1) All fabrication, packaging/labelling, testing, storage and transportation operations that may affect the quality of a drug shall be examined and approved by the person in charge of the quality control department before their implementation.

(10)

Breath freshener products

(2)

The person in charge of the quality control department shall cause to be investigated any complaint or information that is received respecting the quality of a drug or its deficiencies or hazards and cause any necessary corrective action to be taken, in the case where the complaint or information relates to an activity over which the department exercises quality control. (2.1) In the case where the complaint or information that is received does not relate to an activity over which the quality control department exercises quality control, the person in charge of the department shall forward the complaint or information to the person in charge of the quality control department that exercises quality control over that activity.

(10)

100 p.p.m.

(3)

The person in charge of the quality control department shall cause all tests or examinations required pursuant to this Division to be performed by a competent laboratory. C.02.016 (1) Each lot or batch of packaging material shall, prior to its use in the packaging of a drug, be examined or tested against the specifications for that packaging material.

(11)

Creamed cottage cheese

(2)

No lot or batch of packaging material shall be used in the packaging of a drug unless the lot or batch of packaging material complies with the specifications for that packaging material. (b) be acceptable to the Minister who shall take into account the specifications contained in any publication mentioned in Schedule B to the Act; and (c) be approved by the person in charge of the quality control department. C.02.017 (1) The examination or testing referred to in section C.02.016 shall be performed on a sample taken (a) after receipt of each lot or batch of packaging material on the premises of the person who packages a drug; or (b) subject to subsection (2), before receipt of each lot or batch of packaging material on the premises of the person who packages a drug, if (i) that person (A) has evidence satisfactory to the Minister to demonstrate that packaging materials sold to him by the vendor of that lot or batch of packaging material are consistently manufactured in accordance with and consistently comply with the specifications for those packaging materials, and (B) undertakes periodic complete confirmatory examination or testing with a frequency satisfactory to the Minister, (ii) the packaging material has not been transported or stored under conditions that may affect its compliance with the specifications for that packaging material.

(11)

80 p.p.m.

(2)

After a lot or batch of packaging material is received on the premises of the person who packages a drug, (a) the lot or batch of the packaging material shall be examined or tested for identity; and (b) the labels shall be examined or tested in order to ensure that they comply with the specifications for those labels. Finished Product Testing C.02.018 (1) Each lot or batch of a drug shall, before it is made available for further use in fabrication or for sale, be tested against the specifications for that drug.

(12)

0.2% of the pumping pickle

(2)

No lot or batch of a drug shall be made available for further use in fabrication or for sale unless it complies with the specifications for that drug. (b) be approved by the person in charge of the quality control department; and (c) comply with the Act and these Regulations. C.02.019 (1) A packager/labeller of a drug, a distributor referred to in paragraph C.01A.003(b) and an importer of a drug other than an active ingredient shall perform the finished product testing on a sample of the drug that is taken either (a) after receipt of each lot or batch of the drug on their premises in Canada; or (b) before receipt of each lot or batch of the drug on their premises in Canada if the following conditions are met: (A) has evidence satisfactory to the Minister to demonstrate that drugs sold to them by the vendor of that lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for those drugs, and (B) undertakes periodic complete confirmatory testing, with a frequency satisfactory to the Minister, and (ii) the drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

(13)

Sausage casings

(2)

If the packager/labeller, distributor or importer receives a lot or batch of a drug on their premises in Canada the useful life of which is more than 30 days, the lot or batch shall be tested for identity and the packager/ labeller shall confirm the identity after the lot or batch is packaged/labelled.

(13)

0.15% of the casing

(3)

Subsections (1) and (2) do not apply to a distributor if the drug is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes that activity.

(14)

Liquid Smoke Flavours

(4)

Subsections (1) and (2) do not apply to a distributor or importer if the drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and they retain a copy of the batch certificate for each lot or batch of the drug that they receive. (4.1) Subsections (1) and (2) do not apply to a distributor or importer of a COVID-19 drug if it is the subject of a written request made under section C.04.015. (4.2) Subsection (1) does not apply to a packager/ labeller, distributor or importer if the following conditions are met: (a) the drug is a radiopharmaceutical or a radionuclide generator, as defined in section C.03.001, and has a useful life of no more than 30 days; and (b) the packager/labeller, distributor or importer maintains evidence satisfactory to the Minister to demonstrate that (i) the drug has been tested against the specifications for that drug, and (ii) the drug has not been transported or stored under conditions that may affect its compliance with those specifications. (4.3) Subsections (1) and (2) do not apply to a packager/ labeller, distributor or importer if the following conditions are met: (a) the drug is (iii) listed in Schedule D to the Act, (iv) not a vaccine, and (v) composed of genetically modified autologous human nucleated cells or is delivered to cells using an adeno-associated virus vector; and (b) the packager/labeller, distributor or importer maintains evidence satisfactory to the Minister to demonstrate that (i) the drug has been tested against the specifications for that drug, and (ii) the drug has not been transported or stored under conditions that may affect its compliance with those specifications.

(14)

Good Manufacturing Practice. Residues of Polysorbate 80 must not exceed 275 p.p.m. in the finished food

(5)

Subsections (1) and (2) do not apply to a distributor or importer of a drug that is not a prescription drug and that is part of a class of drugs that is set out in column 1 of the List of Non-prescription Drugs Not Subject to Certain Testing Requirements if all of the following conditions are met: (a) the drug contains, as its only active ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6; and (b) the drug is (i) fabricated in Canada or in a recognized country or region, (ii) packaged/labelled in Canada or in a recognized country or region, and (iii) tested in a recognized country or region. (c) the distributor or the importer retains a copy of the batch certificate for each lot or batch of the drug that is distributed or imported, as the case may be.

(15)

Vegetable oils

(6)

A drug that is referred to in subsection (4.2), (4.3) or (5) and that is imported may be shipped directly to a person other than the importer if the following conditions are met: (a) before importing the drug, the importer receives a document that demonstrates that the drug complies with the specifications for that drug; (b) the importer and the distributor have measures in place to ensure that all the requirements of these Regulations in respect of the importation of the drug are met. C.02.020 (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall maintain at each of their establishments the following records on their premises in Canada for each drug that they fabricate, package/label, distribute or import: (a) except in the case of an importer of an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act, master production documents for the drug; (b) evidence that each lot or batch of the drug has been fabricated, packaged/labelled, tested and stored in accordance with the procedures described in the master production documents; (c) evidence that the conditions under which the drug was fabricated, packaged/labelled, tested and stored are in compliance with the requirements of this Division; (d) evidence that establishes the period during which the drug in the container in which it is sold or made available for further use in fabrication will meet the specifications for that drug; and (e) evidence that the finished product testing referred to in section C.02.018 was carried out and the results of that testing.

(15)

0.125%

(2)

Every distributor referred to in paragraph C.01A.003(b) and importer shall make available to the Minister, on request, the results of testing performed on raw materials and packaging/labelling materials for each lot or batch of a drug that it distributes or imports.

(16)

Annatto formulations

(3)

Every fabricator shall maintain on their premises written specifications for all raw materials and adequate evidence of the testing of those raw materials referred to in section C.02.009 and of the test results.

(16)

25% of the total colour formulation

(4)

Every person who packages a drug shall maintain on their premises written specifications for all packaging materials and adequate evidence of the examination or testing of those materials referred to in section C.02.016 and of any test results.

(17)

Turmeric formulations

(5)

Every fabricator, packager/labeller and tester shall maintain on their premises in Canada detailed plans and specifications of each building in Canada where they fabricate, package/label or test drugs and a description of the design and construction of those buildings.

(17)

50% of the total colour formulation

(6)

Every fabricator, packager/labeller and tester shall maintain on their premises in Canada personnel records in respect of each person who is employed to supervise the fabrication, packaging/labelling and testing of drugs, including the person’s title, responsibilities, qualifications, experience and training. C.02.021 (1) All records and evidence of the fabrication, packaging/labelling, finished product testing referred to in section C.02.018 and storage of a drug in dosage form that are required to be maintained under this Division shall be retained for one year after the expiration date of the drug unless the person’s establishment licence specifies some other period.

(18)

Liquid smoke flavour concentrate

(2)

Subject to subsection (4), all records and evidence of the fabrication, packaging/labelling, finished product testing referred to in section C.02.018 and storage of an active ingredient that are required to be maintained under this Division shall be retained in respect of each lot or batch of the active ingredient for the following period unless the person holds an establishment licence that specifies some other period: (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or (b) in any other case, one year after the expiration date of the lot or batch.

(19)

Unstandardized salad dressings P.3 Polyoxyethylene (20) Sorbitan Monostearate; Polysorbate 60

(3)

Subject to subsection (4), all records and evidence of the raw material testing referred to in section C.02.009 and of the testing of packaging/labelling materials that are required to be maintained under this Division shall be retained for five years after the raw materials and packaging/labelling materials were last used in the fabrication or packaging/labelling of a drug unless the person's establishment licence specifies some other period.

(1)

Imitation dry cream mix; Vegetable oil creaming agent; Whipped vegetable oil topping; Vegetable oil topping mix PART B Foods

(4)

If a fabricator is required to maintain records and evidence in respect of the same active ingredient under subsections (2) and (3), they shall maintain them for the longest period that is applicable. C.02.022 (1) Every wholesaler, distributor referred to in section C.01A.003 and importer of a drug in dosage form shall retain records of sale of each lot or batch of the drug, which enable them to recall the lot or batch from the market, for one year after the expiration date of that lot or batch unless their establishment licence specifies some other period.

Section B.16.100

Column I | Column II | Column III

(2)

Every distributor of an active ingredient referred to in paragraph C.01A.003(a) and every wholesaler and importer of an active ingredient shall retain records of sale of each lot or batch of the active ingredient, which enable them to recall the lot or batch from the market, for the following periods unless the person holds an establishment licence that specifies some other period: (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or (b) in any other case, one year after the expiration date of the lot or batch. C.02.023 (1) On receipt of a complaint or any information respecting the quality of a drug or its deficiencies or hazards, every fabricator, packager/labeller, wholesaler, distributor referred to in section C.01A.003 and importer of the drug shall make a record of the complaint or information that contains the following: (b) the name and business address of the person in charge of the quality control department to whom the complaint or information was forwarded under subsection C.02.015(2.1) and the date on which it was forwarded.

(2)

Cakes

(2)

Records referred to in subsection (1) shall be retained for the following period unless the person holds an establishment licence that specifies some other period: (a) in the case of a drug in dosage form, one year after the expiration date of the lot or batch of the drug; and (i) if the active ingredient has a retest date, three years after the lot or batch has been completely distributed, or (ii) in any other case, one year after the expiration date of the lot or batch of the active ingredient. (a) maintain records of the results of the self-inspection program required by section C.02.012 and of any action taken in connection with that program; and (b) retain those records for a period of at least three years. (a) maintain records on the operation of the sanitation program required to be implemented under section C.02.007; and (b) retain those records for a period of at least three years. C.02.024.1 Every distributor of an active ingredient referred to in paragraph C.01A.003(a) and every fabricator, packager/labeller, wholesaler and importer of an active ingredient shall add all of the following information to the documentation that accompanies the active ingredient, immediately after any like information that has been added by another person: (a) their establishment licence number, or if there is none, their name, address, telephone number, fax number and email address; (b) an indication whether they have fabricated, packaged/labelled, wholesaled, distributed or imported the active ingredient and the date on which that activity was carried out; (c) the expiration date; and C.02.025 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for one year after the expiration date of the drug unless their establishment licence specifies otherwise.

(6)

Pie fillings; Puddings | (6) 0.5% on a dry weight basis

(2)

Subject to subsection (4), the fabricator of a drug in dosage form shall retain a sample of each lot or batch of the raw materials used in the fabrication for two years after the materials were last used in the fabrication unless their establishment licence specifies some other period.

(8)

Sour Cream Substitute | (8) 0.1%

(3)

Subject to subsection (4), the fabricator of an active ingredient shall retain a sample of each lot or batch of it for the following period unless their establishment licence specifies some other period: (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or (b) in any other case, one year after the expiration date of the lot or batch.

(9)

Unstandardized dressings; Unstandardized prepared canned cooking sauces | (9) 0.3%

(4)

If a fabricator is required to maintain samples in respect of the same active ingredient under subsections (2) and (3), they shall maintain them for the longest period that is applicable. C.02.026 The samples referred to in section C.02.025 shall be in an amount that is sufficient to determine whether the drug or raw material complies with the specifications for that drug or raw material. Stability C.02.027 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug.

(10)

Fat base formulation for self-basting of poultry by injection | (10) 0.25%

(2)

Every fabricator and importer of an active ingredient shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug. C.02.028 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.

(11)

Unstandardized sandwich spreads; Unstandardized dips | (11) 0.2%

(2)

Every fabricator and importer of an active ingredient shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold. Sterile Products C.02.029 In addition to the other requirements of this Division, a drug that is intended to be sterile shall be fabricated and packaged/labelled (b) under the supervision of personnel trained in microbiology; and (c) by a method scientifically proven to ensure sterility. drug means a drug that is listed in Schedule C to the Act that is in dosage form or a drug that is an active ingredient of biological origin that can be used in the preparation of a drug listed in that Schedule; (drogue) master lot means a quantity of a drug from which a lot is prepared for sale by subsequent dilution or mixture; (maître-lot) radionuclide generator means a radioactive parent and daughter (b) dissolved in a suitable solvent in a liquid-liquid extraction system where the radioactive daughter is separated from its parent by (c) elution from the ion exchange column, or C.03.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division. C.03.012 On written request from the Minister, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot or master lot of the drug before it is sold, and no person shall sell a lot of which the protocol or sample fails to meet the requirements of these Regulations. C.03.013 No person shall fabricate or import a drug that is derived from animal tissue unless the tissue is obtained from a healthy animal free from infectious disease. C.03.015 (1) Every package of a drug that is a prescription drug shall carry the symbol “Pr” on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label. (c) a radiopharmaceutical as defined in section C.03.201; or Radiopharmaceuticals C.03.201 In these Regulations, radiopharmaceutical means a drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. (a) on both the inner and the outer labels, (i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name, (ii) the name of the distributor referred to in paragraph C.01A.003(b), (iii) the lot number, and (b) on the outer label (i) the address of the distributor referred to in paragraph C.01A.003(b), (ii) the standard that the drug professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act, (iii) a statement of the pharmaceutical form or the route of administration of the drug, (iv) a statement of the recommended use and the recommended radioactivity to be administered for that use, or a reference to an accompanying package insert that shows such information, (vi) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “RAYONNEMENT — DANGER — RADIATION”, (vii) the names and a statement of the amounts of any preservatives or stabilizing agents contained in the drug, (x) a statement of the total volume of the drug including overfill, except where its contents are entirely in gaseous, capsule or lyophilized form, (xi) a statement of the concentration of radioactive material in the drug expressed as except where the contents of the drug are entirely in gaseous or lyophilized form, (xiii) a statement of the reference time in respect of the radioactivity values mentioned in subparagraphs (ix), (xi) and (xii), the name of the month being written or designated by letter abbreviation, (xiv) a statement of the recommended useful life or the date after which the drug is not recommended for use, the name of the month being written or designated by letter abbreviation, and (xv) a statement of the special storage requirements with reference to temperature and light.

(12)

Dry soup base or mix | (12) 250 p.p.m. in soup as consumed

(2)

Subparagraph (1)(a)(iv) does not apply to a radiopharmaceutical that is (a) compounded by a pharmacist under a prescription or by a practitioner; or (i) its proper name, common name or brand name, (ii) its potency, and (iii) the name of its manufacturer.

(13)

Dry batter coating mixes | (13) 0.5% of the dry mix

(3)

Subparagraph (1)(b)(viii) of this section does not apply where the information referred to in that subparagraph is shown on a package insert that accompanies the drug. (a) the proper name of the radionuclide generator, which proper name, where there is a brand name, shall immediately precede or follow the brand name; (b) the name and address of the distributor referred to in paragraph C.01A.003(b); (c) the lot number; (d) the standard that the radionuclide generator professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act; (f) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “RAYONNEMENT — DANGER — RADIATION”; (h) a statement of the hour and date at which the radioactivity value mentioned in paragraph (g) is valid, the name of the month being written or designated by letter abbreviation; (i) a statement of the recommended useful life or the date after which the radionuclide generator is not recommended for use, the name of the month being written or designated by letter abbreviation; (j) a statement of the recommended useful life of the drug after removal from the radionuclide generator; (l) complete directions for use or a reference to an accompanying package insert that sets out such directions; and (m) a statement cautioning against the dismantling of the radionuclide generator.

(14)

Prepared alcoholic cocktails | (14) 120 p.p.m. in beverage as consumed P.4 | Polyoxyethylene (20) Sorbitan Tristearate; Polysorbate 65

(2)

Paragraphs (1)(i) and (j) of this section do not apply where the information referred to in those subparagraphs is shown on a package insert that accompanies the radionuclide generator. C.03.204 (1) No person shall sell a drug that contains technetium-99m at any time during its useful life if it also contains a radionuclidic impurity set out in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication set out in item 8 of Schedule B to the Act, in an amount greater than that shown in the monograph.

(3)

Unstandardized frozen desserts | (3) 0.1% PART B Foods

(2)

No person shall sell a radionuclide generator from which can be removed a drug that contains technetium-99m, at any time during the useful life of the drug, if the drug also contains a radionuclidic impurity set out in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication set out in item 8 of Schedule B to the Act, in an amount greater than that shown in the monograph. Drugs, other than Radionuclides, Sold or Represented for Use in the Preparation of Radiopharmaceuticals C.03.205 The following definitions apply in this section and in sections C.03.206 to C.03.209. component means (a) a unit of a drug, other than a radionuclide, separately packaged in a kit; or kit means a package that is intended to be used in the preparation of radiopharmaceuticals and that (a) contains one or more separately packaged units of a drug, other than a radionuclide; and (a) adequate identification of the component and an adequate description of its function; (b) where applicable, a quantitative list of its ingredients or a reference to the label of the kit that shows such information; (c) the name of the distributor referred to in paragraph C.01A.003(b); (e) a statement of any special storage requirements with respect to temperature and light; (f) the date after which the component is not recommended for use, the name of the month being written in full or designated by letter abbreviation; and (g) adequate directions for use or a reference to the accompanying package insert that shows such directions. (a) its proper name; (b) its brand name, if any; (c) a list of its contents; (g) a statement of any special storage requirements with respect to temperature and light. (h) the date after which the kit is not recommended for use, the name of the month being written in full or designated by letter abbreviation; (i) where the label of a component makes reference to the label of the kit that shows information as to the ingredients of the component, a quantitative list of the ingredients of that component; (k) adequate directions for preparing the radiopharmaceutical or a reference to the accompanying package insert that shows such directions; (n) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use, or a reference to the accompanying package insert that shows such information; and C.03.209 A package insert shall be included in every kit and shall show (a) the proper name and the brand name, if any, of the kit and a description of its use; (c) the name and address of the distributor referred to in paragraph C.01A.003(b) of the kit; (e) directions for preparing the radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical; (h) indications and contraindications in respect of the prepared radiopharmaceutical; (i) warnings and precautions in respect of the components and the prepared radiopharmaceutical; (j) the adverse reactions, if any, associated with the prepared radiopharmaceutical; (k) where applicable, the pharmacology and toxicology of the prepared radiopharmaceutical or a statement that such information is available on request; (m) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use; (n) a statement of the route of administration of the prepared radiopharmaceutical; and (o) a recommendation that the radiochemical purity and radioactivity content of the prepared radiopharmaceutical be checked prior to administration. C.03.301 The following definitions apply in this section and in sections C.03.302 to C.03.319. adverse reaction means an undesirable and unintended response in a study subject or other person to a study drug that is caused by the administration of any dose of the study drug. (réaction indésirable) good clinical practices means generally accepted clinical practices that are designed to protect the rights, safety and well-being of study subjects and other persons. (bonnes pratiques cliniques) import means, in respect of a study drug, to import it into Canada for sale for the purpose of a study. (importer) other person means an individual who comes into physical contact with a study subject. (autre personne) protocol means a document that describes the objectives, design, methodology, statistical considerations and organization of a study. (protocole) qualified investigator means the physician and member in good standing of a professional medical association in Canada to whom a sponsor gives the responsibility for the proper conduct of the study at a given study site, who is entitled to practise their profession under the laws of the province where the study site is located. (chercheur qualifié) serious adverse reaction means an adverse reaction that results in any of the following consequences for the study subject or other person: (a) their in-patient hospitalization or its prolongation; (c) persistent or significant disability or incapacity; serious unexpected adverse reaction means a serious adverse reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the study drug. (réaction indésirable grave et imprévue) sponsor means a person who is responsible for the conduct of a study. (promoteur) study means a basic clinical research study that involves human subjects and that is described in sections C.03.304 and C.03.305. (étude) study site means the location where all or part of a study is conducted. (lieu d’étude)

Section B.16.100

Column I | Column II | Column III

(3)

Sections C.03.303 to C.03.319 do not apply to a study drug manufactured from a bulk process intermediate that is of biological origin. Prohibition C.03.303 No person shall sell or import a study drug unless all of the following requirements are met: (a) the study drug is for use only in a study; (b) the study drug has been previously tested in human subjects and its safety in humans has been demonstrated; (c) if the study drug is to be imported, the manufacturer of the drug has a representative in Canada who is responsible for its sale; C.03.304 (1) The purpose of a study is to obtain data on any of the following: (c) changes caused to human biochemistry or physiology by aging, disease or medical interventions.

(8)

Breath freshener products | (8) 200 p.p.m. P.5 | Polyoxyethylene (8) Stearate | Unstandardized bakery products | 0.4%. P.7 | Potassium Carrageenan | Same foods as listed for Carrageenan | Same levels as prescribed for Carrageenan. P.8 | Potassium Chloride | Unstandardized foods | Good Manufacturing Practice. P.12 | Propylene Glycol Alginate | (1) Ale; Beer; French dressing; Light beer; Malt liquor; Mustard pickles; Porter; Relishes; Salad dressing; Stout | (1) Good Manufacturing Practice. | (3) Sherbet | (3) 0.75%. | (4) Unstandardized foods | (4) Good Manufacturing Practice. PART B Foods

(2)

A study is not primarily intended to do any of the following: (b) identify adverse reactions; C.03.305 (1) A study shall meet all of the following requirements: (a) before the study drug is used in the study, there is sufficient data from testing it in animals and humans to demonstrate its safety in humans; (b) the amount of active ingredients or combination of active ingredients in the study drug has been shown not to cause any clinically detectable pharmacodynamic effect in humans; (c) the total radiation dose incurred annually by a study subject, including from multiple administrations of the study drug, from significant contaminants or from impurities and from the use of other procedures for the purposes of the study, will be not more than 50 mSv; (d) any concomitant drug used in the study has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a concomitant drug that is a new drug, has been issued a notice of compliance under section C.08.004; (e) study subjects shall be at least 18 years old and have legal capacity at the time of the study; (i) be confirmed at the outset of the study, on the basis of a pregnancy test, as not being pregnant or state in writing that they are not pregnant, and (ii) be advised that if they are lactating, they are to suspend lactation for 24 hours after the administration of the study drug; and (g) the study shall not involve more than 30 study subjects.

Section B.16.100

Column I | Column II | Column III

(2)

Despite paragraph (1)(g), a study may involve more than 30 study subjects if the sponsor provides the Minister with a scientific rationale for the increase and the Minister approves it. Research Ethics Board C.03.306 A research ethics board has all of the following characteristics: (a) its principal mandate is to approve the initiation of and to periodically review biomedical research that involves human subjects in order to protect their rights, safety and well-being; (b) it has at least five members, a majority of whom are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act, is composed of both men and women and includes at least the following: (i) two members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical discipline, (ii) one member knowledgeable in ethics, (iii) one member knowledgeable in Canadian laws relevant to the research to be approved, (iv) one member whose primary experience and expertise are in a non-scientific discipline, and (v) one member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or with the study site; and (c) it has no affiliations with the sponsor that could compromise its ability to fulfill its principal mandate, or that could be perceived to do so. Application for Authorization C.03.307 (1) The sponsor shall submit to the Minister an application for authorization to sell or import a study drug that contains the information set out in subsection (2) as well as sufficient information to demonstrate that all of the following criteria are met: (b) the study is not contrary to the best interests of the study subjects; and (c) the objectives of the study can reasonably be achieved.

(6)

Sour cream | (6) 0.5% in accordance with the requirements of clause B.08.077(b)(vii)(A)

(2)

The application shall contain all of the following information: (b) the purposes and a concise description of the study; (j) the sponsor’s name and civic address, its postal address if different, and its telephone number, fax number and email address; (k) the manufacturer’s name and civic address, its postal address if different, and its telephone number, fax number and email address; (l) in the case of an application for importation, the name and civic address, the postal address if different, and the telephone number, fax number and email address of the manufacturer’s representative in Canada who is responsible for the sale of the study drug; (o) the proposed starting date for the study at each study site, if known; (p) for each study site, the name, civic address, telephone number, fax number and email address of the research ethics board; (q) a statement, dated and signed by the research ethics board for each study site, that certifies that it has reviewed and approved the study, the protocol and the statement of the risks and anticipated benefits arising to the health of study subjects as a result of participating in the study that is set out in the informed consent form; (r) a list of any previous applications for an authorization to sell or import a drug for a study related to the current study; and (s) a statement, dated and signed by the sponsor’s senior medical or scientific officer in Canada and senior executive officer, that certifies both of the following: (i) the study will be conducted in accordance with these Regulations, and (ii) all of the information contained or referred to in the application is complete and accurate and is not false or misleading. Additional Information C.03.308 If the information submitted under section C.03.307 is insufficient to enable the Minister to determine whether the sale or importation of the study drug should be authorized, the Minister may, by notice in writing, request the sponsor to provide any additional information that is necessary to make the determination and that is relevant to the study drug, the study or the protocol, by the date specified in the notice. Authorization C.03.309 After examining the application and any additional information, the Minister shall authorize the sponsor to sell or import the study drug if she or he determines that the application complies with the requirements of section C.03.307, and shall send a notice of that decision to the sponsor that specifies the study drug. C.03.310 The sponsor shall notify the Minister in writing of the day on which the sale or importation of the study drug is intended to start in respect of each study site, not later than 15 days before that day. C.03.311 A sponsor shall ensure that each study is conducted in accordance with good clinical practices and that (a) the study is scientifically sound and clearly described in its protocol; (b) the study is conducted, and the study drug is used, in accordance with the protocol and with these Regulations; (c) systems and procedures are implemented that assure the quality of every aspect of the study; (e) at each study site, medical care and medical decisions, in respect of the study, are under the supervision of the qualified investigator; (f) each individual who is involved in the conduct of the study is qualified by their education, training and experience to perform their respective tasks; (g) before a study subject participates in the study, a copy of their signed consent form is included in the records for the study; (h) the requirements respecting information and records set out in section C.03.315 are met; and (i) the study drug is manufactured, handled and stored in accordance with Division 2, other than sections C.02.019, C.02.025 and C.02.026. C.03.312 Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the study drug (a) bears an inner label that sets out both of the following: (ii) the radiation warning symbol set out in Schedule 3 to the *Radiation Protection Regulations* and the words “RAYONNEMENT – DANGER – RADIATION”; and (b) is accompanied by a package insert that sets out all of the following information: (i) a statement that indicates that the study drug is to be used only under the supervision of a qualified investigator, (iv) the name and civic address of the sponsor, (vi) the warnings and precautions in respect of the use of the study drug, and (vii) a list of the possible adverse reactions that are associated with the use of the study drug. C.03.313 (1) On the Minister’s written request, a sponsor shall submit, within the period specified in the request, information to establish the safety of the study drug if the Minister has reason to believe any of the following: (b) the study may be contrary to the best interests of the study subjects; (c) a qualified investigator is not respecting their undertaking made under paragraph C.03.315(3)(f); or

(7)

Canned asparagus; Canned green beans; Canned wax beans; Canned peas | (7) 1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)

(2)

The Minister may, by notice in writing, require the sponsor to provide the Minister with any information or records referred to in subsection C.03.315(3) to assess the safety of the study drug or the health of the study subjects or other persons, by the date specified in the notice. Adverse Reaction Reporting C.03.314 (1) During the course of a study, the sponsor shall notify the Minister of any serious adverse reaction or serious unexpected adverse reaction that occurs inside or outside Canada, within the following period: (a) if the adverse reaction is fatal or life-threatening, within seven days after becoming aware of it; or (b) if the adverse reaction is not fatal or life-threatening, within 15 days after becoming aware of it.

(8)

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients) | (8) 0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8 P.14 | Propylene Glycol Mono Fatty Acid Esters | (1) Ice cream mix | (1) 0.35% of the ice cream made from the mix | | (2) Unstandardized foods | (2) Good Manufacturing Practice | | (2) Coarse crystal salt | (2) 15 p.p.m. | | (3) Glaze of frozen fish | (3) Good Manufacturing Practice Column I Column II Column III Maximum Level of Use S.4 Sodium Carrageenan Same levels as prescribed for Carrageenan S.5 Sodium Cellulose Glycolate S.6 Sodium Citrate

(2)

The sponsor shall, within eight days after having notified the Minister under subsection (1), file with the Minister a complete report in respect of the adverse reaction, including an assessment of the importance and implication of the findings. C.03.315 (1) The sponsor shall record, handle and store all information in respect of a study in a way that allows it to be reported completely and accurately and to be interpreted and verified.

(4)

Sherbet

(2)

The sponsor shall maintain complete and accurate records to establish that the study is conducted in accordance with these Regulations.

(1)

4.0%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(3)

The sponsor shall maintain all of the following records in respect of the use of the study drug in each study: (a) records respecting all adverse reactions that occur inside or outside Canada, including the indications for use and the dosage form of the study drug at the time of the adverse reaction; (b) written procedures for subject monitoring and for the documentation and reporting of adverse reactions; (c) articles from scientific journals or other publications that were used in support of the safety profile of the study drug in respect of humans; (d) records in respect of each study subject, including respecting their enrolment, a copy of their signed consent form and sufficient information to enable them to be identified and contacted in the event that the sale of the study drug may endanger their health or that of another person; (e) records respecting the shipment, receipt, sale, return and destruction or other disposition of the study drug; (f) for each study site, an undertaking, dated and signed by the qualified investigator before the start of the study, that they will (i) conduct the study in accordance with good clinical practices, and (ii) on discontinuance of the study by the sponsor, for any reason related to health or safety, immediately inform both the study subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of study subjects or other persons; (g) for each study site, a copy of the informed consent form; and (h) for each study site, a copy of the certifying statement described in paragraph C.03.307(2)(a), of the protocol for the study and of the statement of the risks and anticipated benefits arising to the health of study subjects as a result of participating in the study that is set out in the informed consent form.

(2)

0.1% singly or in combination with sodium phosphate, dibasic

(4)

The sponsor shall maintain all records for five years after the day on which the study ends. C.03.316 (1) If a sponsor discontinues a study in its entirety or at a study site, the sponsor shall notify all qualified investigators of the discontinuance as soon as possible in writing, and include in the notice the reasons for the discontinuance and whether the study presented any risks to the health of study subjects or other persons.

(3)

0.5%

(2)

If the discontinuance is for reasons that would affect the health or safety of study subjects or other persons, the sponsor shall notify the Minister in writing within 15 days after the discontinuance, and include in the notice the reasons for the discontinuance and whether it will have an impact on any proposed or ongoing studies in respect of the study drug in Canada by the sponsor. C.03.317 (1) The Minister shall suspend an authorization to sell or import a study drug, in its entirety or in respect of a study site, in any of the following circumstances: (a) information provided by the sponsor under section C.03.307, C.03.308 or C.03.313 proves to be inaccurate or incomplete; (b) the sponsor fails to provide the Minister with sufficient information to establish the safety of the study drug pursuant to a written request under section C.03.313, by the date specified in the request; (c) the sponsor fails to notify the Minister of an adverse reaction or file a report in respect of an adverse reaction in accordance with section C.03.314; or

(4)

0.75% S.7 Sodium Furcelleran S.8 Sodium Gluconate

(2)

In determining whether to suspend an authorization in its entirety or in respect of a study site, the Minister shall consider whether the reason for the suspension affects the study in its entirety or affects only a certain study site.

(1)

4.0%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4 PART B Foods

(3)

Before suspending an authorization, the Minister shall send the sponsor a notice that (a) specifies whether the suspension is of the study authorization in its entirety or in respect of a study site and sets out the reasons for the proposed suspension and the effective date; (b) if applicable, specifies the corrective action that the sponsor must take and the period within which it must be taken; and (c) gives the sponsor a reasonable opportunity to be heard in writing concerning the proposed suspension.

Section B.16.100

Column I | Column II | Column III

(4)

Despite subsection (3), the Minister shall immediately suspend an authorization if she or he has reason to believe that it is necessary to do so to prevent injury to the health of a study subject or any other person.

(1)

Mustard pickles; Relishes | (1) Good Manufacturing Practice

(5)

When the Minister suspends an authorization under subsection (4), the Minister must send the sponsor a notice that (a) sets out the reasons for the suspension; (b) if applicable, specifies the corrective action that the sponsor must take and the period within which it must be taken; and (c) gives the sponsor a reasonable opportunity to be heard in writing concerning the suspension. C.03.318 (1) Subject to subsection (2), the Minister shall reinstate the authorization if the sponsor provides the Minister with sufficient evidence to establish that the study does not present a risk of injury to the health of study subjects or other persons, within the following periods: (a) in the case of a suspension under subsection C.03.317(1), 30 days after the day on which the suspension is effective; or

(2)

Ice cream; Ice cream mix; Ice milk; Ice milk mix | (2) 0.5%

(2)

If the Minister does not reinstate any part of an authorization that was suspended, the Minister shall amend the authorization to remove that part. Cancellation C.03.319 (1) The Minister shall cancel an authorization, in its entirety or in respect of a study site, in either of the following circumstances: (a) the study is discontinued in its entirety or at that study site by the sponsor under section C.03.316; or (b) the sponsor fails to provide the Minister with the evidence required by subsection C.03.318(1) within the specified period.

(4)

Sherbet | (4) 0.75%

(2)

When the Minister cancels all or part of an authorization, she or he shall send the sponsor a notice that sets out the reasons for the cancellation and the effective date. date of manufacture means (a) in the case of a product for which a standard of potency exists, the date it satisfactorily passes a potency test, (b) in the case of an animal product for which no standard of potency exists, the date of its removal from the animal, and (c) in the case of a product other than an animal product for which no standard of potency exists, the date of cessation of growth; (date de fabrication) drug means a drug that is listed in Schedule D to the Act that is in dosage form or a drug that is an active ingredient that can be used in the preparation of a drug listed in that Schedule; (drogue) C.04.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division. C.04.002 This Division does not apply to a drug in oral dosage form that contains micro-organisms if the drug is recommended solely for restoring, normalizing or stabilizing the intestinal flora. C.04.003 The date of issue of a drug shall be the date on which the finished product is removed from cold storage but in any case shall be, not later than (a) six months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 10°C; (b) 12 months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 5°C; or (c) two years after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 0°C. C.04.013 Every fabricator and packager/labeller shall safely segregate all work with spore-bearing, pathogenic micro-organisms and other infectious agents known to require special precautions in manipulation and shall take such care of equipment and arrangements for supervision that the possibility of contamination of other drugs is avoided. C.04.014 No person shall conduct laboratory procedures of a diagnostic nature in their premises unless those procedures are entirely segregated from the fabrication, packaging/labelling and testing of drugs. C.04.015 On written request from the Minister, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot of the drug before it is sold, and no person shall sell any lot of that drug if the protocol or sample fails to meet the requirements of these Regulations. C.04.016 All animals from which drugs are prepared and preserved shall be (a) under the direct supervision of competent medical or veterinary personnel; (b) kept in quarantine by the fabricator for at least seven days before use; and (c) healthy and free from infectious disease. C.04.017 A fabricator shall keep necropsy records of all animals that die or are killed after having been used in the production of a drug. C.04.018 A fabricator shall immediately segregate, and report the fact to the Minister, any animal with actual or suspected vesicular stomatitis, foot and mouth disease, encephalomyelitis, infectious anaemia, glanders, anthrax, tetanus or any other serious infectious disease. C.04.019 The provisions of section C.01.004 do not apply to a drug as defined in this Division but every package of such drug shall carry (a) on both the inner and the outer labels (i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name in type not less than one-half the size of that of the brand name, (ii) the name of the distributor referred to in paragraph C.01A.003(b), (b) on the outer label (i) the address of the distributor referred to in paragraph C.01A.003(b), (iii) the proper name, or the common name if there is no proper name, and the amount, of any preservative in the drug, (iv) a statement that the drug shall be stored at a temperature of not less than 2°C and not more than 10°C, unless the Minister has received evidence demonstrating that such a statement is not required, (v) a statement of the net contents in terms of weight, measure, or number, and Food and Drug Regulations (vi) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner: C.04.020 Except in the case of the following drugs, every package of a drug that is a prescription drug shall carry the symbol “Pr” on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label: (a) a drug sold to a person who holds an establishment license; and C.04.050 Except as provided in this Division, a bacterial vaccine shall be a sterile suspension of killed cultures of bacteria, with or without the addition of other medication, and shall not include an autogenous vaccine. C.04.051 No person shall sell a bacterial vaccine unless the culture that has been used in its preparation has been tested by an acceptable method for identity and purity and when so tested it shall be true to name and a pure strain, and a record of the culture shall be maintained which shall include a statement of its origin, properties and characteristics. C.04.052 No fabricator shall use a substrate (culture medium), in the production of a bacterial vaccine, that contains any horse meat or horse serum. C.04.053 A fabricator of a bacterial vaccine prepared from a bacterium that does not grow readily in ordinary culture media shall test its sterility in media which are specially favourable to the growth of such bacterium, and it shall be sterile. C.04.054 Except as provided in sections C.04.083, C.04.084 and C.04.090, both the inner and outer labels of every multiple-dose container and the outer label of every single-dose container of a bacterial vaccine shall carry a statement of (c) the exact nature and amount of any substance, other than a simple diluent, combined with such vaccine, and and the inner label of a single-dose container shall carry a statement that it contains only one dose. C.04.055 The expiration date of a bacterial vaccine shall be not later than 18 months after the date of manufacture or the date of issue. C.04.060 Cultures of Salmonella typhosa used in the preparation of typhoid vaccine shall be smooth, motile, and in the Vi form, with the following antigenic structure IX,XII,Vi; d:-. C.04.061 No person shall sell any lot of typhoid vaccine unless such lot has been shown to meet a test for potency made by an acceptable method. C.04.065 A fabricator shall, in the preparation of pertussis (whooping cough) vaccine, use only strains of Bordetella pertussis that meet the requirements of an antigenic test made by an acceptable method. C.04.066 No person shall sell any lot of pertussis (whooping cough) vaccine unless such lot has been shown to meet a test for potency made by an acceptable method. C.04.070 B.C.G. vaccine shall be prepared from living B.C.G. organisms that (a) have been obtained directly from a source approved by the Minister; (b) are proved to be non-pathogenic by an acceptable method; and (c) have a history of successful use in the production of B.C.G. vaccine. C.04.071 No fabricator shall employ any person in the manufacture of B.C.G. vaccine unless such person (a) has been and remains free from all forms of tuberculosis infection, (b) undergoes every six months a medical examination, that shall include an X-ray examination of the chest, for the presence of tuberculosis, such examination being made by a qualified, practising physician who shall sign a certificate of such person’s freedom from tuberculosis, and such certificate shall be kept on file and be available at all times, and (c) resides in a household that is at all times free from active tuberculosis, nor shall a fabricator employ such person in any other laboratory position. C.04.072 The preparation, preservation and packaging/labelling of B.C.G. vaccine shall be conducted under the direct supervision of an experienced bacteriologist who has (a) not less than three years postgraduate training in bacteriology and immunology; (b) specialized in the field of bacteriology; and (c) at least one year of practical experience in the manufacture of B.C.G. vaccine. C.04.073 No fabricator shall permit any culture that is not a B.C.G. culture to be at any time on any premises that are used for the manufacture of B.C.G. vaccine. C.04.074 A packager/labeller shall test by an acceptable method, after filling of the final container, each lot of B.C.G. vaccine for the presence of contaminating micro-organisms and when so tested it shall be free therefrom. C.04.075 Notwithstanding section C.04.074, a fluid B.C.G. vaccine may be released for sale if no growth has appeared upon the test culture medium after an incubation of 24 hours, but if there is evidence of the presence of contaminating micro-organisms in any lot during the test period of 10 days the packager/labeller shall at once recall such lot. C.04.076 Every fabricator and packager/labeller shall determine the number of viable B.C.G. organisms in each lot of vaccine by an acceptable method and shall keep a record of the number. C.04.077 A fabricator of B.C.G. vaccine shall keep, at a temperature not exceeding 5.0°C, and for not less than six months, (a) the culture on glycerine-water potato medium from which the Sauton I and Sauton II subcultures were made, and (b) not less than six vials of the final product from each lot thereof. C.04.078 Every fabricator and packager/labeller of B.C.G. vaccine shall keep, in form satisfactory to the Minister, continuous clinical records of the use of B.C.G. vaccine in humans. C.04.079 A fabricator of B.C.G. vaccine shall examine pathologically all test animals used and shall immediately report to the Minister any evidence of active, progressive tuberculosis in any such animals. C.04.080 The expiration date for B.C.G. vaccine shall be not more than (a) 10 days after harvesting in the case of fluid vaccine; (b) 12 months after harvesting in the case of freeze dried vaccine stored at a temperature of 4°C or above; or (c) 20 months after harvesting in the case of freeze dried vaccine stored at a temperature below 4°C. C.04.081 No person shall sell fluid B.C.G. vaccine that is not packaged in containers sealed by fusion. (b) the route of administration of the vaccine. (b) the route of administration of the vaccine. (a) a bacterial antigen, other than a bacterial vaccine, such as a lysate, or (b) an extract prepared from a bacterial culture, and shall conform to the requirements of these Regulations for bacterial vaccines except those of paragraphs (a) and (b) of C.04.054. C.04.091 The expiration date of a product analogous to a bacterial vaccine shall be not later than 18 months after the date of manufacture or the date of issue, but for dried tuberculin and tuberculin containing at least 50 per cent glycerin the expiration date shall be not later than five years after the date of manufacture or the date of issue, and for all other tuberculins not more than 12 months after the date of manufacture or the date of issue. C.04.101 No person shall sell a virus or a rickettsial vaccine unless the fabricator has submitted to the Minister details of the source of the strains of viruses or rickettsiae used, the method of their propagation, the method of fabrication of the vaccine, the methods employed for determining sterility, safety, identity and potency and any other tests required by these Regulations. C.04.102 Upon written request from the Minister every fabricator and packager/labeller shall submit with respect to each lot of virus or rickettsial vaccine, when ready for sale, detailed protocols of sterility, safety, identity, potency, and of any other tests required by these Regulations. (b) shall be the living virus of vaccinia or its derivatives obtained from (i) the vesicles produced in the skin of healthy calves by inoculation of vaccinia virus, (iii) suitable tissue culture infected with vaccinia virus or its derivatives; and (c) shall be in fluid or dried form. C.04.111 Every fabricator and packager/labeller shall fabricate and package/label smallpox vaccine only in an independent unit that is isolated from all other laboratory activities, and in or about which no extraneous materials are permitted or stored. C.04.112 A fabricator shall exclude the personnel who care for the vaccine animals from horse stables and paddocks and from contact with horses while smallpox vaccine is being propagated. C.04.113 Every fabricator and packager/labeller shall dispense smallpox vaccine only in sterile glass containers that are sealed under aseptic conditions. C.04.114 Every fabricator and packager/labeller shall test smallpox vaccine to establish that it is free from C.04.115 Smallpox vaccine, when tested by acceptable methods, (a) shall be free from extraneous micro-organisms, in the case of vaccine prepared for use by jet gun; and (b) shall contain not more than 500 viable non-pathogenic bacteria per millilitre, in the case of vaccine prepared for use by the multiple pressure technique or by scarification. C.04.116 Smallpox vaccine must demonstrate evidence of disease prevention that is at least equivalent to that of a vaccine that (a) is known to prevent human to human transmission of smallpox; and (a) in the case of fluid vaccine, it has been stored at a temperature below -10°C; (b) in the case of dried vaccine, it has been stored at a temperature below 10°C; and (c) the outer label carries a statement that it shall be stored at a temperature of not more than 5°C. C.04.118 Notwithstanding the provisions of section C.04.003, the date of issue of smallpox vaccine shall be not later than (a) in the case of fluid vaccine, nine months after the date of manufacture; and (b) in the case of dried vaccine, 24 months after the date of manufacture. C.04.119 The expiration date of smallpox vaccine shall not exceed the following, unless supported by evidence of stability satisfactory to the Minister: (a) in the case of fluid vaccine, 3 months after the date of issue; or (b) in the case of dried vaccine, 12 months after the date of issue. C.04.120 No inner label shall be required for smallpox vaccine in single-dose containers or when dispensed in capillary tubes. C.04.121 No person shall sell smallpox vaccine to which an antibiotic has been added. C.04.123 Poliomyelitis vaccine shall be prepared in acceptable tissue culture medium from strains of poliomyelitis virus proven capable of producing vaccine of acceptable potency. C.04.124 Poliomyelitis vaccine in its final form shall contain not more than 0.35 milligram per millilitre of total nitrogen, nor more than one part per million of animal serum. C.04.125 No person shall sell poliomyelitis vaccine unless it has been tested by an acceptable method for potency and safety and when so tested it shall be safe and of acceptable potency. C.04.126 The outer label shall carry a statement of any antibiotic present in the vaccine. C.04.127 The expiration date of the poliomyelitis vaccine shall be not later than 12 months after the date of the last satisfactory potency test unless evidence, satisfactory to the Minister, is presented that a longer period is appropriate. C.04.128 Poliovirus Vaccine, Live, Oral or Poliovirus Vaccine, Live, Oral (Naming the strains) shall be prepared from living poliomyelitis virus types I, II and III that (a) have been obtained directly from a source acceptable to the Minister; (b) are shown to be genetically stable by an acceptable method; (c) are shown to be non-pathogenic when given orally to humans; (e) have a history of successful use in the production of polio-virus vaccine, live, oral. C.04.129 Poliovirus vaccine, live, oral, shall be fabricated, packaged/labelled and tested in premises separated from buildings where other products are fabricated, packaged/labelled or tested, and from buildings where control tests involving the use of cell lines or virus strains C.04.130 No fabricator shall permit the introduction of any bacterial or viral cultures other than those used in the manufacture of poliovirus vaccine, live, oral on any premises that are used for the manufacture of poliovirus vaccine, live, oral. C.04.131 Notwithstanding sections C.04.129 and C.04.130, a fabricator may manufacture other drugs in an area in which polio-virus vaccine, live, oral is manufactured at times when that vaccine is not being manufactured, (a) both prior to and following each manufacture the area is cleaned and disinfected by methods acceptable to the Minister; and (b) the fabricator has received written permission from the Minister to carry out such manufacture. (a) in a tissue culture, (b) in a medium, and (c) by methods acceptable to the Minister. C.04.133 No fabricator shall sell poliovirus vaccine, live, oral, unless he has tested each lot for extraneous micro-organisms and the vaccine is free therefrom. C.04.134 A fabricator of poliovirus vaccine, live, oral shall test, by a method acceptable to the Minister, each lot of vaccine for neurovirulence and for genetic markers and it shall meet the requirements established by the Minister. C.04.135 No fabricator shall employ any person in the manufacture of poliovirus vaccine, live, oral unless such person (a) is free from infectious disease; (b) has been vaccinated successfully against poliomyelitis by poliovirus vaccine, live, oral; and (c) has been proved by periodic tests to be a non-carrier of poliomyelitis virus. C.04.136 A fabricator of poliovirus vaccine, live, oral shall not permit the entry to a building in which the vaccine is manufactured of any person who (a) is not directly concerned with the manufacturing processes; or (b) has been working on the same day with experimental animals or with infectious agents. C.04.137 Bacteriophage shall be a virus preparation with specific lytic action against micro-organisms actually or potentially pathogenic. C.04.138 The expiration date of bacteriophage shall be not later than 12 months after the date of manufacture or the date of issue. (b) Schick control; and (c) diphtheria toxin for Schick test with control. C.04.141 Diphtheria toxin for Schick test shall be sterile diluted diphtheria toxin stabilized by an acceptable method. C.04.142 Schick control shall be suitably diluted (b) sterile diphtheria toxin heated at a temperature of 95°C for five minutes. C.04.143 The human test dose of diphtheria toxin for Schick test, when aged toxin containing a preservative is used, shall be determined by (a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction but mixed with 1/1,250 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction”; and (b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/50 of one test dose must not cause, and 1/25 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”. C.04.144 The human test dose of diphtheria toxin for Schick test, when fresh toxin containing no preservative is used, shall be determined by (a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction but mixed with 1/1,500 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction”; and (b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/100 of one test dose must not cause, and 1/50 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”. C.04.145 The human test dose for the Schick control shall give a negative Schick reaction when injected intracutaneously into normal guinea pigs. C.04.146 No person shall sell diphtheria toxin for Schick test unless both the inner and the outer labels carry a statement of the number of human test doses it contains together with the name of any stabilizer. C.04.147 The expiration date of Schick test reagents for the diagnosis of susceptibility to diphtheria shall be not later than 12 months after the date of manufacture or the date of issue. C.04.163 No fabricator shall use a culture medium for the production of diphtheria toxin that contains horse protein or Witte peptone or that has not been freed as far as possible from any other allergenic ingredient. C.04.164 Diphtheria toxin from which diphtheria toxoid is prepared shall have a toxicity, as indicated by an L+ dose, of not more than 0.20 millilitre or by an M.L.D. of not more than 0.0025 millilitre. C.04.165 A fabricator shall test each bulk container of diphtheria toxoid, before being dispensed into the final containers, for toxicity by an acceptable method, and it shall be non-toxic. C.04.166 No person shall sell any lot of diphtheria toxoid unless such lot has been shown to meet a test for antigenicity made by an acceptable method. C.04.167 A fabricator shall fill diphtheria toxoid aseptically into clear glass containers and where preservative is not added shall seal the containers by fusion. C.04.168 No person shall sell diphtheria toxoid that contains phenol. C.04.169 No person shall sell diphtheria toxoid unless both the inner and the outer labels carry a statement of the appropriate dose for purposes of immunization. C.04.170 The expiration date of diphtheria toxoid shall be not later than two years after the date of manufacture or the date of issue. C.04.183 No fabricator shall use a culture medium for the production of tetanus toxoid that contains horse protein or Witte peptone or that has not been freed as far as possible from any other allergenic ingredient. C.04.184 Tetanus toxin from which tetanus toxoid is prepared shall have a toxicity as indicated by an M.L.D. for the guinea pig of not more than 0.0001 millilitre. C.04.185 A packager/labeller shall test each bulk container of tetanus toxoid, before being dispensed into the final containers, for toxicity by an acceptable method, and it shall be non-toxic. C.04.186 No person shall sell any lot of tetanus toxoid unless such lot has been shown to meet a test for antigenicity made by an acceptable method. C.04.187 No person shall sell tetanus toxoid unless both the inner and the outer labels carry a statement of the appropriate dose for purposes of immunization. C.04.188 A fabricator shall fill tetanus toxoid aseptically into clear glass containers and where a preservative is not added shall seal the container by fusion. C.04.189 No person shall sell tetanus toxoid that contains phenol. C.04.190 The expiration date of tetanus toxoid shall be not later than two years after the date of manufacture or the date of issue. C.04.210 An antitoxin or antiserum shall be the serum or fraction thereof separated from the blood of animals that have been artificially immunized against the by-products or antigenic fractions of specific cultures of micro-organisms, or against specific venoms. C.04.211 The potency of an antitoxin or antiserum shall be determined by an acceptable method and where applicable the unit of potency shall be the International Unit. C.04.215 A dried antitoxin shall be prepared from a liquid antitoxin and, when reconstituted to the original volume of the liquid antitoxin, shall have a potency not less than that prescribed for such liquid antitoxin. C.04.217 Each lot of antitoxin or antiserum shall be tested by an acceptable method for pyrogenicity and it shall be pyrogen-free, and, after filling into the final containers, for identity and it shall be true to name. C.04.218 No person shall sell an antitoxin or antiserum unless both the inner and the outer labels carry a statement of the species of animal used, when other than the horse, and the net contents in millilitres or the number of units in the container. (a) for liquid antitoxins with standards of potency, not later than five years after the date of manufacture; (b) for dried antitoxins with standards of potency, not later than five years after the date of manufacture. (c) for liquid antitoxins with no standards of potency, not later than 12 months after the date of manufacture; and (d) for dried antitoxins with no standards of potency, not later than five years after the date of manufacture. (a) for liquid antisera with standards of potency, not later than three years after the date of manufacture; (b) for dried antisera with standards of potency, not later than five years after the date of manufacture; (c) for liquid antisera with no standards of potency, not later than 12 months after the date of manufacture; and (d) for dried antisera with no standards of potency, not later than five years after the date of manufacture. Preparations from Human Sources C.04.230 Preparations from human sources shall be pooled blood plasma, or pooled blood serum, or fractions of either separated by a method satisfactory to the Minister. C.04.231 A fabricator shall obtain human serum, or human plasma, only from a person certified by a qualified medical practitioner to be healthy. C.04.232 A fabricator shall not use a person to serve as a donor of blood, placenta, or cord who has a history of a disease transmissible by blood transfusion including syphilis, infectious hepatitis, or malaria. C.04.233 The operation of drawing blood from a donor shall be under the supervision of a qualified medical practitioner, and shall be carried out in a suitable bleeding room under the control of the fabricator. C.04.234 A fabricator shall obtain human placenta and cord used in the manufacture of preparations from human sources only from women confined in public C.04.236 A fabricator shall provide directions or means for the removal of particles of such size as to be dangerous to the recipient from preparations from human sources that are issued in fluid form or that are reconstituted from the dried form. C.04.237 A fabricator of preparations from human sources shall maintain complete records of all donors, which records shall include the medical certificate required by section C.04.231. C.04.238 A fabricator, packager/labeller or distributor referred to in paragraph C.01A.003(b) may issue human serum or human plasma, or fractions of either of them, for prophylactic or therapeutic use in any of the following forms: (a) immune human serum, which shall be serum separated from the blood of persons recovered from the disease or from persons specifically immunized against the disease for which the serum is intended as a prophylactic or therapeutic agent; (b) immune human globulins, or other immune human serum fractions, which shall be prepared from immune human serum or plasma; (c) normal human serum, or normal human plasma, or fractions of either of these prepared from the blood of normal individuals; and C.04.239 No person shall sell a preparation from human sources unless both the inner and the outer labels clearly indicate that the preparation is derived from human sources. C.04.240 The expiration date for preparations from human sources issued in fluid or dried form shall be not later than five years after the date of filling the immediate container. C.04.550 (1) Insulin means the active principle of the pancreas that affects the metabolism of carbohydrates in the animal body and that is of value in the treatment of diabetes mellitus.

(5)

Unstandardized foods | (5) Good Manufacturing Practice

(2)

The Canadian Reference Standard for insulin shall be the International Standard therefor.

(7)

A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n) | (7) 0.1%

(3)

The insulin preparations described in these Regulations shall contain insulin to which may be added only such ingredients as are prescribed in these Regulations. C.04.551 No person shall sell or dispense an insulin preparation that has not been stored by him continuously at a temperature between 35° and 50°F (2° and 10°C). C.04.552 The zinc-insulin crystals used in an insulin preparation shall contain, as determined by an acceptable method, (a) not less than 21 International Units of insulin per milligram, and C.04.553 The insulin preparation, “Insulin injection” or “Insulin” shall be a clear colourless or almost colourless sterile solution free from turbidity and insoluble matter, prepared from insulin or zinc insulin crystals, shall have a pH of not less than 2.5 or more than 3.5, or not less than 7.0 or more than 7.8 and shall contain (b) as determined by an acceptable method, for each 1,000 International Units of insulin, (i) not more than 7.0 milligrams of nitrogen for Insulin Injection prepared from zinc-insulin crystals, and not more than 8.5 milligrams of nitrogen for Insulin Injection other than that made from zinc-insulin crystals, (ii) not less than 0.10 milligram and not more than 0.40 milligram of zinc for Insulin Injection prepared from zinc-insulin crystals, and not more than 0.40 milligram of zinc for Insulin Injection other than that made from zinc-insulin crystals, and (iii) in the case of Insulin Injection other than that made from zinc-insulin crystals, not more than 1.0 milligram of ash. (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; (b) the vial label indicates that each cubic centimetre has a potency equal to (c) each cubic centimetre thereof has an actual potency that is at least 95 per cent and does not exceed 105. (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister; (b) has furnished the Minister with such additional information as the Minister may require; and (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

(2)

Cottage cheese; Creamed cottage cheese | (2) 0.5%

(2)

A submission filed pursuant to subsection (1) shall include at least, (a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Injection (i) protocols of assay of its potency expressed in International Units per cubic centimetre, in the case of insulin, and in International Units per milligram, in the case of zinc-insulin crystals, (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, (iii) a report of the ash content in the case of insulin, and (iv) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; (b) for the first finished lot of Insulin Injection prepared from each master lot of insulin or zinc-insulin crystals, a report on the amount of each component thereof; and (c) for the first filling of the first finished lot of Insulin Injection from each master lot of insulin or zinc-insulin crystals, (i) a report of assay of its nitrogen content in milligrams per 1,000 International Units of insulin, (ii) a report of assay of its zinc content in milligrams per 1,000 International Units of insulin, and C.04.556 The expiration date printed on the inner and outer labels of every package of Insulin Injection shall be a date not later than two years after the date of removal for distribution from the fabricator’s place of storage. C.04.557 The insulin preparation “Insulin Zinc Suspension — Rapid” shall be a sterile suspension in a buffered aqueous medium, of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain, (b) as determined by an acceptable method, for each 1,000 International Units of insulin, (i) not more than 7.0 milligrams of nitrogen; and (ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid. C.04.558 The insulin used in the preparation of Insulin Zinc Suspension — Rapid shall be obtained from one or more master lots and shall be present in an amount C.04.559 The clear supernatant liquid obtained from Insulin Zinc Suspension — Rapid shall contain not more than 1.0 International Unit of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method. (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and (b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly, (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister; (b) has furnished the Minister such additional information as the Minister may require; and (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

(4)

Sour cream | (4) 0.05% in accordance with the requirements of clause B.08.077(b)(vii)(C)

(2)

A submission filed pursuant to subsection (1) shall include at least, (a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension — Rapid, (i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals, (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and (iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; (b) for the first finished lot of Insulin Zinc Suspension — Rapid prepared from each master lot of insulin or zinc-insulin crystals (i) a report on the amount of each component used in the preparation, (ii) a report of assay of its nitrogen content per 1,000 International Units of insulin, (iii) a report of assay of its zinc content per 1,000 International Units of insulin, (iv) a report of the insulin content in International Units per cubic centimetre of the supernatant liquid after removal of the suspended precipitate, (v) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate, (vi) a report on the determination of its pH, and (vii) a report on the microscopic appearance of the suspended precipitate; and (c) for the first filling of the first finished lot of Insulin Zinc Suspension — Rapid from each master lot of insulin or zinc-insulin crystals, (i) a report on the determination of its pH, (ii) a report on the microscopic examination of the precipitate, and (iii) a report on its identification, as determined by an acceptable method. C.04.562 The expiration date printed on the inner and outer labels of every package of Insulin Zinc Suspension — Rapid shall be a date not later than two years after the date of filling of the immediate container. C.04.563 The insulin preparation “Insulin Zinc Suspension — Medium” shall be a sterile suspension, in a buffered aqueous medium, of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of a mixture of crystals and amorphous material in an approximate ratio of seven parts of crystals to three parts of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain, (b) as determined by an acceptable method, for each 1,000 International Units of insulin, (i) not more than 7.0 milligrams of nitrogen of which not less than 63 per cent and not more than 73 per cent shall be in the crystalline component, and (ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid. C.04.564 The insulin used in the preparation of Insulin Zinc Suspension — Medium shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin per cubic centimetre. Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly. C.04.565 The clear supernatant liquid obtained from Insulin Zinc Suspension — Medium shall contain not more than 1.0 International Unit of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method. (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and (b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly, (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister; (b) has furnished the Minister with such additional information as the Minister may require; and (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

(5)

Unstandardized Foods | (5) Good Manufacturing Practice Column I S.13 Sodium Phosphate, tribasic Column II

(2)

A submission filed pursuant to subsection (1) shall include at least, (a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension-Medium, (i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals, (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and (iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; (b) for the first finished lot of Insulin Zinc Suspension-Medium prepared from each master lot of insulin or zinc-insulin crystals, (i) a report on the amount of each component used in the preparation, (iv) a report of the insulin content, in International Units per cubic centimetre, of the supernatant liquid after removal of the suspended precipitate, (v) a report on the determination of the proportion of the nitrogen in the crystalline component of the suspended precipitate, (vi) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate, (vii) a report on the determination of its pH, and (viii) a report on the microscopic appearance of the suspended precipitate; and (c) for the first filling of the first finished lot of Insulin Zinc Suspension — Medium from each master lot of insulin or zinc-insulin crystals, (i) a report on the determination of its pH, (ii) a report on the microscopic examination of the precipitate, and (iii) a report on its identification as determined by an acceptable method. C.04.568 The expiration date printed on the inner and outer labels of Insulin Zinc Suspension — Medium shall be a date not later than two years after the date of filling of the immediate container. C.04.569 The insulin preparation “Insulin Zinc Suspension — Prolonged” shall be a sterile suspension in a buffered aqueous medium of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of crystals with not more than a trace of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain (b) as determined by an acceptable method, for each 1,000 International Units of insulin, (i) not more than 7.0 milligrams of nitrogen, of which not less than 90 per cent shall be in the crystalline component, and (ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid. C.04.570 The insulin used in the preparation of Insulin Zinc Suspension — Prolonged shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International C.04.571 The clear supernatant liquid obtained from Insulin Zinc Suspension — Prolonged shall contain not more than 1.0 International Unit of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method. (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and (b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly, (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister; (b) has furnished the Minister with such additional information as the Minister may require; and (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

(2)

Unstandardized foods Column III Maximum Level of Use

(2)

A submission filed pursuant to subsection (1) shall include at least, (a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension — Prolonged, (i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals, (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and (iii) reports of assay of the nitrogen content in milligrams and of its zinc content in milligrams per 1,000 International Units of insulin; (b) for the first finished lot of Insulin Zinc Suspension — Prolonged prepared from each master lot of insulin or zinc-insulin crystals, (i) a report on the amount of each component used in the preparation, (iv) a report of the insulin content, in International Units per cubic centimetre, of the supernatant liquid after removal of the suspended precipitate, (v) a report of the determination of the proportion of the nitrogen in the crystalline component of the suspended precipitate, (vi) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate, (vii) a report on the determination of its pH, and (viii) a report on the microscopic appearance of the suspended precipitate; and (c) for the first filling of the first finished lot of Insulin Zinc Suspension — Prolonged from each master lot of insulin or zinc-insulin crystals, (i) a report on the determination of its pH, (ii) a report on the microscopic examination of the precipitate, and (iii) a report on its identification as determined by an acceptable method. C.04.574 The expiration date printed on the inner and outer labels of every package of Insulin Zinc Suspension — Prolonged shall be a date not later than two years after the date of filling of the immediate container. Globin Insulin with Zinc C.04.575 The insulin preparation “Globin Insulin with Zinc” shall be a sterile solution of insulin modified by the addition of globin prepared from beef blood, in the form of globin hydrochloride, and zinc, shall be a clear, yellowish, or almost colourless liquid free from insoluble matter and acceptably free from turbidity, shall have a pH of not less than 3.4 and not more than 3.8 and shall contain, (a) weight by volume, not less than 1.3 per cent and not more than 1.7 per cent glycerin, and either (b) as determined by an acceptable method, for each 1,000 International Units of insulin, (i) not more than 15.0 milligrams of total nitrogen, (ii) not less than 36.0 milligrams and not more than 40.0 milligrams of globin calculated as 6.0 times the nitrogen content of the globin, and (iii) not less than 2.5 milligrams and not more than 3.5 milligrams of zinc. C.04.576 The globin hydrochloride used in the preparation of Globin Insulin with Zinc shall contain not less than 16.0 per cent and not more than 17.5 per cent nitrogen calculated on a dry, ash-free and hydrochloric acid-free basis, and its ash content shall be not more than 0.3 per cent as determined by an acceptable method. C.04.577 The insulin used in the preparation of Globin Insulin with Zinc shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40 or 80 International Units of insulin in each cubic centimetre of the Globin Insulin with Zinc. C.04.578 (1) The Canadian Reference Standard for Globin Insulin with Zinc shall be the standard adopted therefor by the Minister from time to time.

(1)

B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(2)

Upon application of a person who holds an establishment licence, the Minister shall furnish him with a portion of the Canadian Reference Standard with directions for comparative testing.

(2)

Good Manufacturing Practice S.14 Sodium Potassium Tartrate

(3)

The testing of the biological reaction of Globin Insulin with Zinc shall be made by an acceptable method and that biological reaction shall be comparable to the biological reaction of the portion of the Canadian Reference Standard furnished by the Minister. C.04.579 No person shall sell Globin Insulin with Zinc unless (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and C.04.580 (1) A fabricator shall not sell Globin Insulin with Zinc unless he (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister; (b) has furnished the Minister with such additional information as the Minister may require; and (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

(2)

Unstandardized foods

(2)

A submission filed pursuant to subsection (1) shall include at least, (a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Globin Insulin with Zinc, (i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals, (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and (iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; (b) for the master lot of globin hydrochloride used in the preparation of Globin Insulin with Zinc, reports of assay of (i) its nitrogen content in per cent calculated on a dry, ash-free and hydrochloric acid free basis, (ii) its chloride content in per cent calculated as hydrochloride, and (iii) its ash content in percentage; (c) for the components used in the preparation of the trial mixture of Globin Insulin with Zinc, a report on the quantity of (i) insulin in grams, or in International Units, (iii) globin hydrochloride in grams or in milligrams, per 1,000 International Units of insulin, and (i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin, (iii) protocols of the biological reaction showing the retardation of the insulin effect, and (iv) a report on the determination of its pH; (e) for the first finished lot of Globin Insulin with Zinc from each trial mixture of Globin Insulin with Zinc, a report on the amount of each component in the preparation; and (f) for the first filling of the first finished lot of Globin Insulin with Zinc from each trial mixture of Globin Insulin with Zinc, (i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin, (ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin, and (iii) a report on the determination of its pH. C.04.581 The expiration date printed on the inner and outer labels of every package of Globin Insulin with Zinc shall be a date not later than two years after the date of filling of the immediate container. C.04.582 The insulin preparation “NPH Insulin” or “Isophane Insulin” shall be a sterile preparation of rod-shaped crystals containing insulin, protamine and zinc, suspended in a buffered aqueous medium, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain not more than 0.17 per cent metacresol and not less than 0.06 and not more than 0.07 per cent phenol, or (b) as determined by an acceptable method, for each 1,000 International Units of insulin, (i) not more than 8.5 milligrams of nitrogen, (ii) not less than 3.0 milligrams and not more than 6.0 milligrams of protamine except that the ratio of the protamine to the insulin shall be not less than the isophane ratio and shall not exceed the isophane ratio by more than 10 per cent, (iii) not less than 0.16 milligram and not more than 0.40 milligram of zinc, and (iv) no protease activity significant for the stability of NPH insulin. C.04.583 The protamine used in preparing NPH Insulin shall be obtained from the sperm or from the mature testes of fish belonging to the family Salmonidae, genera Oncorhynchus Suckley, or Salmo Linne. C.04.584 The isophane ratio means the minimum number of milligrams of protamine required to precipitate 100 International Units of insulin and shall be determined by an acceptable method. C.04.585 The insulin used in the preparation of NPH Insulin shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly. C.04.586 The clear supernatant liquid obtained from NPH insulin shall contain not more than 0.4 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, not more than 0.6 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 80 units per cubic centimetre and not more than 0.7 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 100 units (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister; (b) has furnished the Minister with such additional information as the Minister may require; and (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

(1)

3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(2)

A submission filed pursuant to subsection (1) shall include at least, (a) for each master lot of zinc-insulin crystals employed in the manufacture of NPH Insulin, (i) protocols of assay of its potency in International Units per milligram, (ii) a report of its moisture content in per cent determined by drying to constant weight at 100°C, and (iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; (b) for the master lot of protamine, a report of the isophane ratio for the insulin used in the preparation of the NPH Insulin; (c) for the trial mixture of NPH Insulin, (i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin, (iv) a report on the determination of its pH, and (d) for the first finished lot of NPH Insulin from each trial mixture of NPH Insulin, a report on the amount of each component in the preparation; and (e) for the first filling of the first finished lot of NPH Insulin from each trial mixture of NPH Insulin, (i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin, (iii) a report on the determination of its pH, (iv) a report on the microscopic examination of the precipitate, and (v) a report of its identification as determined by an acceptable method. C.04.589 The expiration date printed on the inner and outer labels of NPH Insulin shall be a date not later than two years after the date of filling of the immediate container. C.04.590 The insulin preparation “Protamine Zinc Insulin” shall be a sterile white suspension in a buffered aqueous medium, containing insulin modified by the addition of protamine and zinc, shall have a pH of not less than 7.1 and not more than 7.4, and shall contain, (b) as determined by an acceptable method, for each 1,000 International Units of insulin, (i) not more than 12.5 milligrams of total nitrogen, (ii) not less than 10.0 milligrams and not more than 15.0 milligrams of protamine, (iii) not less than 1.7 milligrams and not more than 2.5 milligrams of zinc. C.04.591 The protamine used in the preparation of Protamine Zinc Insulin shall be obtained from the sperm or from the mature testes of fish belonging to the family Salmonidae, genera Oncorhynchus Suckley or Salmo Linne. C.04.592 The insulin used in the preparation of Protamine Zinc Insulin shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly. C.04.593 (1) The Canadian Reference Standard for Protamine Zinc Insulin shall be the standard adopted therefor by the Minister from time to time.

(2)

Good Manufacturing Practice S.15 Sodium Pyrophosphate, tetrabasic

(2)

Upon application of a person who holds an establishment licence, the Minister shall furnish him with a portion of the Canadian Reference Standard with directions for comparative testing.

(2)

Unstandardized foods

(3)

The testing of the biological reaction of Protamine Zinc Insulin shall be made by an acceptable method and that biological reaction shall be comparable to the biological reaction of the portion of the Canadian Reference Standard furnished by the Minister. (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister; (b) has furnished the Minister with such additional information as the Minister may require; and (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

(1)

3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(2)

A submission filed pursuant to subsection (1) shall include at least, (a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Protamine Zinc Insulin, (i) protocols of assay of its potency in International Units per cubic centimetre in the case of insulin and in International Units per milligram in the case of zinc-insulin crystals, (ii) a report on its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and (iii) reports of assay of its nitrogen content in milligrams, and its zinc content in milligrams per 1,000 International Units of insulin; (b) for the components used in the preparation of the trial mixture of Protamine Zinc Insulin, a report on the quantity of (i) insulin in grams or in International Units, (iii) protamine in grams or in milligrams, per 1,000 International Units of insulin, and (i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin, (iii) protocols of its biological reaction showing retardation of the insulin effect, and (iv) a report on the determination of its pH; (d) for the first finished lot of Protamine Zinc Insulin from each trial mixture of Protamine Zinc Insulin, a report on the amount of each component in the preparation; and (e) for the first filling of the first finished lot of Protamine Zinc Insulin from each trial mixture of Protamine Zinc Insulin, (i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units, (ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units, and (iii) a report on the determination of its pH. C.04.596 The expiration date printed on the inner and outer labels of every package of Protamine Zinc Insulin shall be a date not later than two years after the date of filling of the immediate container. Sulphated Insulin C.04.597 The insulin preparation “Sulphated Insulin” shall be a clear or slightly turbid, colourless or almost colourless, sterile, isotonic preparation of zinc-insulin crystals chemically modified by treatment with sulphuric acid, shall have a pH of not less than 6.0 and not more than 7.0, and shall contain, (b) as determined by an acceptable method, (i) not more than 200 milligrams protein for each 1,000 International Units of insulin, and (ii) not less than 5.5 and not more than 6.5 sulphate groups per insulin molecule. C.04.598 The neutralization ratio means the amount of anti-beef-insulin serum required to neutralize one unit of Sulphated Insulin divided by the amount required to neutralize one unit of beef insulin, and shall be determined by an acceptable method. C.04.599 The neutralization ratio of Sulphated Insulin shall be not less than 4 to 1. C.04.600 No person shall sell Sulphated Insulin unless (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres, and (b) each cubic centimetre thereof provides 100 International Units of insulin as determined by an acceptable method. (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister; (b) has furnished the Minister with such additional information as the Minister may require; and (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

(2)

Good Manufacturing Practice

(2)

A submission filed pursuant to subsection (1) shall include at least, (a) for each master lot of zinc-insulin crystals employed in the manufacture of Sulphated Insulin, (i) protocols of assay of its potency in International Units per milligram, (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C, and (iii) reports of assays of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; and (b) for each lot of Sulphated Insulin prepared from each master lot of zinc-insulin crystals, (i) a report of the amount of each component, (ii) a report of the protein content in milligrams per 1,000 International Units of insulin, (iii) a report on the determination of the neutralization ratio, (iv) a report on the determination of the number of sulphate groups per insulin molecule, (v) protocols of assay of its potency expressed as International Units per cubic centimetre, and (vi) a report on the determination of its pH. C.04.602 The expiration date printed on the inner and outer labels of every package of Sulphated Insulin shall be a date not later than two years after the date of filling of the immediate container. Labelling of Insulin Preparations C.04.650 The packager/labeller of Insulin Injection may label that insulin preparation “Insulin made from Zinc-Insulin crystals” only when it has been prepared from zinc-insulin crystals. C.04.651 The packager/labeller of an insulin preparation shall print the information required by these Regulations to appear on both the inner and outer labels of every package of that insulin preparation as set out in the Table to this section. | Item | Insulin Preparation | Potency of Preparation | Special Printing Requirements for Label | | 1 | Insulin Injection, not labelled as set out in item 2. | (a) 40 units per cc. | (a) black ink on yellow stock. | | 2 | Insulin Injection, labelled “Insulin made from Zinc-Insulin crystals.” | (a) 40 units per cc. | (a) red ink on grey stock. | | 4 | Globin Insulin with Zinc. | (a) 40 units per cc. | (a) red ink on brown stock except that the expression “40 units per cubic centimetre” may be printed in white letters on a red background. | | | | (b) 80 units per cc. | (b) green ink on brown stock except that the expression “80 units per cubic centimetre” may be printed in white letters on a green background. | Food and Drug Regulations Labelling of Insulin Preparations Potency of Preparation Special Printing Requirements for Label (c) black ink on white stock. (c) black ink on white stock. C.04.652 The packager/labeller of an insulin preparation shall print on the outer label of every package thereon instructions to store the preparation in a refrigerator at 35° to 50°F (2° to 10°C) and to avoid exposing it to freezing. C.04.653 The packager/labeller of an insulin preparation that consists of a precipitate suspended in a buffered aqueous medium shall print on the inner label of every package thereof the statement “Shake Carefully”. C.04.654 The packager/labeller of an insulin preparation may, in lieu of printing adequate directions for its use on both the inner and outer labels thereof as required by subparagraph C.04.019(a)(vii), print the descriptions for use in a descriptive circular prepared in accordance with section C.04.655, but in such case he shall (a) enclose a copy of the circular in the package containing the preparation; and (b) state on the outer label of the package that such a circular is enclosed therein. C.04.655 The descriptive circular referred to in section C.04.654 shall include, at least, the following information: (i) the treatment of diabetes mellitus requires medical supervision and review, (ii) insulin preparations should be used only as determined by a physician for each patient in the light of blood-sugar and urinary-sugar findings, and (iii) the physician’s instructions concerning diet, dosage, rest and exercise should be followed carefully; (b) an outline of the procedure to be followed in withdrawing the insulin preparation from the vial, including techniques for sterilization of the syringe and needle, vial-stopper and site of injection; (c) a statement explaining that injections should be subcutaneous, and not intravenous or intramuscular, and a caution against successive injections in any one site; (d) a statement that doses are specified in terms of Units of potency per cubic centimetre and that the volume of each dose will depend upon the potency in terms of units per cubic centimetre stated on the label of the insulin preparation and that, for these reasons, it is important that the patient understand the markings on syringes; (e) a brief explanation of hypoglycemia together with emergency measures suitable for use by patients and those caring for patients in the event of hypoglycemic reactions; (f) a statement indicating the possibility of undesirable reactions associated with illness or infection, with the omission or loss of a meal, and with a shortage of the insulin preparation; (g) a statement warning against using any other type of insulin preparation than that prescribed by the physician; (h) a statement that the use of a package should not be commenced after the expiration date printed on the package; (i) a statement that the contents should be used as continuously as practicable and that any vial from which a part of the contents has been withdrawn should be discarded in the event of its being in disuse for several weeks’ time; (j) a statement stressing the importance of visiting a physician regularly and of carefully following his instructions; (k) in the case of insulin preparations consisting of a clear, colourless or almost colourless solution, free from turbidity and from insoluble matter, a statement that if the contents of the vial become cloudy or turbid, use of that vial should be discontinued; (l) in the case of insulin preparations consisting of a precipitate suspended in a buffered aqueous medium, a statement explaining that it is necessary to shake the vial carefully before withdrawing a dose, noting that if the contents have become lumpy or granular in appearance or have formed a deposit of particles on the wall of the container, the use of that vial should be discontinued; (m) instructions that the insulin preparation should be stored in a refrigerator at 35° to 50°F (2° to 10°C) and should not be exposed to freezing; and (n) in the case of Sulphated Insulin, a statement explaining that this insulin preparation is not for ordinary use, but is a chemically modified insulin which may be more effective than the usual insulin preparations in certain insulin-resistant or insulin-allergic diabetic patients. C.04.656 (1) Notwithstanding section C.04.554, a person who holds an establishment licence may sell Insulin Injection made from zinc-insulin crystals contained in vials of approximately 20 cubic centimetre capacity each of which vials (c) notwithstanding section C.04.651, both the inner and outer labels are printed in black ink on white stock and overprinted in narrow brown and white diagonal stripes, of which there shall be at least five but not more than 20 to each inch; (e) each package contains a descriptive circular that conforms to the requirements of section C.04.655 and, in addition, includes, (i) at the beginning of the circular the statement: “Warning — This insulin preparation contains 500 International Units of insulin in each cubic centimetre. Extreme caution must be observed in the measurement of doses because inadvertent overdose may result in irreversible shock. Serious consequences may result if it is used other than under constant medical supervision. Unless specifically prescribed it should never be (ii) a statement that Insulin made from Zinc-Insulin crystals 500 International Units per cubic centimetre should not be administered intravenously, and (iii) a statement giving information for the safe and effective use by physicians of the drug in insulin shock therapy and in the treatment of diabetic patients with high insulin resistance (daily requirement more than 200 International Units of insulin). C.04.675 Anterior pituitary extract shall include all natural products, prepared from the anterior lobe of the pituitary gland of animals, having physiological properties associated with the hormones of the anterior pituitary gland and their proper names shall be (e) Gonadotrophic Hormone, Gonadotrophin, followed by qualifying words to indicate the gonadotrophic activity associated with the extract, (f) Pituitary Extract Anterior Lobe followed by qualifying words to indicate the physiological properties associated with it. (b) where no International Standard exists, the Canadian Reference Standard shall be that established and kept by the Minister from whom portions for comparative testing may be had upon application, and (c) where neither an International Standard nor a Canadian Reference Standard exists, a provisional reference standard that shall be a suitable quantity of the product submitted by the distributor referred to in paragraph C.01A.003(b) to the Minister for checking the uniformity of the product. C.04.677 Both the inner and outer labels of an anterior pituitary extract shall carry a statement of the potency in terms of the reference standard for anterior pituitary extract provided in section C.04.676 as determined by an acceptable method, except that where no reference standard for an anterior pituitary extract exists, the distributor referred to in paragraph C.01A.003(b) shall include, with every package of the anterior pituitary extract, an acceptable statement of the unit of potency and the method of assay used. C.04.678 No person who holds an establishment licence shall sell corticotrophic hormones for subcutaneous or intramuscular use unless the preparation has been assayed by an acceptable method involving subcutaneous injection and, where the preparation is recommended for intravenous use, the label carries specific dosage instructions for that use. C.04.679 No person shall sell as such adrenocorticotrophic hormone, thyrotrophic hormone, growth hormone pituitary, lactogenic hormone, or gonadotrophic hormone that is not acceptable free from any anterior pituitary extract other than the one for which it is named. C.04.680 The outer label of a mixture of two or more of adrenocorticotrophic hormone, thyrotrophic hormone, growth hormone pituitary, lactogenic hormone and gonadotrophic hormone, or a mixture of any of those with pituitary extract other than those, shall carry a declaration of the proper name and the amount of each component of the mixture. (a) showing the species of animal from which the glands used in the preparation of the anterior pituitary extract were obtained, (b) that it shall be stored at refrigerator temperature, and (c) that, except in the case of gonadotrophic hormones, it is to be used only on the advice or on the prescription of a physician. Drugs for Clinical Trials Involving Human Subjects C.05.001 The definitions in this section apply in this Division. adverse event means any adverse occurrence in the health of a clinical trial subject who is administered a drug, that may or may not be caused by the administration of the drug, and includes an adverse drug reaction. (incident thérapeutique) clinical trial means an investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug. (essai clinique) drug means a drug for human use that is to be tested in a clinical trial. (drogue) good clinical practices means generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons, and the good clinical practices referred to in section C.05.010. (bonnes pratiques cliniques) import means to import a drug into Canada for the purpose of sale in a clinical trial. (importer) investigator’s brochure means, in respect of a drug, a document containing the preclinical and clinical data on the drug that are described in paragraph C.05.005(e). (brochure du chercheur) protocol means a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. (protocole) qualified investigator means the person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial site is located, and who is (a) in the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; and (b) in any other case, a physician and a member in good standing of a professional medical association. (chercheur qualifié) research ethics board means a body that is not affiliated with the sponsor, and (a) the principal mandate of which is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being; and (b) that has at least five members, that has a majority of members who are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act, that is composed of both men and women and that includes at least (i) two members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical rule of a professional medical or dental association; (ii) a member knowledgeable in ethics, (iii) a member knowledgeable in the applicable laws that govern biomedical research, (iv) a member whose primary experience and expertise are in a non-scientific discipline, and (v) a member who is not affiliated with the sponsor and is not part of the community or an organization interested in the areas of research to be approved. (research ethics board) discipline or, if the clinical trial is in respect of a drug to be used for dental purposes only, is from a medical or dental discipline, (ii) one member knowledgeable in ethics, (iii) one member knowledgeable in Canadian laws relevant to the biomedical research to be approved, (iv) one member whose primary experience and expertise are in a non-scientific discipline, and (v) one member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or the site where the clinical trial is to be conducted. (comité d’éthique de la recherche) serious adverse drug reaction means an adverse drug reaction that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (réaction indésirable grave à une drogue) sponsor means an individual, corporate body, institution or organization that conducts a clinical trial. (promoteur) C.05.002 (1) Subject to subsection (2), this Division applies to the sale or importation of drugs to be used for the purposes of clinical trials involving human subjects. Prohibition (a) the person is authorized under this Division; (c) if the drug is to be imported, the person has a representative in Canada who is responsible for the sale of the drug. General C.05.004 Despite these Regulations, a sponsor may submit an application under this Division to sell or import a drug for the purposes of a clinical trial that contains a substance the sale of which is prohibited by these Regulations, if the sponsor establishes, on the basis of scientific information, that the inclusion of the substance in the drug may result in a therapeutic benefit for a human being. Application for Authorization C.05.005 An application by a sponsor for authorization to sell or import a drug for the purposes of a clinical trial under this Division shall be submitted to the Minister, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer and shall contain the following information and documents: (b) a copy of the statement, as it will be set out in each informed consent form, that states the risks and anticipated benefits arising to the health of clinical trial subjects as a result of their participation in the clinical trial; (c) a clinical trial attestation, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer, containing (i) the title of the protocol and the clinical trial number, (ii) the brand name, the chemical name or the code for the drug, (vii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor, (viii) if the drug is to be imported, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor’s representative in Canada who is responsible for the sale of the drug, (ix) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the qualified investigator, if known at the time of submitting the application, (x) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved the protocol referred to in paragraph (a) and approved an informed consent form containing the statement referred to in paragraph (b), if known at the time of submitting the application, and (A) that the clinical trial will be conducted in accordance with good clinical practices and these Regulations, and (B) that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading; (d) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve the protocol referred to in paragraph (a), its reasons for doing so and the date on which the refusal was given, if known at the time of submitting the application; (e) an investigator's brochure that contains the following information, namely, (i) the physical, chemical and pharmaceutical properties of the drug, (ii) the pharmacological aspects of the drug, including its metabolites in all animal species tested, (iii) the pharmacokinetics of the drug and the drug metabolism, including the biological transformation of the drug in all animal species tested, (iv) any toxicological effects in any animal species tested under a single dose study, a repeated dose study or a special study in respect of the drug, (v) any results of carcinogenicity studies in any animal species tested in respect of the drug, (vi) any results of clinical pharmacokinetic studies of the drug, (vii) any information regarding drug safety, pharmacodynamics, efficacy and dose responses of the drug that were obtained from previous clinical trials, (viii) if the drug is a radiopharmaceutical as defined in section C.03.201, information regarding directions for preparing the radiopharmaceutical, the radiation dosimetry in respect of the prepared radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical; (f) if the drug contains a human-sourced excipient, including any used in the placebo, (i) information that indicates the human-sourced excipient has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, issued a notice of compliance under subsection C.08.004(1), as the case may be, or (ii) in any other case, sufficient information to support the identity, purity, potency, stability and safety of the human-sourced excipient; (g) if the drug has not been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, a notice of compliance has not been issued under section C.08.004 or C.08.004.01, the chemistry and manufacturing information in respect of the drug, including its site of manufacture; (h) the proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application. Authorization C.05.006 (1) Subject to subsection (3), a sponsor may sell or import a drug, other than a drug described in subsection (2), for the purposes of a clinical trial if (a) the sponsor has submitted to the Minister an application in accordance with section C.05.005; (b) the Minister does not, within 30 days after the date of receipt of the application, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug for any of the following reasons: (i) that the information and documents in respect of the application (A) were not provided in accordance with these Regulations, or (B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or (ii) that based on an assessment of the application, an assessment of any information submitted under section C.05.009 or a review of any other information, the Minister has reasonable grounds to believe that (A) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, (B) the clinical trial is contrary to the best interests of a clinical trial subject, or (C) the objectives of the clinical trial will not be achieved; (c) for each clinical trial site, the sponsor has obtained the approval of the research ethics board in respect of the protocol referred to in paragraph C.05.005(a) and in respect of an informed consent form that contains the statement referred to in paragraph C.05.005(b); (d) before the sale or importation of the drug at a clinical trial site, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h), if it was not submitted in respect of that clinical trial site at the time of submitting the application.

(3)

0.1% S.15A Sodium Stearoyl-2-Lac-tylate

(2)

Subject to subsection (3), a sponsor may sell or import a drug for the purposes of a clinical trial in respect of (a) a new drug that has been issued a notice of compliance under subsection C.08.004(1), if the clinical trial is in respect of a purpose or condition of use for which the notice of compliance was issued; or (b) a drug, other than a new drug, that has been assigned a drug identification number under subsection C.01.014.2(1), if the clinical trial is in respect of a use or purpose for which the drug identification number was assigned.

(1)

Icing and icing mixes

(3)

A sponsor may not sell or import a drug for the purposes of a clinical trial (a) during the period of any suspension made under section C.05.016 or C.05.017; or (b) after a cancellation made under section C.05.016 or C.05.017. Notification C.05.007 If the sale or importation of a drug is authorized under this Division, the sponsor may make one or more of the following changes if the sponsor notifies the Minister in writing within 15 days after the date of the change: (a) a change to the chemistry and manufacturing information that does not affect the quality or safety of the drug, other than a change for which an amendment is required by section C.05.008; and Notification (b) a change to the protocol that does not alter the risk to the health of a clinical trial subject, other than a change for which an amendment is required by section C.05.008. Amendment C.05.008 (1) Subject to subsections (4) and (5), when the sale or importation of a drug is authorized under this Division and the sponsor proposes to make an amendment referred to in subsection (2), the sponsor may sell or import the drug for the purposes of the clinical trial in accordance with the amended authorization, if the following conditions are met: (a) the sponsor has submitted to the Minister an application for amendment in accordance with subsection (3); (b) the Minister does not, within 30 days after the date of receipt of the application for amendment, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug in accordance with the amendment for any of the following reasons, namely, (i) that the information and documents in respect of the application for amendment (A) were not provided in accordance with these Regulations, or (B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or (ii) that based on an assessment of the application for amendment, an assessment of any information submitted under section C.05.009 or a review of any other information, the Minister has reasonable grounds to believe that (A) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, (B) the clinical trial is contrary to the best interests of a clinical trial subject, or (C) the objectives of the clinical trial will not be achieved; (c) before the sale or importation of the drug, the sponsor submits to the Minister (i) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved any amended protocol submitted under paragraph (3)(a) or approved any amended statement submitted under paragraph (3)(c), and (ii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve any amendment to the protocol, its reasons for doing so and the date on which the refusal was given; (ii) the information referred to in subparagraph C.05.005(c)(ix), if any of that information has changed since it was submitted; (e) before the sale or importation of the drug in accordance with the amended authorization, the sponsor ceases to sell or import the drug in accordance with the existing authorization; and (f) the sponsor conducts the clinical trial in accordance with the amended authorization.

(2)

Fillings and filling mixes

(2)

For the purposes of subsection (1), amendments are (a) amendments to the protocol that affect the selection, monitoring or dismissal of a clinical trial subject; (b) amendments to the protocol that affect the evaluation of the clinical efficacy of the drug; (c) amendments to the protocol that alter the risk to the health of a clinical trial subject; (e) amendments to the protocol that extend the duration of the clinical trial; and (f) amendments to the chemistry and manufacturing information that may affect the safety or quality of the drug.

(3)

Puddings and pudding mixes

(3)

The application for amendment referred to in subsection (1) shall contain a reference to the application submitted under section C.05.005 and shall contain the following documents and information: (a) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (e), a copy of the amended protocol that indicates the amendment, a copy of the protocol submitted under paragraph C.05.005(a), and the rationale for the amendment; (b) if the application is in respect of an amendment referred to in paragraph (2)(e), a copy of the amended investigator’s brochure or an addendum to the investigator’s brochure that indicates the new information, including supporting toxicological studies and clinical trial safety data; (c) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (f) and, as a result of that amendment, it is necessary to amend the statement referred to in paragraph C.05.005(b), a copy of the amended statement that indicates the amendment; and (d) if the application is in respect of an amendment referred to in paragraph (2)(f), a copy of the amended chemistry and manufacturing information that indicates the amendment, and the rationale for that amendment.

(4)

Sour cream substitutes

(4)

If the sponsor is required to immediately make one or more of the amendments referred to in subsection (2) because the clinical trial or the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, the sponsor shall immediately make the amendment and shall provide the Minister with the information referred to in subsection (3) within 15 days after the date of the amendment.

(5)

Vegetable oil creaming agents

(5)

A sponsor may not sell or import a drug for the purposes of a clinical trial (a) during the period of any suspension made under section C.05.016 or C.05.017; or (b) after a cancellation made under section C.05.016 or C.05.017. Additional Information and Samples C.05.009 If the information and documents submitted in respect of an application under section C.05.005 or an application for amendment under section C.05.008 are Food and Drug Regulations DIVISION 5 Drugs for Clinical Trials Involving Human Subjects Additional Information and Samples insufficient to enable the Minister to determine whether any of the reasons referred to in paragraph C.05.006(1)(b) or C.05.008(1)(b) exist, the Minister may require the sponsor to submit, within two days after receipt of the request, samples of the drug or additional information relevant to the drug or the clinical trial that are necessary to make the determination. Sponsor's Obligations C.05.010 Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, shall ensure that (a) the clinical trial is scientifically sound and clearly described in a protocol; (b) the clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division; (c) systems and procedures that assure the quality of every aspect of the clinical trial are implemented; (e) at each clinical trial site, there is no more than one qualified investigator; (f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the qualified investigator; (g) each individual involved in the conduct of the clinical trial is qualified by education, training and experience to perform his or her respective tasks; (h) written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of (i) the risks and anticipated benefits to his or her health arising from participation in the clinical trial, and (ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial; (i) the requirements respecting information and records set out in section C.05.012 are met; and (j) the drug is manufactured, handled and stored in accordance with the applicable good manufacturing practices referred to in Divisions 2 to 4 except sections C.02.019, C.02.025 and C.02.026. C.05.011 Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the drug bears a label that sets out the following information in both official languages: (a) a statement indicating that the drug is an investigational drug to be used only by a qualified investigator; (c) the expiration date of the drug; (e) the lot number of the drug; (g) the protocol code or identification; and (h) if the drug is a radiopharmaceutical as defined in section C.03.201, the information required by subparagraph C.03.202(1)(b)(vi). C.05.012 (1) The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification.

(6)

Batter mix

(2)

The sponsor shall maintain complete and accurate records to establish that the clinical trial is conducted in accordance with good clinical practices and these Regulations.

(7)

Unstandardized cream-based liquors

(3)

The sponsor shall maintain complete and accurate records in respect of the use of a drug in a clinical trial, including (b) records respecting each change made to the investigator’s brochure, including the rationale for each change and documentation that supports each change; (c) records respecting all adverse events in respect of the drug that have occurred inside or outside Canada, including information that specifies the indication for use and the dosage form of the drug at the time of the adverse event; (d) records respecting the enrolment of clinical trial subjects, including information sufficient to enable all clinical trial subjects to be identified and contacted in the event that the sale of the drug may endanger the health of the clinical trial subjects or other persons; (e) records respecting the shipment, receipt, disposition, return and destruction of the drug; (f) for each clinical trial site, an undertaking from the qualified investigator that is signed and dated by the qualified investigator prior to the commencement of his or her responsibilities in respect of the clinical trial, that states that (i) the qualified investigator will conduct the clinical trial in accordance with good clinical practices, and (ii) the qualified investigator will immediately, on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical trial subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; (g) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by the research ethics board for that clinical trial site; and (h) for each clinical trial site, an attestation, signed and dated by the research ethics board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices.

(1)

0.4% of dry ingredient weight

(4)

The sponsor shall maintain all records referred to in this Division for a period of 15 years. Submission of Information and Samples C.05.013 (1) The Minister shall require a sponsor to submit, within two days after receipt of the request, information concerning the drug or the clinical trial, or samples of the drug, if the Minister has reasonable grounds to believe that (a) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person; (b) the clinical trial is contrary to the best interests of a clinical trial subject; (c) the objectives of the clinical trial will not be achieved; (e) information submitted in respect of the drug or the clinical trial is false or misleading.

(2)

0.5% of dry ingredient weight

(2)

The Minister may require the sponsor to submit, within seven days after receipt of the request, any information or records kept under section C.05.012, or samples of the drug, in order to assess the safety of the drug or the health of clinical trial subjects or other persons. Serious Unexpected Adverse Drug Reaction Reporting C.05.014 (1) During the course of a clinical trial, the sponsor shall inform the Minister of any serious unexpected adverse drug reaction in respect of the drug that has occurred inside or outside Canada as follows: (a) if it is neither fatal nor life threatening, within 15 days after becoming aware of the information; and (b) if it is fatal or life threatening, within seven days after becoming aware of the information.

(4)

1.0% of dry ingredient weight

(2)

The sponsor shall, within eight days after having informed the Minister under paragraph (1)(b), submit to the Minister a complete report in respect of that information that includes an assessment of the importance and implication of any findings made. C.05.015 (1) If a clinical trial is discontinued by the sponsor in its entirety or at a clinical trial site, the sponsor shall (a) inform the Minister no later than 15 days after the date of the discontinuance; (b) provide the Minister with the reason for the discontinuance and its impact on the proposed or ongoing clinical trials in respect of the drug conducted in Canada by the sponsor; (c) as soon as possible, inform all qualified investigators of the discontinuance and of the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; and (d) in respect of each discontinued clinical trial site, stop the sale or importation of the drug as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the drug that have been sold.

(5)

2.0% of dry ingredient weight

(2)

If the sponsor has discontinued the clinical trial in its entirety or at a clinical trial site, the sponsor may resume selling or importing the drug for the purposes of a clinical trial in its entirety or at a clinical trial site if, in respect of each clinical trial site where the sale or importation is to be resumed, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h). Suspension and Cancellation C.05.016 (1) Subject to subsection (2), the Minister shall suspend the authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, if the Minister has reasonable grounds to believe that (a) the sponsor has contravened these Regulations or any provisions of the Act relating to the drug; (b) any information submitted in respect of the drug or clinical trial is false or misleading; (c) the sponsor has failed to comply with good clinical practices; or (i) information or samples of the drug as required under section C.05.009 or C.05.013, or

(6)

0.75% of dry ingredient weight S.16 Sodium Tartrate Column II:

(2)

Subject to section C.05.017, the Minister shall not suspend an authorization referred to in subsection (1) unless (a) the Minister has sent to the sponsor a written notice of the intention to suspend the authorization that indicates whether the authorization is to be suspended in its entirety or at a clinical trial site and the reason for the intended suspension; (b) the sponsor has not, within 30 days after receipt of the notice referred to in paragraph (a), provided the Minister with information or documents that demonstrate that the authorization should not be suspended on the grounds that (i) the situation giving rise to the intended suspension did not exist, or (ii) the situation giving rise to the intended suspension has been corrected; and (c) the Minister has provided the sponsor with the opportunity to be heard in paragraph (b).

(8)

Salad dressing; French dressing

(3)

The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension.

(9)

Soups Column III:

(4)

If the Minister has suspended an authorization under subsection (1), the Minister shall (a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension has been corrected; or (b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a). C.05.017 (1) The Minister shall suspend an authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, before giving the sponsor an opportunity to be heard if the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a clinical trial subject or other person.

(1)

0.4%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4 S.16A Sodium Tripolyphosphate Column II: Column III:

(2)

The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension.

0.1%

S.18 Sorbitan Monostearate Column II:

(3)

If the Minister has suspended an authorization under subsection (1), the Minister shall (a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension did not exist or that it has been corrected; or (b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a). Canadian Standard Drugs General (a) solubility and specific gravity shall be determined at 25°C; (b) tests for identity, quantitative tests for arsenic, lead, copper, zinc, fluorine, and sulphur dioxide, and limit tests shall be made by the official methods; and (c) determination of physical and chemical constants shall be carried out by acceptable methods. C.06.002 [S]. Conjugated estrogens shall be the drug conjugated estrogens described in The Pharmacopeia of the United States of America, XVIII (1970), except that (a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981. (a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981. (a) the dilute assay preparation A, assay preparations A and B and equilibrant reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981. C.06.120 [S]. Digitoxin shall be the drug digitoxin described in the Pharmacopeia of the United States of America. C.06.121 [S]. Digitoxin tablets shall be the drug digitoxin tablets described in the Pharmacopeia of the United States of America. C.06.130 [S]. Digoxin shall be the drug digoxin described in the Pharmacopeia of the United States of America. C.06.131 [S]. Digoxin Elixir shall be the drug digoxin elixir described in the Pharmacopeia of the United States of America. C.06.132 [S]. Digoxin injection shall be the drug digoxin injection described in the Pharmacopeia of the United States of America. C.06.133 [S]. Digoxin tablets shall be the drug digoxin tablets described in the Pharmacopeia of the United States of America. C.06.170 Gelatin shall be the drug gelatin described in the Pharmacopeia of the United States or the British Pharmacopeia. C.06.250 Thyroid shall be the cleaned, dried, powdered thyroid glands of domestic animals used for food, and shall contain not less than 0.17 per cent, and not more than 0.23 per cent iodine and no added iodine in either inorganic or organic form, and (a) its characters are (i) General, — thyroid occurs as a cream-coloured, amorphous powder; the odour and taste are faint and meat-like, and (ii) Microscopical, — when suitably mounted and examined under the microscope, thyroid shows the following: numerous smooth to striated hyaline fragments of colloids, of angular to irregular shape, that are colourless to pale yellow in water mounts, brown in Mallory’s stain and pink in solution of eosin, some of these fragments containing granules, minute vacuoles, crystalloid bodies and cells; numerous irregular fragments of follicular epithelium staining brown with Mallory’s stain, the individual cells more or less polygonal to rounded-angular and irregularly cuboidal, often with prominent nuclei staining dark blue, their cytoplasm purplish with Delafield’s solution of haematoxylin; slender glistening segments of capillaries of closely undulate outline; numerous slender segments of neuroaxons; numerous aggregates of particles of intercellular substance and slender, mostly striated, bundles of tissue fibres staining blue to greenish blue with a mixture of Mallory’s stain and solution of phosphotungstic acid, the bundles of fibres often appearing reddish brown in Mallory’s stain; few glistening fragments of blood vessels with serrated or crenated ends as viewed in water mounts; and (b) the tests for its purity are (i) Inorganic iodine, — add to one gram of thyroid 10 millilitres of a saturated solution of zinc sulphate in water, shake, allow to stand five minutes, and filter through a fritted glass filter; add to five millilitres of the filtrate 0.5 millilitre of mucilage of starch and four drops each of a 10 per cent w/v solution of sodium nitrite in water and dilute sulphuric acid, shaking after each addition: no blue colour is produced, and (a) assayed by official method DO-26, Thyroid, October 15, 1981; and (b) stored in a cool place and in a tightly-closed container. Sale of Drugs for the Purposes of Implementing the General Council Decision C.07.001 The definitions in this section apply in this Division. Commissioner of Patents means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. (commissaire aux brevets) C.07.002 This Division applies to the sale of drugs for the purposes of implementing the General Council Decision. Application for Authorization C.07.003 An application by a manufacturer for authorization to sell a drug under this Division shall be submitted to the Minister and shall contain the following information and documents: (a) a statement that the manufacturer intends to file an application with the Commissioner of Patents under section 21.04 of the Patent Act; (b) in respect of a new drug, the submission number and date of filing of the new drug submission or abbreviated new drug submission filed under section C.08.002 or C.08.002.1, respectively, and of any supplement filed under section C.08.003 in respect of the drug; (c) in respect of a drug that is not a new drug, (i) the application number and date of filing of the application that has been filed under section C.01.014.1 in respect of the drug, or (ii) the drug identification number, if one has been assigned in respect of the drug pursuant to section C.01.014.2; (d) for a drug in a solid dosage form, the manner in which the drug is marked in accordance with paragraph C.07.008(a) and evidence that such manner does not alter the safety and efficacy of the drug; (e) for a drug in a dosage form that is not solid, the manner in which the immediate container is marked in accordance with paragraph C.07.008(a); and (f) a sample of the label for the drug that includes the information required by paragraph C.07.008(c). Authorization C.07.004 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer's drug meets the requirements of the Act and these Regulations if (a) the manufacturer has submitted to the Minister an application in accordance with section C.07.003 and a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act; (b) in respect of a new drug, an examination of the new drug submission or abbreviated new drug submission or supplement to either submission by the Minister demonstrates that the submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1; (c) in respect of a drug that is not a new drug, a drug identification number has been assigned pursuant to section C.01.014.2; and (a) the Minister has notified the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the *Patent Act* that the drug meets the requirements of the Act and these Regulations; and (b) the manufacturer has received authorization under section 21.04 of the *Patent Act*. Notice to Commissioner of Patents C.07.007 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the *Patent Act* in the event that the Minister is of the opinion that the manufacturer’s drug authorized to be sold under this Division has ceased to meet the requirements of the Act and these Regulations. Marking and Labelling C.07.008 No person shall sell a drug under this Division unless (a) the drug itself permanently bears the mark “XCL”, in the case of a drug in a solid dosage form, or the immediate container permanently bears the mark “XCL”, in the case of a drug in a dosage form that is not solid; (b) the colour of the drug itself is significantly different from the colour of the version of the drug sold in Canada, in the case of a drug in a solid dosage form; and (c) the label of the drug permanently bears the mark “XCL”, followed by the export tracking number assigned by the Minister under section C.07.009 and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” C.07.009 The Minister shall assign an export tracking number to each drug in respect of which the Minister has notified the Commissioner of Patents under section C.07.004. C.07.010 The manufacturer shall, with respect to a drug authorized to be sold under this Division, (a) establish and maintain records, in a manner that enables an audit to be made, respecting the information referred to in subsection C.08.007(1), and retain those records for at least seven years from the day on which they were established; and (b) provide to the Minister the summaries referred to in section C.08.008. Notice to Minister C.07.011 The manufacturer shall notify the Minister in writing not less than 15 days before commencing the manufacture of the first lot of a drug authorized to be sold under this Division and not less than 15 days before the exportation of each subsequent lot of the drug. C.08.001 For the purposes of the Act and this Division, new drug means a drug, other than a veterinary health product, (a) that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug; (b) that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or (c) with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration or duration of action, and that has not been sold for that use or condition of use in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug. C.08.001.1 For the purposes of this Division, Canadian reference product means (a) a drug in respect of which a notice of compliance is issued under section C.08.004 or C.08.004.01 and which is marketed in Canada by the innovator of the drug, (b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01 cannot be used for that purpose because it is no longer marketed in Canada, or specifications means a detailed description of a new drug and of its ingredients and includes (a) a statement of all properties and qualities of the ingredients that are relevant to the manufacture and use of the new drug, including the identity, potency and purity of the ingredients, (b) a detailed description of the methods used for testing and examining the ingredients, and (c) a statement of the tolerances associated with the properties and qualities of the ingredients. (spécifications) (a) the manufacturer of the new drug has filed with the Minister a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission relating to the new drug that is satisfactory to the Minister; (b) the Minister has issued, under section C.08.004 or C.08.004.01, a notice of compliance to the manufacturer of the new drug in respect of the submission; and (c) the notice of compliance in respect of the submission has not been suspended under section C.08.006.

(1)

Imitation dry cream mix; Vegetable oil creaming agent; Whipped vegetable oil topping; Vegetable oil topping mix

(2)

A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following: (a) a description of the new drug and a statement of its proper name or its common name if there is no proper name; (b) a statement of the brand name of the new drug or the identifying name or code proposed for the new drug; (e) details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the new drug; (f) details of the tests to be applied to control the potency, purity, stability and safety of the new drug; (g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended; (h) substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended; (i) a statement of the names and qualifications of all the investigators to whom the new drug has been sold; (j) in the case of a new drug for veterinary use, a draft of every label to be used in connection with the new drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug; (j.1) in the case of a new drug for human use, mock-ups of every label to be used in connection with the new drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug — and mock-ups of the new drug’s packages; (k) a statement of all the representations to be made for the promotion of the new drug respecting (i) the recommended route of administration of the new drug, (ii) the proposed dosage of the new drug, (iii) the claims to be made for the new drug, and (iv) the contra-indications and side effects of the new drug; (l) a description of the dosage form in which it is proposed that the new drug be sold; (m) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; (n) in the case of a new drug intended for administration to food-producing animals, the withdrawal period of the new drug; and (o) in the case of a new drug for human use other than a designated COVID-19 drug, an assessment as to whether there is a likelihood that the new drug will be mistaken for another drug for which a drug identification number has been assigned due to a resemblance between the brand name that is proposed to be used in respect of the new drug and the brand name, common name or proper name of the other drug. (2.1) A manufacturer may file, for a designated COVID-19 drug, a new drug submission that does not meet the requirements set out in paragraphs (2)(g) and (h) if the submission contains (a) a statement that the submission contains evidence to establish that the requirement set out in paragraph (b) is met; and (b) sufficient evidence to support the conclusion that the benefits associated with the designated COVID-19 drug outweigh the risks for the purpose and under the conditions of use recommended, with consideration given to the uncertainties relating to those benefits and risks as well as the public health need related to COVID-19. (2.2) A manufacturer may file, for a designated COVID-19 drug for human use, a new drug submission that does not meet the requirements set out in paragraph (2.1)(j) if the submission contains a draft of every label to be used in connection with the designated COVID-19 drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the designated COVID-19 drug. (2.3) If, at the time a new drug submission is filed for a designated COVID-19 drug, the manufacturer is unable to provide the Minister with information or material referred to in any of paragraphs (2)(e) to (k), (m) and (n) or in paragraph (2.1)(b) or subsection (2.2) or that information or material is incomplete, the manufacturer shall provide the Minister, at that time, with a plan that specifies how and when the manufacturer will provide the Minister with the missing information or material. (a) the new drug submission contains a statement that the submission is for a designated COVID-19 drug; and (b) the purpose and conditions of use specified in the new drug submission in respect of the designated COVID-19 drug relate only to COVID-19 and the submission contains a statement to that effect. (2.5) Subsections (2.1) to (2.3) do not apply if the manufacturer is seeking a notice of compliance for a designated COVID-19 drug on the basis of a direct or indirect comparison between the designated COVID-19 drug and another designated COVID-19 drug.

(2)

Cake; Cake mix

(3)

The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of a new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material: (a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold; (c) samples of the new drug in the dosage form in which it is proposed that the new drug be sold; and (a) the new drug is intended for (i) emergency use in situations where persons have been exposed to a chemical, biological, radiological or nuclear substance and action is required to treat, mitigate or prevent a life-threatening or other serious disease, disorder or abnormal physical state, or its symptoms, that results, or is likely to result, from that exposure, or (ii) preventative use in persons who are at risk of exposure to a chemical, biological, radiological or nuclear substance that is potentially lethal or permanently disabling; and (i) exposing human volunteers to the substance referred to in paragraph (a) would be potentially lethal or permanently disabling, and (ii) the circumstances in which exposure to the substance occurs are sporadic and infrequent. (a) an attestation, signed and dated by the senior executive officer in Canada of the manufacturer filing the submission and by the manufacturer’s senior medical or scientific officer, certifying that the conditions referred to in paragraphs (1)(a) and (b) are met, together with sufficient supporting information to enable the Minister to determine that those conditions are met; and (b) sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following: (ii) information respecting the pathophysiological mechanism for the toxicity of the chemical, biological, radiological or nuclear substance and describing the new drug’s ability to treat, mitigate or prevent that mechanism, (iii) detailed reports of in vitro studies respecting the toxicity and activity of the new drug in relation to the recommended purpose, (iv) detailed reports of studies, in an animal species that is expected to react with a response that is predictive for humans, establishing the safety of the new drug, and providing substantial evidence of its effect, when used for the purpose and under the conditions of use recommended, (v) information confirming that the end point of animal studies is clearly related to the desired benefit in humans, (vi) information demonstrating that there is a sufficient understanding of the pharmacokinetics and pharmacodynamics of the new drug in animals and in humans to enable inferences to be drawn in respect of humans so as to allow for the selection of an effective dose in humans, (vii) information respecting the safety of the new drug in humans, including detailed reports of clinical trials, if any, establishing the safety of the new drug, (viii) information, if any, respecting the effectiveness of the new drug in humans for the purpose or under the conditions of use recommended, (ix) a plan for monitoring and establishing the safety and effectiveness of the new drug under the conditions of use recommended that includes procedures for gathering and analyzing data, and (x) any available assessment reports regarding the new drug prepared by regulatory authorities in countries other than Canada.

(4)

Cake icing; Cake icing mix

(3)

Reports referred to in subparagraph (2)(b)(iii) or information referred to in subparagraph (2)(b)(vi) may be omitted if the extraordinary use new drug submission includes a detailed scientific explanation as to why the reports are or the information is not available.

(5)

Unstandardized beverage bases; Unstandardized beverage mixes Column III: PART B Foods

(4)

Any information or material that is necessary to enable the Minister to assess the safety and effectiveness of the new drug shall, at the request of the Minister, be added to the extraordinary use new drug submission, including (a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed to be sold; (c) samples of the new drug in the dosage form in which it is proposed to be sold; and

Section B.16.100

Column I | Column II | Column III S.18B | Sorbitan Tristearate |

(5)

If an extraordinary use new drug submission is in respect of a new purpose for a new drug for which a notice of compliance has been issued under section C.08.004, the information and material referred to in subparagraph (2)(b)(i) may be omitted unless any of it is different from that which was originally submitted. C.08.002.02 Despite sections C.08.002 and C.08.003, no manufacturer or importer shall sell a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01 except to (a) the Government of Canada or the government of a province for the use of a department or agency of that government, on receipt of a written order signed by the minister responsible for the department or by the person in charge of the agency, or by their duly authorized representative; or (b) a municipal government, or an institution of such a government, on receipt of a written order signed by the senior official of the government or institution or by his or her duly authorized representative. C.08.002.1 (1) A manufacturer of a new drug may file an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for the new drug where, in comparison with a Canadian reference product, (a) the new drug is the pharmaceutical equivalent of the Canadian reference product; (b) the new drug is bioequivalent with the Canadian reference product, based on the pharmaceutical and, where the Minister considers it necessary, bioavailability characteristics; (c) the route of administration of the new drug is the same as that of the Canadian reference product; and

(1)

Margarine; Shortening | (1) 1.0%

(2)

An abbreviated new drug submission or an abbreviated extraordinary use new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following: (a) the brand name of the new drug or the identifying name or code proposed for the new drug; (b) the name and address of the manufacturer of the new drug; (c) the name and address of the manufacturer of the Canadian reference product; (f) the specifications for the new drug and for the Canadian reference product; (g) the method of manufacture of the new drug; (h) the method of manufacture of the Canadian reference product; (i) the results of the comparative bioavailability studies; (j) the results of the comparative pharmacokinetic studies; (l) the results of the comparative clinical studies; (m) the results of the comparative non-clinical studies; (n) the results of the comparative stability studies; (o) the results of the comparative studies on the route of administration; (p) the results of the comparative studies on the conditions of use; (q) the results of the comparative studies on the indications for use; (r) the results of the comparative studies on the warnings and precautions; (s) the results of the comparative studies on the contraindications; (t) the results of the comparative studies on the adverse reactions; (u) the results of the comparative studies on the interactions with other drugs; (v) the results of the comparative studies on the overdose; (w) the results of the comparative studies on the pharmacological properties; (x) the results of the comparative studies on the toxicological properties; (y) the results of the comparative studies on the therapeutic properties; (aa) the results of the comparative studies on the pharmacodynamics; (bb) the results of the comparative studies on the clinical efficacy; (cc) the results of the comparative studies on the clinical safety; (dd) the results of the comparative studies on the clinical pharmacology; (ee) the results of the comparative studies on the clinical pharmacokinetics; (ff) the results of the comparative studies on the clinical pharmacodynamics; (gg) the results of the comparative studies on the clinical toxicology; (hh) the results of the comparative studies on the clinical therapeutic properties; (ii) the results of the comparative studies on the clinical pharmacological properties; (jj) the results of the comparative studies on the clinical pharmacokinetics; (ll) the results of the comparative studies on the clinical toxicological properties; (mm) the results of the comparative studies on the clinical therapeutic properties; (nn) the results of the comparative studies on the clinical pharmacological properties; (oo) the results of the comparative studies on the clinical pharmacokinetics; (pp) the results of the comparative studies on the clinical pharmacodynamics; (qq) the results of the comparative studies on the clinical toxicological properties; (rr) the results of the comparative studies on the clinical therapeutic properties; (ss) the results of the comparative studies on the clinical pharmacological properties; (tt) the results of the comparative studies on the clinical pharmacokinetics; (vv) the results of the comparative studies on the clinical toxicological properties; (ww) the results of the comparative studies on the clinical therapeutic properties; (xx) the results of the comparative studies on the clinical pharmacological properties; (yy) the results of the comparative studies on the clinical pharmacokinetics; (aaa) the results of the comparative studies on the clinical toxicological properties; (bbb) the results of the comparative studies on the clinical therapeutic properties; (ccc) the results of the comparative studies on the clinical pharmacological properties; (ddd) the results of the comparative studies on the clinical pharmacokinetics; (eee) the results of the comparative studies on the clinical pharmacodynamics; (fff) the results of the comparative studies on the clinical toxicological properties; 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(yyyy) the results of the comparative studies on the clinical toxicological properties; (aaaaa) the results of the comparative studies on the clinical pharmacological properties; (bbbbb) the results of the comparative studies on the clinical pharmacokinetics; (ccccc) the results of the comparative studies on the clinical pharmacodynamics; (ddddd) the results of the comparative studies on the clinical toxicological properties; (eeeee) the results of the comparative studies on the clinical therapeutic properties; (fffff) the results of the comparative studies on the clinical pharmacological properties; (ggggg) the results of the comparative studies on the clinical pharmacokinetics; (hhhhh) the results of the comparative studies on the clinical pharmacodynamics; (iiiii) the results of the comparative studies on the clinical toxicological properties; (jjjjj) the results of the comparative studies on the clinical therapeutic properties; (lllll) the results of the comparative studies on the clinical pharmacokinetics; (mmmmm) the results of the comparative studies on the clinical pharmacodynamics; (ooooo) the results of the comparative studies on the clinical therapeutic properties; (ppppp) the results of the comparative studies on the clinical pharmacological properties; (qqqqq) the results of the comparative studies on the clinical pharmacokinetics; (rrrrr) the results of the comparative studies on the clinical pharmacodynamics; (sssss) the results of the comparative studies on the clinical toxicological properties; (ttttt) the results of the comparative studies on the clinical therapeutic properties; (vvvvv) the results of the comparative studies on the clinical pharmacokinetics; (wwwww) the results of the comparative studies on the clinical pharmacodynamics; (xxxxx) the results of the comparative studies on the clinical toxicological properties; (bbbbbb) the results of the comparative studies on the clinical pharmacodynamics; (cccccc) the results of the comparative studies on the clinical toxicological properties; (eeeeee) the results of the comparative studies on the clinical pharmacological properties; (ffffff) the results of the comparative studies on the clinical pharmacokinetics; (gggggg) the results of the comparative studies on the clinical pharmacodynamics; (hhhhhh) the results of the comparative studies on the clinical toxicological properties; (jjjjjj) the results of the comparative studies on the clinical pharmacological properties; (llllll) the results of the comparative studies on the clinical pharmacodynamics; (mmmmmm) the results of the comparative studies on the clinical toxicological properties; (oooooo) the results of the comparative studies on the clinical pharmacological properties; (pppppp) the results of the comparative studies on the clinical pharmacokinetics; (qqqqqq) the results of the comparative studies on the clinical pharmacodynamics; (rrrrrr) the results of the comparative studies on the clinical toxicological properties; (ssssss) the results of the comparative studies on the clinical therapeutic properties; (tttttt) the results of the comparative studies on the clinical pharmacological properties; (vvvvvv) the results of the comparative studies on the clinical pharmacodynamics; (wwwwww) the results of the comparative studies on the clinical toxicological properties; (xxxxxx) the results of the comparative studies on the clinical therapeutic properties; (bbbbbbb) the results of the comparative studies on the clinical toxicological properties; (ccccccc) the results of the comparative studies on the clinical therapeutic properties; (ddddddd) the results of the comparative studies on the clinical pharmacological properties; (eeeeeee) the results of the comparative studies on the clinical pharmacokinetics; (fffffff) the results of the comparative studies on the clinical pharmacodynamics; (ggggggg) the results of the comparative studies on the clinical toxicological properties; (hhhhhhh) the results of the comparative studies on the clinical therapeutic properties; (iiiiiii) the results of the comparative studies on the clinical pharmacological properties; (jjjjjjj) the results of the comparative studies on the clinical pharmacokinetics; (lllllll) the results of the comparative studies on the clinical toxicological properties; (mmmmmmm) the results of the comparative studies on the clinical therapeutic properties; (nnnnnnn) the results of the comparative studies on the clinical pharmacological properties; (ooooooo) the results of the comparative studies on the clinical pharmacokinetics; (ppppppp) the results of the comparative studies on the clinical pharmacodynamics; (qqqqqqq) the results of the comparative studies on the clinical toxicological properties; (rrrrrrr) the results of the comparative studies on the clinical therapeutic properties; (sssssss) the results of the comparative studies on the clinical pharmacological properties; (ttttttt) the results of the comparative studies on the clinical pharmacokinetics; (vvvvvvv) the results of the comparative studies on the clinical toxicological properties; (wwwwwww) the results of the comparative studies on the clinical therapeutic properties; (xxxxxxx) the results of the comparative studies on the clinical pharmacological properties; (bbbbbbb) the results of the comparative studies on the clinical therapeutic properties; (ccccccc) the results of the comparative studies on the clinical pharmacological properties; (ddddddd) the results of the comparative studies on the clinical pharmacokinetics; (eeeeeee) the results of the comparative studies on the clinical pharmacodynamics; (fffffff) the results of the comparative studies on the clinical toxicological properties; (ggggggg) the results of the comparative studies on the clinical therapeutic properties; (hhhhhhh) the results of the comparative studies on the clinical pharmacological properties; (iiiiiii) the results of the comparative studies on the clinical pharmacokinetics; (jjjjjjj) the results of the comparative studies on the clinical pharmacodynamics; (lllllll) the results of the comparative studies on the clinical therapeutic properties; (mmmmmmm) the results of the comparative studies on the clinical pharmacological properties; (nnnnnnn) the results of the comparative studies on the clinical pharmacokinetics; (ooooooo) the results of the comparative studies on the clinical pharmacodynamics; (ppppppp) the results of the comparative studies on the clinical toxicological properties; (qqqqqqq) the results of the comparative studies on the clinical therapeutic properties; (rrrrrrr) the results of the comparative studies on the clinical pharmacological properties; (sssssss) the results of the comparative studies on the clinical pharmacokinetics; (ttttttt) the results of the comparative studies on the clinical pharmacodynamics; (wwwwwww) the results of the comparative studies on the clinical pharmacological properties; (xxxxxxx) the results of the comparative studies on the clinical pharmacokinetics; (bbbbbbb) the results of the comparative studies on the clinical pharmacological properties; (ccccccc) the results of the comparative studies on the clinical pharmacokinetics; (ddddddd) the results of the comparative studies on the clinical pharmacodynamics; (eeeeeee) the results of the comparative studies on the clinical toxicological properties; (fffffff) the results of the comparative studies on the clinical therapeutic properties; (ggggggg) the results of the comparative studies on the clinical pharmacological properties; (hhhhhhh) the results of the comparative studies on the clinical pharmacokinetics; (jjjjjjj) the results of the comparative studies on the clinical toxicological properties; (lllllll) the results of the comparative studies on the clinical pharmacological properties; (mmmmmmm) the results of the comparative studies on the clinical pharmacokinetics; (ooooooo) the results of the comparative studies on the clinical toxicological properties; (qqqqqqq) the results of the comparative studies on the clinical pharmacological properties; (rrrrrrr) the results of the comparative studies on the clinical pharmacokinetics; (sssssss) the results of the comparative studies on the clinical pharmacodynamics; (ttttttt) the results of the comparative studies on the clinical toxicological properties; (vvvvvvv) the results of the comparative studies on the clinical pharmacological properties; (wwwwwww) the results of the comparative studies on the clinical pharmacokinetics; (xxxxxxx) the results of the comparative studies on the clinical pharmacodynamics; (bbbbbbb) the results of the comparative studies on the clinical pharmacokinetics; (ccccccc) the results of the comparative studies on the clinical pharmacodynamics; (ddddddd) the results of the comparative studies on the clinical toxicological properties; (eeeeeee) the results of the comparative studies on the clinical therapeutic properties; (fffffff) the results of the comparative studies on the clinical pharmacological properties; (a) the information and material described in (b) information identifying the Canadian reference product used in any comparative studies conducted in connection with the submission; (c) evidence from the comparative studies conducted in connection with the submission that the new drug is (i) the pharmaceutical equivalent of the Canadian reference product, and (ii) where the Minister considers it necessary on the basis of the pharmaceutical and, where applicable, bioavailability characteristics of the new drug, bioequivalent with the Canadian reference product as demonstrated using bioavailability studies, pharmacodynamic studies or clinical studies; (d) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and (e) for a drug intended for administration to food-producing animals, sufficient information to confirm that the withdrawal period is identical to that of the Canadian reference product.

(4)

Unstandardized frozen desserts | (4) 0.035% S.19 | Stearyl Monoglyceridyl Citrate | Shortening | Good Manufacturing Practice S.20 | Sucrose esters of fatty acids |

(3)

The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of an abbreviated new drug submission or an abbreviated extraordinary use new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material: (a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold; (c) samples of the new drug in the dosage form in which it is proposed that the new drug be sold; and

(1)

Carotenoid colour preparations | (1) 1.5%

(4)

For the purposes of this section, in the case of an abbreviated new drug submission, a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01 is not a Canadian reference product. C.08.003 (1) Despite section C.08.002, no person shall sell a new drug in respect of which a notice of compliance has been issued to the manufacturer of that new drug and has not been suspended under section C.08.006 if any of the matters specified in subsection (2) are significantly different from the information or material contained in the new drug submission, extraordinary use new drug submission, abbreviated new drug submission or abbreviated extraordinary use new drug submission, unless (a) the manufacturer of the new drug has filed with the Minister a supplement to that submission; (b) the Minister has issued a notice of compliance to the manufacturer of the new drug in respect of the supplement; and (c) the notice of compliance in respect of the supplement has not been suspended under section C.08.006.

(2)

Unstandardized confectionery; Unstandardized confectionery coatings | (2) 0.5% T.2 | [Repealed, SOR/2006-91, s. 5] T.3 | Tragacanth Gum |

(2)

The matters specified for the purposes of subsection (1), in relation to the new drug, are the following: (b) the brand name of the new drug or the identifying name or code proposed for the new drug; (e) the method of manufacture and the controls used in manufacturing, preparation and packaging the new drug; (f) the tests applied to control the potency, purity, stability and safety of the new drug; (g) the labels used in connection with the new drug; (g.1) in the case of a new drug for human use, its packages; (h) the representations made with regard to the new drug respecting (i) the recommended route of administration of the new drug, (iii) the claims made for the new drug, (iv) the contra-indications and side effects of the new drug, and (v) the withdrawal period of the new drug; and (i) the dosage form in which it is proposed that the new drug be sold.

(1)

French dressing; Mustard pickles; Salad dressing; Relishes | (1) Good Manufacturing Practice

(3)

A supplement to a submission referred to in subsection (1), with respect to the matters that are significantly different from those contained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to those matters. (3.1) A supplement to a submission referred to in subsection (1) shall contain, as the case may be, (i) in the case of a new drug for veterinary use, a draft of every label to be used in connection with the new drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug, or (ii) in the case of a new drug for human use, mock-ups of every label to be used in connection with the new drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug — and mock-ups of the new drug’s packages; or (i) an assessment as to whether there is a likelihood that the new drug will be mistaken for another drug for which a drug identification number has been assigned due to a resemblance between the brand name that is proposed to be used in respect of the new drug and the brand name, common name or proper name of the other drug, and (ii) mock-ups of every label to be used in connection with the new drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug — and mock-ups of the new drug’s packages. C.08.003.01 (1) The following definitions apply in this section. submission means (a) a new drug submission that is filed under section C.08.002; (b) an extraordinary use new drug submission that is filed under section C.08.002.01; (c) an abbreviated new drug submission that is filed under section C.08.002.1; or supplement means a supplement to a submission that is filed under section C.08.003. (supplément)

(3)

Sherbet | (3) 0.75%

(2)

Despite sections C.08.002, C.08.002.01, C.08.002.1 and C.08.003 and subject to subsection (3), the manufacturer of a new drug is not permitted to file a submission or supplement for the new drug on the basis of a direct or indirect comparison to any new drug in respect of which an authorization was issued under the ISAD Interim Order.

(4)

Lumpfish Caviar | (4) 1.0%

(3)

Subsection (2) does not prevent the manufacturer of a new drug from filing a submission or supplement for the new drug on the basis of a direct or indirect comparison to another new drug in respect of which an authorization was issued under the ISAD Interim Order if (a) a notice of compliance is issued under section C.08.004 or C.08.004.01 in respect of a submission or supplement for that other new drug; and (b) the comparison is in respect of the matters that were approved by the notice of compliance. C.08.003.1 In examining a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the Minister may examine any information or material filed with the Minister by any person pursuant to Division 5 or section C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 or C.08.005.1 to establish the safety and effectiveness of the new drug for which the submission or supplement has been filed. C.08.004 (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission, (a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

(5)

Unstandardized foods | (5) Good Manufacturing Practice

(2)

If a new drug submission or an abbreviated new drug submission or a supplement to either submission does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material within 90 days after the day on which the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) or within any longer period specified by the Minister.

(6)

Calorie-reduced margarine | (6) 0.5% in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

(3)

Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission, (a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

(7)

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Cold-pack (naming the variety cheese); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) | (7) 0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8 PART B Foods

(4)

A notice of compliance issued in respect of a new drug on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug. C.08.004.01 (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission, (a) if that submission or supplement complies with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or (b) if that submission or supplement does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

Section B.16.100

Column I | Column II | Column III

(2)

If an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material within 90 days after the day on which the Minister issues a notice to the manufacturer under paragraph C.08.004.01(1)(b) or within any longer period specified by the Minister.

X

1 | Xanthan Gum

(3)

Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission, or material filed in respect of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission, (a) if that submission or supplement complies with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or (b) if that submission or supplement does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

(1)

French Dressing; Salad Dressing; Unstandardized Foods

(4)

A notice of compliance issued in respect of a new drug for extraordinary use on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug. C.08.004.1 (1) The following definitions apply in this section. innovative drug means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. (drogue innovante) pediatric populations means the following groups: pre-mature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age. (population pédiatrique) (1.1) For the purposes of the definition innovative drug in subsection (1), a medicinal ingredient is not considered to be approved in a drug by reason of the Minister having issued or amended an authorization under the ISAD Interim Order in respect of a COVID-19 drug that contains the medicinal ingredient.

(2)

Cottage Cheese; Creamed Cottage Cheese

(2)

The purpose of this section is to implement Articles 20.48 and 20.49 of the Agreement between Canada, the United States of America and the United Mexican States, as defined in the definition Agreement in section 2 of the Canada–United States–Mexico Agreement Implementation Act, and paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the Agreement Establishing the World Trade Organization, as defined in the definition Agreement in subsection 2(1) of the World Trade Organization Agreement Implementation Act.

(3)

Calorie-reduced margarine

(3)

If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug, (a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and (b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug. (a) the innovator provides the Minister with the description and results of clinical trials relating to the use of the innovative drug in relevant pediatric populations in its first new drug submission for the innovative drug or in any supplement to that submission that is filed within five years after the issuance of the first notice of compliance for that innovative drug; and (b) before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug, the Minister determines that the clinical trials were designed and conducted for the purpose of increasing knowledge of the use of the innovative drug in those pediatric populations and this knowledge would thereby provide a health benefit to members of those populations.

(5)

Mustard pickles; relishes

(5)

Subsection (3) does not apply if the innovative drug is not being marketed in Canada.

(6)

Ice Cream Mix

(6)

Paragraph (3)(a) does not apply to a manufacturer if the innovator consents to the filing of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission by the manufacturer before the end of the period of six years specified in that paragraph.

(7)

Ice Milk Mix

(7)

Paragraph (3)(a) does not apply to a manufacturer if the manufacturer files an application for authorization to sell its new drug under section C.07.003.

(8)

Sherbet

(9)

The Minister shall maintain a register of innovative drugs that includes information relating to the matters specified in subsections (3) and (4). C.08.005 (1) Subject to subsection (1.1) and notwithstanding sections C.08.002 and C.08.003, a manufacturer of a new drug may sell it to a qualified investigator to be used solely for the purpose of clinical testing to obtain evidence with respect to the safety, dosage and effectiveness of that new drug, when the following conditions are met: (a) before the sale, the manufacturer has filed with the Minister, in compliance with section C.08.005.1, a pre-clinical submission containing information and material respecting (i) the brand name of the new drug or the identifying name or code proposed for the new drug, (ii) the chemical structure or other specific identification of the composition of the new drug, (iv) a detailed protocol of the clinical testing, (v) the results of investigations made to support the clinical use of the new drug, (vi) the contra-indications and precautions known in respect of the new drug and the suggested treatment of overdosage of the new drug, (viii) the methods, equipment, plant and controls used in the manufacture, processing and packaging of the new drug, (ix) the tests applied to control the potency, purity and safety of the new drug, and (x) the names and qualifications of all investigators to whom the drug is to be sold and the names of all institutions in which the clinical testing is to be carried out; (b) the Minister has not, within 60 days after the date of receipt of the preclinical submission, sent by registered mail to the manufacturer a notice in respect of that new drug indicating that the preclinical submission is not satisfactory; (c) all inner labels and outer labels used in conjunction with the sale of the new drug to qualified investigators carry the statements (i) has the facilities for the clinical testing to be conducted by the investigator, and (ii) has received the information and material referred to in subparagraphs (a)(i) to (vi); and (e) every qualified investigator to whom the new drug is to be sold has agreed in writing with the manufacturer that the investigator will (i) not use the new drug or permit it to be used other than for clinical testing, (ii) not permit the new drug to be used by any person other than the investigator except under the investigator’s direction, (iii) report immediately to that manufacturer and, if so required by the Minister, report to the Minister all serious adverse reactions encountered during the clinical testing, (iv) account to the manufacturer for all quantities of the new drug received, where so requested by the manufacturer. (1.1) This section applies only in respect of a new drug for veterinary use.

(1)

Good Manufacturing Practice

(2)

Notwithstanding subsection (1), no manufacturer shall sell a new drug to a qualified investigator unless that manufacturer has, in respect of all previous sales of that new drug to any qualified investigator, (a) kept accurate records of the distribution of that new drug and of the results of the clinical testing and has made those records available to the Minister for inspection on the request of the Minister; and (b) immediately reported to the Minister all information he has obtained with respect to serious adverse reactions.

(4)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

(3)

The Minister may notify the manufacturer of a new drug that sales of that new drug to qualified investigators are prohibited if, in the opinion of the Minister, it is in the interest of public health to do so.

(5)

0.1%

(4)

Notwithstanding subsection (1), no manufacturer shall sell a new drug to a qualified investigator if the Minister has notified the manufacturer of that drug that such sales are prohibited.

(9)

0.02% TABLEAU IV Additifs alimentaires autorisés comme émulsifs, agents gélatinisants, stabilisants ou épaississants

(5)

Paragraph (1)(c) does not apply to a radiopharmaceutical as defined in section C.03.201 or to a component or kit as defined in section C.03.205. C.08.005.1 (1) Every manufacturer who files a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission, a supplement to any of those submissions or a submission for the clinical testing of a new drug for veterinary use shall, in addition to the information and material that is required under section C.08.002, C.08.002.01, C.08.002.1, C.08.003 or C.08.005, include in the submission or supplement (b) a sectional report in respect of each human, animal and in vitro study included in the submission or supplement; (c) a comprehensive summary of each human, animal and in vitro study referred to or included in the submission or supplement; and

Article | Colonne I | Colonne II | Colonne III

Additifs | Permis dans ou sur | Limites de tolérance A.1 | Gomme arabique

(2)

A sectional report referred to in paragraph (1)(b) shall include (a) a summary of each study included in the submission or supplement; (b) a summary of any additional information or material filed to amend the submission or supplement; and (c) where raw data is available to the manufacturer in respect of a study, (iii) a description of the conditions under which the experiments from which the data were obtained were conducted, (iv) the details of the data treatment process, and (v) the results and conclusions of the study.

(1)

Achards (relish); cornichons à la moutarde; crème; lait (indication de l’arôme); lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; sauce à salade; sauce française

(3)

The comprehensive summary referred to in paragraph (1)(c) shall include a summary of the methods used, results obtained and conclusions arrived at in respect of all studies referred to or included in the submission or supplement and shall be cross-referenced to the relevant portions of the sectional reports. (a) certify that all information and material included in the submission or supplement and any additional information or material filed to amend the submission or supplement are accurate and complete, and that the sectional reports and the comprehensive summary correctly represent the information and material referred to or included in the submission or supplement; and (b) be signed and dated by (i) the senior executive officer in Canada of the manufacturer filing the submission or supplement, and (ii) the senior medical or scientific officer of the manufacturer.

(2)

Crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

(6)

Every manufacturer who has filed a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission, a supplement to any of those submissions or a submission for the clinical testing of a new drug for veterinary use and who has any relating clinical case reports or raw data that were not included in the submission or supplement shall keep those reports or data and shall, within 30 days after receiving a written request from the Minister, submit them to the Minister. C.08.006 (1) For the purposes of subsection (2), evidence or new information obtained by the Minister includes any information or material filed by any person under Division 5 or section C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 or C.08.005.1.

(1)

Bonnes pratiques industrielles

(2)

The Minister may, by notice to a manufacturer, suspend, for a definite or indefinite period, a notice of compliance issued to that manufacturer in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions if the Minister considers (a) that the drug is not safe for the use represented in the submission or supplement, as shown by evidence obtained from (i) clinical or other experience not reported in the submission or supplement or not available to the Minister at the time the notice of compliance was issued, or (ii) tests by new methods or tests by methods not reasonably applicable at the time the notice of compliance was issued; (b) that, upon the basis of new information obtained after the issuance of the notice of compliance, there is lack of substantial evidence that the drug will have the effect it is represented to have under the conditions of use prescribed, recommended or proposed by the manufacturer; (d) that the manufacturer has failed to establish a system for maintaining required records or has repeatedly or deliberately failed to maintain such records; (e) that, on the basis of new information obtained after the issuance of the notice of compliance, the methods, equipment, plant and controls used in the manufacturing, processing and packaging of the drug are inadequate to assure and preserve the identity, strength, quality or purity of the new drug; (f) that, on the basis of new information obtained after the issuance of the notice of compliance, the labelling of the drug is false or misleading or incomplete in any particular and that this defect was not corrected by the manufacturer upon receipt of a written notice from the Minister specifying the respect in which the labelling is false or misleading or incomplete; or (g) that, in the case of a new drug for extraordinary use, the manufacturer has not adhered to the plan referred to in subparagraph C.08.002.01(2)(b)(ix).

(2)

0,5 % PART B Foods

(3)

The Minister may, by notice to a manufacturer, suspend for a definite or indefinite period a notice of compliance issued to that manufacturer in respect of a new drug submission, an extraordinary new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions if, after the Minister has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(a)(iii) to conduct an assessment of the new drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health, (a) the holder fails to comply with the order; or (b) the holder complies with the order but the Minister determines that the results of the assessment are C.08.007 (1) Where a manufacturer has received a notice of compliance issued in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the manufacturer shall establish and maintain records, in a manner that enables an audit to be made, respecting (a) animal or clinical experience, studies, investigations and tests conducted by the manufacturer or reported to him by any person concerning that new drug; (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that new drug; (c) experience, investigations, studies and tests involving the chemical or physical properties or any other properties of that new drug; (d) any substitution of another substance for that new drug or any mixing of another substance with that new drug; (e) any error in the labelling of that new drug or in the use of the labels designed for that new drug; (f) any bacteriological or any significant chemical or physical or other change or deterioration in any lot of that new drug; (g) any failure of one or more distributed lots of the new drug to meet the specifications established for that new drug in the submission or supplement; and (h) any unusual failure in efficacy of that new drug. (1.1) The manufacturer shall retain the records respecting the information referred to in subsection (1) for at least seven years from the day on which they were established.

Section B.16.100

(2)

A manufacturer or importer who sells a new drug for extraordinary use in accordance with section C.08.002.02 shall retain the written order for at least 15 years from the day on which the order was filled. C.08.008 No manufacturer shall sell a new drug unless the manufacturer has, with respect to all the manufacturer’s previous sales of that new drug, furnished to the Minister (a) a summary of a record respecting any information referred to in paragraphs C.08.007(1)(a) to (c), on receipt of a request from the Minister for the summary; (b) a summary of a record respecting any information referred to in paragraph C.08.007(1)(d) to (f), immediately after the manufacturer establishing the record; and (c) a summary of a record respecting any information referred to in paragraph C.08.007(1)(g) or (h), within 15 days after the day on which the manufacturer established the record. C.08.008.1 Where a manufacturer has received a notice of compliance issued in respect of an extraordinary use new drug submission, an abbreviated extraordinary use new drug submission or a supplement to either of those submissions, the manufacturer (b) shall, before the first day of October in each year and whenever requested to do so by the Minister for the purposes of assessing the safety and effectiveness of the drug to which the notice of compliance relates, provide a report on the use of the drug, including a critical analysis of any available updated information respecting the drug’s safety and effectiveness. C.08.009 (1) Where the Minister has decided (a) to notify the manufacturer of a new drug for veterinary use that the sale of that drug to qualified investigators is prohibited, or the manufacturer, if dissatisfied with that decision, may require the Minister to provide him with the reasons for the decision.

Article | Additifs | Colonne II Permis dans ou sur | Colonne III Limites de tolérance

---|---|---|--- A.1A | Gomme d’acacia modifiée avec l’anhydride octénylsuccinique (AOS) | (3) Sorbet laitier (4) Aliments non normalisés (5) Margarine réduite en calories (6) Asperges en conserve, haricots jaunes en conserve; haricots verts en conserve; pois en conserve (1) Glaces; sauce à salade; sauces d’assaisonnement non normalisées; sauces non normalisées; sauce vinaigrette (2) Boissons non normalisées (3) Préparations aromatisantes non normalisées | (3) 0,75 % (4) Bonnes pratiques industrielles (5) 0,5 % selon les exigences de l’article B.09.017 (6) 1,0 % selon les exigences de la disposition B.11.002d)(viii)(C). (1) 1 % (2) 0,1 % (3) 0,05 % A.2 | Monoglycérides acétylés | Aliments non normalisés | Bonnes pratiques industrielles A.3 | Esters tartriques des mono- et diglycérides acétylés | (1) Pain (2) Aliments non normalisés (3) Préparations pour nourrissons à base d’acides aminés cristallisés | (1) 6 000 p.p.m. de farine (2) Bonnes pratiques industrielles (3) 0,024 % de la préparation pour nourrissons prête à consommer A.4 | Agar-agar | (1) Achards (relish); cornichons à la moutarde; crème; fromage de porc; gelée (nom du fruit) avec pectine; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; lait à viande ou liant à (désignation du produit de viande) lorsqu’il est vendu pour servir dans la viande préparée et dans les sous-produits de viande préparés dans lesquels il est permis d’ajouter un agent gélatinisant; (nom de la volaille) en conserve; pain de viande; poisson et viande préparés (Titre 21); sous-produits de viande en pain; sous-produits de viande en pot; pâte fromagée; viande en pot (2) Crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé (3) Sorbet laitier (4) Aliments non normalisés (5) Margarine réduite en calories | (1) Bonnes pratiques industrielles (2) 0,5 % (3) 0,75 % (4) Bonnes pratiques industrielles (5) 0,5 % selon les exigences de l’article B.09.017 A.5 | Algine | (1) Achards (relish); bière; cornichons à la moutarde; crème; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait (indication de l’arôme); | (1) Bonnes pratiques industrielles Colonne I

(2)

Where the manufacturer has received the reasons for a decision of the Minister pursuant to subsection (1), he may require the Minister to refer that decision to a New Drug Committee and thereupon shall provide the Minister with a statement of the reasons for his dissatisfaction and any information and material upon which he relies in support of those reasons.

Article

Additifs A.6 Acide alginique A.7 Alginate d’ammonium A.8 Carraghénine ammoniacale A.9 Furcellaran d’ammonium A.9A Sel d’ammonium de glycéride phosphorylé Colonne II Permis dans ou sur Mêmes aliments que pour l’algine Mêmes aliments que pour l’algine Mêmes aliments que pour la carraghénine Mêmes aliments que pour le furcellaran

(3)

Where the Minister has been required to refer a decision to a New Drug Committee pursuant to subsection (2), he shall appoint a member of the New Drug Committee, the dissatisfied manufacturer shall appoint a member of the New Drug Committee and the two members so appointed shall appoint a third member of the New Drug Committee who shall be chairman, or, if they are unable to do so within a reasonable time, the Minister shall appoint a third member of the New Drug Committee who shall be chairman.

(1)

Achards (relish); cornichons à la moutarde; crème; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait indication de l’arôme; lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; pain

(4)

Any person who is in the full-time employment of the Department or in the full-time employment of the dissatisfied manufacturer shall not be appointed a member of a New Drug Committee. (4.1) A member of a New Drug Committee shall, on appointment, sign an undertaking not to disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

(2)

Crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé Colonne III Limites de tolérance Mêmes limites de tolérance que pour l’algine Mêmes limites de tolérance que pour l’algine Mêmes limites de tolérance que pour la carraghénine Mêmes limites de tolérance que pour le furcellaran

(5)

The Minister shall pay the reasonable fees and costs incurred by the member of the New Drug Committee appointed by the Minister, and the dissatisfied manufacturer shall pay the reasonable fees and costs incurred by the member appointed by the dissatisfied manufacturer, and the Minister and the dissatisfied manufacturer shall each pay half of the reasonable fees and costs incurred by the chairman.

(1)

Bonnes pratiques industrielles

(6)

The New Drug Committee formed pursuant to subsection (3) shall consider the reasons for the decision of the Minister, the reasons for the dissatisfaction of the dissatisfied manufacturer and any information or material in support of the reasons of the Minister or the dissatisfied manufacturer and may consider other evidence, material, information or representations.

(2)

0,5 % PART B Foods

(7)

The New Drug Committee formed pursuant to subsection (3) shall report its findings and recommendations to the Minister. (7.1) No member of a New Drug Committee shall disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

Section B.16.100

Règlement sur les aliments et drogues

(8)

Where the Minister has received the findings and recommendations of a New Drug Committee, he may reconsider the decision to which those findings and recommendations relate. foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère) C.08.009.02 Sections C.08.009.03 to C.08.009.05 apply in respect of a designated COVID-19 drug if the following conditions are met: (a) a notice of compliance has not been issued under section C.08.004 or C.08.004.01 in respect of the designated COVID-19 drug; and (b) Her Majesty in right of Canada has entered into a contract for the procurement of the designated COVID-19 drug. C.08.009.03 (1) The holder of an establishment licence may import a designated COVID-19 drug if the following conditions are met: (a) the Chief Public Health Officer provides the Minister with (i) information indicating that (A) the designated COVID-19 drug is the subject of a new drug submission that was filed under section C.08.002, or (B) an application has been submitted to a foreign regulatory authority to authorize the sale of the designated COVID-19 drug, (v) the name and contact information of any holder of an establishment licence who is proposed to be an importer of the designated COVID-19 drug, and (vi) the civic address of the place where the designated COVID-19 drug will be stored after importation; (b) the holder provides the Minister with (i) the name and contact information of each fabricator, packager/labeller and tester of the designated COVID-19 drug and the civic address of each building at which the designated COVID-19 drug will be fabricated, packaged/labelled or tested, specifying for each building (A) the activities referred to in Table I to section C.01A.008 that apply to the designated COVID-19 drug, (B) the categories referred to in Table II to that section that apply to the designated COVID-19 drug, and (C) for each category, the dosage form classes, if any, and whether the designated COVID-19 drug will be in a sterile form, and (ii) a certificate from an inspector indicating that each fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4 or, alternatively, other evidence establishing that those requirements are met; and (c) the holder is one of those specified in the information that the Chief Public Health Officer provides under subparagraph (a)(v).

PARTIE B Aliments

(2)

Paragraph (1)(b) does not apply to the holder of an establishment licence in respect of a building referred to in subparagraph (1)(b)(i) if (a) the building is listed in the licence; and (b) the information referred to in clauses (1)(b)(i)(A) to (C) that the holder submitted in respect of the building in their application for the licence under section C.01A.005 or in an application to amend the licence under section C.01A.006, has not changed.

TITRE 16 Additifs alimentaires

(3)

If the conditions set out in subsection (1) are met, the Minister shall send a letter to the Chief Public Health Officer to that effect. C.08.009.04 Sections A.01.040 and C.01.004.1, subsection C.01A.004(1), section C.01A.006 and Divisions 2 to 4, other than the following provisions, do not apply in respect of the importation, under section C.08.009.03, of a designated COVID-19 drug by the holder of an establishment licence: (a) sections C.02.003.1, C.02.004 and C.02.006, as they apply to the storage of the designated COVID-19 drug by the holder; (e) subsection C.02.021(1), as it applies to the storage of the designated COVID-19 drug by the holder; (j) section C.04.001.1, as it applies to the storage of the designated COVID-19 drug by the holder. C.08.009.05 Despite anything in these Regulations, the holder of an establishment licence may distribute a designated COVID-19 drug that they have imported under section C.08.009.03 if the following conditions are met: (a) the Chief Public Health Officer provides the Minister with the name of the designated COVID-19 drug and the civic address of the place where it will be stored after the distribution; and (b) the designated COVID-19 drug is distributed to a person who will store it at that place. Disclosure of Information in Respect of Clinical Trials C.08.009.1 (1) In sections C.08.009.2 and C.08.009.3, information in respect of a clinical trial means information in respect of a clinical trial, within the meaning of section C.05.001, that is contained in a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for a new drug filed under this Division or section C.08.002, C.08.002.01 or C.08.003 or in a supplement to any of those submissions filed under section C.08.003.

Article B.16.100

Colonne I

(2)

For greater certainty, the definition information in respect of a clinical trial includes information that is contained in a submission or supplement referred to in that definition and that is in respect of clinical testing involving human subjects in regards to which an application was filed under this Division before September 1, 2001. C.08.009.2 (1) Information in respect of a clinical trial that is confidential business information ceases to be confidential business information when one of the following circumstances occurs with respect to the submission or supplement:

Article

Additifs A.10 Arabinogalactane B.1 Levure de boulanger Glycan

(2)

Subsection (1) does not apply to information in respect of a clinical trial that (a) was not used by the manufacturer in the submission or supplement to support the proposed conditions of use for the new drug or the purpose for which the new drug is recommended; or (b) describes tests, methods or assays that are used exclusively by the manufacturer. C.08.009.3 The Minister may disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, any information in respect of a clinical trial that has ceased to be confidential business information. Sale of New Drug for Emergency Treatment C.08.010 (1) The Minister may issue a letter of authorization to a manufacturer of a new drug authorizing the sale of a specified quantity of the new drug for human or veterinary use to a practitioner, for use in the emergency treatment of an animal or a person under the care of that practitioner, if (a) the practitioner provides the following information to the Minister: (i) the name of the new drug and details concerning the medical emergency for which the new drug is required, (ii) the quantity of the new drug that is required, (iii) subject to subsection (2), the information in the possession of the practitioner in respect of the use, safety and efficacy of the new drug, (iv) the name and the civic address of the person to whom the new drug is to be shipped, and (v) any other information the Minister may request to enable the Minister to determine whether to issue the letter of authorization; (i) provide a report to the manufacturer of the new drug and to the Minister describing the results obtained following the use of the new drug to address the medical emergency, including information respecting any adverse drug reactions observed by the practitioner, and (ii) account to the Minister, on request, for all quantities of the new drug received; (c) in the case of a new drug for human use, the person referred to in subparagraph (a)(iv) is a practitioner or a pharmacist; and

C

1 Alginate de calcium

(2)

Subparagraph (1)(a)(iii) does not apply if the following conditions are met: (a) the sale of the new drug has been authorized under subsection (1) to address the same medical emergency on at least one previous occasion; (b) the European Medicines Agency or the United States Food and Drug Administration has authorized the sale of the new drug without terms or conditions, for the same use in its jurisdiction; and (c) the Minister has not cancelled the assignment of a drug identification number for the new drug under paragraph C.01.014.6(2)(b) or (c) or subsection C.01.014.6(3).

C

2 Carbonate de calcium

(4)

The letter of authorization must contain the following information: (b) the name and the civic address of the person to whom the new drug may be shipped; (c) the name of the new drug and the medical emergency in respect of which it may be sold; and

C

3 Carraghénine calcique

(5)

For the purposes of this section, the practitioner is not required to know the identity of the animal or the person under the care of that practitioner at the time the letter of authorization is issued. C.08.011 (1) Despite section C.08.002, the manufacturer may sell a new drug in accordance with a letter of authorization issued under subsection C.08.010(1).

C

4 Citrate de calcium

(2)

In the case of the sale under subsection (1) of a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A and that was not imported under section C.08.012.1, an annual report identifying the total quantity of the new drug that was sold, including an estimate of the quantity sold in respect of each animal species for which the drug is intended, must be submitted to the Minister by the manufacturer, if the new drug was present in Canada at the time of sale, otherwise by the practitioner.

C

5 Furcellaran de calcium

(3)

The sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations other than this section.

C

6 Gluconate de calcium

(4)

The annual report described in subsection (2) is for a period of one calendar year and must be submitted on or before March 31 of the year following the calendar year covered by the report, beginning with the first full calendar year during which the drug is first sold. C.08.011.1 (1) The Minister may issue a letter of authorization to the manufacturer of a new drug authorizing the holder of an establishment licence to import a specified quantity of the new drug for human or veterinary use, if the following conditions are met: (a) the manufacturer provides the following information to the Minister: (i) the name of the new drug and details concerning the medical emergency for which the new drug will be imported, (iv) the civic address of the facility where the new drug is to be stored in Canada, and (v) any other information the Minister may request to enable the Minister to determine whether to issue the letter of authorization; (b) the establishment licence authorizes the importation of a new drug in the same category as the one to be imported; and (c) the quantity that is to be imported does not exceed the amount that the Minister determines is likely to be required to address the medical emergency.

C

7 Glycérophosphate de calcium

(3)

The letter of authorization must contain the following information: (a) the name of the new drug and the medical emergency in respect of which the letter is issued; (b) the quantity of the new drug that may be imported to address the medical emergency; (c) the name of the holder of an establishment licence who is authorized to import the new drug; and

C

8 Hypophosphite de calcium

(2)

Section C.01A.006 and Divisions 2 to 4, except for the following provisions, do not apply to the importation of a new drug referred to in the letter of authorization: (a) sections C.02.003.1 and C.02.004, as they apply to the storage of the new drug by the holder of an establishment licence; (b) section C.02.006, as it applies to the storage of the new drug by the holder of an establishment licence; (e) section C.02.015, as it applies to the storage and transportation of the new drug by the holder of an establishment licence; (f) subsection C.02.021(1), as it applies to the storage of the new drug by the holder of an establishment licence. (k) section C.04.001.1, as it applies to the storage of the new drug by the holder of an establishment licence.

C

9 Phosphate bicalcique

(2)

The holder of an establishment licence who distributes to a practitioner, in accordance with subsection (1), a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A must submit to the Minister an annual report identifying the total quantity of the new drug that was distributed, including an estimate of the quantity distributed in respect of each animal species for which the drug is intended.

C

10 Phosphate tricalcique Colonne II Permis dans ou sur

(3)

The distribution of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations other than this section.

(3)

Sorbet laitier

(4)

The annual report described in subsection (2) is for a period of one calendar year and must be submitted on or before March 31 of the year following the calendar year covered by the report, beginning with the first full calendar year during which the drug is first distributed. Sale of Medicated Feeds C.08.012 (1) Notwithstanding anything in this Division, a person may sell, pursuant to a written prescription of a veterinary practitioner, a medicated feed if (a) as regards the drug or drugs used as the medicating ingredient of the medicated feed, (i) the Minister has assigned a drug identification number pursuant to section C.01.014.2, or (b) the medicated feed is for the treatment of animals under the direct care of the veterinary practitioner who signed the prescription; (c) the medicated feed is for therapeutic purposes only; and (d) the written prescription contains the following information: (i) the name and address of the person named on the prescription as the person for whom the medicated feed is to be mixed, (ii) the species, production type and age or weight of the animals to be treated with the medicated feed, (iii) the type and amount of medicated feed to be mixed, (iv) the proper name, or the common name if there is no proper name, of the drug or each of the drugs, as the case may be, to be used as medicating ingredients in the preparation of the medicated feed, and the dosage levels of those medicating ingredients, (v) any special mixing instructions, and (vi) labelling instructions including (B) a warning statement respecting the withdrawal period to be observed following the use of the medicated feed, and (C) where applicable, cautions with respect to animal health or to the handling or storage of the medicated feed.

(4)

Aliments non normalisés

(2)

For the purposes of this section, medicated feed has the same meaning as in the Feeds Regulations, 2024. C.08.013 (1) Notwithstanding anything in this Division, a person may sell a new drug proposed for use in animals to an experimental studies investigator in a quantity specified by the Minister for the purpose of conducting an experimental study in animals if (a) the experimental studies investigator has been issued an experimental studies certificate pursuant to subsection C.08.015(1) and the certificate has not been suspended or cancelled pursuant to section C.08.018; and (b) the drug is labelled in accordance with subsection C.08.016(1). C.08.014 (1) For the purpose of obtaining an experimental studies certificate, an applicant shall submit to the Minister, in writing, the following information and material: (a) the brand name of the new drug or the identifying name or code proposed for the new drug; (b) the objectives and an outline of the proposed experimental study of the new drug; (c) the species, number and production type of animals in respect of which the new drug is to be administered; (e) the address of the premises in which the experimental study is to be conducted; (g) the name, address and qualifications of the proposed experimental studies investigator; (h) the chemical structure, if known, and the relevant compositional characteristics of the new drug; (i) the proposed quantity of the new drug to be used for the experimental study; (j) the results of any toxicological or pharmacological studies that may have been conducted with the new drug; (k) the written agreement referred to in subsection (2); and (l) such other information and material as the Minister may require.

(5)

Produits de chocolat; produits du cacao Bases pour boissons non normalisées; huiles essentielles; mélanges pour boissons non normalisées; mélanges pour garnitures à tarte; mélanges pour poudings; sauces d’assaisonnement non normalisées Aliments non normalisés Mêmes aliments que pour l’algine

(2)

Where a food-producing animal is involved in an experimental study, the applicant referred to in subsection (1) shall, for the purposes of obtaining an experimental studies certificate, obtain from the owner of the animals, or from a person authorized by the owner, a written agreement not to sell the animal or any products from it without prior authorization from the experimental studies investigator.

(1)

Aliments non normalisés

(3)

The Minister may request the manufacturer of a new drug to submit to him samples of the new drug or of any ingredient of the drug and, in satisfactory form and manner, any other information that the Minister requests and where such samples or information are not submitted, the Minister may refuse to issue an experimental studies certificate. C.08.015 (1) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Minister has determined that (a) the applicant is qualified as an experimental studies investigator for the purposes of the proposed experimental study, (b) the facilities for the conduct of the experimental study are adequate for the purposes of the proposed experimental study, and (c) the proposed experimental study can be conducted without undue foreseeable risk to humans or animals, the Minister shall issue an experimental studies certificate for the purposes of the proposed experimental study and shall specify therein the quantity of the new drug that may be sold to the experimental studies investigator.

(2)

Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n) Mêmes aliments que pour la carraghénine

(2)

If, on receipt of the information and material submitted under section C.08.014, the Minister determines that the requirements of paragraphs (1)(a), (b) and (c) have not been met, the Minister shall refuse to issue an experimental studies certificate. C.08.016 (1) The label of a new drug that is sold pursuant to section C.08.013 shall show (a) the brand name of the new drug or the identifying name or code proposed for the new drug; (b) a warning statement to the effect that the drug is for use only in an experimental study in animals; (c) the lot number of the drug; (e) the name of the person to whom the drug has been supplied.

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(2)

Sections C.01.004, C.01.005 and C.01.014 do not apply to a new drug that is sold pursuant to section C.08.013 and labelled in accordance with subsection (1). (a) use the new drug only in accordance with the outline of the experimental study; (b) report immediately to the Minister all serious adverse drug reactions associated with the use of the new drug; (c) report promptly to the Minister, on request, the results of the experimental study; (e) maintain all records of the experimental study for a period of at least two years after the conclusion of the study and, on request, make such records available to the Minister; (f) report promptly to the Minister any known disposition of animals involved in the study or of any products from the animals that is contrary to the terms of the agreement referred to in subsection C.08.014(2); and (g) account to the Minister, on request, for all quantities of the new drug received by him. C.08.018 (1) If the Minister determines that it is necessary in order to safeguard animal health or public health or to promote public safety, he or she may suspend for a definite or indefinite period or cancel an experimental studies certificate.

(2)

Aliments non normalisés Mêmes aliments que pour le furcellaran Aliments non normalisés Mélanges pour desserts non normalisés Mélanges pour desserts non normalisés

(2)

Without limiting the generality of subsection (1), the Minister may suspend or cancel an experimental studies certificate if (a) the information and material submitted pursuant to section C.08.014 contains an untrue statement or omits any omission concerning the properties of the new drug that were known or ought reasonably to have been known to the manufacturer or the experimental studies investigator; (b) the labelling of the new drug is, at any time, false, misleading, deceptive or incomplete; (c) the qualifications of the experimental studies investigator prove to be inadequate; (d) there is evidence that the experimental studies investigator has not complied with the conditions referred to in section C.08.017; or (e) an action of the manufacturer in respect of the new drug has resulted in his conviction for a violation of section C.08.002. C.09.001 This Division does not apply to (a) a drug that is required by these Regulations or the Narcotic Control Regulations to be sold only on prescription; or General C.09.010 No manufacturer or importer shall, after June 30, 1986, sell a drug for analgesia that contains a combination of (a) a salt or derivative of salicylic acid with another salt or derivative of salicylic acid or with salicylamide; or (b) acetaminophen with a salt or derivative of salicylic acid or with salicylamide. C.09.011 Each label of a drug that is intended for internal use and contains acetaminophen, salicylic acid or a salt or derivative thereof shall, after June 30, 1986, carry a caution (a) to consult a physician if the underlying condition requires continued use for more than five days; and (b) that it is hazardous to exceed the maximum recommended dose unless advised by a physician. C.09.012 Each label of a drug that is intended for internal use and contains salicylic acid or a salt or derivative thereof shall after June 30, 1986, carry a warning statement to consult a physician before taking the drug during the last three months of pregnancy or when nursing. C.09.021 (1) In this Division, acetaminophen product means a drug that contains (a) acetaminophen as a single medicinal ingredient; or (b) acetaminophen in combination with caffeine.

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(2)

No manufacturer or importer shall sell an acetaminophen product unless it meets the requirements of this Division.

(2)

Aliments non normalisés Aliments non normalisés Colonne III Limites de tolérance

(2)

An acetaminophen product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain 500 mg of acetaminophen per individual dosage form if it has a label that states that it is not a standard dosage unit product.

(3)

0,75 %

(3)

An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration may contain 325 mg of acetaminophen for immediate release and another 325 mg for subsequent release, if it has a label that states that it is not a standard dosage unit product.

(4)

Bonnes pratiques industrielles

(4)

An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per individual dosage form.

(5)

0,7 % Bonnes pratiques industrielles Bonnes pratiques industrielles Mêmes limites de tolérance que pour l’algine

(5)

An acetaminophen product in the form of a liquid that is intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per millilitre of the product.

(1)

Bonnes pratiques industrielles

(6)

A package of an acetaminophen product described in subsection (5) shall be accompanied by a measuring device capable of accurately delivering 0.5 mL of the product.

(2)

Bonnes pratiques industrielles Mêmes limites de tolérance que pour la carraghénine

(7)

An acetaminophen product in the form of a liquid that is not intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit per teaspoon of the product.

(1)

4,0 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(8)

An acetaminophen product in the form of a liquid shall contain one adult standard dosage unit of acetaminophen per teaspoon of the product. (a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 325 mg; and (b) in the case of choline salicylate, 435 mg. (a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 80 mg; and (b) in the case of choline salicylate, 110 mg. C.09.031 (1) In this Division, salicylate product means a drug that contains (a) a salt or derivative of salicylic acid as a single medicinal ingredient; (b) a salt or derivative of salicylic acid in combination with caffeine; (c) a salt or derivative of salicylic acid in combination with one or more buffering agents or antacids; or

(2)

Bonnes pratiques industrielles Mêmes limites de tolérance que pour le furcellaran Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles

(2)

No manufacturer or importer shall sell a salicylate product after June 30, 1986 unless it meets the requirements of this Division.

(1)

3,5 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(3)

No manufacturer or importer shall, until June 30, 1986, sell a salicylate product in a dosage unit other than one mentioned in this Division, unless the salicylate product was legally available for sale in Canada on February 1, 1984.

(2)

Bonnes pratiques industrielles Bonnes pratiques industrielles PART B Foods

(2)

A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain per individual dosage form if it has a label that states that it is not a standard dosage unit product.

Section B.16.100

Règlement sur les aliments et drogues

(3)

A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain (a) two adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains two adult standard dosage units; and (b) three adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains three adult standard dosage units.

PARTIE B Aliments

(2)

A salicylate product in the form of a liquid may contain (a) two adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains two adult standard dosage units; and (b) three adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains three adult standard dosage units. C.09.034 A salicylate product that is claimed to be buffered shall provide at least 1.9 milliequivalents of acid neutralizing capacity per adult standard dosage unit of a salicylate. C.09.035 A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of a salicylate per individual dosage form. C.10.001 (1) The following definitions apply in this section and in section C.10.002. public health official means (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act; (b) the Chief Medical Officer of Health, or equivalent, of a province; (c) the Surgeon General of the Canadian Armed Forces; or

TITRE 16 Additifs alimentaires

(2)

Despite sections A.01.040 and C.01.004.1, any person who holds an establishment licence that authorizes the importation of a drug may import a drug for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, or for which a drug identification number has not been assigned under subsection C.01.014.2(1), if the following conditions are met: (a) a public health official has, within the past year, notified the Minister in writing of (i) an urgent public health need for the immediate use of the drug within their jurisdiction, and (b) the drug is authorized by a foreign regulatory authority in the United States, Switzerland or the European Union to be sold for the same use or purpose as that described under subparagraph (a)(ii); (c) the drug is in the same category as the category for which the licence was issued; (d) the drug is imported directly from the country in which it is authorized to be sold by the foreign regulatory authority; and (e) the drug is one for which the following information is set out in the List of Drugs for an Urgent Public Health Need that is published by the Government of Canada on its website, as amended from time to time: (v) route of administration, and (vi) identifying code or number, if any, assigned in the country in which the drug was authorized for sale.

Article B.16.100

Colonne I

(3)

Sections C.01A.006 and C.01A.007 do not apply in respect of the importation of a drug under subsection (2).

Article

(4)

For greater certainty, a licensee may, despite subsection C.01A.004(1), import a drug under subsection (2) without having their licence amended under section C.01A.006.

C

11

(5)

Divisions 2 to 4, other than the following provisions, do not apply to the importation of a drug under subsection (2): (a) sections C.02.003.1 and C.02.004 as they apply to the storage of the drug by the licensee; Food and Drug Regulations (e) section C.02.015 as it applies to the storage and transportation of the drug by the licensee; (f) subsection C.02.021(1) as it applies to the storage of the drug by the licensee; (k) section C.04.001.1 as it applies to the storage of the drug by the licensee. C.10.002 (1) A sale of a drug that is imported under subsection C.10.001(2) is exempt from the provisions of these Regulations only if the drug is sold to a person within the jurisdiction of a public health official who has notified the Minister as described in paragraph C.10.001(2)(a), for use in respect of the same urgent public health need for which it was imported.

C

12

(2)

Any person who wholesales such a drug must hold an establishment licence to wholesale a drug in the same category and despite subsection (1), the following provisions apply in respect of the wholesaler: (a) sections C.02.003.1 and C.02.004 as they apply to the storage of the drug by the licensee; (b) section C.02.006 as it applies to the storage of the drug by the licensee; (d.1) section C.02.014; (e) section C.02.015 as it applies to the storage and transportation of the drug by the licensee; (e.1) subsection C.02.021(1) as it applies to storage; C.10.003 Every licensee who imports a drug under subsection C.10.001(2) must notify the Minister within 15 days after the day on which it is imported by providing the following information: (a) the name, title and contact information of the person who imported the drug; (c) the medicinal ingredients, strength, dosage form and route of administration of the drug and any identifying code or number assigned to it in the country in which it was authorized for sale; (d) the name of the country from which the drug was imported; and C.10.004 (1) The following definitions apply in this section and in sections C.10.005 to C.10.011. designated drug means a drug that is set out in the List of Drugs for Exceptional Importation and Sale. (drogue désignée) drug means any of the following drugs for human use: (a) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act; (c) drugs that are listed in Schedule C or D to the Act; and (d) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner. (drogue) List of Drugs for Exceptional Importation and Sale means the List of Drugs for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste des drogues destinées aux importations et aux ventes exceptionnelles)

C

13

(2)

In sections C.10.006 and C.10.009, batch certificate, fabricate, MRA country, package/label and recognized building have the same meanings as in subsection C.01A.001(1). C.10.005 (1) The Minister may add a drug to the List of Drugs for Exceptional Importation and Sale only if the Minister has reasonable grounds to believe that (a) there is a shortage or risk of shortage of another drug for which a notice of compliance has been issued under section C.08.004 or C.08.004.01 or for which a drug identification number has been assigned under subsection C.01.014.2(1); and (b) the drug to be added to that list can be substituted for the drug referred to in paragraph (a).

C

14

(2)

In subsection (1), shortage has the same meaning as in section C.01.014.8. C.10.006 (1) A person who holds an establishment licence that authorizes the importation of a drug may import a designated drug if the following conditions are met: (a) the licensee provides the Minister, electronically in a format specified by or acceptable to the Minister and not later than the third business day before the day on which the designated drug is imported, with a notification that contains the following information: (ii) the name and contact information of each fabricator, packager/labeller and tester of the designated drug and the address of each building in which it is fabricated, packaged/labelled or tested, (iii) in respect of the designated drug, (A) its brand name, (B) its medicinal ingredients, (C) its dosage form, (D) its strength, (E) its route of administration, (F) any code or identification number assigned to it in the country in which its sale is authorized, (F) its identifying code or number, if any, assigned in the country in which it is authorized for sale, and (G) a detailed description of its conditions of use, (iv) the intended port of entry into Canada, (v) the estimated date of arrival of the shipment of the designated drug, and (vi) the total quantity of the designated drug that is intended to be imported on the date referred to in subparagraph (v); (b) the designated drug is authorized to be sold by a foreign regulatory authority within its jurisdiction; (c) the designated drug is in the same category as the category for which the establishment licence was issued; (d) the following information is set out in the List of Drugs for Exceptional Importation and Sale in respect of the designated drug: (iii) the name of the foreign regulatory authority referred to in paragraph (b), and (iv) the date after which it may no longer be imported; (e) the lot number of the designated drug is set out in the list referred to in paragraph (d), if applicable; (g) the designated drug is imported on or before the date referred to in subparagraph (d)(iv); and (h) the licensee has prepared a plan that specifies the measures to be taken in order for the licensee to comply with section C.10.011.

C

15 Additifs Sulfate de calcium Tartrate de calcium Carboxyméthylcellulose Gomme de caroube Carraghénine Colonne II Permis dans ou sur

(2)

In subsection (1), business day means a day other than C.10.007 Sections A.01.040, A.01.044 and C.01.004.1 do not apply in respect of the importation, under section C.10.006, of a designated drug by a person who holds an establishment licence. C.10.008 (1) Subject to sections C.10.009 and C.10.010, a sale of a designated drug that is imported under section C.10.006 is exempt from the following provisions: (b) the provisions of Part C other than (ii) the provisions of Divisions 1A and 2, and

(1)

Crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

(2)

For greater certainty, for the purposes of section C.01.016, the manufacturer of a designated drug is required to comply only with the requirements set out in sections C.01.017 and C.01.019 in respect of the drug.

(2)

Sorbet laitier

(3)

Subsections (1) and (2) cease to apply in respect of the sale of a designated drug on its expiration date. C.10.009 (1) Section C.02.019 does not apply to a person who holds an establishment licence in respect of a designated drug that they import under section C.10.006.

(3)

Aliments non normalisés

(2)

The licensee shall perform the finished product testing on a sample of the designated drug that is taken either (a) after receipt of each lot or batch of the designated drug on their premises in Canada; or (b) before receipt of each lot or batch of the designated drug on their premises in Canada if the following conditions are met: (i) the licensee has evidence satisfactory to the Minister to demonstrate that lots or batches of the designated drug sold to them by the vendor of the drug comply with the specifications set out for that lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for that drug, and (ii) the designated drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

(4)

Fromage cottage en crème

(3)

In subsection (2), a reference to specifications is a reference to the specifications with which the designated drug is required to comply within the jurisdiction of the foreign regulatory authority referred to in paragraph C.10.006(1)(b).

(5)

Crème à fouetter thermisée à une chaleur supérieure à 100 °C

(4)

If the licensee receives on their premises in Canada a lot or batch of a designated drug whose useful life is more than 30 days, they shall visually inspect the lot or batch to confirm the identity of the product.

(6)

Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n) Aliments non normalisés Mêmes aliments que pour la carboxyméthylcellulose sodique

(5)

Subsections (2) and (4) do not apply to the licensee if the designated drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and the following conditions are met: (a) the address of the building is set out in their establishment licence, and (b) they retain a copy of the batch certificate for each lot or batch of the designated drug that they receive for at least one year after the expiration date of the lot or batch.

(1)

Achards (relish); cornichons à la moutarde; crème; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé additionné de solides du lait; fromage cottage; fromage cottage en crème; crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

(6)

In this section, specifications has the same meaning as in section C.02.002. C.10.010 (1) A person who holds an establishment licence and who imports a designated drug under section C.10.006 is required to comply with paragraphs C.02.020(1)(a), (b) and (d) in respect of the drug but is not required to maintain the records referred to in those paragraphs on their premises in Canada.

(3)

Margarine hypocalorique

(3)

The licensee shall provide the requested records electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. C.10.011 (1) A person who holds an establishment licence shall not sell a designated drug that they imported under section C.10.006 unless they ensure that the information referred to in clause C.10.006(1)(a)(iii)(G) is available in English and French and in a manner that permits the safe use of the drug.

(4)

Sorbet laitier

(2)

The licensee shall ensure that the information is available in accordance with subsection (1) until at least the end of the day on the latest expiration date of the designated drug that they imported. Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling C.11.001 (1) The following definitions apply in this Division. public health official means (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act; (b) the Chief Medical Officer of Health, or equivalent, of a province; (c) the Medical Officer of Health, or equivalent, of a municipality;

(5)

Crème sure

(2)

This Division applies to a drug for human use in dosage form for which a drug identification number has not been assigned under subsection C.01.014.2(1) or for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, including drugs that have ceased to be considered to be natural health products by virtue of subsection 103.15(2) of the Natural Health Products Regulations. C.11.002 (1) In order to address an actual, imminent or potential emergency, event or incident affecting public health or the health of members of the Canadian Armed Forces, a public health official may, on application to the Minister, obtain an authorization that permits a drug manufacturer to sell a specified quantity of a drug to the public health official, for immediate use or stockpiling of the drug.

(6)

Aliments non normalisés

(2)

The application must (a) set out the name of the public health official and include information setting out how they may be contacted at any time; (b) set out the name of the manufacturer and include information setting out how they may be contacted at any time; (c) describe the emergency, event or incident; (e) describe the use of the drug that is intended to address the emergency, event or incident; (f) set out the civic address of the place to which the drug is to be shipped by the manufacturer; (g) set out the following information about the drug: (i) its brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark, (iii) its strength, (iv) its dosage form, (v) the recommended dosage for the use described under paragraph (e), (vi) its recommended route of administration, (vii) the indications that have been approved by any foreign regulatory authority, if applicable, (viii) its contraindications, (ix) a summary of its safety profile, and (x) the recommended storage conditions for the drug; (i) include a statement by the public health official, accompanied by supporting information or documents, attesting that (i) there is an actual, imminent or potential emergency, event or incident affecting public health or the health of the members of the Canadian Armed Forces that is likely to result, in humans, in a serious or life-threatening disease, disorder or abnormal physical state, (ii) immediate action is or would likely be required to diagnose, treat, mitigate or prevent the disease, disorder or abnormal physical state or its symptoms, (iii) conventional therapies, if any, have failed, are unsuitable or are unavailable in Canada at the time the application is made, and (iv) the known and potential benefits associated with the use of the drug described under paragraph (e) outweigh the known and potential risks associated with that use; (j) include any information or document available to the public health official concerning the safety, efficacy and quality of the drug in respect of the use described under paragraph (e), including information published in a medical or scientific journal; and (k) set out the following information, if known by the public health official: (i) the names of the foreign regulatory authorities that have authorized the sale of the drug in their jurisdictions for the same use as that described under paragraph (e), (ii) the names of the foreign regulatory authorities that have received an application for authorization to sell the drug in their jurisdictions for the use described under paragraph (e) but that have not yet made a decision in respect of that application at the time the public health official makes the application under subsection (1), and (iii) the names of the foreign regulatory authorities that have refused to authorize the sale of the drug in their jurisdictions for any use, as well as the reason for the refusal.

(7)

Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage (indication de la variété) conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

(3)

The public health official must provide the Minister with any additional information or document that the Minister determines is necessary for the purpose of reviewing the application, by the date specified by the Minister. C.11.003 (1) The Minister may, after review of the application, issue an authorization to a manufacturer authorizing the sale of a specified quantity of the drug to the public health official for the use described in the application.

(1)

Ale; bière; fromage de porc; (nom de la volaille) en conserve; crème; sauce vinaigrette; fromage de tête ou tête fromagée; gelée à (nom du fruit) avec pectine; bière légère; liqueur de malt; lait; lait en conserve; produit pour servir dans les viandes ou dans les sous-produits de la viande Colonne III Limites de tolérance

(2)

In reviewing the application, the Minister must consider whether there is an alternative mechanism that would address the emergency, event or incident.

(1)

0,5 %

(3)

The authorization must (b) set out the name and contact information of the public health official; (c) set out the name and contact information of the manufacturer; (e) state whether the drug is for immediate use or stockpiling or both; (f) describe the use for which the sale of the drug is authorized in order to address the emergency, event or incident; (g) set out the civic address of the place to which the drug is to be shipped by the manufacturer; (h) set out the following information about the drug: (i) its brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark, (iii) its strength, (iv) its dosage form, (v) its recommended dosage and route of administration, and (vi) its recommended storage conditions; and C.11.004 The initial public health official must notify the Minister, in writing, of any change to the information provided under paragraph C.11.002(2)(g), subparagraph C.11.002(2)(i)(iv), paragraph C.11.002(2)(j) or subsection C.11.002(3), within 30 days after the day on which they become aware of the change. C.11.005 (1) Subject to subsection C.11.008(2), these Regulations, other than sections A.01.010, A.01.014 and A.01.045, subsections C.01.001(1) and (1.1) and this Division, do not apply to a drug that is sold in accordance with an authorization.

(2)

0,75 %

(2)

In the case of a drug described in Schedule C or D of the Act, a drug that is sold in accordance with an authorization is exempt from the application of section 12 of the Act. C.11.006 (1) The initial public health official must ensure that the drug bears a label or is accompanied by a document that clearly sets out the following information in English and French: (b) a statement that the Minister has authorized the sale of the drug to address the emergency, event or incident described in the authorization; (c) a statement that the drug is to be used only for the use described in the authorization; (h) the drug’s recommended dosage and route of administration; (i) the drug’s lot number, if known; (j) all warnings and precautions in respect of the use of the drug, if any; (k) the drug’s expiration date, or, if there is no expiration date, the stability testing date or the date on which the drug should be retested, as specified by the manufacturer; (l) the drug’s recommended storage conditions; and (m) the net contents of the drug’s container, in terms of the weight, volume, size or number of units of the drug in the container.

(3)

Bonnes pratiques industrielles

(2)

Any subsequent public health official must ensure that the drug bears the label or is accompanied by the document.

(4)

0,05 %

(3)

If the initial public health official becomes aware of a change to any of the information referred to in paragraph (1)(a), (h), (j), (k) or (l), they must (a) ensure that the information on the drug’s label or in the accompanying document is updated; and (b) notify of the change, in writing and without delay, any person to whom they have sold any quantity of the drug.

(5)

0,005 %

(4)

If the person notified under paragraph (3)(b) is a subsequent public health official, they must notify of the change, in writing and without delay, any person to whom they have sold any quantity of the drug.

(6)

0,06 % Bonnes pratiques industrielles Mêmes limites de tolérance que pour la carboxyméthylcellulose sodique

(5)

Any person who is notified under paragraph (3)(b) or subsection (4) must ensure that the updated information C.11.007 (1) In addition to the information required under subsection C.11.006(1), the initial public health official or any subsequent public health official, as the case may be, must make the following information available to the following persons, in writing, in English and French: (a) to the persons to whom the drug is administered and the persons who administer the drug, the known and potential benefits and risks associated with the use for which the sale of the drug is authorized, the recommended duration of use, if any, of the drug and instructions on how to report serious adverse drug reactions; and

(1)

Bonnes pratiques industrielles

(2)

If the initial public health official becomes aware of a change to any of the information referred to in subsection (1), they must, in writing and without delay, notify the relevant persons of the change. C.11.008 (1) If the initial public health official is a person referred to in paragraph (d) of the definition public health official in subsection C.11.001(1), they must submit a written report to the Minister in respect of any serious adverse drug reaction to the drug, and include in the report the information referred to in paragraphs C.01.020.1(2)(b) to (f), no later than the 30th day after the day on which they become aware of the reaction.

(2)

0,5 %

(2)

If the initial public health official is a person referred to in any of paragraphs (a) to (c) or (e) of the definition public health official in subsection C.11.001(1), the written report is not required and section C.01.020.1 applies in respect of the provision of information relating to serious adverse drug reactions. C.11.009 (1) The initial public health official must monitor the response to the drug in the emergency, event or incident — including monitoring information they receive relating to serious adverse drug reactions — and must take reasonable steps to obtain information on that response.

(3)

0,5 % selon les exigences de l’alinéa B.09.017b)

(2)

The initial public health official must, on request of the Minister, submit a written report to the Minister on the monitoring of the response to the drug in the emergency, event or incident during the time period specified by the Minister, as well as on any corrective measures taken as a result of the monitoring. C.11.010 (1) The initial public health official must maintain all information about the sale and use of the drug in a way that allows them to submit the information, notices and reports referred to in sections C.11.004 and C.11.008 and subsection C.11.009(2).

(4)

0,75 %

(2)

The initial public health official and any subsequent public health official must maintain all information about the sale and use of the drug in a way that allows them to communicate with persons to whom the drug has been administered if the health of those persons may be endangered by its use. C.11.011 The initial public health official or any subsequent public health official, as the case may be, must maintain the information, notices and reports referred to in sections C.11.004 and C.11.008, subsection C.11.009(2) and section C.11.010, as applicable, for 15 years after the end of the period to which the information, notices and reports relate. C.11.012 The initial public health official must account to the Minister for any unused quantity of stockpiled drug remaining in their possession at the end of the preceding calendar year by the January 30 that follows the first full calendar year during which the drug is stockpiled and then by January 30 of each subsequent year. C.11.013 (1) The Minister may cancel an authorization if the Minister has reasonable grounds to believe that the drug presents a serious or imminent risk of injury to human health.

(5)

0,5 % selon les exigences de la disposition B.08.077vii)(A)

(2)

If the Minister cancels an authorization, the initial public health official must, without delay, notify of the cancellation any person to whom they have directly distributed any quantity of the drug.

(6)

Bonnes pratiques industrielles

(3)

These Regulations apply to any unused quantity of the drug as of the day on which the cancellation takes effect. C.11.014 (1) The Minister may issue an authorization that permits an initial public health official who is a person referred to in paragraph (a), (d) or (e) of the definition public health official in subsection C.11.001(1) to sell a specified quantity of a stockpiled drug to a practitioner for use in the emergency treatment of a person under the care of that practitioner, if (a) the manufacturer of the drug has been issued a letter of authorization under subsection C.08.010(1) that authorizes the sale of a specified quantity of the drug to that practitioner for the emergency treatment of that person; and (b) the use of the drug specified in the letter of authorization is the same as the use described in the authorization issued to the manufacturer under subsection C.11.003(1).

(7)

0,5 %, conformément aux exigences des articles B.08.035, B.08.037, B.08.038, B.08.041, B.08.041.1, B.08.041.2 et B.08.041.3

(2)

This Division, other than this section, does not apply to a drug sold in accordance with an authorization issued under subsection (1). Vitamins, Minerals and Amino Acids brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French, (a) that is assigned to the drug by its manufacturer, (b) under which the drug is sold or advertised, and (c) that is used to distinguish the drug; (marque nominative) common name means, with reference to a salt or derivative of a vitamin, the name in English or French by which the salt or derivative is (a) commonly known, and (b) designated in scientific or technical journals; human milk fortifier has the same meaning as in section B.25.001; (fortifiant pour lait humain) human milk substitute has the same meaning as in section B.25.001; (succédané de lait humain) prepackaged product means any food that is contained in a package in the manner in which it is ordinarily sold to, or used or purchased by, a person; (produit préemballé) reasonable daily intake, in respect of a food named in an item in Column I of Schedule K, means the amount of that food set out in Column II of that item; (ration quotidienne normale) supplemented food has the same meaning as in section B.01.001; (aliment supplémenté) testimonial, with respect to a food or drug that is represented as containing a vitamin, mineral nutrient or mineral, means any dramatized or undramatized pictorial, written or oral representation as to the result that is, has been or may be produced by the addition to a person’s diet of that vitamin, mineral nutrient or mineral, as the case may be; (témoignage)

(1)

Bonnes pratiques industrielles PART B Foods

(2)

For the purposes of this Part, a serving of stated size of a food shall be (a) based on the food as offered for sale; (b) in either of the following cases, the net quantity of the food in the package: (i) if the quantity of food in the package can reasonably be consumed by one person at a single eating occasion, or (ii) if the package contains less than 200% of the reference amount for the food; and (c) in all other cases, the amount indicated for the food according to the criteria set out in column 3A of the Table of Reference Amounts.

Section B.16.100

Règlement sur les aliments et drogues

(3)

A serving of stated size of a food shall be expressed as follows: (a) in the case of a single-serving prepackaged product to which paragraph (2)(b) applies, per package and using the following units: (i) in grams, if the net quantity of the food is shown on the label by weight or by count, and (ii) in millilitres, if the net quantity of the food is shown on the label by volume; and (b) in the case of a multiple-serving prepackaged product to which paragraph (2)(c) applies, according to the following units set out in column 3B of the Table of Reference Amounts and according to the manner set out in that column: (i) the household measure that applies to the product, and (ii) the metric measure that applies to the product. (a) set out in column 2, if the food is intended solely for infants six months of age or older but less than one year of age; (b) set out in column 3, if the food is intended for infants six months of age or older but less than one year of age or for children one year of age or older but less than four years of age; and (c) set out in column 4, in any other case.

PARTIE B Aliments

(2)

Subsection (1) does not apply if the food is (b) a human milk substitute intended solely for infants less than six months of age. (a) the height of the upper case letters in the statement or claim must not exceed two times the height of the upper case letters, excluding any accents, in the nutrition symbol, other than the words “Health Canada” and “Santé Canada”; and (b) the height of the tallest ascender of the lower case letters in the statement or claim must not exceed two times the height of the tallest ascender of the lower case letters in the nutrition symbol, other than in the words “Health Canada” and “Santé Canada”. Vitamins in Foods D.01.002 (1) In this Division, vitamin means any of the following vitamins:

TITRE 16 Additifs alimentaires

(2)

For the purposes of this Division, no expression, other than an expression set out in subsection (1), shall be used to declare the vitamin content of a food.

Article B.16.100

Colonne I

(3)

This Division applies only in respect of foods represented as containing a vitamin for use in human nutrition. D.01.003 (1) For the purposes of these Regulations, the vitamin content of a food — other than a formulated liquid diet, human milk fortifier, human milk substitute or food represented as containing a human milk substitute — shall be determined (a) in the case of vitamin A, in terms of the content of retinol and its derivatives and beta-carotene, calculated in micrograms of retinol activity equivalents (RAE) and expressed in micrograms on the basis of the following relationships: (i) 1 RAE = 1 microgram of retinol, and (b) in the case of vitamin D, in terms of the content of cholecalciferol and ergocalciferol, expressed in micrograms; (c) in the case of vitamin E, in terms of the content of d-alpha-tocopherol and dl-alpha-tocopherol and their derivatives, expressed in milligrams on the basis of the following relationships: (i) one milligram d-alpha-tocopherol = one milligram vitamin E, and (e) in the case of vitamin C, in terms of the content of L-ascorbic acid and L-dehydroascorbic acid and their derivatives, calculated in milligram equivalents of L-ascorbic acid and expressed in milligrams; (ff) in the case of thiamin, thiamine or vitamin B₁, and its derivatives, in terms of the content of thiamin, expressed in milligrams; (gg) in the case of riboflavin or vitamin B₂ and its derivatives, in terms of the content of riboflavin, expressed in milligrams; (hh) in the case of niacin, in terms of the content of niacin and its derivatives, calculated in milligrams of nicotinic acid, plus the content of tryptophan, calculated in milligrams and divided by 60, with the total niacin equivalents (NE) expressed in milligrams; (ii) in the case of vitamin B₆, in terms of the content of pyridoxine, pyridoxal and pyridoxamine and their derivatives, calculated in milligram equivalents of pyridoxine and expressed in milligrams; (jj) in the case of folate, in terms of the content of folic acid (pteroylmonoglutamic acid) and related compounds exhibiting the biological activity of folic acid, calculated on the basis of micrograms of dietary folate equivalents (DFE) and expressed in micrograms on the basis of the following relationships: (i) 1 DFE = 1 μg food folate, and (ii) 1 DFE = 0.6 μg folic acid from food with added folic acid; (kk) in the case of vitamin B₁₂, in terms of the content of cyanocobalamin and related compounds exhibiting the biological activity of cyanocobalamin, calculated in microgram equivalents of cyanocobalamin and expressed in micrograms; (ll) in the case of pantothenic acid or pantothenate, in terms of the content of d-pantothenic acid, expressed in milligrams; (mm) in the case of biotin, in terms of the content of biotin, expressed in micrograms; and (nn) in the case of choline, in terms of the content of choline, expressed in milligrams.

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance conditionnés dans lesquels un agent gélatinisant est autorisé); sous-produits de la viande en pain; pain de viande; lait (indication de l’arôme); cornichons à la moutarde; porter; viande en pot; sous-produits de la viande en pot; poisson ou viande conditionnés (Titre 21); achards (relish); sauce à salade; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; stout

(2)

For the purpose of paragraph (1)(hh), the content of tryptophan may be calculated (a) where the protein originates from a food that contains protein from more than one source or from a source other than milk, meat, poultry, fish or eggs, as constituting 1.1 per cent of the protein; (b) where the protein originates from milk, meat, poultry or fish, as constituting 1.3 per cent of the protein; and (c) where the protein originates from eggs, as constituting 1.5 per cent of the protein. D.01.004 (1) It is prohibited, on the label of or in any advertisement for a food — other than a formulated liquid diet, human milk fortifier, human milk substitute or food represented as containing a human milk substitute — to make a statement or claim concerning the vitamin content of the food unless (a) the vitamin is set out in column 1 of Part 2 of the Table of Daily Values; (b) the percentage of the daily value of the vitamin, per serving of stated size, is 5% or more; and (c) the vitamin content is declared on the label or in the advertisement as a percentage of the daily value per serving of stated size. (1.1) The condition set out in paragraph (1)(c) need not be met if the statement or claim described in subsection (1) is made on a label of or in any advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating.

(2)

Fromage cottage; fromage cottage en crème; crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

(2)

If a statement or claim described in subsection (1) is made in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the percentage of the daily value, per serving of stated size, shall, (a) in the case of an advertisement, other than a radio or television advertisement, be (i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and (ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; (b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim; or (c) in the case of a television advertisement, be communicated (i) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions, or (ii) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.

(3)

Lait évaporé

(3)

The percentage of the daily value, per serving of stated size, that is communicated in the visual mode of a television advertisement in accordance with subparagraph (2)(c)(ii) shall (a) appear concurrently with and for at least the same amount of time as the statement or claim; (b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and (c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

(4)

Sorbet laitier

(4)

Paragraph (1)(b) does not apply in respect of a declaration of the vitamin content in a nutrition facts table or supplemented food facts table.

(5)

Préparations pour nourrissons à base d’acides aminés isolés ou d’hydrolysats de protéines, ou les deux

(5)

Paragraph (1)(c) does not apply to a declaration of the biotin content as required by subparagraph B.24.202(a)(vi). D.01.006 No person shall, on the label of or in any advertisement for a food, make any claim concerning the action or effects of a vitamin contained in the food, except to the effect that the vitamin (a) is a factor in the maintenance of good health; and (b) is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development. D.01.007 (1) If a component of an ingredient of a prepackaged product set out in the table to subsection B.01.009(1) is a vitamin, no person shall, on the label or in any advertisement for the prepackaged product, make a statement or claim concerning the vitamin as a component of that ingredient unless (a) despite subsection B.01.008.2(6), the vitamin is declared by its common name, and that common name is shown in parentheses immediately after the ingredient in respect of which it is a component, except that if a source of a food allergen or gluten is required by paragraph B.01.010.1(8)(a) to be shown immediately after that ingredient, the common name of the vitamin is instead shown immediately after that source; and

(6)

Préparations pour nourrissons

(2)

Paragraph (1)(b) does not apply to flour used as an ingredient in the manufacture of a prepackaged product referred to in subsection (1). D.01.009 Subject to section D.01.010, no person shall sell a food to which any of the following vitamins have been added unless a reasonable daily intake of that food by a person would result in the daily intake by such person of that vitamin in an amount not less than, (c) in the case of riboflavin, 1.0 milligram; (e) in the case of ascorbic acid, 20 milligrams; and (f) in the case of vitamin D, 300 International Units. D.01.010 Where a food to which any of the following vitamins have been added is represented as being solely for use in the feeding of children under two years of age, no person shall sell such food unless a reasonable daily intake of that food by a child under two years of age would result in the daily intake by the child of that vitamin in an amount not less than, (b) in the case of thiamine, 0.4 milligram; (c) in the case of riboflavin, 0.6 milligram; (g) in the case of vitamin D, 300 International Units; and D.01.011 No person shall sell a food to which any of the following vitamins have been added if a reasonable daily intake of that food by a person would result in the daily intake by such person of that vitamin in an amount more than, (b) in the case of thiamine, two milligrams; (c) in the case of riboflavin, three milligrams; (g) in the case of vitamin D, 400 International Units; and (a) a food for which a standard is set out in Division 8 of Part B if the standard requires that the food contain vitamin D; or (b) margarine or calorie-reduced margarine. D.01.012 No person shall, in advertising a food that is represented as containing a vitamin or on a label of such food, (a) give any assurance or guarantee of any kind with respect to the result that may be, has been or will be obtained by the addition of the vitamin to a person’s diet; or (b) refer to, reproduce or quote any testimonial. Food and Drug Regulations

(7)

Préparations pour nourrissons prêt à consommer. Si l’on emploie aussi l’algine ou la gomme agar, ou les deux, le total ne doit pas dépasser 0,1 %

PART D Vitamins, Minerals and Amino Acids

DIVISION 1 Vitamins in Foods Item | Vitamin | Units | Amount Mineral Nutrients in Foods D.02.001 (1) In this Division, mineral nutrient means any of the following chemical elements, whether alone or in a compound with one or more other chemical elements: (t) nickel. (mineral nutrient)

(8)

Aliments non normalisés

(2)

This Division applies only in respect of foods that are represented as containing a mineral nutrient for use in human nutrition. D.02.002 (1) It is prohibited, on the label of or in any advertisement for a food — other than salt for table or general household use containing added iodide, prepackaged water and ice, a formulated liquid diet, human milk fortifier, human milk substitute or food represented as containing a human milk substitute — to make a statement or claim concerning the mineral nutrient content of the food unless (a) the mineral nutrient is set out in column 1 of Part 2 of the Table of Daily Values; (b) the percentage of the daily value of the mineral nutrient, per serving of stated size, is 5% or more; and (c) the mineral nutrient content is declared on the label or in the advertisement as a percentage of the daily value, per serving of stated size. (1.1) The condition set out in paragraph (1)(c) need not be met if the statement or claim described in subsection (1) is made on a label of or in any advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating.

(9)

Margarine réduite en calories

(2)

If a statement or claim described in subsection (1) is made in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the percentage of the daily value, per serving of stated size, shall, (a) in the case of an advertisement, other than a radio or television advertisement, be (i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and (ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; (b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim; or (c) in the case of a television advertisement, be communicated (i) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions, or (ii) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.

(10)

Crème sure

(3)

The percentage of the daily value, per serving of stated size, that is communicated in the visual mode of a television advertisement in accordance with subparagraph (2)(c)(ii) shall (a) appear concurrently with and for at least the same amount of time as the statement or claim; (b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and (c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

(11)

Asperges en conserve; haricots jaunes en conserve, haricots verts en conserve, pois en conserve

(4)

Subsection (1) does not apply to a statement or claim made in respect of the sodium or potassium content.

(12)

Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage (indication de la variété) conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

(5)

Paragraphs (1)(a) and (c) do not apply in respect of a declaration of the total fluoride ion content as required by sections B.12.002 and B.12.008.

(2)

0,5 %

(6)

Paragraph (1)(b) does not apply in respect of a declaration of the mineral nutrient content in a nutrition facts table or supplemented food facts table.

(3)

0,015 %

(7)

Paragraph (1)(c) does not apply in respect of a declaration of the chromium, copper, manganese, molybdenum and selenium content as required by subparagraph B.24.202(a)(v). D.02.004 No person shall, on the label of or in any advertisement for a food, make any claim concerning the action or effects of a mineral nutrient contained in the food, except to the effect that the mineral nutrient (a) is a factor in the maintenance of good health; and (b) is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development. D.02.005 (1) If a component of an ingredient of a prepackaged product set out in the table to subsection B.01.009(1) is a mineral nutrient, no person shall, on the label of or in any advertisement for the prepackaged product, make a statement or claim concerning the mineral nutrient as a component of that ingredient unless (a) despite subsection B.01.008.2(6), the mineral nutrient is declared by its common name, and that common name is shown in parentheses immediately after the ingredient in respect of which it is a component, except that if a source of a food allergen or gluten is required by paragraph B.01.010.1(8)(a) to be shown immediately after that ingredient, the common name of the mineral nutrient is instead shown immediately after that source; and

(4)

0,75 %

(2)

Paragraph (1)(b) does not apply to flour used as an ingredient in the manufacture of a prepackaged product referred to in subsection (1). D.02.008 No person shall, in advertising a food that is represented as containing a mineral nutrient or on a label of such food, (a) give any assurance or guarantee of any kind with respect to the result that may be, has been or will be obtained by the addition of the mineral nutrient to a person’s diet; or (b) refer to, reproduce or quote any testimonial. D.02.009 (1) No person shall sell a food to which any of the following mineral nutrients have been added unless a reasonable daily intake of that food by a person would result in the daily intake by such person of that mineral nutrient in an amount not less than, (b) in the case of phosphorus, 300 milligrams; (c) in the case of iron, four milligrams; and

(5)

0,01 %

(2)

Subsection (1) does not apply to a human milk fortifier or a supplemented food. D.02.010 (1) No person shall sell elemental iron powder for use in foods as a source of iron as a mineral nutrient unless (a) subject to paragraph (b), the powder meets the specifications for as set out in the Food Chemicals Codex, Third Edition, 1981, published by the National Academy of Sciences of the United States of America; and (b) in the case of Iron, Reduced, 100 per cent by weight of the particles pass through a 100 mesh sieve and at least 95 per cent by weight of the particles pass through a 325 mesh sieve.

(7)

0,03 % de la préparation pour nourrissons prêt à consommer. Si l’on emploie aussi l’algine ou la gomme agar, ou les deux, le total ne doit pas dépasser 0,03 %

(2)

No person shall sell a food to which elemental iron powder has been added as a source of iron as a mineral nutrient unless the powder meets the requirements referred to in paragraphs (1)(a) and (b). D.02.011 No person shall sell a food to which sodium iron pyrophosphate has been added as a source of iron as a mineral nutrient unless (a) the bioavailability of the iron in the food is not less than 50 per cent of the bioavailability of ferrous sulphate as determined by official method FO-42, Determination of Bioavailability of Iron, December 15, 1982; and (b) that person retains documentary evidence showing that the bioavailability of the iron in the food has been determined by the official method referred to in paragraph (a) and, on request by the Minister, submits such evidence to the Minister. Addition of Vitamins, Mineral Nutrients or Amino Acids to Foods D.03.001 (1) In this Division, the expressions vitamin and mineral nutrient have the same meaning as in Divisions 1 and 2.

(8)

Bonnes pratiques industrielles

(2)

This Division applies only in respect of foods that are represented as containing a vitamin, mineral nutrient or amino acid for use in human nutrition. D.03.002 (1) Subject to section D.03.003, no person shall sell a food, other than a supplemented food, to which a vitamin, mineral nutrient or amino acid has been added unless the food is listed in Column I of the Table to this section and the vitamin, mineral nutrient or amino acid, as the case may be, is listed opposite that food in Column II.

(9)

0,5 % selon les exigences de la disposition B.08.077(b)(viii)(A)

(2)

No milk or milk product or derivative listed in Column I of the Table to this section applies to the lacteal secretion obtained from the mammary gland of any animal other than a cow, genus Bos, or a product or derivative of such secretion unless that animal is identified therein. | 2 Fruit nectars, vegetable drinks, bases and mixes for vegetable drinks and a mixture of vegetable juices | Vitamin C. | | 2.1 Fruit flavoured drinks that meet all the requirements of section B.11.150 | Vitamin C, folic acid, thiamine, iron, potassium. | | 2.2 Bases, concentrates and mixes that are used for making fruit flavoured drinks and that meet all the requirements of section B.11.151 | Vitamin C, folic acid, thiamine, iron, potassium. | | 4 Margarine and other similar substitutes for butter | Vitamin A, Vitamin D, alpha-tocopherol |

(10)

0,5 % selon les exigences de la disposition B.08.077(b)(viii)(C)

6.1 Foods represented for use in a very low energy diet

(11)

1,0 % selon les exigences de la disposition B.11.002(a)(viii)(C)

7 Flavoured beverage mixes and bases recommended for addition to milk

(12)

0,5 % conformément aux exigences des dispositions B.08.036, B.08.037, B.08.038, B.08.041, B.08.041.1 et B.08.041.8 PART B Foods

8 Simulated meat products, simulated poultry meat products, meat product extenders and poultry product extenders

Section B.16.100

Règlement sur les aliments et drogues

9 Meal replacements and nutritional supplements

PARTIE B Aliments

9.1 Ready breakfast, instant breakfast and other similar breakfast replacement foods however described

TITRE 16 Additifs alimentaires

10 Condensed milk, milk, milk powder, sterilized milk, (naming the flavour) milk

Article B.16.100

Colonne I

11 Skim milk with added milk solids, partly skimmed milk with added milk solids, (naming the flavour) skim milk, (naming the flavour) partly skimmed milk, (naming the flavour) skim milk with added milk solids, (naming the flavour) partly skimmed milk with added milk solids, skim milk with added milk solids, skim milk powder

Article

Additifs

12 Evaporated milk

C

17 Gomme de cellulose

13 Evaporated skim milk, concentrated skim milk, evaporated partly skimmed milk, concentrated partly skimmed milk

C

18 Esters citriques des mono- et diglycérides F.1 Furcellaran G.1 Gélatine Colonne II Permis dans ou sur

14 Apple juice, reconstituted apple juice, grape juice, reconstituted grape juice, pineapple juice, reconstituted pineapple juice, apple and (naming the fruit) juice as described in section B.11.132, concentrated fruit juice except frozen concentrated orange juice

(13)

Préparations pour nourrissons sans lactose, à base de protéines du lait Mêmes aliments que pour la carboxyméthylcellulose sodique

15 Flour, White Flour, Enriched Flour or Enriched White Flour

(1)

Préparations pour nourrissons à base d’acides aminés cristallisés ou d’hydrolysats de protéines, ou des deux

18 Dehydrated potatoes

(2)

Aliments non normalisés

19 Products simulating whole egg

Food and Drug Regulations

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

PART D Vitamins, Minerals and Amino Acids

(2)

Aliments non normalisés

22 Partly skimmed goat’s milk, skimmed goat’s milk, partly skimmed goat’s milk powder, skimmed goat’s milk powder

(3)

Margarine réduite en calories

23 Evaporated goat’s milk

(4)

Asperges en conserve; haricots jaunes en conserve; haricots verts en conserve; pois en conserve

24 Evaporated partly skimmed goat’s milk, evaporated skimmed goat’s milk

(1)

Abats (relish); cornichons à la moutarde; crème; fromage de porc; crème de dinde; fromage de tête; jambons, épaules, socs de porc, jambons pique-nique et jambons de longe préparés; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; liant à viande ou liant à (désignation du produit de viande) lorsqu’il est vendu pour servir dans la viande préparée et dans les sous-produits de viande préparés dans lesquels il est permis d’ajouter un agent gélatinisant; (nom de la volaille) en conserve; pain de viande; poisson et viande préparés (Titre 21); sous-produits de viande en pain; sous-produits de viande en pot; tête fromagée; viande en pot

25 Pre-cooked rice as defined in subsection B.13.010.1(1)

(2)

Fromage cottage; fromage cottage en crème; crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

26 Mineral water, spring water, water in sealed containers, prepackaged ice

Vitamins A and D Food and Drug Regulations

(3)

Sorbet laitier

PART D Vitamins, Minerals and Amino Acids

D.03.003 Section D.03.002 does not apply to a food, other than a supplemented food, if all of the following conditions are met: (a) the food is (ii) represented for a special dietary use referred to in paragraph B.24.003(1)(h) or (i); (b) no standard is prescribed in these Regulations for the food; and (c) the food is not advertised. Minerals in Drugs D.05.008 (1) Subject to subsection (2), no person shall sell a drug containing fluorine if the largest recommended daily dosage of that drug as shown on the label thereof would, if consumed by a person, result in a daily intake by that person of more than one milligram of fluoride ion.

(4)

Crème sur le de la disposition B.08.077(b)(vii)(A)

(2)

Subsection (1) does not apply to a drug sold by prescription. D.05.009 Where a drug contains fluorine, both the inner and outer labels of the drug shall carry a cautionary statement that, if the drug is used in an area where the drinking water has a natural fluoride content in excess of 0.7 parts of fluoride ion per million parts of water or is artificially fluoridated, mottling of the tooth enamel of a user of the drug may result. E.01.001 (1) In this Part, cyclamate sweetener means any of the following substances sold as a sweetener: (a) cyclohexyl sulfamic acid or any of its salts; and (b) any substance containing cyclohexyl sulfamic acid or any of its salts.

(5)

Aliments non normalisés

(2)

Part B does not apply to any cyclamate sweetener. E.01.002 No person shall sell a cyclamate sweetener that is not labelled as required by this Part. Advertising E.01.003 No person shall, in advertising a cyclamate sweetener to the general public, make any representation other than with respect to the name, price and quantity of the sweetener. E.01.004 Every cyclamate sweetener shall be labelled to state that it should be used only on the advice of a physician. (a) its energy value expressed, in calories, per teaspoon, drop, tablet or other measure used in the directions for use and per 100 grams or 100 millilitres; and (b) a list of all its ingredients and, in the case of cyclohexyl sulfamic acid or any of its salts or a carbohydrate, its quantity. Controlled Drugs General G.01.001 The following definitions apply in this Part. Act means the Controlled Drugs and Substances Act. (Loi) advertisement includes any representation by any means whatever for the purpose of promoting, directly or indirectly, the sale or other disposal of a controlled drug. (publicité) competent authority means a public authority of a foreign country that is authorized under the laws of that country to approve the importation or exportation of controlled drugs into or from the country. (autorité compétente) compound includes a preparation. (composé) controlled drug means (a) a controlled substance set out in the schedule to this Part; or (b) in respect of a midwife, nurse practitioner or podiatrist, a controlled substance set out in the schedule to this Part that the midwife, nurse practitioner or podiatrist may prescribe, possess or conduct an activity with, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations. (drogue contrôlée) designated criminal offence means (a) an offence involving the financing of terrorism against any of sections 83.02 to 83.04 of the Criminal Code; (b) an offence involving fraud against any of sections 380 to 382 of the Criminal Code; (c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code; (d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; or destroy, in respect of a controlled drug, means to alter or denature it to such an extent that its consumption is rendered impossible or improbable. (destruction) hospital means a facility that is (a) licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness; or (b) owned or operated by the Government of Canada or the government of a province and that provides health services. (hôpital) international obligation means an obligation in respect of a controlled drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale) label has the same meaning as in section 2 of the Food and Drugs Act. (étiquette) midwife has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (sage-femme) nurse practitioner has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (infirmier praticien) package includes anything in which a controlled drug is wholly or partly contained, placed or packed. (emballage) pharmacist means a person who is entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province. (pharmacien) podiatrist has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (podiatre) preparation means a drug that contains a controlled drug and an active medicinal ingredient in a recognized therapeutic dose, other than a controlled drug. (préparation) prescription means an authorization given by a practitioner that a stated amount of a controlled drug be dispensed for the person named in it or the animal identified in it (ordonnance) Security Directive means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website. (Directive en matière de sécurité) senior person in charge means the individual designated under section G.02.003. (responsable principal) test kit means a kit (a) that contains a controlled drug and a reagent system or buffering agent; (b) that is used during the course of a chemical or analytical procedure to test for the presence or quantity of a controlled drug for a medical, laboratory, industrial, educational, law administration or enforcement, or research purposes; and G.01.002 (1) The Act and this Part do not apply in respect of a controlled drug that is contained in an agricultural implant as set out in Part III of the schedule to this Part, but nothing in this section exempts such a drug from the requirements of Part C.

(6)

Fromage à la crème; fromage à la crème (indication de l’arôme); fromage à la crème à tartiner; Colonne III Limites de tolérance

(2)

In this section, agricultural implant means a product that is presented in a form suitable to allow sustained release of an active ingredient over a certain period of time and that is intended for insertion under the skin of a food-producing animal for the purpose of increasing weight gain and improving feed efficiency. Member of police force G.01.003 A member of a police force or a person acting under their direction and control who, in respect of the conduct of the member or person, is exempt from the application of subsection 4(2) or sections 5, 6 or 7 of the Act by virtue of the Controlled Drugs and Substances Act (Police Enforcement) Regulations is, in respect of that conduct, exempt from the application of this Part. Application of Parts C and D G.01.004 Except as otherwise provided in this Part, it is prohibited to sell or provide a controlled drug or a preparation that does not comply with all provisions of Parts C and D that are applicable to it. G.01.005 (1) A person is authorized to possess a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 and 17 of Part I of the schedule to this Part if the person has obtained the controlled drug in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, or from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that controlled drug, and the person (a) requires the controlled drug for their business or profession and is (i) a licensed dealer, (iii) a practitioner who is registered and entitled to practise in the province in which they possess that drug; (b) is a practitioner who is registered and entitled to practise in a province other than the province in which they have that possession for emergency medical purposes only; (c) is a hospital employee or a practitioner in a hospital; (d) has obtained the controlled drug for their own use (i) from a practitioner, or (ii) in accordance with a prescription that was not issued or obtained in contravention of these Regulations; (e) is a practitioner of medicine who received the controlled drug under subsection G.06.003(1) or (2) and their possession is for the purpose of providing or delivering it to a person referred to in subsection G.06.003(3); (f) is an agent or mandatory of a practitioner of medicine who received the controlled drug under subsection G.06.003(1) and their possession is for the purpose of providing or delivering it to a person referred to in subsection G.06.003(2); (g) is employed as an inspector, a member of the Royal Canadian Mounted Police, a police constable, a peace officer or a member of the technical or scientific staff of the Government of Canada, the government of a province or a university in Canada and their possession is in connection with that employment; (h) is not a practitioner of medicine referred to in paragraph (e) or an agent or mandatory referred to in paragraph (f), is exempted under section 56 of the Act with respect to possession of that controlled drug and their possession is for a purpose set out in the exemption; or (i) is the Minister.

(13)

0,05 % de la préparation pour nourrissons prête à consommer. Si l’on emploie aussi l’algine ou la gomme de guar, ou les deux, le total ne doit pas dépasser 0,05 % Mêmes limites de tolérance que pour la carboxyméthylcellulose sodique

(2)

A person is authorized to possess a controlled drug referred to in subsection (1) if the person is acting as the agent or mandatory of any person who is authorized to possess it in accordance with any of paragraphs (1)(a) to (e), (h) and (i).

(1)

0,155 % de la préparation pour nourrissons prête à consommer

(3)

A person is authorized to possess a controlled drug referred to in subsection (1) if they (a) are acting as the agent or mandatory of a person who they have reasonable grounds to believe is a person referred to in paragraph (1)(g); and (b) possess the controlled drug for the purpose of assisting that person in the administration or enforcement of an Act or a regulation. Authorized activities G.01.006 A person may sell, possess or otherwise deal in a test kit if the following conditions are met: (a) a registration number has been issued for the test kit under section G.01.008 and has not been cancelled under section G.01.009; (b) the test kit bears, on its external surface, (ii) the trade name or trademark, and (c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose. Application for registration number G.01.007 (1) The manufacturer of a test kit may obtain a registration number for it by submitting to the Minister an application containing (a) a detailed description of the design and construction of the test kit; (b) a detailed description of the controlled drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component; and (c) a description of the proposed use of the test kit. Signature and attestation

(2)

Bonnes pratiques industrielles

(2)

The application must (a) be signed and dated by the person authorized by the applicant for that purpose; and (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge. Additional information or document

(1)

Bonnes pratiques industrielles

(3)

The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. G.01.008 On completion of the review of the application for a registration number, the Minister must issue a registration number for the test kit, preceded by the letters “TK”, if the Minister determines that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and that it contains (a) a controlled drug and an adulterating or denaturing agent that are combined in such a manner and in such a quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential; or (b) such small quantities or concentrations of any controlled drug as to have no significant drug abuse potential. G.01.009 The Minister must cancel the registration number for a test kit if (a) the test kit is removed from the market by the manufacturer; (b) the Minister has reasonable grounds to believe that the test kit is used or is likely to be used for any purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; or (c) the Minister has reasonable grounds to believe that the cancellation is necessary to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use. Licensed Dealers General G.02.001 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part. Qualified person in charge present

(2)

Bonnes pratiques industrielles

(2)

A licensed dealer may conduct an activity in relation to a controlled drug at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

(3)

0,5 % selon les exigences de l’article B.09.017

(3)

A licensed dealer must obtain a permit to import or export a controlled drug. Possession for export

(4)

1,0 % selon les exigences de la disposition B.11.002(d)(viii)(C)

(4)

A licensed dealer may possess a controlled drug for the purpose of exporting it if they have obtained it in accordance with this Part. G.02.002 The following persons may apply for a dealer’s licence: (b) a corporation that has its head office in Canada or operates a branch office in Canada; or (c) the holder of a position that includes responsibility for controlled drugs on behalf of the Government of Canada, the government of a province, a police force, a hospital or a university in Canada. Senior person in charge G.02.003 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to controlled drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual. Qualified person in charge G.02.004 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to controlled drugs that are specified in the licence application and for ensuring that those activities comply with this Part. The applicant may designate themself if the applicant is an individual. Alternate qualified person in charge

(1)

Bonnes pratiques industrielles

(2)

An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

(2)

0,5 %

(3)

Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge: (b) they (i) are a person entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician, (ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or (iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or (B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province; (c) they have sufficient knowledge of and experience with the use and handling of the controlled drugs specified in the dealer’s licence to properly carry out their duties; and (d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

(3)

0,75 %

(4)

An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if (a) no other individual working at the site meets those requirements; (b) those requirements are not necessary for the activities specified in the licence; and (c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties. G.02.005 An individual is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted, (a) in respect of a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act, the individual (i) was convicted as an adult, or (ii) was a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act; or (b) in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act, (i) the individual was convicted as an adult, or (ii) if they committed the offence when they were at least 14 years old but less than 18 years old, the person received a sentence that was longer than the maximum youth sentence, as that term is defined in subsection 2(1) of the Youth Criminal Justice Act, that could have been imposed under that Act for such an offence. G.02.006 (1) A person who intends to conduct an activity referred to in section G.02.001 must obtain a dealer’s licence for each site at which they intend to conduct activities by submitting an application to the Minister that contains the following information: (a) if the licence is requested by (ii) a corporation, its corporate name and any other name registered with a province, under which it intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself, and (iii) the holder of a position described in paragraph G.02.002(c), the applicant’s name and the title of the position; (b) the municipal address, telephone number and, if applicable, the email address of the proposed site and, if different from the municipal address, its mailing address; (c) the name, date of birth, telephone number and email address of the proposed senior person in charge; (d) with respect to each of the proposed qualified person in charge and any proposed alternate qualified person in charge, (i) their name, date of birth, telephone number and email address, (ii) the title of their position at the site, (iii) the name and title of the position of their immediate supervisor at the site, (iv) if applicable, their profession they practise that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number, and (v) their education, training and work experience that are relevant to their duties; (e) the activities that are to be conducted and the controlled drugs in respect of which each of the activities is to be conducted; (f) if the licence is requested to manufacture or assemble a product or compound that contains a controlled drug, other than a test kit, a list that includes, for each product or compound, (i) the brand name of the product or the name of the compound, (ii) the drug identification number that is assigned to the product under section C.01.014.2, if any, (iii) the name of the controlled drug in the product or compound, (iv) the strength per unit of the controlled drug in it, the number of units per package and the number of packages, (v) if it is to be manufactured or assembled by or for another licensed dealer under a custom order, the name, municipal address and dealer’s licence number of the other licensed dealer, and (vi) if the applicant’s name appears on the label of the product or compound, a copy of the inner label; (g) if the licence is requested in order to produce a controlled drug other than a product or compound that contains a controlled drug, (i) the name of the controlled drug, (ii) the quantity that the applicant expects to produce under their licence and the period during which that quantity would be produced, and (iii) if it is to be produced for another licensed dealer under a custom order, the name, municipal address and licence number of the other licensed dealer; (h) if the licence is requested for an activity that is not described in paragraph (f) or (g), the name of the controlled drug for which the activity is to be conducted and the purpose of the activity; (i) a detailed description of the security measures in place at the site, determined in accordance with the Security Directive; and (j) a detailed description of the method for recording information that the applicant proposes to use for the purpose of section G.02.071.

(4)

0,5 % selon les exigences de la disposition B.08.077(b)(vii)(A)

(2)

An application for a dealer’s licence must be accompanied by the following documents: (a) if the applicant is a corporation, a copy of (i) the certificate of incorporation or other constituting instrument, and (ii) any document filed with the province in which its site is located that states its corporate name and any other name registered with the province under which the applicant intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself; (b) individual declarations signed and dated by each of the proposed senior person in charge, and qualified person in charge and any proposed alternate qualified person in charge, attesting that the person is not ineligible for a reason specified in section G.02.005; (c) a document issued by a Canadian police force in relation to each person referred to in paragraph (b), indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph G.02.005(a)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii); (d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph G.02.005(b)(i) or received a sentence as specified in subparagraph G.02.005(b)(ii); (e) declaration, signed and dated by the proposed senior person in charge, attesting that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs G.02.004(3)(c) and (d); and (f) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement of subparagraph G.02.004(3)(b)(ii), either (ii) a detailed description of the education, training and work experience that is required under paragraph G.02.004(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training. Signature and attestation

(5)

Bonnes pratiques industrielles

(3)

The application must (a) be signed and dated by the proposed senior person in charge; and (b) include an attestation by that person that (i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and (ii) they have the authority to bind the applicant. Additional information and documents

(6)

0,5 %, conformément aux exigences des articles B.08.005, B.08.007, B.08.030, B.08.035. PART B Foods

(4)

The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. G.02.007 Subject to section G.02.009, on completion of the review of the licence application, the Minister must issue a dealer’s licence, with or without terms and conditions, that contains (b) the name of the licensed dealer, their corporate name or the title of the position they hold; (c) the activities that are authorized and the names of the controlled drugs in respect of which each activity may be conducted; (e) the security level at the site, determined in accordance with the Security Directive; (g) the expiry date of the licence, which must be not later than three years after its effective date; (h) any terms and conditions that the Minister has reasonable grounds to believe are necessary to (i) ensure that an international obligation is respected, (ii) ensure conformity with the requirements associated with the security level that is referred to in paragraph (e), or (iii) reduce a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use; and (i) if the licensed dealer produces a controlled drug, the quantity that they may produce and the authorized production period. G.02.008 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section G.02.027 or G.02.028. G.02.009 (1) The Minister must refuse to issue a dealer’s licence if (b) during the 10 years before the day on which the licence application is submitted, the applicant has contravened (i) a provision of the Act, the Cannabis Act or their regulations, or (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations; (c) during the 10 years before the day on which the application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii) or (b)(ii); (d) an activity for which the licence is requested would contravene an international obligation; (e) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested; (f) the method referred to in paragraph G.02.006(1)(j) does not permit the recording of information as required under section G.02.071; (g) the applicant has not complied with the requirements of subsection G.02.006(4) or the information and documents that they have provided are not sufficient to complete the review of the licence application; (h) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application; (i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a controlled drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or (j) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

Section B.16.100

Règlement sur les aliments et drogues

(2)

The Minister must not refuse to issue a licence under paragraph (1)(b) or (h) if the applicant meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use: (a) the applicant does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

PARTIE B Aliments

(3)

Before refusing to issue a licence, the Minister must send the applicant a notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard. G.02.010 (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections G.02.006(1) and (2). Signature and attestation

TITRE 16 Additifs alimentaires

(2)

The application must (a) be signed and dated by the senior person in charge of the site specified in the application; and (b) include an attestation by that person that (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and (ii) they have the authority to bind the licensed dealer. Additional information and documents

Article B.16.100

Colonne I

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. G.02.011 (1) Subject to section G.02.013, on completion of the review of the renewal application, the Minister must issue a renewed dealer’s licence that contains the information specified in section G.02.007. Terms and conditions

Article

Additifs G.2 Gomme gellan G.3 Gomme de guar Colonne II Permis dans ou sur fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

(2)

When renewing a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to (a) ensure that an international obligation is respected; (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence renewal; or (c) reduce a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use. G.02.012 A renewed dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section G.02.027 or G.02.028. G.02.013 (1) The Minister must refuse to renew a dealer’s licence if (a) the licensed dealer may no longer apply for a licence under section G.02.002; (b) during the 10 years before the day on which the renewal application is submitted, the licensed dealer has contravened (i) a provision of the Act, the Cannabis Act or their Regulations, or (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations; (c) during the 10 years before the day on which the renewal application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii) or (b)(ii); (d) an activity for which the renewal is requested would contravene an international obligation; (e) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested; (f) the method referred to in paragraph G.02.006(1)(j) does not permit the recording of information required by section G.02.071; (g) the licensed dealer has not complied with the requirements of subsection G.02.010(3) or the information or documents that they have provided are not sufficient to complete the review of the renewal application; (h) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the renewal application; (i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or (j) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

(1)

Confiseries non normalisées; produits de glaçage

(2)

The Minister must not refuse to renew a licence under paragraph (1)(b) or (h) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use: (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

(2)

Aspics; produits de fruits transformés non normalisés; tartinades de fruits non normalisées

(3)

Before refusing to renew a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. Amendment of Licence G.02.014 (1) Before making a change affecting any information referred to in section G.02.007 that is contained in their dealer’s licence, a licensed dealer must submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in section G.02.006 that are relevant to the proposed amendment. Signature and attestation

(3)

Margarine réduite en calories; tartinades réduites en matière grasse

(2)

The application must (a) be signed and dated by the senior person in charge of the site specified in the application; and (b) include an attestation by that person that (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and (ii) they have the authority to bind the licensed dealer. Additional information and documents

(4)

Produits laitiers non normalisés

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. Amendment G.02.015 (1) Subject to section G.02.017, on completion of the review of the amendment application, the Minister must amend the dealer’s licence. Terms and conditions

(5)

Garnitures; gelées non normalisées; mélanges pour garnitures; mélanges pour poudings; sauce à salade; sauce assaisonnement non normalisée; sauce vinaigrette

(2)

When amending a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to (a) ensure that an international obligation is respected; (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the amendment; or (c) reduce a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use. G.02.016 An amended dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section G.02.027 or G.02.028. G.02.017 (1) The Minister must refuse to amend a dealer’s licence if (a) an activity for which the licence amendment is requested would contravene an international obligation; (b) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence amendment is requested; (c) the method referred to in paragraph G.02.006(1)(j) does not permit the recording of information as required by section G.02.071; Modification (d) the licensed dealer has not complied with the requirements of subsection G.02.014(3) or the information or documents that they have provided are not sufficient to complete the review of the amendment application; (e) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the amendment application; or (f) the Minister has reasonable grounds to believe that the amendment of the licence would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

(6)

Mélanges pour pâtisseries; produits de boulangerie non normalisés

(2)

The Minister must not refuse to amend a licence under paragraph (1)(e) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use: (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

(7)

Glaçages; mélanges pour glaçages; sauces non normalisées; sirops de table non normalisés

(3)

Before refusing to amend a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. Changes Requiring Prior Approval by Minister G.02.018 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written request to the Minister: (b) the replacement of the senior person in charge; (c) the replacement of the qualified person in charge; or Information and documents

(8)

Boissons non normalisées

(2)

The licensed dealer must provide the Minister with the following with respect to a change referred to in subsection (1): (a) in the case of a change affecting the security measures in place at the site specified in the dealer’s licence; (b) in the case of the senior person in charge, (c) in the case of the qualified person in charge or an alternate qualified person in charge, Additional information and documents

(9)

Grignotines

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. G.02.019 (1) Subject to section G.02.020, on completion of the review of the application for approval of the change, the Minister must approve the change. Terms and conditions

(1)

Achards (relish); cornichons à la moutarde; crème; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; mincemeat; pain; sauce à salade; sauce vinaigrette

(2)

When approving a change, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to the licence or modify or delete one in order to (a) ensure that an international obligation is respected; Food and Drug Regulations

(2)

Fromage cottage; fromage cottage en crème; crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

PART G Controlled Drugs

DIVISION 2 Licensed Dealers (b) ensure conformity with the requirements associated with the security level specified in the licence; or (c) reduce a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use. G.02.020 (1) The Minister must refuse to approve the change if (a) during the 10 years before the day on which the application for approval of the change is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii) or (b)(ii); (b) the licensed dealer has not complied with the requirements of subsection G.02.018(3) or the information or documents that they have provided are not sufficient to complete the review of the application for approval of the change; (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the application for approval of the change; or (d) the Minister has reasonable grounds to believe that the change would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

(3)

Préparations pour nourrissons

(2)

The Minister must not refuse to approve a change under paragraph (1)(c) if the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use.

(4)

Sorbet laitier

(3)

Before refusing to approve a change, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard in respect of them. Changes Requiring Notice to Minister G.02.021 (1) A licensed dealer must notify the Minister in writing before (a) making or assembling a product or compound that is not set out in the most recent version of the list referred to in paragraph G.02.006(1)(f) that has been submitted to the Minister; or (b) making a change to a product or compound that is set out in the list, if the change affects any of the information that has previously been submitted. Information and list

(5)

Aliments non normalisés Colonne III Limites de tolérance B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 et B.08.041.8

(2)

The notice must contain the information referred to in paragraph G.02.006(1)(f) that is necessary to update the list and be accompanied by the revised version of the list. G.02.022 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge. G.02.023 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs: (a) a person ceases to act as the senior person in charge; or (b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph G.02.006(1)(f) has been submitted to the Minister. Information and list

(1)

0,5 %

(2)

A notice submitted under paragraph (1)(b) must specify which information referred to in paragraph G.02.006(1)(f) is being changed and be accompanied by the revised version of the list. Notice of cessation of activities G.02.024 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

(2)

0,3 %

(2)

The notice must be signed and dated by the senior person in charge and contain the following information: (a) the expected date of the cessation of activities at the site; (b) a description of the manner in which any remaining controlled drugs on the site as of that date will be disposed of by the licensed dealer, including (i) if some or all of them will be sold or provided to another licensed dealer that will be conducting activities at the same site, the name of that dealer, (ii) if some or all of them will be sold or provided to another licensed dealer that will not be conducting activities at the same site, the name of that dealer and the municipal address of their site, and (iii) if some or all of them will be destroyed, the date on which and the municipal address of the location at which the destruction is to take place; (c) the municipal address of the location at which the licensed dealer’s documents will be kept after activities have ceased; and (d) the name, municipal address, telephone number and, if applicable, the email address of a person who the Minister may contact for further information after activities have ceased.

(3)

0,25 %

(3)

After having ceased to conduct the activities, the licensed dealer must submit to the Minister a detailed update of the information referred to in subsection (2) if it differs from what was set out in the notice. The update must be signed and dated by the senior person in charge. Changes to Terms and Conditions of Licence Addition of or modification to term or condition G.02.025 (1) The Minister may, at any time other than the issuance, renewal or amendment of a dealer’s licence, add a term or condition to it or modify one if the Minister has reasonable grounds to believe that it is necessary to do so to (a) ensure that an international obligation is respected; (b) ensure conformity with the requirements associated with the security level specified in the licence; or (c) reduce a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

(4)

0,1 %

(2)

Before adding a term or condition to a licence or modifying one, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

(5)

0,1 %

(3)

Despite subsection (2), the Minister may add a term or condition to a licence or modify one without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use.

(6)

0,1 % du mélange sec

(4)

The addition or modification of a term or condition that is made under subsection (3) takes effect as soon as the Minister sends the licensed dealer a notice that (a) sets out the reasons for the addition or modification; (b) gives the dealer an opportunity to be heard; and (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out. Deletion of term or condition G.02.026 (1) The Minister may delete a term or condition of a dealer’s licence that the Minister determines is no longer necessary.

(7)

0,05 %

(2)

The deletion takes effect as soon as the Minister sends the licensed dealer a notice to that effect. Suspension and Revocation of Licence G.02.027 (1) The Minister must suspend a dealer’s licence without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use.

(8)

0,08 %

(2)

The suspension takes effect as soon as the Minister sends the licensed dealer a notice that (a) sets out the reasons for the suspension; (b) gives the dealer an opportunity to be heard; and (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

(9)

0,1 %

(3)

The Minister must reinstate the licence if the Minister has reasonable grounds to believe that the suspension is no longer necessary. Revocation G.02.028 (1) Subject to subsection (2), the Minister must revoke a dealer’s licence if (a) the licensed dealer may no longer apply for a licence under section G.02.002; (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the licence or the actual or potential unauthorized use of the licence; (c) the licensed dealer ceases to conduct activities at their site before the expiry of their licence; (e) the licensed dealer has contravened. (i) a provision of the Act, the Cannabis Act or their regulations, or (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations; (f) during the 10 years before the day on which the licence is revoked, the senior person in charge, the qualified person in charge or any alternate qualified person in charge was convicted as specified in subparagraph G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii) or (b)(ii); (g) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of an application relating to the licence; or (h) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled drug to an illicit market or use.

(1)

Bonnes pratiques industrielles

(2)

The Minister must not revoke a dealer’s licence for a ground set out in paragraph (1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use: (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

(2)

0,5 %

(3)

Before revoking a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. G.02.029 The licensed dealer must return the original of the licence to the Minister within 15 days after the effective date of the revocation. G.02.030 (1) A licensed dealer must submit to the Minister, before each importation of a controlled drug, an application for an import permit that contains the following information: (a) their name, municipal address and dealer’s licence number; (b) with respect to the controlled drug to be imported, (i) its name, as specified in the dealer’s licence, (ii) if it is a salt, the name of the salt, (iii) its quantity, and (iv) in the case of a raw material, its purity and its anhydrous content; (c) if the controlled drug is contained in a product to be imported, (i) the brand name of the product, (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and (iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages; (d) the name and municipal address, in the country of export, of the exporter from whom the controlled drug is being obtained; (e) the name of the customs office where the importation is anticipated; and (f) each proposed mode of transportation and any proposed country of transit or transhipment. Signature and attestation

(3)

0,03 % de la préparation pour nourrissons prête à consommer. Si l’additif est utilisé avec de la gomme de caroube ou des deux, le total ne doit pas excéder 0,1 %

(2)

The application must (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge. Additional information and documents

(4)

0,75 %

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. G.02.031 Subject to section G.02.034, on completion of the review of the import permit application, the Minister must issue to the licensed dealer an import permit that contains (c) the effective date of the permit; (i) a date specified by the Minister that is not more than 180 days after its effective date, and (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to (i) ensure that an international obligation is respected, or (ii) reduce a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use. G.02.032 An import permit is valid until the earliest of (d) the date of the suspension or revocation of the export permit that applies to the controlled drug to be imported and that is issued by the competent authority in the country of export. G.02.033 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry. G.02.034 (1) The Minister must refuse to issue an import permit if (a) the licensed dealer is not authorized by their dealer’s licence to import the relevant controlled drug or their licence will expire before the date of importation; (b) the Minister has reasonable grounds to believe that the importation would contravene an international obligation; (c) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of the importation; (d) the licensed dealer has not complied with the requirements of subsection G.02.030(3) or the information or documents that they have provided are not sufficient to complete the review of the permit application; (e) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the permit application; (f) the licensed dealer has been notified that their application to renew or amend their licence will be refused; (g) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment; (h) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

(5)

Bonnes pratiques industrielles PART B Foods

(2)

Before refusing to issue the import permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. G.02.035 The holder of an import permit must provide a copy of the permit to the customs office at the time of importation. G.02.036 The holder of an import permit must provide the Minister, within 15 days after the day of release of the controlled drug specified in the permit in accordance with the Customs Act, with a declaration that contains the following information: (a) their name and the numbers of their dealer’s licence and the import permit that applies to the controlled drug; (b) with respect to the controlled drug, (i) its name, as set out in the dealer’s licence, (ii) if it is a salt, the name of the salt, and (iii) its quantity; (c) if the controlled drug is contained in a product that they have imported, (i) the brand name of the product, (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and (iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages; and (d) the name of the customs office from which the controlled drug was released and the date of the release. G.02.037 (1) The Minister must suspend an import permit without prior notice if (a) the dealer’s licence is suspended; (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use; or (c) the importation would contravene the laws of the country of export or any country of transit or transhipment.

Section B.16.100

Règlement sur les aliments et drogues

(2)

The suspension takes effect as soon as the Minister sends the licensed dealer a notice that (a) sets out the reasons for the suspension; (b) gives the dealer an opportunity to be heard; and (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

PARTIE B Aliments

(3)

The Minister must reinstate the import permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary. Revocation (a) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit; (b) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph G.02.037(2)(c) by the specified date; (c) the licensed dealer has contravened a term or condition of the permit; (d) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information in their application for the permit; (e) the licensed dealer has been convicted of an offence under the Act or the Criminal Code in relation to a controlled drug; (f) the licensed dealer’s licence has been revoked; or (g) the Minister has reasonable grounds to believe that the revocation is necessary to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use. information or false or falsified documents in or in support of the application for the permit; (e) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled drug to an illicit market or use; or (f) the dealer’s licence has been revoked.

TITRE 16 Additifs alimentaires

(2)

The Minister must not revoke an import permit for a ground set out in paragraph (1)(d) or G.02.028(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use: (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

Article B.16.100

Colonne I

(3)

Before revoking an import permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. G.02.039 If an import permit is revoked, the licensed dealer must return the original of the permit to the Minister within 15 days after the effective date of the revocation. G.02.040 (1) A licensed dealer must submit to the Minister, before each exportation of a controlled drug, an application for an export permit that contains the following information and document: (a) their name, municipal address and dealer’s licence number; (b) with respect to the controlled drug to be exported, (i) its name, as specified in the dealer’s licence, (ii) if it is a salt, the name of the salt, (iii) its quantity, and (iv) in the case of a raw material, its purity and its anhydrous content; (c) if the controlled drug is contained in a product to be exported, (i) the brand name of the product, (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and (iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages; (e) the name of the customs office where the exportation is anticipated; (f) each proposed mode of transportation and any proposed country of transit or transhipment; and (g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country. Signature and attestation

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

(2)

The application must (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and (b) include an attestation by that person that, to the best of their knowledge, (i) the exportation does not contravene the laws of the country of final destination or any country of transit or transhipment, and (ii) all of the information and documents submitted in support of the application are correct and complete. Additional information and documents

(6)

Margarine réduite en calories

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. G.02.041 Subject to section G.02.044, on completion of the review of the export permit application, the Minister must issue to the licensed dealer an export permit that contains (c) the effective date of the permit; (i) a date specified by the Minister that is not more than 180 days after its effective date, (iii) the expiry date of the import permit issued by the competent authority in the country of final destination; and (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to (i) ensure that an international obligation is respected, or (ii) reduce a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use. G.02.042 An export permit is valid until the earliest of (d) the date of the expiry, suspension or revocation of the import permit that applies to the controlled drug to be exported and that is issued by the competent authority in the country of final destination. G.02.043 If an export permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry. G.02.044 (1) The Minister must refuse to issue an export permit if (a) the licensed dealer is not authorized by their dealer’s licence to export the relevant controlled drug or their dealer’s licence will expire before the date of export; (b) the Minister has reasonable grounds to believe that the exportation would contravene an international obligation; (c) the licensed dealer has not complied with the requirements of subsection G.02.040(3) or the information or documents that they have provided are not sufficient to complete the review of the permit application; (d) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the permit application; (e) the licensed dealer has been notified that their application to renew or amend their licence will be refused; (f) the Minister has reasonable grounds to believe that the exportation would not be in conformity with the import permit issued by the competent authority of the country of final destination; (g) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment; or (h) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

(6)

0,5 % selon les exigences de l’article B.09.017

(2)

Before refusing to issue the export permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. G.02.045 The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation. G.02.046 The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled drug specified in the permit, with a declaration that contains the following information: (a) their name and the numbers of their dealer’s licence and the export permit that applies to the controlled drug; (b) with respect to the controlled drug, (i) its name, as specified in the dealer’s licence, (ii) if it is a salt, the name of the salt, and (iii) its quantity; (c) if the controlled drug is contained in a product that they have exported, (i) the brand name of the product, (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and (iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages; and (d) the name of the customs office from which the controlled drug was exported and the date of export. G.02.047 (1) The Minister must suspend an export permit without prior notice if (a) the dealer’s licence is suspended; (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use; or (c) the exportation would contravene the laws of the country of final destination or any country of transit or transshipment.

(7)

Crème sure de la disposition B.08.077b)(vii)(A)

(2)

The suspension takes effect as soon as the Minister sends the licensed dealer a notice that (a) sets out the reasons for the suspension; (b) gives the dealer an opportunity to be heard; and (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

(7)

0,5 % selon les exigences

(3)

The Minister must reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary. Revocation G.02.048 (1) Subject to subsection (2), the Minister must revoke an export permit if (a) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or of the actual or potential unauthorized use of the permit; (b) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph G.02.047(2)(c) by the specified date; (c) the licensed dealer has contravened a term or condition of the permit; (d) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of the application for the permit; (e) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled drug to an illicit market or use; or (f) the dealer’s licence has been revoked.

(8)

Asperges en conserve; haricots jaunes en conserve; haricots verts en conserve; pois en conserve

(2)

The Minister must not revoke an export permit for a ground set out in paragraph (1)(d) or G.02.028(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health and safety, including to prevent a controlled drug from being diverted to an illicit market or use: (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

(8)

1,0 % selon les exigences de la disposition B.11.020d)(viii)(C)

(3)

Before revoking an export permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. G.02.049 If an export permit is revoked, the licensed dealer must return the original of the permit to the Minister within 15 days after the effective date of the revocation. Identification G.02.050 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to controlled drugs, including labels, orders, shipping documents, invoices and advertising. Identification Sale of Controlled Drugs Sale to another licensed dealer G.02.051 A licensed dealer may sell or provide a controlled drug to another licensed dealer. G.02.052 (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a pharmacist. Exception — pharmacist named in notice

(9)

Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage (indication de la variété) conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionnée à froid; préparation de fromage conditionnée à froid (avec indication des ingrédients ajoutés)

(2)

A licensed dealer must not sell or provide to a pharmacist named in a notice issued under section G.03.017.2 the controlled drugs referred to in the notice unless the dealer has received a notice of retraction issued under section G.03.017.3. Exception — practitioner named in notice

(9)

0,5 %, conformément aux exigences des articles B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 et B.08.041.8

(2)

A licensed dealer must not sell or provide to a practitioner who is named in a notice issued under section G.04.004.2 the controlled drugs referred to in the notice, unless the dealer has received a notice of retraction issued under section G.04.004.3. G.02.054 A licensed dealer may provide a controlled drug to a hospital employee. G.02.055 A licensed dealer may sell or provide a controlled drug to a person who is exempted under section 56 of the Act with respect to the possession of that drug. Sale to Minister G.02.056 A licensed dealer may sell or provide a drug to the Minister. Written order G.02.057 A licensed dealer may sell or provide a controlled drug under any of sections G.02.051 to G.02.055 if (a) the dealer has received a written order that specifies the name and quantity of the drug to be supplied and is signed and dated (i) in the case of a drug to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to sign the order, and (ii) in any other case, by the person to whom the drug is to be sold or provided; and (b) the dealer has verified the signature, if it is unknown to them. G.02.058 (1) A licensed dealer may sell or provide a controlled drug listed in Part II or III of the schedule to this Part if (a) the dealer has received a verbal order that specifies the name and quantity of the drug to be supplied; and (b) in the case of the provision of the drug to a hospital employee or a practitioner in a hospital, the order has been placed by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to place the order.

(10)

Préparations pour nourrissons sans lactose, à base de protéines du lait

(2)

A licensed dealer that has received a verbal order from a pharmacist or practitioner must, within five working days after filling the order, obtain and keep a receipt that includes (a) the signature of the pharmacist or practitioner who received the controlled drug; (b) the date on which the pharmacist or practitioner received the controlled drug; and (c) the name and quantity of the controlled drug. No further sale without receipt

(10)

0,1 % de la préparation pour nourrissons prête à consommer. Si l’on emploie aussi l’alginate ou la carraghénine, ou les deux, le total ne doit pas dépasser 0,1 %

(3)

If the licensed dealer has not obtained the receipt within five working days, the dealer must not sell or provide a controlled drug to the pharmacist or practitioner in accordance with a further verbal order received from them until after obtaining the receipt. Anticipated multiple sales G.02.059 (1) A licensed dealer may sell or provide a controlled drug more than once in respect of one order if the order indicates (c) the intervals between each sale or provision.

(11)

Préparations pour nourrissons sans lactose, à base de protéines du lait

(2)

A licensed dealer may sell or provide a controlled drug more than once in respect of one order if, at the time of receipt of the order, the dealer temporarily does not have in stock the quantity of the drug ordered, in which case the dealer may sell or provide against the order the quantity of the drug that the dealer has available and deliver the balance later. Packaging and Transportation Packaging — sale and provision G.02.060 (1) A licensed dealer that sells or provides a controlled drug must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal. Packaging — transport and export

(11)

0,05 % de la préparation pour nourrissons prête à consommer. Si l’on emploie aussi l’alginate ou la carraghénine, ou les deux, le total ne doit pas dépasser 0,05 % G.4 Gomme sénégal Mêmes aliments que pour la gomme arabique Mêmes limites de tolérance que pour la gomme arabique H.1 Hydroxyléchithine

(2)

A licensed dealer that transports or exports a controlled drug must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal.

(1)

Produits de chocolat; produits du cacao

(3)

Subsection (1) does not apply to a test kit that contains a controlled drug and that has a registration number. Transport G.02.061 (1) A licensed dealer must, in taking delivery of a controlled drug that they have imported or in making delivery of a controlled drug, (a) take any measures that are necessary to ensure the security of the drug while it is being transported; (b) subject to subsection (2), use a method of transportation that permits an accurate record to be kept of all handling of the drug as well as the signatures of every person handling it until it is delivered to the consignee; (c) in the case of an imported drug, transport it directly to the site specified in their licence after it is released under the Customs Act; and

(1)

Bonnes pratiques industrielles

(2)

A licensed dealer may have a preparation transported by a common carrier. Thefts, Losses and Suspicious Transactions Protective measures G.02.062 A licensed dealer must take any measures that are necessary to ensure the security of any controlled drug in their possession and any licence or permit in their possession. G.02.063 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it. G.02.064 A licensed dealer that becomes aware of a theft of a controlled drug or of a loss of a controlled drug that cannot be explained on the basis of normally accepted business activities must (a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and (b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided. G.02.065 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a controlled drug to an illicit market or use: (a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report; (b) the name and municipal address of the other party to the transaction; (c) details of the transaction, including its date and time, its type, the name and quantity of the controlled drug and, in the case of a product or compound, the quantity of every controlled drug that it contains; (d) in the case of a product that contains the controlled drug, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2; and (e) a detailed description of the reasons for those suspicions.

(2)

Aliments non normalisés

(2)

No civil proceedings lie against a licensed dealer for having provided the report in good faith. Non-disclosure

(2)

Bonnes pratiques industrielles H.1A Hydroxypropyl cellulose Aliments non normalisés Bonnes pratiques industrielles H.2 Hydroxypropyl méthylcellulose

(3)

A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun. Partial protection against self-incrimination G.02.066 A report made under any of sections G.02.063 to G.02.065, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code. Destruction at site G.02.067 A licensed dealer that intends to destroy a controlled drug at the site specified in their licence must ensure that the following conditions are met: (a) the licensed dealer obtains the prior approval of the Minister; (b) the destruction occurs in the presence of two of the following persons, at least one of whom is the person referred to in subparagraph (i): (i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, and (ii) a person who works for or provides services to the licensed dealer and holds a senior position; (c) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and (d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the controlled drug was completely destroyed, to which each signatory must add their name in printed letters. Destruction elsewhere than at site G.02.068 A licensed dealer that intends to destroy a controlled drug elsewhere than at the site specified in their licence must ensure that the following conditions are met: (a) the licensed dealer obtains the prior approval of the Minister; (b) they take the necessary measures to ensure the security of the controlled drug during transport to the (b) the licensed dealer takes any measures that are necessary to ensure the security of the controlled drug while it is being transported in order to prevent its diversion to an illicit market or use; (c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business; (d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and (e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the controlled drug was completely destroyed and containing (i) the municipal address of the place of destruction, (ii) the name and quantity of the controlled drug and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it, (iii) the method of destruction, (iv) the date of destruction, and (v) the names in printed letters and signatures of that person and the other person who was present at the destruction. Application for prior approval G.02.069 (1) A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister’s prior approval to destroy a controlled drug: (a) their name, municipal address and dealer’s licence number; (b) the proposed date of destruction; (c) the municipal address of the place of destruction; (e) if the destruction is to be carried out at the site specified in the dealer’s licence, the names of the persons proposed for the purpose of paragraph G.02.067(b) and information establishing that they meet the conditions of that paragraph; (f) the name of the controlled drug and, if applicable, the brand name of the product containing it or the name of the compound containing it; and (g) the form and quantity of the controlled drug or the product or compound containing it and, if applicable, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages. Signature and attestation

(1)

Sauce vinaigrette; lait (indication de l’arôme); cornichons à la moutarde; achards (relish); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; sauce à salade

(2)

The application must (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and (b) include an attestation by that person that (i) the proposed method of destruction complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction, and (ii) all of the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge. Additional information and documents

(1)

Bonnes pratiques industrielles

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. G.02.070 On completion of the review of the approval application, the Minister must approve the destruction of the controlled drug unless (a) in the case of a destruction that is to be carried out at the site specified in the dealer’s licence, the persons proposed for the purpose of paragraph G.02.067(b) do not meet the conditions of that paragraph; (b) the Minister has reasonable grounds to believe that the controlled drug would not be destroyed; (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the approval application; (d) the controlled drug or a portion of it is required for the purposes of a criminal or administrative investigation or a preliminary inquiry, trial or other proceeding under any Act or its regulations; or (e) the Minister has reasonable grounds to believe that the approval would likely create a risk to public health or safety, including the risk of the controlled drug being diverted to an illicit market or use. Method of recording information G.02.071 A licensed dealer must record any information that they are required to record under this Part using a method that permits an audit of it to be made at any time. G.02.072 A licensed dealer must record the following information: (a) the name, form and quantity of any controlled drug that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order; (b) the name, form and quantity of any controlled drug that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received; (c) in the case of a controlled drug that the dealer sells or provides, (i) the brand name of the product or the name of the compound containing the controlled drug and the name of the controlled drug, (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, (iii) the form and quantity of the controlled drug and, if applicable, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages, (iv) the name and municipal address of the person to whom it was sold or provided, and (v) the date on which it was sold or provided; (d) the name, form and quantity of any controlled drug that the dealer manufactures or assembles and the date on which it was placed in stock and, if applicable, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages; (e) the name and quantity of any controlled drug that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock; (f) the name, form and quantity of any controlled drug in stock at the end of each month; (g) the name, form and quantity of any controlled drug that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent; (h) the name, form and quantity of any controlled drug that the dealer imports, the date on which it was imported, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and (i) the name, form and quantity of any controlled drug that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment. G.02.073 A licensed dealer that receives a verbal order for a controlled drug listed in Part II or III of the schedule to this Part and sells or provides it to a pharmacist, practitioner or hospital employee must immediately record (a) the name of the person who placed the order; (b) the date on which the order was received; and (c) the name of the person recording the order. Explainable loss of controlled drug G.02.074 A licensed dealer that becomes aware of a loss of a controlled drug that can be explained on the basis of normally accepted business activities must record the following information: (a) the name of the lost controlled drug and, if applicable, the brand name of the product or the name of the compound containing it; (b) the form and quantity of the controlled drug and, if applicable, the form of the product or compound containing it, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages; (c) the date on which the dealer became aware of the loss; and G.02.075 A licensed dealer must record the following information concerning any controlled drug that they destroy at the site specified in their licence: (b) the name, form and quantity of the controlled drug and, if applicable, the brand name and quantity of the product containing the drug or the name and quantity of the compound containing the drug; (c) the method of destruction; and Annual report G.02.076 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains (a) the name, form and total quantity of each controlled drug that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each controlled drug that they use to manufacture or assemble a product or compound; (b) the name, form and quantity of each controlled drug in physical inventory taken at the site specified in their licence at the end of the calendar year; and (c) the name, form and quantity of any controlled drug that has been lost or stolen in the course of conducting activities during the calendar year. Non-renewal or revocation within first three months

(2)

Aliments non normalisés

(2)

If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister (a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and (b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation. Non-renewal or revocation after third month

(2)

Bonnes pratiques industrielles

(3)

If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation. G.02.077 A licensed dealer and a former licensed dealer must keep any document containing the information that they are required to record under this Part, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time. Location G.02.078 The documents must be kept (a) in the case of a licensed dealer, at the site specified in their licence; and (b) in the case of a former licensed dealer, at a location in Canada. Quality of documents G.02.079 The documents must be complete and readily retrievable and the information in them must be legible and indelible. Pharmacists Record of Controlled Drugs Received G.03.001 (1) A pharmacist, on receipt of a controlled drug from a licensed dealer or from another pharmacist, shall keep a record of the name and quantity of the controlled drug received by them, the name and address of the person who sold or provided it and the date it was received. (a) in a manner that permits an audit to be made; and (b) subject to subsection (3), in a book, register or similar record maintained exclusively for controlled drugs.

I

1 Gélose de mousse d’Irlande Mêmes aliments que pour la carraghénine Mêmes limites de tolérance que pour la carraghénine K.1 Gomme sterculia (Karaya)

(3)

The record of information referred to in subsection (1) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b). Sale of Controlled Drugs G.03.002 No pharmacist shall, except as otherwise provided in this Part, sell or provide a controlled drug to any person unless the pharmacist has first been provided with a prescription for it, and (a) if the prescription is in writing, it has been signed and dated by the practitioner issuing the same and the signature of the practitioner where not known to the pharmacist, has been verified by him; or (b) if the prescription is given verbally, the pharmacist has taken reasonable precaution to satisfy himself that the person giving the prescription is a practitioner. Prohibition — pharmacist or practitioner named in notice (a) sell or provide a controlled drug, other than a preparation, to a pharmacist named in a notice given by the Minister under section G.03.017.2; (b) sell or provide a preparation to a pharmacist named in a notice given by the Minister under section G.03.017.2; (c) dispense, sell or provide a controlled drug, other than a preparation, to, or pursuant to a prescription or order given by, a practitioner named in a notice given by the Minister under section G.04.004.2; or (d) dispense, sell or provide a preparation to a practitioner or pursuant to a prescription or order given by a practitioner named in a notice given by the Minister under section G.04.004.2. G.03.002.2 Section G.03.002.1 does not apply to a pharmacist to whom the Minister has issued a notice of retraction of the notice (a) under section G.03.017.3, in respect of a pharmacist named in a notice issued by the Minister under section G.03.017.2; or (b) under section G.04.004.3, in respect of a practitioner named in a notice issued by the Minister under section G.04.004.2. G.03.003 (1) A pharmacist may sell or provide a controlled drug to a practitioner for use in their practice (a) upon a written order, signed and dated by that practitioner, that has been verified if the signature of the practitioner is unknown to the pharmacist; or (b) upon a verbal order specifying the name and quantity of the drug if the pharmacist has taken reasonable precautions to satisfy themself that the person making the order is a practitioner. G.03.004 A pharmacist shall, in respect of controlled drugs sold or provided to a practitioner under section G.03.003, keep in a special prescription file a record showing the date, the name and address of the practitioner, and the quantity and kind of controlled drug sold or provided. G.03.005 A pharmacist may provide a controlled drug to a hospital employee or to a practitioner in a hospital on receipt of a written order signed and dated by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to sign the order, if the signature of that pharmacist or practitioner is known to the pharmacist or, if unknown, has been verified by the pharmacist. (a) the practitioner, at the time that he issued the prescription, directed in writing, in the case of a controlled drug listed in Part I of the schedule to this Part, or directed in writing or orally, in the case of a controlled drug listed in Part II or III of the schedule to this Part, that the prescription be refilled, the number of times that it may be refilled and the dates for or the intervals between refills; and (b) the pharmacist keeps a record of each refilling of a prescription. G.03.007 If, in accordance with a written order or prescription, a pharmacist dispenses a controlled drug listed in Part I of the schedule to this Part, other than a preparation, the pharmacist must immediately enter in a book, register or similar record maintained for such purposes (a) their name or initials; (b) the name, initials and municipal address of the practitioner who issued the order or prescription; (c) the name and municipal address of the person named in the order or prescription; (e) the date on which the controlled drug was dispensed; and G.03.008 A pharmacist must, before dispensing a controlled drug in accordance with a verbal order or prescription, make a written record of it that sets out (a) their name or initials; (b) the name, initials and municipal address of the practitioner who issued the order or prescription; (c) the name and municipal address of the person named in the order or prescription; (e) the directions for use given with the order or prescription; (f) the date on which the controlled drug was dispensed; and (g) the number assigned to the order or prescription. File by date and number G.03.009 A pharmacist must maintain a special prescription file in which are filed, in sequence as to date and number, all written orders and prescriptions for controlled drugs that they have dispensed and the written record of all controlled drugs that they have dispensed in accordance with a verbal order or prescription. G.03.010 A pharmacist shall retain in his possession for a period of at least two years, any records which he is required to keep by this Part. Providing information and assisting inspector (a) furnish such information respecting the dealings of the pharmacist in any controlled drug in such form and at such times as the Minister may require; (b) make available and produce to an inspector upon request his special prescription file together with any books, records or documents which he is required to keep; (c) permit an inspector to make copies of or to take extracts from such files, books, records or documents; and G.03.012 A pharmacist shall take all reasonable steps that are necessary to protect controlled drugs on his premises or under his control against loss or theft. Loss or theft — report G.03.013 A pharmacist shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof. Return, Sale and Transfer Written order G.03.014 A pharmacist may, upon receiving a written order for a controlled drug signed and dated by (a) the licensed dealer who sold or provided that drug to them, return that drug to that licensed dealer; (b) another pharmacist, sell or provide any quantity of that drug to that other pharmacist that is specified in the order as being required for emergency purposes; (c) the Minister, sell or provide to the Minister any quantity of that drug, specified in the order, that is required by the Minister in connection with his or her duties; and (d) a person exempted under section 56 of the Act with respect to that controlled drug, sell or provide to that person any quantity of that drug that is specified in the order. G.03.015 A pharmacist shall immediately after receiving, selling or providing a controlled drug under paragraph G.03.014(b) or (c) or subsection G.05.003(4) enter the details of the transaction in a book, register or other record maintained for the purpose of recording such transactions. Notice to Minister G.03.016 A pharmacist shall forthwith after removing, transporting or transferring a controlled drug from his place of business to any other place of business operated by him notify the Minister, setting out the details. Communication of Information by Minister to Licensing Authority Contraventions by pharmacist G.03.017 The Minister must provide in writing any factual information about a pharmacist that has been obtained under the Act or this Part to the provincial professional licensing authority that is responsible for the authorization of the person to practise their profession (a) in the province in which the pharmacist is or was entitled to practise if (i) the authority submits to the Minister a written request that sets out the pharmacist’s name and address, a description of the information being requested and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or (ii) the Minister has reasonable grounds to believe that the pharmacist has (A) contravened a rule of conduct established by the authority, (B) been convicted of a designated substance offence, or (b) in a province in which the pharmacist is not entitled to practise, if the authority submits to the Minister (i) a written request that sets out the pharmacist’s name and address and a description of the information being requested, and (ii) a document that shows that (A) the pharmacist has applied to that authority to practise in that province, or (B) the authority has reasonable grounds to believe that the pharmacist is practising in that province without being authorized to do so. Notice of Prohibition of Sale Request by pharmacist G.03.017.1 A pharmacist may make a written request to the Minister to send to the persons and authorities specified in subsection G.03.017.2(3) a notice, issued under section G.03.017.2, advising them that recipients of the notice must not sell or provide a controlled drug other than a preparation, a preparation, or both, to that pharmacist. Notice by Minister G.03.017.2 (1) In the circumstances described in subsection (2), the Minister must send a notice to the persons and authorities specified in subsection (3) advising them that pharmacists practising in the notified pharmacies and licensed dealers must not sell or provide to the pharmacist named in the notice a controlled drug other than a preparation or a preparation.

(1)

Sauce vinaigrette; lait (indication de l’arôme); cornichons à la moutarde; achards (relish); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé Colonne I

(2)

The notice must be sent if the pharmacist named in the notice has (a) made a request to the Minister in accordance with section G.03.017.1 to send the notice; (b) contravened a rule of conduct established by the provincial professional licensing authority of the province in which the pharmacist is practising and the authority has requested the Minister in writing to send the notice; or (c) been convicted of a designated substance offence or of a contravention of this Part.

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

(3)

The notice must be sent to (a) all licensed dealers; (b) all pharmacies within the province in which the pharmacist named in the notice is entitled to practise and is practising; (c) the provincial professional licensing authority of the province in which the pharmacist named in the notice is entitled to practise; (d) all pharmacies in an adjacent province in which an order from the pharmacist named in the notice may be filled; and (e) any provincial professional licensing authority in another province that has requested the Minister in writing to send the notice.

L

1 Mono- et diglycérides lactylés

(4)

The Minister may send the notice described in subsection (1) to the persons and authorities specified in subsection (3) if the Minister has taken the measures specified in subsection (5) and has reasonable grounds to believe that the pharmacist named in the notice (a) has contravened a provision of the Act or this Part; (b) has, on more than one occasion, self-administered a controlled drug, other than a preparation, contrary to accepted pharmaceutical practice; (c) has, on more than one occasion, self-administered a preparation, contrary to accepted pharmaceutical practice; (d) has, on more than one occasion, provided or administered a controlled drug, other than a preparation, to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice; (e) has, on more than one occasion, provided or administered a preparation to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice; or (f) is unable to account for the quantity of controlled drug for which the pharmacist was responsible under this Part.

(1)

Shortening

(5)

The measures that must be taken before sending the notice are that the Minister has (a) consulted with the provincial professional licensing authority of the province in which the pharmacist to whom the notice relates is entitled to practise; (b) given that pharmacist an opportunity to be heard; and (c) considered (i) the compliance history of the pharmacist in respect of the Act and its regulations, and (ii) whether the actions of the pharmacist pose a risk to public health or safety, including the risk of the controlled drug being diverted to an illicit market or use. G.03.017.3 The Minister must provide the licensed dealers, pharmacies and provincial professional licensing authorities who were sent a notice under subsection G.03.017.2(1) with a notice of retraction of that notice if (a) in the circumstance described in paragraph G.03.017.2(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was sent by the Minister; or (b) in a circumstance described in any of paragraphs G.03.017.2(2)(b) and (c) and (4)(a) to (f), the pharmacist named in the notice has (i) requested in writing that a retraction of the notice be sent, and (ii) provided a letter from the provincial professional licensing authority of the province in which the pharmacist is entitled to practise, in which the authority consents to the retraction of the notice. Administration of Designated Drugs and Other Controlled Drugs Restriction G.04.001 (1) Subject to subsections (2) and (3) and to an exemption granted under section 56 of the Act with respect to the administration of the controlled drug specified in the exemption, a practitioner must not administer a controlled drug to any person or animal.

(2)

Aliments non normalisés

(2)

A practitioner may administer a controlled drug, other than a designated drug, to a person or to an animal, if (a) that person or animal is under their professional treatment; and (b) the controlled drug is required for the condition for which that person or animal is receiving treatment. Purposes

(3)

Sorbet laitier

(3)

A practitioner of medicine, dentistry or veterinary medicine or a nurse practitioner may administer a designated drug to a person or an animal who is under their professional treatment if the designated drug is for the treatment of any of the following conditions: Restriction (v) hypotensive states associated with anesthesia; or (b) in the case of animals, depression of cardiac and respiratory centres.

(4)

Aliments non normalisés

(4)

The following definitions apply in this section. administer includes to prescribe, sell or provide a drug. (administrer) designated drug means any of the following controlled drugs: (a) amphetamine and its salts; (b) benzphetamine and its salts; (c) methamphetamine and its salts; Record of controlled drugs sold or provided G.04.002 (1) A practitioner who sells or provides a controlled drug to a person for self-administration or for administration to an animal shall, whether or not the practitioner charges for the drug, keep a record showing the name and quantity of the controlled drug sold or provided, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided if the quantity of the controlled drug exceeds (a) three times the maximum daily dosage recommended by the manufacturer or assembler of the controlled drug; or (b) three times the generally recognized maximum daily therapeutic dosage for that controlled drug if the manufacturer or assembler has not recommended a maximum daily dosage.

(5)

Margarine réduite en calories

(2)

A practitioner who is required by this section to keep a record shall keep the record in a place, form and manner that will permit an inspector readily to examine and obtain information from it. (a) furnish to the Minister on request such information respecting (i) the use by the practitioner of controlled drugs received — including the administering, selling or providing of the drugs to a person —, and (ii) the prescriptions for controlled drugs issued by the practitioner, as the Minister may require; (b) produce to an inspector on request any records that these Regulations require the practitioner to keep; (c) permit an inspector to make copies of such records or to take extracts therefrom; (e) retain in his possession for at least two years any record that these Regulations require him to keep; (f) take adequate steps to protect controlled drugs in his possession from loss or theft; and (g) report to the Minister any loss or theft of a controlled drug within 10 days of the practitioner’s discovery of the loss or theft. Communication of Information by Minister to Licensing Authority Contraventions by practitioner G.04.004 The Minister must provide in writing any factual information about a practitioner that has been obtained under the Act or this Part to the provincial professional licensing authority responsible for the registration and authorization of the person to practise their profession (a) in the province in which the practitioner is or was registered and entitled to practise if (i) the authority submits to the Minister a written request that sets out the practitioner’s name and address, a description of the information being requested and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or (ii) the Minister has reasonable grounds to believe that the practitioner has (A) contravened a rule of conduct established by the authority, (B) been convicted of a designated substance offence, or (b) in a province in which the practitioner is not registered and entitled to practise, if the authority submits to the Minister (i) a written request that sets out the practitioner’s name and address and a description of the information being requested, and (ii) a document that shows that (A) the practitioner has applied to that authority to practise in that province, or (B) the authority has reasonable grounds to believe that the practitioner is practising in that province without being authorized to do so. Notice of Prohibition of Sale Request by practitioner G.04.004.1 A practitioner may make a written request to the Minister to send to licensed dealers and pharmacies a notice, issued under section G.04.004.2, advising them of one or more of the following requirements: (a) recipients of the notice must not sell or provide a controlled drug, other than a preparation, to that practitioner; (b) recipients of the notice must not sell or provide a preparation to that practitioner; (c) pharmacists practising in the notified pharmacies must not fill a prescription or order for a controlled drug, other than a preparation, from that practitioner; and Notice by Minister G.04.004.2 (1) In the circumstances described in subsection (2), the Minister must send a notice to the persons and authorities specified in subsection (3) advising them that (a) pharmacists practising in the notified pharmacies and licensed dealers must not sell or provide to the practitioner named in the notice a controlled drug other than a preparation or a preparation; (b) pharmacists practising in the notified pharmacies must not fill a prescription or order from the practitioner named in the notice for a controlled drug other than a preparation or a preparation; or (c) the prohibitions in both paragraphs (a) and (b) apply with respect to the practitioner named in the notice.

(1)

0,8 % (sauf que le total des mono- et des diglycérides et des mono- et diglycérides lactylés, ne doit pas dépasser 20,0 % du shortening)

(2)

The notice must be sent if the practitioner named in the notice has (a) made a request to the Minister in accordance with section G.04.004.1 to send the notice; (b) contravened a rule of conduct established by the provincial professional licensing authority of the province in which the practitioner is practising and the authority has requested the Minister in writing to issue the notice; or (c) been convicted of a designated substance offence or of a contravention of this Part.

(2)

Bonnes pratiques industrielles

(3)

The notice must be sent to (a) all licensed dealers; (b) all pharmacies within the province in which the practitioner named in the notice is registered and entitled to practise and is practising; (c) the provincial professional licensing authority of the province in which the practitioner named in the notice is registered and entitled to practise; (d) all pharmacies in an adjacent province in which a prescription or order from the practitioner named in the notice may be filled; and (e) any provincial professional licensing authority in another province that has requested the Minister in writing to send the notice; and

(3)

0,75 %

(4)

The Minister may send the notice described in subsection (1) to the persons and authorities specified in subsection (3) if the Minister has taken the measures specified in subsection (5) and has reasonable grounds to believe that the practitioner named in the notice (a) has contravened a provision of the Act or this Part; (b) has, on more than one occasion, self-administered a controlled drug, other than a preparation, under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted professional practice; (c) has, on more than one occasion, self-administered a preparation under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted professional practice; (d) has, on more than one occasion, prescribed, provided or administered a controlled drug, other than a preparation, to a person who is a spouse, common-law partner, parent or child of the practitioner, including a child adopted in fact, contrary to accepted professional practice; (e) has, on more than one occasion, prescribed, provided or administered a preparation to a person who is a spouse, common-law partner, parent or child of the practitioner, including a child adopted in fact, contrary to accepted professional; or (f) is unable to account for the quantity of controlled drug for which the practitioner was responsible under this Part.

(4)

Bonnes pratiques industrielles

(5)

The measures that must be taken before sending the notice are that the Minister has (a) consulted with the provincial professional licensing authority of the province in which the practitioner to whom the notice relates is registered and entitled to practise; (b) given that practitioner an opportunity to be heard and (c) considered (i) the compliance history of the practitioner in respect of the Act and its regulations, and (ii) whether the actions of the practitioner pose a risk to public health or safety, including the risk of the controlled drug being diverted to an illicit market or use. G.04.004.3 The Minister must provide the licensed dealers, pharmacies and provincial professional licensing authorities who were sent a notice under subsection G.04.004.2(1) with a notice of retraction of that notice if (a) in the circumstance described in paragraph G.04.004.2(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was sent by the Minister; or (b) in a circumstance described in any of paragraphs G.04.004.2(2)(b) and (c) and (4)(a) to (f), the practitioner named in the notice has (i) requested in writing that a retraction of the notice be sent, and G.05.001 (1) A person who is in charge of a hospital shall keep or cause to be kept a record of the following information: (a) the name and quantity of any controlled drug received for the hospital by a hospital employee or a practitioner in the hospital; (b) the name and address of the person from whom any controlled drug was received and the date on which it was received; (c) the name and quantity of any controlled drug used in the making or assembling of a product or compound containing that controlled drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock; (c.1) the name and quantity of any controlled drug produced and the date on which it was placed in stock; (f) the date on which a controlled drug was ordered or prescribed and the form and quantity thereof. Record keeping (a) in a manner that permits an audit to be made; (b) in a book, register or similar record maintained exclusively for controlled drugs; and (c) for a period of at least two years.

(5)

0,5 % selon les exigences de l’article B.09.017

(4)

The information referred to in subsection (1) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b). Providing information and assisting inspector G.05.002 A person who is in charge of a hospital shall (a) furnish such information respecting the use of controlled drugs therein, in such form and at such times as the Minister may require; (b) produce to an inspector any books, records or documents required by these regulations to be kept; (c) permit an inspector to make copies thereof or take extracts from such books, records and documents; and Selling, providing or administering controlled drug G.05.003 (1) No person in charge of a hospital shall permit a controlled drug to be sold, provided or administered except in accordance with this section. Prescription or written order

L

1A Esters lactyliques d’acides gras Aliments non normalisés Bonnes pratiques industrielles

(2)

On receipt of a prescription or a written order signed and dated by a practitioner, the person in charge of a hospital may permit a controlled drug to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided to the person or to the person in charge of the animal. Emergency — other hospital

L

2 Lécithine

(3)

Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be provided, for emergency purposes, to a hospital employee or a practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order.

(1)

Pain; crème; lait (indication de l’arôme); crèmes à la moutarde; achards (relish); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait

(4)

Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist. Research purposes

(2)

Crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

(5)

The person in charge of a hospital may permit a controlled drug to be provided to a person employed in a research laboratory in that hospital for the purpose of research.

(3)

Préparations pour nourrissons

(6)

No person in charge of a hospital shall permit a controlled drug to be sold or provided under subsection (3) or (4) unless the signature of the pharmacist in the other hospital or of the practitioner authorized by the person in charge of the other hospital to sign an order is known to the person who sells or provides the controlled drug or has been verified. G.05.004 A person who is in charge of a hospital shall take all steps necessary to protect controlled drugs in the hospital against loss or theft and shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof. General Labelling — drug dispensed in accordance with prescription G.06.001 In the case of a controlled drug that is dispensed by a pharmacist in accordance with a prescription, section C.01.004 does not apply but the label of the package in which the controlled drug is contained must include the following: (c) the name of the person for whom the controlled drug is dispensed; (e) directions for use; and (f) any other information that the prescription requires be shown on the label. G.06.002 Section C.01.004 does not apply to a test kit that contains a controlled drug and that has a registration number. Identification or analysis of controlled drug G.06.003 (1) Despite anything in this Part, a person may, for the purpose of identification or analysis of a controlled drug, provide or deliver the drug to (b) an agent or mandatary of a practitioner of medicine, if the agent or mandatary is exempted under section 56 of the Act with respect to the possession of that drug for that purpose.

(4)

Sorbet laitier

(2)

An agent or mandatary of a practitioner of medicine who receives the controlled drug must immediately provide or deliver it to

(5)

Aliments non normalisés

(3)

A practitioner of medicine who receives the controlled drug must immediately provide or deliver it (a) for the purpose of its identification or analysis, to a person exempted under section 56 of the Act with Food and Drug Regulations

(6)

Margarine

PART G Controlled Drugs

respect to the possession of that drug for that purpose; or Advertising G.06.004 It is prohibited to (a) advertise a controlled drug to the general public; or (b) publish any written advertisement respecting a controlled drug unless that advertisement displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page: Record keeping — specific cases G.06.005 Every person who is exempted under section 56 of the Act with respect to the possession or administration of a controlled drug and every practitioner of medicine who has received a controlled drug under subsection G.06.003(1) or (2) and every agent or mandatary of a practitioner of medicine who has received a controlled drug under subsection G.06.003(1) must (a) keep a record of the following information for a two-year period beginning on the day on which the record is made: (i) the name and quantity of any controlled drug purchased or received by them and the date on which it was purchased or received, (ii) the name and address of the person from whom the controlled drug was purchased or received, and (b) provide any information respecting those controlled drugs that the Minister may require; and (c) permit access to the records required to be kept by this Part. Communication of information by Minister to nursing statutory body G.06.006 (1) The Minister may provide to a nursing statutory body any information concerning any member of that body that has been obtained under this Part, the Act or the Food and Drugs Act. Non-application

(7)

Margarine réduite en calories

(2)

Subsection (1) does not apply to a nurse practitioner.

(8)

Fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(3)

The following definitions apply in this section. member means any person who is authorized by a nursing statutory body to practice nursing. (membre) nursing statutory body means any provincial professional licensing authority that, in accordance with the laws of that province, authorizes a person to practice nursing. (organisme régissant la profession d’infirmier) Notification of application for order of restoration G.06.007 (1) For the purpose of subsection 24(1) of the Act, notification of an application for an order of restoration must be given in writing to the Attorney General by registered mail and be mailed not less than 15 days before the date on which the application is to be made to a justice. (a) the name of the justice to whom the application is to be made; (b) the time and place at which the application is to be heard; (c) details concerning the controlled drug or other thing in respect of which the application is to be made; and (d) the evidence on which the applicant intends to rely to establish that they are entitled to possession of the controlled drug or other thing referred to in paragraph (c).

(9)

Poudre de lait

1 Amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, excluding those substances set out in item 1 of Part I of the schedule to Part J but including:

(10)

Produits de chocolat; produits du cacao

2 Methylphenidate (methyl 2-phenyl-2-(piperidin-2-yl)acetate), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including:

(1)

Bonnes pratiques industrielles

3 Methaqualone (2-methyl-3-(2-methylphenyl)-4(3H)quinazolinone) and any salt thereof

(2)

0,5 %, seul ou en combinaison avec d’autres agents émulsifiants

4 Phendimetrazine (3,4-dimethyl-2-phenylmorpholine) and any salt thereof

(3)

0,03 % de la préparation pour nourrissons prête à consommer

5 Phenmetrazine (3-methyl-2-phenylmorpholine) and any salt thereof

(4)

0,75 %

8 4-hydroxybutanoic acid (GHB) and any salt thereof

(5)

Bonnes pratiques industrielles

9 Aminorex (5-phenyl-4,5-dihydro-1,3-oxazol-2-amine), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including

(6)

0,5 %

12 Lefetamine (l-(N,N-dimethyl-α-phenylbenzeneethanamine), its salts, derivatives and isomers and salts of derivatives and isomers

(7)

0,5 %

1 Barbiturates, their salts and derivatives, excluding the substances set out in items 6 and 7 of Part I of this schedule, as well as barbituric acid (2,4,6(1H,3H,5H)-pyrimidinetrione) and its salts and 1,3-dimethylbarbituric acid (1,3-dimethyl-2,4,6(1H,3H,5H)-pyrimidinetrione) and its salts, but including

(8)

0,5 %

2 Thiobarbiturates, their salts and derivatives, including:

Food and Drug Regulations

(9)

1,0 %

PART G Controlled Drugs

(10)

1,0 %

4 Diethylpropion (2-(diethylamino)propiophenone) and any salt thereof

L

3 Gomme de caroube Mêmes aliments que pour la gomme de caroube Mêmes limites de tolérance que pour la gomme de caroube.

8 Pyrovalerone (4′-methyl-2-(1-pyrrolidinyl)valerophenone) and any salt thereof

M

1 Chlorure de magnésium Tofu 0,3 %, calculé en sel anhydre PART B Foods

1 Anabolic steroids and their derivatives, including:

Food and Drug Regulations

Section B.16.100

Règlement sur les aliments et drogues

PART G Controlled Drugs

J.01.001 The following definitions apply in this Part. Act means the Controlled Drugs and Substances Act. (Loi) competent authority means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of restricted drugs into or from the country. (autorité compétente) compound includes a preparation. (composé) designated criminal offence means (a) an offence involving the financing of terrorism against any of sections 83.02 to 83.04 of the Criminal Code; (b) an offence involving fraud against any of sections 380 to 382 of the Criminal Code; (c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code; (d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; destroy, in respect of a restricted drug, means to alter or denature it to such an extent that its consumption is rendered impossible or improbable. (destruction) hospital means a facility that is (a) licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness; or (b) owned or operated by the Government of Canada or the government of a province and that provides health services. (hôpital) institution means any institution engaged in research on drugs and includes a hospital, a university in Canada or a department or agency of the Government of Canada or of a government of a province or any part of them. (établissement) international obligation means an obligation in respect of a restricted drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale) label has the same meaning as in section 2 of the Food and Drugs Act. (étiquette) package includes anything in which a restricted drug is wholly or partly contained, placed or packed. (emballage) proper name, in respect of a restricted drug, means the name in English or French that (a) is assigned to the drug in section C.01.002; (b) appears in bold face type for the drug in these Regulations and, if the drug is dispensed in a form other than that described in Part C, the name of the dispensing form; or (c) is assigned in any of the publications mentioned in Schedule B to the Food and Drugs Act in the case of a drug not included in paragraph (a) or (b). (nom propre) qualified investigator means, in respect of a restricted drug, a person whose use and possession of that drug are authorized by the Minister under subsection J.01.059(4) and who is (a) employed by or connected with an institution; or restricted drug means a controlled substance that is set out in the schedule to this Part. (drogue d’usage restreint) Security Directive means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website. (Directive en matière de sécurité) senior person in charge means the individual designated under section J.01.011. (responsable principal) test kit means a kit (a) that contains a restricted drug and a reagent system or buffering agent; (b) that is used during the course of a chemical or analytical procedure to test for the presence or quantity of a restricted drug for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and General Temporary accelerated scheduling J.01.002 (1) The Minister may, by order, add to column 1 of Part III of the schedule to this Part any item or portion of an item listed in Schedule V to the Act for a period referred to in column 2 that is the same as that listed in Schedule V for that item. Deletion

PARTIE B Aliments

(2)

The Minister may, by order, delete any item or portion of an item from column 1 of Part III of the schedule to this Part. Deletion — Schedule V to Act

TITRE 16 Additifs alimentaires

(3)

An item or portion of an item listed in Part III of the schedule to this Part is deemed to be deleted on the day on which it is no longer listed in Schedule V to the Act. Non-application — member of police force J.01.003 A member of a police force or a person acting under their direction and control who, in respect of the conduct of the member or person, is exempt from the application of subsection 4(2) or sections 5, 6 or 7 of the Act by virtue of the Controlled Drugs and Substances Act (Police Enforcement) Regulations is, in respect of that conduct, exempt from the application of this Part. J.01.004 (1) The following persons are authorized to possess a restricted drug listed in Part I of the schedule to this Part: (a) a licensed dealer; (b) a qualified investigator who possesses the drug for the purpose of conducting clinical testing or laboratory research in an institution; (c) an inspector, member of the Royal Canadian Mounted Police, police constable, peace officer, member of the technical or scientific staff of the Government of Canada, the government of a province or a university in Canada who possesses the drug in connection with their employment;

Article B.16.100

Colonne I

(2)

A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part if they are acting as the agent or mandatary of a person referred to in paragraph (1)(a), (b), (d) or (e). Agent or mandatary — person referred to in paragraph (1)(c)

Article

Additifs

(3)

A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part if they (a) are acting as the agent or mandatary of a person who they have reasonable grounds to believe is a person referred to in paragraph (1)(c); and (b) possess the restricted drug for the purpose of assisting that person in the administration or enforcement of an Act or regulation. Authorized activities J.01.005 A person may sell, possess or otherwise deal in a test kit if the following conditions are met: (a) a registration number has been issued for the test kit under section J.01.007 and has not been cancelled under section J.01.008; (b) the test kit bears, on its external surface, (ii) the trade name or trademark, and (c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose. Application for registration number J.01.006 (1) The manufacturer of a test kit may obtain a registration number for it by submitting to the Minister an application containing (a) a detailed description of the design and construction of the test kit; (b) a detailed description of the restricted drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component; and (c) a description of the proposed use of the test kit. Signature and attestation

M

2 Méthylcellulose

(2)

The application must (a) be signed and dated by the person authorized by the applicant for that purpose; and (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge. Additional information or document

M

3 Cellulose méthyl-éthylique

(3)

The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. J.01.007 On completion of the review of the application for a registration number, the Minister must issue a registration number for the test kit, preceded by the letters “TK”, if the Minister determines that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and that it contains (a) a restricted drug and an adulterating or denaturing agent that are combined in such a manner and in such a quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential; or (b) such small quantities or concentrations of any restricted drug as to have no significant drug abuse potential. J.01.008 The Minister must cancel the registration number for a test kit if (a) the test kit is removed from the market by the manufacturer; (b) the Minister has reasonable grounds to believe that the test kit is used or is likely to be used for any purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; or (c) the Minister has reasonable grounds to believe that the cancellation is necessary to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use. Licensed Dealers General J.01.009 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part. Qualified person in charge present

M

4 Monoglycérides

(2)

A licensed dealer may conduct an activity in relation to a restricted drug at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

M

5 Mono- et diglycérides Colonne II Permis dans ou sur

(3)

A licensed dealer must obtain a permit to import or export a restricted drug. Possession for export

(1)

Ale; bière; sauce vinaigrette; bière légère; liqueur de malt; porter; sauce à salade; stout

(4)

A licensed dealer may possess a restricted drug for the purpose of exporting it if they have obtained it in accordance with this Part. J.01.010 The following persons may apply for a dealer’s licence: (b) a corporation that has its head office in Canada or operates a branch office in Canada; or (c) the holder of a position that includes responsibility for restricted drugs on behalf of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada. Senior person in charge J.01.011 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to restricted drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual. Qualified person in charge J.01.012 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to restricted drugs that are specified in the licence application and for ensuring that those activities comply with this Part. The applicant may designate themself if the applicant is an individual. Alternate qualified person in charge

(2)

Aliments non normalisés Aliments non normalisés

(2)

An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

(1)

Pain; crème; pâte de poisson

(3)

Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge: (b) they (i) are a person entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician, (ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or (iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or (B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province; (c) they have sufficient knowledge of and experience with the use and handling of the restricted drugs specified in the dealer’s licence to properly carry out their duties; and (d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

(2)

Produits de chocolat; produits du cacao

(4)

An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if (a) no other individual working at the site meets those requirements; (b) those requirements are not necessary for the activities specified in the licence; and (c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties. J.01.013 An individual is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted, (a) in respect of a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act, the individual (i) was convicted as an adult, or (ii) was a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act; or (b) in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act, (i) the individual was convicted as an adult, or (ii) if the offence was committed when they were at least 14 years old but less than 18 years old, the individual received a sentence that was longer than the maximum youth sentence, as that term is defined in subsection 2(1) of the Youth Criminal Justice Act, that could have been imposed under that Act for such an offence. J.01.014 (1) A person who intends to conduct an activity referred to in section J.01.009 must obtain a dealer’s licence for each site at which they intend to conduct activities by submitting an application to the Minister that contains the following information: (a) if the licence is requested by (ii) a corporation, its corporate name and any other name registered with a province under which it intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself, and (iii) the holder of a position mentioned in paragraph J.01.010(e), the applicant’s name and the title of the position; (b) the municipal address, telephone number and, if applicable, the email address of the proposed site and, if different from the municipal address, its mailing address; (c) the name, date of birth, telephone number and email address of the proposed senior person in charge; (d) with respect to each of the proposed qualified person in charge and any proposed alternate qualified person in charge, (i) their name, date of birth, telephone number and email address, (ii) the title of their position at the site, (iii) the name and title of the position of their immediate supervisor at the site, (iv) if applicable, the profession they practise that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number, and (v) their education, training and work experience that are relevant to their duties; (e) the activities that are to be conducted and the restricted drugs in respect of which each of the activities is to be conducted; (f) if the licence is requested to manufacture or assemble a product or compound that contains a restricted drug, other than a test kit, a list that includes, for each product or compound, (i) the brand name of the product or the name of the compound, (ii) the name of the restricted drug in the product or compound, (iii) the strength per unit of the restricted drug in it, the number of units per package and the number of packages, (iv) if it is to be manufactured or assembled by or for another licensed dealer under a custom order, the name, municipal address and dealer’s licence number of the other licensed dealer, and (v) if the applicant’s name appears on the label of the product or compound, a copy of the inner label; (g) if the licence is requested in order to produce a restricted drug other than a product or compound that contains a restricted drug, (ii) the quantity that the applicant expects to produce under their licence and the period during which that quantity would be produced, and (iii) if it is to be produced for another licensed dealer under a custom order, the name, municipal address and licence number of the other licensed dealer; (h) if the licence is requested for an activity that is not described in paragraph (f) or (g), the name of the restricted drug for which the activity is to be conducted and the purpose of the activity; (i) a detailed description of the security measures in place at the site, determined in accordance with the Security Directive; and (j) a detailed description of the method for recording information that the applicant proposes to use for the purpose of section J.01.075.

(3)

Mélange pour crème glacée; mélange pour lait glacé

(2)

An application for a dealer’s licence must be accompanied by the following documents: (a) if the applicant is a corporation, a copy of (i) the certificate of incorporation or other constituting instrument, and (ii) any document filed with the province in which its site is located that states its corporate name and any other name registered with the province under which the applicant intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself; (b) individual declarations signed and dated by each of the proposed senior person in charge, and qualified person in charge and any proposed alternate qualified person in charge, attesting that the person is not ineligible for a reason specified in section J.01.013; (c) a document issued by a Canadian police force in relation to each person referred to in paragraph (b), indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph J.01.013(a)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii); (d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph J.01.013(b)(i) or received a sentence as specified in subparagraph J.01.013(b)(ii); (e) declaration, signed and dated by the proposed senior person in charge, attesting that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs J.01.012(3)(c) and (d); and (f) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement of subparagraph J.01.012(3)(b)(i), either (ii) a detailed description of the education, training and work experience that is required under paragraph J.01.012(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training. Signature and attestation

(4)

Fromage cottage en crème

(3)

The application must (a) be signed and dated by the proposed senior person in charge; and (b) include an attestation by that person that (i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and (ii) they have the authority to bind the applicant. Additional information and documents

(5)

Préparations pour nourrissons

(4)

The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. J.01.015 Subject to section J.01.017, on completion of the review of the licence application, the Minister must issue a dealer’s licence, with or without terms and conditions, that contains (b) the name of the licensed dealer, their corporate name or the title of the position they hold; (c) the activities that are authorized and the names of the restricted drugs in respect of which each activity may be conducted; (e) the security level at the site, determined in accordance with the Security Directive; (g) the expiry date of the licence, which must be not later than three years after its effective date; (h) any terms and conditions that the Minister has reasonable grounds to believe are necessary to (i) ensure that an international obligation is respected, (ii) ensure conformity with the requirements associated with the security level that is referred to in paragraph (e), or (iii) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use; and (i) if the licensed dealer produces a restricted drug, the quantity that they may produce and the authorized production period. J.01.016 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section J.01.035 or J.01.036. J.01.017 (1) The Minister must refuse to issue a dealer’s licence if (b) during the 10 years before the day on which the licence application is submitted, the applicant has contravened (i) a provision of the Act, the Cannabis Act or their regulations, or (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations; (c) during the 10 years before the day on which the licence application is submitted the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii) or (b)(ii); (d) an activity for which the licence is requested would contravene an international obligation; (e) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested; (f) the method referred to in paragraph J.01.014(1)(j) does not permit the recording of information as required under section J.01.075; (g) the applicant has not complied with the requirements of subsection J.01.014(4) or the information and documents that they have provided are not sufficient to complete the review of the licence application; (h) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application; (i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or (j) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

(6)

Boyaux de saucisse

(2)

The Minister must not refuse to issue a licence under paragraph (1)(b) or (h) if the applicant meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use: (a) the applicant does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

(7)

Margarine

(3)

Before refusing to issue a licence, the Minister must send the applicant a notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard. J.01.018 (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections J.01.014(1) and (2). Signature and attestation

(8)

Sorbet laitier

(2)

The application must (a) be signed and dated by the senior person in charge of the site specified in the application; and (b) include an attestation by that person that (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and (ii) they have the authority to bind the licensed dealer. Additional information and documents

(9)

Shortening

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. J.01.019 (1) Subject to section J.01.021, on completion of the review of the renewal application, the Minister must issue a renewed dealer’s licence that contains the information specified in section J.01.015. Terms and conditions

(10)

Crème sure

(2)

When renewing a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to (a) ensure that an international obligation is respected; (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence renewal; or (c) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use. J.01.020 A renewed dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section J.01.035 or J.01.036. J.01.021 (1) The Minister must refuse to renew a dealer’s licence if (a) the licensed dealer may no longer apply for a licence under section J.01.010; (b) during the 10 years before the day on which the renewal application is submitted, the licensed dealer has contravened (i) a provision of the Act, the Cannabis Act or their Regulations, or (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations; (c) during the 10 years before the day on which the renewal application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph J.01.013(a)(ii) or (b)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii) or (b)(ii); (d) an activity for which the renewal is requested would contravene an international obligation; (e) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested; (f) the method referred to in paragraph J.01.014(1)(j) does not permit the recording of information as required under section J.01.075; (g) the licensed dealer has not complied with the requirements of subsection J.01.018(3) or the information or documents that they have provided are not sufficient to complete the review of the renewal application; (h) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the renewal application; (i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or (j) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

(11)

Aliments non normalisés

(2)

The Minister must not refuse to renew a licence under paragraph (1)(b) or (h) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use: (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

(12)

Fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(3)

Before refusing to renew a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. Amendment of Licence J.01.022 (1) Before making a change affecting any information referred to in section J.01.015 that is contained in their dealer’s licence, a licensed dealer must submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in section J.01.014 that are relevant to the proposed amendment. Signature and attestation

(1)

Pain; crème; pâte de poisson

(2)

The application must (a) be signed and dated by the senior person in charge of the site specified in the application; and (b) include an attestation by that person that (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and (ii) they have the authority to bind the licensed dealer. Additional information and documents

(2)

Produits de chocolat; produits du cacao

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. Amendment J.01.023 (1) Subject to section J.01.025, on completion of the review of the amendment application, the Minister must amend the dealer’s licence. Terms and conditions

(3)

Mélange pour crème glacée; mélange pour lait glacé

(2)

When amending a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to (a) ensure that an international obligation is respected; (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the amendment; or (c) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use. J.01.024 An amended dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section J.01.035 or J.01.036. J.01.025 (1) The Minister must refuse to amend a dealer’s licence if (a) an activity for which the licence amendment is requested would contravene an international obligation; (b) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence amendment is requested; (c) the method referred to in paragraph J.01.014(1)(j) does not permit the recording of information as required by section J.01.075; Modification information or documents that they have provided are not sufficient to complete the review of the amendment application; (e) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the amendment application; or (f) the Minister has reasonable grounds to believe that the amendment of the licence would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

(4)

Fromage cottage; Fromage cottage en crème

(2)

The Minister must not refuse to amend a licence under paragraph (1)(e) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use: (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

(5)

Préparations pour nourrissons

(3)

Before refusing to amend a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. Changes Requiring Prior Approval by Minister J.01.026 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister: (b) the replacement of the senior person in charge; Food and Drug Regulations Licensed Dealers (c) the replacement of the qualified person in charge; or Information and documents

(6)

Boyaux de saucisse

(2)

The licensed dealer must provide the Minister with the following with respect to a change referred to in subsection (1): (a) in the case of a change affecting the security measures in place at the site specified in the dealer’s licence, details of the change; (b) in the case of the senior person in charge, (c) in the case of the qualified person in charge or an alternate qualified person in charge, Additional information and documents

(7)

Margarine

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. J.01.027 (1) Subject to section J.01.028, on completion of the review of the application for approval of the change, the Minister must approve the change. Terms and conditions

(8)

Sorbet laitier

(2)

When approving a change, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to the licence or modify or delete one in order to (a) ensure that an international obligation is respected; (b) ensure conformity with the requirements associated with the security level specified in the licence; or (c) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use. J.01.028 (1) The Minister must refuse to approve the change if (a) during the 10 years before the day on which the application for approval of the change is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii) or (b)(ii); (b) the licensed dealer has not complied with the requirements of subsection J.01.026(3) or the information or documents that they have provided are not sufficient to complete the review of the application for approval of the change; (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the application for approval of the change; or (d) the Minister has reasonable grounds to believe that the change would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

(9)

Shortening Colonne III Limites de tolérance

(2)

The Minister must not refuse to approve a change under paragraph (1)(c) if the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use.

(1)

Bonnes pratiques industrielles

(3)

Before refusing to approve a change, the Minister must send the licensed dealer a notice that sets out the Minister's reasons and gives the dealer an opportunity to be heard in respect of them. Changes Requiring Notice to Minister J.01.029 (1) A licensed dealer must notify the Minister in writing before (a) making or assembling a product or compound that is not set out in the most recent version of the list referred to in paragraph J.01.014(1)(f) that has been submitted to the Minister; or (b) making a change to a product or compound that is set out in the list, if the change affects any of the information that has previously been submitted. Information and list

(2)

Bonnes pratiques industrielles

(2)

The notice must contain the information referred to in paragraph J.01.014(1)(f) that is necessary to update the list and be accompanied by the revised version of the list. J.01.030 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge. J.01.031 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs: (a) a person ceases to act as the senior person in charge; or (b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph J.01.014(1)(f) that has been submitted to the Minister. Information and list

(1)

Bonnes pratiques industrielles

(2)

A notice submitted under paragraph (1)(b) must specify which information referred to in paragraph J.01.014(1)(f) is being changed and be accompanied by the revised version of the list. Notice of cessation of activities J.01.032 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

(1)

1,5 %

(2)

The notice must be signed and dated by the senior person in charge and contain the following information: (a) the expected date of the cessation of activities at the site; (b) a description of the manner in which any remaining restricted drugs on the site as of that date will be disposed of by the licensed dealer, including (i) if some or all of them will be sold or provided to another licensed dealer that will be conducting activities at the same site, the name of that dealer, (ii) if some or all of them will be sold or provided to another licensed dealer that will not be conducting activities at the same site, the name of that dealer and the municipal address of their site, and (iii) if some or all of them will be destroyed, the date on which and the municipal address of the location at which the destruction is to take place; (c) the municipal address of the location at which the licensed dealer’s documents will be kept after activities have ceased; and (d) the name, municipal address, telephone number and, if applicable, the email address of a person who the Minister may contact for further information after activities have ceased.

(3)

Stabilisants dans la proportion totale de 0,5 %, conformément aux sous-alinéas B.08.061b)(vi) et B.08.071b)(vi)

(3)

After having ceased to conduct the activities, the licensed dealer must submit to the Minister a detailed update of the information referred to in subsection (2) if it differs from what was set out in the notice. The update must be signed and dated by the senior person in charge. Changes to Terms and Conditions of Licence Addition of or modification to term or condition J.01.033 (1) The Minister may, at any time other than at the issuance, renewal or amendment of a dealer’s licence, add a term or condition to it or modify one if the Minister has reasonable grounds to believe that it is necessary to do so to (a) ensure that an international obligation is respected; (b) ensure conformity with the requirements associated with the security level specified in the licence; or (c) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

(4)

Bonnes pratiques industrielles

(2)

Before adding a term or condition to a licence or modifying one, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

(5)

0,25 % de la préparation pour nourrissons prête à consommer

(3)

Despite subsection (2), the Minister may add a term or condition to a licence or modify one without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use.

(6)

0,35 % du boyau

(4)

The addition or modification of a term or condition that is made under subsection (3) takes effect as soon as the Minister sends the licensed dealer a notice that (a) sets out the reasons for the addition or modification; (b) gives the dealer an opportunity to be heard; and (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out. Deletion of term or condition J.01.034 (1) The Minister may delete a term or condition of a dealer’s licence that the Minister determines is no longer necessary.

(7)

0,5 %

(2)

The deletion takes effect as soon as the Minister sends the licensed dealer a notice to that effect. Suspension and Revocation of Licence J.01.035 (1) The Minister must suspend a dealer’s licence without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use.

(8)

0,75 %

(2)

The suspension takes effect as soon as the Minister sends the licensed dealer a notice that (a) sets out the reasons for the suspension; (b) gives the dealer an opportunity to be heard; and (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

(9)

10,0 % (sauf que le total des mono et diglycérides et des mono et diglycérides lactylés ne doit pas dépasser 20,0 % du shortening)

(3)

The Minister must reinstate the licence if the Minister has reasonable grounds to believe that the suspension is no longer necessary. Revocation J.01.036 (1) Subject to subsection (2), the Minister must revoke a dealer’s licence if (a) the licensed dealer may no longer apply for a licence under section J.01.010; (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the licence or the actual or potential unauthorized use of the licence; (c) the licensed dealer ceases to conduct activities at their site before the expiry of their licence; (e) the licensed dealer has contravened (i) a provision of the Act, the Cannabis Act or their regulations, or (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations; (f) during the 10 years before the day on which the licence is revoked, the senior person in charge, the qualified person in charge or any alternate qualified person in charge was convicted as specified in subparagraph J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii) or (b)(ii); (g) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of an application relating to the licence; or (h) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use.

(10)

0,3 %

(2)

The Minister must not revoke a dealer’s licence for a ground set out in paragraph (1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use: (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

(11)

Bonnes pratiques industrielles

(3)

Before revoking a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. J.01.037 The licensed dealer must return the original of the licence to the Minister within 15 days after the effective date of the revocation. J.01.038 (1) A licensed dealer must submit to the Minister, before each importation of a restricted drug, an application for an import permit that contains the following information: (a) their name, municipal address and dealer’s licence number; (b) with respect to the restricted drug to be imported, (i) its name, as specified in the dealer’s licence, (ii) if it is a salt, the name of the salt, (iii) its quantity, and (iv) in the case of a raw material, its purity and its anhydrous content; (c) if the restricted drug is contained in a product to be imported, (i) the brand name of the product, (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and (iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages; (d) the name and municipal address, in the country of export, of the exporter from whom the restricted drug is being obtained; (e) the name of the customs office where the importation is anticipated; and (f) each proposed mode of transportation and any proposed country of transit or transhipment. Signature and attestation

(12)

0,5 % conformément aux exigences des titres B.08.040, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(2)

The application must (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge. Additional information and documents

(1)

1,5 %

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. J.01.039 Subject to section J.01.042, on completion of the review of the import permit application, the Minister must issue to the licensed dealer an import permit that contains (c) the effective date of the permit; (i) a date specified by the Minister that is not more than 180 days after its effective date, and (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to (i) ensure that an international obligation is respected, or (ii) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use. J.01.040 An import permit is valid until the earliest of (c) the date of the suspension or revocation of the dealer’s licence under section J.01.035 or J.01.036, and (d) the date of the suspension or revocation of the export permit that applies to the restricted drug to be imported and that is issued by the competent authority in the country of export. J.01.041 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry. J.01.042 (1) The Minister must refuse to issue an import permit if (a) the licensed dealer is not authorized by their dealer’s licence to import the relevant restricted drug or their licence will expire before the date of importation; (b) the Minister has reasonable grounds to believe that the importation would contravene an international obligation; (c) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of the importation; (d) the licensed dealer has not complied with the requirements of subsection J.01.038(3) or the information or documents that they have provided are not sufficient to complete the review of the permit application; (e) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the permit application; (f) the licensed dealer has been notified that their application to renew or amend their licence will be refused; (g) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment; or (h) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

(3)

Stabilisants dans la proportion totale de 0,5 %, conformément aux sous-alinéas B.08.061b)(vi) et B.08.071b)(vi)

(2)

Before refusing to issue the import permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. J.01.043 The holder of an import permit must provide a copy of the permit to the customs office at the time of importation. J.01.044 The holder of an import permit must provide the Minister, within 15 days after the day of release of the restricted drug specified in the permit in accordance with the Customs Act, with a declaration that contains the following information: (a) their name and the numbers of their dealer’s licence and the import permit that applies to the restricted drug; (b) with respect to the restricted drug, (i) its name, as set out in the dealer’s licence, (ii) if it is a salt, the name of the salt, and (iii) its quantity; (c) if the restricted drug is contained in a product that they have imported, (i) the brand name of the product, (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and (iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages; and (d) the name of the customs office from which the restricted drug was released and the date of the release. J.01.045 (1) The Minister must suspend an import permit without prior notice if (a) the dealer’s licence is suspended; (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use; or (c) the importation would contravene the laws of the country of export or any country of transit or transhipment.

(4)

Bonnes pratiques industrielles

(2)

The suspension takes effect as soon as the Minister sends the licensed dealer a notice that (a) sets out the reasons for the suspension; (b) gives the dealer an opportunity to be heard; and (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

(5)

0,25 % de la préparation pour nourrissons prête à consommer

(3)

The Minister must reinstate the import permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary. Revocation (a) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit; (b) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph J.01.045(2)(c) by the specified date; (c) the licensed dealer has contravened a term or condition of the permit; (d) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of the application for the permit; (e) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use; or (f) the dealer’s licence has been revoked.

(6)

0,35 % du boyau

(2)

The Minister must not revoke an import permit for a ground set out in paragraph (1)(d) or J.01.036(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use: (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

(7)

0,5 %

(3)

Before revoking an import permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. J.01.047 If an import permit is revoked, the licensed dealer must return the original of the permit to the Minister within 15 days after the effective date of the revocation. J.01.048 (1) A licensed dealer must submit to the Minister, before each exportation of a restricted drug, an application for an export permit that contains the following information and document: (a) their name, municipal address and dealer’s licence number; (b) with respect to the restricted drug to be exported, (i) its name, as specified in the dealer’s licence, (ii) if it is a salt, the name of the salt, (iii) its quantity, and (iv) in the case of a raw material, its purity and its anhydrous content; (c) if the restricted drug is contained in a product to be exported, (i) the brand name of the product, (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and (iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages; (e) the name of the customs office where the exportation is anticipated; (f) each proposed mode of transportation and any proposed country of transit or transhipment; and (g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country. Signature and attestation

(8)

0,75 %

(2)

The application must (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and (b) include an attestation by that person that, to the best of their knowledge, (i) the exportation does not contravene the laws of the country of final destination or any country of transit or transshipment, and (ii) all of the information and documents submitted in support of the application are correct and complete. Additional information and documents

(9)

10,0 % (sauf que le total des mono et diglycérides et des mono et diglycérides lactylés ne doit pas dépasser 20,0 % du shortening) Colonne I

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. J.01.049 Subject to section J.01.052, on completion of the review of the export permit application, the Minister must issue to the licensed dealer an export permit that contains (c) the effective date of the permit; (i) a date specified by the Minister that is not more than 180 days after its effective date, (iii) the expiry date of the import permit issued by the competent authority in the country of final destination; and (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to (i) ensure that an international obligation is respected, or (ii) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use. J.01.050 An export permit is valid until the earliest of (c) the date of the suspension or revocation of the dealer’s licence under section J.01.035 or J.01.036, and (d) the date of the expiry, suspension or revocation of the import permit that applies to the restricted drug to be exported and that is issued by the competent authority in the country of final destination. J.01.051 If an export permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry. J.01.052 (1) The Minister must refuse to issue an export permit if (a) the licensed dealer is not authorized by their dealer’s licence to export the relevant restricted drug or their dealer’s licence will expire before the date of export; (b) the Minister has reasonable grounds to believe that the exportation would contravene an international obligation; (c) the licensed dealer has not complied with the requirements of subsection J.01.048(3) or the information or documents that they have provided are not sufficient to complete the review of the permit application; (d) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the permit application; (e) the licensed dealer has been notified that their dealer’s licence renewal application has been refused. (e) the licensed dealer has been notified that their application to renew or amend their licence will be refused; (f) the Minister has reasonable grounds to believe that the exportation would not be in conformity with the import permit issued by the competent authority of the country of final destination; (g) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transshipment; or (h) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Article

Additifs

(2)

Before refusing to issue the export permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. J.01.053 The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation. J.01.054 The holder of an export permit must provide the Minister, within 15 days after the day of export of the restricted drug specified in the permit, with a declaration that contains the following information: (a) their name and the numbers of their dealer’s licence and the export permit that applies to the restricted drug; (b) with respect to the restricted drug, (i) its name, as specified in the dealer’s licence, (ii) if it is a salt, the name of the salt, and (iii) its quantity; (c) if the restricted drug is contained in a product that they have exported, (i) the brand name of the product, (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and (iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages; and (d) the name of the customs office from which the restricted drug was exported and the date of export. J.01.055 (1) The Minister must suspend an export permit without prior notice if (a) the dealer’s licence is suspended; (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use; or (c) the exportation would contravene the laws of the country of final destination or any country of transit or transshipment.

M

6 Sels monosodiques de mono- et diglycérides phosphorylés P.1 Gomme d’avoine Pectine P.1A Esters polyglycérolés d’acides gras P.1B Esters polyglycéroliques d’acides gras d’huile de ricin transestérifiés Colonne II Permis dans ou sur

(2)

The suspension takes effect as soon as the Minister sends the licensed dealer a notice that (a) sets out the reasons for the suspension; (b) gives the dealer an opportunity to be heard; and (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

(10)

Crème sure

(3)

The Minister must reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary. Revocation (a) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit; (b) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph J.01.055(2)(c) by the specified date; (c) the licensed dealer has contravened a term or condition of the permit; (d) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of the application for the permit; (e) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use; or (f) the dealer’s licence has been revoked.

(11)

Aliments non normalisés

(2)

The Minister must not revoke an export permit for a ground set out in paragraph (1)(d) or J.01.036(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use: (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

(12)

Fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(3)

Before revoking an export permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard. J.01.057 If an export permit is revoked, the licensed dealer must return the original of the permit to the Minister within 15 days after the effective date of the revocation. Identification J.01.058 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to restricted drugs, including labels, orders, shipping documents, invoices and advertising. J.01.059 (1) Despite section C.08.002 and subject to subsections (3) and (4), a licensed dealer may sell a restricted drug to an institution for one of the following purposes if the institution submits to the dealer or the Minister an application to purchase the drug and the Minister issues a prior written authorization for the sale: (a) clinical testing in the institution by qualified investigators for the purpose of determining the hazards and efficacy of the drug; or (b) laboratory research in the institution by qualified investigators.

(1)

Émulsions à base d’huiles végétales comestibles servant d’enduits pour batterie de cuisine

(2)

The application must contain the following information: (b) the names and qualifications of the qualified investigators; (c) the name, form, quantity and strength per unit of the restricted drug being requested; (e) the name and municipal address of the licensed dealer from whom the institution proposes to purchase the drug. Application to licensed dealer

(1)

Aliments non normalisés

(3)

If the institution submits the application to the licensed dealer, the dealer must provide a copy of it to the Minister. Authorization by Minister

(1)

Achards (relish); confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); cornichons à la pectine; gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; gelée aromatisée (indication de l’arôme); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; marmelade d’ananas; marmelade d’ananas avec pectine; marmelade de figues; marmelade de figues avec pectine; marmelade de (nom de l’agrume) avec pectine; mincemeat; sauce à salade; sauce vinaigrette

(4)

After reviewing the application received from the institution or the copy of it received from the licensed dealer, the Minister may, subject to any terms and conditions that the Minister has reasonable grounds to believe are necessary, authorize in writing (a) the sale by the licensed dealer to the institution of the restricted drug applied for in the form, quantity and strength per unit specified by the Minister; and (b) the possession of the restricted drug by qualified investigators for clinical testing of the drug in the institution for the purpose of determining its hazards and efficacy or to conduct laboratory research with the drug in the institution.

(2)

Crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

(5)

The institution must use the restricted drug only in accordance with the written authorization. Sale to Minister J.01.060 A licensed dealer may sell or provide a restricted drug to the Minister. Provision for identification or analysis J.01.061 (1) Despite anything in this Part, a person may, for the purpose of identification or analysis of a restricted drug, provide or deliver it to (b) an agent or mandatary of a practitioner of medicine, if the agent or mandatary has been exempted under section 56 of the Act with respect to the possession of that restricted drug for that purpose.

(3)

Crème sure

(2)

An agent or mandatary of a practitioner of medicine who receives the restricted drug must immediately provide or deliver it to

(4)

Sorbet laitier

(3)

A practitioner of medicine who receives the restricted drug must immediately provide or deliver it (a) for the purpose of its identification or analysis, to a person exempted under section 56 of the Act with respect to the possession of that restricted drug for that purpose; or Packaging, Labelling and Transportation Packaging — sale and provision J.01.062 (1) A licensed dealer that sells or provides a restricted drug must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal. Packaging — transport and export

(5)

Aliments non normalisés

(2)

A licensed dealer that transports or exports a restricted drug must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal.

(1)

Aliments non normalisés

(3)

Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number. J.01.063 (1) A licensed dealer that sells or provides a restricted drug must ensure that its package is labelled so that its inner and outer labels show (a) the proper name or, if there is no proper name, the name of the drug; (c) the unit strength of the drug and the number of units per package, if applicable; (e) the expression “Restricted Drug”; and

(2)

Huiles végétales

(2)

Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number. Non-application Transport J.01.064 A licensed dealer must, in taking delivery of a restricted drug that they have imported or in making delivery of a restricted drug, (a) take any measures that are necessary to ensure the security of the drug while it is being transported; (b) use a method of transportation that permits an accurate record to be kept of all handling of the drug as well as of the signatures of every person handling it until it is delivered to the consignee; (c) in the case of an imported drug, transport it directly to the site specified in their licence after it is released under the Customs Act; and Thefts, Losses and Suspicious Transactions Protective measures — licences and permits J.01.065 A licensed dealer must take any measures that are necessary to ensure the security of any licence or permit in their possession. Protective measures — restricted drugs J.01.066 The following persons must take any measures that are necessary to ensure the security of any restricted drugs in their possession: (a) a licensed dealer; (c) a qualified investigator who possesses the restricted drug for the purpose of clinical testing or laboratory research in an institution; and J.01.067 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it. J.01.068 (1) Subject to subsection (2), any person referred to in section J.01.066 who becomes aware of a theft or loss of a restricted drug must (a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and (b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided. Explainable loss — licensed dealer

(3)

Margarine réduite en calories

(2)

Subsection (1) does not apply to a licensed dealer that becomes aware of a loss of a restricted drug that can be explained on the basis of normally accepted business activities. J.01.069 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a restricted drug to an illicit market or use: (a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report; (b) the name and municipal address of the other party to the transaction; (c) details of the transaction, including its date and time, its type, the name and quantity of the restricted drug and, in the case of a product or compound, the quantity of every restricted drug that it contains; (d) in the case of a product that contains the restricted drug, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2, if any; and (e) a detailed description of the reasons for those suspicions.

(1)

Produits de chocolat

(2)

No civil proceedings lie against a licensed dealer for having provided the report in good faith. Non-disclosure

(2)

Enrobages de confiserie non normalisés à saveur de chocolat

(3)

A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun. Partial protection against self-incrimination J.01.070 A report made under any of sections J.01.067 to J.01.069, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code. Destruction at site J.01.071 A licensed dealer that intends to destroy a restricted drug at the site specified in their licence must ensure that the following conditions are met: (a) the licensed dealer obtains the prior approval of the Minister; (b) the destruction occurs in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i): (i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, (ii) a person who works for or provides services to the licensed dealer and holds a senior position; (c) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and (d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the restricted drug was completely destroyed, to which each signatory must add their name in printed letters. Destruction elsewhere than at site J.01.072 A licensed dealer that intends to destroy a restricted drug elsewhere than at the site specified in their licence must ensure that the following conditions are met: (a) the licensed dealer obtains the prior approval of the Minister; (b) the licensed dealer takes any measures that are necessary to ensure the security of the restricted drug while it is being transported in order to prevent its diversion to an illicit market or use; (c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business; (d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and (e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the restricted drug was completely destroyed and containing (i) the municipal address of the place of destruction, (ii) the name and quantity of the restricted drug and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it, (iii) the method of destruction, (iv) the date of destruction, and (v) the names in printed letters and signatures of that person and the other person who was present at the destruction. Application for prior approval J.01.073 (1) A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister’s prior approval to destroy a restricted drug: (a) their name, municipal address and dealer’s licence number; (b) the proposed date of destruction; (c) the municipal address of the place of destruction; (e) if the destruction is to be carried out at the site specified in the dealer’s licence, the names of the persons proposed for the purpose of paragraph J.01.071(b) and information establishing that they meet the conditions of that paragraph; (f) the name of the restricted drug and, if applicable, the brand name of the product containing it or the name of the compound containing it; and (g) the form and quantity of the restricted drug or the product or compound containing it and if applicable, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages. Signature and attestation

(3)

Émulsions à base d’huiles végétales comestibles pour enduire les moules à cuisson Colonne III Limites de tolérance

(2)

The application must (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and (b) include an attestation by that person that (i) the proposed method of destruction complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction, and (ii) all of the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge. Additional information and documents

(10)

0,3 %

(3)

The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. J.01.074 On completion of the review of the application for approval, the Minister must approve the destruction of the restricted drug unless (a) in the case of a destruction that is to be carried out at the site specified in the dealer’s licence, the conditions proposed for the purpose of paragraph J.01.071(b) do not meet the conditions of that paragraph; (b) the Minister has reasonable grounds to believe that the restricted drug would not be destroyed; (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the approval application; (d) the restricted drug or a portion of it is required for the purposes of a criminal or administrative investigation or a preliminary inquiry, trial or other proceeding under any Act or its regulations; or (e) the Minister has reasonable grounds to believe that the approval would likely create a risk to public health or safety, including the risk of the restricted drug being diverted to an illicit market or use. Licensed Dealers Method of recording information J.01.075 A licensed dealer must record any information that they are required to record under this Part using a method that permits an audit of it to be made at any time. J.01.076 A licensed dealer must record the following information: (a) the name, form and quantity of any restricted drug that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order; (b) the name, form and quantity of any restricted drug that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received; (c) in the case of a restricted drug that the dealer sells or provides, (i) the brand name of the product or the name of the compound containing the restricted drug and the name of the restricted drug, (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, (iii) the form and quantity of the restricted drug and, if applicable, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages, (iv) the name and municipal address of the person to whom it was sold or provided, and (v) the date on which it was sold or provided; (d) the name, form and quantity of any restricted drug that the dealer manufactures or assembles and the date on which it was placed in stock and, if applicable, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages; (e) the name and quantity of any restricted drug that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock; (f) the name, form and quantity of any restricted drug in stock at the end of each month; (g) the name, form and quantity of any restricted drug that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent; (h) the name, form and quantity of any restricted drug imported, the date on which it was that the dealer imports, the name and municipal address of the exporter, the country of exportation and any country of transit or transshipment; and (i) the name, form and quantity of any restricted drug that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transshipment. J.01.077 A licensed dealer that becomes aware of a loss of a restricted drug that can be explained on the basis of normally accepted business activities must record the following information: (a) the name of the lost restricted drug and, if applicable, the brand name of the product or the name of the compound containing it; (b) the form and quantity of the restricted drug and, if applicable, the form of the product or compound containing it, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages; (c) the date on which the dealer became aware of the loss; and J.01.078 A licensed dealer must record the following information concerning any restricted drug that they destroy at the site specified in their licence: (b) the name, form and quantity of the restricted drug and, if applicable, the brand name and quantity of the product containing the drug or the name and quantity of the compound containing the drug; (c) the method of destruction; and Annual report J.01.079 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains (a) the name, form and total quantity of each restricted drug that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each restricted drug that they use to manufacture or assemble a product or compound; (b) the name, form and quantity of each restricted drug in physical inventory taken at the site specified in their licence at the end of the calendar year; and (c) the name, form and quantity of any restricted drug that has been lost in the course of conducting activities during the calendar year. Non-renewal or revocation within first three months

(11)

Bonnes pratiques industrielles

(2)

If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister (a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and (b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation. Non-renewal or revocation after third month

(12)

0,5 % conformément aux exigences des articles B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(3)

If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation. Method of recording information J.01.080 An institution must record any information that it is required to record under this Part using a method that permits an audit of the information to be made at any time. J.01.081 An institution must record the following information: (a) the name and quantity of any restricted drug that the institution orders, the name of the person who placed the order on the institution’s behalf and the date of the order; (b) the name and quantity of any restricted drug that the institution receives as well as the name and municipal address of the licensed dealer that sold or provided it and the date on which it was received; (c) details of the use of restricted drugs in the institution; (e) all clinical data with respect to the use of every restricted drug received by the institution. Drug Received for Identification and Analysis Method of recording information J.01.082 A person who records information in accordance with section J.01.083 must do so using a method that permits an audit of the information to be made at any time. J.01.083 A person who receives a restricted drug in accordance with section J.01.061 must record the following information: (a) the name and quantity of the restricted drug, as well as the name and municipal address of the person who provided it to them and the date on which it was received; (b) details regarding the identification or analysis of the restricted drug; and (c) the names of the persons who handled the restricted drug during the process of identifying or analyzing it. J.01.084 A licensed dealer, a former licensed dealer, an institution and a person referred to in section J.01.083 must keep any document containing the information that they are required to record under this Part, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time. Location J.01.085 The documents must be kept (a) in the case of a licensed dealer, at the site specified in their licence; (b) in the case of an institution, at the institution; (c) in the case of a person referred to in section J.01.083, at a location in Canada; and (d) in the case of a former licensed dealer, at a location in Canada. Quality of documents J.01.086 The documents must be complete and readily retrievable and the information in them must be legible and indelible. Notification of Application for Order of Restoration Written notification J.01.087 (1) For the purpose of subsection 24(1) of the Act, notification of an application for an order of restoration must be given in writing to the Attorney General by registered mail and be mailed at least 15 days before the date on which the application is to be made to a justice. (a) the name of the justice to whom the application is to be made; (b) the time and place at which the application is to be heard; (c) details concerning the restricted drug or other thing in respect of which the application is to be made; and (d) the evidence on which the applicant intends to rely to establish that they are entitled to possession of the restricted drug or other thing referred to in paragraph (c).

(1)

4,0 %

1 The following amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues:

Food and Drug Regulations

(1)

Bonnes pratiques industrielles

(10)

N,N-dimethyl-3,4-methylenedioxyamphetamine (N,N, α-trimethyl-1,3-benzodioxole-5-ethanamine) Food and Drug Regulations

(1)

Bonnes pratiques industrielles

4 N,N-Dimethyltryptamine (DMT) (3-[(2-dimethylamino)ethyl]indole) and any salt thereof

(2)

0,5 %

5 N-Methyl-3-piperidyl benzilate (LBJ) (3-[(hydroxy(diphenylacetyl)oxy]-1-methylpiperidine) and any salt thereof

(3)

0,5 % conformément à la disposition B.08.077b)(viii)(A)

6 Harmaline (4,9-dihydro-7-methoxy-1-methyl-3H-pyrido(3,4-b)indole) and any salt thereof

(4)

0,75 %

7 Harmalol (4,9-dihydro-1-methyl-3H-pyrido(3,4-b)indol-7-ol) and any salt thereof

(5)

Bonnes pratiques industrielles

8 Psilocin (3-[2-(dimethylamino)ethyl]-4-hydroxyindole) and any salt thereof

(1)

Bonnes pratiques industrielles

9 Psilocybin (3-[2-(dimethylamino)ethyl]-4-phosphoryloxyindole) and any salt thereof

(2)

0,025 %

10 N-(1-phenylcyclohexyl)ethylamine (PCE) and any salt thereof

(3)

2,0 % conformément aux exigences de l’alinéa B.09.017c)

12 1-Phenyl-N-propylcyclohexamine and any salt thereof

(1)

0,5 %

15 2-Methylamino-1-phenyl-1-propanone and any salt thereof

(2)

0,25 %

16 1-[1-(Phenylmethyl)cyclohexyl]piperidine and any salt thereof

(3)

2,0 % PART B Foods

17 1-[1-(4-Methylphenyl)cyclohexyl]piperidine and any salt thereof

Section B.16.100

Règlement sur les aliments et drogues

20 Benzylpiperazine (BZP), namely 1-benzylpiperazine and its salts, isomers and salts of isomers

PARTIE B Aliments

21 Trifluoromethylphenylpiperazine (TFMPP), namely 1-(3-trifluoromethylphenyl)piperazine and its salts, isomers and salts of isomers

TITRE 16 Additifs alimentaires

22 Methylenedioxypyrovalerone (MDPV), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues

Article B.16.100

23 Cathinone ((-)-α-aminopropiophenone) and its salts

Article

P.2 Colonne I Additifs Mono-oléate polyoxyéthylenique (20) de sorbitan Polysorbate 80 Colonne II Permis dans ou sur

24 2C-phenethylamines and their salts, derivatives, isomers and salts of derivatives and isomers that correspond to the following chemical description:

any substance that has a 1-amino-2-phenylethane structure substituted at the 2′ and 5′ or 2′ and 6′ positions of the benzene ring by an alkoxy or haloalkoxy group, or substituted at two adjacent carbon atoms of the benzene ring which results in the formation of a furan, dihydrofuran, pyran, dihydropyran or methylenedioxy group — whether or not further substituted on the benzene ring to any extent, whether or not substituted at the amino group by one or two, or a combination of, methyl, ethyl, propyl, isopropyl, hydroxyl, benzyl (or benzyl substituted to any extent) or benzoyl (or benzoylene substituted to any extent) groups and whether or not substituted at the 2-ethyl (beta carbon) position by a hydroxyl, oxo or alkoxy group — and its salts and derivatives and salts of derivatives, including

(1)

Crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé; sorbet laitier

25 AH-7921 (1-(3,4-dichlorobenzamidomethyl)cyclohexylmethylamine), its salts, isomers and salts of isomers

(2)

Desserts congelés non normalisés

26 MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including

but not including

(3)

Achards (relish) et cornichons

(5)

Lefetamine ((-)-N,N-dimethyl-α-phenylbenzeneethanamine), its salts, derivatives and isomers and salts of derivatives and isomers

(4)

Bases pour boissons non normalisées; mélanges pour boissons non normalisés

27 W-18 (4-chloro-N-[1-[2-(4-nitrophenyl)ethyl]-2-piperidylidene]benzenesulfonamide), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues

(5)

Mélange imitation de crème en poudre

28 U-47700 (3,4-dichloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide), its salts, derivatives, isomers and analogues, and salts of derivatives, isomers and analogues, including

(6)

Garnitures fouettées à l’huile végétale

1 Salvia divinorum (S. divinorum), its preparations and derivatives, including

(7)

Glaces à gâteaux; mélanges pour glaces à gâteaux

2 Catha edulis Forsk, its preparations, derivatives, alkaloids and salts, including

but not including Food and Drug Regulations Reasonable Daily Intake for Various Foods Item No. Bacon (side) simulated meat product that resembles side bacon, (cooked) ....................................................................................... 1.0 oz. 28 g Beverage Bases and Mixes, Flavoured, for Addition to Milk (ready to serve) ....................................................................................... 16.0 fl.oz. 454 ml Cheese (other than Cottage Cheese) .......................................... 2.0 oz. 57 g Condensed Milk ............................................................................ 15.0 fl.oz. 426 ml Infant Formulas, Prepared (ready to serve) ................................ As directed by Label Instant Breakfast, Ready Breakfast (ready to serve) ................... As directed by Label Food and Drug Regulations SCHEDULE K Reasonable Daily Intake for Various Foods Item No. | Name and Description

(8)

Sel

43 Simulated Meat Products excluding a simulated meat product that resembles side bacon ................................................................. 3.5 oz. 100 g

(9)

Crème fouettée

48 Skim Milk with Added Milk Solids, Partly Skimmed Milk with Added Milk Solids ...................................................................................... 30.0 fl.oz. 852 ml

(10)

Rafraîchisseurs d’haleine

55 Vegetable (other than baked beans and cooked potatoes) ......................... 3.5 oz. 100 g

Forms (Under section 37 of the Food and Drugs Act) The undersigned exporter hereby certifies that the (description of article) packaged and labelled as follows: and marked in distinct overprinting with the word “Export”

(11)

Fromage cottage en crème

1 is manufactured or prepared in Canada,

(12)

Huiles d’épice et oléorésines d’épice utilisées dans le mélange de salaison pour mariner des viandes de salaison ou des sous-produits de viande de salaison (Titre 14)

2 is not manufactured or sold for consumption or use in Canada, and

(13)

Boyaux de saucisse

3 the packages and the contents of those packages do not contravene any known requirement of the law of

to which it is or is about to be consigned. Dated at __________________________ the _______ day of __________________________ 20 __ . (name of country or countries) Canada : __________________________ In the matter of an Export Certificate under the Food and Drugs Act, Province of __________________________ in the __________________________ of __________________________ of __________________________

(14)

Agents aromatisants à saveur de fumée

1 that I am the “Exporter” issuing the certificate above set out and have a knowledge of the matters

and facts herein declared to by me, I am the __________________________ of __________________________ of __________________________ the “Exporter” issuing the certificate above set out and have a knowledge of the matters and facts herein declared to by me (describe position of declarant as the agent of the “Exporter” in case of a Corporation issuing the certificate),

(15)

Huiles végétales

2 that the information set out in the said certificate is true,

(16)

Préparations de rocou

3 that all information relevant to the purpose of the said certificate is set out herein and no informa-

And I make this solemn declaration conscientiously believing it to be true, and knowing that it is of the same force and effect as if made under oath, and by virtue of The Canada Evidence Act. Declared before me at __________________________ this __________________________ A Commissioner for Taking Oaths 3,0 oz | 85 g 1,0 oz | 28 g 2,0 oz | 57 g 1,0 oz | 28 g 2,0 oz | 57 g 15,0 oz liq | 426 ml 2,0 oz | 57 g 7,0 oz | 200 g 4,0 oz liq | 114 ml 4,0 oz liq | 114 ml 4,0 oz liq | 114 ml 1,0 oz liq | 28 ml 1,0 oz liq | 28 ml 2,0 oz | 57 g Food and Drug Regulations SCHEDULE K (French)

(17)

Préparations de curcuma

59 Yogourt, nature .......................................................................... 5,0 oz 150 g

Province ___________________________ Nutrition Symbols and Formats High in High in High in High in High in High in High in High in High in High in High in High in High in High in The image contains text in both English and French, primarily in tabular format. Below is the extracted text: Food and Drug Regulations High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in High in Sugars High in Sodium High in Sugars High in Sodium High in Sat fat / Gras sat High in Sat fat / Gras sat High in Sugars / Sucres High in Sat fat / Gras sat High in Sat fat / Gras sat High in Sugars / Sucres High in Sodium High in High in High in High in High in High in High in High in High in High in High in High in Saturated fat High in High in High in Saturated fat Supplemented Food Caution Identifier Formats ! Supplemented Supplemented ! Supplemented Supplemented

(18)

Arômes de fumée liquide concentrés

66 Packages of drugs that are labelled in accordance with Part C of the Food and Drug Regulations, as those Regulations read on December 31, 1996, are not required to comply with the labelling requirements in these Regulations until January 1, 1999.

(19)

Sauces à salade non normalisées Colonne III Limites de tolérance

10 For the purposes of sections 11 to 13, Director has the same meaning as in section A.01.010 of the Food and Drugs Regulations.

(1)

0,1 %. Si l’on emploie le tristearate polyoxyéthylenique (20) de sorbitan, le total ne doit pas dépasser 0,1 %

11 Despite sections 1 and 7 to 9, if a numbered certificate of registration has been issued in respect of a drug but a drug identification number has not been assigned under section C.01.014.2 of the Food and Drug Regulations, as amended by section 4 of these Regulations, or under section 12 of these Regulations, then section C.01.014, paragraphs C.01.015(2)(b) and C.01.062(5)(b) and Division 10 of the schedule and the table to Division 10 of Part C of the Food and Drug Regulations, as they read immediately before the coming into force of these Regulations, remain in force in respect of that drug until October 1, 1998, except to the extent that they require information that is not required by those provisions as amended by these Regulations.

(2)

0,1 %

12 (1) Despite these Regulations and subject to subsection (3), if the conditions set out in subsection (2) are satisfied, the Director shall, until October 1, 1998, provide to a manufacturer or importer referred to in paragraph (2)(c),

(a) if the information referred to in section C.01.014.3 of the Food and Drug Regulations as amended by section 5 of these Regulations has not been submitted in respect of the drug, the document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations, as amended by section 4 of these Regulations; or (b) in any other case, (i) a drug identification number for the drug preceded by the letters “DIN”, or (ii) where there are two or more brand names for the drug, the drug identification numbers assigned. by the Director for the drug, each of which pertains to one of the brand names and is preceded by the letters “DIN”.

(3)

0,05 %

(2)

The conditions referred to in subsection (1) are: (a) a numbered certificate of registration has been issued for the drug under subsection C.10.004(1) of the Food and Drug Regulations as it read before the coming into force of these Regulations; (b) the numbered certificate of registration has not been cancelled under section C.10.008 of the Food and Drug Regulations as it read immediately before the coming into force of these Regulations; and (c) prior to September 1, 1998, the manufacturer or importer has submitted to the Director (i) the name of the drug for which a drug identification number is to be issued, and

(4)

0,05 % de la boisson. Si l’on emploie aussi le monostéarate de sorbitan, le total ne doit pas dépasser 0,05 % de la boisson

(3)

If more than one numbered certificate of registration has been issued for a drug on the sole basis of a difference in colour, flavour or fragrance, a single drug identification number shall be assigned in respect of the drug.

(5)

0,1 %. Si l’on emploie aussi le monostéarate polyoxyéthylenique (20) de sorbitan, le tristearate polyoxyéthylenique (20) de sorbitan ou le monostéarate de sorbitan, seuls ou mélangés, le total ne doit pas dépasser 0,4 %

13 Despite section 4 of these Regulations and subject to section C.10.005 of the Food and Drug Regulations as that section read immediately before the coming into force of these Regulations, the Director may, until September 30, 1998, issue a numbered certificate of registration, if

(a) the manufacturer expressly requests that a numbered certificate of registration be issued for the drug; and (b) its application was accepted by the Director for review before the coming into force of these Regulations.

(6)

0,5 %. Si l’on emploie aussi le monostéarate polyoxyéthylenique (20) de sorbitan, le tristearate polyoxyéthylenique (20) de sorbitan ou le monostéarate de sorbitan, seuls ou mélangés, le total ne doit pas dépasser 0,5 % de la glace à gâteau finie

14 Despite section 2, a manufacturer may, until September 30, 2000, label a drug with the label that was in use on September 30, 1998.

An application concerning the sale of a drug for human use for the purposes of a clinical trial that is received under Division 8 of the Food and Drug Regulations before September 1, 2001 is subject to those Regulations and any procedures established under those Regulations as they read at the time the application was received. The following definitions apply in this section. former Regulations means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force. (règlement antérieur) manufacturer has the same meaning as in section A.01.010 of the Food and Drug Regulations. (fabricant) prepackaged product has the same meaning as in section B.01.001 of the Food and Drug Regulations. (produit préemballé) Despite sections 1 to 37 and subject to subsection (3), the former Regulations continue to apply to a prepackaged product that is labelled in accordance with the former Regulations until the day that is three years after the day on which these Regulations come into force, unless the label of the product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains (a) a statement or claim set out in column 4 of any of items 15, 16 and 22 to 26 of the table following section B.01.513 of the Food and Drug Regulations, as enacted by section 20 of these Regulations; (b) a statement or claim set out in column 1 of the table following section B.01.603 of the Food and Drug Regulations, as enacted by section 20 of these Regulations; or In applying subsection (2) to a prepackaged product that is sold by a manufacturer who had gross revenues from sales in Canada of food of less than $1,000,000 for the 12-month period immediately prior to the day on which these Regulations come into force, the reference to “three years” in that subsection shall be read as a reference to “five years”.

(8)

10 parties par million

2 Section C.08.004.1 of the Food and Drug Regulations, as it read immediately before the coming into force of these Regulations, applies to a drug in respect of which a notice of compliance was issued before June 17, 2006.

(9)

0,1 %

12 Sections 1 to 6 and 11 of these Regulations do not apply to cheese that is made before these Regulations come into force.

(10)

100 p.p.m.

17 (1) Every person who, on the day on which these Regulations come into force, fabricates, packages/labels, tests or imports an active pharmaceutical ingredient may continue to do so without an establishment licence if they submit an application for a licence under section C.01A.005 of the Food and Drug Regulations within three months after that day.

(11)

80 p.p.m.

(2)

Subsection (1) applies until the determination of the licence application under section C.01A.008 or C.01A.010 of the Food and Drug Regulations.

(12)

0,2 % de la matière grasse

18 The Food and Drug Regulations, as they read immediately before the coming into force of these Regulations, continue to apply in respect of whole blood and blood components until the day before the day on which subsection 3(2) of the Blood Regulations comes into force.

(13)

0,15 % de boyau

12 If, on the day on which these Regulations come into force, the Director has not yet issued a letter of authorization under subsection C.08.010(1) of the Food and Drug Regulations in response to a request that was made by a practitioner before that day, subsection C.08.010(1.1) of those Regulations, as enacted by section 11, applies in respect of the request.

(14)

Bonnes pratiques industrielles. Les résidus de polysorbate 80 ne doivent pas dépasser 275 p.p.m. dans le produit

13 For the purpose of paragraph 11(2)(a) of the Statutory Instruments Act, these Regulations apply before they are published in the Canada Gazette.

(15)

0,125 %

14 The following definitions apply in sections 15 to 32:

submission means any of the following: (a) a new drug submission that is filed under section C.08.002 of the Food and Drug Regulations; (b) an extraordinary use new drug submission that is filed under section C.08.002.01 of those Regulations; (c) an abbreviated new drug submission that is filed under section C.08.002.1 of those Regulations; or supplement means a supplement to a submission that is filed under section C.08.003 of the Food and Drug Regulations. (supplément)

(16)

0,4 % de la préparation colorante totale

15 Subsection C.01.014.1(2) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to an application for a drug identification number that is made under subsection C.01.014.1(1) of those Regulations before the day on which section 1 comes into force.

(17)

0,4 % de la préparation colorante totale

16 Subsection C.08.002(2), subparagraph C.08.002.01(2)(b)(i) or paragraph C.08.002.1(2)(a) of the Food and Drug Regulations, as the case may be, as the applicable provision read immediately before the day on which section 1 comes into force, applies to a submission that is filed before the day on which section 1 comes into force.

(18)

Bonnes pratiques industrielles. Les résidus de polysorbate 80 ne peuvent dépasser 0,3 % dans le produit fini

17 Section C.08.003 of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to a supplement that is filed before the day on which section 1 comes into force.

(19)

0,25 % PART B Foods

18 If a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued for a drug in respect of an application referred to in section 15 or a submission referred to in section 16, section C.01.014.3 of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

Section B.16.100

Règlement sur les aliments et drogues

19 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug in respect of a submission referred to in section 16, paragraph C.08.002(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

PARTIE B Aliments

20 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations, for a drug in respect of a supplement referred to in section 17, paragraph C.08.003(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

TITRE 16 Additifs alimentaires

21 In sections 22 to 32, drug means a drug for human use in dosage form other than a drug that belongs to one of the following classes:

(b) drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner.

Article B.16.100

22 Section A.01.016 of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of a drug during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

Article | Colonne I | Colonne II | Colonne III

Additifs | Permis dans ou sur | Limites de tolérance P.3 | Monostéarate polyoxyéthylenique (20) de sorbitan Polysorbate 60 | (1) Mélange imitation de crème en poudre; agents de crémage à l’huile végétale; garnitures fouettées à l’huile végétale; mélange pour garnitures à l’huile végétale | (1) 0,4 %. Si l’on emploie aussi le tristearate polyoxyéthylenique (20) de sorbitan, le monostéarate de sorbitan, ou le mono-oléate polyoxyéthylenique (20) de sorbitan, soit séparément, soit ensemble, le total ne doit pas dépasser 0,4 %, sauf que, dans les garnitures fouettées renfermant de l’huile végétale, on peut employer une combinaison de polysorbate (60) et de monostéarate de sorbitan de plus de 0,4 %, si la proportion de polysorbate (60) ne dépasse pas 0,7 % et celle du monostéarate de sorbitan ne dépasse pas 0,27 % de la garniture fouettée renfermant de l’huile végétale | (2) Gâteaux | (2) 0,5 % du poids à l’état sec. Si l’on emploie aussi le tristearate polyoxyéthylenique (20) de sorbitan, le total ne doit pas dépasser 0,5 % du poids sec | (3) Gâteaux; mélanges à gâteaux | (3) 0,5 % du poids à l’état sec. Si l’on emploie aussi le monostéarate de sorbitan ou le mono-oléate polyoxyéthylenique (20) de sorbitan, seuls ou mélangés, le total ne doit pas dépasser 0,5 % du poids à l’état sec | (4) Enrobages de confiserie non normalisés et produits de confiserie moulés non normalisés utilisés comme confiserie ou pour la cuisson | (4) 0,5 %. Si l’on emploie aussi un mélange de l’un quelconque des ingrédients suivants : tristearate polyoxyéthylenique [polyoxyéthylenique (20) de sorbitan, monostéarate de sorbitan ou tristearate de sorbitan, le total ne doit pas dépasser 1,0 % | (5) Glaces à gâteaux; mélange pour glaces à gâteaux | (5) 0,5 % de la glace à gâteau finie. Si l’on emploie aussi le monostéarate de sorbitan ou le mono-oléate polyoxyéthylenique (20) de sorbitan, seuls ou mélangés, le total ne doit pas dépasser 0,5 % de la glace à gâteau finie | (6) Garnitures à tarte; poudings | (6) 0,5 % du poids à l’état sec | (7) Bases pour boissons non normalisées; mélanges pour boissons non normalisées | (7) 0,3 % | (8) Substitut de crème sure (aigre) | (8) 0,3 % | (9) Sauces cuisinées, non normalisées, en conserve; sauces d’assaisonnement non normalisées | (9) 0,3 % | (10) Base de matière grasse pour l’auto-arrosage de la volaille par injection | (10) 0,25 % | (11) Tartinades à sandwich non normalisées; trempettes non normalisées | (11) 0,2 % | (12) Bases ou mélanges secs pour soupes | (12) 250 p.p.m. dans la soupe prête à consommer PART B Foods

23 Section A.01.017 of the Food and Drug Regulations, as enacted by section 2, and section C.01.004.01 of those Regulations, as enacted by subsection 4(1), do not apply in respect of a drug during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

Section B.16.100

Règlement sur les aliments et drogues

24 Paragraph C.01.014.1(2)(m) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to an application for a drug identification number in respect of a drug that is made under subsection C.01.014.1(1) of those Regulations during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

PARTIE B Aliments

25 Paragraph C.08.002(2)(g) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to a submission in respect of a drug that is filed during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

TITRE 16 Additifs alimentaires

26 If a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued for a drug in respect of an application referred to in section 24 or a submission referred to in section 25, section C.01.014.3 of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

Article B.16.100

Colonne I

27 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug in respect of a submission referred to in section 25, paragraph C.08.002(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

Article

Additifs P.4 Polyoxyéthylène (20) Tristéarate de sorbitan; Polysorbate 65 P.5 Stéarate polyoxyéthylenique (8) P.6 Alginate de potassium P.7 Carraghénine potassique P.8 Chlorure de potassium P.9 Citrate de potassium Colonne II Permis dans ou sur

28 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug in respect of a supplement that is filed

during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force, paragraph C.08.003(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

(13)

Mélange sec de pâte à frire d’enrobage

29 Paragraphs C.01.014.1(2)(m.1) and (o) of the Food and Drug Regulations, as enacted by subsection 7(3), do not apply to an application referred to in section 24.

(14)

Cocktails alcoolisés préparés

30 Paragraphs C.08.002(2)(j.1) and (o) of the Food and Drug Regulations, as enacted by subsections 10(3) and (5) respectively, do not apply to a submission referred to in section 25.

(1)

Lait (indication de l’arôme); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait

31 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug, paragraph C.08.003(2)(g.1) of those Regulations, as enacted by subsection 13(3), does not apply in respect of the drug during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

(2)

Crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé; sorbet laitier

32 Subsection C.08.003(3.1) of the Food and Drug Regulations, as enacted by subsection 13(4), does not apply to a supplement referred to in section 28.

former Regulations means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force. (règlement antérieur)

(3)

Desserts congelés non normalisés

(2)

Despite sections 11 to 16, if, on the day immediately before the day on which these Regulations come into force, a saccharin sweetener was sold in accordance with Part E of the former Regulations, the sale of the sweetener may continue in accordance with Part E of the former Regulations for a period of one year beginning on the day on which these Regulations come into force.

(4)

Gâteaux

76 (1) The following definitions apply in this section.

former Regulations means the provisions of the Food and Drug Regulations that are amended or repealed by these Regulations — other than those that are amended or repealed by any of sections 12 or 49 to 56 — as they read immediately before the day on which these Regulations come into force. (règlement antérieur)

(5)

Enrobages de confiserie non normalisés

(2)

Despite these Regulations, a prepackaged product may be labelled in accordance with the former Regulations or these Regulations until the day that is five years after the day on which these Regulations come into force.

(6)

Bases pour boissons non normalisées; mélanges pour boissons non normalisés

11 (1) In this section, fabricate, package/label, import and active pharmaceutical ingredient have the same meaning as in subsection C.01A.001(1) of the Food and Drug Regulations.

(7)

Mélange imitation de crème en poudre; agents de crémage à l’huile végétale; garnitures fouettées à l’huile végétale; mélange pour garniture à l’huile végétale

(2)

Every person who, on or before the day on which section 7, subsections 8(1) and (3) and section 9 of these Regulations come into force, fabricates, packages/labels, tests or imports an active pharmaceutical ingredient for veterinary use may continue to do so without an establishment licence if they submit an application for a licence under section C.01A.005 of the Food and Drug Regulations within 14 months after that day.

(8)

Rafraîchisseurs d’haleine Produits de boulangerie non normalisés Mêmes aliments que pour l’algine Mêmes aliments que pour la carraghénine Aliments non normalisés

(3)

Subsection (2) applies until the determination of the licence application is made under section C.01A.008 or C.01A.010 of the Food and Drug Regulations.

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage Colonne III Limites de tolérance

24 In sections 25 and 26, drug means a drug that is listed in Schedule C to the Food and Drugs Act, that is in dosage form and that was available for sale in Canada before the day on which these Regulations come into force.

(13)

0,5 % du mélange sec

25 (1) Despite these Regulations, if the labels of a drug display information in accordance with one of the following provisions of the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force, that provision continues to apply in respect of the drug:

(a) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force, (i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 24 months after the day on which the final decision on the application is made, and (ii) in the case of any other drug, 12 months after the day on which the final decision on the application is made; and (b) if an application for a drug identification number for the drug is not made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force, (i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 30 months after the day on which these Regulations come into force, and (ii) in the case of any other drug, 18 months after the day on which these Regulations come into force.

(14)

120 p.p.m. dans la boisson prête à consommer

26 (1) Despite these Regulations, subsection C.01.014(2) of the Food and Drug Regulations, as it read immediately before the day on which these Regulations come into force, continues to apply in respect of a drug.

(a) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force and a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued in respect of the drug, on the day on which the document is issued; (b) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force and the final decision on the application is a refusal to issue a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations in respect of the drug, (i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 24 months after the day on which the final decision is made, and (ii) in the case of any other drug, 12 months after the day on which the final decision is made; and (c) in the cases referred to in paragraph 25(2)(b), at the end of the period referred to in subparagraph 25(2)(b)(i) or (ii), as the case may be.

(1)

0,5 %

4 In sections 5 and 6, information in respect of a clinical trial has the same meaning as in section C.08.009.1 of the Food and Drug Regulations.

(2)

0,1 %. Si l’on emploie aussi le mono-oléate polyoxyéthylénique (20) de sorbitan, le total ne doit pas dépasser 0,1 %

5 Despite subsection C.08.009.2(1) of the Food and Drug Regulations, information in respect of a clinical trial that is confidential business information and that is contained in a submission or supplement with respect to which one of the following circumstances occurred before the day on which these Regulations come into force ceases to be confidential business information on the day on which these Regulations come into force:

(a) the Minister issued a notice of compliance under section C.08.004 or C.08.004.01 of the Food and Drug Regulations; (b) the Minister, after having notified the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(1)(b) of the Food and Drug Regulations that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations, issued a notice to the manufacturer, in view of the omission by the manufacturer to amend the submission or supplement, that indicated that the submission or supplement was considered to have been withdrawn; (c) the Minister notified the manufacturer under paragraph C.08.004(3)(b) or C.08.004.01(3)(b) of the Food and Drug Regulations that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations.

(3)

0,1 %

6 (1) This section applies to information in respect of a drug that is confidential business information and that is contained in a submission or supplement

(a) that was filed within 90 days before the day on which these Regulations come into force; and (b) with respect to which the Minister notified the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(1)(b) of the Food and Drug Regulations before the day on which these Regulations come into force that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of the Food and Drug Regulations.

(6)

0,05 % du poids à l’état sec. Si l’on emploie aussi le monostéarate polyoxyéthylénique (20) de sorbitan, le total ne doit pas dépasser 0,5 % du poids de la boisson

(2)

Despite subsection C.08.009.2(1) of the Food and Drug Regulations, information in respect of a clinical trial that is contained in a submission or supplement ceases to be confidential business information upon the expiry of whichever of the following periods applies if the manufacturer does not amend the submission or supplement within that period: (a) 90 days after the day on which these Regulations come into force; or

(7)

0,4 %. Si l’on emploie aussi le monostéarate polyoxyéthylénique (20) de sorbitan, le monostéarate et le mono-oléate polyoxyéthylénique (20) de sorbitan, seuls ou mélangés, le total ne doit pas dépasser 0,4 %

6 Despite these Regulations, beer may, until December 13, 2022, be sold in accordance with the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force.

(8)

200 p.p.m. 0,4 % Mêmes limites de tolérance que pour l’algine Mêmes limites de tolérance que pour la carraghénine

2 Despite these Regulations, vodka may, until December 13, 2022, be sold in accordance with the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force.

(1)

4,0 %, conformément aux articles B.08.041, B.08.041.2, B.08.041.3 et B.08.041.4 Colonne I

18 (1) The following definitions apply in this section and in sections 19 to 30:

authorization means an authorization that was issued under the ISAD Interim Order in respect of a new drug on the basis of (a) an application submitted under section 3 of the ISAD Interim Order other than an application that was submitted on the basis of a direct or indirect comparison of the new drug to another drug; or supplement means a supplement to a new drug submission that is filed under section C.08.003 of the Food and Drug Regulations. (supplément)

Article

Additifs P.10 Furcellaran de potassium P.11 Phosphate dipotassique P.12 Alginate de propylèneglycol P.13 Ether propylèneglycolique de méthylcellulose P.14 Esters monoacides gras de propylèneglycol Colonne II Permis dans ou sur Mêmes aliments que pour le furcellaran

(2)

Unless the context otherwise requires, words and expressions used in this section and in sections 19 to 30 have the meanings assigned by the Food and Drug Regulations.

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

19 (1) Despite subsection 2(1) of the ISAD Interim Order, the manufacturer of a new drug who is the holder of an authorization in respect of the new drug may file a new drug submission under section C.08.002 of the Food and Drug Regulations, or a supplement, for the new drug and subsection C.01.014.1(3) and Division 8 of Part C of those Regulations apply in respect of the submission or supplement.

(1)

Ale; bière; sauce vinaigrette; bière légère; liqueur de malt; cornichons à la moutarde; porter; fromage fondu; fromage fondu (indication de la variété); sauce à salade; crème glacée; mélange pour crème glacée;

(2)

The authorization is revoked if the manufacturer does not file a new drug submission under section C.08.002 of the Food and Drug Regulations, or a supplement, for the new drug within one of the following periods, as applicable: (a) in the case of an authorization that was issued before the day on which this section comes into force, 90 days after the day on which this section comes into force; or (b) in the case of an authorization that is issued on or after the day on which this section comes into force, 90 days after the day on which the authorization is issued.

(3)

Sorbet laitier

(3)

If the manufacturer files a new drug submission under section C.08.002 of the Food and Drug Regulations, or a supplement, for the new drug within the applicable period set out in paragraph (2)(a) or (b), the authorization is revoked when one of the following circumstances occurs: (a) the Minister issues a notice of compliance under section C.08.004 of those Regulations in respect of the submission or supplement; (b) if the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) of those Regulations in respect of the submission or supplement and the manufacturer does not amend the submission or supplement in accordance with subsection C.08.002(4) of those Regulations, the period referred to in subsection C.08.002(4) expires; (c) the Minister issues a notice to the manufacturer under paragraph C.08.004(3)(b) of those Regulations in respect of the submission or supplement.

(4)

Aliments non normalisés

20 The Food and Drug Regulations — other than the following provisions — do not apply to a new drug in respect of which an authorization was issued to the manufacturer of the new drug, if immediately before the day on which this section comes into force, the authorization was neither suspended nor revoked:

(c) the provisions of Divisions 1A and 2 of Part C;

(5)

Margarine réduite en calories

21 (1) The drug identification number that was assigned under subsection 7(1) of the ISAD Interim Order in relation to a new drug that is referred to in section 20 continues to be assigned for the distinct combination of dosage form, strength and route of administration of the new drug.

(6)

Crème sure

(2)

A reference in Divisions 1 and 1A of Part C of the Food and Drug Regulations — other than in sections C.01.050, C.01.052, C.01.053 and C.01A.003 — to a drug identification number is deemed to include a reference to the drug identification number that is referred to in subsection (1).

(7)

Asperges en conserve; haricots jaunes en conserve; haricots verts en conserve; pois en conserve

(3)

A reference in section C.01A.003 of the Food and Drug Regulations to a distributor who holds a drug identification number is deemed to include a reference to the manufacturer who is referred to in section 20.

(8)

Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété) conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés) Mêmes aliments que l’hydroxypropyl méthylcellulose

22 The manufacturer who is referred to in section 20 shall, within 15 days after the day on which the new drug is first sold in Canada, notify the Minister, in writing, of the date of that first sale, unless the manufacturer has already done so under section 8 of the ISAD Interim Order.

(1)

Mélange pour crème glacée

23 The manufacturer who is referred to in section 20 shall, within 15 days after the day on which the manufacturer permanently discontinues the sale in Canada of the new drug, notify the Minister, in writing, of the date on which the sale was permanently discontinued, unless the manufacturer has already done so under section 9 of the ISAD Interim Order.

(2)

Aliments non normalisés Colonne III Limites de tolérance Mêmes limites de tolérance que pour le furcellaran

24 Despite the definition drug in section C.01.014.8 of the Food and Drug Regulations, sections C.01.014.9 and

C.01.014.10 of those Regulations apply, with any necessary modifications, to the manufacturer who is referred to in section 20 in respect of the new drug.

(1)

3,5 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

25 (1) Subject to subsection (2), sections 20 to 24 cease to apply to a new drug that is referred to in section 20 90 days after the day on which this section comes into force.

(1)

Bonnes pratiques industrielles

(2)

If the manufacturer who is referred to in section 20 files, for the new drug, a new drug submission under section C.08.002 of the Food and Drug Regulations or a supplement, within the period referred to in subsection (1) or has filed such a submission or supplement before the day on which this section comes into force, sections 20 to 24 cease to apply to the new drug when one of the circumstances referred to in paragraphs 19(3)(a) to (c) occurs.

(3)

0,75 %

26 (1) Despite subsection 1(3) of the ISAD Interim Order, for the purposes of the definition innovative drug in subsection C.08.004.1(1) of the Food and Drug Regulations, a medicinal ingredient is not considered to be approved in a drug by reason of the Minister having issued or amended an authorization under the ISAD Interim Order in respect of a COVID-19 drug that contains the medicinal ingredient.

(4)

Bonnes pratiques industrielles

(2)

Subsection (1) ceases to apply on the day on which the ISAD Interim Order ceases to have effect.

(5)

0,5 % selon les exigences de l’article B.09.017

27 (1) Any terms and conditions of an establishment licence — other than those that are imposed by the Minister under the ISAD Interim Order — are deemed to be imposed by the Minister under subsection C.01A.008(4) of the Food and Drug Regulations.

(6)

0,5 % selon les exigences de la disposition B.08.077(b)(vii)(A)

(2)

Any terms and conditions of an establishment licence that are imposed by the Minister under the ISAD Interim Order are deemed to be imposed by the Minister under section C.01A.012.1 of the Food and Drug Regulations.

(7)

1,0 % selon les exigences de la disposition B.11.002(d)(viii)(C)

28 (1) Despite subsection 26(1) of the ISAD Interim Order, any establishment licence that is referred to in that subsection is not cancelled immediately before the ISAD Interim Order ceases to have effect if the holder of the establishment licence notifies the Minister in writing,

before the day on which the ISAD Interim Order ceases to have effect, of their intention to continue to conduct activities in respect of the COVID-19 drug under the establishment licence.

(8)

0,5 %, conformément aux exigences des articles B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 et B.08.041.8 Mêmes limites de tolérance que pour l’hydroxypropyl méthylcellulose

(2)

Despite subsection 26(2) of the ISAD Interim Order, any amendment that is referred to in that subsection to an establishment licence continues to have effect after the ISAD Interim Order ceases to have effect if the holder of the establishment licence notifies the Minister in writing, before the day on which the ISAD Interim Order ceases to have effect, of their intention to continue to conduct activities in respect of the COVID-19 drug under the amended establishment licence.

(1)

0,35 % de la crème glacée faite de mélange

29 Information and material in respect of a designated COVID-19 drug that were provided under paragraphs 28(1)(a) and (b) or 30(a) of the ISAD Interim Order are deemed to have been provided under, as the case may be, paragraphs C.08.009.03(1)(a) and (b) or C.08.009.05(a) of the Food and Drug Regulations.

(2)

Bonnes pratiques industrielles PART B Foods

30 Section C.08.009.05 of the Food and Drug Regulations applies, with any necessary modifications, in respect of a designated COVID-19 drug that was imported under section 28 of the ISAD Interim Order.

Section B.16.100

Règlement sur les aliments et drogues

25 (1) In this section, new Regulations means the Food and Drug Regulations as they read on the day on which these Regulations come into force.

PARTIE B Aliments

(2)

A human milk fortifier, as defined in section B.25.001 of the new Regulations, that is set out in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 that is published on a Government of Canada website does not need to be labelled in accordance with the new Regulations if it is labelled in the same way as it was labelled immediately before the day on which these Regulations come into force.

TITRE 16 Additifs alimentaires

(3)

Subsections (1) and (2) cease to have effect on the second anniversary of the day on which these Regulations come into force.

Article B.16.100

Colonne I

9 A person who holds an establishment licence and who created a record in accordance with the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply), made by the Minister of Health on November

27, 2020 and published in Part I of the Canada Gazette on December 12, 2020, must retain the record in accordance with subsection C.01.014.14(2) of the Food and Drug Regulations.

Article

S.1 S.2 S.2A S.3 Colonne II Additifs Pyrophosphate acide de sodium Alginate de sodium Phosphate double d’aluminium et de sodium Carboxyméthylcellulose sodique Permis dans ou sur

10 (1) In this section and in sections 11 to 15, Exceptional Importation and Shortages Interim Order No. 2 means the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health on March 1, 2021 and published in Part I of the Canada Gazette on March 20, 2021.

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner avec indication des ingrédients ajoutés)

(2)

In sections 11 to 15, designated biocide, designated drug, designated food for a special dietary purpose, designated hand sanitizer and designated medical device have the same meaning as in the Exceptional Importation and Shortages Interim Order No. 2.

(1)

Mêmes aliments que pour l’algine

11 (1) Section C.10.008 of the Food and Drug Regulations applies in respect of a designated drug that was imported under the Exceptional Importation and Shortages Interim Order No. 2.

(2)

Gros cristaux de sel

(2)

Sections C.10.009 to C.10.011 of those Regulations apply to a person that holds an establishment licence in respect of a designated drug that they imported under that Interim Order.

(3)

Lustre de poisson congelé

12 (1) Subject to subsection (2), subsections C.10.008(1) and (2) of the Food and Drug Regulations apply in respect of a designated biocide that was imported under the Exceptional Importation and Shortages Interim Order No. 2.

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner avec (indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(2)

For the purposes of subsection (1), that subsection C.10.008(1) is to be read without reference to

(1)

Achards (relish); cornichons à la moutarde; crème; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; sauce à salade; sauce vinaigrette

(3)

Subsection (1) ceases to apply on December 31, 2022 in respect of the sale of a designated biocide, other than at retail sale, that was imported under the Exceptional Importation and Shortages Interim Order No. 2.

(2)

Fromage cottage; fromage cottage en crème; crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

(4)

An importer must not sell a designated biocide that they imported under that Interim Order unless they ensure that the information referred to in paragraph 12(2)(d) of that Interim Order is available in English and French and in a manner that permits the safe use of the biocide.

(3)

Sorbet laitier

(5)

The importer must ensure that the information is available in accordance with subsection (4) until at least the expiration of the period that corresponds to the useful life of whichever of the designated biocides that they imported has the latest useful life.

(4)

Aliments non normalisés

14 (1) Sections A.01.014 and A.01.016 of the Food and Drug Regulations, the provisions of Part B of those Regulations — other than sections B.24.100 and B.24.300 — and the provisions of Part D of those Regulations do not apply in respect of the sale of a designated food for a special dietary purpose that was imported under the Exceptional Importation and Shortages Interim Order No. 2.

(5)

Lustre de poisson congelé

(2)

A sale of a designated food for a special dietary purpose that was imported under the Interim Order is exempt from paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the use or presence of any of the substances or materials referred to in paragraphs 24(2)(a) to (g) of that Interim Order.

(6)

Fromage (indication de la variété) fondu; fromage (indication de la variété) fondu (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés)

(3)

Subsections (1) and (2) cease to apply in respect of the sale of a designated food for a special dietary purpose on the food’s expiration date.

(7)

Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec Colonne III Limites de tolérance

(4)

An importer must not sell a designated food for a special dietary purpose that they imported under the Exceptional Importation and Shortages Interim Order No. 2 unless they ensure that the information referred to in subparagraphs 25(2)(c)(ii) to (vi) of that Interim Order is available in English and French and in a manner that permits the safe preparation and use of the food.

(1)

3,5 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(5)

The importer shall ensure that the information is available in accordance with subsection (4) until at least the end of the day on the latest expiration date of the food. designated food for a special dietary purpose that they imported.

(1)

Mêmes limites de tolérance que pour l’algine

(6)

In this section, expiration date has the same meaning as in section B.25.001 of the Food and Drug Regulations.

(2)

1,5 p.m.

15 A person who, immediately before the Exceptional Importation and Shortages Interim Order No. 2 ceased to have effect, was permitted, under subsection 30(2) of that Interim Order, to conduct an activity in respect of a designated hand sanitizer may continue to do so without holding an establishment licence that authorizes them to do so until the earliest of

(a) the occurrence of one of the circumstances referred to in paragraphs 30(2)(a) to (c) of that Interim Order, and (b) September 1, 2023.

(3)

Bonnes pratiques industrielles

10 (1) Unless the context requires otherwise, words and expressions used in this section have the same meaning as in subsection C.01A.001(1) of the Food and Drug Regulations.

(1)

3,5 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(2)

Subject to subsection (3), during the three-month period that begins on the day on which these Regulations come into force, a drug that has, until that day, been exempt, under subsection 37(1) of the Act, from the provisions prescribed in section A.01.048 of the Food and Drug Regulations and that continues to meet the conditions set out in subsection 37(1) (a) may, despite section C.01A.004 of those Regulations, continue to be fabricated, packaged/labelled, tested, distributed or wholesaled by a person that conducted the activity before that day and that does not hold an establishment licence that authorizes the activity in respect of the drug; and (b) is exempt from the provisions of Divisions 2 to 4 of Part C of those Regulations that are prescribed in section A.01.048.

(1)

Bonnes pratiques industrielles

(3)

If, before the end of the three-month period, a person referred to in paragraph (2)(a) submits — in accordance with section C.01A.005 or C.01A.006 of the Food and Drug Regulations — an application for, or to amend, an establishment licence to authorize the activity that they have been conducting in respect of the drug, the person is, in respect of the activity, exempt from the requirement to hold an establishment licence and from the provisions referred to in paragraph (2)(b) until the Minister of Health (b) notifies the person, after giving them the opportunity to be heard, that the licence will not be issued or amended.

(2)

0,5 %

(4)

The exemptions referred to in subsection (3) cease to apply if the person withdraws the application.

(3)

0,75 %

53 (1) The following definitions apply in this section.

former Regulations means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force. (ancien règlement)

(4)

Bonnes pratiques industrielles

(2)

A prepackaged product is not required to be labelled in accordance with the following provisions of the Food and Drug Regulations if the product is labelled in accordance with the former Regulations and no change has been made to the label of the product to bring the product into compliance with any of the following provisions:

(5)

Bonnes pratiques industrielles

(3)

A prepackaged product is not required to be labelled in accordance with the following provisions of the Food and Drug Regulations if it is labelled in accordance with the former Regulations and no change has been made to the label of the product to bring the product into compliance with any of the following provisions:

(6)

0,5 %

(4)

A prepackaged product is not required to be labelled in accordance with the following provisions of the Food and Drug Regulations if it is labelled in accordance with the former Regulations and no change has been made to the label of the product to bring the product into compliance with any of the following provisions:

(7)

0,5 %, conformément aux exigences des articles B.08.035, B.08.037, B.08.038, B.08.039, Colonne I

(5)

A food to which any of the following provisions of the Food and Drug Regulations applies is not required to contain an amount of vitamin D that complies with the requirement set out in the provision if the food contains an amount of vitamin D that complies with the requirement set out in the provision of the former Regulations: (q) subparagraph B.09.016(b)(iii), including as it applies to calorie-reduced margarine.

Article

Additifs S.4 Carraghénine sodique S.5 Glycolate sodique de cellulose S.6 Citrate de sodium S.7 Furcellaran sodique S.8 Gluconate de sodium S.9 Hexamétaphosphate de sodium Colonne II Permis dans ou sur Mêmes aliments que pour la carraghénine Mêmes aliments que pour le carboxyméthylcellulose sodique

(6)

For the purposes of the prohibitions set out in section B.08.029 of the Food and Drug Regulations, a food is not required to contain the amount of vitamin D set out in the applicable subsection of that section if the food contains an amount of vitamin D that falls within the range set out in the subsection of the former Regulations.

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(7)

This section ceases to have effect on December 31, 2025.

(2)

Lait évaporé; lait écrémé évaporé ou lait écrémé concentré; lait évaporé partiellement écrémé ou lait concentré partiellement écrémé

31 (1) The following definitions apply in this section and sections 32 to 36.

Threshold Levels for Cautionary Statements and Other Conditions of Use means the document entitled Threshold Levels for Cautionary Statements and Other Conditions of Use, published by the Government of Canada on its website, as it reads on the day on which these Regulations come into force. (Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation) TMAL Lists means one or more of the following lists, published by the Government of Canada on its website, as they read on the day on which these Regulations come into force: (b) the List of caffeinated energy drinks; (c) the List of traditional ales. (Listes LAMT) (b) the List of caffeinated energy drinks; and (c) the List of conventional foods. (Listes LAMT)

(3)

Crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

(2)

Unless the context requires otherwise, words and expressions used in this section and sections 32 to 36 have the same meaning as in the Food and Drugs Act and the Food and Drug Regulations.

(4)

Sorbet laitier Mêmes aliments que pour le furcellaran

32 (1) Subject to section 35, the manufacturer of a food for which a Temporary Marketing Authorization Letter was issued under subsection B.01.054(1) of the Food and Drug Regulations and for which a Temporary Marketing Authorization number is set out in the TMAL Lists is exempt from the application of the Food and Drug Regulations in respect of the food if the following conditions are met:

(a) when the Letter expired, the food was not the subject of an outstanding request that it be withdrawn from the market; and (b) since the expiration of the Letter, (i) subject to subsection (2), the manufacturer has complied with the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force, except any provision set out in Appendix 1 to the Letter with which the food does not need to comply, (ii) the manufacturer has complied with the following conditions set out in Appendix 1 to the Letter, as applicable: (A) there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women, (B) the food contains the substances referred to in Appendix 2 to the Letter in the amounts set out in that Appendix, (C) the statements set out in Appendix 1 to the Letter, or statements with equivalent meaning, are shown on the label of the food, (D) no claims are made on the label of the food relating to physical performance or health benefits of the food, and (E) the conditions set out in Appendix 3 to the Letter are complied with, and (iii) no substance set out in column 1 of the List of Permitted Supplemental Ingredients has been added to the food, with the exception of a substance (A) set out in Appendix 2 to the Letter, or (B) used as a food additive to which a marketing authorization applies.

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(2)

The manufacturer may, in respect of the food referred to in subsection (1), comply with the provisions of the Food and Drug Regulations that were amended by sections 1 to 11, 13 to 48, and 57 to 75 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours), as they read on December 13, 2016.

(2)

Cornichons à la moutarde; achards (relish);

33 (1) Subject to section 35, if a manufacturer of a food has submitted a request for a Temporary Marketing Authorization Letter for the food before the day on which these Regulations come into force and a Temporary Marketing Authorization Letter has not been issued under subsection B.01.054(1) of the Food and Drug Regulations before that day, the manufacturer is exempt from the application of the Food and Drug Regulations in respect of the food if the following conditions are met:

(a) the Minister notifies the manufacturer, in accordance with subsection (2), that the sale of the food is authorized; (b) subject to subsections (3) and (4), the manufacturer complies with the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force; (c) no substance set out in column 1 of the List of Permitted Supplemental Ingredients has been added to the food, with the exception of a substance (i) contained in the food in the amount specified in the request in response to which the Minister has issued a notice referred to in paragraph (a), or (ii) used as a food additive to which a marketing authorization applies; (d) with respect to a food, other than a food referred to in paragraphs (f) and (g), if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a food additive to which a marketing authorization applies — and the total amount of that substance contained in the food is equal to or above the thresholds set out in columns 2 to 6 of the table for that substance, the label of the food carries the applicable cautionary statements set out in the headings to columns 2 to 6 of that table or statements with equivalent meaning; (e) if the cautionary statement “Not intended for children”, “For adults only” or “If you are pregnant or breastfeeding consult a Health Care Practitioner prior to use”, or a statement with equivalent meaning, appears on the label of the food, there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women, as the case may be; (f) with respect to a food that is a beverage that contains added caffeine and has a total amount of caffeine of more than 200 parts per million, the label of the food carries the following cautionary statements or statements with equivalent meaning: (i) if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a food additive to which a marketing authorization applies — and the total amount of that substance contained in the food is equal to or above the threshold level set out in column 8 for that substance, the applicable cautionary statement set out in the heading to column 8 of that table or a statement with equivalent meaning, and (ii) the cautionary statements set out in the headings to columns 2 to 4 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use or statements with equivalent meaning; (g) with respect to a food that contains added caffeine, other than a food referred to in paragraph (f), the label of that food carries the following cautionary statements or statements with equivalent meaning: (i) if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a food additive to which a marketing authorization applies — and the total amount of that substance contained in the food is equal to or above the threshold level set out in column 8 for that substance, the applicable cautionary statement set out in the heading to column 8 of that table or a statement with equivalent meaning, and (ii) the cautionary statements set out in the headings to columns 2 to 4 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use or statements with equivalent meaning. amount of that substance contained in the food is equal to or above the thresholds set out in columns 2 to 6 for that substance, the applicable cautionary statements set out in the headings to columns 2 to 6 of that table or statements with equivalent meaning, and (ii) if the total amount of caffeine contained in the food is equal to or above the thresholds set out in columns 2 to 4 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the food belongs, the applicable cautionary statements set out in the headings to columns 2 to 4 of the table to Part II or statements with equivalent meaning; (h) with respect to a food referred to in paragraph (f) or (g), the manufacturer complies with the conditions of use set out in column 6 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the food belongs; and (i) if the cautionary statement “Not recommended for children, pregnant or breastfeeding women and individuals sensitive to caffeine,” or a statement with equivalent meaning, appears on the label of the food, there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women.

(3)

Préparations pour nourrissons

(2)

The Minister must provide written notification to the manufacturer that the sale of the food is authorized if (a) the manufacturer submits to the Minister (i) the information referred to in subparagraphs B.01.054(1)(a)(i) to (vii) of the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force, and (ii) any other information requested by the Minister to assess the information referred to in subparagraph (i); and (b) the food belongs to a food category set out in column 1 of the List of Permitted Supplemented Food Categories; (c) in the case where a substance set out in column 1 of the table to Part I to the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food, the total amount of that substance contained in the food does not exceed the maximum daily level set out in column 7 or 9 of Part I of the table for that substance; and (d) in the case where caffeine has been added to the food, the total amount of caffeine contained in the food does not exceed the maximum level per serving set out in column 5 of the table to Part II to the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category to which the food belongs.

(4)

Sorbet laitier Colonne III Limites de tolérance Mêmes limites de tolérance que pour la carraghénine Mêmes limites de tolérance que pour le carboxyméthylcellulose sodique

(3)

The manufacturer need not, in respect of the food referred to in subsection (1), comply with the following provisions of the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force: (i) in respect of caffeine that has been added to the food for a use other than a use set out in columns 2 to 4 of item C.1 of the List of Permitted Food Additives with Other Accepted Uses, published by the Government of Canada on its website, as amended from time to time, or (ii) in respect of an extraction solvent that has been used in the manufacturing of an extract that has been added to the food other than as a flavouring; (b) section B.01.045, in respect of caffeine that has been added to the food and that does not meet the specifications set out in the Food Chemicals Codex, tenth edition, 2016, published by the United States Pharmacopeial Convention, Rockville, MD, United States of America, as that or any subsequent edition, including their supplements, may be amended from time to time;

(1)

4,0 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2 et B.08.041.8

(4)

The manufacturer may, in respect of the food referred to in subsection (1), comply with the provisions of the Food and Drug Regulations that were amended by sections 1 to 11, 13 to 48 and 57 to 75 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours), as they read on December 13, 2016.

(2)

0,1 % seul ou associé à du phosphate disodique

(5)

For greater certainty, the notification referred to in paragraph (1)(a) cannot be a Temporary Marketing Authorization Letter issued under subsection B.01.054(1) of the Food and Drug Regulations.

(3)

0,5 %

34 A manufacturer that is exempted under section 32(1) or subsection 33(1) is also exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect only of a substance set out in column 1 of the List of Permitted Supplemental Ingredients that has been added to the food.

(4)

0,75 % Mêmes limites de tolérance que pour le furcellaran

35 A manufacturer is not exempted under subsection 32(1) or subsection 33(1) in respect of the food referred to in subsection 32(1) or subsection 33(1), as the case may be, if the Minister notifies the manufacturer, in writing, that the Minister has reasonable grounds to believe that the use of the food is detrimental to the health of the consumer.

(1)

4,0 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2 et B.08.041.8

36 Sections 32 to 35 cease to have effect on December 31, 2025.

(2)

Bonnes pratiques industrielles

76 The Food and Drug Regulations¹ are amended by adding the following after section A.01.068:

Non-application A.01.069 These Regulations do not apply to a drug referred to in paragraph (b) or (c) of the definition biocide in subsection 1(1) of the Biocides Regulations.

(3)

0,05 % de la préparation pour nourrissons prête à consommer

77 Subsection C.01.004.02(6) of the Regulations is amended by adding “and” at the end of paragraph (a), by striking out “and” at the end of paragraph (b) and by repealing paragraph (c).

(4)

0,75 % Colonne I

78 Paragraphs C.01.014.1(2)(c) and (d) of the Regulations are replaced by the following:

(c) the recommended route of administration;

Article

S.11 S.12 Additifs Phosphate disodique Phosphate monosodique Colonne II Permis dans ou sur

79 Subsection C.01.040.2(5) of the Regulations is repealed.

(5)

Aliments non normalisés

80 The definition antimicrobial agent in subsection C.01A.001(1) of the Regulations is repealed.

(6)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

81 Subsection C.01A.002(1) of the Regulations is amended by adding “and” at the end of paragraph (c), by striking out “and” at the end of paragraph (d) and by repealing paragraph (e).

(7)

Mélange de poisson et de viande préparés visé à l’alinéa B.21.006h)

82 Section C.02.002.1 of the Regulations is repealed.

¹ C.R.C., c. 870

(1)

Achards (relish); cornichons à la moutarde; lait écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé additionné de solides du lait (indication de l’arôme); lait condensé écrémé; lait condensé écrémé additionné de solides du lait; lait condensé partiellement écrémé; lait condensé partiellement écrémé additionné de solides du lait; fromage cottage en crème

1 Section C.01.051 of the Food and Drug Regulations and the heading before it are replaced by the following:

Recall Reporting C.01.051 (1) If a manufacturer who sells a drug in dosage form or an active ingredient or a person who imports into and sells a drug in dosage form or an active ingredient in Canada decides to recall any of those drugs without being ordered to do so by the Minister, the manufacturer or importer shall, within 24 hours after making the decision, provide the Minister with the following information in writing: (a) the drug’s proper name or the common name, if there is no proper name; (b) an indication as to whether the drug is a drug in dosage form or an active ingredient; (c) in the case of a drug in dosage form, (v) the names of the persons in Canada, other than consumers that purchased the drug at the retail level, to whom the drug was sold by the manufacturer or importer and the quantity sold to each of the named persons, and (vi) an assessment of the effect that the recall may have on the manufacturer’s or importer’s ability to meet demand for the drug in Canada; (g) the quantity of the drug that was fabricated in Canada; (h) the quantity of the drug that was imported; C.R.C., c. 870 (i) the quantity of the drug that the manufacturer or importer sold to persons in Canada and the period during which it was sold; (j) the quantity of the drug that the manufacturer or importer exported, as well as the quantity exported, by country; (k) the quantity of the drug in Canada that is in the possession or control of the manufacturer or importer; (l) an assessment of the risk of injury to human health posed by the drug, including because of a failure of its effectiveness; (m) the names and civic addresses of the manufacturer and fabricator of the drug and of any importers of the drug; (n) the name and contact information of the individual who is responsible for the recall; (o) the expected dates for the start and completion of the recall; and (p) the reasons for the recall and the date on which and manner in which the situation that prompted the recall was discovered. (a) before starting the recall, provide the Minister with a copy of any communications that the manufacturer or importer intends to use in connection with the start of the recall; and (b) after starting the recall, provide the Minister, on request and within the time specified by the Minister, with a copy of any additional communications that the manufacturer or importer uses, or intends to use, in connection with the recall.

(3)

Lait évaporé; lait écrémé évaporé ou lait écrémé concentré; lait évaporé partiellement écrémé ou lait concentré partiellement écrémé

(3)

The manufacturer or importer shall, within 72 hours after making the decision to recall the drug, provide the Minister with the following information in writing: (a) the strategy for conducting the recall, including the time and manner in which the Minister will be informed of the progress of the recall; and (b) a description of the measures that are intended to be taken to prevent a recurrence of the situation that prompted the recall.

(4)

Crème sure

(4)

The manufacturer or importer shall, within 30 days after completing the recall, provide the Minister with the following information in writing: (a) the results of the recall; and (b) a description of the measures that have been or will be taken to prevent a recurrence of the situation that prompted the recall.

(5)

Aliments non normalisés

(5)

In this section and in section C.01.051.1, active ingredient and fabricate have the same meaning as in subsection C.01A.001(1). C.01.051.1 (1) A person who is ordered by the Minister under section 21.3 of the Act to recall a drug in dosage form, or an active ingredient, shall provide the Minister with the following information in the time and manner specified by the Minister: (a) the quantity of the drug that has been sold by the person at the retail level to consumers in Canada; (b) if the person has sold the drug to persons in Canada other than consumers referred to in paragraph (a), (i) the names of those persons and the quantity that has been sold to each of them, and (ii) the period during which the drug was sold to those persons; (c) the quantity of the drug that the person has exported from Canada, as well as the quantity exported by country; (e) the name, title and contact information of an individual from whom the Minister may obtain additional information concerning the recall; (f) the strategy for conducting the recall; (g) any other information that the Minister has reasonable grounds to believe is necessary to mitigate the risk of injury to human health; and (h) if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they intend to take to prevent a recurrence.

(6)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Colonne III Limites de tolérance

(2)

The person shall notify the Minister without delay of any change to the information referred to in paragraph (1)(e). (a) before starting the recall, provide the Minister with a copy of any communications that the person intends to use in connection with the start of the recall; and (b) after starting the recall, provide the Minister with, on request and within the time specified by the Minister, a copy of any additional communications that the person uses, or intends to use, in connection with the recall.

(5)

Bonnes pratiques industrielles

(4)

The person shall notify the Minister in writing, within 24 hours, of the start and completion of the recall.

(6)

3,5 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(5)

The person shall, within 30 days after completing the recall, provide the Minister with the following information in writing: (a) the results of the recall; and (b) if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they have taken or will take to prevent a recurrence.

(7)

0,1 %

3 Paragraph C.02.012(1)(a) of the French version of the Regulations is replaced by the following:

(1)

Bonnes pratiques industrielles

5 (1) Subsection C.02.022(1) of the French version of the Regulations is replaced by the following:

(3)

0,1 % seul ou associé à du citrate de sodium

(2)

The portion of subsection C.02.022(2) of the French version of the Regulations before paragraph (a) is replaced by the following:

(4)

0,05 % selon les exigences de la disposition B.08.077b)(viii)(C)

(5)

Bonnes pratiques industrielles

(6)

3,5 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4 PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

S.13 S.14 S.15 S.15A Additifs Phosphate trisodique Tartrate double de potassium et de sodium Pyrophosphate tétrasodique Stéaroyl-2-lactylate de sodium Colonne II Permis dans ou sur

(2)

Aliments non normalisés

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(2)

Aliments non normalisés

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(2)

Aliments non normalisés

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(2)

Aliments non normalisés

(3)

Mélange de poisons et de viande préparés visé à l’alinéa B.21.006n)

(1)

Glaces et mélanges à glaces

(2)

Garnitures et mélanges pour garnitures

(3)

Poudings et mélanges à poudings

(4)

Substituts de crème sûre (aigre)

(5)

Agents de crèmeage de l’huile végétale

(6)

Mélange de pâte à frire

(7)

Spiritueux à base de crème non normalisés

(8)

Sauce à salade; sauce vinaigrette Colonne III Limites de tolérance

(2)

Bonnes pratiques industrielles

(1)

3,5 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(2)

Bonnes pratiques industrielles

(1)

4,0 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(2)

Bonnes pratiques industrielles

(1)

3,5 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(2)

Bonnes pratiques industrielles

(3)

0,4 % du poids des ingrédients secs

(1)

0,4 % du poids des ingrédients secs

(2)

0,4 % du poids des ingrédients secs

(3)

0,4 % du poids des ingrédients secs

(4)

0,4 % du poids des ingrédients secs

(5)

0,4 % du poids des ingrédients secs

(6)

0,75 % du poids des ingrédients secs

(7)

0,35 % du poids du produit fini

(8)

0,4 % du poids du produit fini 432 À jour au 11 novembre 2024 Dernière modification le 17 juin 2024 PART B Foods

Section B.16.100

Colonne I

Article

Additifs S.16 Tartrate de sodium S.16A Tripolyphosphate de sodium S.18 Monostéarate de sorbitan Colonne II Permis dans ou sur

(9)

Soupes

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n)

(1)

Mélange imitation de crème en poudre; agents de crémage à l’huile végétale; garnitures fouettées à l’huile végétale; mélange pour garnitures à l’huile végétale

(2)

Gâteaux; mélanges à gâteaux

(3)

Enrobages de confiserie non normalisés et produits de confiserie moulés non normalisés utilisés comme confiserie ou pour la cuisson

(4)

Glaces à gâteaux; mélanges pour glaces à gâteaux

(5)

Bases pour boissons non normalisées; mélanges pour boissons non normalisés Colonne III Limites de tolérance

(9)

0,2 % du produit fini

(1)

4,0 %, conformément aux exigences articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4 0,1 %

(1)

0,4 %. Si l’on emploie aussi le stéarate polyoxyéthylène (20) de sorbitan, le polysorbate (60) ou le mono-oléate polyoxyéthylénique (20) de sorbitan, soit séparément, soit ensemble, le total ne doit pas dépasser 0,4 %, et si la proportion de monostéarate de sorbitan ne dépasse pas 0,27 % et celle du polysorbate (60) ne dépasse pas 0,77 % du poids de la garniture fouettée renfermant de l’huile végétale

(2)

0,6 % du poids à l’état sec. Si l’on emploie aussi le monostéarate polyoxyéthylénique (20) de sorbitan le total ne doit pas dépasser 0,7 % du poids à l’état sec

(3)

1,0 %. Si l’on emploie aussi un mélange de l’un quelconque des stéarates polyoxyéthyléniques (20) de sorbitan, trisorbate (20) de sorbitan, trisorbate (20) de sorbitan, le total ne doit pas dépasser 1,0 % du poids à l’état sec

(4)

0,5 %. Si l’on emploie aussi le mono-oléate polyoxyéthylénique (20) de sorbitan, le total ne doit pas dépasser 0,5 % du poids à l’état sec

(5)

0,4 %. Si l’on emploie aussi le monostéarate polyoxyéthylénique (20) Colonne I

Article

Additifs S.18A Trioléate de sorbitan S.18B Tristéarate de sorbitan S.19 Monoglycéryl-citrate de stéaryle S.20 Esters saccharosiques d’acides gras T.2 [Abrogé, DORS/2006-91, art. 5] T.3 Gomme adragante --- Colonne II Permis dans ou sur Boyaux de saucisse

(1)

Margarine; shortening

(2)

Enrobages de confiserie non normalisés et produits de confiserie moulés non normalisés utilisés comme confiserie ou pour la cuisson

(3)

Mélange pour crème glacée

(4)

Desserts congelés non normalisés Shortening

(1)

Préparations colorantes de caroténoïdes

(2)

Confiseries non normalisées; enrobages de confiserie non normalisés

(1)

Sauce vinaigrette; cornichons à la moutarde; sauce à salade; achards (relish)

(2)

Fromage cottage; fromage cottage en crème; crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

(3)

Sorbet laitier

(4)

Caviar de lump

(5)

Aliments non normalisés

(6)

Margarine réduite en calories

(7)

Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété) conditionné à froid (avec indication des ingrédients ajoutés) --- Colonne III Limites de tolérance 0,35 % de boyau

(1)

1 %

(2)

1 %, si l’on emploie aussi un mélange d’un ou plusieurs des ingrédients suivants : monostéarate de sorbitan, tristearate polyoxyéthylénique (20) de sorbitan, tristearate ou monostéarate de sorbitan, le total ne doit pas dépasser 1 %

(3)

0,035 % de la crème glacée faite du mélange

(4)

0,035 % Bonnes pratiques industrielles

(1)

1,5 %

(2)

0,5 %

(1)

Bonnes pratiques industrielles

(2)

0,5 %

(3)

0,75 %

(4)

1,0 %

(5)

Bonnes pratiques industrielles

(6)

0,5 % selon les exigences de l’article B.08.019

(7)

0,5 %, selon les exigences aux exigences des articles B.08.035, B.08.036, B.08.037, B.08.041.1 et B.08.041.6 PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs

X

1 Gomme xanthane Colonne II Permis dans ou sur ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(8)

Poisson et viande préparés déchiquetés, sauf le caviar de lompe; poisson de salaison et chair de poisson de salaison déchiquetés (Titre 21)

(1)

Sauce vinaigrette; sauce à salade; aliments non normalisés

(2)

Fromage cottage; fromage cottage en crème

(3)

Margarine réduite en calories

(4)

Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage (indication de la variété) conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

(5)

Cornichons à la moutarde; achards (relish)

(6)

Mélange pour crème glacée

(7)

Mélange pour lait glacé

(8)

Sorbet laitier

(9)

Crème à fouetter thermisée à une chaleur supérieure à 100 °C Colonne III Limites de tolérance

(8)

0,75 %

(1)

Bonnes pratiques industrielles

(2)

0,5 %. Si l’on emploie aussi d’autres stabilisants, le total ne doit pas dépasser 0,5 %

(3)

0,5 % selon les exigences de l’article B.09.017

(4)

0,5 %. Conformément aux exigences des articles B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.8 et B.08.041.7 et B.08.041.8

(5)

0,1 %

(6)

0,1 %. Si l’on emploie aussi de la cellulose microcristalline et d’autres stabilisants, le total ne doit pas dépasser 0,5 %

(7)

0,1 %. Si l’on emploie aussi d’autres stabilisants, le total ne doit pas dépasser 0,75 %

(8)

0,1 %. Si l’on emploie aussi d’autres stabilisants, le total ne doit pas dépasser 0,75 %

(9)

0,02 % SOR/78-403, ss. 5(F) to 13(F), 14 to 16, 17(F) to 21(F); SOR/86-656, ss. 1, 14, 16; SOR/87-786, s. 2; SOR/89-650, ss. 10 to 15; SOR/93-72, s. 2; SOR/94-785, s. 4; SOR/98-481, ss. 7 to 10; SOR/98-482, ss. 4, 5; SOR/98-483, s. 2; SOR/98-484, s. 2; SOR/98-485, s. 2; SOR/98-486, s. 2; SOR/98-487, s. 2; SOR/98-488, s. 2; SOR/98-489, s. 2; SOR/98-490, s. 2; SOR/98-491, s. 2; SOR/98-492, s. 2; SOR/98-493, s. 2; SOR/98-494, s. 2; SOR/98-495, s. 2; SOR/98-496, s. 2; SOR/98-497, s. 2; SOR/98-498, s. 2; SOR/98-499, s. 2; SOR/98-500, s. 2; SOR/98-501, s. 2; SOR/98-502, s. 2; SOR/98-503, s. 2; SOR/98-504, s. 2; SOR/98-505, s. 2; SOR/98-506, s. 2; SOR/98-507, s. 2; SOR/98-508, s. 2; SOR/98-509, s. 2; SOR/98-510, s. 2; SOR/98-511, s. 2; SOR/98-512, s. 2; SOR/98-513, s. 2; SOR/98-514, s. 2; SOR/98-515, s. 2; SOR/98-516, s. 2; SOR/98-517, s. 2; SOR/98-518, s. 2; SOR/98-519, s. 2; SOR/98-520, s. 2; SOR/98-521, s. 2; SOR/98-522, s. 2; SOR/98-523, s. 2; SOR/98-524, s. 2; SOR/98-525, s. 2; SOR/98-526, s. 2; SOR/98-527, s. 2; SOR/98-528, s. 2; SOR/98-529, s. 2; SOR/98-530, s. 2; SOR/98-531, s. 2; SOR/98-532, s. 2; SOR/98-533, s. 2; SOR/98-534, s. 2; SOR/98-535, s. 2; SOR/98-536, s. 2; SOR/98-537, s. 2; SOR/98-538, s. 2; SOR/98-539, s. 2; SOR/98-540, s. 2; SOR/98-541, s. 2; SOR/98-542, s. 2; SOR/98-543, s. 2; SOR/98-544, s. 2; SOR/98-545, s. 2; SOR/98-546, s. 2; SOR/98-547, s. 2; SOR/98-548, s. 2; SOR/98-549, s. 2; SOR/98-550, s. 2; SOR/98-551, s. 2; SOR/98-552, s. 2; SOR/98-553, s. 2; SOR/98-554, s. 2; SOR/98-555, s. 2; SOR/98-556, s. 2; SOR/98-557, s. 2; SOR/98-558, s. 2; SOR/98-559, s. 2; SOR/98-560, s. 2; SOR/98-561, s. 2; SOR/98-562, s. 2; SOR/98-563, s. 2; SOR/98-564, s. 2; SOR/98-565, s. 2; SOR/98-566, s. 2; SOR/98-567, s. 2; SOR/98-568, s. 2; SOR/98-569, s. 2; SOR/98-570, s. 2; SOR/98-571, s. 2; SOR/98-572, s. 2; SOR/98-573, s. 2; SOR/98-574, s. 2; SOR/98-575, s. 2; SOR/98-576, s. 2; SOR/98-577, s. 2; SOR/98-578, s. 2; SOR/98-579, s. 2; SOR/98-580, s. 2; SOR/98-581, s. 2; SOR/98-582, s. 2; SOR/98-583, s. 2; SOR/98-584, s. 2; SOR/98-585, s. 2; SOR/98-586, s. 2; SOR/98-587, s. 2; SOR/98-588, s. 2; SOR/98-589, s. 2; SOR/98-590, s. 2; SOR/98-591, s. 2; SOR/98-592, s. 2; SOR/98-593, s. 2; SOR/98-594, s. 2; SOR/98-595, s. 2; SOR/98-596, s. 2; SOR/98-597, s. 2; SOR/98-598, s. 2; SOR/98-599, s. 2; SOR/98-600, s. 2; SOR/98-601, s. 2; SOR/98-602, s. 2; SOR/98-603, s. 2; SOR/98-604, s. 2; SOR/98-605, s. 2; SOR/98-606, s. 2; SOR/98-607, s. 2; SOR/98-608, s. 2; SOR/98-609, s. 2; SOR/98-610, s. 2; SOR/98-611, s. 2; SOR/98-612, s. 2; SOR/98-613, s. 2; SOR/98-614, s. 2; SOR/98-615, s. 2; SOR/98-616, s. 2; SOR/98-617, s. 2; SOR/98-618, s. 2; SOR/98-619, s. 2; SOR/98-620, s. 2; SOR/98-621, s. 2; SOR/98-622, s. 2; SOR/98-623, s. 2; SOR/98-624, s. 2; SOR/98-625, s. 2; SOR/98-626, s. 2; SOR/98-627, s. 2; SOR/98-628, s. 2; SOR/98-629, s. 2; SOR/98-630, s. 2; SOR/98-631, s. 2; SOR/98-632, s. 2; SOR/98-633, s. 2; SOR/98-634, s. 2; SOR/98-635, s. 2; SOR/98-636, s. 2; SOR/98-637, s. 2; SOR/98-638, s. 2; SOR/98-639, s. 2; SOR/98-640, s. 2; SOR/98-641, s. 2; SOR/98-642, s. 2; SOR/98-643, s. 2; SOR/98-644, s. 2; SOR/98-645, s. 2; SOR/98-646, s. 2; SOR/98-647, s. 2; SOR/98-648, s. 2; SOR/98-649, s. 2; SOR/98-650, s. 2; SOR/98-651, s. 2; SOR/98-652, s. 2; SOR/98-653, s. 2; SOR/98-654, s. 2; SOR/98-655, s. 2; SOR/98-656, s. 2; SOR/98-657, s. 2; SOR/98-658, s. 2; SOR/98-659, s. 2; SOR/98-660, s. 2; SOR/98-661, s. 2; SOR/98-662, s. 2; SOR/98-663, s. 2; SOR/98-664, s. 2; SOR/98-665, s. 2; SOR/98-666, s. 2; SOR/98-667, s. 2; SOR/98-668, s. 2; SOR/98-669, s. 2; SOR/98-670, s. 2; SOR/98-671, s. 2; SOR/98-672, s. 2; SOR/98-673, s. 2; SOR/98-674, s. 2; SOR/98-675, s. 2; SOR/98-676, s. 2; SOR/98-677, s. 2; SOR/98-678, s. 2; SOR/98-679, s. 2; SOR/98-680, s. 2; SOR/98-681, s. 2; SOR/98-682, s. 2; SOR/98-683, s. 2; SOR/98-684, s. 2; SOR/98-685, s. 2; SOR/98-686, s. 2; SOR/98-687, s. 2; SOR/98-688, s. 2; SOR/98-689, s. 2; SOR/98-690, s. 2; SOR/98-691, s. 2; SOR/98-692, s. 2; SOR/98-693, s. 2; SOR/98-694, s. 2; SOR/98-695, s. 2; SOR/98-696, s. 2; SOR/98-697, s. 2; SOR/98-698, s. 2; SOR/98-699, s. 2; SOR/98-700, s. 2; SOR/98-701, s. 2; SOR/98-702, s. 2; SOR/98-703, s. 2; SOR/98-704, s. 2; SOR/98-705, s. 2; SOR/98-706, s. 2; SOR/98-707, s. 2; SOR/98-708, s. 2; SOR/98-709, s. 2; SOR/98-710, s. 2; SOR/98-711, s. 2; SOR/98-712, s. 2; SOR/98-713, s. 2; SOR/98-714, s. 2; SOR/98-715, s. 2; SOR/98-716, s. 2; SOR/98-717, s. 2; SOR/98-718, s. 2; SOR/98-719, s. 2; SOR/98-720, s. 2; SOR/98-721, s. 2; SOR/98-722, s. 2; SOR/98-723, s. 2; SOR/98-724, s. 2; SOR/98-725, s. 2; SOR/98-726, s. 2; SOR/98-727, s. 2; SOR/98-728, s. 2; SOR/98-729, s. 2; SOR/98-730, s. 2; SOR/98-731, s. 2; SOR/98-732, s. 2; SOR/98-733, s. 2; SOR/98-734, s. 2; SOR/98-735, s. 2; SOR/98-736, s. 2; SOR/98-737, s. 2; SOR/98-738, s. 2; SOR/98-739, s. 2; SOR/98-740, s. 2; SOR/98-741, s. 2; SOR/98-742, s. 2; SOR/98-743, s. 2; SOR/98-744, s. 2; SOR/98-745, s. 2; SOR/98-746, s. 2; SOR/98-747, s. 2; SOR/98-748, s. 2; SOR/98-749, s. 2; SOR/98-750, s. 2; SOR/98-751, s. 2; SOR/98-752, s. 2; SOR/98-753, s. 2; SOR/98-754, s. 2; SOR/98-755, s. 2; SOR/98-756, s. 2; SOR/98-757, s. 2; SOR/98-758, s. 2; SOR/98-759, s. 2; SOR/98-760, s. 2; SOR/98-761, s. 2; SOR/98-762, s. 2; SOR/98-763, s. 2; SOR/98-764, s. 2; SOR/98-765, s. 2; SOR/98-766, s. 2; SOR/98-767, s. 2; SOR/98-768, s. 2; SOR/98-769, s. 2; SOR/98-770, s. 2; SOR/98-771, s. 2; SOR/98-772, s. 2; SOR/98-773, s. 2; SOR/98-774, s. 2; SOR/98-775, s. 2; SOR/98-776, s. 2; SOR/98-777, s. 2; SOR/98-778, s. 2; SOR/98-779, s. 2; SOR/98-780, s. 2; SOR/98-781, s. 2; SOR/98-782, s. 2; SOR/98-783, s. 2; SOR/98-784, s. 2; SOR/98-785, s. 2; SOR/98-786, s. 2; SOR/98-787, s. 2; SOR/98-788, s. 2; SOR/98-789, s. 2; SOR/98-790, s. 2; SOR/98-791, s. 2; SOR/98-792, s. 2; SOR/98-793, s. 2; SOR/98-794, s. 2; SOR/98-795, s. 2; SOR/98-796, s. 2; SOR/98-797, s. 2; SOR/98-798, s. 2; SOR/98-799, s. 2; SOR/98-800, s. 2; SOR/98-801, s. 2; SOR/98-802, s. 2; SOR/98-803, s. 2; SOR/98-804, s. 2; SOR/98-805, s. 2; SOR/98-806, s. 2; SOR/98-807, s. 2; SOR/98-808, s. 2; SOR/98-809, s. 2; SOR/98-810, s. 2; SOR/98-811, s. 2; SOR/98-812, s. 2; SOR/98-813, s. 2; SOR/98-814, s. 2; SOR/98-815, s. 2; SOR/98-816, s. 2; SOR/98-817, s. 2; SOR/98-818, s. 2; SOR/98-819, s. 2; SOR/98-820, s. 2; SOR/98-821, s. 2; SOR/98-822, s. 2; SOR/98-823, s. 2; SOR/98-824, s. 2; SOR/98-825, s. 2; SOR/98-826, s. 2; SOR/98-827, s. 2; SOR/98-828, s. 2; SOR/98-829, s. 2; SOR/98-830, s. 2; SOR/98-831, s. 2; SOR/98-832, s. 2; SOR/98-833, s. 2; SOR/98-834, s. 2; SOR/98-835, s. 2; SOR/98-836, s. 2; SOR/98-837, s. 2; SOR/98-838, s. 2; SOR/98-839, s. 2; SOR/98-840, s. 2; SOR/98-841, s. 2; SOR/98-842, s. 2; SOR/98-843, s. 2; SOR/98-844, s. 2; SOR/98-845, s. 2; SOR/98-846, s. 2; SOR/98-847, s. 2; SOR/98-848, s. 2; SOR/98-849, s. 2; SOR/98-850, s. 2; SOR/98-851, s. 2; SOR/98-852, s. 2; SOR/98-853, s. 2; SOR/98-854, s. 2; SOR/98-855, s. 2; SOR/98-856, s. 2; SOR/98-857, s. 2; SOR/98-858, s. 2; SOR/98-859, s. 2; SOR/98-860, s. 2; SOR/98-861, s. 2; SOR/98-862, s. 2; SOR/98-863, s. 2; SOR/98-864, s. 2; SOR/98-865, s. 2; SOR/98-866, s. 2; SOR/98-867, s. 2; SOR/98-868, s. 2; SOR/98-869, s. 2; SOR/98-870, s. 2; SOR/98-871, s. 2; SOR/98-872, s. 2; SOR/98-873, s. 2; SOR/98-874, s. 2; SOR/98-875, s. 2; SOR/98-876, s. 2; SOR/98-877, s. 2; SOR/98-878, s. 2; SOR/98-879, s. 2; SOR/98-880, s. 2; SOR/98-881, s. 2; SOR/98-882, s. 2; SOR/98-883, s. 2; SOR/98-884, s. 2; SOR/98-885, s. 2; SOR/98-886, s. 2; SOR/98-887, s. 2; SOR/98-888, s. 2; SOR/98-889, s. 2; SOR/98-890, s. 2; SOR/98-891, s. 2; SOR/98-892, s. 2; SOR/98-893, s. 2; SOR/98-894, s. 2; SOR/98-895, s. 2; SOR/98-896, s. 2; SOR/98-897, s. 2; SOR/98-898, s. 2; SOR/98-899, s. 2; SOR/98-900, s. 2; SOR/98-901, s. 2; SOR/98-902, s. 2; SOR/98-903, s. 2; SOR/98-904, s. 2; SOR/98-905, s. 2; SOR/98-906, s. 2; SOR/98-907, s. 2; SOR/98-908, s. 2; SOR/98-909, s. 2; SOR/98-910, s. 2; SOR/98-911, s. 2; SOR/98-912, s. 2; SOR/98-913, s. 2; SOR/98-914, s. 2; SOR/98-915, s. 2; SOR/98-916, s. 2; SOR/98-917, s. 2; SOR/98-918, s. 2; 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SOR/98-1347, s. 2; SOR/98-1348, s. 2; SOR/98-1349, s. 2; SOR/98-1350, s. 2; SOR/98-1351, s. 2; SOR/98-1352, s. 2; SOR/98-1353, s. 2; SOR/98-1354, s. 2; SOR/98-1355, s. 2; SOR/98-1356, s. 2; SOR/98-1357, s. 2; SOR/98-1358, s. 2; SOR/98-1359, s. 2; SOR/98-1360, s. 2; SOR/98-1361, s. 2; SOR/98-1362, s. 2; SOR/98-1363, s. 2; SOR/98-1364, s. 2; SOR/98-1365, s. 2; SOR/98-1366, s. 2; SOR/98-1367, s. 2; SOR/98-1368, s. 2; SOR/98-1369, s. 2; SOR/98-1370, s. 2; SOR/98-1371, s. 2; SOR/98-1372, s. 2; SOR/98-1373, s. 2; SOR/98-1374, s. 2; SOR/98-1375, s. 2; SOR/98-1376, s. 2; SOR/98-1377, s. 2; SOR/98-1378, s. 2; SOR/98-1379, s. 2; SOR/98-1380, s. 2; SOR/98-1381, s. 2; SOR/98-1382, s. 2; SOR/98-1383, s. 2; SOR/98-1384, s. 2; SOR/98-1385, s. 2; SOR/98-1386, s. 2; SOR/98-1387, s. 2; SOR/98-1388, s. 2; SOR/98-1389, s. 2; SOR/98-1390, s. 2; SOR/98-1391, s. 2; SOR/98-1392, s. 2; SOR/98-1393, s. 2; SOR/98-1394, s. 2; SOR/98-1395, s. 2; SOR/98-1396, s. 2; SOR/98-1397, s. 2; SOR/98-1398, s. 2; SOR/98-1399, s. 2; SOR/98-1400, s. 2; SOR/98-1401, s. 2; SOR/98-1402, s. 2; SOR/98-1403, s. 2; SOR/98-1404, s. 2; SOR/98-1405, s. 2; SOR/98-1406, s. 2; SOR/98-1407, s. 2; SOR/98-1408, s. 2; SOR/98-1409, s. 2; SOR/98-1410, s. 2; SOR/98-1411, s. 2; SOR/98-1412, s. 2; SOR/98-1413, s. 2; SOR/98-1414, s. 2; SOR/98-1415, s. 2; SOR/98-1416, s. 2; SOR/98-1417, s. 2; SOR/98-1418, s. 2; SOR/98-1419, s. 2; SOR/98-1420, s. 2; SOR/98-1421, s. 2; SOR/98-1422, s. 2; SOR/98-1423, s. 2; SOR/98-1424, s. 2; SOR/98-1425, s. 2; SOR/98-1426, s. 2; SOR/98-1427, s. 2; SOR/98-1428, s. 2; SOR/98-1429, s. 2; SOR/98-1430, s. 2; SOR/98-1431, s. 2; SOR/98-1432, s. 2; SOR/98-1433, s. 2; SOR/98-1434, s. 2; SOR/98-1435, s. 2; SOR/98-1436, s. 2; SOR/98-1437, s. 2; SOR/98-1438, s. 2; SOR/98-1439, s. 2; SOR/98-1440, s. 2; SOR/98-1441, s. 2; SOR/98-1442, s. 2; SOR/98-1443, s. 2; SOR/98-1444, s. 2; SOR/98-1445, s. 2; SOR/98-1446, s. 2; SOR/98-1447, s. 2; SOR/98-1448, s. 2; SOR/98-1449, s. 2; SOR/98-1450, s. 2; SOR/98-1451, s. 2; SOR/98-1452, s. 2; SOR/98-1453, s. 2; SOR/98-1454, s. 2; SOR/98-1455, s. 2; SOR/98-1456, s. 2; SOR/98-1457, s. 2; SOR/98-1458, s. 2; SOR/98-1459, s. 2; SOR/98-1460, s. 2; SOR/98-1461, s. 2; SOR/98-1462, s. 2; SOR/98-1463, s. 2; SOR/98-1464, s. 2; SOR/98-1465, s. 2; SOR/98-1466, s. 2; SOR/98-1467, s. 2; SOR/98-1468, s. 2; SOR/98-1469, s. 2; SOR/98-1470, s. 2; SOR/98-1471, s. 2; SOR/98-1472, s. 2; SOR/98-1473, s. 2; SOR/98-1474, s. 2; SOR/98-1475, s. 2; SOR/98-1476, s. 2; SOR/98-1477, s. 2; SOR/98-1478, s. 2; SOR/98-1479, s. 2; SOR/98-1480, s. 2; SOR/98-1481, s. 2; SOR/98-1482, s. 2; SOR/98-1483, s. 2; SOR/98-1484, s. 2; SOR/98-1485, s. 2; SOR/98-1486, s. 2; SOR/98-1487, s. 2; SOR/98-1488, s. 2; SOR/98-1489, s. 2; SOR/98-1490, s. 2; SOR/98-1491, s. 2; SOR/98-1492, s. 2; SOR/98-1493, s. 2; SOR/98-1494, s. 2; SOR/98-1495, s. 2; SOR/98-1496, s. 2; SOR/98-1497, s. 2; SOR/98-1498, s. 2; SOR/98-1499, s. 2; SOR/98-1500, s. 2; SOR/98-1501, s. 2; SOR/98-1502, s. 2; SOR/98-1503, s. 2; SOR/98-1504, s. 2; SOR/98-1505, s. 2; SOR/98-1506, s. 2; SOR/98-1507, s. 2; SOR/98-1508, s. 2; SOR/98-1509, s. 2; SOR/98-1510, s. 2; SOR/98-1511, s. 2; SOR/98-1512, s. 2; SOR/98-1513, s. 2; SOR/98-1514, s. 2; SOR/98-1515, s. 2; SOR/98-1516, s. 2; SOR/98-1517, s. 2; SOR/98-1518, s. 2; SOR/98-1519, s. 2; SOR/98-1520, s. 2; SOR/98-1521, s. 2; SOR/98-1522, s. 2; SOR/98-1523, s. 2; SOR/98-1524, s. 2; SOR/98-1525, s. 2; SOR/98-1526, s. 2; SOR/98-1527, s. 2; SOR/98-1528, s. 2; SOR/98-1529, s. 2; SOR/98-1530, s. 2; SOR/98-1531, s. 2; SOR/98-1532, s. 2; SOR/98-1533, s. 2; SOR/98-1534, s. 2; SOR/98-1535, s. 2; SOR/98-1536, s. 2; SOR/98-1537, s. 2; SOR/98-1538, s. 2; SOR/98-1539, s. 2; SOR/98-1540, s. 2; SOR/98-1541, s. 2; SOR/98-1542, s. 2; SOR/98-1543, s. 2; SOR/98-1544, s. 2; SOR/98-1545, s. 2; SOR/98-1546, s. 2; SOR/98-1547, s. 2; SOR/98-1548, s. 2; SOR/98-1549, s. 2; SOR/98-1550, s. 2; SOR/98-1551, s. 2; SOR/98-1552, s. 2; SOR/98-1553, s. 2; SOR/98-1554, s. 2; SOR/98-1555, s. 2; SOR/98-1556, s. 2; SOR/98-1557, s. 2; SOR/98-1558, s. 2; SOR/98-1559, s. 2; SOR/98-1560, s. 2; SOR/98-1561, s. 2; SOR/98-1562, s. 2; SOR/98-1563, s. 2; SOR/98-1564, s. 2; SOR/98-1565, s. 2; SOR/98-1566, s. 2; SOR/98-1567, s. 2; SOR/98-1568, s. 2; SOR/98-1569, s. 2; SOR/98-1570, s. 2; SOR/98-1571, s. 2; SOR/98-1572, s. 2; SOR/98-1573, s. 2; SOR/98-1574, s. 2; SOR/98-1575, s. 2; SOR/98-1576, s. 2; SOR/98-1577, s. 2; SOR/98-1578, s. 2; SOR/98-1579, s. 2; SOR/98-1580, s. 2; SOR/98-1581, s. 2; SOR/98-1582, s. 2; SOR/98-1583, s. 2; SOR/98-1584, s. 2; SOR/98-1585, s. 2; SOR/98-1586, s. 2; SOR/98-1587, s. 2; SOR/98-1588, s. 2; SOR/98-1589, s. 2; SOR/98-1590, s. 2; SOR/98-1591, s. 2; SOR/98-1592, s. 2; SOR/98-1593, s. 2; SOR/98-1594, s. 2; SOR/98-1595, s. 2; SOR/98-1596, s. 2; SOR/98-1597, s. 2; SOR/98-1598, s. 2; SOR/98-1599, s. 2; SOR/98-1600, s. 2; SOR/98-1601, s. 2; SOR/98-1602, s. 2; SOR/98-1603, s. 2; SOR/98-1604, s. 2; SOR/98-1605, s. 2; SOR/98-1606, s. 2; SOR/98-1607, s. 2; SOR/98-1608, s. 2; SOR/98-1609, s. 2; SOR/98-1610, s. 2; SOR/98-1611, s. 2; SOR/98-1612, s. 2; SOR/98-1613, s. 2; SOR/98-1614, s. 2; SOR/98-1615, s. 2; SOR/98-1616, s. 2; SOR/98-1617, s. 2; SOR/98-1618, s. 2; SOR/98-1619, s. 2; SOR/98-1620, s. 2; SOR/98-1621, s. 2; SOR/98-1622, s. 2; SOR/98-1623, s. 2; SOR/98-1624, s. 2; SOR/98-1625, s. 2; SOR/98-1626, s. 2; SOR/98-1627, s. 2; SOR/98-1628, s. 2; SOR/98-1629, s. 2; SOR/98-1630, s. 2; SOR/98-1631, s. 2; SOR/98-1632, s. 2; SOR/98-1633, s. 2; SOR/98-1634, s. 2; SOR/98-1635, s. 2; SOR/98-1636, s. 2; SOR/98-1637, s. 2; SOR/98-1638, s. 2; SOR/98-1639, s. 2; SOR/98-1640, s. 2; SOR/98-1641, s. 2; SOR/98-1642, s. 2; SOR/98-1643, s. 2; SOR/98-1644, s. 2; SOR/98-1645, s. 2; SOR/98-1646, s. 2; SOR/98-1647, s. 2; SOR/98-1648, s. 2; SOR/98-1649, s. 2; SOR/98-1650, s. 2; SOR/98-1651, s. 2; SOR/98-1652, s. 2; SOR/98-1653, s. 2; SOR/98-1654, s. 2; SOR/98-1655, s. 2; SOR/98-1656, s. 2; SOR/98-1657, s. 2; SOR/98-1658, s. 2; SOR/98-1659, s. 2; SOR/98-1660, s. 2; SOR/98-1661, s. 2; SOR/98-1662, s. 2; SOR/98-1663, s. 2; SOR/98-1664, s. 2; SOR/98-1665, s. 2; SOR/98-1666, s. 2; SOR/98-1667, s. 2; SOR/98-1668, s. 2; SOR/98-1669, s. 2; SOR/98-1670, s. 2; SOR/98-1671, s. 2; SOR/98-1672, s. 2; SOR/98-1673, s. 2; SOR/98-1674, s. 2; SOR/98-1675, s. 2; SOR/98-1676, s. 2; SOR/98-1677, s. 2; SOR/98-1678, s. 2; SOR/98-1679, s. 2; SOR/98-1680, s. 2; SOR/98-1681, s. 2; SOR/98-1682, s. 2; SOR/98-1683, s. 2; SOR/98-1684, s. 2; SOR/98-1685, s. 2; SOR/98-1686, s. 2; SOR/98-1687, s. 2; SOR/98-1688, s. 2; SOR/98-1689, s. 2; SOR/98-1690, s. 2; SOR/98-1691, s. 2; SOR/98-1692, s. 2; SOR/98-1693, s. 2; SOR/98-1694, s. 2; SOR/98-1695, s. 2; SOR/98-1696, s. 2; SOR/98-1697, s. 2; SOR/98-1698, s. 2; SOR/98-1699, s. 2; SOR/98-1700, s. 2; SOR/98-1701, s. 2; SOR/98-1702, s. 2; SOR/98-1703, s. 2; SOR/98-1704, s. 2; SOR/98-1705, s. 2; SOR/98-1706, s. 2; SOR/98-1707, s. 2; SOR/98-1708, s. 2; SOR/98-1709, s. 2; SOR/98-1710, s. 2; SOR/98-1711, s. 2; SOR/98-1712, s. 2; SOR/98-1713, s. 2; SOR/98-1714, s. 2; SOR/98-1715, s. 2; SOR/98-1716, s. 2; SOR/98-1717, s. 2; SOR/98-1718, s. 2; SOR/98-1719, s. 2; SOR/98-1720, s. 2; SOR/ TABLE V Column I A.01 A.02 A.1 α-Acetolactate decarboxylase Aminopeptidase Amylase Column II Bacillus subtilis ToC46 (pUW235) Lactococcus lactis Aspergillus niger var.; Aspergillus oryzae var.; Bacillus subtilis var.; Rhizopus oryzae var.; Barley Malt Aspergillus niger STz18-9 (pHUda7) Column III

(1)

Brewers’ Mash

(2)

Distillers’ Mash

(1)

Cheddar cheese; (naming the variety) Cheese

(1)

Ale; Beer; Light beer; Malt liquor; Porter; Stout

(2)

Bread; Flour; Whole wheat flour

(3)

Cider; Wine

(4)

Chocolate syrup

(5)

Distillers’ Mash

(6)

Malt-flavoured dried breakfast cereals

(7)

Single-strength fruit juices

(8)

Pre-cooked (instant) breakfast cereals

(9)

Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup)

(10)

Unstandardized bakery products

(11)

Plant-based beverages

(12)

Infant cereal products

(1)

Ale; Beer; Light beer; Malt liquor; Porter; Stout

(2)

Distillers’ Mash

(3)

Starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids Column IV Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice

(6)

Good Manufacturing Practice

(7)

Good Manufacturing Practice

(8)

Good Manufacturing Practice

(9)

Good Manufacturing Practice

(10)

Good Manufacturing Practice

(11)

Good Manufacturing Practice

(12)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice PART B Foods

Section B.16.100

Column I A.1 Column II Amylase (maltogenic) Column III Bacillus amyloliquefaciens EBA 20 (pUBH2); Bacillus licheniformis; Bacillus licheniformis BML 592 (pAmyAP); Bacillus licheniformis BML 730 (pAmyAP); Bacillus licheniformis LA 57 (pDN981); Bacillus licheniformis LAT8 (pLAT3); Bacillus licheniformis LiH 1159 (pLiH1108); Bacillus licheniformis LiH 1464 (pLiH1436); Bacillus licheniformis PL 1303 (pPL1171); Bacillus licheniformis MOL2083 (pCA164-LE399) Bacillus licheniformis 3253 (pClaH-3253); Bacillus licheniformis 3266 (pClaH-3266ori1); Bacillus stearothermophilus; Bacillus subtilis B1.109 (pCPC800) Bacillus subtilis B1.109 (pCPC720) (ATCC 39, 705) Column IV (dried glucose syrup), maltose

(1)

Distillers’ Mash

(2)

Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup)

(3)

Brewers’ Mash

(1)

Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup)

(2)

Distillers’ Mash

(3)

Brewers’ Mash

(4)

Bread; Flour; Whole wheat flour

(5)

Unstandardized bakery products

(1)

Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup) Column V Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice

(1)

Good Manufacturing Practice A.2 Amylase (maltogenic) Bacillus subtilis BRG-1 (pBRG1); Bacillus subtilis DN1143 (pDN1143); Bacillus subtilis LFA 63 (pLFA63); Bacillus subtilis RB-147 (pRB147)

(1)

Starch used in the production of dextrins, maltose, dextrose, glucose, (glucose syrup) or glucose solids (dried glucose syrup)

(2)

Bread; Flour; Whole wheat flour

(3)

Unstandardized bakery products

(1)

Good manufacturing practice

(2)

Good manufacturing practice

(3)

Good manufacturing practice A.3 Asparaginase Aspergillus niger ASP72; Aspergillus oryzae (pCaHj621/BECh2#10)

(1)

Bread; Flour; Whole wheat flour

(2)

Unstandardized bakery products

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice B.1 Bovine Rennet Good Manufacturing Practice PART B Foods

Section B.16.100

Column I B.2

C

1

C

2

C

3 Bromelain Catalase Cellulase Chymosin (i) Chymosin A Column II The pineapples *Ananas comosus* and *Ananas bracteatus* *Aspergillus niger var.*; *Micrococcus lysodeikticus*; Bovine (*Bos taurus*) liver *Aspergillus niger var.* *Trichoderma reesei* QM 9414 *Escherichia coli* K-12, GE81 (pPFZ87A) Column III

(1)

Ale; Beer; Light beer; Malt liquor; Porter; Stout

(2)

Bread; Flour; Whole wheat flour

(3)

Sausage casings

(5)

Meat cuts

(6)

Meat tenderizing preparations

(8)

Sugar wafers, waffles, pancakes

(1)

Soft drinks

(2)

Liquid egg-white (liquid albumen), liquid whole egg or liquid yolk, destined for drying

(1)

Distillers’ Mash

(2)

Liquid coffee concentrate

(3)

Spice extracts; Natural flavour and colour extractives

(1)

Single-strength fruit juices

(2)

Tea leaves for the production of tea solids Column IV Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice

(6)

Good Manufacturing Practice

(8)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(1)

Good Manufacturing Practice PART B Foods

Section B.16.100

Column I | Column II | Column III | Column IV (ii) Chymosin B | Aspergillus niger var. awamori, GCC0349 (pGAMpR); Kluyveromyces marxianus var. lactis, DS1182 (pKS105) | (1) Cheddar cheese; (naming the variety) cheese; Cottage cheese; Cream cheese; Cream cheese spread with (naming the added ingredients); Sour cream | (1) Good Manufacturing Practice | | | (2) Unstandardized milk-based dessert preparations | (2) Good Manufacturing Practice F.1 | Ficin | Latex of fig tree (Ficus sp.) | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | | | (2) Sausage casings | (2) Good Manufacturing Practice | | | (4) Meat cuts | (4) Good Manufacturing Practice | | | (5) Meat tenderizing preparations | (5) Good Manufacturing Practice G.1 | Glucoamylase (Amyloglucosidase; Maltase) | Aspergillus niger var.; Aspergillus oryzae var.; Rhizopus oryzae var. | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | | | (2) Bread; Flour; Whole wheat flour | (2) Good Manufacturing Practice | | | (3) Chocolate syrups | (3) Good Manufacturing Practice | | | (4) Distillers’ Mash | (4) Good Manufacturing Practice | | | (5) Pre-cooked (instant) breakfast cereals | (5) Good Manufacturing Practice | | | (6) Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup), or glucose solids (dried glucose syrup) | (6) Good Manufacturing Practice | | | (7) Unstandardized bakery products | (7) Good Manufacturing Practice | Aspergillus niger STz18-9 (pHUda7) | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | | | (2) Distillers’ Mash | (2) Good Manufacturing Practice Column I Column II Column III Column IV Maximum Level of Use G.2 Glucanase Aspergillus niger var.; Bacillus subtilis var.

(1)

Ale; Beer; Light beer; Malt liquor; Porter; Stout

(2)

Corn for degermination

(3)

Distillers’ Mash

(4)

Mash destined for vinegar manufacture

(5)

Unstandardized bakery products

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice Rhizopus niveus var.

(1)

Distillers’ Mash

(2)

Mash destined for vinegar manufacture

(3)

Starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), maltose

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice Rhizopus delemar var.; Multiplicis sporus

(1)

Brewers’ Mash

(2)

Distillers’ Mash

(3)

Mash destined for vinegar manufacture

(4)

Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup), or glucose solids (dried glucose syrup)

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice Humicola insolens var.

(1)

Ale; Beer; Light beer; Malt liquor; Porter; Stout

(2)

Distillers’ Mash

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice G.3 Glucose oxidase Aspergillus niger var.; Aspergillus oryzae Mtl-72 (pHUda107)

(1)

Soft drinks

(2)

Liquid egg-white (liquid albumen), liquid whole egg or liquid yolk, destined for drying

(3)

Bread; flour; Whole wheat flour

(4)

Unstandardized bakery products

(1)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice G.4 Glucose Isomerase Bacillus coagulans var.; Streptomyces olivochromogenes var.; Actinoplanes missouriensis var.; Streptomyces olivaceus var.; Microbacterium arborescens NRRL B-11022; Streptomyces murinus DSM

(1)

Good Manufacturing Practice PART B Foods

Section B.16.100

H.1 | Hemicellulase | Bacillus subtilis var. | (1) Distillers’ Mash | (1) Good Manufacturing Practice | | | (2) Liquid coffee concentrate | (2) Good Manufacturing Practice | | | (3) Mash destined for vinegar manufacture | (3) Good Manufacturing Practice

I

01 | Inulinase | Aspergillus niger var. Tieghem | Inulin | Good Manufacturing Practice

I

1 | Invertase | Aspergillus japonicus | Sucrose used in the production of fructooligosaccharides | Good Manufacturing Practice | | Saccharomyces sp. | (1) Unstandardized soft-centred and liquid-centred confectionery | (1) Good Manufacturing Practice | | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice

L

1 | Lactase | Aspergillus niger var.; Aspergillus oryzae var.; Kluyveromyces fragilis (Kluyveromyces marxianus var. marxianus); Kluyveromyces lactis (Kluyveromyces marxianus var. lactis); Saccharomyces sp. | (1) Lactose-reducing enzyme preparations | (1) Good Manufacturing Practice | | | (2) Milk destined for use in ice cream mix | (2) Good Manufacturing Practice | | | (3) Bread; Flour; whole wheat flour | (3) Good Manufacturing Practice | | Cell-free extracts from Candida pseudotropicalis | (1) Milk destined for use in ice cream mix | (1) Good Manufacturing Practice | | | (2) Yogurt | (2) Good Manufacturing Practice | | | (3) Whey | (3) Good Manufacturing Practice PART B Foods

Section B.16.100

---|---|---|---|---

L

2 | Lipase | Animal pancreatic tissue; Aspergillus niger var.; Aspergillus oryzae var.; Edible forestomach tissue of calves, kids or lambs; Rhizopus oryzae var. | (1) Dairy based flavouring preparations | (1) Good Manufacturing Practice | | | (2) Dried egg-white (dried albumen); Liquid egg-white (liquid albumen) | (2) Good Manufacturing Practice | | | (4) Bread; Flour; Whole wheat flour | (4) Good Manufacturing Practice | | | (5) Unstandardized bakery products | (5) Good Manufacturing Practice | Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)); Rhizopus niveus | (1) Modified fats and oils | (1) Good Manufacturing Practice | | | (2) Cheddar cheese; (naming the variety) Cheese | (2) Good Manufacturing Practice | Aspergillus oryzae AL-11 (pBoel 960) | (1) Bread; Flour; Whole wheat flour | (1) Good Manufacturing Practice | | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice | | | (3) Modified fats and oils | (3) Good Manufacturing Practice | Aspergillus oryzae BECh2#3 (pCaHj595); Aspergillus oryzae (MStr115) (pMStr20) | (1) Bread; Flour; Whole wheat flour | (1) Good Manufacturing Practice | | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice | | | (3) Modified lecithin | (3) Good Manufacturing Practice | | | (4) Unstandardized egg products | (4) Good Manufacturing Practice | Aspergillus niger (pCaHj600/MBin118#11) | Modified fats and oils | Good Manufacturing Practice | Penicillium camembertii | (1) Edible fats and oils | (1) Good Manufacturing Practice

L

3 | Lipoxidase | Soyabean whey or meal | (1) Bread; Flour; Whole wheat flour | (1) Good Manufacturing Practice

L

4 | Lysozyme | Egg-white | Cheddar cheese; (naming the variety) Cheese | (1) Good Manufacturing Practice

M

1 | Milk coagulating enzyme | Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)) or Mucor pusillus Lindt by pure culture fermentation process | (1) Cheddar cheese; Cottage cheese; (naming the variety) Cheese; Sour cream | (1) Good Manufacturing Practice PART B Foods

Section B.16.100

P.1 Pancreatin | Pancreas of the hog (Sus scrofa) or ox (Bos taurus) | (1) Dried egg-white (dried albumen); Liquid egg-white (liquid albumen) | (1) Good Manufacturing Practice | | | (2) Pre-cooked (instant) breakfast cereals | (2) Good Manufacturing Practice | | | (3) Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup), or glucose solids (dried glucose syrup) | (3) Good Manufacturing Practice | | | (4) Hydrolyzed animal, milk and vegetable proteins | (4) Good Manufacturing Practice P.2 Papain | Fruit of the papaya Carica papaya L. (Fam. Caricaceae) | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | | | (2) Beef before slaughter | (2) Good Manufacturing Practice | | | (3) Sausage casings; Water-soluble edible collagen films | (3) Good Manufacturing Practice | | | (5) Meat cuts | (5) Good Manufacturing Practice | | | (6) Meat tenderizing preparations | (6) Good Manufacturing Practice | | | (7) Pre-cooked (instant) breakfast cereals | (7) Good Manufacturing Practice | | | (8) Pumping pickle for the curing of beef cuts | (8) Good Manufacturing Practice | | | (9) Unstandardized bakery products | (9) Good Manufacturing Practice P.3 Pectinase | Aspergillus niger var.; Rhizopus oryzae var. | (1) Cider; Wine | (1) Good Manufacturing Practice | | | (2) Distillers’ Mash | (2) Good Manufacturing Practice | | | (3) Single-strength fruit juices | (3) Good Manufacturing Practice PART B Foods

Section B.16.100

P.4 | Pentosanase | Aspergillus oryzae Km-1-1 (pA2PE1) | (1) Cider; Wine | (1) Good Manufacturing Practice | | | (2) Single-strength fruit juices | (2) Good Manufacturing Practice | Aspergillus niger var.; Bacillus subtilis var. | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | | | (2) Corn for degermination | (2) Good Manufacturing Practice | | | (3) Distillers’ Mash | (3) Good Manufacturing Practice | | | (4) Mash destined for vinegar manufacture | (4) Good Manufacturing Practice | | | (5) Unstandardized bakery products | (5) Good Manufacturing Practice | | | (6) Bread; Flour; Whole wheat flour | (6) Good Manufacturing Practice | Trichoderma reesei (QM9414) | (1) Bread; Flour; Whole wheat flour | (1) Good Manufacturing Practice | | | (2) Distiller’s Mash | (2) Good Manufacturing Practice | | | (3) Unstandardized bakery products | (3) Good Manufacturing Practice P.5 | Pepsin | Glandular layer of porcine stomach | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | | | (3) Defatted soya flour | (3) Good Manufacturing Practice | | | (4) Pre-cooked (instant) breakfast cereals | (4) Good Manufacturing Practice | | | (5) Hydrolyzed animal, milk and vegetable proteins | (5) Good Manufacturing Practice PART B Foods

Section B.16.100

P.5A Phospholipase Streptomyces violaceoruber

(1)

Modified lecithin

(1)

Good Manufacturing Practice Aspergillus oryzae (pPFJo142)

(2)

Unstandardized egg products

(2)

Good Manufacturing Practice Aspergillus niger (PLA-54)

(3)

Good Manufacturing Practice

(1)

Bread; Flour; Whole wheat flour

(1)

Good Manufacturing Practice

(2)

Unstandardized bakery products

(2)

Good Manufacturing Practice

(3)

Unstandardized whole egg; unstandardized egg yolk

(3)

Good Manufacturing Practice

(4)

Modified lecithin

(4)

Good Manufacturing Practice Aspergillus oryzae var.; Aspergillus niger var.; Bacillus subtilis var.

(1)

Ale; Beer; Light beer; Malt liquor; Porter; Stout

(1)

Good Manufacturing Practice

(2)

Bread; Flour; Whole wheat flour

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Distillers’ Mash

(4)

Good Manufacturing Practice

(5)

Sausage casings

(5)

Good Manufacturing Practice

(6)

Good Manufacturing Practice

(7)

Industrial spray-dried cheese powder

(7)

Good Manufacturing Practice

(8)

Meat cuts

(8)

Good Manufacturing Practice

(9)

Meat tenderizing preparations

(9)

Good Manufacturing Practice

(10)

Pre-cooked (instant) breakfast cereals

(10)

Good Manufacturing Practice

(11)

Unstandardized bakery products

(11)

Good Manufacturing Practice

(12)

Good Manufacturing Practice

(13)

Plant-based beverages

(13)

Good Manufacturing Practice Micrococcus caseolyticus var.

(1)

(naming the variety) Cheese

(1)

Good Manufacturing Practice Bacillus licheniformis (Cx)

(1)

Good Manufacturing Practice P.7 Pullulanase Bacillus acidopullulyticus NCIB 11647; Bacillus

(1)

Bread; Flour; Whole wheat flour

(1)

Good Manufacturing Practice PART B Foods

Section B.16.100

licheniformis SE2-Pu-int211 (pUBCDEBR A11DNSI)

(2)

Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose

(3)

Unstandardized bakery products

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice Bacillus licheniformis BMP 139 (pR11Amp)

(1)

Bread; Flour; Whole wheat flour

(2)

Brewers’ Mash

(3)

Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose

(4)

Unstandardized bakery products

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice Bacillus subtilis B1-163 (pEB301)

(1)

Bread; Flour; Whole wheat flour

(2)

Brewers’ Mash

(3)

Distillers’ Mash

(4)

Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose

(5)

Unstandardized bakery products

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice Bacillus subtilis RB121 (pDG268)

(1)

Brewers’ Mash

(2)

Distillers’ Mash

(3)

Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or maltose

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice R.1 Rennet

(1)

Good Manufacturing Practice PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Column I | Column II | Column III | Column IV T.01 | Transglutaminase | Streptoverticillium mobaraense strain S-8112 | (1) Unstandardized prepared fish products | (1) Good Manufacturing Practice | | | (2) Simulated meat products | (2) Good Manufacturing Practice | | | (3) Unstandardized cheese products | (3) Good Manufacturing Practice | | | (5) Unstandardized cream cheese products | (5) Good Manufacturing Practice | | | (6) Yogurt | (6) Good Manufacturing Practice | | | (naming the variety) Cheese; Sour cream | T.1 | Trypsin | Pancreas of the hog (Sus scrofa) | (1) Hydrolyzed animal, milk and vegetable proteins | (1) Good Manufacturing Practice

X

1 | Xylanase | Aspergillus oryzae Fa 1–1 (pA2X1TI) | (1) Bread; Flour; Whole wheat flour | (1) Good Manufacturing Practice | | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice | | Aspergillus oryzae JaL 339 (pJaL537); Bacillus subtilis D1K 0115 (pBU110 OIS2) | (1) Bread; Flour; Whole wheat flour | (1) Good Manufacturing Practice | | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice | | Bacillus subtilis CF 307 (pJHPaprE-xynAss-BS3xylanase#1) | (1) Bread; Flour; Whole wheat flour | (1) Good Manufacturing Practice | | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice TABLEAU V Additifs alimentaires autorisés comme enzymes dans les aliments Colonne I | Colonne II | Colonne III | Colonne IV

Article | Additifs | Source permise | Permis dans ou sur | Limites de tolérance

A.01 | α-Acétolactate décarboxylase | Bacillus subtilis ToC46 (pUW235) | (1) Moût de bière | (1) Bonnes pratiques industrielles | | | (2) Moût de distillerie | (2) Bonnes pratiques industrielles A.02 | Aminopeptidase | Lactococcus lactis | (1) Fromage cheddar; fromage (indication de la variété) | (1) Bonnes pratiques industrielles | | | (2) Préparations aromatisantes à base de produits laitiers | (2) Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

A.1 Colonne II Additifs Amylase Source permise Aspergillus niger var.; Aspergillus oryzae var.; Bacillus subtilis var.; Rhizopus oryzae var.; Malt d’orge Colonne III Permis dans ou sur

(3)

Protéines hydrolysées d’origine animale, végétale ou provenant du lait

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Farine; farine de blé entier; pain

(3)

Cidre; vin

(4)

Sirop au chocolat

(5)

Moût de distillerie

(6)

Céréales à déjeuner sèches à saveur de malt

(7)

Jus de fruits non concentrés

(8)

Céréales à déjeuner précuites (instantanées)

(9)

Amidon utilisé dans la production des dextrines, du maltose, du dextrose, du glucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté)

(10)

Produits de boulangerie non normalisés

(11)

Boissons végétales

(12)

Produits céréaliers pour bébés Aspergillus niger STz18-9 (pHUda7)

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Moût de distillerie

(3)

Amidon utilisé dans la production des dextrines, du maltose, du dextrose, du glucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté) Bacillus amyloliquefaciens EBA 20 (pUBH2); Bacillus licheniformis; Bacillus licheniformis BML 592 (pAmyAmp); Bacillus licheniformis BML 730 (pAmyAmp); Bacillus

(1)

Moût de distillerie

(2)

Amidon utilisé dans la production des dextrines, du maltose, du dextrose, du glucose (sirop de glucose) ou de solides de Colonne IV Limites de tolérance

(3)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(6)

Bonnes pratiques industrielles

(7)

Bonnes pratiques industrielles

(8)

Bonnes pratiques industrielles

(9)

Bonnes pratiques industrielles

(10)

Bonnes pratiques industrielles

(11)

Bonnes pratiques industrielles

(12)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Article

A.1 Additifs licheniformis LA 57 (pDN1981); Bacillus licheniformis LAT8 (pLAT3); Bacillus licheniformis LiH 1159 (pLiH1108); Bacillus licheniformis LiH 1464 (pLiH1346); Bacillus licheniformis PL 1303 (pPL1117); Bacillus licheniformis MOL2083 (pCA164-LE399) Bacillus licheniformis 3253 (pCatH-3253); Bacillus licheniformis 3266 (pCatH-3266ori1); Bacillus stearothermophilus; Bacillus subtilis B1.109 (pCPC800) Colonne II Source permise Colonne III Permis dans ou sur glucose (sirop de glucose déshydraté)

(3)

Moût de bière

(1)

Amidon utilisé dans la production des dextrines, du maltose, du dextrose, du glucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté)

(2)

Moût de distillerie

(3)

Moût de bière

(4)

Farine; farine de blé entier; pain

(5)

Produits de boulangerie non normalisés Bacillus subtilis B1.109 (pCPC720) (ATCC 39, 705)

(1)

Amidon utilisé dans la production des dextrines, du maltose, du dextrose, du glucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté)

(2)

Farine; farine de blé entier; pain

(3)

Produits de boulangerie non normalisés Colonne IV Limites de tolérance

(3)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles A.2 Amylase maltogène Bacillus subtilis BRG-1 (pBRG1); Bacillus subtilis DN1413 (pDN1413); Bacillus subtilis LFA 63 (pLFA63); Bacillus subtilis RB-147 (pRB147)

(1)

Amidon utilisé dans la production des dextrines, du maltose, du dextrose, du glucose, (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté)

(2)

Farine; farine de blé entier; pain

(3)

Produits de boulangerie non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles A.3 Asparaginase Aspergillus niger ASP72; Aspergillus oryzae (pCahJ621/BECh2#10)

(1)

Farine; farine de blé entier; pain

(2)

Aliments non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles B.1 Présure de bovin Extrait aqueux du 4e (véritable) estomac de bovins, de moutons et de chèvres adultes Fromage à la crème; fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage à la Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I Additifs Colonne II Source permise Colonne III Permis dans ou sur Colonne IV Limites de tolérance B.2 Broméline Les ananas Ananas comosus et Ananas bracteatus

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Farine; farine de blé entier; pain

(3)

Boyaux de saucisse

(4)

Protéine hydrolysée d’origine animale, végétale ou provenant du lait

(5)

Pièces de viande

(6)

Produits pour attendrir la viande

(7)

Marinade employée dans la salaison de parties de bœuf

(8)

Gaufrettes sucrées, gaufres, crêpes

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(6)

Bonnes pratiques industrielles

(7)

Bonnes pratiques industrielles selon l’alinéa B.14.009g)

(8)

Bonnes pratiques industrielles

C

1 Catalase Aspergillus niger var.; Micrococcus lysodeikticus; Foie de bœuf (Bos taurus)

(1)

Boissons préparées (gazeuses et non gazeuses)

(2)

Blanc d’œuf liquide (albumen liquide), jaune d’œuf liquide ou œuf entier liquide, destinés au séchage

(3)

Petit-lait liquide traité au peroxyde d’hydrogène, conformément à l’article H.1, du tableau VIII

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

C

2 Cellulase Aspergillus niger var.

(1)

Moût de distillerie

(2)

Concentré de café liquide

(3)

Extraits d’épices; préparations aromatisantes naturelles et colorants

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles Trichoderma reesei QM 9414

(1)

Jus de fruits non concentrés

(2)

Feuilles de thé destinées à la production de solides de thé

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

C

3 Chymosine (i) Chymosine A Escherichia coli K-12, GE81 (pPFZ87A)

(1)

Fromage cheddar; fromage (indication de la variété); fromage cottage

(1)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Colonne II Additifs Colonne III Source permise Colonne IV Permis dans ou sur Limites de tolérance (ii) Chymosine B Aspergillus niger var. awamori, GCC0349 (pGAMpR); Kluyveromyces marxianus var. lactis, DS1182 (pKS105)

(1)

Fromage cheddar; fromage (indication de la variété); fromage cottage; fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); crème sure

(2)

Produits pour desserts à base de lait non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles F.1 Ficîne Latex de figuier (Ficus sp.)

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Boyaux de saucisse

(3)

Protéine hydrolysée d’origine animale, végétale ou provenant du lait

(4)

Pièces de viande

(5)

Produits pour attendrir la viande

(6)

Marinade employée dans la salaison de parties de bœuf

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(6)

Bonnes pratiques industrielles selon l’alinéa B.14.009(9) G.1 Glucoamylase (Amyloglucosidase; maltase) Aspergillus niger var.; Aspergillus oryzae var.; Rhizopus oryzae var.

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Farine; farine de blé entier; pain

(3)

Sirop au chocolat

(4)

Moût de distillerie

(5)

Céréales à déjeuner précuites (instantanées)

(6)

Amidon employé dans la production des dextrines, du maltose, du

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(6)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Source permise Colonne III Permis dans ou sur Colonne IV Limites de tolérance dextrose, du glucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté)

(7)

Produits de boulangerie non normalisés

(7)

Bonnes pratiques industrielles Aspergillus niger STz18-9 (pHUda7)

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Moût de distillerie

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Amidon utilisé dans la production des dextrines, du dextrose, du glucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté) ou du maltose

(3)

Bonnes pratiques industrielles Rhizopus niveus var.

(1)

Moût de distillerie

(1)

Bonnes pratiques industrielles Rhizopus delemar var.; Multiplici sporus

(1)

Moût de bière

(2)

Moût de distillerie

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Moût servant à la fabrication du vinaigre

(4)

Amidon employé dans la production des dextrines, du maltose, du dextrose, du glucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté)

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles G.2 Glucanase Aspergillus niger var.; Bacillus subtilis var.

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Maïs pour égrenage

(3)

Moût de distillerie

(4)

Moût servant à la fabrication du vinaigre

(5)

Produits de boulangerie non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles Humicola insolens var.

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Moût de distillerie

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

G.3 G.4 H.1

I

01

I

1

L

1 Colonne II Additifs Glucose-oxydase Glucose-isomérase Hemicellulase Inulinase Invertase Lactase Source permise Aspergillus niger var.; Aspergillus oryzae Mtl-72 (pHUda107) Bacillus coagulans var.; Streptomyces olivochromogenes var.; Actinoplanes missouriensis var.; Streptomyces olivaceus var.; Microbacterium arborescens NRRL B-11022; Streptomyces murinus DSM 3252; Streptomyces rubiginosus ATCC No. 21,175; Streptomyces rubiginosus SYC S406 (pSYC5239) Bacillus subtilis var. Aspergillus niger var. Tieghm Aspergillus japonicus Saccharomyces sp. Aspergillus niger var.; Aspergillus oryzae var.; Kluyveromyces fragilis (Kluyveromyces Marxianus var. marxianus); Kluyveromyces lactis (Kluyveromyces Marxianus var. lactis); Saccharomyces sp. Colonne III Permis dans ou sur

(1)

Boissons préparées (gazeuses et non gazeuses)

(2)

Blanc d’œuf liquide (albumen liquide), jaune d’œuf liquide ou œuf entier liquide, destinés au séchage

(3)

Farine; farine de blé entier; pain

(4)

Produits de boulangerie non normalisés

(1)

Glucose (sirop de glucose) à être partiellement ou complètement transformé en fructose par isomérisation

(1)

Moût de distillerie

(2)

Concentré de café liquide

(3)

Moût destiné à la fabrication du vinaigre Inuline Saccharose utilisé dans la production de fructo-oligosaccharides

(1)

Confiseries non normalisées avec centre mou ou liquide

(2)

Produits de boulangerie non normalisés

(1)

Produits enzymatiques pour la réduction du lactose

(2)

Lait destiné à la fabrication du mélange pour la crème glacée

(3)

Farine; farine de blé entier; pain

(4)

Lait (indication de l’arôme); lait écrémé (indication de l’arôme); lait partiellement écrémé Colonne IV Limites de tolérance

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles selon les alinéas B.22.034b) et B.22.036b)

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles 453 À jour au 11 novembre 2024 Dernière modification le 17 juin 2024 PART B Foods

Section B.16.100

Article | Colonne I Additifs | Colonne II Source permise | Colonne III Permis dans ou sur | Colonne IV Limites de tolérance

Extraits acellulaires de *Candida pseudotropicalis* (indication de l’arôme); lait malté (indication de l’arôme); lait écrémé additionné de solides du lait (indication de l’arôme); lait partiellement écrémé additionné de solides du lait (indication de l’arôme);

(1)

Lait destiné à la fabrication du mélange pour la crème glacée

(1)

Bonnes pratiques industrielles

(2)

Yogourt

(2)

Bonnes pratiques industrielles

(3)

Petit-lait

(3)

Bonnes pratiques industrielles

(4)

Lait (indication de l’arôme); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé additionné de solides du lait (indication de l’arôme); lait partiellement écrémé additionné de solides du lait (indication de l’arôme)

(4)

Bonnes pratiques industrielles

L

2 Lipase *Aspergillus niger var.; Aspergillus oryzae var.; Rhizopus oryzae var.; Tissus comestibles des préestomacs d’agneaux, de chevreaux ou de veaux; Tissus pancréatiques d’animaux*

(1)

Préparations aromatisantes à base de produits laitiers

(1)

Bonnes pratiques industrielles

(2)

Blanc d’œuf liquide (albumen liquide); poudre de blanc d’œuf (poudre d’albumen)

(2)

Bonnes pratiques industrielles

(3)

Fromage cheddar; fromage fondu cheddar; fromage (indication de la variété)

(3)

Bonnes pratiques industrielles

(4)

Farine; farine de blé entier; pain

(4)

Bonnes pratiques industrielles

(5)

Produits de boulangerie non normalisés

(5)

Bonnes pratiques industrielles

(6)

Protéines hydrolysées d’origine animale, végétale ou provenant du lait

(6)

Bonnes pratiques industrielles

(7)

Graisses et huiles modifiées

(7)

Bonnes pratiques industrielles

(8)

Fromage cheddar; fromage (indication de la variété)

(8)

Bonnes pratiques industrielles *Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)); Rhizopus niveus* PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Colonne II Additifs Colonne III Source permise Colonne IV Permis dans ou sur Colonne V Limites de tolérance Aspergillus oryzae Al-11 (pBoel 960)

(1)

Farine; farine de blé entier; pain

(2)

Produits de boulangerie non normalisés

(3)

Graisses et huiles modifiées

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles Aspergillus oryzae BECh2#3 (pCaJ#559); Aspergillus oryzae (MStr115) (pMStr20)

(1)

Farine; farine de blé entier; pain

(2)

Produits de boulangerie non normalisés

(3)

Lécithine modifiée

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles Aspergillus niger (pCaJ#600/MB1n118#11)

(4)

Produits des œufs non normalisés

(4)

Bonnes pratiques industrielles Penicillium camemberti Graisses et huiles modifiées Bonnes pratiques industrielles

L

3 Grumeaux ou farine de fine Soja

(1)

Farine; farine de blé entier; pain

(1)

Bonnes pratiques industrielles

L

4 Lysozyme Blanc d’œuf Fromage cheddar; fromage (indication de la variété) Bonnes pratiques industrielles

M

1 Enzyme coagulant le lait Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)) ou Mucor pusillus Lindt par fermentation de culture pure ou Aspergillus oryzae RET-1 (pBoel777)

(1)

Crème sûre; fromage cheddar; fromage cottage; fromage (indication de la variété)

(2)

Préparations aromatisantes à base de produits laitiers

(3)

Protéines hydrolysées d’origine animale, végétale ou provenant du lait

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles Endothia parasitica par fermentation de culture pure

(1)

Fromage Emmental (Emmental ou Suisse)

(2)

Fromage Parmesan

(3)

Fromage Romano

(4)

Fromage Mozzarella (Scamorza)

(5)

Fromage Mozzarella partiellement écrémé

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I | Colonne II | Colonne III | Colonne IV

Article | Additifs | Source permise | Permis dans ou sur | Limites de tolérance

P.1 Pancréatine | Pancréas de porc (Sus scrofa) ou de bœuf (Bos taurus) | (Scamorza partiellement écrémé)

(1)

Blanc d’œuf liquide (albumen liquide); poudre de blanc d’œuf (poudre d’albumen) | (1) Bonnes pratiques industrielles

(2)

Céréales à déjeuner précuites (instantanées) | (2) Bonnes pratiques industrielles

(3)

Amidon utilisé dans la production des dextrines, du maltose, du dextrose, du glucose (sirop de glucose ou de solides de glucose (sirop de glucose déshydraté)) | (3) Bonnes pratiques industrielles

(4)

Protéines hydrolysées d’origine animale ou végétale ou provenant du lait | (4) Bonnes pratiques industrielles P.2 Papaïne | Fruit du papayer Carica papaya L. (Fam. du Caricaceae) | (1) Ale; bière; bière légère; liqueur de malt; porter; stout | (1) Bonnes pratiques industrielles

(2)

Bœuf avant l’abattage | (2) Bonnes pratiques industrielles

(3)

Boyaux de saucisse; pellicules de collagène hydrosolubles comestibles | (3) Bonnes pratiques industrielles

(4)

Protéine hydrolysée d’origine animale, végétale ou provenant du lait | (4) Bonnes pratiques industrielles

(5)

Pièces de viande | (5) Bonnes pratiques industrielles

(6)

Produits pour attendrir la viande | (6) Bonnes pratiques industrielles

(7)

Céréales à déjeuner précuites (instantanées) | (7) Bonnes pratiques industrielles

(8)

Marinade employée dans la salaison de parties de bœuf | (8) Bonnes pratiques industrielles

(9)

Produits de boulangerie non normalisés | (9) Bonnes pratiques industrielles P.3 Pectinase | Aspergillus niger var.; Rhizopus oryzae var. | (1) Cidre; vin | (1) Bonnes pratiques industrielles

(2)

Moût de distillerie | (2) Bonnes pratiques industrielles

(3)

Jus de fruits non concentrés | (3) Bonnes pratiques industrielles

(4)

Préparations naturelles aromatisantes et colorants | (4) Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Source permise Colonne III Permis dans ou sur Colonne IV Limites de tolérance

(5)

Pelures d’agrumes destinées à la fabrication de confiture, de marmelade et de fruits confits

(5)

Bonnes pratiques industrielles

(6)

Bouillon de légume employé dans les soupes

(6)

Bonnes pratiques industrielles

(7)

Feuilles de thé destinées à la production de solides de thé

(7)

Bonnes pratiques industrielles Aspergillus oryzae Km-1-1 (pA2PE1)

(1)

Cidre; vin

(1)

Bonnes pratiques industrielles

(2)

Jus de fruits non concentrés

(2)

Bonnes pratiques industrielles

(3)

Produits à base de fruits et de légumes non normalisés

(3)

Bonnes pratiques industrielles P.4 Pentosanase Aspergillus niger var.; Bacillus subtilis var.

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(1)

Bonnes pratiques industrielles

(2)

Maïs pour égrenage

(2)

Bonnes pratiques industrielles

(3)

Moût de distillerie

(3)

Bonnes pratiques industrielles

(4)

Moût destiné à la fabrication du vinaigre

(4)

Bonnes pratiques industrielles

(5)

Produits de boulangerie non normalisés

(5)

Bonnes pratiques industrielles

(6)

Farine; farine de blé entier, pain

(6)

Bonnes pratiques industrielles Trichoderma reesei (QM9414)

(1)

Farine; farine de blé entier, pain

(1)

Bonnes pratiques industrielles

(2)

Moût de distillerie

(2)

Bonnes pratiques industrielles

(3)

Produits de boulangerie non normalisés

(3)

Bonnes pratiques industrielles P.5 Pepsine Muqueuse glandulaire de l’estomac de porc

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(1)

Bonnes pratiques industrielles

(2)

Fromage à la crème; fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage à la crème (avec indication des ingrédients ajoutés); fromage cheddar; fromage cottage; fromage cottage (indication de la variété)

(2)

Bonnes pratiques industrielles

(3)

Farine de soja dégraissée

(3)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Article | Colonne I Additifs | Colonne II Source permise | Colonne III Permis dans ou sur | Colonne IV Limites de tolérance

P.5A Phospholipase Streptomyces violaceoruber

(1)

Lécithine modifiée

(1)

Bonnes pratiques industrielles Aspergillus oryzae (pPFJo142)

(2)

Produits des œufs non normalisés

(2)

Bonnes pratiques industrielles Fromage cheddar; fromage (indication de la variété)

(3)

Bonnes pratiques industrielles Aspergillus niger (PLA-54)

(1)

Farine; farine de blé entier; pain

(1)

Bonnes pratiques industrielles

(2)

Produits de boulangerie non normalisés

(2)

Bonnes pratiques industrielles

(3)

Œuf entier non normalisé; jaune d'œuf non normalisé

(3)

Bonnes pratiques industrielles

(4)

Lécithine modifiée

(4)

Bonnes pratiques industrielles P.6 Protéase Aspergillus oryzae var.; Aspergillus niger var.; Bacillus subtilis var.

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(1)

Bonnes pratiques industrielles

(2)

Farine; farine de blé entier; pain

(2)

Bonnes pratiques industrielles

(3)

Préparations aromatisantes à base de produits laitiers

(3)

Bonnes pratiques industrielles

(4)

Moût de distillerie

(4)

Bonnes pratiques industrielles

(5)

Boyaux de saucisses

(5)

Bonnes pratiques industrielles

(6)

Protéines hydrolysées d'origine animale, végétale, ou provenant du lait

(6)

Bonnes pratiques industrielles

(7)

Poudre de fromage de pulvérisation séchée industrielle

(7)

Bonnes pratiques industrielles

(8)

Pièces de viande

(8)

Bonnes pratiques industrielles

(9)

Produits pour attendrir la viande

(9)

Bonnes pratiques industrielles

(10)

Céréales à déjeuner précuites (instantanées)

(10)

Bonnes pratiques industrielles

(11)

Produits de boulangerie non normalisés

(11)

Bonnes pratiques industrielles

(12)

Fromage cheddar; fromage cheddar destiné

(12)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Source permise Colonne III Permis dans ou sur Colonne IV Limites de tolérance P.7 Pullulanase Micrococcus caseolyticus var.

(1)

Fromage (indication de la variété)

(1)

Bonnes pratiques industrielles Bacillus licheniformis (Cx)

(1)

Protéines hydrolysées d’origine animale, végétale ou provenant du lait

(1)

Bonnes pratiques industrielles Bacillus acidopullulyticus NCIB 11647; Bacillus licheniformis SE2-Pul-int211 (pUBCDEBRA11DNSI)

(1)

Farine; farine de blé entier; pain

(1)

Bonnes pratiques industrielles

(2)

Amidon utilisé dans la production des dextrines, du dextrose, du glucose (sirop de glucose), de solides de glucose (sirop de glucose déshydraté) ou de sirops et solides de fructose, du maltose

(2)

Bonnes pratiques industrielles

(3)

Produits de boulangerie non normalisés

(3)

Bonnes pratiques industrielles Bacillus licheniformis BMP 139 (pR11Amp)

(1)

Farine; farine de blé entier; pain

(1)

Bonnes pratiques industrielles

(2)

Moût de bière

(2)

Bonnes pratiques industrielles

(3)

Amidon utilisé dans la production des dextrines, du dextrose, du glucose (sirop de glucose), de solides de glucose (sirop de glucose déshydraté) ou de sirops et solides de fructose, du maltose

(3)

Bonnes pratiques industrielles

(4)

Produits de boulangerie non normalisés

(4)

Bonnes pratiques industrielles Bacillus subtilis B1-163 (pEB301)

(1)

Farine; farine de blé entier; pain

(1)

Bonnes pratiques industrielles

(2)

Moût de bière

(2)

Bonnes pratiques industrielles

(3)

Moût de distillerie

(3)

Bonnes pratiques industrielles

(4)

Amidon utilisé dans la production des dextrines, du dextrose, du glucose (sirop de glucose), de solides de glucose (sirop de glucose déshydraté) ou PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Colonne II Additifs Colonne III Source permise Colonne IV Permis dans ou sur Colonne V Limites de tolérance Bacillus subtilis RB121 (pDG268)

(1)

Moût de bière

(2)

Moût de distillerie

(3)

Amidon utilisé dans la production des dextrines, du dextrose, du glucose (sirop de glucose), du maltose ou de solides de glucose (sirop de glucose déshydraté)

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles R.1 Présure Extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux

(1)

Crème sure; fromage à la crème; fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage à la crème (avec indication des ingrédients ajoutés); fromage cheddar; fromage cottage; fromage (indication de la variété)

(2)

Produits pour desserts à base de lait non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles T.01 Transglutaminase Streptoverticillium mobaraense souche S-8112

(1)

Produits de poisson préparé non normalisés

(2)

Simili-produits de viande

(3)

Produits de fromage non normalisés

(4)

Produits de fromage fondu non normalisés

(5)

Produits de fromage à la crème non normalisés

(6)

Yogourt

(7)

Desserts laitiers congelés non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(6)

Bonnes pratiques industrielles

(7)

Bonnes pratiques industrielles T.1 Trypsine Pancréas de porc (Sus scrofa)

(1)

Protéines hydrolysées d’origine animale ou végétale ou provenant du lait

(1)

Bonnes pratiques industrielles

X

1 Xylanase Aspergillus oryzae Fa 1–1 (pA2X1TI)

(1)

Farine; farine de blé entier; pain

(2)

Produits de boulangerie non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Article

Colonne I Additifs Colonne II Source permise Colonne III Permis dans ou sur Colonne IV Limites de tolérance Aspergillus oryzae JaL 339 (pJaL537); Bacillus subtilis DIDK 0115 (pUB110 OIS2) Bacillus subtilis CF 307 (pJHPapF-XynAss-BS3xylanase#1)

(1)

Farine; farine de blé entier; pain

(2)

Produits de boulangerie non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles TABLE VI Column I Column II Column III Maximum Level of Use A.1 Aluminum Sulphate

(2)

Unstandardized foods

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice A.2 Ammonium Aluminum Sulphate

(2)

Unstandardized foods

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

C

1 Calcium Chloride

(1)

Canned apples

(2)

Canned grapefruit

(3)

(naming the variety) cheese; Cheddar cheese

(4)

Cottage cheese

(5)

Glaze of frozen fish

(6)

Olives

(8)

Tomatoes; Canned vegetables (naming the vegetable); Frozen apples

(9)

Unstandardized foods

(10)

Canned apricots

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice

(6)

1.5% of the brine

(7)

0.4%

(9)

Good Manufacturing Practice

C

2 Calcium Citrate

(1)

Tomatoes; Canned vegetables; Frozen apples; Frozen sliced apples

(2)

Canned apples PART B Foods

Section B.16.100

Column I | Column II | Column III

C

3 | Calcium Gluconate | Unstandardized foods | Good Manufacturing Practice

C

3A | Calcium Lactate | (1) Canned grapefruit | (1) 0.035% of the total calcium content, whether added or otherwise present

C

4 | Calcium Phosphate, dibasic | Unstandardized foods | Good Manufacturing Practice | | (3) Unstandardized foods | (3) Good Manufacturing Practice P.1 | Potassium Aluminum Sulphate | (1) Pickles and relishes | (1) Good Manufacturing Practice | | (2) Unstandardized foods | (2) Good Manufacturing Practice S.1 | Sodium Aluminum Sulphate | (1) Pickles and relishes | (1) Good Manufacturing Practice | | (2) Unstandardized foods | (2) Good Manufacturing Practice TABLEAU VI Additifs alimentaires autorisés comme agents raffermissants Colonne I | Colonne II | Colonne III

Article | Additifs | Permis dans ou sur | Limites de tolérance

A.1 | Sulfate d’aluminium | (1) Crabe; homard; saumon; crevettes et thon en conserve; cornichons et achards (relish) | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Bonnes pratiques industrielles A.2 | Sulfate double d’aluminium et d’ammonium | (1) Cornichons et achards (relish) | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Bonnes pratiques industrielles

C

1 | Chlorure de calcium | (1) Pommes en conserve | (1) 0,026 % calculé en calcium | | (2) Pamplemousses en conserve | (2) 0,035 % de la teneur totale en calcium, qu’il soit ajouté ou autrement présent | | (3) Fromage (indication de la variété); fromage cheddar | (3) 0,02 % du lait et des produits du lait utilisés | | (4) Fromage cottage | (4) Bonnes pratiques industrielles | | (5) Glacage de poisson congelé | (5) Bonnes pratiques industrielles | | (6) Olives | (6) Bonnes pratiques industrielles | | (7) Cornichons et achards (relish) | (7) Bonnes pratiques industrielles | | (8) Tomates; légumes en conserve (nom du légume); pommes congelées; pommes tranchées congelées | (8) 0,026 %, calculé en calcium | | (9) Aliments non normalisés | (9) Bonnes pratiques industrielles | | (10) Abricots en conserve | (10) 0,022 %, calculé en calcium

C

2 | Citrate de calcium | (1) Tomates; légumes en conserve; pommes congelées; pommes tranchées congelées | (1) 0,026 %, calculé en calcium PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

C

3 Gluconate de calcium Aliments non normalisés Bonnes pratiques industrielles

C

3A Lactate de calcium

(1)

Pamplemousses en conserve

(2)

Pois en conserve

(1)

0,035 % de la teneur totale en calcium, qu’il soit ajouté ou autrement présent

(2)

0,035 % calculé en calcium

C

4 Phosphate bicalcique Aliments non normalisés Bonnes pratiques industrielles

C

5 Phosphate monocalcique

(1)

Tomates; légumes en conserve; pommes congelées

(2)

Pommes en conserve

(3)

Aliments non normalisés

(1)

0,02 %, calculé en calcium

(2)

0,02 %, calculé en calcium

(3)

Bonnes pratiques industrielles

C

6 Sulfate de calcium

(1)

Tomates; légumes en conserve; pommes congelées

(2)

Pommes en conserve

(1)

0,026 %, calculé en calcium

(2)

0,026 %, calculé en calcium P.1 Sulfate double d’aluminium et de potassium

(1)

Cornichons et achards (relish)

(2)

Aliments non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles S.1 Sulfate double d’aluminium et de sodium

(1)

Cornichons et achards (relish)

(2)

Aliments non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles SOR/78-402, s. 7; SOR/96-660, ss. 11, 12; SOR/79-752, s. 2; SOR/93-445, s. 5; SOR/2007-202, s. 4; SOR/2010-45, s. 8; SOR/2012-43, ss. 29, 30. TABLE VII Column I Column II Column III Maximum Level of Use A.1 Acetylated Monoglycerides

(1)

Unstandardized confectionery

(2)

Frozen fish

(1)

0.4 %

(2)

Good Manufacturing Practice B.1 Beeswax Unstandardized confectionery

0.4 %

C

1 Carnauba Wax Unstandardized confectionery

0.4 %

C

2 Candelilla Wax Unstandardized confectionery

0.4 %

G.1 Gum Arabic Unstandardized confectionery

0.4 %

G.2 Gum Benzoin Unstandardized confectionery

0.4 %

M

1 Magnesium Silicate Unstandardized confectionery

0.4 %

M

2 Mineral Oil Unstandardized confectionery

0.15 %

P.1 Petrolatum Unstandardized confectionery

0.15 %

S.1 Shellac Cake decorations; Unstandardized confectionery

0.4 %

S.2 Spermaceti Wax Unstandardized confectionery

0.4 %

Z.1 Zein Unstandardized confectionery

1.0 %

TABLEAU VII Additifs alimentaires autorisés comme agents de satinage ou de glaçage Colonne I | Colonne II | Colonne III

Article | Additifs | Permis dans ou sur | Limites de tolérance

A.1 | Monoglycérides acétylés | (1) Confiseries non normalisées | (1) 0,4 % | | (2) Poisson congelé | (2) Bonnes pratiques industrielles B.1 | Cire d’abeilles | Confiseries non normalisées | 0,4 %

C

1 | Cire de carnauba | Confiseries non normalisées | 0,4 %

C

2 | Cire de candelilla | Confiseries non normalisées | 0,4 % G.1 | Gomme arabique | Confiseries non normalisées | 0,4 % G.2 | Résine de benjoin | Confiseries non normalisées | 0,4 %

M

1 | Silicate de magnésium | Confiseries non normalisées | 0,4 %

M

2 | Huile minérale | Confiseries non normalisées | 0,4 % P.1 | Vaseline | Confiseries non normalisées | 0,15 % S.1 | Gomme laque | Confiseries non normalisées, décorations à gâteaux | 0,4 % S.2 | Spermaceti | Confiseries non normalisées | 0,4 % Z.1 | Zéine | Confiseries non normalisées | 1,0 % TABLE VIII Column I | Column II | Column III | Column IV A.01 | Acacia Gum | Ale; Beer; Light beer; Malt liquor; Porter; Stout; Wine | Fining agent | Good Manufacturing Practice A.1 | Acetylated Monoglycerides | Unstandardized foods | Coating; Release agent | Good Manufacturing Practice A.1.01 | Agar | Wine | Fining agent | Good Manufacturing Practice A.1.1 | Aluminum Sulphate | Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk | To stabilize albumen during pasteurization | 0.036% A.2 | Ammonium Persulphate | Brewer’s yeast | Antimicrobial agent | 0.1% A.3 | [Repealed, SOR/93-276, s. 4] A.4 | [Repealed, SOR/93-276, s. 5] B.2 | Beeswax | Unstandardized foods | Antisticking agent | 0.4% PART B Foods

Section B.16.100

Column I | Column II | Column III | Column IV

C

3 | Calcium Carbonate | (1) Flour; Whole wheat flour | (1) Carrier of benzoyl peroxide | (1) 900 p.p.m., in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi) | (2) [Repealed, SOR/94-227, s. 5] | | | | (3) Unstandardized confectionery | (3) Creaming and fixing agent | (3) Good Manufacturing Practice | (4) Chewing gum | (4) Filler | (4) Good Manufacturing Practice | (5) Unstandardized foods | (5) Carrier and dusting agent | (5) Good Manufacturing Practice

C

3A | Calcium Lactate | (1) Egg albumen (delysozymized) | (1) Restoration of functional properties | (1) Good Manufacturing Practice (Quantity of calcium added not to exceed that lost during processing) | (2) A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n) | (2) To modify texture | (2) Good Manufacturing Practice | (2) A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n) | (2) To modify texture | (2) Good Manufacturing Practice

C

5 | Calcium Phosphate dibasic | (1) Flour; Whole wheat flour | (1) Carrier of benzoyl peroxide | (1) 900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi)

C

6 | Calcium Phosphate, tribasic | (1) Flour; Whole wheat flour | (1) Carrier of benzoyl peroxide | (1) 900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi) | (2) [Repealed, SOR/94-227, s. 6] | | | PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Column I | Column II | Column III | Column IV

C

7 | Calcium Silicate | Oil-soluble annatto | Carrier | Good Manufacturing Practice

C

8 | Calcium Stearate | Unstandardized confectionery | Release agent | Good Manufacturing Practice

C

9 | Calcium Stearoyl-2-Lactylate |

(1)

Frozen egg-white (frozen albumen); Liquid egg-white (liquid albumen) | (1) Whipping agent | (1) 0.05%

(2)

Dried egg-white (dried albumen) | (2) Whipping agent | (2) 0.5%

(3)

Vegetable fat toppings | (3) Whipping agent | (3) 0.3%

(4)

Dehydrated potatoes | (4) Conditioning agent | (4) 0.2% of dry weight

C

10 | Calcium Sulphate |

(1)

Flour, Whole wheat flour | (1) Carrier of benzoyl peroxide | (1) 900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi)

C

11 | Carbon Dioxide |

(2)

Unstandardized foods | (2) Carbonation and pressure dispensing agent | (2) Good Manufacturing Practice

(2)

[Repealed, SOR/94-227, s. 7]

(2)

[Repealed, SOR/94-227, s. 8]

(3)

Baking powder | (3) Neutral filler | (3) Good Manufacturing Practice Column I

C

11.1 | Carboxymethyl Cellulose, cross-linked (Sodium Carboxymethyl Cellulose, cross-linked)

C

12 | Castor Oil

C

13 | [Repealed, SOR/2010-142, s. 35]

C

13.1 | Cellulose, Powdered

C

14A | Chloropentafluoroethane

C

15 | Citric Acid

C

16 | Copper gluconate

C

17 | Copper Sulphate

D

1 | Dimethylpolysiloxane Formulations Column II

(3)

Cottage Cheese; Creamed Cottage Cheese Table-top sweetener tablets that contain acesulfame-potassium, aspartame, erythritol, neotame or sucralose Unstandardized confectionery

(1)

Batter and breading

(2)

Canapé toast

(4)

Unstandardized edible ices

(5)

Fillings

(6)

Foods sold in tablet form

(7)

Icings

(8)

Seasonings

(9)

Sweet baked goods Unstandardized foods

(1)

Beef blood

(2)

Unstandardized foods Wine Column III

(3)

To extend durable life Tablet disintegration Release agent

(1)

Bulking agent

(2)

Bulking agent

(3)

Bulking agent

(4)

Bulking agent

(5)

Bulking agent

(6)

Bulking agent

(7)

Bulking agent

(8)

Bulking agent

(9)

Bulking agent

(1)

Anticoagulant

(2)

Culture nutrient Fining agent

(1)

Antifoaming agent Column IV Maximum Level of Use

(3)

Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice

(1)

1%

(2)

2%

(3)

25%

(4)

3%

(5)

0.5%

(6)

50%

(7)

1%

(8)

3%

(9)

8% Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice 50 p.p.m.

(1)

10 p.p.m. of dimethylpolysiloxane PART B Foods

Section B.16.100

Column I | Column II | Column III | Column IV juice; Shortening; Skim milk powder; Wine

(2)

Anti-foaming agent

(2)

10 p.p.m. of dimethylpolysiloxane

(3)

Release agent

(3)

Good Manufacturing Practice (Residue of dimethylpolysiloxane in food not to exceed 10 p.p.m.)

(4)

Unstandardized foods

(4)

Antifoaming agent

(4)

10 p.p.m. of dimethylpolysiloxane

(5)

Antifoaming agent

(5)

10 p.p.m. of dimethylpolysiloxane

D

3 | Dioctyl sodium sulfosuccinate | (1) Fumaric acid-acidulated dry beverage bases | (1) Wetting agent | (1) 10 p.p.m. in the finished drink

(2)

Sausage casings | (2) Reduce casing breakage | (2) 200 p.p.m. of the casing E.1 | Ethoxyquin | Paprika; Ground chili pepper | To promote colour retention | 100 p.p.m. E.2 | [Repealed, SOR/2016-143, s. 1] F.1 | Ferrous Gluconate | Ripe olives | Colour retention | Good Manufacturing Practice G.1 | Gelatin | Beer; Cider; Wine | Fining agent | Good Manufacturing Practice G.2 | [Repealed, SOR/89-175, s. 2] G.2A | Glucono delta lactone | (1) Cooked sausage, Meat Loaf | (1) To accelerate colour fixing | (1) 0.5%

(2)

Dry Sausage | (2) To assist in curing | (2) Good Manufacturing Practice G.3 | Glycerol | (1) Meat curing compounds; Sausage casings | (1) Humectant | (1) Good Manufacturing Practice

(2)

Preserved meats (Division 14) | (2) Glaze for preserved meats | (2) Good Manufacturing Practice

(3)

Unstandardized foods | (3) Humectant; Plasticizer | (3) Good Manufacturing Practice G.4 | Glycerol ester of wood or spruce oils | Beverages containing citrus oils | Density adjusting agent | 100 p.p.m. H.1 | Hydrogen Peroxide | (1) Brewers’ mash | (1) Clarification aid | (1) 135 p.p.m. in the mash

(2)

Liquid whey destined for the manufacture of dried whey products | (2) To decolourize and maintain pH | (2) 100 p.p.m. (see also subitem C.1(3) of Table V)

(3)

Oat hulls used in the manufacture of oat hull fibre | (3) Bleaching agent | (3) Good Manufacturing Practice PART B Foods

Section B.16.100

Column I | Column II | Column III | Column IV

L

3 | Lecithin | (1) Surfaces that come in contact with food | (1) Release agent | (1) Good Manufacturing Practice | | (2) Infant cereal products | (2) Release agent | (2) 1.75% as consumed

L

4 | L-Leucine | Table-top sweetener tablets that contain acesulfame-potassium, aspartame, erythritol, neotame or sucralose | Lubricant or binder in tablet manufacture | Good Manufacturing Practice

M

1 | Magnesium Aluminum Silicate | Chewing gum | Dusting agent | Good Manufacturing Practice

M

2 | Magnesium Carbonate | (1) Flour, Whole wheat flour | (1) Carrier of benzoyl peroxide | (1) 900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi) | | (2) [Repealed, SOR/94-227, s. 9] | | | | (3) Unstandardized confectionery | (3) Release agent | (3) Good Manufacturing Practice

M

3 | Magnesium Silicate | (1) Unstandardized confectionery | (1) Release agent | (1) Good Manufacturing Practice | | (2) Chewing gum | (2) Dusting agent | (2) Good Manufacturing Practice | | (3) Rice | (3) Coating | (3) Good Manufacturing Practice

M

4 | Magnesium Stearate | (1) Unstandardized confectionery | (1) Release agent | (1) Good Manufacturing Practice | | (2) Foods sold in tablet form | (2) Binding agent | (2) Good Manufacturing Practice

M

5A | [Repealed, SOR/93-276, s. 6] | | |

M

5C | Methyl Ethyl Cellulose | Unstandardized foods | Aerating agent | Good Manufacturing Practice

M

6 | Microcrystalline Cellulose | (1) Ice milk mix | (1) Bodying and texturizing agent | (1) 1.5% | | (2) Sherbet | (2) Bodying and texturizing agent | (2) 0.5% Column I Column II Column III Column IV Maximum Level of Use

(4)

Whipped vegetable oil topping

(4)

Bodying and texturizing agent

(4)

1.5%

(5)

Unstandardized frozen desserts

(5)

Bodying and texturizing agent

(5)

0.5%

(6)

Unstandardized sandwich spreads; Unstandardized dips

(6)

Bodying and texturizing agent

(6)

3.0%

(7)

Bodying and texturizing agent

(7)

2.0%

(8)

Ice cream mix

(8)

Bodying and texturizing agent

(9)

Table-top sweetener tablets containing aspartame

(9)

Tablet disintegration

(9)

2.2%

(10)

Cream for whipping

(10)

Stabilizing and thickening agent

(10)

0.2%

(11)

Breath freshener products

(11)

Bodying and texturizing agent

(11)

9.0%

M

7 Mineral Oil

(1)

Bakery products; Seeded raisins; Unstandardized confectionery

(1)

Release agent

(2)

Fresh fruits and vegetables

(2)

Coating

(3)

Sausage casings

(3)

Lubricant

(3)

5% in accordance with paragraph B.01.047(e) (Residues of mineral oil in a raw sausage prepared with such casings not to exceed 200 p.p.m.; in cooked sausage, 30 p.p.m.)

M

8 Monoacetin

(4)

Salt Substitute

(4)

0.6% in accordance with paragraph B.01.047(h)

(1)

Antifoaming agent

(1)

Good Manufacturing Practice PART B Foods

Section B.16.100

Column I | Column II | Column III | Column IV

M

10 | Mono-glycerides | Unstandardized foods | (2) Antifoaming agent; Humectant; Release agent | (2) Good Manufacturing Practice N.1 | Nitrogen | (1) Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients) | (1) To improve spreadability | (1) Good Manufacturing Practice | | (2) Margarine | (2) To improve spreadability | (2) Good Manufacturing Practice | | (3) Unstandardized foods | (3) Pressure dispensing agent | (3) Good Manufacturing Practice N.2 | Nitrous Oxide | Unstandardized foods | Pressure dispensing agent | Good Manufacturing Practice O.2 | Oxystearin | Cotton seed oil; Peanut oil; Soy bean oil | To inhibit crystal formation | 0.125% O.3 | Ozone | (1) Cider | (1) Maturing agent | (1) Good Manufacturing Practice | | (3) Wine | (3) Maturing agent | (3) Good Manufacturing Practice P.1 | Pancreas Extract | Acid producing bacterial cultures | To control bacteriophages | Good Manufacturing Practice P.1A | Paraffin Wax | (1) Fresh fruits and vegetables | (1) Coating | (1) 0.3% in accordance with section B.01.047 P.2A | Polyethylene glycol (molecular weight 3000-9000) | (2) Fresh fruits and vegetables | (2) Coating | (2) 0.3% in accordance with section B.01.047 | | (1) Soft drinks | (1) Antifoaming agent | (1) 10 p.p.m. | | (2) Table-top sweetener tablets containing aspartame | (2) Lubricant | (2) 1.0% Column I Column II Column III Column IV Maximum Level of Use P.2B | Polydextrose

(3)

L-Lysine tablets

(3)

Tablet binder

(3)

7.0% Unstandardized foods Good Manufacturing Practice P.3 | Polyvinylpyrrolidone

(1)

Ale; Beer; Cider; Light beer; Malt liquor; Porter; Stout; Wine

(1)

Fining agent

(2)

Table-top sweetener tablets containing aspartame

(2)

Tablet binder

(2)

0.3%

(3)

Colour lake dispersions for use in unstandardized confectionery in tablet form

(3)

Good Manufacturing Practice (Residues of polyvinyl pyrrolidone not to exceed 100 p.p.m. in the finished foods) P.4 | Potassium Aluminum Sulphate Flour; Whole wheat flour 900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi) P.4.1 | Potassium Ferrocyanide Wine Fining agent Good Manufacturing Practice P.5 | Potassium Stearate

(1)

Chewing gum

(1)

Plasticizing agent

(1)

Good Manufacturing Practice

(2)

Emulsifying preparations containing propylene glycol monoesters

(2)

Stabilizing agent

(2)

2% P.6 | Propane Unstandardized foods Good Manufacturing Practice P.7 | Propylene Glycol

(1)

Oil-soluble annatto

(1)

Solvent

(1)

Good Manufacturing Practice

(2)

Unstandardized foods

(2)

Humectant

(2)

Good Manufacturing Practice Q.1 | Quillaia Extract Foaming Agent Good Manufacturing Practice S.1 | Saponin Foaming agent Good Manufacturing Practice S.1.01 | Silicon Dioxide Suspending agent

2.0% of preparation

S.1.1 | Sodium Acid Pyrophosphate S.2 | Sodium Aluminum Sulphate Flour; Whole wheat flour 900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi) S.3 | Sodium Bicarbonate

(1)

Unstandardized confectionery

(1)

Aerating agent

(1)

Good Manufacturing Practice

(2)

Salt

(2)

To stabilize potassium iodide in salt

(2)

Good Manufacturing Practice Column I S.3A | Sodium Carbonate S.3B | Sodium Carboxymethyl Cellulose S.4 | Sodium Citrate S.5 | Sodium Ferrocyanide Decahydrate S.6 | Sodium Hexametaphosphate S.6A | Sodium Hydroxide S.6.1 | Sodium Lauryl Sulphate S.6.2 | Sodium Potassium Copper Chlorophyllin S.7 | Sodium Phosphate, dibasic S.7.1 | Sodium Pyrophosphate, tetrabasic S.8 | Sodium Silicate S.9 | Sodium Stearate S.9A | Sodium Stearoyl-2-Lactylate Column II

(1)

Beef blood

(2)

Sour cream Dendritic salt

(1)

Beef blood

(3)

Gelatin intended for marshmallow compositions

(1)

Dried egg-white (dried albumen)

(2)

Frozen egg-white (frozen albumen); Liquid egg-white (liquid albumen)

(3)

Gelatin intended for marshmallow compositions

(1)

Frozen fish

(2)

Frozen mushrooms Chewing gum

(1)

Frozen egg-white (frozen albumen); Liquid egg-white (liquid albumen) Column III Coating to enable peeling

(1)

Anticoagulant

(2)

Flavour precursor

(3)

To modify texture As an adjuvant in the production of dendritic salt crystals

(1)

Anti-coagulant

(2)

To reduce thaw drip

(3)

Whipping agent

(1)

Whipping agent

(2)

Whipping agent

(3)

Whipping agent

(1)

To prevent cracking of glaze

(2)

To prevent discolouration

(1)

Whipping agent Column IV Maximum Level of Use 15% of the combination of sodium carbonate and sodium hexametaphosphate

0.25% of the casing

(1)

0.5%

(2)

0.1%

(3)

Good Manufacturing Practice

(1)

0.2%

(3)

2%

(1)

0.1%

(2)

0.0125%

(3)

0.5% 700 p.p.m.

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice

(1)

0.05% PART B Foods

Section B.16.100

Column I | Column II | Column III | Column IV S.9B | Sodium Sulphate | Frozen mushrooms | To prevent discolouration | Good Manufacturing Practice S.9C | Sodium Sulphite | Canned flaked tuna | To prevent discolouration | 300 p.p.m. S.10 | Sodium Thiosulphate | Salt | To stabilize potassium iodide in salt | Good Manufacturing Practice S.12 | [Repealed, SOR/93-276, s. 8] S.14 | Stearic Acid | (1) Unstandardized confectionery | (1) Release agent | (1) Good Manufacturing Practice | | (2) Chewing gum | (2) Plasticizing agent | (2) Good Manufacturing Practice | | (3) Foods sold in tablet form | (3) Release agent and lubricant | (3) Good Manufacturing Practice S.15A | [Repealed, SOR/93-276, s. 9] S.17 | Sulphuric Acid | Coffee beans | To improve the extraction yield of coffee solids | Good Manufacturing Practice T.1 | Talc | (1) Dried split legumes; Rice | (1) Coating agent | (1) Good Manufacturing Practice | | (2) Chewing gum base | (2) Filler | (2) Good Manufacturing Practice | | (3) Chewing gum | (3) Dusting agent | (3) Good Manufacturing Practice PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Column I | Column II | Column III | Column IV T.2 | Tannic Acid | (1) Chewing gum | (1) To reduce adhesion | (1) Good Manufacturing Practice | | (2) Cider; Honey wine; Wine | (2) Fining agent | (2) 200 p.p.m T.2A | [Repealed, SOR/93-276, s. 10] T.3 | Triacetin | Cake mixes | Wetting agent | Good Manufacturing Practice T.4 | Triethyl Citrate | Dried egg-white (dried albumen); Frozen egg-white (frozen albumen); Liquid egg-white (liquid albumen) | Whipping agent | 0.25%

X

1 | [Repealed, SOR/93-276, s. 11] TABLEAU VIII Additifs alimentaires divers Colonne I | Colonne II | Colonne III | Colonne IV

Article | Additifs | Permis dans ou sur | But de l’emploi | Limites de tolérance

A.01 | Gomme arabique | Ale; bière; bière légère; liqueur de malt; porter; stout; vin | Agent de collage | Bonnes pratiques industrielles A.1 | Mono-glycérides acétylés | Aliments non normalisés | Couverture; agent de démoulage | Bonnes pratiques industrielles A.1.01 | Agar-agar | Vin | Agent de collage | Bonnes pratiques industrielles A.1.1 | Sulphate d’aluminium | Blanc d’œuf congelé (albumen congelé); blanc d’œuf liquide (albumen liquide); jaune d’œuf congelé; jaune d’œuf liquide; œuf entier congelé; œuf entier liquide; poudre de blanc d’œuf (poudre d’albumen); poudre de jaune d’œuf; poudre d’œuf entier | Pour stabiliser l’albumen durant la pasteurisation | 0,036 % A.2 | Persulfate d’ammoniaque | Levure de bière | Agent anti- microbien | 0,1 % A.3 | [Abrogé, DORS/93-276, art. 4] A.4 | [Abrogé, DORS/93-276, art. 5] B.2 | Cire d’abeilles | Aliments non normalisés | Agent anticollant | 0,4 % B.2.1 | Peroxyde de benzoyle | Petit-lait liquide destiné à la fabrication de produits de petit-lait séché autres que ceux entrant dans les préparations pour nourrissons | Décolorer | 100 p.p.m. B.3 | Huile végétale bromée | Préparation aromatisante de (nom de l’arôme) pour utilisation dans les boissons contenant des huiles d’agrumes ou d’épinettes | Agent modificateur de la densité | 15 p.p.m. dans les boissons contenant des huiles d’agrumes ou d’épinettes sous leur forme consommable B.4 | n-Butane | Enduits aux casseroles, à base d’huile végétale | Agent de propulsion | Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I | Colonne II | Colonne III | Colonne IV

Article | Additifs | Permis dans ou sur | But de l’emploi | Limites de tolérance

C

1 | Caféine | Breuvages de type cola | Caractéristique du produit | 200 p.p.m. dans le produit fini

C

2 | Citrate de caféine | Breuvages de type cola | Caractéristique du produit | 200 p.p.m., calculé en caféine, dans le produit fini

C

3 | Carbonate de calcium | (1) Farine; farine de blé entier | (1) Véhicule du peroxyde de benzoyle | (1) 900 p.p.m., conformément aux sous-alinéas B.13.001e)(vi) et B.13.005d)(vi) | | (2) [Abrogé, DORS/94-227, art. 5] | | | | (3) Confiseries non normalisées | (3) Créer et fixer | (3) Bonnes pratiques industrielles | | (4) Gomme à mâcher | (4) Agent de remplissage | (4) Bonnes pratiques industrielles | | (5) Aliments non normalisés | (5) Véhicule et agent de saupoudrage | (5) Bonnes pratiques industrielles

C

3.01 | Chlorure de calcium | Saucisse avec enrobage comestible | Stabiliser l’enrobage comestible | Bonnes pratiques industrielles

C

3A | Lactate de calcium | (1) Albumine de l’œuf (désylosylée) | (1) Restauration des propriétés fonctionnelles | (1) Bonnes pratiques industrielles lors du processus de transformation

C

4 | Oxyde de calcium | (2) Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n) | (2) Modifier la texture | (2) Bonnes pratiques industrielles | | (3) Saucisse avec enrobage comestible | (3) Stabiliser l’enrobage comestible | (3) Bonnes pratiques industrielles | | (1) Crustacés et mollusques congelés | (1) Faciliter l’enlèvement des matières étrangères et réduire la déperdition d’humidité pendant la cuisson | (1) Lorsque employé en combinaison avec le chlorure de sodium (sel) et l’hydroxyde de sodium en solution, l’oxyde de calcium ajouté ne doit pas dépasser 30 p.p.m.

C

5 | Phosphate bicalcique | (2) Mélange de poisson et de viande préparés visés à l’alinéa B.21.006n) | (2) Modifier la texture | (2) Bonnes pratiques industrielles | | (1) Farine; farine de blé entier | (1) Véhicule du peroxyde de benzoyle | (1) 900 p.p.m., conformément aux sous-alinéas B.13.001e)(vi) et B.13.005d)(vi)

C

6 | Phosphate tricalcique | (1) Farine; farine de blé entier | (1) Véhicule du peroxyde de benzoyle | (1) 900 p.p.m., conformément aux sous-alinéas B.13.001e)(vi) et B.13.005d)(vi) | | (2) [Abrogé, DORS/94-227, art. 6] | | | | (3) Petit-lait liquide destiné à la fabrication de produits de petit-lait séché autres que | (3) Véhicule du peroxyde de benzoyle | (3) 0,04 % des produits de petit-lait séché PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III But de l’emploi Colonne IV Limites de tolérance ceux entrant dans les préparations pour nourrissons

(4)

Fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(4)

Améliorer la couleur, la texture, la consistance et la tartinabilité

(4)

1,0 %

C

7 Silicate de calcium Rocou soluble dans l’huile Véhicule Bonnes pratiques industrielles

C

8 Stéarate de calcium Confiseries non normalisées Agent de démoulage Bonnes pratiques industrielles

C

9 Stéaryl-2-lactylate de calcium

(1)

Blanc d’œuf congelé (albumen congelé); blanc d’œuf liquide (albumen liquide)

(2)

Poudre de blanc d’œuf (poudre d’albumen)

(3)

Garnitures de graisse végétale

(4)

Pommes de terre déshydratées

(1)

Faire monter en neige

(2)

Faire monter en neige

(3)

Faire mousser

(4)

Agent de conditionnement

(1)

0,05 %

(2)

0,5 %

(3)

0,3 %

(4)

0,2 % du poids à l’état sec

C

10 Sulfate de calcium

(1)

Farine; farine de blé entier

(1)

Véhicule du peroxyde de benzoyle

(1)

900 p.p.m. conformément aux sous-alinéas B.13.001(1)e)(vi) et B.13.005d)(vi)

(2)

[Abrogé, DORS/94-227, art. 8]

(3)

Poudre à pâte

(3)

Remplissage neutre

(3)

Bonnes pratiques industrielles

(4)

Petit-lait liquide destiné à la fabrication de produits de petit-lait sèche autres que ceux entrant dans les préparations pour nourrissons

(4)

Véhicule du peroxyde de benzoyle

(4)

0,3 % des produits de petit-lait séché

C

11 Anhydride carbonique

(1)

Ale; bière; jus de (nom du fruit) gazeux; bière légère; liqueur de malt; porter; cidre; stout; vins; eau dite eau minérale ou eau de source

(1)

Rendre mousseux

(1)

Bonnes pratiques industrielles

(2)

Aliments non normalisés

(2)

Agent pulseur ou pour rendre mousseux

(2)

Bonnes pratiques industrielles

(3)

Fromage cottage; fromage cottage en crème

(3)

Prolonger la durée de conservation

(3)

Bonnes pratiques industrielles

C

11.1 Carboxyméthylcellulose, réticulé Édulcorants de table sous forme de comprimé Désagrégation des comprimés Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I | Colonne II | Colonne III | Colonne IV

Article | Additifs | Permis dans ou sur | But de l’emploi | Limites de tolérance

(Carboxyméthylcellulose sodique, réticulé) | contenant de l’acésulfame-potassium, de l’aspartame, de l’érythritol, du néotame ou du sucralose

C

12 | Huile de ricin | Confiseries non normalisées | Agent de démoulage | Bonnes pratiques industrielles

C

13 | [Abrogé, DORS/2010-142, art. 35]

C

13.1 | Cellulose en poudre | (1) Pâte à frire et chapelure | (1) Agent de remplissage | (1) 1 % | | (2) Biscuits | (2) Agent de remplissage | (2) 2 % | | (3) Confiseries non normalisées qui répondent aux critères mentionnés à la colonne 2 de l’article 3 du tableau suivant l’article B.01.513 en regard du sujet « énergie réduite » visé à la colonne 1 | (3) Agent de remplissage | (3) 25 % | | (4) Glaces comestibles non normalisées | (4) Agent de remplissage | (4) 3 % | | (5) Garnitures | (5) Agent de remplissage | (5) 0,5 % | | (6) Aliments vendus sous forme de comprimés | (6) Agent de remplissage | (6) 50 % | | (7) Glaçages | (7) Agent de remplissage | (7) 8 % | | (8) Assaisonnements | (8) Agent de remplissage | (8) 3 % | | (9) Produits de boulangerie sucrés | (9) Agent de remplissage | (9) 8 %

C

14A | Chloropentafluoréthane | Aliments non normalisés | Agent pulseur et agent d’aération | Bonnes pratiques industrielles

C

15 | Acide citrique | (1) Sang de bœuf | (1) Anticoagulant | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Nourrir les cultures | (2) Bonnes pratiques industrielles

C

16 | Gluconate de cuivre | Rafraîchisseurs d’haleine | Caractéristique du produit | 50 p.p.m.

C

17 | Sulfate de cuivre | Vin | Agent de collage | 0,0001 % calculé en cuivre dans le produit fini

D

1 | Formules à base de diméthyl-polysiloxane | (1) Confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; huiles et graisses; jus de citron reconstitué; jus de lime reconstitué; lait écrémé en poudre; marmelade d’ananas; marmelade d’ananas avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; marmelade de figues; marmelade de figues avec pectine; shortening; vin | (1) Agent antimousse | (1) 10 p.p.m. de diméthylpolysiloxane PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III But de l’emploi Colonne IV Limites de tolérance

(2)

Jus d’ananas; Mélanges de jus d’ananas avec d’autres jus de fruits; ananas en conserve (lorsque le jus d’ananas est utilisé comme véhicule de conditionnement)

(2)

Agent anti-mousse

(2)

10 p.p.m. de diméthylpolysiloxane

(3)

Surfaces entrant en contact avec les aliments

(3)

Agent de démoulage

(3)

Bonnes pratiques industrielles. (Les résidus de diméthylpolysiloxane dans l’aliment ne doivent pas excéder 10 p.p.m.)

(4)

Aliments non normalisés

(4)

Agent antimousse

(4)

10 p.p.m. de diméthylpolysiloxane

(5)

Moût utilisé dans la fabrication d’ale, de bière, de bière légère, de liqueur de malt, de porter et de stout

(5)

Agent antimousse

(5)

10 p.p.m. de diméthylpolysiloxane

D

3 Dioctyl sulfo-succinate sodique

(1)

Bases sèches de boissons acidulées à l’acide fumarique

(1)

Agent humidifiant

(1)

10 p.p.m. dans la boisson finie

(2)

Boyaux de saucisse

(2)

Réduit la rupture et la rigidité

(2)

200 p.p.m. au boyau E.1 Ethoxyquin Paprika; piment rouge moulu Pour favoriser la conservation de la couleur 100 p.p.m. E.2 [Abrogé, DORS/2016-143, art. 1] F.1 Gluconate ferreux Olives mûres Fixer la couleur Bonnes pratiques industrielles G.1 Gélatine Bière; cidre; vin Agent de collage Bonnes pratiques industrielles G.2 [Abrogé, DORS/89-175, art. 2] G.2A Glucono-delta-lactone

(1)

Pain de viande; saucisse cuite

(1)

Activer la fixation de la couleur

(1)

0,5 %

(2)

Saucisse sèche

(2)

Faciliter le séchage

(2)

Bonnes pratiques industrielles G.3 Glycérol

(1)

Mélanges de salaison des viandes; boyaux à saucisse

(1)

Humidifier

(1)

Bonnes pratiques industrielles

(2)

Viandes de salaison (Titre 14)

(2)

Glacer la surface de ces viandes

(2)

Bonnes pratiques industrielles

(3)

Aliments non normalisés

(3)

Humidifier; lustrer

(3)

Bonnes pratiques industrielles G.4 Ester glycérique de la colophane Boissons contenant des huiles d’agrumes ou d’épinette Agent modificateur de la densité 100 p.p.m. H.1 Peroxyde d’hydrogène

(1)

Moût de bière

(1)

Adjuvant de clarification

(1)

135 p.p.m. dans le moût

(2)

Petit-lait liquide destiné à la fabrication de produits de petit-lait séché

(2)

Pour décolorer et maintenir le pH

(2)

100 p.p.m. (voir aussi le paragraphe C.1(3) du tableau V)

(3)

Balle d’avoine utilisée dans la fabrication de fibre de balle d’avoine

(3)

Agent de blanchiment

(3)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III But de l’emploi Colonne IV Limites de tolérance I Isobutane Enduits pour casseroles à base d’huile végétale comestible, de lécithine ou d’un mélange des deux Agent de propulsion Bonnes pratiques industrielles

L

1 Esters lactyliques d’acides gras Aliments non normalisés Agent plastifiant Bonnes pratiques industrielles

L

2 Lanoline Gomme à mâcher Agent plastifiant Bonnes pratiques industrielles

L

3 Lécithine

(1)

Surfaces entrant en contact avec les aliments

(1)

Agent de démoulage

(1)

Bonnes pratiques industrielles

(2)

Produits céréaliers pour bébés

(2)

Agent de démoulage

(2)

1,75 % du produit céréalier pour bébés prêt à consommer

L

4 L-Leucine Édulcorants de table sous forme de comprimé contenant de l’acésulfame-potassium, de l’aspartame, de l’érythritol, du néotame ou du sucralose Lubrifiant au liant utilisé dans la fabrication des comprimés Bonnes pratiques industrielles

M

1 Silicate d’aluminium et de magnésium Gomme à mâcher Agent de saupoudrage Bonnes pratiques industrielles

M

2 Carbonate de magnésium

(1)

Farine; farine de blé entier

(1)

Prévenir le peluchage des aliments aux sous-alinéas B.13.001(1)(vi) et B.13.005d)(vi)

(2)

[Abrogé, DORS/94-227, art. 9]

(3)

Confiseries non normalisées

(3)

Agent de démoulage

(3)

Bonnes pratiques industrielles

M

2A Chlorure de magnésium Albumine de l’œuf (délysosymisée) Restauration des propriétés fonctionnelles Bonnes pratiques industrielles (la quantité de magnésium ajoutée ne doit pas excéder celle perdue lors du processus de transformation)

M

3 Silicate de magnésium

(1)

Confiseries non normalisées

(1)

Agent de démoulage

(1)

Bonnes pratiques industrielles

(2)

Gomme à mâcher

(2)

Agent de saupoudrage

(2)

Bonnes pratiques industrielles

(3)

Riz

(3)

Enrober

(3)

Bonnes pratiques industrielles

M

4 Stéarate de magnésium

(1)

Confiseries non normalisées

(1)

Agent de démoulage

(1)

Bonnes pratiques industrielles

(2)

Aliments vendus sous forme de comprimés

(2)

Liant

(2)

Bonnes pratiques industrielles

M

4A Sulfate de magnésium Albumine de l’œuf (délysosymisée) Restauration des propriétés fonctionnelles Bonnes pratiques industrielles (la quantité de magnésium ajoutée ne doit pas excéder celle perdue lors du processus de transformation)

M

5A [Abrogé, DORS/93-276, art. 6]

M

5C Cellulose méthyl-éthylique Aliments non normalisés Agent d’aération Bonnes pratiques industrielles PART B Foods

Section B.16.100

Article | Colonne I | Colonne II | Colonne III | Colonne IV

---|---|---|---|---

M

6 | Additifs | Permis dans ou sur | But de l’emploi | Limites de tolérance | Cellulose microcristalline | (1) Mélange pour lait glacé | (1) Agent texturant et épaississant | (1) 1,5 % | | (2) Sorbet laitier | (2) Agent texturant et épaississant | (2) 0,5 % | | (3) Aliments non normalisés qui répondent aux critères mentionnés à la colonne 2 de l’article 3 du tableau suivant l’article B.01.513 en regard du sujet « énergie réduite » visé à la colonne 1 | (3) Agent de remplissage | (3) Bonnes pratiques industrielles | | (4) Garniture fouettée à l’huile végétale | (4) Agent texturant et épaississant | (4) 1,5 % | | (5) Desserts congelés non normalisés | (5) Agent texturant et épaississant | (5) 0,5 % | | (6) Tartinades à sandwich non normalisées; trempettes non normalisées | (6) Agent texturant et épaississant | (6) 3,0 % | | (7) Aliments non normalisés autres que les aliments non normalisés mentionnés au présent article | (7) Agent texturant et épaississant | (7) 2,0 % | | (8) Mélange pour crème glacée | (8) Agent texturant et épaississant | (8) 0,8 % ou, s’il est employé en association avec des agents stabilisants, la quantité totale ne doit pas dépasser 0,5 % de la partie sèche totale du mélange | | (9) Édulcorant de table sous forme de comprimé contenant de l’aspartame | (9) Désagrégation des comprimés | (9) 2,2 % | | (10) Crème à fouetter | (10) Agent stabilisant et épaississant | (10) 0,2 % | | (11) Rafraîchisseurs d’haleine | (11) Agent texturant et épaississant | (11) 9,0 %

M

7 | Huile minérale | (1) Confiseries non normalisées; produits de boulangerie; raisins secs épépinés | (1) Agent de démoulage | (1) 0,3 %, conformément à l’article B.01.047. Si la vaseline est également utilisée dans les produits de boulangerie, comme agent de démoulage, la quantité totale de toute combinaison de vaseline et d’huile minérale ne doit pas dépasser 0,15 % | | (2) Fruits et légumes frais | (2) Badigeonner | (2) 0,3 % conformément à l’article B.01.047 | | (3) Boyaux de saucisse | (3) Lubrifiant | (3) 5 % conformément à l’alinéa B.01.047c) (les résidus d’huile minérale dans les saucisses crues préparées avec ces boyaux ne doivent pas dépasser PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I | Colonne II | Colonne III | Colonne IV

Article | Additifs | Permis dans ou sur | But de l’emploi | Limites de tolérance

M

8 | Monoacétyne | (4) Succédané de sel | (4) Agent liant et enrobe protecteur | 200 p.p.m.; dans les saucisses cuites, 30 p.p.m. (4) 0,6 %, conformément à l’alinéa B.01.047h)

M

9 | Mono- et diglycérides | Produits de boulangerie non normalisés | Agent plastifiant | Bonnes pratiques industrielles | | (1) Confiture de pommes (ou de rhubarbe) et de (nom du fruit); huiles et graisses; marmelade de figues; marmelade de figues avec pectine; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; marmelade de (nom du fruit); marmelade de (nom de l’agrume) avec pectine; marmelade d’ananas; marmelade d’ananas avec pectine | (1) Agent antimousse | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | |

M

10 | Mono-glycérides | Aliments non normalisés | Agent antimousse; humidifiant; agent de démoulage | (2) Bonnes pratiques industrielles N.1 | Azote | (1) Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés) | (1) Pour améliorer la tartinabilité | (1) Bonnes pratiques industrielles | | (2) Margarine | (2) Pour améliorer la tartinabilité | (2) Bonnes pratiques industrielles | | (3) Aliments non normalisés | (3) Agent pulseur | (3) Bonnes pratiques industrielles N.2 | Oxyde d’azote | Aliments non normalisés | Agent pulseur | Bonnes pratiques industrielles O.1 | Octafluoro-cyclobutane | Aliments non normalisés | Agent pulseur et agent d’aération | Bonnes pratiques industrielles O.2 | Oxystéarine | Huile de graines de cotonnier; huile d’arachides; huile de soja | Empêcher la formation de cristaux | 0,125 % O.3 | Ozone | (1) Cidre | (1) Agent de maturation | (1) Bonnes pratiques industrielles | | (2) Eau dite eau minérale ou eau de source | (2) Stérilisant chimique | (2) Bonnes pratiques industrielles | | (3) Vin | (3) Agent de maturation | (3) Bonnes pratiques industrielles P.1 | Extrait de pancréas | Cultures bactériennes productrices d’acides | Pour enrayer les bactériophages | Bonnes pratiques industrielles PART B Foods

Section B.16.100

Article | Colonne I Additifs | Colonne II Permis dans ou sur | Colonne III But de l'emploi | Colonne IV Limites de tolérance

---|---|---|---|--- P.1A | Paraffine | (1) Fruits et légumes frais | (1) Enrober | (1) 0,3 % conformément à l'article B.01.047 | | (2) Fromage et navets | (2) Enrober | (2) Bonnes pratiques industrielles conformément à l'article B.01.047 P.2 | Vaseline | (1) Produits de boulangerie | (1) Agent de démoulage | (1) 0,15 %, conformément à l'article B.01.047. Si on utilise également une huile minérale comme agent de démoulage, la quantité totale de toute combinaison de vaseline et d'huile minérale ne doit pas dépasser 0,15 % | | (2) Fruits et légumes frais | (2) Enrober | (2) 0,3 %, conformément à l'article B.01.047 P.2A | Polyéthylèneglycol (gamme de poids moléculaires de 3 000 à 9 000) | (1) Boissons gazeuses | (1) Agent antimousse | (1) 10 p.p.m. | | (2) Édulcorant de table sous forme de comprimé contenant de l'aspartame | (2) Lubrifiant | (2) 1,0 % | | (3) Comprimés de L-lysine | (3) Agent liant pour comprimés | (3) 7,0 % P.2B | Polydextrose | Aliments non normalisés | Agent texturant et épaississant | Bonnes pratiques industrielles P.3 | Polyvinyl-pyrrolidone | (1) Ale; bière; bière légère; cidre; liqueur de malt; porter; stout; vin | (1) Agent de collage | (1) 2 p.p.m. dans le produit fini | | (2) Édulcorant de table sous forme de comprimé contenant de l'aspartame | (2) Liant pour comprimés | (2) 0,3 % | | (3) Dispersions de pigment laqué de colorant pour utilisation dans les confiseries non normalisées sous forme de comprimé | (3) Agent réducteur de la viscosité et stabilisant dans les dispersions de pigment laqué | (3) Bonnes pratiques industrielles (les résidus de polyvinylpyrrolidone ne doivent pas dépasser 100 p.p.m. dans le produit fini) P.4 | Sulfate double d'aluminium et de potassium | Farine; farine de blé entier | Véhicule du peroxyde de benzoyle | 900 p.p.m., conformément aux sous-alinéas B.13.001e)(vi) et B.13.005d)(vi) P.4.1 | Ferrocyanure de potassium | Vin | Agent de collage | Bonnes pratiques industrielles P.5 | Stéarate de potassium | (1) Gomme à mâcher | (1) Agent plastifiant | (1) Bonnes pratiques industrielles | | (2) Préparations émulsifiantes contenant des mono-esters de propylèneglycol | (2) Agent stabilisant | (2) 2 % P.6 | Propane | Aliments non normalisés | Agent pulseur et agent d'aération | Bonnes pratiques industrielles P.7 | Propylène-glycol | (1) Rocou soluble dans l'huile | (1) Solvant | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Humidifiant | (2) Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I | Colonne II | Colonne III | Colonne IV

Article | Additifs | Permis dans ou sur | But de l’emploi | Limites de tolérance

Q.1 | Essence de quillaja | Bases de boissons; mélanges pour boissons; liqueurs douces | Faire mousser | Bonnes pratiques industrielles S.1 | Saponine | Bases de boissons; mélanges pour boissons; liqueurs douces | Faire mousser | Bonnes pratiques industrielles S.1.01 | Dioxyde de silicium | Émulsions à base d’huiles végétales comestibles servant d’enduits pour batterie de cuisine | Agent de suspension | 2,0 % de la préparation S.1.1 | Pyrophosphate acide de sodium | Filets de poisson congelés; poisson haché congelé; homard congelé; crabe congelé; clams congelés; crevettes congelées | Réduire les pertes dues au traitement et la formation d’exsudats lors de la décongélation | Si employé en association avec le tripolyphosphate de sodium et le pyrophosphate tétrasodique, la quantité totale de phosphate ajouté, calculée en phosphate dibasique de sodium, ne doit pas dépasser 0,5 % S.2 | Sulfate d’aluminium et de sodium | Farine; farine de blé entier | Véhicule du peroxyde de benzoyle | 900 p.p.m. conformément aux sous-alinéas B.13.001(6)(vi) et B.13.005(d)(vi) S.3 | Bicarbonate de sodium | (1) Confiseries non normalisées (2) Sel ordinaire | (1) Agent d’aération (2) Stabilisant de l’iodure de potassium | (1) Bonnes pratiques industrielles (2) Bonnes pratiques industrielles S.3A | Carbonate de sodium | Mélangé avec l’hexamétaphosphate de sodium, filets de poisson congelés, homard congelé, crabe congelé, clams congelés et crevettes congelées | Pour empêcher de suinter en dégélant | 15 % du mélange de carbonate de sodium et d’hexamétaphosphate de sodium S.3B | Carboxyméthyl cellulose de sodium | Boyaux de saucisse | Enrobage pour faciliter l’épluchage | 0,25 % de boyaux S.4 | Citrate de sodium | (1) Sang de bœuf (2) Crème sure (3) Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n) | (1) Anticoagulant (2) Précurseur de saveur (3) Modifier la texture | (1) 0,5 % (2) 0,1 % (3) Bonnes pratiques industrielles S.5 | Décahydrate de ferrocyanure de sodium | Sel dendritique | Adjuvant dans la production de cristaux de sel dendritique | 13 p.p.m. calculé en ferrocyanure anhydre de sodium S.6 | Hexamétaphosphate de sodium | (1) Filets de poisson congelés; homards congelés; crabe congelé; clams congelés et crevettes congelées (3) Gélatine qui entre dans la composition des guimauves | (1) Anticoagulant (2) Empêcher de suinter en dégélant (3) Agent de fouettage | (1) 0,2 % (2) 0,5 % de phosphate ajouté total, calculé en phosphate dibasique de sodium (3) 2 % S.6A | Hydroxyde de sodium | Crustacés et mollusques congelés | Faciliter l’enlèvement des matières étrangères et | Lorsque employé en combinaison avec le PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

S.6.1 S.6.2 S.7 S.7.1 S.8 S.9 S.9A S.9B S.9C S.10 S.11 Colonne II Additifs Lauryl-sulfate de sodium Chlorophylline de sodium, potassium et cuivre Phosphate dibasique de sodium Pyrophosphate tétrasodique Silicate de sodium Stéarate de sodium Stéaroyl-2-lactylate de sodium Sulfate de sodium Sulfite de sodium Thiosulfate de sodium Tripolyphosphate de sodium Colonne III Permis dans ou sur

(1)

Poudre de blanc d’œuf (poudre d’albumen)

(2)

Blanc d’œuf congelé (albumen congelé); blanc d’œuf liquide (albumen liquide)

(3)

Gélatine qui entre dans la composition des guimauves Rafraîchisseurs d’haleine

(1)

Poisson congelé

(2)

Champignons congelés Filets de poisson congelés; poisson haché congelé; homard congelé; crabe congelé; clams congelés; crevettes congelées Eau potable en boîtes Gomme à mâcher

(1)

Blanc d’œuf congelé (albumen congelé); blanc d’œuf liquide (albumen liquide)

(2)

Poudre de blanc d’œuf (poudre d’albumen)

(3)

Garnitures à l’huile ou mélanges pour garnitures

(4)

Pommes de terre déshydratées Champignons congelés Miettes de thon en conserve Sel Clams congelés; crabe congelé; crevettes congelées; filets de poisson congelés; homard congelé; poisson haché congelé et poisson haché menu congelé Colonne IV But de l’emploi réduire la déperdition d’humidité pendant la cuisson

(1)

Faire monter en neige

(2)

Faire monter en neige

(3)

Agent de fouettage Caractéristique du produit

(1)

Empêcher l’éclatement de la glace

(2)

Empêcher la décoloration Empêcher les pertes dues au traitement et la formation d’exsudat lors de la décongélation Anticorrosif Agent plastifiant

(1)

Faire monter en neige

(2)

Faire monter en neige

(3)

Faire mousser

(4)

Agent de conditionnement Empêcher la décoloration Stabilisant de l’iodure de potassium Réduire les pertes dues au traitement et la formation d’exsudat lors de la décongélation Colonne V Limites de tolérance chlorure de sodium (sel) et l’oxyde de calcium en solution, l’hydroxyde de sodium ne doit pas dépasser 70 p.p.m.

(1)

0,1 %

(2)

0,0125 %

(3)

0,5 % 700 p.p.m. Bonnes pratiques industrielles Si employé seul ou en association avec le tripolyphosphate de sodium, la quantité totale de phosphate ajouté, calculé en phosphate dibasique de sodium, ne doit pas dépasser 0,5 % Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

0,05 %

(2)

0,5 %

(3)

0,3 %

(4)

0,2 % du poids à l’état sec Bonnes pratiques industrielles 300 p.p.m. Bonnes pratiques industrielles Si employé seul ou en association avec le pyrophosphate acide de sodium et le pyrophosphate tétrasodique, la quantité S.12 [Abrogé, DORS/93-276, art. 8] S.13 Chlorure stanneux

(1)

Asperges conservées dans des contenants en verre ou des contenants métalliques vernis sur toute leur surface intérieure

(1)

Stabiliser la couleur et la saveur

(1)

25 p.p.m. calculé en étain

(2)

Boissons gazeuses en boîtes; jus de citron; jus de fruit concentré sauf le jus d’orange concentré congelé; jus de lime

(2)

Stabiliser la couleur et la saveur

(2)

Bonnes pratiques industrielles S.14 Acide stéarique

(1)

Confiseries non normalisées

(1)

Agent de démoulage

(1)

Bonnes pratiques industrielles

(2)

Gomme à mâcher

(2)

Agent plastifiant

(2)

Bonnes pratiques industrielles

(3)

Aliments vendus sous forme de comprimés

(3)

Agent de démoulage

(3)

Bonnes pratiques industrielles S.15 Sulfate de méthyle et de sodium Pectine Améliorer la rendement de la pectine par l’action de l’acide sulfurique et de l’alcool méthylique, le bicarbonate de sodium agissant comme neutralisant 0,1 % de pectine S.15A [Abrogé, DORS/93-276, art. 9] S.16 Acétate isobutyrate de sucrose Préparation aromatisante de (nom de l’arôme) pour utilisation dans les boissons contenant des huiles d’agrumes ou d’épinette Agent modificateur de la densité 300 p.p.m. dans les boissons contenant des huiles d’agrumes ou d’épinette sous leur forme consommable S.17 Acide sulfurique Grains de café Améliorer le rendement de l’extraction des solides de café Bonnes pratiques industrielles T.1 Talc

(1)

Légumineuses sèches et cassées; riz

(1)

Enrobage

(1)

Bonnes pratiques industrielles

(2)

Base de gomme à mâcher

(2)

Remplissage

(2)

Bonnes pratiques industrielles

(3)

Gomme à mâcher

(3)

Agent de saupoudrage

(3)

Bonnes pratiques industrielles T.2 Acide tannique

(1)

Gomme à mâcher

(1)

Pour diminuer l’adhérence

(1)

Bonnes pratiques industrielles

(2)

Cidre; vin; vin de miel

(2)

Agent de collage

(2)

200 p.p.m. T.2A [Abrogé, DORS/93-276, art. 10] T.3 Triacétine Mélanges à gâteau Agent humidifiant Bonnes pratiques industrielles T.4 Triéthylcitrate Blanc d’œuf congelé (albumen congelé); blanc d’œuf liquide (albumen liquide) Faire monter en neige 0,25 % PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Colonne II Additifs Permis dans ou sur Colonne III But de l’emploi Colonne IV Limites de tolérance

X

1 [Abrogé, DORS/93-276, art. 11] TABLE IX Column I Column II Column III Maximum Level of Use A.1 Aspartame

(1)

Table-top sweeteners

(1)

Good Manufacturing Practice

(2)

Breakfast cereals

(2)

0.5%

(3)

Unstandardized beverage concentrates; Unstandardized beverage mixes; Unstandardized beverages

(4)

Filling mixes; Fillings; Topping mixes; Toppings; Unstandardized dessert mixes; Unstandardized desserts; Yogurt

(5)

Chewing gum; Breath freshener products

(5)

1.0% Column I | Column II | Column III

(6)

Unstandardized fruit spreads; Unstandardized purées; Unstandardized sauces; Unstandardized table syrups | (6) 0.2%

(7)

Nut spreads; Peanut spreads; Unstandardized salad dressings | (7) 0.05%

(8)

Unstandardized condiments | (8) 0.2%

(9)

Confectionery glazes for snack foods; Sweetened seasonings or coating mixes for snack foods | (9) 0.1%

(10)

Unstandardized confectionery; Unstandardized confectionery coatings | (10) 0.3% E.1 | Erythritol |

(1)

Table-top sweeteners | (1) Good Manufacturing Practice

(2)

Dietetic beverages | (2) 3.5%

(3)

Fat-based cream fillings and toppings | (3) 60%

(4)

Dietetic cookies and wafers | (4) 7%

(5)

Soft candies | (5) 40%

(6)

Hard candies | (6) 50%

(7)

Chewing gum | (7) 60% Isomalt | Unstandardized foods | Good Manufacturing Practice

I

1 | Lactitol | Unstandardized foods | Good Manufacturing Practice

M

1 | Maltitol | Unstandardized foods | Good Manufacturing Practice

M

2 | Maltitol syrup | Unstandardized foods | Good Manufacturing Practice

M

3 | Mannitol | Unstandardized foods | Good Manufacturing Practice N.1 | Neotame |

(1)

Table-top sweeteners | (1) Good Manufacturing Practice

(2)

Breakfast cereals | (2) 0.016%

(3)

Unstandardized beverage concentrates; Unstandardized beverage mixes; Unstandardized beverages | (3) 0.003% in beverages as consumed

(4)

Filling mixes; Fillings; Topping mixes; Toppings; Unstandardized dessert mixes; Unstandardized desserts; Yogurt | (4) 0.01% in products as consumed

(5)

Breath freshener products; Chewing gum | (5) 0.032%

(6)

Unstandardized fruit spreads; Unstandardized purées; Unstandardized sauces; Unstandardized table syrups | (6) 0.007%

(7)

Nut spreads; Peanut spreads; Unstandardized salad dressings | (7) 0.002%

(8)

Unstandardized condiments | (8) 0.007% Column I S.1 | Sorbitol S.1.1 | Sorbitol syrup S.2 | Sucralose T.1 | Thaumatin

X

1 | Xylitol Column II

(10)

Unstandardized confectionery; Unstandardized confectionery coatings

(11)

Baking mixes; Unstandardized bakery products

(2)

Unstandardized foods Unstandardized foods

(1)

Table-top sweeteners

(2)

Breakfast cereals

(3)

Unstandardized beverage concentrates; Unstandardized beverage mixes; Unstandardized beverages; Unstandardized dairy beverages

(4)

Filling mixes; Fillings; Topping mixes; Toppings; Unstandardized dessert mixes; Unstandardized desserts; Yogurt

(5)

Chewing gum; Breath freshener products

(7)

Unstandardized condiments; Unstandardized salad dressings

(8)

Confectionery glazes for snack foods; Sweetened seasonings or coating mixes for snack foods; Unstandardized confectionery; Unstandardized confectionery coatings

(9)

Baking mixes; Unstandardized bakery products

(11)

Unstandardized alcoholic beverages

(12)

Puddings; Pudding mixes

(13)

Unstandardized table syrups

(14)

Canned (naming the fruit); Unstandardized canned fruit

(15)

Pickles; Relishes

(1)

Chewing gum; Breath freshener products

(2)

Salt substitutes

(3)

(naming the flavour) Flavour referred to in section B.10.005; Unstandardized flavouring preparations Unstandardized foods Column III Maximum Level of Use

(9)

0.0032%

(10)

0.01%

(1)

6.0%

(2)

Good Manufacturing Practice Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

0.1%

(5)

0.15%

(6)

0.045%

(7)

0.04%

(8)

0.07%

(10)

0.015%

(11)

0.07%

(13)

0.15%

(14)

0.025%

(15)

0.015%

(1)

500 p.p.m.

(2)

400 p.p.m.

(3)

100 p.p.m. Good Manufacturing Practice TABLEAU IX Additifs alimentaires qui peuvent être utilisés comme édulcorants Colonne I | Colonne II | Colonne III

Article | Additifs | Permis dans ou sur | Limites de tolérance

A.01 | Acésulfame-potassium | (1) Édulcorants de table | (1) Bonnes pratiques industrielles | | (2) Boissons gazéifiées | (2) 0,025 % dans les boissons, sous leur forme consommable | | (3) Boissons laitières non normalisées; boissons non normalisées; concentrés de boissons non normalisées; mélanges pour boissons non normalisés | (3) 0,05 % dans les boissons, sous leur forme consommable | | (4) Desserts non normalisés; garnitures; glaçages; mélanges pour desserts non normalisés; mélanges pour garnitures; mélanges pour glaçages; yogourt | (4) 0,1 % dans les produits, sous leur forme consommable | | (5) Gomme à mâcher; rafraîchisseurs d’haleine | (5) 0,35 % | | (6) Tartinades de fruits non normalisées | (6) 0,1 % | | (7) Sauces à salade non normalisées | (7) 0,05 % | | (8) Confiseries non normalisées | (8) 0,25 % | | (9) Assaisonnements pour produits de boulangerie non normalisés | (9) 0,1 % | | (10) Fruits en conserve non normalisés; (nom du fruit) en conserve | (10) 0,007 % A.1 | Aspartame | (1) Édulcorants de table | (1) Bonnes pratiques industrielles | | (2) Céréales à déjeuner | (2) 0,5 % | | (3) Boissons non normalisées; concentrés de boissons non normalisées; mélanges pour boissons non normalisés | (3) 0,1 % dans les boissons, sous leur forme consommable | | (4) Desserts non normalisés; garnitures; glaçages; mélanges pour desserts non normalisés; mélanges pour garnitures; mélanges pour glaçages; yogourt | (4) 0,3 % dans les produits, sous leur forme consommable | | (5) Gomme à mâcher; rafraîchisseurs d’haleine | (5) 1,0 % | | (6) Purées non normalisées; sauces non normalisées; sirops de table non normalisés; tartinades de fruits non normalisées | (6) 0,1 % | | (7) Sauces à salade non normalisées; tartinades d’arachides; tartinades de fruits à écale | (7) 0,05 % | | (8) Condiments non normalisés | (8) 0,2 % | | (9) Assaisonnements sucrés ou mélanges pour enrobage des grignotines; glaçages à confiserie pour grignotines | (9) 0,1 % | | (10) Confiseries non normalisées; enrobages de confiserie non normalisés | (10) 0,3 % PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs A.2 Aspartame, en capsules, pour prévenir sa dégradation pendant la cuisson E.1 Érythritol H.1 Hydrolysat d’amidon hydrogéné

I

1 Isomalt

L

1 Lactitol

M

1 Maltitol

M

2 Sirop de maltitol

M

3 Mannitol N.1 Néotame S.1 Sorbitol Colonne II Permis dans ou sur Mélanges pour pâtisseries; produits de boulangerie non normalisés

(1)

Édulcorants de table

(2)

Boissons diététiques

(3)

Garnitures et glaçages à la crème faits à base de gras

(4)

Biscuits et gaufrettes diététiques

(5)

Bonbons mous

(6)

Bonbons durs

(7)

Gomme à mâcher Aliments non normalisés Aliments non normalisés Aliments non normalisés Aliments non normalisés Aliments non normalisés Aliments non normalisés

(1)

Édulcorants de table

(2)

Céréales à déjeuner

(3)

Boissons non normalisées; concentrés de boissons non normalisées; mélanges pour boissons non normalisées

(4)

Desserts non normalisés; garnitures; glaçages; mélanges pour desserts non normalisés; mélanges pour garnitures; mélanges pour glaçages; yogourt

(5)

Gomme à mâcher; rafraîchisseurs d’haleine

(6)

Purées non normalisées; sauces non normalisées; sirops de table non normalisés; tartinades de fruits non normalisées

(7)

Sauces à salade non normalisées; tartinades d’arachides; tartinades de fruits à écale

(8)

Condiments non normalisés

(9)

Assaisonnements sucrés ou mélanges pour enrobage des grignotines; glaçages à confiserie pour grignotines

(10)

Confiseries non normalisées; enrobages de confiserie non normalisés

(11)

Mélanges pour pâtisseries; produits de boulangerie non normalisés

(1)

Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n) Colonne III Limites de tolérance 0,4 % dans les produits, sous leur forme consommable

(1)

Bonnes pratiques industrielles

(2)

3,5 %

(3)

60 %

(4)

7 %

(5)

40 %

(6)

50 %

(7)

Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

0,016 %

(3)

0,003 % dans les boissons, sous leur forme consommable

(4)

0,01 % dans les produits, sous leur forme consommable

(5)

0,032 %

(6)

0,007 %

(7)

0,002 % dans les produits

(8)

0 %

(9)

0,032 %

(10)

0,01 %

(11)

0,013 % dans les produits, sous leur forme consommable

(1)

6,0 % PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs S.1.1 Sirop de sorbitol S.2 Sucralose T.1 Thaumatin

X

1 Xylitol Colonne II Permis dans ou sur

(2)

Aliments non normalisés Aliments non normalisés

(1)

Édulcorants de table

(2)

Céréales à déjeuner

(3)

Boissons laitières non normalisées; boissons non normalisées; concentrés de boissons non normalisées; mélanges pour boissons non normalisées

(4)

Assaisonnements non normalisés; garnitures; glaçages; mélanges pour desserts non normalisés; mélanges pour garnitures; mélanges pour glaçages; yogourt

(5)

Gommes à mâcher; rafraîchisseurs d’haleine

(6)

Tartinades de fruits non normalisées

(7)

Condiments non normalisés; sauces à salade non normalisées

(8)

Assaisonnements pour enrobage des grignotines; confiseries non normalisées; glaçages à confiserie pour grignotines

(9)

Mélanges pour pâtisseries; produits de boulangerie non normalisés

(10)

Produits de fruits et de légumes transformés non normalisés, sauf les fruits en conserve non normalisés

(11)

Boissons alcooliques non normalisées

(12)

Poudings; mélanges pour poudings

(13)

Sirops de table non normalisés

(14)

Fruits en conserve non normalisés; (nom du fruit) en conserve

(1)

Gommes à mâcher; rafraîchisseurs d’haleine

(2)

Succédanés de sel

(3)

Une préparation aromatisante de (nom de l’arôme) visée à l’article B.10.005; préparations aromatisantes non normalisées Aliments non normalisés Colonne III Limites de tolérance

(2)

Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

0,1 %

(3)

0,025 % dans les boissons, sous leur forme consommable

(4)

0,025 % dans les produits, sous leur forme consommable

(5)

0,15 %

(6)

0,045 %

(7)

0,08 %

(8)

0,065 % dans les produits, sous leur forme consommable

(9)

0,065 % dans les produits, sous leur forme consommable

(10)

0,015 %

(11)

0,07 %

(12)

0,04 % dans les produits, sous leur forme consommable

(13)

0,15 %

(14)

0,04 %

(15)

0,015 %

(1)

500 p.p.m.

(2)

400 p.p.m.

(3)

100 p.p.m. Bonnes pratiques industrielles SOR/93-276, s. 12; SOR/94-425, s. 5; SOR/94-688, s. 21(F); SOR/99-175, s. 3; SOR/99-512, ss. 3, 4; SOR/2002-401, s. 2; SOR/2007-76, s. 3; SOR/2010-176, s. 7; SOR/2012-104, ss. 11 to 15. DORS/93-276, art. 12; DORS/94-425, art. 5; DORS/94-688, art. 21(F); DORS/99-175, art. 3; DORS/99-512, art. 3 et 4; DORS/2002-401, art. 2; DORS/2007-76, art. 3; DORS/2010-176, art. 7; DORS/2012-104, art. 52 à 55. TABLE X Column I | Column II | Column III A.1 Acetic Acid

(1)

Good Manufacturing Practice

(2)

Canned Asparagus

(2)

Good Manufacturing Practice

(3)

Gelatin

(3)

Good Manufacturing Practice

(4)

Unstandardized foods

(4)

Good Manufacturing Practice A.2 Adipic Acid Unstandardized foods Good Manufacturing Practice A.3 Ammonium Aluminum Sulphate

(1)

Baking powder

(1)

Good Manufacturing Practice

(2)

Unstandardized foods

(2)

Good Manufacturing Practice A.4 Ammonium Bicarbonate

(1)

Cocoa products

(2)

Unstandardized foods

(2)

Good Manufacturing Practice A.5 Ammonium Carbonate

(1)

Cocoa products

(2)

Unstandardized foods

(2)

Good Manufacturing Practice A.6 Ammonium Citrate, dibasic Unstandardized foods Good Manufacturing Practice A.7 Ammonium Citrate, monobasic Unstandardized foods Good Manufacturing Practice A.8 Ammonium Hydroxide

(1)

Cocoa products

(2)

Gelatin

(2)

Good Manufacturing Practice

(3)

Unstandardized foods

(3)

Good Manufacturing Practice A.9 Ammonium Phosphate, dibasic

(1)

Ale; Bacterial cultures; Baking powder; Beer; Light beer; Malt liquor; Porter; Stout

(1)

Good Manufacturing Practice

(2)

Unstandardized bakery products

(2)

Good Manufacturing Practice A.10 Ammonium Phosphate, monobasic

(1)

Ale; Bacterial cultures; Baking powder; Beer; Light beer; Malt liquor; Porter; Stout

(1)

Good Manufacturing Practice

(2)

Unstandardized bakery products

(2)

Good Manufacturing Practice

(3)

0.1% Column I

C

1 Calcium Acetate

C

1A Calcium Acid Pyrophosphate

C

2 Calcium Carbonate

C

3 Calcium Chloride

C

4 Calcium Citrate

C

5 Calcium Fumarate

C

6 Calcium Gluconate

C

7 Calcium Hydroxide

C

8 Calcium Lactate

C

9 Calcium Oxide

C

10 Calcium Phosphate, dibasic

C

11 Calcium Phosphate, monobasic Column II

(1)

Ale; Beer; Light beer; Malt liquor; Porter; Stout

(2)

Unstandardized foods

(1)

Baking powder

(2)

Unstandardized foods

(1)

Ice cream mix; Ice milk mix; Wine

(3)

Grape juice

(4)

Unstandardized foods

(5)

Cocoa products

(1)

Ale; Beer; Light beer; Malt liquor; Porter; Stout

(2)

Unstandardized foods

(1)

Infant formula

(2)

Unstandardized foods Unstandardized foods Unstandardized foods

(1)

Ale; Beer; Ice cream mix; Ice milk mix; Light beer; Malt liquor; Porter; Stout

(2)

Canned peas

(3)

Infant formula

(4)

Grape Juice

(5)

Unstandardized foods

(1)

Baking powder

(2)

Unstandardized foods

(1)

Ale; Beer; Ice cream mix; Ice milk mix; Light beer; Malt liquor; Porter; Stout

(2)

Unstandardized foods Unstandardized foods

(1)

Ale; Baking powder; Beer; Light beer; Malt liquor; Porter; Stout Column III Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

0.01%

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice Good Manufacturing Practice

(1)

Good Manufacturing Practice Column I

C

12

C

13

C

13A

C

14 Calcium Phosphate, tribasic Calcium Sulphate Carbon Dioxide Citric Acid Column II

(2)

Unstandardized foods Unstandardized foods Ale; Beer; Light beer; Malt liquor; Porter; Stout; Wine

(1)

Ale; Beer; Cider; Honey wine; Malt liquor; Porter; Stout; Wine

(3)

Canned shellfish; Canned spring mackerel; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Frozen cooked shrimp; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Gelatin; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk

(4)

Cocoa products Column III Maximum Level of Use

(2)

Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(5)

Good Manufacturing Practice Column I

C

15 F.1 G.1 G.2 H.1

L

1

M

2

M

3 Cream of Tartar Fumaric Acid Gluconic Acid Glucono-delta-lactone Hydrochloric Acid Lactic Acid Magnesium Carbonate Magnesium Citrate Column II

(1)

Gelatin

(2)

Unstandardized foods

(3)

Wine Unstandardized foods Unstandardized foods

(1)

Ale; Beer; Gelatin; Light beer; Malt liquor; Porter; Stout

(2)

Infant formula

(1)

Ale; Baking powder; Beer; Bread; Cider; Cottage cheese; Creamed cottage cheese; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; French dressing; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Ice cream mix; Ice milk mix; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk; Malt liquor; Mayonnaise; Olives; Pickles; Porter; Relishes; Salad dressing; Sherbet; Stout

(2)

Canned pears; Canned strawberries

(3)

Margarine

(5)

Unstandardized foods

(6)

Wine

(1)

Cocoa products

(2)

Ice cream mix; Ice milk mix

(3)

Unstandardized foods Column III Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice

(6)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice Good Manufacturing Practice Column I

M

4 | Magnesium Fumarate

M

5 | Magnesium Hydroxide

M

6 | Magnesium Oxide

M

6A | Magnesium Phosphate

M

7 | Magnesium Sulphate

M

8 | Malic Acid

M

8A | Manganese Sulphate

M

9 | Metatartaric Acid P.1 | Phosphoric Acid Column II Unstandardized foods

(1)

Canned peas

(2)

Cocoa products

(3)

Gelatin; Ice cream mix; Ice milk mix

(4)

Bacterial cultures Bacterial cultures

(1)

Ale; Beer; Light beer; Malt liquor; Porter; Stout

(2)

Bacterial cultures

(2)

Canned applesauce; Canned pears; Canned strawberries

(4)

Unstandardized foods

(5)

Wine Bacterial cultures Wine

(1)

Ale; Beer; Cottage Cheese; Creamed cottage cheese; Gelatin; Light beer; Malt liquor; Mono-glycerides and mono- and diglycerides; Porter; Stout Column III Maximum Level of Use Good Manufacturing Practice

(1)

0.05%

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice Good Manufacturing Practice

0.01%

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice Column I Column II Column III Maximum Level of Use P.2 Potassium Acid Tartrate

(1)

Baking powder; Honey wine

(2)

Unstandardized foods

(3)

Wine

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

0.42% P.3 Potassium Aluminum Sulphate

(1)

Ale; Baking powder; Beer; Light beer; Malt liquor; Oil-soluble annatto; Porter; Stout

(2)

Unstandardized foods

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice P.4 Potassium Bicarbonate

(2)

Cocoa products

(4)

Infant formula

(5)

Margarine

(6)

Unstandardized foods

(7)

Wine

(1)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice

(6)

Good Manufacturing Practice

(7)

Good Manufacturing Practice Column I P.5 | Potassium Carbonate Column II

(1)

Cocoa products

(3)

Margarine

(4)

Unstandardized foods

(6)

Wine Column III Maximum Level of Use

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice

(6)

Good Manufacturing Practice --- Column I P.6 | Potassium Chloride P.7 | Potassium Citrate P.8 | Potassium Fumarate P.9 | Potassium Hydroxide P.9A | Potassium Lactate P.10 | Potassium Phosphate, dibasic P.11 | Potassium Sulphate P.12 | Potassium Tartrate Column II P.6 | Ale; Beer; Light beer; Malt liquor; Porter; Stout P.7 | (1) Infant formula

(2)

Margarine

(3)

Unstandardized foods

(4)

Wine P.8 | Unstandardized foods P.9 | (1) Oil-soluble annatto

(2)

Cocoa products

(4)

Infant formula

(5)

Margarine

(6)

Grape juice

(7)

Unstandardized foods P.9A | Margarine P.10 | Unstandardized foods P.11 | Ale; Beer; Light beer; Malt liquor; Porter; Stout P.12 | Cider Column III Maximum Level of Use P.6 | Good Manufacturing Practice P.7 | (1) Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice P.8 | Good Manufacturing Practice P.9 | (1) 0.1%

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice

(6)

Good Manufacturing Practice

(7)

Good Manufacturing Practice P.9A | Good Manufacturing Practice P.10 | Good Manufacturing Practice P.11 | Good Manufacturing Practice P.12 | Good Manufacturing Practice PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Column I | Column II | Column III S.1 | Sodium Acetate | Unstandardized foods | Good Manufacturing Practice S.2 | Sodium Acid Pyrophosphate | (1) Baking powder | (1) Good Manufacturing Practice | | (2) Unstandardized foods | (2) Good Manufacturing Practice S.3 | Sodium Acid Tartrate | Baking Powder | Good Manufacturing Practice S.4 | Sodium Aluminum Phosphate | Unstandardized foods | Good Manufacturing Practice S.5 | Sodium Aluminum Sulphate | (1) Baking powder | (1) Good Manufacturing Practice | | (2) Unstandardized foods | (2) Good Manufacturing Practice | | (4) Infant formula | (4) Good Manufacturing Practice | | (5) Margarine | (5) Good Manufacturing Practice | | (6) Unstandardized foods | (6) Good Manufacturing Practice S.7 | Sodium Bisulphate | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice Column I S.8 Sodium Carbonate Column II

(2)

Cocoa products

(4)

Margarine

(5)

Unstandardized foods Column III Maximum Level of Use

(1)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice --- Column I S.9 Sodium Citrate Column II

(2)

Infant formula

(3)

Unstandardized foods Column III Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice PART B Foods

Section B.16.100

Column I | Column II | Column III S.12 Sodium Fumarate | Unstandardized foods | Good Manufacturing Practice S.13 Sodium Gluconate | Unstandardized foods | Good Manufacturing Practice S.14 Sodium Hexametaphosphate | Unstandardized foods | Good Manufacturing Practice | (3) Infant formula | (3) Good Manufacturing Practice | (4) Margarine | (4) Good Manufacturing Practice | (5) Unstandardized foods | (5) Good Manufacturing Practice | (6) (Naming the variety) Whey cheese; Whey cheese | (6) Good Manufacturing Practice S.16 Sodium Lactate | (1) Margarine | (1) Good Manufacturing Practice | (2) Unstandardized foods | (2) Good Manufacturing Practice S.17 Sodium Phosphate, dibasic | (1) Ale; Bacterial culture; Beer; Cream; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | (2) Unstandardized foods | (2) Good Manufacturing Practice S.18 Sodium Phosphate, monobasic | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | (2) Unstandardized foods | (2) Good Manufacturing Practice S.19 Sodium Phosphate, tribasic | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | (2) Unstandardized foods | (2) Good Manufacturing Practice | (2) Unstandardized foods | (2) Good Manufacturing Practice | (3) Margarine | (3) Good Manufacturing Practice S.21 Sodium Pyrophosphate, tetrabasic | Unstandardized foods | Good Manufacturing Practice S.22 Sodium Tripolyphosphate | Unstandardized foods | Good Manufacturing Practice S.23 Sulphuric Acid | Ale; Beer; Light beer; Malt liquor; Porter; Stout | Good Manufacturing Practice Column I T.1 Tartaric Acid Column II

(2)

Canned pears; Canned strawberries

(4)

Margarine

(5)

Unstandardized foods

(6)

Cocoa products Column III Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice TABLEAU X Additifs alimentaires autorisés comme rajusteurs du pH, substances à réaction acide et agents correcteurs de l’eau

Article

A.1 Acide acétique Colonne II Permis dans ou sur

(1)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à Colonne III Limites de tolérance

(1)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Colonne II Additifs Permis dans ou sur Colonne III Limites de tolérance A.2 Acide adipique Aliments non normalisés Bonnes pratiques industrielles A.3 Sulfate double d’aluminium et d’ammonium

(1)

Poudre à pâte

(2)

Aliments non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles A.4 Bicarbonate d’ammonium

(1)

Produits du cacao

(1)

En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005 A.5 Carbonate d’ammonium

(1)

Produits du cacao

(2)

Aliments non normalisés

(1)

En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005

(2)

Bonnes pratiques industrielles A.6 Citrate d’ammonium dibasique Aliments non normalisés Bonnes pratiques industrielles A.7 Citrate d’ammonium monobasique Aliments non normalisés Bonnes pratiques industrielles A.8 Hydroxyde d’ammonium

(1)

Produits du cacao

(1)

En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005 A.9 Phosphate d’ammonium dibasique

(1)

Ale; cultures bactériennes; poudre à pâte; bière; bière légère; liqueur de malt; porter; stout

(2)

Produits de boulangerie non normalisés

(3)

Lait de beurre sans culture

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

0,1 % A.10 Phosphate d’ammonium monobasique

(1)

Ale; cultures bactériennes; poudre à pâte; bière; bière légère; liqueur de malt; porter; stout

(2)

Produits de boulangerie non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

C

1 Acétate de calcium

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Aliments non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

C

1A Pyrophosphate acide de calcium

(1)

Poudre à pâte

(2)

Aliments non normalisés

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

C

2

C

3

C

4

C

5

C

6

C

7

C

8

C

9

C

10

C

11 Additifs Carbonate de calcium Chlorure de calcium Citrate de calcium Fumarate de calcium Gluconate de calcium Hydroxyde de calcium Lactate de calcium Oxyde de calcium Phosphate bicalcique Phosphate monocalcique Colonne II Permis dans ou sur

(1)

Mélange pour crème glacée; mélange pour lait glacé; vin

(2)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(3)

Jus de raisin

(4)

Aliments non normalisés

(5)

Produits du cacao

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Aliments non normalisés

(1)

Préparations pour nourrissons

(2)

Aliments non normalisés Aliments non normalisés Aliments non normalisés

(1)

Ale; bière; mélange pour crème glacée; mélange pour lait glacé; bière légère; liqueur de malt; porter; stout

(2)

Pois en conserve

(3)

Préparations pour nourrissons

(4)

Jus de raisin

(5)

Aliments non normalisés

(1)

Poudre à pâte

(2)

Aliments non normalisés

(1)

Ale; bière; mélange pour crème glacée; mélange pour lait glacé; bière légère; liqueur de malt; porter; stout

(2)

Aliments non normalisés Aliments non normalisés

(1)

Ale; poudre à pâte; bière; bière légère; liqueur de malt; porter; stout

(2)

Aliments non normalisés Colonne III Limites de tolérance

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

0,01 %

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles 505 À jour au 11 novembre 2024 Dernière modification le 17 juin 2024 PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

C

12

C

13

C

13A

C

14 Additifs Phosphate tricalcique Sulfate de calcium Dioxyde de carbone Acide citrique Colonne II Permis dans ou sur Aliments non normalisés Ale; bière; bière légère; liqueur de malt; porter; stout; vin Fromage (indication de la variété)

(1)

Ale; bière; cidre; liqueur de malt; porter; stout; vin; vin de miel

(2)

Achards (relish); champignons congelés; champignons en conserve; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); cornichons; fèves au lard; gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; haricots; jus de raisins; jus de tomates; marmelade d’ananas; marmelade d’ananas avec pectine; marmelade de figues; marmelade de figues avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; mincemeat; nectar d’abricot; nectar de (nom du fruit) (nom du fruit) congelé; (nom du fruit) en conserve; olives; pâte de tomates; pâte de tomates concentrée; pulpe de tomates; purée de tomates; tomates en conserve

(3)

Blanc d’œuf congelé (albumen congelé); blanc d’œuf liquide (albumen liquide); crevettes cuites congelées; crustacés et mollusques en conserve; gélatine; jaune d’œuf congelé; jaune d’œuf liquide; maquereau de printemps en conserve; œuf entier congelé; œuf entier liquide; poudre de blanc d’œuf (poudre d’albumen); poudre de jaune d’œuf; poudre d’œuf entier

(4)

Produits du cacao

(5)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); fromage cottage; fromage cottage en crème; fromage de petit-lait (indication de la variété); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des Colonne III Limites de tolérance Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

1,0 %, seul ou en association avec de l’acide tartrique, calculé sans matières grasses

(5)

Bonnes pratiques industrielles

Article

Colonne I Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

C

15 Crème de tartre Mêmes aliments que pour le tartrate acide de potassium Bonnes pratiques industrielles F.1 Acide fumarique

(1)

Gélatine

(2)

Aliments non normalisés

(3)

Vin

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles G.1 Acide gluconique Aliments non normalisés Bonnes pratiques industrielles G.2 Glucono-delta-lactone Aliments non normalisés Bonnes pratiques industrielles H.1 Acide chlorhydrique

(1)

Ale; bière; gélatine; bière légère; liqueur de malt; porter; stout

(2)

Préparations pour nourrissons

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

L

1 Acide lactique

(1)

Ale; achards (relish); bière; blanc d’œuf congelé (albumen congelé); blanc d’œuf liquide (albumen liquide); cidre; cornichons; fromage cottage; fromage cottage en crème; jaune d’œuf congelé; jaune d’œuf liquide; liqueur de malt; mayonnaise; mélange pour crème glacée; mélange pour lait glacé; œuf entier congelé; œuf entier liquide; olives; pain; porter; poudre à pâte; poudre de blanc d’œuf (poudre d’albumen); poudre de jaune d’œuf; poudre d’œuf entier; sauce à salade; sauce vinaigrette; sorbet laitier; stout

(2)

Poires en conserve; fraises en conserve

(3)

Margarine

(4)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid; fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); mélange pour crème glacée; mélange pour lait glacé; préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); sorbet laitier

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles Colonne I

Article

Additifs

M

2 Carbonate de magnésium

M

3 Citrate de magnésium

M

4 Fumarate de magnésium

M

5 Hydroxyde de magnésium

M

6 Oxyde de magnésium

M

6A Phosphate de magnésium

M

7 Sulfate de magnésium

M

8 Acide malique Colonne II Permis dans ou sur

(1)

Produits du cacao

(2)

Mélange pour crème glacée; mélange pour lait glacé

(3)

Aliments normalisés Liqueurs douces Aliments non normalisés

(1)

Pois en conserve

(2)

Produits du cacao

(3)

Gélatine; mélange pour crème glacée; mélange pour lait glacé

(4)

Cultures bactériennes Cultures bactériennes

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Cultures bactériennes

(1)

Asperges en conserve; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; marmelade d’ananas; marmelade d’ananas avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; marmelade de figues avec pectine; nectar d’abricot; nectar de pêche; nectar de poire; (nom du fruit) pressé

(2)

Compote de pommes en conserve; poires en conserve; fraises en conserve

(3)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(5)

Aliments non normalisés

(6)

Vin Colonne III Limites de tolérance

(1)

En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

0,05 %

(2)

En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(6)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs

M

8A Sulfate de manganèse

M

9 Acide métatartrique P.1 Acide phosphorique P.2 Tartrate acide de potassium P.3 Sulfate double d’aluminium et de potassium Colonne II Permis dans ou sur Cultures bactériennes Vin

(1)

Ale; bière; bière légère; fromage cottage; fromage cottage en crème; gélatine; liqueur de malt; monoglycérides et mono- et diglycérides; porter; stout

(2)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(3)

Protéines de poisson

(4)

Aliments non normalisés

(5)

Produits du cacao

(1)

Poudre à pâte; hydromel vineux

(2)

Aliments non normalisés

(3)

Vin

(1)

Ale; poudre à pâte; bière; bière légère; liqueur de malt; roucou soluble dans l’huile; porter; stout

(2)

Aliments non normalisés Colonne III Limites de tolérance Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

0,5 %, exprimé en P2O5 calculé sur matières grasses

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

0,42 % PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

P.4 P.5 Additifs Bicarbonate de potassium Carbonate de potassium Colonne II Permis dans ou sur

(1)

Lait malté; poudre à pâte; poudre de lait malté;

(2)

Produits du cacao

(3)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(4)

Préparations pour nourrissons

(5)

Margarine

(6)

Aliments non normalisés

(7)

Vin

(1)

Produits du cacao

(2)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(3)

Margarine

(4)

Aliments non normalisés Colonne III Limites de tolérance

(1)

Bonnes pratiques industrielles

(2)

En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(6)

Bonnes pratiques industrielles

(7)

Bonnes pratiques industrielles

(1)

En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles 510 À jour au 11 novembre 2024 Dernière modification le 17 juin 2024 PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I | Colonne II | Colonne III

Article | Additifs | Permis dans ou sur | Limites de tolérance

P.6 | Chlorure de potassium | (5) Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n)

(6)

Vin | (5) Bonnes pratiques industrielles

(6)

Bonnes pratiques industrielles P.7 | Citrate de potassium | (1) Préparations pour nourrissons

(2)

Margarine

(3)

Aliments non normalisés

(4)

Vin | (1) Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles P.8 | Fumarate de potassium | Aliments non normalisés | Bonnes pratiques industrielles P.9 | Hydroxyde de potassium | (1) Rocou soluble dans l’huile

(2)

Produits du cacao | (1) 1,0 %

(2)

En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005 P.9A | Lactate de potassium | (3) Marinade, saumure et mélange de salaison à sec employés dans le marinage des viandes conditionnées ou conservées et des sous-produits de viande conditionnés ou conservés; marinade pour crème glacée; mélange pour lait glacé

(4)

Préparation pour nourrissons

(5)

Margarine

(6)

Jus de raisin

(7)

Aliments non normalisés | (3) Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(6)

Bonnes pratiques industrielles

(7)

Bonnes pratiques industrielles P.10 | Phosphate bipotassique | Aliments non normalisés | Bonnes pratiques industrielles P.11 | Sulfate de potassium | Ale; bière; bière légère; liqueur de malt; porter; boissons non alcoolisées; stout | Bonnes pratiques industrielles P.12 | Tartrate de potassium | Cidre | Bonnes pratiques industrielles S.1 | Acétate de sodium | Aliments non normalisés | Bonnes pratiques industrielles S.2 | Pyrophosphate acide de sodium | (1) Poudre à pâte

(2)

Aliments non normalisés | (1) Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles S.3 | Tartrate acide de sodium | Poudre à pâte | Bonnes pratiques industrielles S.4 | Phosphate d’aluminium et de sodium | Aliments non normalisés | Bonnes pratiques industrielles S.5 | Sulfate double d’aluminium et de sodium | (1) Poudre à pâte

(2)

Aliments non normalisés | (1) Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles S.6 | Bicarbonate de sodium | (1) Blanc d’œuf congelé (albumen congelé); blanc d’œuf liquide (albumen liquide); confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) de (nom du fruit); gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; jaune d’œuf congelé; jaune d’œuf liquide; marinade, saumure et mélange de salaison à sec employés dans le marinage des viandes conditionnées ou conservées | (1) Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance et des sous-produits de viande conditionnés ou conservés; marmelade d’ananas; marmelade d’ananas avec pectine; marmelade de figues; marmelade de figues avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; mélange pour crème glacée; mélange pour lait glacé; œuf entier congelé; œuf entier liquide; poudre à pâte; poudre de blanc d’œuf (poudre d’albumen); poudre de jaune d’œuf; poudre de lait malté; poudre d’œuf entier; rocou soluble dans l’huile

(2)

Produits du cacao

(2)

En quantité suffisante pour traiter les produits du cacao conformément à l’alinéa B.04.005

(3)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(3)

Bonnes pratiques industrielles

(4)

Préparations pour nourrissons

(4)

Bonnes pratiques industrielles

(5)

Margarine

(5)

Bonnes pratiques industrielles

(6)

Aliments non normalisés

(6)

Bonnes pratiques industrielles S.7 Bisulfate de sodium

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(1)

Bonnes pratiques industrielles

(2)

Produits de boulangerie non normalisés

(2)

Bonnes pratiques industrielles S.8 Carbonate de sodium

(1)

Blanc d’œuf congelé (albumen congelé); blanc d’œuf liquide (albumen liquide); beurre de pomme (du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; jaune d’œuf congelé; jaune d’œuf liquide; lait à viande (à désignation du produit de viande) lorsqu’il est vendu pour servir dans les viandes PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs S.9 Citrate de sodium Colonne II Permis dans ou sur conditionnées ou conservées et dans les sous-produits de viande conditionnés ou conservés; marmelade d’ananas; marmelade d’ananas avec pectine; marmelade de figues; marmelade de figues avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; mélange pour crème glacée; mélange pour lait glacé; œuf entier congelé; œuf entier liquide; poudre de blanc d’œuf (poudre d’albumen); poudre de jaune d’œuf; poudre d’œuf entier

(2)

Produits du cacao

(3)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(4)

Margarine

(5)

Aliments non normalisés

(1)

Confitures de (nom du fruit); confitures de (nom du fruit) avec pectine; confitures de pommes (ou de rhubarbe) et de (nom du fruit); crème; fromage cottage; fromage cottage à la crème; gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; marmelade d’ananas ou de figues; marmelade d’ananas ou de figues avec pectine; marmelade de (nom des agrumes); marmelade de (nom des agrumes) avec pectine; mélange pour crème glacée; mélange pour lait glacé; sorbet laitier

(2)

Préparations pour nourrissons

(3)

Aliments non normalisés

(4)

Margarine Colonne III Limites de tolérance

(2)

En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I | Colonne II | Colonne III

Article | Additifs | Permis dans ou sur | Limites de tolérance

S.12 | Fumarate de sodium | Aliments non normalisés | Bonnes pratiques industrielles S.13 | Gluconate de sodium | Aliments non normalisés | Bonnes pratiques industrielles S.14 | Hexamétaphosphate de sodium | Aliments non normalisés | Bonnes pratiques industrielles S.15 | Hydroxyde de sodium | (1) Produits du cacao | (1) En quantité suffisante pour traiter les produits du cacao conformément à l’article B.04.005 | | (2) Gélatine; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); marinade, saumure et mélange de salaison à sec employés dans le marinage des viandes conditionnées ou conservées et des sous-produits de viande conditionnés ou conservés; mélange pour crème glacée; mélange pour lait glacé | (2) Bonnes pratiques industrielles | | (3) Préparations pour nourrissons | (3) Bonnes pratiques industrielles | | (4) Margarine | (4) Bonnes pratiques industrielles | | (5) Aliments non normalisés | (5) Bonnes pratiques industrielles S.16 | Lactate de sodium | (1) Fromage de petit-lait; fromage de petit-lait (indication de la variété) | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Bonnes pratiques industrielles S.17 | Phosphate bisodique | (1) Ale; culture bactérienne; bière; crème; bière légère; liqueur de malt; porter; stout | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Bonnes pratiques industrielles S.18 | Phosphate monosodique | (1) Ale; bière; bière légère; liqueur de malt; porter; stout | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Bonnes pratiques industrielles S.19 | Phosphate trisodique | (1) Ale; bière; bière légère; liqueur de malt; porter; stout | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Bonnes pratiques industrielles S.20 | Tartrate double de sodium et de potassium | (1) Confitures de pommes (ou de rhubarbe) et de (nom du fruit); confitures de (nom du fruit) avec pectine; gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; marmelade (nom des agrumes); marmelade de (nom des agrumes) avec pectine; marmelade d’ananas ou de figues; marmelade d’ananas ou de figues avec pectine | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Bonnes pratiques industrielles | | (3) Margarine | (3) Bonnes pratiques industrielles S.21 | Pyrophosphate tétrasodique | Aliments non normalisés | Bonnes pratiques industrielles S.22 | Polyphosphate trisodique | Aliments non normalisés | Bonnes pratiques industrielles S.23 | Acide sulfurique | Ale; bière; bière légère; liqueur de malt; porter; stout | Bonnes pratiques industrielles Colonne I

Article

S.24 Acide sulfureux T.1 Acide tartrique Colonne II Additifs Permis dans ou sur Gélatine

(1)

Ale; asperges en conserve; bière; bière légère; cidre; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confitures de pommes (ou de rhubarbe) et de (nom du fruit); gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; liqueur de malt; marmelade d’ananas; marmelade d’ananas avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; marmelade de figues; marmelade de figues avec pectine; mayonnaise; mélange pour crème glacée; mélange pour lait glacé; poudre à pâte; sauce à salade; sauce vinaigrette; sorbet laitier; stout; vin; vin de miel;

(2)

Poires en conserve; fraises en conserve

(3)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit lait (indication de la variété)

(4)

Margarine

(5)

Aliments non normalisés

(6)

Produits du cacao Colonne III Limites de tolérance Bonnes pratiques industrielles, pourvu que le produit fini contienne au plus 500 p.p.m. exprimés en anhydride sulfureux

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(6)

1,0 %, seul ou en association avec de l’acide citrique, calculé sans matières grasses TABLE XI PART I Column I | Column II | Column III A.1 Acetic Acid

(2)

Unstandardized foods

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice A.2 Ascorbic Acid

(2)

Canned applesauce

(3)

Canned peaches

(4)

Unstandardized foods

(5)

Canned mandarin oranges

(1)

Good Manufacturing Practice

(2)

If used either singly or in combination with Iso-Ascorbic Acid, the total not to exceed 150 p.p.m.

(3)

550 p.p.m.

(4)

Good Manufacturing Practice

(5)

400 p.p.m.

C

1 Calcium Ascorbate E.1 Erythorbic Acid

(2)

Canned applesauce

(3)

Unstandardized foods

(1)

Good Manufacturing Practice

(2)

If used either singly or in combination with Ascorbic Acid, the total not to exceed 150 p.p.m.

(3)

Good Manufacturing Practice

I

1 Iso-Ascorbic Acid PART B Foods

Section B.16.100

Column I | Column II | Column III PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Column I | Column II | Column III

(3)

Side bacon

(2)

Canned clams | (1) Same levels as prescribed for Erythorbic Acid

(2)

350 p.p.m. PART B Foods

Section B.16.100

Column I | Column II | Column III S.5 Sodium Nitrite

(3)

Side bacon Column I Column II Column III Maximum Level of Use W.1 Wood Smoke

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Unstandardized foods

(3)

Good Manufacturing Practice ---

PARTIE I

Additifs alimentaires autorisés comme agents de conservation de la catégorie I Colonne I Colonne II Colonne III Permis dans ou sur Limites de tolérance A.1 Acide acétique

(1)

Poisson de salaison; viandes de salaison; sous-produits de viande de salaison; viande de volaille de salaison; sous-produits de viande de volaille de salaison; marinade; saumure et mélange de salaison à sec, employés dans l’apprêt des viandes de salaison ou des sous-produits de viande de salaison

(1)

Bonnes pratiques industrielles

(2)

Aliments non normalisés

(2)

Bonnes pratiques industrielles A.2 Acide ascorbique

(1)

Ale; asperges blanches en conserve; bière; bière légère; champignons en conserve; citre; fruits congelés; glaçage pour poisson congelé; tête de fromage ou tête fromagée; liant à viande pour viandes conservées et sous-produits de viande conservée (titre 14 seulement); liqueur de malt; marinade injectée; poisson déchiqueté congelé; poisson conservé;

(1)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

C

1 Ascorbate de calcium

(1)

Ale; bière; cidre; fruits congelés; tête en fromage ou tête fromagée; bière légère; liqueur de malt; liant à viande pour viandes de salaison et sous-produits de la viande de salaison (Titre 14 seulement); porter; poison de salaison; poisson haché congelé; poisson déchiqueté congelé; glaçage pour poisson congelé; viande de salaison; sous-produits de la viande de salaison; viande de volaille de salaison; sous-produits de la viande de volaille de salaison; marinade; saumure et mélange de salaison à sec employés dans le conditionnement des viandes ou des sous-produits de la viande de salaison; stout; vin

(2)

Compote de pommes en conserve

(3)

Aliments non normalisés

(2)

S’il est utilisé seul ou en combinaison avec l’acide isoascorbique, la quantité totale n’excède pas 150 p.p.m.

(3)

Bonnes pratiques industrielles E.1 Acide érythorbique Mêmes aliments que pour l’acide ascorbique Mêmes limites de tolérance que pour l’acide ascorbique

I

1 Acide isoascorbique Mêmes aliments que pour l’acide érythorbique Mêmes limites de tolérance que pour l’acide érythorbique P.1 Nitrate de potassium

(1)

Liant à viande pour saucisse séchée; saucisse semi-séchée; viande conservée et sous-produits de viande conservée, préparés selon des méthodes de salaison lente (Titre 14)

(1)

À la condition qu’il ne soit utilisé selon les modes d’emploi décrits sur l’étiquette et qu’il soit assorti d’instructions précisant que, dans le produit alimentaire fini, la quantité de nitrate de potassium ou de sodium, exprimée en nitrate, n’excède pas 200 p.p.m. pour la saucisse séchée, la saucisse semi-séchée, la viande conservée et les sous-produits de viande conservée, ou 0,32 once par 100 livres de viande pour le poisson haché congelé, et qu’il ne soit fumé, cuit ou fermenté. PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs P.2 Nitrite de potassium Colonne II Permis dans ou sur

(1)

Liant à viande; marinade; saumure et mélange de salaison à sec, utilisés dans le marinage de la viande conservée et des sous-produits de viande conservée (Titre 14)

(2)

Viande conservée, sauf le bacon de flanc, et sous-produits de viande conservée (Titre 14) Colonne III Limites de tolérance

(2)

Si la saumure ou le mélange de salaison à sec est utilisé selon le mode d’emploi donné sur l’étiquette, le nitrite de potassium soit ajouté seul ou avec du nitrate de sodium, la quantité totale de tous les nitrates ainsi ajoutés à chaque lot de viande conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit soit fumé, cuit ou fermenté.

(3)

Si le nitrate de potassium est ajouté seul ou avec du nitrate de sodium, la quantité totale de tous les nitrates ajoutés à chaque lot de saucisse séchée, saucisse semi-séchée, ou sous-produits de viande conservée, ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit soit fumé, cuit ou fermenté.

(4)

Si est utilisé seul ou avec du nitrate de sodium, le produit contiendra une quantité maximale de 200 p.p.m. (basée sur le lait). Le résidu dans le fromage fini ne devra pas excéder 50 p.p.m.

(5)

Si est utilisé seul ou avec du nitrate de sodium, le produit contiendra une quantité maximale de 200 p.p.m. (basée sur le lait). Le résidu dans le fromage fini ne devra pas excéder 50 p.p.m.

(2)

Saumure et mélange de salaison à sec employés dans le marinage des viandes conservées et des sous-produits de viande conservée, préparés selon des méthodes de salaison lente (Titre 14)

(3)

Saucisse séchée; saucisse semi-séchée; viande conservée et sous-produits de viande conservée, préparés selon des méthodes de salaison lente (Titre 14)

(4)

Fromage mûri, ne contenant pas plus de 68 % d’humidité calculée sur la matière non-grasse, et dans la fabrication duquel la fermentation de l’acide lactique et le salage sont complétés plus de 12 heures après la coagulation de la caillebote par des enzymes alimentaires, et à l’extérieur duquel on applique du sel, soit à l’état sec ou sous forme de saumure

(5)

Fromage mûri; moulé; empaqueté à vide Colonne I

Article

Additifs S.1 Ascorbate de sodium S.2 Erythorbate de sodium S.3 Iso-ascorbate de sodium S.4 Nitrate de sodium Colonne II Permis dans ou sur Mêmes aliments que pour l'acide ascorbique

(1)

Mêmes aliments que pour l'acide érythorbique

(2)

Clams en conserve Mêmes aliments que pour l'acide érythorbique

(1)

Liant à viande pour saucisse séchée; saucisse semi-séchée; viande conservée et sous-produits de viande conservée, préparés selon des méthodes de salaison lente (Titre 14)

(2)

Saumure et mélange de salaison à sec utilisés dans le marinage de viande conservée et de sous-produits de viande conservée, préparés selon des méthodes de salaison lente (Titre 14)

(3)

Saucisse séchée; saucisse semi-séchée; viande conservée et sous-produits de viande conservée, préparés selon des méthodes de salaison lente (Titre 14) Colonne III Limites de tolérance Mêmes limites de tolérance que pour l'acide ascorbique

(1)

Mêmes limites de tolérance que pour l'acide érythorbique

(2)

350 p.p.m. Mêmes limites de tolérance que pour l'acide érythorbique

(1)

Si le liant à viande est utilisé selon le mode d'emploi donné sur l'étiquette, la teneur totale de tels nitrates ainsi ajoutés ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculées avant que le produit ne soit fumé, cuit ou fermenté.

(2)

Si la saumure et le mélange de salaison à sec sont utilisés selon le mode d'emploi donné sur l'étiquette, la teneur totale de tels nitrates ainsi ajoutés ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculées avant que le produit ne soit fumé, cuit ou fermenté.

(3)

Si le nitrate est utilisé selon le mode d'emploi donné sur l'étiquette, la teneur totale de tels nitrates ainsi ajoutés ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculées avant que le produit ne soit fumé, cuit ou fermenté. Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

(4)

Fromage mûri, ne contenant pas plus de 68 % d'humidité calculée sur la matière non-grasse, et dans la fabrication duquel la fermentation de l'acide lactique et le salage sont complétés plus de 12 heures après la coagulation de la caillé obtenue par des enzymes alimentaires et à l'exception duquel on applique du sel, soit à l'état sec ou sous forme de saumure

(5)

Fromage mûri; moulé; empaqueté à vide viande conservée ou de sous-produits de viande conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté.

(4)

S'il est utilisé seul ou avec du nitrate de potassium, le produit contient une quantité maximale de 200 p.p.m. (base sur le lait). Le résidu dans le fromage fini ne devra pas excéder 50 p.p.m.

(5)

S'il est utilisé seul ou avec du nitrate de potassium, le produit contient une quantité maximale de 200 p.p.m. (base sur le lait). Le résidu dans le fromage fini ne devra pas excéder 50 p.p.m. S.5 Nitrite de sodium

(1)

Liant à viande; marinade; saumure et mélange de salaison à sec utilisés pour le marinage de viande conservée et de sous-produits de viande conservée (Titre 14)

(2)

Viande conservée, sauf le bacon, et sous-produits de viande conservée (Titre 14)

(3)

Bacon de flanc

(4)

Viande de volaille conservée et sous-produits de viande de volaille conservée (Titre 22)

(1)

Si le nitrite de sodium est ajouté seul ou avec du nitrate de potassium, la quantité totale des nitrites ainsi ajoutée à chaque lot de viande conservée ou de sous-produits de viande conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté.

(2)

Si le nitrite de sodium est ajouté seul ou avec du nitrate de potassium, la quantité totale des nitrites ajoutée à chaque lot de viande conservée, sauf le bacon de flanc, ou de sous-produits de viande conservée, ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté.

(3)

Si le nitrite de sodium est ajouté seul ou avec du nitrate de potassium, la quantité totale des nitrites ajoutée à chaque lot de bacon de flanc ne doit pas excéder 0,27 once par 100 livres ou 120 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté.

(4)

Si le nitrite de sodium est ajouté seul ou avec du nitrate de potassium, la quantité totale des nitrites ajoutée à chaque lot de viande de volaille conservée ou de sous-produits de PART B Foods

Section B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance W.1 Fumée de bois

(1)

Fromage (indication de la variété); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

(2)

Poisson conservé; viande conservée (titres 14 et 21); sous-produits de viande conservés (titres 14 et 21); viande de volaille conservée; sous-produits de viande de volaille conservés; saucisses

(3)

Aliments non normalisés

(1)

Bonnes pratiques industrielles viande de volaille conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté.

(3)

Bonnes pratiques industrielles PART II Column I Column II Column III Maximum Level of Use B.1 Benzoic Acid

(2)

Unstandardized foods [except unstandardized preparations of

(1)

1,000 p.p.m.

(2)

1,000 p.p.m. Column I Column II Column III Maximum Level of Use

(3)

Margarine

(3)

If used singly or in combination with Sorbic Acid, the total shall not exceed 1,000 p.p.m.

C

1 Calcium Sorbate

C

2 Carnobacterium maltaromaticum CB1

(1)

Vacuum-packed wieners

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice H.1 4-Hexylresorcinol Crustaceans

M

1 Methyl-p-hydroxy Benzoate

(1)

1,000 p.p.m.

(2)

Unstandardized foods [except unstandardized preparations of

M

2 Methyl Paraben P.1 Potassium Benzoate P.2 Potassium Bisulphite P.3 Potassium Metabisulphite P.4 Potassium Sorbate PART B Foods

Section B.16.100

Column I | Column II | Column III

(2)

Unstandardized foods [except unstandardized preparations of (c) poultry meat and poultry meat by-product] | (1) 1,000 p.p.m.

(2)

1,000 p.p.m.

(2)

Unstandardized preparations of (b) poultry meat and poultry meat by-product | (1) Good Manufacturing Practice

(2)

Good Manufacturing Practice

(2)

Unstandardized preparations of | (1) 0.25% of final product weight

(2)

0.25% of final product weight Column I | Column II | Column III | (2) Unstandardized foods [except unstandardized preparations of (c) poultry meat and poultry meat by-product] | (2) 1,000 p.p.m. | (3) Olive brine | (3) 300 p.p.m. | (4) Margarine | (4) If used singly or in combination with Benzoic Acid, the total shall not exceed 1,000 p.p.m. S.10 | Sulphurous Acid | (5) Unstandardized salad dressings | (5) 3,350 p.p.m. PART B Foods

Section B.16.100

Column I | Column II | Column III ---

PARTIE II

Additifs alimentaires autorisés comme agents de conservation de la catégorie II Colonne I | Colonne II | Colonne III

Article | Additifs | Permis dans ou sur | Limites de tolérance

B.1 | Acide benzoïque | (1) Achards (relish); catsup de tomates; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); cornichons; gelée | (1) 1 000 p.p.m. PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

C

1 Sorbate de calcium Mêmes aliments que pour l’acide sorbique

(3)

Si utilisé seul ou en association avec de l’acide sorbique, la quantité totale ne doit pas excéder 1 000 p.p.m.

C

2 Carnobacterium maltaromaticum CB1

(1)

Saucisse fumée emballée sous vide

(2)

Rôti de bœuf tranché emballé sous vide conformément à l’article B.14.005

(3)

Jambon cuit tranché emballé sous vide conformément à l’article B.14.005 ou B.14.031

(4)

Dinde cuite tranchée emballée sous vide conformément à l’article B.22.006 ou B.22.021

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles H.1 4-Hexylrésorcine Crustacés Bonnes pratiques industrielles. Les résidus dans la partie comestible du produit non cuit ne doivent pas dépasser 1,0 p.p.m.

M

1 Benzoate de p-hydroxyméthyle

(1)

Achards (relish); catsup de tomates; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); cornichons; gelée de (nom du fruit) avec pectine; jus de (nom du fruit); jus de (nom du fruit) concentré sauf le jus d’orange concentré congelé; jus de (noms des fruits); marmelade d’ananas avec pectine; marmelade de figues avec pectine; marmelade de (nom de l’agrume) avec pectine; mincemeat; pâte de tomates; produits de poisson ou de chair de poisson emballés, marinés ou conditionnés à froid par une autre méthode (Titre 21); pulpe de tomates; purée de tomates

(2)

Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(3)

Margarine

(1)

1 000 p.p.m. Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

M

2 Méthylparabène Mêmes aliments que pour le benzoate de p-hydroxyméthyle Mêmes limites de tolérance que pour le benzoate de p-hydroxyméthyle P.1 Benzoate de potassium Mêmes aliments que pour l'acide benzoïque 1 000 p.p.m., calculé en acide benzoïque P.2 Bisulfite de potassium Mêmes aliments que pour l'anhydride sulfureux Mêmes limites de tolérance que pour l'anhydride sulfureux P.3 Métabisulfite de potassium Mêmes aliments que pour l'anhydride sulfureux Mêmes limites de tolérance que pour l'anhydride sulfureux P.4 Sorbate de potassium Mêmes aliments que pour l'acide sorbique 1 000 p.p.m. P.5 Benzoate de p-hydroxypropyle

(1)

Achards (relish); catsup de tomates; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de (nom du fruit) avec jus de (nom du fruit); cornichons; gelée de (nom du fruit) avec pectine; jus de (nom du fruit); jus de (nom du fruit) concentré sauf le jus d'orange concentré congelé; jus de (noms des fruits); marmelade d'ananas avec pectine; marmelade de figues avec pectine; marmelade de (nom de l'agrume) avec pectine; mincemeat; pâte de tomates; produits de poisson ou de chair de poisson emballés, marinés ou conditionnés à froid par une autre méthode (Titre 21); pulpe de tomates; purée de tomates

(2)

Aliments non normalisés, [à l'exception des préparations non normalisées de a) viande et de sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(2)

1 000 p.p.m. P.6 Propylparabène Mêmes aliments que pour le benzoate de p-hydroxypropyle Mêmes limites de tolérance que pour le benzoate de p-hydroxypropyle S.01 Acétate de sodium

(1)

Fromage de porc; pain de viande; saucisse; sous-produits de viande conditionnés ou conservés; sous-produits de viande de volaille conditionnés ou conservés; sous-produits de viande en pain; sous-produits de viande en pot; sous-produits de viande préparés; sous-produits de viande préparés et conditionnés ou conservés; viande conditionnée ou conservée; viande de volaille

(1)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance S.1 Benzoate de sodium Mêmes aliments que pour l’acide benzoïque 1 000 p.p.m., calculé en acide benzoïque S.2 Bisulfite de sodium Mêmes aliments que pour l’anhydride sulfureux Mêmes limites de tolérance que pour l’anhydride sulfureux S.21 Diacétate de sodium

(1)

Fromage de porc; pain de viande; poisson et viande préparés (Titre 21); poisson de salaison et chair de poisson de salaison (Titre 21); saucisse; sous-produits de viande conditionnés ou conservés; sous-produits de viande de volaille conditionnés ou conservés; sous-produits de viande en pain; sous-produits de viande en pot; sous-produits de viande préparés; sous-produits de viande de volaille préparés; fromage; viande conditionnée ou conservée; viande de volaille conditionnée ou conservée; viande de volaille préparée; viande en pot; viande préparée

(2)

Préparations non normalisées de : a) viande et sous-produits de viande (titres 14 et 21); b) poisson; c) viande de volaille et sous-produits de viande de volaille

(2)

Bonnes pratiques industrielles

(2)

0,25 % du poids final du produit S.3 Métabisulfite de sodium Mêmes aliments que pour l’anhydride sulfureux Mêmes limites de tolérance que pour l’anhydride sulfureux S.4 Sel sodique de l’acide p-hydroxyméthyl benzoïque Mêmes aliments que pour le benzoate de p-hydroxyméthyle 1 000 p.p.m., calculé en benzoate de p-hydroxyméthyle S.5 Sel sodique de l’acide p-hydroxypropyl Mêmes aliments que pour le benzoate de p-hydroxypropyl 1 000 p.p.m., calculé en benzoate de p-hydroxypropyl S.6 Sorbate de sodium Mêmes aliments que pour l’acide sorbique 1 000 p.p.m. S.7 Sulfite de sodium Mêmes aliments que pour l’anhydride sulfureux Mêmes limites de tolérance que pour l’anhydride sulfureux S.8 Dithionite de sodium Mêmes aliments que pour l’anhydride sulfureux Mêmes limites de tolérance que pour l’anhydride sulfureux S.9 Acide sorbique

(1)

Achards (relish); catsup de tomates; confiture (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes ou rhubarbe de (nom du fruit); cornichons; gelée de (nom du fruit avec pectine); jus de (nom du fruit); jus de (nom du fruit) concentré sauf le jus d’orange

(1)

1 000 p.p.m. PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance S.10 Anhydride sulfureux

(1)

Cidre; vin de miel; vin

(2)

Ale; bière; bière légère; liqueur de malt; porter; stout

(3)

Achards (relish); catsup de tomates; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe et de (nom du fruit)); cornichons; gélatine; gelée de (nom du fruit) avec pectine; jus de (nom du fruit); jus de (nom du fruit) concentré sauf le jus d’orange concentré congelé; jus de (noms des fruits); marmelade d’ananas avec pectine; marmelade de figues avec pectine; marmelade de (nom de l’agrume) avec pectine; mélasse de raffineur; mélasse de table; mélasse qualité fantaisie; mincemeat; pâte de tomates; pommes tranchées, congelées; pulpe de tomates; purée de tomates; sirop (nom de la source de glucose)

(4)

Boissons non normalisées

(5)

Fruits et légumes desséchés

(6)

Aliments non normalisés, [à l’exception des aliments reconnus comme sources de thiamine et des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21);

(2)

1 000 p.p.m.

(3)

500 p.p.m., calculé en anhydride sulfureux

(4)

100 p.p.m., calculé en anhydride sulfureux

(5)

2 500 p.p.m., calculé en anhydride sulfureux

(6)

500 p.p.m., calculé en anhydride sulfureux b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(3)

Saumure d’olive

(4)

Margarine

(5)

Sauces à salade non normalisées

(2)

15 p.p.m., calculé en anhydride sulfureux

(3)

33 000 p.p.m.

(4)

Si utilisé seul ou en association avec de l’acide benzoïque, la quantité totale ne doit pas excéder 1 000 p.p.m.

(6)

Aliments non normalisés [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille] concentré congelé; jus de (noms des fruits); marmelade d’ananas avec pectine; marmelade de figues avec pectine; marmelade de (nom de l’agrume) avec pectine; mincemeat; pâte de poisson fumé et salé conditionné à froid; pâte de tomates; poisson desséché, fumé ou salé; pulpe de tomates; purée de tomates; sirop (nom de la source de glucose)

(2)

Aliments non normalisés [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille] PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance b) poisson; et c) viande de volaille et sous-produits de viande de volaille)

(7)

Champignons congelés

(7)

90 p.p.m., calculé en anhydride sulfureux

(8)

Dextrose anhydre; monohydrate de dextrose

(8)

20 p.p.m., calculé en anhydride sulfureux

(9)

Glucose ou sirop de glucose

(9)

40 p.p.m., sauf pour le glucose ou le sirop de glucose utilisés pour la fabrication des confiseries, pas plus de 400 p.p.m., calculé en anhydride sulfureux

(10)

Solides de glucose ou sirop de glucose déshydraté

(10)

40 p.p.m., sauf pour les solides de glucose ou le sirop de glucose déshydraté utilisés pour la fabrication des confiseries, pas plus de 150 p.p.m., calculé en anhydride sulfureux

(11)

Crustacés

(11)

Bonnes pratiques industrielles. Les résidus dans la partie comestible du produit non cuit ne doivent pas dépasser 100 p.p.m., calculé en anhydride sulfureux. PART III Column I Column II Column III Maximum Level of Use

C

1 Calcium Propionate

(2)

Soft flour tortillas

(2)

4,000 p.p.m.

C

2 Calcium Sorbate N.1 Natamycin

(1)

20 p.p.m. in accordance with the requirements of sections B.08.033 and B.08.034

(2)

10 p.p.m. in accordance with the requirements of sections B.08.033 and B.08.034 P.1 Potassium Sorbate

(2)

Soft flour tortillas

(2)

5,000 p.p.m. P.2 Propionic Acid

(1)

Bread

(1)

2,000 p.p.m.

(2)

2,000 p.p.m. or 3,000 p.p.m., as the case may be, in accordance with the requirements of sections B.08.033, B.08.034, B.08.035, B.08.037, B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 and B.08.041.8 Column I S.1 Sodium Diacetate S.2 Sodium Propionate S.3 Sodium Sorbate S.4 Sorbic Acid Column II (naming the added ingredients);

(3)

Unstandardized foods except unstandardized preparations of

(1)

Bread

(2)

Unstandardized foods [except unstandardized preparations of

(1)

Bread

(3)

Cider; Wine; Honey Wine

(4)

Unstandardized foods except unstandardized preparations of Column III Maximum Level of Use

(3)

2,000 p.p.m.

(1)

3,000 p.p.m.

(2)

3,000 p.p.m.

(1)

1,000 p.p.m.

(2)

3,000 p.p.m. in accordance with the requirements of sections B.08.033, B.08.034, B.08.035, B.08.037, B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 and B.08.041.8

(3)

500 p.p.m.

(4)

1,000 p.p.m. Column I Column II Column III

PARTIE III

Additifs alimentaires autorisés comme agents de conservation de la catégorie III Colonne I Colonne II Colonne III

Article Additifs Permis dans ou sur Limites de tolérance

C

1 Propionate de calcium

(1)

Mêmes aliments que pour l’acide propionique

(2)

Tortillas molles

(1)

2 000 p.p.m., calculé sous forme d’acide propionique

(2)

4 000 p.p.m.

C

2 Sorbate de calcium Mêmes aliments que pour l’acide sorbique Mêmes limites de tolérance que pour l’acide sorbique N.1 Natamycine

(1)

La surface du fromage (indication de la variété) et du fromage cheddar

(1)

20 p.p.m., conformément aux exigences des articles B.08.033 et B.08.034

(2)

La surface du fromage râpé fin ou en filaments (indication de la variété) et du fromage cheddar râpé fin ou en filaments

(2)

10 p.p.m., conformément aux exigences des articles B.08.033 et B.08.034 P.1 Sorbate de potassium

(1)

Mêmes aliments que pour l’acide sorbique

(2)

Tortillas molles

(1)

Mêmes limites de tolérance que pour l’acide sorbique

(2)

5 000 p.p.m. P.2 Acide propionique

(1)

Pain

(2)

Fromage (indication de la variété); fromage cheddar; fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

(3)

Aliments non normalisés, à l’exception des préparations non normalisées a) de viande et de sous-produits de viande (titres 14 et 21); b) de poisson; et

(1)

2 000 p.p.m.

(2)

2 000 p.p.m. ou 3 000 p.p.m., suivant le cas, conformément aux exigences des articles B.08.033, B.08.034, B.08.035, B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1 et B.08.041.8

(3)

2 000 p.p.m. PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs S.1 Diacétate de sodium S.2 Propionate de sodium S.3 Sorbate de sodium S.4 Acide sorbique Colonne II Permis dans ou sur c) de viande de volaille et de sous-produits de viande de volaille

(1)

Pain;

(2)

Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille)] Mêmes aliments que pour l’acide propionique Mêmes aliments que pour l’acide sorbique

(1)

Pain

(2)

Fromage (indication de la variété); fromage cheddar; fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

(3)

Cidre; vin; vin de miel

(4)

Aliments non normalisés, à l’exception des préparations non normalisées a) de viande et de sous-produits de viande (titres 14 et 21); b) de poisson; et c) de viande de volaille et de sous-produits de viande de volaille Colonne III Limites de tolérance

(1)

3 000 p.p.m.

(2)

3 000 p.p.m. 2 000 p.p.m., calculé en acide propionique Mêmes limites de tolérance que pour l’acide sorbique

(1)

1 000 p.p.m.

(2)

3 000 p.p.m., conformément aux exigences des articles B.08.033, B.08.034, B.08.035, B.08.037, B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 et B.08.041.8

(3)

500 p.p.m.

(4)

1 000 p.p.m. PART IV Column I | Column II | Column III A.1 | Ascorbic Acid | (1) Fats and oils; Lard; Monoglycerides and diglycerides; Shortening | (1) Good Manufacturing Practice | | (2) Unstandardized foods | (2) Good Manufacturing Practice A.2 | Ascorbyl Palmitate | (1) Fats and oils; Lard; Monoglycerides and diglycerides; Shortening | (1) Good Manufacturing Practice | | (2) Unstandardized foods [except unstandardized preparations of | | (c) poultry meat and poultry meat by-product] | (2) Good Manufacturing Practice A.3 | Ascorbyl Stearate | (1) Fats and oils; Lard; Monoglycerides and diglycerides; Shortening | (1) Good Manufacturing Practice | | (7) Vitamin A liquids for addition to food | (7) 5 mg/1,000,000 International Units | | (8) Dry beverage mixes; Dry dessert and confectionery mixes | (8) 0.009% | | (9) Active dry yeast | (9) 0.1% | | (10) Other unstandardized foods [except unstandardized preparations of | (10) 0.02% of the fat or oil content of the food. If butylated hydroxytoluene or propyl gallate or PART B Foods

Section B.16.100

Column I | Column II | Column III

(12)

Margarine

(11)

10 mg/1,000,000 International Units

(13)

Dried cooked poultry meat B.2 Butylated Hydroxytoluene (3,5-ditertiarybutyl-4-hydroxytoluene)

(1)

Fats and oils, lard, shortening

(2)

Dried breakfast cereals; Dehydrated potato products

(3)

Chewing gum

(4)

Essential oils; Citrus oil flavours; Dry flavours

(5)

Citrus oils

(7)

Vitamin A liquids for addition to food

(7)

5 mg/1,000,000 International Units

(8)

0.0035%

(9)

Other unstandardized foods [except unstandardized preparations of

(10)

10 mg/1,000,000 International Units

(11)

Margarine Column I

C

1 | Citric Acid Column II

(1)

Fats and oils; Lard; Monoglycerides and diglycerides; Shortening

(2)

Unstandardized foods [except unstandardized preparations of

(3)

Dried cooked poultry meat Column III Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

C

1.01 | Citric Acid Esters of Mono- and Di-glycerides Column II

(1)

Fats and oils; Lard; Monoglycerides and diglycerides; Shortening

(2)

Unstandardized foods [except unstandardized preparations of

(3)

Margarine Column III Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

C

1.1 | L-Cysteine Column II Nutritional supplements set out in section B.24.201 Column III Maximum Level of Use Good Manufacturing Practice

C

2 | L-Cysteine Hydrochloride Column II Column III Maximum Level of Use Good Manufacturing Practice G.1 | Gum Guaiacum Column II

(1)

Fats and oils; Lard; Monoglycerides and diglycerides; Shortening

(2)

Unstandardized foods [except unstandardized preparations of Column III Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

L

1 | Lecithin Column II

(1)

Fats and oils; Lard; Monoglycerides and diglycerides; Shortening

(2)

Unstandardized foods [except unstandardized preparations of Column III Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice Column I

L

2 Lecithin Citrate Column II

(1)

Fats and oils; Lard; Monoglycerides and diglycerides; Shortening

(2)

Unstandardized foods [except unstandardized preparations of Column III Maximum Level of Use

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

M

1 Monoglyceride Citrate

(1)

Fats and oils; Lard; Monoglycerides and diglycerides; Shortening

(2)

Unstandardized foods [except unstandardized preparations of

(3)

Margarine

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

M

2 Monoiso­propyl Citrate

(1)

Fats and oils; Lard; Monoglycerides and diglycerides; Shortening

(2)

Unstandardized foods [except unstandardized preparations of

(3)

Margarine

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice P.1 Propyl Gallate

(1)

Fats and oils, lard, shortening

(2)

Dried breakfast cereals; Dehydrated potato products

(3)

Chewing gum Column I Column II Column III Maximum Level of Use

(4)

Essential oils; Dry flavours

(5)

Citrus oils

(6)

Other unstandardized foods [except unstandardized preparations of

(7)

Margarine

(8)

Dried cooked poultry meat T.1 Tartaric Acid

(1)

Fats and oils; Lard; Monoglycerides and diglycerides; Shortening

(1)

Good Manufacturing Practice

(2)

Unstandardized foods [except unstandardized preparations of

(2)

Good Manufacturing Practice T.1A Tertiary Butyl Hydroquinone

(1)

Fats and oils; Lard; Monoglycerides and diglycerides; Shortening

(1)

Good Manufacturing Practice

(2)

Unstandardized foods [except unstandardized preparations of

(2)

Good Manufacturing Practice

(3)

Infant formula

PARTIE IV

Additifs alimentaires autorisés comme agents de conservation de la catégorie IV

Article | Colonne I | Colonne II | Colonne III

Additifs | Permis dans ou sur | Limites de tolérance A.1 | Acide ascorbique | (1) Huiles et graisses; saindoux; monoglycérides et diglycérides; shortening | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Bonnes pratiques industrielles A.2 | Palmitate d’ascorbyle | (1) Huiles et graisses; saindoux; monoglycérides et diglycérides; shortening | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille] | (2) Bonnes pratiques industrielles | | (3) Margarine | (3) 0,02 % de la teneur en gras. Si on emploie aussi le stéarate d’ascorbyle, la quantité totale ne doit pas excéder 0,02 % de la teneur en gras | | (4) Préparations pour nourrissons | (4) 0,01 % de la préparation pour nourrissons prêts à consommer A.3 | Stéarate d’ascorbyle | (1) Graisses et huiles; saindoux; monoglycérides et diglycérides; shortening | (1) Bonnes pratiques industrielles | | (2) Margarine | (2) 0,02 % de la teneur en gras. Si on emploie aussi le palmitate d’ascorbyle, la quantité totale ne doit pas excéder 0,02 % de la teneur en gras B.1 | Hydroxyanisole butylé (mélange de 2-tertibutyl-4-hydroxyanisole et de 3-tertibutyl-4-hydroxyanisole) | (1) Graisses et huiles, saindoux, shortening | (1) 0,02 %. Si on emploie aussi l’hydroxytoluène butylé, l’hydroquinone butyle tertiaire ou le gallate de propyle, ou les deux à la fois, la quantité totale ne doit pas dépasser 0,02 % | | (2) Céréales à déjeuner sèches; produits déshydratés de pommes de terre | (2) 0,005 %. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, ou les deux à la fois, la quantité totale ne doit pas dépasser 0,005 % | | (3) Gomme à mâcher | (3) 0,02 %. Si on emploie aussi l’hydroxytoluène butylé, l’hydroquinone butyle tertiaire ou le gallate de propyle, ou les deux à la fois, la quantité totale ne doit pas dépasser 0,02 % | | (4) Huiles essentielles; essences à base d’huile d’agrumes; substances aromatiques sèches | (4) 0,125 %. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, ou les deux à la fois, la quantité totale ne doit pas dépasser 0,125 % | | (5) Huiles d’agrumes | (5) 0,5 %. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, ou les deux à la fois, la quantité totale ne doit pas dépasser 0,5 % PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs Colonne II Permis dans ou sur Colonne III Limites de tolérance

(6)

Tissus gras de porc ou de bœuf partiellement dégraissés

(6)

0,0065 %. Si on emploie aussi l’hydroxytoluène butylé, la quantité ne doit pas en dépasser 0,0065 %

(7)

Liquides renfermant de la vitamine A et devant servir d’additifs alimentaires

(7)

5 mg/1 000 000 unités internationales

(8)

Mélanges secs pour boissons; mélanges secs pour desserts et confiseries

(8)

0,009 %

(9)

Levure active séchée

(9)

0,1 %

(10)

Autres aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille)]

(10)

0,02 % de la teneur de l’aliment en gras ou en huile. Si on emploie aussi l’hydroxytoluène butylé, ou le gallate de propyle, ou les deux, la quantité totale ne peut pas dépasser 0,02 % de la teneur de l’aliment en gras ou en huile

(11)

Préparations sèches de vitamine D devant être ajoutées aux aliments

(11)

10 mg/1 000 000 unités internationales

(12)

Margarine

(12)

0,02 %. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, ou les deux, la quantité totale ne doit pas excéder 0,01 % de la teneur en gras

(13)

Viande de volaille cuite et séchée

(13)

0,015 % de la teneur en gras. Si on emploie aussi le gallate de propyle ou l’acide citrique, ou les deux, la quantité totale ne doit pas excéder 0,015 % de la teneur en gras B.2 Hydroxytoluène butylé (3,5-ditertioctbutyl-4-hydroxytoluène)

(1)

Graisses et huiles, saindoux, shortening

(1)

0,02 %. Si on emploie aussi l’hydroxytoluène butylé, l’hydroxytoluène de butyle tertiaire ou le gallate de propyle, seul ou en association, la quantité totale ne doit pas dépasser 0,02 %

(2)

Céréales à déjeuner sèches; produits de pommes de terre déshydratés

(2)

0,005 %. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, ou les deux, la quantité totale ne doit pas dépasser 0,005 %

(3)

Gomme à mâcher

(3)

0,02 %. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, ou les deux, la quantité totale ne doit pas dépasser 0,02 %

(4)

Huiles essentielles; essences à base d’huiles d’agrumes; substances aromatiques sèches

(4)

0,015 %. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, ou les deux, la quantité totale ne doit pas dépasser 0,125 %

(5)

Huiles d’agrumes

(5)

0,015 %. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, ou les deux, la quantité totale ne doit pas dépasser 0,125 %

(6)

Tissus gras de porc ou de bœuf, partiellement dégraissés

(6)

0,0065 %. Si on emploie aussi l’hydroxytoluène butylé, la quantité ne doit pas en dépasser 0,0065 % PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Article

Additifs Colonne I Permis dans ou sur Colonne II Limites de tolérance

(7)

Liquides renfermant de la vitamine A et devant servir d’additifs alimentaires

(7)

5 mg/l 1 000 000 unités internationales

(8)

Riz à demi cuit

(8)

0,0035 %

(9)

Autres aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et de sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(9)

0,02 % de la teneur de l’aliment en gras ou en huile. Si on emploie aussi l’hydroxyanisole butylé ou le gallate de propyle, ou les deux, la quantité totale ne doit pas dépasser 0,02 % de la teneur de l’aliment en gras ou en huile

(10)

Préparations sèches de vitamine D à ajouter aux aliments

(10)

10 mg/l 1 000 000 unités internationales

(11)

Margarine

(11)

0,01 % de la teneur en gras. Si on emploie aussi l’hydroxyanisole butylé ou le gallate de propyle ou les deux, la quantité totale ne doit pas excéder 0,01 % de la teneur en gras

C

1 Acide citrique

(1)

Graisses et huiles; saindoux; monoglycérides et diglycérides; shortening

(1)

Bonnes pratiques industrielles

(2)

Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(2)

Bonnes pratiques industrielles

(3)

Viande de volaille cuite et séchée

(3)

0,015 % de la teneur en gras. Si on emploie aussi l’hydroxyanisole butylé ou le gallate de propyle, ou les deux, la quantité totale ne doit pas excéder 0,015 % de la teneur en gras

C

1.01 Esters citriques des mono- et diglycérides

(1)

Graisses et huiles; monoglycérides et diglycérides; saindoux; shortening

(1)

Bonnes pratiques industrielles

(2)

Aliments non normalisés [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(2)

Bonnes pratiques industrielles

(3)

Margarine

(3)

0,01 % de la teneur en gras. Si on emploie aussi le citrate de monoglycéride, le citrate de monoisopropyle ou le citrate de stéaryle, seul ou en association, la quantité totale ne doit pas dépasser 0,01 % de la teneur en gras

C

1.1 L-cystéine Suppléments nutritifs conformes à l’article B.24.201 Bonnes pratiques industrielles

C

2 Chlorhydrate de L-cystéine Formules de remplacement des sulfites pour les fruits et les légumes préparés Bonnes pratiques industrielles G.1 Résine de gaïac

(1)

Graisses et huiles; saindoux; monoglycérides et diglycérides; shortening

(1)

Bonnes pratiques industrielles

(2)

Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(2)

Bonnes pratiques industrielles

L

1 Lécithine

(1)

Graisses et huiles; saindoux; monoglycérides et diglycérides; shortening

(1)

Bonnes pratiques industrielles

(2)

Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(2)

Bonnes pratiques industrielles

L

2 Citrate de lécithine

(1)

Graisses et huiles; saindoux; monoglycérides et diglycérides; shortening

(1)

Bonnes pratiques industrielles

(2)

Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(2)

Bonnes pratiques industrielles

M

1 Citrate de monoglycéride

(1)

Graisses et huiles; saindoux; monoglycérides et diglycérides; shortening

(1)

Bonnes pratiques industrielles

(2)

Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(2)

Bonnes pratiques industrielles

(3)

Margarine

(3)

0,01 % de la teneur en gras. Si on emploie aussi du citrate de monoisopropyle, le citrate de stéaryle ou les esters citriques des mono- et diglycérides, seuls ou en association, la quantité totale ne doit pas excéder 0,01 % de la teneur en gras.

M

2 Citrate de monoisopropyle

(1)

Graisses et huiles; saindoux; monoglycérides et diglycérides; shortening

(1)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs P.1 Gallate de propyle Colonne II Permis dans ou sur

(1)

Graisses et huiles, saindoux, shortening

(2)

Céréales à déjeuner sèches; produits déshydratés de pommes de terre

(3)

Gomme à mâcher

(4)

Huiles essentielles; substances aromatiques sèches

(5)

Huiles d’agrumes

(6)

Autres aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille]

(7)

Margarine

(8)

Viande de volaille cuite et séchée Colonne III Limites de tolérance

(1)

0,02 %. Si on emploie aussi l’hydroxyanisole butylé ou l’hydroxytoluène butylé, ou les deux, la quantité totale ne doit pas dépasser 0,02 %

(2)

0,005 %. Si on emploie aussi l’hydroxyanisole butylé ou l’hydroxytoluène butylé, ou les deux, la quantité totale ne doit pas dépasser 0,005 %

(3)

0,02 %. Si on emploie aussi l’hydroxyanisole butylé ou l’hydroxytoluène butylé, ou les deux, la quantité totale ne doit pas dépasser 0,02 %

(4)

0,125 %. Si on emploie aussi l’hydroxyanisole butylé ou l’hydroxytoluène butylé, ou les deux, la quantité totale ne doit pas dépasser 0,125 %

(5)

0,05 %. Si on emploie aussi l’hydroxyanisole butylé ou l’hydroxytoluène butylé, ou les deux, la quantité totale ne doit pas dépasser 0,05 %

(6)

0,01 % de la teneur en gras. Si on emploie aussi le citrate de monoglycéride, le citrate de stéaryle ou les esters citriques des mono- et diglycérides, ou ces en association, la quantité totale ne doit pas dépasser 0,01 % de la teneur en gras

(7)

0,01 % de la teneur en gras. Si on emploie aussi l’hydroxyanisole butylé ou l’hydroxytoluène butylé, ou les deux, la quantité totale ne doit pas dépasser 0,01 % de la teneur en gras

(8)

0,015 % de la teneur en gras. Si on emploie aussi l’hydroxyanisole butylé PART B Foods

Section B.16.100

Article | Colonne I | Colonne II | Colonne III

Additifs | Permis dans ou sur | Limites de tolérance T.1 | Acide tartrique | (1) Graisses et huiles; saindoux; monoglycérides et diglycérides; shortening

(2)

Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille)] | ou l’acide citrique, ou les deux, la quantité totale ne doit pas excéder 0,015 % de la teneur en gras.

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles T.1A | Hydroquinone de butyle tertiaire | Graisses et huiles, saindoux, shortening | 0,02 %. Si on emploie aussi l’hydroxyanisole butylé, l’hydroxytoluène butylé ou le gallate de propyle, seul ou en association, la quantité totale ne doit pas dépasser 0,02 % T.2 | Tocophérols (alphatocophérol; concentré de tocophérols mixtes) | (1) Graisses et huiles; saindoux; monoglycérides et diglycérides; shortening

(2)

Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous-produits de viande de volaille)]

(3)

Préparations pour nourrissons | (1) Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

0,001 % de la préparation pour nourrissons prête à consommer TABLE XII Column I | Column II | Column III A.1 | Ammonium Citrate, dibasic | Unstandardized foods | Good Manufacturing Practice A.2 | Ammonium Citrate, monobasic | Unstandardized foods | Good Manufacturing Practice

C

1 | Calcium Citrate | Unstandardized foods | Good Manufacturing Practice

C

2 | Calcium Disodium Ethylenediaminetetraacetate (Calcium Disodium EDTA) | (1) Ale; Beer; Malt liquor; Porter; Stout Column I Column II Column III Maximum Level of Use

(3)

Potato salad; Unstandardized sandwich spreads

(4)

Canned shrimp; Canned tuna

(5)

Canned crabmeat; Canned lobster; Canned salmon

(6)

Margarine

(7)

Canned clams

(8)

Beans; Beans with pork; Canned legumes except canned green beans, canned peas and canned wax beans

(10)

Ready-to-drink teas; Soft drinks

(11)

Pasteurized sous-vide potatoes

(11)

100 p.p.m., singly or in combination with disodium EDTA, calculated as the anhydrous disodium EDTA form

C

3 [Repealed, SOR/2012-43, s. 43]

C

4 Calcium Phosphate, monobasic

(1)

Ice cream mix; Ice milk mix; Sherbet

(1)

Good Manufacturing Practice

(2)

Unstandardized dairy products

(2)

Good Manufacturing Practice

C

5 Calcium Phosphate, tribasic Good Manufacturing Practice

C

6 Calcium Phytate Good Manufacturing Practice

C

7 Citric Acid

(1)

Good Manufacturing Practice

(2)

Unstandardized foods

(2)

Good Manufacturing Practice

(3)

0.1%

D

1 Disodium Ethylenediaminetetraacetate (Disodium EDTA)

(1)

Dressing and sauces

(1)

170 p.p.m.

(2)

Unstandardized sandwich spreads

(2)

90 p.p.m.

(3)

Beans; Beans with pork; Canned legumes except canned green beans, canned peas and canned wax beans

(3)

165 p.p.m.

(4)

Dried banana products

(4)

265 p.p.m.

(5)

1% of the colour preparation

(6)

Pasteurized sous-vide potatoes

(6)

100 p.p.m., singly or in combination with calcium disodium EDTA, calculated as anhydrous disodium EDTA

D

2 [Repealed, SOR/2012-43, s. 45] G.1 Glycine Mono- and diglycerides

0.02%

PART B Foods

Section B.16.100

Column I | Column II | Column III P.1 | Phosphoric Acid | Mono- and diglycerides | 0.02% P.2 | Potassium Phosphate, monobasic | (1) Ice cream mix; Ice milk mix; Sherbet | (1) Good Manufacturing Practice | (2) Unstandardized foods | (2) Good Manufacturing Practice P.3 | Potassium Pyrophosphate, tetrabasic | (1) Meat tenderizers | (1) Good Manufacturing Practice | (2) Ice cream mix; Ice milk mix | (2) Good Manufacturing Practice | (5) Unstandardized foods | (5) Good Manufacturing Practice | (2) Unstandardized foods | (2) Good Manufacturing Practice | (2) Ice cream mix; Ice milk mix | (2) Good Manufacturing Practice | (5) Unstandardized foods | (5) Good Manufacturing Practice PART B Foods

Section B.16.100

Column I | Column II | Column III S.4 Sodium Phosphate, dibasic

(1)

Ice cream mix; Ice milk mix; Sherbet

(2)

Injection or cover solution for the curing of poultry or poultry meat

(4)

Unstandardized foods

(7)

800 p.p.m. in the concentrated or dried whey products

(1)

Good Manufacturing Practice

(4)

Good Manufacturing Practice

(1)

Ice cream mix; Ice milk mix; Sherbet

(2)

Injection or cover solution for the curing of poultry or poultry meat

(4)

Unstandardized foods

(1)

Good Manufacturing Practice

(4)

Good Manufacturing Practice S.6 Sodium Pyrophosphate, tetrabasic

(1)

Ice cream mix; Ice milk mix; Sherbet

(2)

Meat tenderizers

(3)

Injection or cover solution for the curing of poultry or poultry meat

(5)

Unstandardized foods

(1)

Good Manufacturing Practice

(2)

Good Manufacturing Practice

(5)

Good Manufacturing Practice S.7 Sodium Tripolyphosphate

(1)

Injection or cover solution for the curing of poultry or poultry meat

(2)

Meat tenderizers

(4)

Unstandardized foods

(2)

Good Manufacturing Practice

(4)

Good Manufacturing Practice PART B Foods

Section B.16.100

Column I | Column II | Column III TABLEAU XII Additifs alimentaires autorisés comme chélateurs ou agents séquestrants Colonne I | Colonne II | Colonne III

Article | Additifs | Permis dans ou sur | Limites de tolérance

A.1 | Citrate diammonique | Aliments non normalisés | Bonnes pratiques industrielles A.2 | Citrate monoammonique | Aliments non normalisés | Bonnes pratiques industrielles

C

1 | Citrate de calcium | Aliments non normalisés | Bonnes pratiques industrielles

C

2 | Éthylènediaminetétraacétate de calcium disodique (EDTA de calcium disodique) | (1) Ale; bière; liqueur de malt; porter; stout | (1) 25 p.p.m., calculé sous forme anhydre | | (2) Mayonnaise; sauce à salade; sauces d’assaisonnement non normalisées; sauces non normalisées; sauce vinaigrette | (2) 75 p.p.m., calculé sous forme anhydre | | (3) Salade de pommes de terre; tartinades à sandwich non normalisées | (3) 100 p.p.m., calculé sous forme anhydre | | (4) Crevettes en conserve; thon en conserve | (4) 250 p.p.m., calculé sous forme anhydre | | (5) Crabe en conserve; homard en conserve; saumon en conserve | (5) 275 p.p.m., calculé sous forme anhydre | | (6) Margarine | (6) 75 p.p.m., calculé sous forme anhydre | | (7) Clams en conserve | (7) 340 p.p.m., calculé sous forme anhydre | | (8) Fèves; fèves au lard; légumineuses en conserve, à l’exception des haricots jaunes en conserve, des haricots verts en conserve et des pois en conserve | (8) 365 p.p.m., calculé sous forme anhydre | | (9) Escargots en conserve; limaces de mer en conserve | (9) 300 p.p.m., calculé sous forme anhydre | | (10) Boissons gazeuses; thés prêts à boire | (10) 33 p.p.m., calculé sous forme anhydre | | (11) Pommes de terre pasteurisées sous-vide | (11) 100 p.p.m., seul ou en association avec de l’EDTA disodique, calculé sous forme d’EDTA disodique anhydre

C

3 | [Abrogé, DORS/2012-43, art. 43]

C

4 | Phosphate monocalcique | (1) Mélange pour crème glacée; mélange pour lait glacé; sorbet laitier | (1) Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I | Colonne II | Colonne III

Article | Additifs | Permis dans ou sur | Limites de tolérance

C

5 | Phosphate tricalcique | (2) Produits laitiers non normalisés | (2) Bonnes pratiques industrielles | | Mélange pour crème glacée; mélange pour lait glacé | Bonnes pratiques industrielles

C

6 | Phytate de calcium | Fruits glacés ou confits | Bonnes pratiques industrielles

C

7 | Acide citrique | (1) Marinade, saumure et mélange de salaison à sec employés dans le marinage des viandes conditionnées ou conservées et des sous-produits de viande conditionnés ou conservés | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Bonnes pratiques industrielles | | (3) Filets de poisson congelés; poisson haché congelé; poisson haché menu congelé | (3) 0,1 %

D

1 | Éthylènediaminététraacétate disodique (EDTA disodique) | (1) Sauces et condiments | (1) 70 p.p.m. | | (2) Tartinades à sandwich non normalisées | (2) 70 p.p.m. | | (3) Fèves; fèves au lard; légumineuses en conserve, à l’exception des haricots jaunes en conserve, des haricots verts en conserve et des pois en conserve | (3) 165 p.p.m. | | (4) Produits à base de pommes de terre | (4) 265 p.p.m. | | (5) Préparation de couverture ou suspension aqueuse pour utilisation dans l’enrobage de tablettes de confiseries | (5) 1 % de la préparation de couverture | | (6) Pommes de terre pasteurisées sous-vide | (6) 100 p.p.m., seul ou en association avec l’EDTA de calcium disodique, calculé sous forme d’EDTA disodique anhydre | | (7) Enrobage comestible pour les saucisses | (7) 80 p.p.m. dans l’enrobage comestible, calculé en fonction de la saucisse entière

D

2 | [Abrogé, DORS/2012-43, art. 45] G.1 | Glycine | Mono- et diglycérides | 0,02 % P.1 | Acide phosphorique | Mono- et diglycérides | 0,02 % P.2 | Phosphate mono-potassique | (1) Mélange pour crème glacée; mélange pour lait glacé; sorbet laitier | (1) Bonnes pratiques industrielles | | (2) Aliments non normalisés | (2) Bonnes pratiques industrielles | | (3) Viande coupée solide; viande préparée; sous-produit de viande préparée; viande de volaille coupée solide; viande de volaille préparée; sous-produit de viande de volaille préparée | (3) 0,5 % en phosphates totaux ajoutés, calculés en phosphate disodique P.3 | Pyrophosphate tétrapotassique | (1) Produits pour attendrir la viande | (1) Bonnes pratiques industrielles | | (3) Viande coupée solide; viande préparée; sous-produit de viande préparée; viande de volaille coupée solide; viande de volaille préparée; sous-produit de viande de volaille préparée | (3) 0,5 % en phosphates totaux ajoutés, calculés en phosphate disodique PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs P.4 Phosphate dipotassique S.1 Pyrophosphate acide de sodium S.2 Citrate de sodium S.3 Hexamétaphosphate de sodium Colonne II Permis dans ou sur

(1)

Viande coupée solide; viande préparée; sous-produit de viande préparée; viande de volaille coupée solide; viande de volaille préparée; sous-produit de viande de volaille préparée

(1)

Fruits de mer en conserve

(2)

Mélange pour crème glacée; mélange pour lait glacé

(3)

Solution d’injection ou d’immersion servant à la salaison de la volaille ou de la viande de volaille

(4)

Marinade servant à la salaison de coupes de porc, de bœuf ou d’agneau

(5)

Aliments non normalisés

(6)

Viande coupée solide; viande préparée; sous-produit de viande préparée; viande de volaille coupée solide; viande de volaille préparée; sous-produit de viande de volaille préparée

(1)

Marinade, saumure et mélange de salaison à sec employés dans le marinage des viandes conditionnées ou conservées et des sous-produits de viande conditionnés ou conservés; mélange pour crème glacée; mélange pour lait glacé; sorbet laitier

(2)

Aliments non normalisés

(1)

Fruits de mer en conserve

(2)

Mélange pour crème glacée; mélange pour lait glacé

(3)

Solution d’injection ou d’immersion servant à la salaison de la volaille ou de la viande de volaille

(4)

Marinade servant à la salaison de coupes de porc, de bœuf ou d’agneau

(5)

Aliments non normalisés

(6)

Viande coupée solide; viande préparée; sous-produit de viande préparée; viande de volaille coupée solide; viande de volaille préparée; sous-produit de viande de volaille préparée Colonne III Limites de tolérance

(1)

0,5 % en phosphates totaux ajoutés, calculés en phosphate disodique

(1)

Si employé seul ou en association avec de l’hexamétaphosphate de sodium ou le tripolyphosphate de sodium, ou les deux, la quantité totale de phosphate ajouté, calculée sous forme de phosphate dibasique de sodium, ne doit pas dépasser 0,5 %

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles et conformément à B.22.021e)

(4)

Bonnes pratiques industrielles et conformément à B.14.009f) et B.14.031h)

(5)

Bonnes pratiques industrielles

(6)

0,5 % en phosphates totaux ajoutés, calculés en phosphate disodique

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(1)

Si employé seul ou en association avec le pyrophosphate acide de sodium ou le tripolyphosphate de sodium, ou les deux, la quantité totale de phosphate ajouté, calculée sous forme de phosphate dibasique de sodium, ne doit pas dépasser 0,5 %

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles et conformément à B.22.021e)

(4)

Bonnes pratiques industrielles et conformément à B.14.009f) et B.14.031h)

(5)

Bonnes pratiques industrielles

(6)

0,5 % en phosphates totaux ajoutés, calculés en phosphate disodique PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs S.4 Phosphate disodique S.5 Phosphate monosodique S.6 Pyrophosphate tétrasodique Colonne II Permis dans ou sur

(7)

Petit-lait liquide destiné à la fabrication de produits de petit-lait concentré ou séché

(1)

Mélange pour crème glacée; mélange pour lait glacé; sorbet laitier

(2)

Solution d’injection ou d’immersion servant à la salaison de la volaille ou de la viande de volaille

(3)

Marinade servant à la salaison de coupes de porc, de bœuf ou d’agneau

(4)

Aliments non normalisés

(5)

Viande coupée solide; viande préparée; sous-produit de viande préparée; viande de volaille coupée solide; viande de volaille préparée; sous-produit de viande de volaille préparée

(1)

Mélange pour crème glacée; mélange pour lait glacé; sorbet laitier

(2)

Produits pour attendrir la viande

(3)

Solution d’injection ou d’immersion servant à la salaison de la volaille ou de la viande de volaille

(4)

Marinade servant à la salaison de coupes de porc, de bœuf ou d’agneau

(5)

Aliments non normalisés

(6)

Viande coupée solide; viande préparée; sous-produit de viande préparée; viande de volaille coupée solide; viande de volaille préparée; sous-produit de viande de volaille préparée Colonne III Limites de tolérance

(7)

800 p.p.m. dans les produits de petit-lait concentré ou séché

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles et conformément à B.22.021e)

(3)

Bonnes pratiques industrielles et conformément à B.14.009f) et B.14.031h)

(4)

Bonnes pratiques industrielles

(5)

0,5 % en phosphates totaux ajoutés, calculés en phosphate disodique

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles et conformément à B.22.021e)

(3)

Bonnes pratiques industrielles et conformément à B.14.009f) et B.14.031h)

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I | Colonne II | Colonne III

Article | Additifs | Permis dans ou sur | Limites de tolérance

S.7 | Tripolyphosphate de sodium | (1) Solution d’injection ou d’immersion servant à la salaison de la volaille ou de la viande de volaille | (2) Produits pour attendrir la viande | (3) Marinade servant à la salaison de coupes de porc, de bœuf ou d’agneau | (4) Aliments non normalisés | (5) Viande coupée solide; viande préparée; sous-produit de viande préparée; viande de volaille coupée solide; viande de volaille préparée; sous-produit de viande de volaille préparée | (6) Fruits de mer en conserve | (1) Bonnes pratiques industrielles et conformément à B.22.021e) | (2) Bonnes pratiques industrielles | (3) Bonnes pratiques industrielles et conformément à B.14.009f) et B.14.031h) | (4) Bonnes pratiques industrielles | (5) 0,5 % en phosphates totaux ajoutés, calculés en phosphate disodique | (6) S’il employé seul ou en association avec le pyrophosphate acide de sodium ou le métaphosphate de sodium, ou les deux, la quantité totale ne doit pas dépasser 0,5 % de phosphates ajoutés, calculés en phosphate disodique. S’il est employé seul ou en association avec les esters citriques de mono- et diglycérides, seuls ou en association, la quantité totale ne doit pas dépasser 0,01 % de la teneur en gras S.8 | Citrate de stéaryle | Margarine TABLE XIII Column I | Column II | Column III A.1 | Acetic Anhydride | Starch | Good Manufacturing Practice A.2 | Adipic Acid | Starch | Good Manufacturing Practice A.3 | Aluminum Sulphate | Starch | Good Manufacturing Practice E.1 | [Repealed, SOR/2016-143, s. 2] H.1 | Hydrochloric Acid | Starch | Good Manufacturing Practice H.2 | Hydrogen Peroxide | Starch | Good Manufacturing Practice

M

1 | Magnesium Sulphate | Starch | 0.4% N.1 | Nitric Acid | Starch | Good Manufacturing Practice O.1 | Octenyl Succinic Anhydride (OSA) | Starch | Good Manufacturing Practice P.1 | Peracetic Acid | Starch | Good Manufacturing Practice P.2 | Phosphorus Oxychloride | Starch | Good Manufacturing Practice Column I Column II Column III P.4 Propylene Oxide Starch 25% S.1 Sodium Acetate Starch Good Manufacturing Practice S.2 Sodium Bicarbonate Starch Good Manufacturing Practice S.3 Sodium Carbonate Starch Good Manufacturing Practice S.4 Sodium Chlorite Starch Good Manufacturing Practice S.5 Sodium Hydroxide Starch Good Manufacturing Practice S.6 Sodium Hypochlorite Starch Good Manufacturing Practice S.8 Succinic Anhydride Starch Good Manufacturing Practice S.9 Sulphuric Acid Starch Good Manufacturing Practice TABLEAU XIII Additifs alimentaires autorisés comme agents modifiants de l’amidon Colonne I Colonne II Colonne III

Article Additifs Permis dans ou sur Limites de tolérance

A.1 Anhydride acétique Amidon Bonnes pratiques industrielles A.2 Acide adipique Amidon Bonnes pratiques industrielles A.3 Sulfate d’aluminium Amidon Bonnes pratiques industrielles E.1 [Abrogé, DORS/2016-143, art. 2] H.1 Acide chlorhydrique Amidon Bonnes pratiques industrielles H.2 Peroxyde d’hydrogène Amidon Bonnes pratiques industrielles

M

1 Sulfate de magnésium Amidon 0,4 % N.1 Acide nitrique Amidon Bonnes pratiques industrielles O.1 Anhydride octénylsuccinique (AOS) Amidon Bonnes pratiques industrielles P.1 Peracide acétique Amidon Bonnes pratiques industrielles P.2 Oxychlorure de phosphore Amidon Bonnes pratiques industrielles P.3 Permanganate de potassium Amidon 50 p.p.m. de sulfate de manganèse calculé en manganèse P.4 Oxyde de propylène Amidon 25 % S.1 Acétate de sodium Amidon Bonnes pratiques industrielles S.2 Bicarbonate de sodium Amidon Bonnes pratiques industrielles S.3 Carbonate de sodium Amidon Bonnes pratiques industrielles S.4 Chlorite de sodium Amidon Bonnes pratiques industrielles S.5 Hydroxyde de sodium Amidon Bonnes pratiques industrielles S.6 Hypochlorite de sodium Amidon Bonnes pratiques industrielles S.7 Trimetaphosphate de sodium Amidon 400 p.p.m., calculé en phosphore S.7A Tripolyphosphate de sodium Amidon Phosphate résiduel total ne devant pas dépasser 0,4 % (calculé en phosphore) S.8 Anhydride succinique Amidon Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

S.9 Acide sulfurique Amidon Bonnes pratiques industrielles SOR/94-689, s. 2; SOR/2012-106, s. 2; SOR/2016-143, s. 2. DORS/94-689, art. 2; DORS/2012-106, art. 2; DORS/2016-143, art. 2. TABLE XIV Column I | Column II | Column III A.1 | Ammonium Chloride | (1) Flour; Whole wheat flour | (1) 2,000 p.p.m. of the flour | | (2) Bread | (2) 2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m) A.2 | Ammonium Phosphate, dibasic | (3) Unstandardized foods | (3) Good Manufacturing Practice | | (1) Bread | (1) 2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m) A.3 | Ammonium Phosphate, monobasic | (2) Cider; Honey wine; Wine | (2) Good Manufacturing Practice | | (3) Unstandardized bakery products | (3) Good Manufacturing Practice | | (1) Bread | (1) 2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m) A.4 | Ammonium Sulphate | (2) Ale; Beer; Cider; Honey wine; Light beer; Malt liquor; Porter; Stout; Wine | (2) Good Manufacturing Practice | | (3) Unstandardized bakery products | (3) Good Manufacturing Practice | | (1) Bread | (1) 2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m)

C

1 | Calcium Carbonate | (2) Cider; Honey wine; Wine | (2) Good Manufacturing Practice | | (3) Unstandardized bakery products | (3) Good Manufacturing Practice | | (1) Bread | (1) 2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m)

C

2 | Calcium Chloride | Unstandardized bakery products | Good Manufacturing Practice

C

3 | Calcium Citrate | Unstandardized bakery products | Good Manufacturing Practice

C

4 | Calcium Lactate | (1) Bread | (1) 2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m) | | (2) Unstandardized bakery products | Good Manufacturing Practice

C

5 | Calcium Phosphate, dibasic | (1) Bread | (1) 2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m) | | (2) Unstandardized bakery products | Good Manufacturing Practice

C

6 | Calcium Phosphate, monobasic | (1) Bread | (1) 7,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m) | | (2) Flour | (2) 7,500 p.p.m. of flour | | (3) Unstandardized bakery products | (3) Good Manufacturing Practice

C

7 | Calcium Phosphate, tribasic | Unstandardized bakery products | Good Manufacturing Practice PART B Foods

Section B.16.100

Column I | Column II | Column III

C

8 | Calcium Sulphate | (1) Bread | (1) 5,000 p.p.m. of the flour | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice F.1 | Ferrous Sulphate | Bacterial cultures | Good Manufacturing Practice

M

1 | Manganese Sulphate | Ale; Beer; Light beer; Malt liquor; Porter; Stout | Good Manufacturing Practice P.1 | Phosphoric Acid | Ale; Beer; Light beer; Malt liquor; Porter; Stout | Good Manufacturing Practice P.2 | Potassium Chloride | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice P.4 | Potassium Phosphate, dibasic | (1) Ale; Beer; Cider; Honey wine; Light beer; Malt liquor; Porter; Stout; Wine | (1) Good Manufacturing Practice | | (2) Unstandardized bakery products | (2) Good Manufacturing Practice P.5 | Potassium Phosphate, monobasic | Ale; Beer; Cider; Honey wine; Light beer; Malt liquor; Porter; Stout; Wine | Good Manufacturing Practice S.1 | Sodium Sulphate | Unstandardized bakery products | Good Manufacturing Practice U.1 | [Repealed, SOR/87-5, s. 1] Z.1 | Zinc Sulphate | (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout | (1) Good Manufacturing Practice | | (2) Bacterial cultures | (2) Good Manufacturing Practice TABLEAU XIV Additifs alimentaires autorisés comme nourriture des levures Colonne I | Colonne II | Colonne III

Article | Additifs | Permis dans ou sur | Limites de tolérance

A.1 | Chlorure d’ammonium | (1) Farine; farine de blé entier | (1) 2 000 p.p.m. de farine | | (2) Pain | (2) 2 500 p.p.m. de farine. Pour les mélanges, voir l’alinéa B.13.021m) | | (3) Aliments non normalisés | (3) Bonnes pratiques industrielles A.2 | Phosphate diammonique | (1) Pain | (1) 2 500 p.p.m. de farine. Pour les mélanges, voir l’alinéa B.13.021m) | | (2) Cidre; vin de miel; vin | (2) Bonnes pratiques industrielles | | (3) Produits de boulangerie non normalisés | (3) Bonnes pratiques industrielles A.3 | Phosphate monoammonique | (1) Pain | (1) 2 500 p.p.m. de farine. Pour les mélanges, voir l’alinéa B.13.021m) | | (2) Ale; bière; cidre; vin de miel; bière légère; liqueur de malt; porter; stout; vin | (2) Bonnes pratiques industrielles | | (3) Produits de boulangerie non normalisés | (3) Bonnes pratiques industrielles A.4 | Sulfate d’ammonium | (1) Pain | (1) 2 500 p.p.m. de farine. Pour les mélanges, voir l’alinéa B.13.021m) | | (2) Cidre; vin de miel; vin | (2) Bonnes pratiques industrielles | | (3) Produits de boulangerie non normalisés | (3) Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Additifs

C

1 Carbonate de calcium

C

2 Chlorure de calcium

C

3 Citrate de calcium

C

4 Lactate de calcium

C

5 Phosphate bicalcique

C

6 Phosphate monocalcique

C

7 Phosphate tricalcique

C

8 Sulfate de calcium F.1 Sulfate ferreux

M

1 Sulfate de manganèse P.1 Acide phosphorique P.2 Chlorure de potassium P.4 Phosphate bipotassique P.5 Phosphate monopotassique S.1 Sulfate de sodium U.1 [Abrogé, DORS/87-5, art. 1] Z.1 Sulfate de zinc Colonne II Permis dans ou sur

(1)

Pain

(2)

Produits de boulangerie non normalisés Produits de boulangerie non normalisés Produits de boulangerie non normalisés

(1)

Pain

(2)

Produits de boulangerie non normalisés

(1)

Pain

(2)

Produits de boulangerie non normalisés

(1)

Pain

(2)

Farine

(3)

Produits de boulangerie non normalisés Produits de boulangerie non normalisés

(1)

Pain

(2)

Produits de boulangerie non normalisés Cultures bactériennes Ale; bière; cidre; vin de miel; bière légère; liqueur de malt; porter; stout Ale; bière; bière légère; liqueur de malt; porter; stout

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Produits de boulangerie non normalisés

(1)

Ale; bière; cidre; vin de miel; bière légère; liqueur de malt; porter; stout; vin

(2)

Produits de boulangerie non normalisés Produits de boulangerie non normalisés

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(2)

Cultures bactériennes Colonne III Limites de tolérance

(1)

2 500 p.p.m. de farine. Pour les mélanges, voir l’alinéa B.13.021m)

(2)

Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

2 500 p.p.m. de farine. Pour les mélanges, voir l’alinéa B.13.021m)

(2)

Bonnes pratiques industrielles

(1)

2 500 p.p.m. de farine. Pour les mélanges, voir l’alinéa B.13.021m)

(2)

Bonnes pratiques industrielles

(1)

7 500 p.p.m. de farine. Pour les mélanges, voir l’alinéa B.13.021m)

(2)

7 500 p.p.m. de farine

(3)

Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

5 000 p.p.m. de farine

(2)

Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles SOR/87-5, s. 1; SOR/94-689, s. 2(F); SOR/95-281, ss. 6, 7; SOR/2010-41, ss. 7(E), 9(E). DORS/87-5, art. 1; DORS/94-689, art. 2(F); DORS/95-281, art. 6 et 7; DORS/2010-41, art. 7A1 et 9A1. TABLE XV Column I | Column II | Column III | Column IV 1 | Acetone | (1) Spice extracts; Natural extractives | (1) 30 p.p.m. | (2) Good Manufacturing Practice | | (2) Meat and Egg Marking Inks | | 2 | Benzyl Alcohol | (1) (naming the flavour) Flavour (Division 10) | | (1) Good Manufacturing Practice | | (2) Unstandardized flavouring preparations | | (2) Good Manufacturing Practice 3 | 1,3-Butylene Glycol | (1) (naming the flavour) Flavour (Division 10) | | (1) Good Manufacturing Practice | | (2) Unstandardized flavouring preparations | | (2) Good Manufacturing Practice | | (2) Spice extracts; Natural extractives; (naming the flavour) Flavour (Division 10); Hop extract in accordance with subparagraph B.02.130(b)(iv) and paragraph B.02.133(b); Pre-isomerized hop extract in accordance with subparagraph B.02.134(1)(a)(iii) | | (2) Good Manufacturing Practice | | (3) Egg Products | | | | (4) Cocoa powder | | 4 | Castor Oil | Oil-soluble annatto; Annatto butter colour; Annatto margarine colour | | Good Manufacturing Practice

4.1 | Citric Acid Esters of Mono- and Di-glycerides | (1) Natural extractives; Spice extracts | | (1) Good Manufacturing Practice

| | (2) Unstandardized flavouring preparations | | (2) Good Manufacturing Practice 5 | Ethyl Acetate | (1) Spice extracts; Natural extractives; (naming the flavour) Flavour (Division 10) | | (1) Good Manufacturing Practice | | (2) Unstandardized flavouring preparations | | (2) Good Manufacturing Practice | | (4) Tea leaves for decaffeination purposes | (4) 50 p.p.m. | 6 | Ethyl Alcohol (Ethanol) | (1) Spice extracts; Natural extractives; (naming the flavour) Flavour (Division 10) | | Good Manufacturing Practice PART B Foods

Section B.16.100

Column I | Column II | Column III | Column IV

(2)

Unstandardized flavouring preparations | (2) Good Manufacturing Practice

(3)

Colour mixtures and preparations (Division 6) | (3) Good Manufacturing Practice

(4)

Meat and Egg Marking Inks | (4) Good Manufacturing Practice

(5)

Food additive preparations | (5) Good Manufacturing Practice

(6)

Hop extract in accordance with subparagraph B.02.130(b)(v) and paragraph B.02.133(b); Pre-isomerized hop extract in accordance with subparagraph B.02.134(1)(a)(iii) | (6) Good Manufacturing Practice

6.A | Ethyl alcohol denatured with methanol | Vegetable oil seed meals | 10 p.p.m. methanol |

7 | [Repealed, SOR/82-406, s. 1] 8 | Glycerol (Glycerin) | (1) (naming the flavour) Extract; (naming the flavour) Essence; (naming the flavour) Flavour (Division 10) | (1) Good Manufacturing Practice | (2) Unstandardized flavouring preparations | (2) Good Manufacturing Practice | (3) Colour mixtures and preparations (Division 6) | (3) Good Manufacturing Practice | (4) Food additive preparations | (4) Good Manufacturing Practice 9 | Glyceryl diacetate | (1) (naming the flavour) Flavour (Division 10) | (1) Good Manufacturing Practice | (2) Unstandardized flavouring preparations | (2) Good Manufacturing Practice 10 | Glyceryl triacetate (Triacetin) | (1) (naming the flavour) Flavour (Division 10) | (1) Good Manufacturing Practice | (2) Unstandardized flavouring preparations | (2) Good Manufacturing Practice 11 | Glyceryl tributyrate (Tributyrin) | (1) (naming the flavour) Flavour (Division 10) | (1) Good Manufacturing Practice | (2) Unstandardized flavouring preparations | (2) Good Manufacturing Practice 12 | Hexane | (1) Spice extracts; Natural extractives | (1) 25 p.p.m. | (2) Hop extract in accordance with subparagraph B.02.130(b)(v) and paragraph B.02.133(a) | (2) 2.2% | (3) Vegetable fats and oils | (3) 10 p.p.m. | (4) Vegetable oil seed meals | (4) 10 p.p.m. | (5) Pre-isomerized hop extract in accordance with subparagraph | (5) 1.5 p.p.m. per percent iso-alpha acid content of PART B Foods

Section B.16.100

Column I | Column II | Column III | Column IV 13 | Isopropyl Alcohol (Isopropanol) | B.02.134(1)(a)(i) and subsection B.02.134(2)

(1)

Spice extracts; Natural extractives

(2)

Fish protein

(3)

(naming the flavour) Flavour (Division 10)

(4)

Unstandardized flavouring preparations

(1)

50 p.p.m.

(2)

0.15% | (3) Good Manufacturing Practice

(4)

Good Manufacturing Practice

(5)

Good Manufacturing Practice 14 | Methyl Alcohol (methanol) | (1) Spice extracts; Natural extractives

(2)

Hop extract in accordance with subparagraph B.02.130(b)(v) and paragraph B.02.133(a)

(3)

Meat and Egg Marking Inks | (1) 50 p.p.m.

(2)

2.2% | (3) Good Manufacturing Practice

14.1 | Methyl ethyl ketone (2-Butanone) | Spice extracts; Natural extractives | 50 p.p.m. |

15 | Methylene Chloride (Dichloro-methane) | (1) Spice extracts; Natural extractives

(2)

Hop extract in accordance with subparagraph B.02.130(b)(v) and paragraph B.02.133(a)

(3)

Green coffee beans and Tea leaves for decaffeination purposes | (1) 30 p.p.m.

(2)

2.2% in hop extract 16 | Monoglycerides and diglycerides | (1) (naming the flavour) Flavour (Division 10)

(2)

Oil-soluble annatto; Annatto butter colour; Annatto margarine colour

(3)

Unstandardized flavouring preparations

(4)

Food additive preparations | | (1) Good Manufacturing Practice

(2)

Good Manufacturing Practice

(3)

Good Manufacturing Practice

(4)

Good Manufacturing Practice 17 | Monoglyceride citrate | (1) Spice extracts; Natural extractives

(2)

Unstandardized flavouring preparations | | (1) Good Manufacturing Practice

(2)

Good Manufacturing Practice 18 | [Repealed, SOR/2016-143, s. 3] | | | 19 | 1,2-Propylene glycol (1,2-propanediol) | (1) (naming the flavour) Extract; (naming the flavour) Essence; (naming the flavour) Flavour (Division 10) | | (1) Good Manufacturing Practice PART B Foods

Section B.16.100

Column I | Column II | Column III | Column IV 20 | Propylene glycol mono-esters and diesters of fat-forming fatty acids | (2) Oil-soluble annatto; Annatto butter colour; Annatto margarine colour (3) Unstandardized flavouring preparations (4) Colour mixtures and preparations (Division 6) (5) Food additive preparations | | (2) Good Manufacturing Practice (3) Good Manufacturing Practice (4) Good Manufacturing Practice (5) Good Manufacturing Practice 21 | Triethyl-citrate | (1) (naming the flavour) Flavour (Division 10) (2) Unstandardized flavouring preparations | | (1) Good Manufacturing Practice (2) Good Manufacturing Practice TABLEAU XV Additifs alimentaires autorisés comme solvants de support ou d’extraction Colonne I | Colonne II | Colonne III | Colonne IV

Article | Additifs | Permis dans ou sur | Résidu maximal | Limites de tolérance

1 | Acétone | (1) Extraits d’épices; extraits naturels (2) Encres à marquer la viande et les œufs | (1) 30 p.p.m. | (2) Bonnes pratiques industrielles 2 | Alcool benzylique | (1) Préparation aromatisante de (nom de l’arôme) (Titre 10) (2) Préparations aromatisantes non normalisées | | (1) Bonnes pratiques industrielles (2) Bonnes pratiques industrielles 3 | 1,3-Butylène-glycol | (1) Préparation aromatisante de (nom de l’arôme) (Titre 10) (2) Préparations aromatisantes non normalisées | | (1) Bonnes pratiques industrielles (2) Bonnes pratiques industrielles

3.1 | Dioxyde de carbone | (1) Graines de café vertes et feuilles de thé destinées à la décaféination (2) Extraits d’épices; extraits naturels; préparation aromatisante de (nom de l’arôme) (titre 10); extrait de houblon, conformément au sous-alinéa B.02.130(b)(v) et à l’alinéa B.02.133b); extrait de houblon pré-isomérisé, conformément au sous-alinéa B.02.134(1)a)(ii) | | (1) Bonnes pratiques industrielles (2) Bonnes pratiques industrielles

PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

4

4.1

5 6

6.A

7 8 Additifs Huile de ricin Esters éthiques des mono- et diglycérides Acétate d’éthyle Alcool éthylique (éthanol) Alcool éthylique dénaturé avec méthanol [Abrogé, DORS/82-46, art. 1] Glycérol (glycérine) Colonne II Permis dans ou sur Roucou soluble dans l’huile; roucou, colorant pour le beurre; roucou, colorant pour la margarine

(1)

Extraits naturels; extraits d’épices

(2)

Préparations aromatisantes non normalisées

(1)

Extraits d’épices; extraits naturels; préparation aromatisante de (nom de l’arôme) (Titre 10)

(2)

Préparations aromatisantes non normalisées

(3)

Graines de café vertes destinées à la décaféination

(4)

Feuilles de thé destinées à la décaféination

(1)

Extraits d’épices; extraits naturels; préparation aromatisante de (nom de l’arôme) (Titre 10)

(2)

Préparations aromatisantes non normalisées

(3)

Mélanges colorants et préparations colorantes (Titre 6)

(4)

Encres à marquer la viande et les œufs

(5)

Préparations d’additifs alimentaires

(6)

Extrait de houblon, conformément au sous-alinéa B.02.130b)(v) et à l’alinéa B.02.133b); extrait de houblon pré-isomérisé, conformément au sous-alinéa B.02.134(1)a)(iii) Farine de graines végétales oléagineuses Extrait de (nom de l’arôme); essence de (nom de l’arôme); préparation Colonne III Résidu maximal

(3)

10 p.p.m. dans les cafés faits de graines rôties et les cafés décaféinés solubles (instantanés)

(4)

50 p.p.m. 10 p.p.m. de methanol Colonne IV Limites de tolérance

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles

(5)

Bonnes pratiques industrielles

(6)

Bonnes pratiques industrielles

(1)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Article B.16.100

Colonne I

Article

Colonne II Additifs Permis dans ou sur Colonne III Résidu maximal Colonne IV Limites de tolérance 9 Diacétate de glycérile

(1)

Préparation aromatisante de (nom de l’arôme) (Titre 10)

(2)

Préparations aromatisantes non normalisées

(3)

Mélanges colorants et préparations colorantes (Titre 6)

(4)

Préparations d’additifs alimentaires

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles 10 Triacétate de glycérile (triacétine)

(1)

Préparation aromatisante de (nom de l’arôme) (Titre 10)

(2)

Préparations aromatisantes non normalisées

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles 11 Tributyrate de glycérile (tributyrine)

(1)

Préparation aromatisante de (nom de l’arôme) (Titre 10)

(2)

Préparations aromatisantes non normalisées

(1)

Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles 12 Hexane

(1)

Extraits d’épices; extraits naturels

(2)

Extrait de houblon, conformément au sous-alinéa B.02.130b)(v) et à l’alinéa B.02.133a)

(3)

Graisses et huiles végétales

(4)

Farine de graines végétales oléagineuses

(5)

Extrait de houblon pré-isomérisé, conformément au sous-alinéa B.02.134(1)a)(ii) et au paragraphe B.02.134(2)

(1)

25 p.p.m.

(2)

2,2 %

(3)

10 p.p.m.

(4)

10 p.p.m.

(5)

1,5 p.p.m., par rapport à la teneur, exprimée en pourcentage, d’acide iso-alpha dans l’extrait de houblon pré-isomérisé. 13 Alcool isopropylique (Isopropanol)

(1)

Extraits d’épices; extraits naturels

(2)

Protéines de poisson

(3)

Préparation aromatisante de (nom de l’arôme) (Titre 10)

(4)

Préparations aromatisantes non normalisées

(1)

50 p.p.m.

(2)

0,15 %

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles PART B Foods

Section B.16.100

Article | Colonne I Additifs | Colonne II Permis dans ou sur | Colonne III Résidu maximal | Colonne IV Limites de tolérance

---|---|---|---|--- 14 | Alcool méthylique (méthanol) | (5) Encres à marquer la viande et les œufs

(1)

Extraits d’épices; extraits naturels

(2)

Extrait de houblon, conformément au sous-alinéa B.02.130b)(v) et à l’alinéa B.02.133a)

(3)

Encres à marquer la viande et les œufs | (1) 50 p.p.m.

(2)

2,2 % | (5) Bonnes pratiques industrielles

14.1 | Méthyléthyl-cétone (2-Butanone) | Extraits d’épices; extraits naturels | 50 p.p.m. | (3) Bonnes pratiques industrielles

15 | Chlorure de méthylène (Dichloro-méthane) | (1) Extraits d’épices; extraits naturels

(2)

Extrait de houblon, conformément au sous-alinéa B.02.130b)(v) et à l’alinéa B.02.133a) | (1) 30 p.p.m.

(2)

2,2 % dans l’extrait de houblon | (1) Bonnes pratiques industrielles 16 | Monoglycérides et diglycérides | (1) Préparation aromatisante de (nom de l’arôme) (Titre 10)

(2)

Rocou soluble dans l’huile; rocou, colorant pour le beurre; rocou, colorant pour la margarine

(3)

Préparations aromatisantes non normalisées

(4)

Préparations d’additifs alimentaires | (1) Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles

(4)

Bonnes pratiques industrielles 17 | Citrate de monoglycérides | (1) Extraits d’épices; extraits naturels

(2)

Préparations aromatisantes non normalisées | (1) Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles 18 | [Abrogé, DORS/2016-143, art. 31] | | | 19 | 1,2-Propylène-glycol (1,2-propanédiol) | (1) Extrait de (nom de l’arôme); essence de (nom de l’arôme); préparation aromatisante de (nom de l’arôme) (Titre 10)

(2)

Rocou soluble dans l’huile; rocou, colorant pour le beurre; rocou, colorant pour la margarine

(3)

Préparations aromatisantes non normalisées | (1) Bonnes pratiques industrielles

(2)

Bonnes pratiques industrielles

(3)

Bonnes pratiques industrielles PART B Foods Sections B.16.100-B.17.001 Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 16 Additifs alimentaires

Articles B.16.100-B.17.001

Colonne I

Article

Colonne II Additifs Colonne III Permis dans ou sur Colonne IV Résidu maximal Colonne V Limites de tolérance

(4)

Mélanges colorants et préparations colorantes (Titre 6)

(4)

Bonnes pratiques industrielles

(5)

Préparations d’additifs alimentaires

(5)

Bonnes pratiques industrielles 20 Mono et diesters de propylène-glycol et d’acides gras lipogènes Rocou soluble dans l’huile; rocou, colorant pour le beurre, rocou, colorant pour la margarine

(1)

Préparation aromatisante de (nom de l’arôme) (Titre 10)

(1)

Bonnes pratiques industrielles 21 Citrate de triéthyle

(2)

Préparations aromatisantes non normalisées

(2)

Bonnes pratiques industrielles SOR/83-903, art. 26 et 27; SOR/82-833, s. 12; SOR/82-913, s. 1; SOR/82-1071, s. 21; SOR/84-541, s. 10; SOR/86-178, s. 4; SOR/86-111, s. 2; SOR/96-259, s. 1; SOR/98-689, s. 2; SOR/96-259, s. 1; SOR/96-377, s. 1; SOR/2012-135, s. 16; SOR/2016-143, s. 3. DORS/83-903, art. 26 et 27; DORS/82-833, art. 12; DORS/82-913, art. 1; DORS/82-1071, art. 21; DORS/84-541, art. 10; DORS/86-178, art. 4; DORS/86-111, art. 2; DORS/96-259, art. 1; DORS/98-689, art. 2; DORS/96-259, art. 1; DORS/96-377, art. 1; DORS/2012-135, art. 16; DORS/2016-143, art. 3. DIVISION 17 Salt (i) calcium aluminum silicate, calcium phosphate tribasic, calcium silicate, calcium stearate, magnesium carbonate, magnesium silicate, magnesium stearate, silicon dioxide and sodium aluminum silicate, the total amount not to exceed one per cent and, in the case of fine grained salt, the total amount not to exceed two per cent, (ii) propylene glycol in an amount not exceeding 0.035 per cent, and (i) 1.4 per cent, singly or in combination, of calcium sulphate or potassium chloride,

TITRE 17

Sel B.17.001 (1) [N]. Le sel, autre que le sel gemme à l’état brut, doit être du chlorure de sodium cristallisé et peut renfermer a) un ou plusieurs des agents anti-agglomérants suivants : (i) silicate double d’aluminium et de calcium, phosphate tricalcique, silicate de calcium, stéarate de calcium, carbonate de magnésium, silicate de magnésium, stéarate de magnésium, bioxyde de silicium et silicate double d’aluminium et de sodium, le total ne devant pas dépasser un pour cent et, dans le cas du sel à grains fins, ne devant pas dépasser deux pour cent, (ii) propylèneglycol en une quantité n’excédant pas 0,035 pour cent, et (iii) déchydrate de ferrocyanure de sodium, en une quantité n’excédant pas 13 parties par million, calculée en ferrocyanure de sodium anhydre; b) au plus (i) 1,4 pour cent, séparément ou ensemble, de sulfate de calcium ou de chlorure de potassium, (ii) 13 parties par million de ferrocyanure de sodium anhydre lorsqu’il est ajouté comme (iii) 10 parts per million of polyoxyethylene (20) sorbitan monooleate when used in the production of coarse crystal salt, (v) 0.1 per cent other ingredients; and

(2)

[Repealed, SOR/97-151, s. 26] SOR/79-662, s. 18; SOR/86-1125, s. 3; SOR/97-151, s. 26. B.17.002 [Repealed, SOR/79-662, s. 18] DIVISION 18 Sweetening Agents B.18.001 [S]. Sugar (b) shall contain not less than 99.8 per cent sucrose. B.18.006 [S]. Icing Sugar (a) shall be powdered sugar; and (ii) either not more than five per cent starch or an anticaking agent. B.18.007 [S]. Brown Sugar, Yellow Sugar or Golden Sugar (i) 4.5 per cent moisture, and (ii) 3.5 per cent sulphate ash; and B.18.008 [S]. Refined Sugar Syrup, Refiners’ Syrup or Golden Syrup (i) 35 per cent moisture, and (ii) 2.5 per cent sulphated ash. B.18.009 [S]. Fancy Molasses (i) 25 per cent moisture, and (ii) 3 per cent sulphated ash. B.18.005 [N]. Il est interdite la vente de sucre liquide ou de sucre inverti liquide à moins que l’étiquette ne déclare le pourcentage de sa teneur en sucre ou en sucre inverti. B.18.006 [N]. Le sucre à glacer a) doit être du sucre en poudre; et b) peut renfermer (i) un colorant pour aliments, et (ii) soit au plus cinq pour cent d’amidon, ou un agent anti-agglomérant. B.18.007 [N]. La cassonade, le sucre brun ou sucre doré a) doit être le produit alimentaire obtenu des sirops provenant du raffinage du sucre; b) peut renfermer au plus (i) 4,5 pour cent d’humidité, et (ii) 3,5 pour cent de cendres sulfatées; et c) doit renfermer au moins 90 pour cent de sucre et de sucre inverti. B.18.008 [N]. Le sirop de sucre raffiné, le sirop de raffineur ou le sirop doré a) doit être le produit alimentaire fait du sirop obtenu au cours du raffinage du sucre; b) peut être hydrolysé; et c) doit renfermer au plus (i) 35 pour cent d’humidité, et (ii) 2,5 pour cent de cendres sulfatées. B.18.009 [N]. La mélasse qualité fantaisie a) doit être le produit alimentaire sirupeux obtenu par évaporation et inversion partielle du jus de la canne à sucre, clarifié ou non, et dont aucun sucre n’a été extrait auparavant; b) peut renfermer de l’acide sulfureux ou ses sels; c) doit contenir au plus (i) 25 pour cent d’humidité, et (ii) trois pour cent de cendres sulfatées. B.18.010 [S]. Table Molasses (a) shall be the liquid food obtained in the process of manufacturing raw or refined sugar; (i) 25 per cent moisture, and (ii) 3 per cent sulphated ash. B.18.011 [S]. Refiners’ Molasses, Blackstrap Molasses or Cooking Molasses (a) shall be the residual liquid food obtained in the process of manufacturing raw or refined sugar; (i) 25 per cent moisture, and (ii) 12 per cent sulphated ash. (b) shall contain not less than 99.5 per cent D-glucose on a dry basis; (d) shall contain not less than 98 per cent total solids; and (b) shall contain not less than 99.5 per cent D-glucose on a dry basis; (d) shall contain not less than 90 per cent total solids; and B.18.016 [S]. Glucose or Glucose Syrup SOR/84-300, s. 51. B.18.017 [S]. Glucose Solids or Dried Glucose Syrup B.18.018 [S]. (Naming the source of the glucose) Syrup (a) shall be glucose; (i) a sweetening agent, (ii) a flavouring preparation, (iii) sorbic acid, (v) salt, and (vi) water; and (i) 35 per cent moisture; and (ii) 3 per cent ash. SOR/94-83, s. 1. B.18.019 [S]. Lactose (i) be anhydrous, (b) shall not contain less than 99.0 per cent anhydrous lactose on a moisture free basis; (c) shall not contain more than 0.3 per cent sulphated ash on a moisture free basis; (d) shall have a weight loss of not more than 6.0 per cent on drying; and Honey (a) the nectar of blossoms, (b) secretions of living plants, or (d) a fluid, viscous or partly or wholly crystallized consistency; (b) more than 20 per cent moisture; (c) more than 5 per cent apparent sucrose; (d) more than 0.1 per cent water insoluble solids, except that pressed honey shall contain not more than 0.5 per cent water insoluble solids; (e) more than 0.6 per cent ash; and (f) more than 40 milliequivalents acid per 1 000 grams.

(2)

Honey derived mainly from the nectar of lavender, rubinia, alfalfa, or banksia menziesii shall meet the requirements of paragraphs (1)(a), (b) and (d) to (f) and shall contain not more than 10 per cent apparent sucrose. (b) more than 20 per cent moisture; (c) more than 10 per cent apparent sucrose; (d) more than 0.1 per cent water insoluble solids, except that pressed honey shall contain not more than 0.5 per cent water insoluble solids; (e) more than 1.0 per cent ash; and (f) more than 40 milliequivalents acid per 1 000 grams. SOR/84-300, s. 52. DIVISION 19 Vinegar SOR/92-626, s. 16; SOR/93-243, s. 2. (a) 1.8 grams of solids, and (b) 0.2 gram of ash. DIVISION 20 Tea SOR/82-768, s. 61. SOR/82-768, s. 61. SOR/82-768, s. 61. B.20.005 [S]. Decaffeinated (indicating the type of tea) SOR/90-429, s. 2. DIVISION 21 (d) milk powder, skim milk powder, buttermilk powder or whey powder, and (e) starch; (remplissage) (a) fish, (d) frogs. (animaux marins et animaux d’eau douce) SOR/82-768, s. 62. (i) sodium tripolyphosphate, sodium hexametaphosphate or a combination of sodium tripolyphosphate, sodium acid pyrophosphate and sodium pyrophosphate tetrabasic, or SOR/88-534, s. 8; SOR/91-149, s. 5. (c) in the case of fish paste, contain filler, fish binder, monoglycerides or mono and diglycerides; (d) in the case of canned crabmeat, lobster, salmon, shrimp and tuna, contain aluminum sulphate and calcium disodium ethylenediaminetetraacetate; (e) in the case of canned tuna, contain ascorbic acid; (g) contain liquid smoke flavour or liquid smoke flavour concentrate; (j) contain salt; (k) in the case of canned clams, canned sea snails and canned snails, contain calcium disodium ethylenediaminetetraacetate; (l) in the case of canned flaked tuna, contain sodium sulphite; (m) in the case of lumpfish caviar, contain tragacanth gum; (o) in the case of crustaceans, contain potassium bisulphite, potassium metabisulphite, sodium bisulphite, sodium dithionite, sodium metabisulphite, sodium sulphite or sulphurous acid; (r) in the case of canned clams, contain sodium erythorbate at a level of use not exceeding 350 parts per million; SOR/80-13, s. 9; SOR/81-60, s. 12; SOR/84-602, s. 4; SOR/86-102, s. 2; SOR/89-197, s. 2; SOR/89-394, s. 6; SOR/93-179, s. 12; SOR/94-145, s. 2; SOR/96-259, s. 3; SOR/98-481, s. 8; SOR/2001-161, s. 2; SOR/2007-662, s. 3; SOR/2008-215, s. 12; SOR/2009-67, s. 4; SOR/2011-280, s. 9; SOR/2012-43, s. 46; SOR/2017-18, ss. 8, 8(F), 17; SOR/2018-69, s. 6. SOR/2017-18, s. 10(F); SOR/2018-69, s. 7(F). Prepared Fish (b) 70 per cent moisture where such prepared fish contains filler. B.21.022 and B.21.023 [Repealed, SOR/79-252, s. 4] SOR/80-13, s. 10; SOR/82-566, s. 5; SOR/82-768, s. 64; SOR/88-198, s. 17; SOR/94-567, s. 4. B.21.027 [S]. Fish Protein (c) shall not contain (c) shall not contain (ii) and (iii) [Repealed, SOR/97-148, s. 8] SOR/82-768, s. 65; SOR/97-148, s. 8. Frogslegs SOR/82-768, s. 66. DIVISION 22 SOR/80-13, s. 11. SOR/80-13, s. 12. (i) sodium acid pyrophosphate, (ii) sodium hexametaphosphate, (iii) sodium phosphate, dibasic, (iv) sodium phosphate, monobasic, (v) sodium pyrophosphate, tetrabasic, (vi) sodium tripolyphosphate, (vii) potassium phosphate, monobasic, (viii) potassium phosphate, dibasic, and (ix) potassium pyrophosphate, tetrabasic; SOR/81-934, s. 16; SOR/94-262, s. 13; SOR/2010-264, s. 5; SOR/2011-280, s. 11. SOR/82-768, s. 67; SOR/84-300, s. 54(E); SOR/86-875, s. 6. B.22.006 [N]. La viande de volaille préparée et les sous-produits de viande de volaille préparée doivent être, respectivement, de la viande de volaille ou des sous-produits de viande de volaille, hachés ou non, auxquels a été ajouté tout ingrédient permis par le présent règlement, ou qui ont été soumis à un procédé de conservation, qui ont été placés dans un contenant hermétiquement fermé ou qui ont été cuits, et peuvent renfermer a) lorsque le présent titre prescrit une teneur totale minimale en protéines ou une teneur minimale en protéines de viande, un ou plusieurs des sels de phosphate suivants, en une proportion n’excédant pas la limite de tolérance calculée en phosphate disodique conformément au tableau XII de l’article B.16.100 : (i) du pyrophosphate acide de sodium, (ii) de l’hexamétaphosphate de sodium, (iii) du phosphate disodique, (iv) du phosphate monosodique, (v) du pyrophosphate tétrasodique, (vi) du tripolyphosphate de sodium, (vii) du phosphate monopotassique, (viii) du phosphate dipotassique, (ix) du pyrophosphate tétrapotassique; a.1) un agent de conservation de la catégorie II; b) s’il s’agit de viande de volaille cuite et séchée, un agent de conservation de la catégorie IV; c) s’il s’agit de dinde cuite tranchée emballée sous vide, du Carnobacterium maltaromaticum CB1. DORS/81-934, art. 16; DORS/94-262, art. 13; DORS/2010-264, art. 5; DORS/2011-280, art. 11. B.22.008 Dans le présent titre, agent de remplissage désigne toute matière végétale, (à l’exclusion de la tomate et de la pulpe de betterave), le lait, les œufs, la levure, ou tout dérivé ou combinaison de ces produits qui serait acceptable comme aliment. DORS/82-768, art. 67; DORS/84-300, art. 54(A); DORS/86-875, art. 6. B.22.009 Est interdite la vente a) de la volaille qui est destinée à être consommée comme aliment et à laquelle a été administré un produit ayant un pouvoir œstrogène; ou SOR/2010-142, s. 4; SOR/2022-186, s. 44. (a) a whole cut of poultry meat; or SOR/94-262, s. 14. (i) sodium acid pyrophosphate, (ii) sodium hexametaphosphate, (iii) sodium phosphate, dibasic, (iv) sodium phosphate, monobasic, (v) sodium pyrophosphate, tetrabasic, (vi) sodium tripolyphosphate, (vii) potassium phosphate, monobasic, (viii) potassium phosphate, dibasic, and (ix) potassium pyrophosphate, tetrabasic. SOR/94-262, s. 14. SOR/94-262, s. 14. Poultry Meat Stews SOR/78-874, s. 3; SOR/2018-69, s. 9(F). (i) if uncooked, 12 per cent or more of the named stew poultry meat, (ii) if cooked, 6 per cent or more of the named stew poultry meat, (iii) 38 per cent or more vegetables; and SOR/78-874, s. 3. B.22.018 [S]. (naming the poultry meat) Stew (i) if uncooked, 20 per cent or more of the named stew poultry meat, (ii) if cooked, 10 per cent or more of the named stew poultry meat, (iii) 30 per cent or more vegetables; and SOR/78-874, s. 3. B.22.019 [S]. Specialty Poultry Meat Stew (i) if uncooked, 25 per cent or more of stew poultry meat, (ii) if cooked, 15 per cent or more of stew poultry meat, (iii) 30 per cent or more vegetables; and SOR/78-874, s. 3. B.22.020 [Repealed, SOR/86-875, s. 7] (b) liquid smoke flavour, liquid smoke flavour concentrate or spices; (c) sweetening agents; (d) vinegar; (f) in the case of vacuum-packed sliced cooked turkey, Carnobacterium maltaromaticum CB1. SOR/80-13, s. 13; SOR/82-856, s. 10; SOR/84-567, s. 5; SOR/2010-264, s. 6; SOR/2011-280, s. 12; SOR/2017-18, s. 12(F); SOR/2018-69, s. 10(F). (b) broth; (c) salt; (d) seasoning; (e) gelling agents; and (f) small amounts of fat. SOR/84-300, s. 55. B.22.024 [Repealed, SOR/2022-143, s. 27] SOR/82-768, s. 69. (a) at all times SOR/78-403, s. 28(F); SOR/88-336, s. 3. Poultry Product Extender SOR/82-768, s. 70. the poultry product extender meets the requirements of paragraphs B.22.027(a) to (c). SOR/82-768, s. 71. (c) notwithstanding sections D.01.009 and D.02.009, contains, per 100 grams on a ready-to-use basis, (A) 50 milligrams calcium, (B) 2.3 milligrams iron, (C) 1.5 milligrams zinc, (D) 130 milligrams potassium, (E) 1000 International Units Vitamin A, (F) 0.10 milligram thiamine, (G) 0.30 milligram riboflavin, (H) 3.60 milligrams niacin, (I) 1.60 milligrams pantothenic acid, (J) 0.20 milligram Vitamin B₆, (K) 0.50 microgram Vitamin B₁₂, (L) 0.02 milligram folic acid, and (M) 2.0 International Units alpha tocopherol, and (d) has a calcium to phosphorous ratio of not less than one part calcium to four parts phosphorous; and SOR/82-768, s. 72; SOR/84-300, s. 56. SOR/82-768, s. 73. B.22.034 [S]. Liquid Whole Egg, Dried Whole Egg or Frozen Whole Egg (i) contain aluminum sulphate, pH adjusting agents and the colour beta carotene, B.22.035 [S]. Liquid Yolk, Dried Yolk or Frozen Yolk (i) contain aluminum sulphate, pH adjusting agents and the colour beta carotene, B.22.036 [S]. Liquid Egg-White, (Liquid Albumen), Dried Egg-White, (Dried Albumen) or Frozen Egg-White (Frozen Albumen) (i) contain whipping agents, aluminum sulphate and pH adjusting agents, B.22.037 [S]. Liquid Whole Egg Mix, Dried Whole Egg Mix, Frozen Whole Egg Mix, Liquid Yolk Mix, Dried Yolk Mix or Frozen Yolk Mix SOR/96-259, s. 2. DIVISION 23 Food Packaging Materials SOR/81-60, s. 13; SOR/86-1125, s. 4. B.23.004 (1) Di (n-octyl)tin S,S′,S″-bis (isooctylmercaptoacetate) shall be the octyltin chemical made from di (n-octyl)tin dichloride and shall contain 15.1 to 16.4 per cent of tin and 8.1 to 8.9 per cent of mercapto sulfur.

(2)

For the purposes of this Division, di (n-octyl)tin dichloride shall be the chemical having an organotin composition of not less than 95 per cent di (n-octyl)tin dichloride and shall contain not more than (a) five per cent total of n-octyltin trichloride or tri(n-octyl)tin chloride or both; (b) 0.2 per cent total of other eight (8) carbon isomeric alkyltin derivatives; and (c) 0.1 per cent total of the higher and lower homologous alkyltin derivatives. SOR/86-1125, s. 5. SOR/86-1125, s. 6(F). B.23.006 (1) (n-octyl)tin S,S′,S″-tris (isooctylmercaptoacetate), being an octyltin chemical having the formula n-C8H17Sn(SCH2CO2C8H17)3, shall be made from (n-octyl)tin trichloride and shall contain 13.4 to 14.8 per cent of tin and 10.9 to 11.9 per cent of mercapto sulfur. (a) five per cent total of di(n-octyl)tin dichloride, tri(n-octyl)tin chloride or the higher (more than eight (8) carbons) alkyltin chlorides or any combination of the foregoing; (b) 0.2 per cent total of alkyltin derivatives; and (c) 0.1 per cent of the lower (less than eight carbons) homologous alkyltin derivatives. SOR/86-1125, s. 7. SOR/82-768, s. 74. SOR/82-541, s. 1. DIVISION 24 (b) for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods; (aliment à usage diététique spécial) (a) an ingredient or the amount of an ingredient in the food, (c) the directions for the preparation and use of the food; (changement majeur) meal replacement [Repealed, SOR/95-474, s. 3] prepackaged meal [Repealed, SOR/95-474, s. 3] very low energy diet means a diet for weight reduction that provides less than 900 kilocalories per day when followed as directed. (régime à très faible teneur en énergie) SOR/78-64, s. 1; SOR/78-688, s. 4; SOR/84-35, s. 1; SOR/95-474, s. 3. (a) to (e) [Repealed, SOR/2003-11, s. 21] (f.2) a nutritional supplement that meets the requirements contained in section B.24.201; (a) “free of energy”, set out in item 1; (c) “free of sodium or salt”, set out in item 31; stomacale à une personne visée à l’alinéa a) de la définition d’aliment à usage diététique spécial; (formulated liquid diet) régime à très faible teneur en énergie Régime amaigrissant qui, lorsqu’il est suivi selon les indications, fournit moins de 900 kilocalories par jour. (very low energy diet) repas préemballé [Abrogé, DORS/95-474, art. 3] substitut de repas [Abrogé, DORS/95-474, art. 3] DORS/78-64, art. 1; DORS/78-688, art. 4; DORS/84-35, art. 1; DORS/95-474, art. 3. B.24.003 (1) Il est interdit d’étiqueter, d’emballer, de vendre ou d’annoncer un aliment de manière à donner l’impression qu’il est à usage diététique spécial, à moins que cet aliment ne soit a) à e) [Abrogés, DORS/2003-11, art. 21] f) une préparation pour régime liquide qui répond aux exigences des articles B.24.101 et B.24.102; f.1) un substitut de repas à usage diététique spécial qui répond aux exigences de l’article B.24.200; f.2) un supplément nutritif qui répond aux exigences de l’article B.24.201; g) un aliment sans gluten répondant aux exigences de l’article B.24.018; h) un aliment présenté comme étant destiné aux régimes à teneur réduite en protéines; i) un aliment présenté comme étant destiné aux régimes à faible teneur en (nom de l’acide aminé); j) un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie qui répond aux exigences mentionnées à l’article B.24.303. (1.1) Malgré le paragraphe (1), il est permis d’étiqueter, d’emballer, de vendre ou d’annoncer un aliment de manière à donner l’impression qu’il est à usage diététique spécial si son étiquette porte une mention ou allégation figurant à la colonne 4 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive, conformément à l’article B.01.503, en regard de l’un des sujets ci-après visé à la colonne 1: a) « sans énergie », visé à l’article 1; b) « peu d’énergie », visé à l’article 2; c) « sans sodium ou sans sel », visé à l’article 31;

(4)

“low in sodium or salt”, set out in item 32; or (e) “free of sugars”, set out in item 37. (a) “free of energy”, set out in item 1; (d) “lower in energy”, set out in item 4; or (e) “free of sugars”, set out in item 37. B.24.004 to B.24.014 [Repealed, SOR/2003-11, s. 22] B.24.015 and B.24.016 [Repealed, SOR/88-559, s. 6] SOR/78-688, s. 6; SOR/94-365, s. 3; SOR/2018-69, ss. 11, 27. DORS/56-444, a. 2; DORS/2011-28, a. 6. B.24.019 [Repealed, SOR/2003-11, s. 23] Formulated Liquid Diets SOR/78-64, s. 7; SOR/78-688, s. 7. (a) if sold ready to serve, or B.24.102 (1) Subject to subsection (4), a formulated liquid diet shall contain, when ready to serve, (a) either

(3)

The amounts of the nutrients specified in paragraphs (1)(a) and (b) and subsection (2) shall be calculated TABLE Per 1,000 available kilocalories Column I | Column II | Column III Vitamins | Minimum | Maximum Vitamin A | 2,000 I.U. | 5,000 I.U. Vitamin D | 100 I.U. | 400 I.U. Vitamin E (a-tocopherol) | 5.0 I.U. | 5.0 I.U. Ascorbic Acid | 20 mg | 20 mg Thiamine | 0.5 mg | 0.5 mg Riboflavin | 0.7 mg | 0.7 mg Niacin | 6.6 mg | 6.6 mg Vitamin B6 | 0.9 mg | 0.9 mg Vitamin B12 | 1.5 µg | 1.5 µg Folic Acid | 100 µg | 100 µg d-pantothenic Acid | 2.5 mg | 2.5 mg Mineral Nutrients Calcium | 400 mg | 400 mg Phosphorus | 400 mg | 400 mg Iron | 8 mg | 8 mg Iodine | 50 µg | 50 µg Magnesium | 150 mg | 150 mg Copper | 1 mg | 1 mg Zinc | 7 mg | 7 mg Per 1,500 available kilocalories Column IV | Column V Vitamins | Minimum | Maximum Vitamin A | 2,000 I.U. | 3,000 I.U. Vitamin D | 100 I.U. | 200 I.U. Vitamin E (a-tocopherol) | 5.0 I.U. | 5.0 I.U. Ascorbic Acid | 20 mg | 20 mg Thiamine | 0.6 mg | 0.6 mg Riboflavin | 0.84 mg | 0.84 mg Niacin | 7.9 mg | 7.9 mg Vitamin B6 | 0.9 mg | 0.9 mg Vitamin B12 | 1.5 µg | 1.5 µg Folic Acid | 100 µg | 100 µg d-pantothenic Acid | 2.5 mg | 2.5 mg Mineral Nutrients Calcium | 400 mg | 400 mg Phosphorus | 400 mg | 400 mg Iron | 8 mg | 8 mg Iodine | 50 µg | 50 µg Magnesium | 150 mg | 150 mg Copper | 1 mg | 1 mg Zinc | 7 mg | 7 mg

(4)

L’alinéa (1)a) ne s’applique pas à une préparation pour régime liquide recommandée pour un régime à teneur réduite en protéines ou à faible teneur en (nom de l’acide aminé). TABLEAU Par 1 000 kcal disponibles Colonne I | Colonne II | Colonne III Vitamines | Quantité minimale | Quantité maximale Vitamine A | 2 000 U.I. | 5 000 U.I. Vitamine D | 100 U.I. | 400 U.I. Vitamine E (a-tocophérol) | 5 U.I. | 5 U.I. Acide ascorbique | 20 mg | 20 mg Thiamine | 0,5 mg | 0,5 mg Riboflavine | 0,7 mg | 0,7 mg Niacine | 6,6 mg | 6,6 mg Vitamine B6 | 0,9 mg | 0,9 mg Vitamine B12 | 1,5 µg | 1,5 µg Acide folique | 100 µg | 100 µg Acide d-pantothénique | 2,5 mg | 2,5 mg Minéraux Calcium | 400 mg | 400 mg Phosphore | 400 mg | 400 mg Fer | 8 mg | 8 mg Iode | 50 µg | 50 µg Magnésium | 150 mg | 150 mg Cuivre | 1 mg | 1 mg Zinc | 7 mg | 7 mg Par 1 500 kcal disponibles Colonne IV | Colonne V Vitamines | Quantité minimale | Quantité maximale Vitamine A | 2 000 U.I. | 3 000 U.I. Vitamine D | 100 U.I. | 200 U.I. Vitamine E (a-tocophérol) | 5 U.I. | 5 U.I. Acide ascorbique | 20 mg | 20 mg Thiamine | 0,6 mg | 0,6 mg Riboflavine | 0,84 mg | 0,84 mg Niacine | 7,9 mg | 7,9 mg Vitamine B6 | 0,9 mg | 0,9 mg Vitamine B12 | 1,5 µg | 1,5 µg Acide folique | 100 µg | 100 µg Acide d-pantothénique | 2,5 mg | 2,5 mg Minéraux Calcium | 400 mg | 400 mg Phosphore | 400 mg | 400 mg Fer | 8 mg | 8 mg Iode | 50 µg | 50 µg Magnésium | 150 mg | 150 mg Cuivre | 1 mg | 1 mg Zinc | 7 mg | 7 mg PART B Foods DIVISION 24 Formulated Liquid Diets Sections B.24.102-B.24.103 Par 1 000 kcal disponibles Colonne I Vitamines Magnésium Cuivre Zinc Colonne II Quantité minimale 150 mg 1 mg 7 mg Colonne III Quantité maximale 150 mg 1 mg 7 mg Par 1 500 kcal disponibles Colonne IV Quantité minimale 150 mg 1 mg 7 mg Colonne V Quantité maximale 150 mg 1 mg 7 mg SOR/86-4, s. 7; SOR/87-688, s. 8; SOR/82-768, s. 75; SOR/87-640, s. 9(F); SOR/90-830, s. 6(F); SOR/2022-197, s. 5. (ii) per unit of ready-to-serve food; (c) a statement of the content in the food of protein or protein equivalent, fat, linoleic acid, available carbohydrate and, where present, crude fibre, expressed in grams (ii) per unit of ready-to-serve food; (ii) per unit of ready-to-serve food; (ii) per unit of ready-to-serve food; Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 24

Préparations pour régime liquide

Articles B.24.102-B.24.103

B.24.103 L’étiquette d’une préparation pour régime liquide doit porter les renseignements suivants : a) une mention indiquant que l’aliment est destiné à être consommé par voie orale ou administré à la sonde stomacale; b) une mention de la valeur énergétique de l’aliment, exprimée en Calories : (i) par 100 grammes ou par 100 millilitres de l’aliment sous sa forme commerciale, (ii) par unité de l’aliment prêt à servir; c) une mention de la teneur de l’aliment en protéines ou en équivalent de protéines, en matières grasses, en acide linoléique, en glucides disponibles et, s’il y a lieu, en fibres brutes, exprimée en grammes : (i) par 100 grammes ou par 100 millilitres de l’aliment sous sa forme commerciale, (ii) par unité de l’aliment prêt à servir; d) une mention de la teneur en vitamines et en minéraux nutritifs énumérés au tableau de l’article B.24.102, exprimée en unités internationales, en milligrammes ou en microgrammes : (i) par 100 grammes ou par 100 millilitres de l’aliment sous sa forme commerciale, (ii) par unité de l’aliment prêt à servir; e) une mention de la teneur en une vitamine ou un minéral nutritif autre que ceux énumérés au tableau de l’article B.24.102, exprimée en milligrammes ou en microgrammes : (i) par 100 grammes ou par 100 millilitres de l’aliment sous sa forme commerciale, (ii) par unité de l’aliment prêt à servir; f) des directives complètes sur la préparation et l’utilisation de l’aliment ainsi que sur son entreposage après ouverture du contenant; (a) the meal replacement provides a minimum of 225 kcal or 945 kJ per serving; (i) of a nutritional quality equivalent to that of casein, or TABLE Column I | Column II | Column III Nutrients | Minimum Amount per Serving | Maximum Amount per Serving VITAMINS Vitamin A | 250 RE | 630 RE Vitamin D | 1.25 µg | 2.50 µg Vitamin E | 2.5 mg | 5.0 mg Vitamin C | 10 mg | 20 mg PART B Foods DIVISION 24 Sections B.24.200-B.24.201 Column I | Column II | Column III Nutrients | Minimum Amount per Serving | Maximum Amount per Serving Thiamine | 300 µg | 750 µg Riboflavin | 400 µg | 800 µg Niacin | 6 NE | 12 NE Vitamin B6 | 400 µg | 750 µg Vitamin B12 | 0.25 µg | 0.75 µg Folacin | 60 µg | 120 µg Pantothenic acid | 1.25 mg | 2.50 mg Biotin | 25 µg | 75 µg MINERAL NUTRIENTS Calcium | 200 mg | 400 mg Phosphorus | 250 mg | 500 mg Iron | 2.5 mg | 5.0 mg Iodide | 40 µg | 120 µg Magnesium | 60 mg | 120 mg Copper | 0.5 mg | 1.0 mg Zinc | 3 mg | 6 mg Potassium | 375 mg Sodium | 250 mg Manganese | 1 mg | 2 mg Selenium | 10 µg | 20 µg Chromium | 10 µg | 20 µg Molybdenum | 20 µg | 40 µg SOR/78-698, s. 9; SOR/80-13, s. 14; SOR/95-474, s. 5. (a) the nutritional supplement contains at least 150 kcal or 630 kJ per serving; (i) of a nutritional quality equivalent to that of casein, or --- Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 24

Substituts de repas, suppléments nutritifs, repas préemballés et aliments vendus par les cliniques d’amaigrissement

Articles B.24.200-B.24.201

Colonne I | Colonne II | Colonne III Éléments nutritifs | Quantité minimale par portion | Quantité maximale par portion Thiamine | 300 µg | 750 µg Riboflavine | 400 µg | 800 µg Niacine | 6 EN | 12 EN Vitamine B6 | 400 µg | 750 µg Vitamine B12 | 0,25 µg | 0,75 µg Folacine | 60 µg | 120 µg Acide pantothénique | 1,25 mg | 2,50 mg Biotine | 25 µg | 75 µg MINÉRAUX NUTRITIFS Calcium | 200 mg | 400 mg Phosphore | 250 mg | 500 mg Fer | 2,5 mg | 5,0 mg Iode | 40 µg | 120 µg Magnésium | 60 mg | 120 mg Cuivre | 0,5 mg | 1,0 mg Zinc | 3 mg | 6 mg Potassium | 375 mg Sodium | 250 mg Manganèse | 1 mg | 2 mg Sélénium | 10 µg | 20 µg Chrome | 10 µg | 20 µg Molybdène | 20 µg | 40 µg DORS/78-698, art. 9; DORS/80-13, art. 14; DORS/95-474, art. 5. B.24.201 (1) Il est interdit de vendre ou d’annoncer un supplément nutritif qui contient moins de 225 kcal ou 945 kJ par portion, à moins qu’il ne réponde aux exigences suivantes : a) il contient au moins 150 kcal ou 630 kJ par portion; b) au moins 15 pour cent et au plus 40 pour cent de l’énergie utilisable provient de sa teneur en protéines; c) les protéines qu’il contient sont : (i) soit d’une qualité nutritive équivalente à celle de la caséine, (ii) soit de qualité nutritive et en quantité suffisante pour donner un résultat d’au moins 15 pour cent lorsque la qualité nutritive de ces protéines est divisée par la qualité nutritive de la caséine et ensuite multipliée par le pourcentage de l’énergie utilisable provenant de sa teneur en protéines; (d) the nutritional supplement contains, per 100 kcal or 420 kJ, each vitamin and mineral nutrient listed in column I of the table to this section (a) the nutritional supplement provides at least 225 kcal or 945 kJ per serving; (i) of a nutritional quality equivalent to that of casein, or TABLE Column I | Column II | Column III Nutrients | Minimum Amount per Available 100 Kcal or 420 KJ | Maximum Amount per Available 100 Kcal or 420 KJ VITAMINS Vitamin A | 100 RE | 250 RE Vitamin D | 0.25 µg | 1 µg Vitamin E | 1.0 mg | 2.0 mg Vitamin C | 5 mg | 10 mg Thiamine | 140 µg | 350 µg Riboflavin | 180 µg | 360 µg Niacin | 3 NE | 6 NE Vitamin B6 | 180 µg | 350 µg Vitamin B12 | 0.1 µg | 0.3 µg Folacin | 30 µg | 60 µg Pantothenic acid | 0.6 mg | 1.2 mg Biotin | 12 µg | 35 µg MINERAL NUTRIENTS Calcium | 100 mg | 175 mg Phosphorus | 100 mg | 175 mg PART B Foods DIVISION 24 Sections B.24.201-B.24.202 Column I | Column II | Column III Nutrients | Minimum Amount per Available 100 Kcal or 420 KJ | Maximum Amount per Available 100 Kcal or 420 KJ Iron | 1.0 mg | 2.0 mg Iodide | 15 µg | 45 µg Magnesium | 20 mg | 40 mg Copper | 0.15 mg | 0.30 mg Zinc | 1.4 mg | 2.0 mg Potassium | 175 mg | - Manganese | 0.45 mg | 0.90 mg Selenium | 4 µg | 8 µg Chromium | 4 µg | 8 µg Molybdenum | 8 µg | 15 µg SOR/78-688, s. 9; SOR/95-474, s. 5. B.24.202 The label of a meal replacement or nutritional supplement shall (i) the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ), (iv) the calcium, phosphorus, iron, iodide, magnesium and zinc contents of the food, expressed (d) include the expiration date of the meal replacement or nutritional supplement; (e) in the case of a meal replacement for use in a weight reduction diet, carry the statement “USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET / UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE” prominently displayed on the principal display panel; and SOR/88-88, s. 9; SOR/88-558, s. 28; SOR/95-474, s. 6; SOR/2016-305, ss. 59, 75(F). (a) [Repealed, SOR/2003-11, s. 24] (b) carry the statement “USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET / UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À à la colonne 4 de la partie 2 du Tableau des valeurs quotidiennes, (B) dans le cas du supplément nutritif, en milligrammes pour le calcium, le phosphore, le fer, le magnésium et le zinc et en microgrammes pour l’iode, (v) sa teneur en cuivre, en potassium, en sodium et en manganèse exprimée en milligrammes, (vi) sa teneur en biotine, en sélénium, en chrome et en molybdène exprimée en microgrammes; b) dans le cas du substitut de repas ou du supplément nutritif auquel il faut ajouter du lait, du lait partiellement écrémé ou du lait écrémé, une mention indiquant que la teneur nutritive de l’aliment a été déterminée compte tenu du lait, du lait partiellement écrémé ou du lait écrémé qui sera ajouté selon le mode d’emploi; c) dans le cas du substitut de repas vendu en annonçant comme étant le substitut de tous les repas de la journée dans un régime amaigrissant, la mode d’emploi qui assurera une consommation ayant un apport énergétique d’au moins 900 Kcal ou 3 780 kJ; d) la date limite d’utilisation du substitut de repas ou du supplément nutritif; e) dans le cas du substitut de repas pour régimes amaigrissants, la mention « UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE / USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET », inscrite bien en évidence dans l’espace principal de l’étiquette; f) dans le cas du substitut de repas pour régimes amaigrissants qui n’est pas présenté comme étant le substitut de tous les repas de la journée, les renseignements requis à l’article B.24.204. DORS/88-88, art. 9; DORS/88-558, art. 28; DORS/95-474, art. 6; DORS/2016-305, art. 59 et 75(F). B.24.203 L’étiquette d’un repas préemballé pour régimes amaigrissants ou d’un aliment destiné à être vendu dans une clinique d’amaigrissement doit porter: a) [Abrogé, DORS/2003-11, art. 24] b) la mention « UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE" prominently displayed on the principal display panel; and SOR/78-688, s. 9; SOR/88-559, s. 29; SOR/95-474, s. 5; SOR/2003-11, s. 24. RÉGIME AMINCISSANT SEULEMENT DANS LE CADRE D’UN RÉGIME RÉDUIT EN ÉNERGIE », inscrite bien en évidence dans l’espace principal de l’étiquette; c) les renseignements requis à l’article B.24.204. DORS/78-688, art. 9; DORS/88-559, art. 29; DORS/95-474, art. 5; DORS/2003-11, art. 24. B.24.204 L’étiquette du repas préemballé ou du substitut de repas, autre que le substitut de repas présenté comme étant le substitut de tous les repas de la journée, qui sont emballés, vendus ou annoncés comme étant pour des régimes amaigrissants, ou l’étiquette d’un aliment destiné à être vendu dans une clinique d’amaigrissement, doit comporter dans le mode d’emploi un menu type de sept jours dans lequel figure le repas préemballé, le substitut de repas ou l’aliment et qui répond aux exigences suivantes : a) chaque repas quotidien comprend au moins une portion, selon la description qui en est donnée dans la publication intitulée Guide alimentaire canadien pour manger sainement, autorisée par le ministre de la Santé nationale et du Bien-être social et publiée en 1992 par le ministère des Approvisionnements et Services, d’aliment de chacun des groupes suivants : (i) lait, produits du lait ou leurs substituts, (ii) viande et substituts de viande, (iii) pain et produits céréaliers, (iv) légumes et fruits; b) l’apport énergétique quotidien n’est pas inférieur à 1 200 kcal ou 5 040 kJ; c) au plus 30 pour cent de l’apport énergétique quotidien total provient de sa teneur en lipides et au plus 10 pour cent de l’apport énergétique quotidien total provient de sa teneur en acides gras saturés; d) l’apport quotidien moyen de chacun des éléments nutritifs énumérés dans la colonne I du tableau du présent article n’est pas inférieur à la quantité indiquée à la colonne II, dans le cas d’un menu recommandé pour les hommes, ou à celle indiquée à la colonne III, dans le cas d’un menu recommandé pour les femmes; e) le menu ne mentionne aucun supplément de vitamines ou de minéraux nutritifs. TABLE Column I | Column II | Column III Nutrients | Men | Women Protein | 65 g | 55 g VITAMINS Vitamin A | 1000 RE | 800 RE Vitamin D | 5 µg | 5 µg Vitamin E | 10 mg | 7 mg Vitamin C | 40 mg | 30 mg Thiamin | 1 mg | 1 mg Riboflavin | 1 mg | 1 mg Niacin | 14 NE | 14 NE Vitamin B₆ | 1.5 mg | 1.5 mg Vitamin B₁₂ | 1 µg | 1 µg Folacin | 230 µg | 200 µg Pantothenic Acid | 5 mg | 5 mg MINERAL NUTRIENTS Calcium | 800 mg | 800 mg Phosphorus | 1000 mg | 850 mg Iron | 9 mg | 13 mg Iodide | 160 µg | 160 µg Magnesium | 250 mg | 210 mg Copper | 2 mg | 2 mg Zinc | 12 mg | 9 mg SOR/78-698, s. 9; SOR/95-474, s. 5. ENERGY-REDUCED DIET / UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE”. SOR/88-688, s. 9; SOR/95-474, s. 5. SOR/94-35, s. 4. (a) a physician; (b) a wholesale druggist; (c) a pharmacist; or (d) a hospital. SOR/94-35, s. 4. SOR/94-35, s. 4. (a) either TABLE Column I Vitamin or Mineral Nutrient 1 Thiamine 2 Riboflavin 3 Niacin 4 Folacin 5 Biotin 6 Pantothenic acid 7 Vitamin B6 8 Vitamin B12 9 Vitamin A 10 Vitamin D 11 Vitamin E 12 Vitamin C 13 Calcium 14 Phosphorus 15 Magnesium 16 Iron 17 Iodine 18 Zinc 19 Copper 20 Manganese 21 Selenium 22 Chromium 23 Molybdenum 24 Sodium 25 Potassium 26 Chloride Column II Minimum amount per day

1.3 mg

1.6 mg

23 mg

0.22 mg

0.15 mg

7.0 mg

1.5 mg

0.001 mg

1000 RE

0.005 mg

10 mg 40 mg 800 mg 1000 mg 250 mg 13 mg

0.16 mg

12 mg 2 mg

3.5 mg

0.07 mg

0.05 mg

0.1 mg

2000 mg 3000 mg 1500 mg (a) a statement of the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ) per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food; (e) the statement “USE ONLY UNDER MEDICAL SUPERVISION” prominently displayed on the principal display panel; SOR/94-35, s. 4. (d) a list of the ingredients of the food, stated quantitatively; (j) a description of the type of packaging to be used; (k) directions for use; B.24.305 (1) Il est interdit de vendre ou d’annoncer en vue de la vente un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie à moins que le fabricant n’ait donné au ministre, au moins 90 jours avant la vente ou l’annonce, un avis écrit de son intention de vendre l’aliment ou de l’annoncer en vue de la vente.

(2)

L’avis visé au paragraphe (1) est signé par le fabricant et contient, à l’égard de l’aliment présenté comme conçu pour un régime à très faible teneur en énergie, les renseignements suivants : a) le nom sous lequel l’aliment sera vendu ou annoncé pour la vente; b) les nom et adresse du principal établissement du fabricant; c) les nom et adresse de chaque établissement où l’aliment est fabriqué; d) la liste des ingrédients de l’aliment et la quantité de chacun; e) les caractéristiques relatives à la qualité nutritive, microbiologique et physique des ingrédients et de l’aliment; f) le détail des techniques de contrôle de la qualité appliquées aux essais des ingrédients et de l’aliment; g) le détail du procédé de fabrication et des techniques de contrôle de la qualité appliquées au cours de la fabrication; h) les résultats des essais effectués pour déterminer la date limite d’utilisation de l’aliment; i) les preuves invoquées pour établir que l’aliment répond aux besoins nutritifs, autres que les besoins énergétiques, des personnes à qui il est destiné, lorsqu’il est consommé suivant le mode d’emploi; j) une description du type d’emballage qui sera utilisé; k) le mode d’emploi; l) le texte des étiquettes, y compris les notices d’accompagnement, qui seront utilisées avec l’aliment; m) les nom et titre du signataire de l’avis et la date de la signature. SOR/94-35, s. 4; SOR/2018-69, ss. 27, 29(F). SOR/94-35, s. 4; SOR/2018-69, ss. 27, 29(F).

(3)

Malgré le paragraphe (1), il est permis de vendre ou d’annoncer en vue de la vente un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie si le ministre, après avoir été avisé par le fabricant conformément à ce paragraphe, informe celui-ci par écrit que l’avis satisfait aux exigences visées au paragraphe (2). DORS/94-35, art. 4; DORS/2018-69, art. 27 et 29(F). B.24.306 (1) Il est interdit de vendre ou d’annoncer en vue de la vente un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie qui a subi un changement majeur, à moins que le fabricant n’ait donné au ministre, au moins 90 jours avant la vente ou l’annonce, un avis écrit de son intention de vendre ou d’annoncer en vue de la vente.

(2)

L’avis visé au paragraphe (1) est signé par le fabricant et contient, à l’égard de l’aliment présenté comme étant conçu pour un régime à très faible teneur en énergie qui a subi un changement majeur, les renseignements suivants : a) le nom sous lequel l’aliment sera vendu ou annoncé en vue de la vente; b) les nom et adresse du principal établissement du fabricant; c) la description du changement majeur; d) les preuves invoquées pour établir que l’aliment répond aux besoins nutritifs, autres que les besoins énergétiques, des personnes à qui il est destiné, lorsqu’il est consommé suivant le mode d’emploi; e) les preuves invoquées pour établir que le changement majeur n’a pas d’effet indésirable sur l’aliment ou son utilisation; f) le texte des étiquettes, y compris les notices d’accompagnement, qui seront utilisées avec l’aliment; g) les nom et titre du signataire de l’avis et la date de la signature.

(3)

Malgré le paragraphe (1), il est permis de vendre ou d’annoncer en vue de la vente un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie qui a subi un changement majeur si le ministre, après avoir été avisé par le fabricant conformément à ce paragraphe, a informé celui-ci par écrit que l’avis satisfait aux exigences visées au paragraphe (2). DORS/94-35, art. 4; DORS/2018-69, art. 27 et 29(F). DIVISION 25 Interpretation (b) for use as an ingredient in a food referred to in paragraph (a); (succédané de lait humain) infant food means a food that is labelled or advertised for consumption by infants; (aliment pour bébés) junior (naming a food) means the named food where it contains particles of a size to encourage chewing by infants, but may be readily swallowed by infants without chewing; (nom d’un aliment) pour enfants en bas âge)

TITRE 25

Définitions B.25.001 Dans le présent titre, aliment pour bébés Tout aliment étiqueté ou annoncé comme pouvant être consommé par des bébés; (infant food) bébé Individu de moins d’un an; (infant) changement majeur Relativement à un fortifiant pour lait humain ou à un succédané de lait humain, un changement d’ingrédient ou de la quantité d’un ingrédient, ou la modification du traitement ou de l’emballage du fortifiant pour lait humain ou du succédané de lait humain, pour autant, selon l’expérience du fabricant ou la théorie généralement admise, altérer les concentrations ou compromettre la disponibilité des éléments nutritifs du fortifiant pour lait humain ou du succédané de lait humain, ou l’innocuité microbiologique ou chimique de ceux-ci; (major change) date limite d’utilisation Relativement à un fortifiant pour lait humain ou à un succédané de lait humain, date, à la fois : a) après laquelle le fabricant recommande de ne pas le consommer, b) jusqu’à laquelle il conserve la stabilité physique et microbiologique et la valeur nutritive indiquée sur son étiquette; (expiration date) fortifiant pour lait humain Aliment qui, à la fois : a) comprend au moins une vitamine, un minéral nutritif ou un acide aminé ajouté, b) est étiqueté ou annoncé comme devant être ajouté au lait humain pour en augmenter la valeur nutritive afin de satisfaire aux besoins alimentaires particuliers d’un bébé présentant un état physique ou physiologique particulier en raison d’une maladie, d’un désordre ou d’un état physique anormal; (human milk fortifier) (nom d’un aliment) en purée ou tamisé Désigne l’aliment nommé qui est composé de particules d’une grosseur généralement uniforme et qui n’exige ni n’encourage la mastication avant d’être avalé par des bébés; (strained (naming a food)) (nom d’un aliment) pour enfants en bas âge désigne l’aliment nommé qui contient normalement des chemical safety of, the human milk fortifier or human milk substitute; (changement majeur) (c) manufactured by a person who manufactures it for the first time; (succédané de lait humain nouveau) SOR/78-637, s. 5; SOR/83-933, s. 1; SOR/90-174, s. 1; SOR/2021-57, s. 12. Infant Foods SOR/83-933, s. 1. (a) strained fruit, (d) cereal,

(2)

Subsection (1) does not apply to strained desserts containing any of the foods mentioned in paragraphs (1)(a) to (d). SOR/83-933, s. 1. Human Milk Fortifiers particules d’une grosseur encourageant la mastication, mais qui peut être facilement avalé par des bébés sans être mastiqué; (junior (naming a food)) succédané de lait humain Tout aliment étiqueté ou annoncé comme pouvant être : a) soit utilisé comme un remplacement partiel ou total du lait humain et destiné à être consommé par des bébés, b) soit utilisé comme un ingrédient d’un aliment visé à l’alinéa a); (human milk substitute) succédané de lait humain nouveau désigne un succédané de lait humain : a) soit qui est fabriqué pour la première fois, b) soit qui est vendu au Canada pour la première fois, c) soit qu’une personne fabrique pour la première fois. (new human milk substitute) DORS/78-637, art. 5; DORS/83-933, art. 1; DORS/90-174, art. 1; DORS/2021-57, art. 12. Aliments pour bébés B.25.002 Est interdite la vente ou la publicité en vue de la vente d’un aliment pour bébés visé à la colonne I du tableau I du présent titre, si cet aliment contient plus que la quantité de sodium indiquée à la colonne II du tableau. DORS/83-933, art. 1. B.25.003 (1) Sous réserve du paragraphe (2), est interdite la vente des aliments pour bébés qui contiennent, a) des fruits en purée, b) des jus de fruit, c) des boissons aux fruits, ou d) des céréales, auxquels du chlorure de sodium a été ajouté.

(2)

Le paragraphe (1) ne s’applique pas aux desserts en purée contenant un aliment visé aux alinéas (1)a) à d). DORS/83-933, art. 1. Fortifiants pour lait humain B.25.010 Sous réserve de l’article B.25.013, il est interdit de vendre ou d’annoncer en vue de sa vente un fortifiant pour lait humain, à moins que le ministre n’ait informé le SOR/2021-57, s. 13. (b) the manufacturer’s name and address; (d) a list of all of the human milk fortifier’s ingredients, stated quantitatively; (k) a description of the type of packaging to be used for the human milk fortifier; SOR/2021-57, s. 13. SOR/2021-57, s. 13. n) le nom et le titre du signataire de la demande d’autorisation et la date de la signature. DORS/2021-57, art. 13. B.25.012 (1) Après avoir fait l’examen des renseignements fournis en application de l’article B.25.011 ainsi que de tout autre renseignement relatif à l’examen de la demande, le ministre informe le fabricant, par écrit, que la vente ou l’annonce en vue de la vente du fortifiant pour lait humain visé par cette demande, selon le cas : a) est autorisée si, à la fois : (i) la demande satisfait aux exigences prévues à l’article B.25.011, (ii) les renseignements sont suffisants pour établir l’innocuité du fortifiant pour lait humain; b) n’est pas autorisée dans tout autre cas.

(2)

Si les conditions prévues à l’alinéa (1)a) ne sont pas remplies, le ministre peut demander au fabricant de fournir, par écrit, les renseignements supplémentaires qui sont nécessaires pour les remplir.

(3)

Après avoir fait l’examen des renseignements supplémentaires fournis par le fabricant, le ministre informe ce dernier, par écrit, que la vente ou l’annonce en vue de la vente du fortifiant pour lait humain, selon le cas : a) est autorisée, si les conditions prévues à l’alinéa (1)a) sont remplies; b) n’est pas autorisée dans tout autre cas.

(4)

Malgré les alinéas (1)a) et (3)a), le ministre n’autorise pas la vente ou l’annonce en vue de la vente de ce fortifiant pour lait humain s’il a des motifs raisonnables de croire que les renseignements fournis par le fabricant sont faux, trompeurs ou mensongers. DORS/2021-57, art. 13. B.25.013 L’interdiction prévue à l’article B.25.010 ne s’applique pas à un fortifiant pour lait humain figurant sur la Liste des fortifiants pour lait humain vendus au Canada au 25 mars 2021 qui est publiée sur un site Web du gouvernement du Canada si, au plus tard le 30 avril 2022, les exigences ci-après sont remplies : a) le fabricant du fortifiant pour lait humain fournit au ministre les renseignements ci-après : (i) une attestation signée et datée par lui-même, ou un individu autorisé à signer en son nom, portant SOR/2021-57, s. 13. SOR/2021-57, s. 13. que le fortifiant pour lait humain n’a pas subi de changement majeur depuis la date indiquée sur la liste en lien avec ce fortifiant pour lait humain, (ii) le texte écrit des étiquettes, y compris des notices d’accompagnement, qui devront être utilisées pour le fortifiant pour lait humain après le deuxième anniversaire de l’entrée en vigueur de l’article B.25.020. b) le ministre informe le fabricant, au titre du paragraphe B.25.014(1) ou de l’alinéa B.25.014(3)a), qu’il est autorisé à continuer à vendre ou à annoncer en vue de la vente son fortifiant pour lait humain. DORS/2021-57, art. 13. B.25.014 (1) Le ministre informe le fabricant, par écrit, qu’il est autorisé à continuer à vendre ou à annoncer en vue de la vente son fortifiant pour lait humain si, à la fois : a) le fabricant a fourni les renseignements visés à l’alinéa B.25.013a) dans un délai suffisant pour permettre au ministre d’en faire l’examen avant le 30 avril 2022; b) le texte écrit des étiquettes présenté en vertu du sous-alinéa B.25.013a)(ii) satisfait les exigences applicables du présent règlement.

(2)

Si les renseignements fournis sont insuffisants pour remplir les conditions prévues au paragraphe (1), le ministre peut demander au fabricant de fournir, par écrit, les renseignements supplémentaires qui sont nécessaires pour les remplir.

(3)

Après avoir fait l’examen des renseignements supplémentaires fournis par le fabricant, le ministre informe ce dernier, par écrit, selon le cas : a) que celui-ci est autorisé à continuer à vendre ou à annoncer en vue de la vente son fortifiant pour lait humain si les conditions prévues au paragraphe (1) sont remplies; b) que celui-ci n’est pas autorisé à continuer à vendre ou à annoncer en vue de la vente son fortifiant pour lait humain dans tout autre cas. DORS/2021-57, art. 13. B.25.015 (1) Il est interdit de vendre ou d’annoncer en vue de sa vente un fortifiant pour lait humain qui a subi un changement majeur, à moins que les conditions suivantes ne soient remplies : a) le fabricant du fortifiant pour lait humain présente au ministre une demande reflétant le changement majeur conformément au paragraphe (2); (b) the manufacturer’s name and address; SOR/2021-57, s. 13. b) le ministre informe le fabricant, au titre des alinéas B.25.016(1)a) ou (3)a), que la vente ou l’annonce en vue de la vente du fortifiant pour lait humain visé par cette demande est autorisée.

(2)

La demande est signée par le fabricant, ou un individu autorisé à signer en son nom, et contient les renseignements suivants : a) la marque et le nom du produit sous lesquels le fortifiant pour lait humain sera vendu ou annoncé en vue de sa vente; b) le nom et l’adresse du fabricant; c) la description et la justification du changement majeur apporté au fortifiant pour lait humain; d) les preuves établissant que le fortifiant pour lait humain a une valeur nutritive suffisante pour favoriser une croissance et un développement acceptables chez les bébés s’il est consommé conformément au mode d’emploi; e) les preuves établissant que le changement majeur n’a pas eu d’effet préjudiciable sur le fortifiant pour lait humain; f) le texte écrit des étiquettes, y compris les notices d’accompagnement, qui seront utilisées pour le fortifiant pour lait humain; g) le nom et le titre du signataire de la demande et la date de la signature. DORS/2021-57, art. 13. B.25.016 (1) Après avoir fait l’examen des renseignements fournis en application du paragraphe B.25.015(2) ainsi que de tout autre renseignement relatif à l’examen de la demande, le ministre informe le fabricant, par écrit, de la vente ou l’annonce en vue de la vente du fortifiant pour lait humain visé par la demande, selon le cas : a) est autorisée si, à la fois : (i) la demande satisfait aux exigences prévues au paragraphe B.25.015(2), (ii) les renseignements sont suffisants pour établir l’innocuité du fortifiant pour lait humain; ou b) n’est pas autorisée dans tout autre cas.

(2)

Si les conditions prévues à l’alinéa (1)a) ne sont pas remplies, le ministre peut demander au fabricant de fournir, par écrit, les renseignements supplémentaires qui sont nécessaires pour les remplir. SOR/2021-57, s. 13. SOR/2021-57, s. 13. SOR/2021-57, s. 13. (i) a hospital, or (ii) an individual, if insuffisantes, il doit en cesser la vente et l’annonce en vue de sa vente jusqu’à ce qu’il présente des preuves supplémentaires et que le ministre l’avise par écrit que ces preuves sont suffisantes.

(5)

Pour l’application du présent article, preuves concernant le fortifiant pour lait humain désigne : a) d’une part, des preuves établissant que le fortifiant pour lait humain a une valeur nutritive suffisante pour favoriser une croissance et un développement acceptables chez les bébés s’il est consommé conformément au mode d’emploi; b) d’autre part, des résultats des examens effectués pour déterminer la date limite d’utilisation du fortifiant pour lait humain. DORS/2021-57, art. 13. B.25.019 (1) Malgré le fait que le ministre ait informé le fabricant que la vente ou l’annonce en vue de la vente d’un fortifiant pour lait humain est autorisée, celui-ci ne peut être vendu que dans les cas suivants : a) il est vendu par le fabricant, selon le cas : (i) à un hôpital, (ii) à un individu si, à la fois : (A) cet individu a reçu un ordre écrit pour un fortifiant pour lait humain d’un médecin, ou d’un infirmier praticien ou d’un diététiste qui est autorisé à l’écrire en vertu des lois d’une province, (B) le fabricant a reçu une demande écrite d’un hôpital précisant le nom du produit et la quantité de fortifiant pour lait humain qui doit être fournie à cet individu; b) il est vendu par un hôpital à un individu qui a reçu un ordre écrit pour un fortifiant pour lait humain soit d’un médecin, soit d’un infirmier praticien ou d’un diététiste qui est autorisé à l’écrire en vertu des lois de la province.

(2)

Les définitions qui suivent s’appliquent au présent article. diététiste Personne qui, d’une part, est inscrite à titre de diététiste et est autorisée à exercer cette profession en vertu des lois d’une province et, d’autre part, qui l’exerce en vertu de ces lois dans cette province. (dietitian) hôpital S’entend au sens de l’article B.24.001. (hospital) SOR/2021-57, s. 13. B.25.020 (1) The following information is required to be displayed on the outer label of a human milk fortifier: (a) a statement of the quantity, expressed in grams, of protein, fat, available carbohydrate and, where present, fibre in a quantity of human milk fortifier specified in the directions for use; (b) a statement of the energy value, expressed in Calories, in a quantity of human milk fortifier specified in the directions for use; (d) a statement of the quantity, expressed in grams, milligrams, micrograms or International Units, of any other nutritive substance that is present in a quantity of human milk fortifier specified in the directions for use; SOR/2021-57, s. 13. (a) the percentage of the daily value of (i) fat, (ii) saturated fatty acids and trans fatty acids, (iii) sodium, (iv) potassium, (v) sugars, (vi) fibre, or (vii) cholesterol; or (i) fat, or SOR/2021-57, s. 13. B.25.045 The common name of a human milk substitute or a new human milk substitute shall be infant formula. (préparation pour nourrissons) SOR/90-174, s. 2. (d) a list of all of its ingredients, stated quantitatively; (j) a description of the type of packaging to be used; (k) directions for use; SOR/90-174, s. 2; SOR/2018-69, ss. 27, 30(F). SOR/90-174, s. 2; SOR/2003-11, s. 25. SOR/90-174, s. 2; SOR/2018-69, ss. 27, 30(F). B.25.050 [Repealed, SOR/90-174, s. 2] SOR/83-933, s. 1. SOR/78-837, s. 6; SOR/82-768, s. 76; SOR/83-933, s. 1. SOR/78-837, s. 6; SOR/82-768, s. 76; SOR/83-933, s. 1. SOR/78-837, s. 7; SOR/83-933, s. 1. (a) per 100 available kilocalories b) a ratio of SOR/78-637, s. 7; SOR/83-933, s. 1. SOR/83-933, s. 1. (ii) not referred to in paragraph B.25.054(1)(a) SOR/78-637, s. 8; SOR/83-933, s. 1. (a) a statement of the content of protein, fat, available carbohydrate, ash, and, where present, crude fibre in the food PART B Foods DIVISION 25

Section B.25.057

(d) a statement of the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a) (f) the expiration date of the human milk substitute. (c) a statement of (d) a statement of c) une déclaration (i) de la teneur en protéines, en matières grasses, en glucides disponibles, en cendres et, s’il y a lieu, en fibres brutes de la portion de succédané de lait humain contenue dans l’aliment, exprimée en grammes par 100 grammes ou par 100 millilitres de la portion de succédané de lait humain contenue dans l’aliment sous sa forme commerciale, (ii) de la valeur énergétique de la portion de succédané de lait humain contenue dans l’aliment, exprimée en calories par 100 grammes ou en calories par 100 millilitres de la portion de succédané de lait humain contenue dans l’aliment sous sa forme commerciale, (iii) de la quantité de toutes les vitamines et de tous les minéraux nutritifs indiqués au tableau II du présent titre et contenue dans la portion de succédané de lait humain que renferme l’aliment, exprimée en unités internationales ou en milligrammes par 100 grammes, ou en unités internationales ou en milligrammes par 100 millilitres de la portion de succédané de lait humain contenue dans l’aliment sous sa forme commerciale; (iv) de la quantité de choline et de la quantité de toute substance nutritive ajoutée et normalement contenue dans le lait humain mais non visée à l’alinéa B.25.054(1)a) contenues dans la portion de succédané de lait humain que renferme l’aliment, exprimées en milligrammes ou en grammes par 100 grammes, ou en milligrammes ou en grammes par 100 millilitres de la portion de succédané de lait humain contenue dans l’aliment sous sa forme commerciale; d) une déclaration (i) de la teneur en protéines, en matières grasses, en glucides disponibles, en cendres et, s’il y a lieu, en fibres brutes, exprimée en grammes par 100 grammes ou par 100 millilitres de l’aliment sous sa forme commerciale et en grammes pour une quantité spécifiée de l’aliment prêt à servir, (ii) de la valeur énergétique, exprimée en calories par 100 grammes ou en calories par 100 millilitres d’aliment sous sa forme commerciale et en grammes pour une quantité spécifiée de l’aliment prêt à servir, (iii) de la quantité de toutes les vitamines et de tous les minéraux nutritifs indiqués au tableau II du présent titre, exprimée en unités internationales ou (f) the expiration date of the food. SOR/83-933, s. 1; SOR/88-559, s. 30. SOR/78-637, s. 9(F); SOR/83-933, s. 1. (a) the percentage of the daily value of (i) fat, (ii) saturated fatty acids and trans fatty acids, (iii) sodium, (iv) potassium, (v) sugars, (vi) fibre, or (vii) cholesterol; or (i) fat, or SOR/2003-11, s. 26; SOR/2016-305, s. 60. SOR/83-933, s. 1; SOR/88-424, s. 2; SOR/90-174, s. 3; SOR/2018-69, ss. 12, 27. [SOR/2021-57, s. 14] SOR/83-933, s. 1; SOR/90-174, s. 4; SOR/2021-57, s. 15.

(2)

Subsection (1) does not apply to (i) fruit purées, and (ii) cereals containing banana; TABLE I Sodium Content in Infant Foods Column I Food 1 Junior Desserts Column II Total Sodium in Grams per 100 Grams of Food

0.10

0.25

PART B Foods DIVISION 25

Section B.25.062

Column I Food 3 Junior Vegetables, Junior Soups ... 4 Strained Desserts ... 5 Strained Meats, Strained Meat Dinners, Strained Dinners, Strained Breakfasts ... 6 Strained Vegetables, Strained Soups ... Column II Total Sodium in Grams per 100 Grams of Food

0.20

0.05

0.15

0.10

SOR/78-637, s. 10; SOR/93-393, s. 1. TABLE II Column I B.1 F.1 N.1 P.1 R.1 T.1 T.2

V

1

V

2

V

3

V

4

V

5

V

6

C

1

C

2

C

3

L

1

L

2

M

1

M

2 P.2 P.3 Vitamin or Mineral nutrient Biotin Folic acid Niacin d-Pantothenic acid Riboflavin Thiamine Alpha-tocopherol Vitamin A Vitamin B6 Vitamin B12 Vitamin C Vitamin D Vitamin K1 Calcium Chloride Copper Iodine Iron Magnesium Manganese Phosphorous Potassium Column II Minimum amount per 100 available kilocalories 2 µg 4 µg 250 µg 300 µg 60 µg 40 µg

0.6 I.U.

250 I.U. 35 µg

0.15 µg

8 mg 40 I.U. 8 µg 50 mg 55 mg 60 µg 5 µg

0.15 mg

6 mg 5 µg 25 mg 80 mg Column III Maximum amount per 100 available kilocalories — — — — — — — 500 I.U. — — — 80 I.U. — — 150 mg — — — — — — 200 mg Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 25

Règles additionnelles

Article B.25.062

Colonne I Aliments 2 Viandes pour enfants en bas âge, repas de viande pour enfants en bas âge, repas pour enfants en bas âge, petits déjeuners pour enfants en bas âge ... 3 Légumes pour enfants en bas âge, soupes pour enfants en bas âge ... 4 Desserts en purée ... 5 Viandes en purée, repas de viande en purée, repas en purée, petits déjeuners en purée ... 6 Légumes en purée, soupes tamisées ... Colonne II Sodium total en grammes par 100 g de l’aliment 0,25 0,20 0,05 0,15 0,10 DORS/78-637, art. 10; DORS/93-393, art. 1. TABLEAU II Colonne I

Article

B.1 F.1 N.1 P.1 R.1 T.1 T.2

V

1

V

2

V

3

V

4

V

5

V

6

C

1

C

2

C

3

L

1

L

2

M

1

M

2 P.2 P.3 Vitamine ou minéral nutritif Biotine Acide folique Niacine Acide d-pantothénique Riboflavine Thiamine Alpha-tocophérol Vitamine A Vitamine B6 Vitamine B12 Vitamine C Vitamine D Vitamine K1 Calcium Chlorure Cuivre Iode Fer Magnésium Manganèse Phosphore Potassium Colonne II Quantité minimale par 100 kilocalories utilisables 2 µg 4 µg 250 µg 300 µg 60 µg 40 µg 0,6 I.U. 250 I.U. 35 µg 0,15 µg 8 mg 40 I.U. 8 µg 50 mg 55 mg 60 µg 5 µg 0,15 mg 6 mg 5 µg 25 mg 80 mg Colonne III Quantité maximale par 100 kilocalories utilisables — — — — — — — 500 I.U. — — — 80 I.U. — — 150 mg — — — — — — 200 mg PART B Foods DIVISION 26 Sections B.26.001-B.26.003 Column I | Column II | Column III Vitamin or | Minimum | Maximum Mineral nutrient | amount per | amount per | 100 available | 100 available | kilocalories | kilocalories S.1 Sodium 20 mg 60 mg Z.1 Zinc 0.5 mg — SOR/83-933, s. 1; SOR/98-458, s. 7(F); SOR/2022-197, s. 7. DIVISION 26 Food Irradiation Interpretation [SOR/2017-16, s. 2(F)] SOR/89-175, s. 3; SOR/2017-16, s. 3. Application SOR/89-175, s. 3. SOR/89-175, s. 3; SOR/2017-16, s. 4. Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 26

Règles additionnelles

Articles B.26.001-B.26.003

Colonne I | Colonne II | Colonne III Vitamine ou | Quantité | Quantité minéral nutritif | minimale par | maximale par | 100 kilocalories | 100 kilocalories | utilisables | utilisables

Article

S.1 Sodium 20 mg 60 mg Z.1 Zinc 0,5 mg — DORS/83-933, art. 1; DORS/98-458, art. 7(F); DORS/2022-197, art. 7.

TITRE 26

Irradiation des aliments Interprétation [DORS/2017-16, art. 2(F)] B.26.001 Au présent titre, irradiation s’entend du traitement au moyen d’un rayonnement ionisant. DORS/89-175, art. 3; DORS/2017-16, art. 3. Application B.26.002 Le présent titre ne s’applique pas aux aliments exposés à un rayonnement ionisant émis par un instrument de mesure utilisé pour déterminer le poids, évaluer la quantité de solides en vrac ou mesurer la teneur en solides d’un liquide, ou à d’autres fins d’inspection. DORS/89-175, art. 3. Dispositions générales B.26.003 (1) Sous réserve du paragraphe (2), il est interdit de vendre un aliment qui a été irradié.

(2)

Il est permis de vendre un aliment qui a été irradié et qui est visé à la colonne I du tableau du présent titre si les exigences ci-après sont remplies : a) le rayonnement ionisant est d’un type et d’une source mentionnés à la colonne 2 et a été fait pour atteindre le but prévu à la colonne 3; b) le rayonnement ionisant absorbé par l’aliment est conforme aux doses prévues aux colonnes 4 et 5 ou, dans les cas où la colonne 4 ne prévoit aucune dose absorbée minimale, n’excède pas la dose absorbée maximale prévue à la colonne 5. DORS/89-175, art. 3; DORS/2017-16, art. 4. Records (e) the type and source of the ionizing radiation; Changes to the Table tout autre traitement qui y est combiné sur la qualité nutritive de l’aliment, cru et prêt à servir; (e) les données établissant que les caractéristiques chimiques, physiques ou microbiologiques de l’aliment irradié n’ont pas été modifiées de façon à le rendre impropre à la consommation humaine; (f) si le ministre le demande, les données établissant que l’irradiation proposée est sans danger dans les conditions envisagées; (g) les conditions recommandées pour l’emmagasinage et l’expédition de l’aliment irradié, notamment la durée, la température ainsi que l’emballage, et une comparaison avec les conditions recommandées pour le même aliment non irradié; (h) le détail de tout autre traitement que l’aliment doit subir avant ou après l’irradiation proposée; (i) toute autre donnée exigée par le ministre qui établit que le consommateur ou l’acheteur de l’aliment irradié n’est pas déçu ou trompé quant à la nature, la valeur, la composition, les avantages et la sûreté de l’aliment irradié. TABLE | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | |----------|----------|----------|----------|----------| | Item | Food | Type and Source of Ionizing Radiation | Purpose of Irradiation | Minimum Absorbed Dose (kGy) | Maximum Absorbed Dose (kGy) | |----------|----------|----------|----------|----------| | 3 | Wheat, flour, whole wheat flour (Triticum spp.) | Gamma radiation from cobalt-60 | To control insect infestation in stored food | - | 0.75 | | | | (2) Gamma radiation from cesium-137 | (2) To reduce microbial load | (2) 10.0 (total overall average dose) | Column 1 Column 2 Column 3 Column 4 Column 5 Item Food Purpose of Irradiation Minimum Absorbed Dose (kGy) Maximum Absorbed Dose (kGy) 6

(1)

Gamma radiation from cobalt-60

(1)

1.5

(1)

7.0

(2)

Gamma radiation from cesium-137

(2)

1.5

(2)

7.0

(3)

1.5

(3)

7.0 (a) 1.5 (a) 7.0 (b) 1.5 (b) 7.0 TABLEAU Colonne 1 Colonne 2 Colonne 3 Colonne 4 Colonne 5

Article

Aliment Type et source de rayonnement ionisant But de l’irradiation Dose absorbée minimale (kGy) Dose absorbée maximale (kGy) 1 Pommes de terre (Solanum tuberosum L.) Rayons gamma provenant du cobalt 60 Inhibition de la germination durant l’entreposage 0,15 2 Oignons (Allium cepa) Rayons gamma provenant du cobalt 60 Inhibition de la germination durant l’entreposage 0,15 3 Blé, farine, farine de blé entier (Triticum spp.) Rayons gamma provenant du cobalt 60 Prévention de l’infestation par des insectes dans l’aliment entreposé 0,75 PART B Foods DIVISION 26 Food Irradiation Changes to the Table

Section B.26.005

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 26 Irradiation des aliments

Modification du tableau

Article B.26.005

Colonne 1

Article

4 5 6 Colonne 2 Aliment Épices entières ou moulues et assaisonnements déshydratés Bœuf haché cru frais Bœuf haché cru congelé Colonne 3 Type et source de rayonnement ionisant

(1)

Rayons gamma provenant du cobalt 60

(2)

Rayons gamma provenant du césium 137

(3)

Électrons provenant d’un appareil radiogène fonctionnant à au plus 3 MeV

(1)

Rayons gamma provenant du cobalt 60

(2)

Rayons gamma provenant du césium 137

(3)

Électrons provenant d’un appareil radiogène fonctionnant à au plus 10 MeV

(4)

Rayons X provenant d’un appareil radiogène fonctionnant à au plus : a) 7,5 MeV, lorsque la matière cible est du tantale ou de l’or; b) 5 MeV, dans les autres cas.

(1)

Rayons gamma provenant du cobalt 60

(2)

Rayons gamma provenant du césium 137

(3)

Électrons provenant d’un appareil radiogène fonctionnant à au plus 10 MeV

(4)

Rayons X provenant d’un appareil radiogène fonctionnant à au plus : a) 7,5 MeV, lorsque la matière cible est du tantale ou de l’or; b) 5 MeV, dans les autres cas. Colonne 4 But de l’irradiation

(1)

Réduction de la charge microbienne

(2)

Réduction de la charge microbienne

(3)

Réduction de la charge microbienne

(1)

Réduction de la charge microbienne, y compris les agents pathogènes

(2)

Réduction de la charge microbienne, y compris les agents pathogènes

(3)

Réduction de la charge microbienne, y compris les agents pathogènes a) Réduction de la charge microbienne, y compris les agents pathogènes b) Réduction de la charge microbienne, y compris les agents pathogènes

(1)

Réduction de la charge microbienne, y compris les agents pathogènes

(2)

Réduction de la charge microbienne, y compris les agents pathogènes

(3)

Réduction de la charge microbienne, y compris les agents pathogènes a) Réduction de la charge microbienne, y compris les agents pathogènes b) Réduction de la charge microbienne, y compris les agents pathogènes Colonne 5 Dose absorbée minimale (kGy)

(1)

10,0

(2)

10,0

(3)

10,0

(1)

1,0

(2)

1,0

(3)

1,0 a) 1,0 b) 1,0

(1)

1,5

(2)

1,5

(3)

1,5 a) 1,5 b) 1,5 Colonne 6 Dose absorbée maximale (kGy)

(1)

10,0 (dose globale moyenne totale)

(2)

10,0 (dose globale moyenne totale)

(3)

10,0 (dose globale moyenne totale)

(1)

4,5

(2)

4,5

(3)

4,5 a) 4,5 b) 4,5

(1)

7,0

(2)

7,0

(3)

7,0 a) 7,0 b) 7,0 PART B Foods DIVISION 27 Food Irradiation Changes to the Table Sections B.26.005-B.27.002 DIVISION 27 water activity means the ratio of the water vapour pressure of a food to the water vapour pressure of pure water, at the same temperature and pressure. (activité de l’eau) SOR/89-309, s. 1. Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 27 Irradiation des aliments

Modification du tableau

Articles B.26.005-B.27.002

TITRE 27

Aliments peu acides emballés dans des récipients hermétiquement fermés B.27.001 Les définitions qui suivent s’appliquent au présent titre. activité de l’eau Rapport de la pression de vapeur d’eau de l’aliment à la pression de vapeur de l’eau pure à la même température et à la même pression. (water activity) aliment peu acide Aliment, à l’exception des boissons alcooliques, dont l’un des constituants a un pH supérieur à 4,6 et une activité de l’eau supérieure à 0,85. (low-acid food) contenant d’expédition Récipient, emballage ou enveloppe dans lequel les contenants d’aliments sont placés pour le transport. (shipping container) récipient hermétiquement fermé Contenant conçu pour protéger son contenu contre les microorganismes, y compris les spores. (hermetically sealed container) réfrigéré Le fait d’être soumis à une température de 4 °C ou moins sans qu’il y ait congélation. (refrigeration) stérilité commerciale État d’un aliment qui a subi un traitement thermique, seul ou en combinaison avec d’autres procédés, pour le rendre exempt de toute forme viable de microorganismes, y compris les spores, susceptibles de se développer dans l’aliment aux températures auxquelles il est destiné à être normalement soumis durant la distribution et l’entreposage. (commercially sterile) DORS/89-309, art. 1. B.27.002 (1) Il est interdit de vendre un aliment peu acide emballé dans un récipient hermétiquement fermé à moins que cet aliment ne soit dans un état de stérilité commerciale.

(2)

Le paragraphe (1) ne s’applique pas aux aliments peu acides emballés dans des récipients hermétiquement fermés lorsque, selon le cas : SOR/89-399, s. 1; SOR/91-149, s. 7; SOR/2018-108, s. 339. SOR/89-399, s. 1. PART B Foods Sections B.27.004-B.28.001 SOR/89-309, s. 1; SOR/2018-69, s. 27. SOR/89-309, s. 1. DIVISION 28 Novel Foods Interpretation genetically modify means to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation. (modifier génétiquement) (c) the microbiological safety, the chemical safety or the safe use of the food. (changement majeur) Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 27 Aliments peu acides emballés dans des récipients hermétiquement fermés

Articles B.27.004-B.28.001

B.27.005 Il est interdit de vendre un aliment peu acide qui est dans un état de stérilité commerciale et qui est emballé dans un récipient hermétiquement fermé, à moins que les conditions suivantes ne soient réunies : a) l’étiquette ou le récipient de l’aliment porte un code ou un numéro de lot qui indique de façon permanente et lisible : (i) l’établissement dans lequel le produit a atteint la stérilité commerciale, (ii) le jour, le mois et l’année où l’aliment a atteint la stérilité commerciale; b) un inspecteur peut obtenir à l’établissement, ou de l’importateur s’il s’agit d’un aliment importé, la signification exacte de chaque élément du code ou du numéro de lot mentionné à l’alinéa a). DORS/89-309, art. 1.

TITRE 28

Aliments nouveaux Définitions B.28.001 Les définitions qui suivent s’appliquent au présent titre. aliment nouveau L’une des substances ou l’un des aliments ci-après, autre qu’un ingrédient supplémentaire ou un aliment supplémenté : a) substance, y compris un micro-organisme, qui ne présente pas d’antécédents d’innocuité comme aliment; b) aliment qui a été fabriqué, préparé, conservé ou emballé au moyen d’un procédé qui : (i) n’a pas été appliqué auparavant à l’aliment, (ii) fait subir à l’aliment un changement majeur; c) aliment dérivé d’une plante, d’un animal ou d’un micro-organisme qui, ayant été modifié génétiquement, selon le cas : (i) présente des caractères qui n’avaient pas été observés auparavant, SOR/93-392, s. 1; SOR/2022-169, s. 20. (ii) ne présente plus des caractères qui avaient été observés auparavant, (iii) présente un ou plusieurs caractères qui ne se trouvent plus dans les limites prévues pour ce végétal, cet animal ou ce micro-organisme. (novel food) changement majeur Changement apporté à un aliment à la suite duquel, selon l’expérience du fabricant ou la théorie généralement admise dans les domaines des sciences de la nutrition et de l’alimentation, les propriétés de celui-ci se situent en dehors des variations naturelles acceptables de l’aliment en ce qui a trait à l’un ou l’autre des éléments suivants : a) la composition, la structure, la qualité nutritive ou les effets physiologiques généralement reconnus de l’aliment; b) la manière dont l’aliment est métabolisé par le corps humain; c) l’innocuité générale, microbiologique ou chimique de l’aliment. (major change) modifier génétiquement Modifier intentionnellement les caractères héréditaires d’un végétal, d’un animal ou d’un micro-organisme. (genetically modify) DORS/93-392, art. 1; DORS/2022-169, art. 20. Avis avant la vente B.28.002 (1) Il est interdit de vendre ou d’annoncer en vue de la vente un aliment nouveau à moins que le fabricant ou l’importateur : a) n’ait donné au ministre un avis écrit de son intention de vendre l’aliment nouveau ou de l’annoncer en vue de la vente; b) n’ait reçu du ministre l’avis visé à l’alinéa B.28.003(1)a) ou au paragraphe B.28.003(2), selon le cas.

(2)

L’avis visé à l’alinéa (1)a) est signé par le fabricant ou l’importateur, ou une personne autorisée à signer en son nom, et contient les renseignements suivants : a) le nom commun sous lequel l’aliment nouveau sera vendu; b) les nom et adresse du principal établissement du fabricant et, si l’adresse est à l’étranger, les nom et adresse du principal établissement de l’importateur; (d) information respecting the estimated levels of consumption by consumers of the novel food; SOR/89-392, s. 1; SOR/2018-69, s. 27. SOR/89-392, s. 1; SOR/2018-69, s. 27. c) la description de l’aliment nouveau, accompagnée : (i) des renseignements sur son élaboration, (ii) des renseignements détaillés sur son mode de fabrication, de préparation, de conservation, d’emballage et d’entreposage, (iii) de la description du changement majeur, le cas échéant, (iv) des renseignements sur son utilisation proposée et son mode de préparation, (v) le cas échéant, des renseignements sur l’historique de son utilisation comme aliment dans un pays autre que le Canada, (vi) de renseignements permettant d’établir son innocuité; d) des renseignements sur les niveaux de consommation estimatifs chez les consommateurs de l’aliment nouveau; e) le texte des étiquettes qui seront utilisées avec l’aliment nouveau; f) les nom et titre du signataire de l’avis et la date de la signature. DORS/89-392, art. 1; DORS/2018-69, art. 27. B.28.003 (1) Dans les quarante-cinq jours suivant la réception de l’avis visé à l’alinéa B.28.002(1)a), le ministre examine les renseignements contenus dans l’avis et : a) si les renseignements établissent l’innocuité de l’aliment nouveau, il avise par écrit le fabricant ou l’importateur que ces renseignements sont suffisants; b) si d’autres renseignements sont nécessaires sur le plan scientifique afin d’évaluer l’innocuité de l’aliment nouveau, il demande par écrit au fabricant ou à l’importateur de les lui fournir.

(2)

Dans les quatre-vingt-dix jours suivant la réception des renseignements additionnels visés à l’alinéa (1)b), le ministre les évalue et, s’ils établissent l’innocuité de l’aliment nouveau, il avise par écrit le fabricant ou l’importateur que ces renseignements sont suffisants. DORS/89-392, art. 1; DORS/2018-69, art. 27. DIVISION 29 Interpretation Directory of Supplemented Food Caution Identifier Specifications means the document entitled Directory of Supplemented Food Caution Identifier Specifications, published by the Government of Canada on its website, as amended from time to time. (Répertoire des spécifications sur l’identifiant des aliments supplémentés avec mise en garde) (b) niacin, if it is a supplemental ingredient. SOR/2022-169, s. 21. Nutrition Labelling Core Information (b) the energy value; (d) the amount of carbohydrate; (e) the amount of protein; (h) the amount of any supplemental ingredient; (l) the % Daily Value interpretative statement; and (m) the “Supplemented with” interpretative statement. (b) the energy value; (d) the amount of carbohydrate; (e) the amount of protein; (h) the amount of any supplemental ingredient; i) la teneur en toute vitamine ou tout minéral nutritif déclaré comme constituant d’un ingrédient — autre que la farine — de l’aliment supplémenté; j) la teneur en tout élément nutritif visé à la colonne 1 de l’un ou l’autre des articles 4, 5, 7, 8, 10, 11 et 13 à 15 du tableau du présent article qui ne peut être exprimée par « 0 » au tableau des renseignements sur les aliments supplémentés; k) la mention « Source négligeable de (désignation de tout élément nutritif omis du tableau des renseignements sur les aliments supplémentés conformément au présent paragraphe) » ou, si l’aliment supplémenté remplit la condition prévue au paragraphe B.29.010(3), la mention « Source négligeable d’autres éléments nutritifs »; l) l’énoncé interprétatif du % de la valeur quotidienne; m) l’énoncé interprétatif du sous-titre « Supplémenté en ».

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Le tableau des renseignements sur les aliments supplémentés d’un aliment supplémenté qui est un produit préemballé à une portion individuelle ne comprend que les renseignements suivants : a) la portion indiquée; b) la valeur énergétique; c) la teneur en lipides; d) la teneur en glucides; e) la teneur en protéines; f) la teneur en tout élément nutritif qui fait l’objet d’une déclaration sur l’étiquette de l’aliment supplémenté ou encore dans l’annonce faite par le fabricant de l’aliment ou sous ses ordres, si la déclaration indique expressément ou implicitement que l’aliment a des propriétés particulières liées à la nutrition ou à la santé, notamment une allégation figurant à la colonne 4 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive, à la colonne 1 du tableau suivant l’article B.01.603 ou aux articles B.01.311, D.01.006 ou D.02.004; g) la teneur en tout polyalcool ajouté; h) la teneur en tout ingrédient supplémentaire; i) les teneurs en acides gras saturés et en acides gras trans, ainsi que la somme des acides gras saturés et des acides gras trans, si l’une de ces teneurs ou cette PART B Foods DIVISION 2.1 Supplemented Foods Nutrition Labelling

Section B.29.002

(k) the % Daily Value interpretative statement; and (l) the “Supplemented with” interpretative statement.

(7)

If the supplemented food facts table on the label of a supplemented food corresponds to Figure 6.5(B), 6.6(B), 6.5.1(B), 6.6.1(B), 7.3(B), 7.4(B), 7.3.1(B), 7.4.1(B), 17.2(E) and (F) or 17.2.1(E) and (F) of the Directory of SFFT Formats, the supplemented food facts table is not required to show the % Daily Value interpretative statement or the “Supplemented with” interpretative statement. TABLE Core Information Column 1 Item Information Column 2 Description Column 3 Unit Column 4 Manner of expression (i) per package, and (ii) in grams or millilitres, in accordance with subparagraph B.01.002A(2)(a)(i) or (ii); and 2 Energy value “Calories”, “Total Calories” or “Calories, Total” (ii) in all other cases, to the nearest multiple of 1 Calorie; “Fat”, “Total Fat” or “Fat, Total” PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.002

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (ii) in all other cases, to the nearest multiple of 0.1 g; (ii) in all other cases, to the nearest multiple of 0.1 g; PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.002

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (b) if it is 0.5 g or more, to the nearest multiple of 1 g. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.002

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (d) if it is 250 mg or more, to the nearest multiple of 50 mg. (d) if it is 250 mg or more, to the nearest multiple of 50 mg. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.002

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression TABLEAU Renseignements principaux Colonne 1 | Colonne 2 | Colonne 3 | Colonne 4

Article | Renseignements | Nomenclature | Unité | Règles d'écriture

1 | Portion indiquée | « Portion (portion indiquée) », « pour (portion indiquée) » ou « par (portion indiquée) » | La portion est exprimée : a) s’agissant d’un aliment supplémenté qui est un produit préemballé à portion individuelle : (i) par emballage, (ii) en grammes ou en millilitres tel qu’il est prévu | (1) La portion exprimée en unité métrique est arrondie : a) lorsqu’elle est inférieure à 10 g ou 10 ml : au plus proche multiple de 0,1 g ou 0,1 ml; b) lorsqu’elle est égale ou supérieure à 10 g ou 10 ml : au plus proche multiple de 1 g ou 1 ml.

(2)

La portion exprimée en fraction est représentée par un numérateur et un dénominateur séparés d’une barre. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.002

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.002

Colonne 1

Article

Colonne 2 Renseignements Colonne 3 Nomenclature Unité Colonne 4 Règles d’écriture aux sous-alinéas B.01.002A(2)a)(ii) et (iii); b) s’agissant d’un aliment supplémenté qui est un produit préemballé à portions multiples, selon les unités ci-après indiquées à la colonne 3B du Tableau des quantités de référence : (i) la mesure domestique applicable à l’aliment, (ii) la mesure métrique applicable à l’aliment.

(3)

La portion comprend le terme « assortis » lorsque le tableau des renseignements sur les aliments supplémentés d’un produit préemballé contient un assortiment d’aliments supplémentés indiqués en regroupements qui correspondent à une valeur composée. 2 Valeur énergétique « Calories » ou « Calories totales » La valeur est exprimée en Calories par portion indiquée. La valeur est arrondie : a) lorsqu’elle est inférieure à 5 Calories : (i) si l’aliment supplémenté répond aux critères mentionnés à la colonne 2 de l’article 1 du Tableau des mentions et allégations autorisées concernant la teneur en nutriments du sujet « sans teneur en énergie » ou au sujet des renseignements sur les aliments supplémentés exprimés en g ou à un tableau des renseignements sur les aliments supplémentés d’un aliment supplémenté visé au sous-alinéa B.29.002A(2)a)(i), au plus proche multiple de 1 Calorie; (ii) dans les autres cas : au plus proche multiple de 5 Calories; b) lorsqu’elle est égale ou supérieure à 5 Calories sans dépasser 50 Calories : au plus proche multiple de 5 Calories; c) lorsqu’elle est supérieure à 50 Calories : au plus proche multiple de 10 Calories. 3 Teneur en lipides « Lipides » ou « Total des lipides » La teneur est exprimée : a) en grammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : (i) si l’aliment supplémenté répond aux critères mentionnés à la colonne 2 de l’article 11 du Tableau des mentions et allégations autorisées concernant la teneur en nutriments du sujet « sans teneur en lipides » ou au sujet des renseignements sur les aliments supplémentés exprimés en g ou à un tableau des renseignements sur les aliments supplémentés d’un aliment supplémenté visé au sous-alinéa B.29.002A(2)a)(i), au plus proche multiple de 0 g; (ii) dans les autres cas : au plus proche multiple de 0,1 g; b) lorsqu’elle est égale ou supérieure à 0,5 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g.

(2)

Le pourcentage est arrondi : a) lorsque la valeur calculée est inférieure à 0,5 % : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 4 Teneur en acides gras saturés « Acides gras saturés », « Lipides » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.002

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.002

Colonne 1

Article

Renseignemen ts Colonne 2 Nomenclature Colonne 3 Unité Colonne 4 Règles d'écriture saturés » ou « saturés » (i) si l’aliment supplémenté répond aux critères mentionnés à la colonne 2 de l’article 18 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « sans acides gras saturés » visé à la colonne 1 : à 0 g; (ii) dans les autres cas : au plus proche multiple de 0,1 g; b) lorsque celle-ci est égale ou supérieure à 0,5 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. 5 Teneur en acides gras trans « Acides gras trans », « Lipides trans » ou « trans » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : (i) si l’aliment supplémenté répond aux critères mentionnés à la colonne 2 de l’article 22 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « sans acides gras trans » visé à la colonne 1 : à 0 g; (ii) dans les autres cas : au plus proche multiple de 0,1 g; b) lorsque celle-ci est égale ou supérieure à 0,5 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. 6 Somme des acides gras saturés et des acides gras trans « Acides gras saturés + acides gras trans », « Lipides saturés + lipides trans » ou « saturés + trans » La somme est exprimée en pourcentage de la valeur quotidienne par portion indiquée. Le pourcentage est arrondi : a) lorsque les teneurs en acides gras saturés et en acides gras trans déclarées sont < 0,9 % : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 7 Teneur en cholestérol « Cholestérol » La teneur : a) est exprimée en milligrammes par portion indiquée; b) peut aussi être exprimée en pourcentage de la valeur quotidienne par portion indiquée. 1) La teneur est arrondie : a) si l’aliment supplémenté répond aux critères mentionnés à la colonne 2 de l’article 27 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « sans cholestérol » visé à la colonne 1 : à 0 mg; b) dans les autres cas : au plus proche multiple de 5 mg. 2) Le pourcentage est arrondi : a) lorsque la teneur déclarée est < 0,9 % : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 8 Teneur en sodium « Sodium » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. 1) La teneur est arrondie : a) lorsqu’elle est inférieure à 5 mg : (i) si l’aliment supplémenté répond aux critères mentionnés à la colonne 2 de l’article 30 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « sans sodium » visé à la colonne 1 : à 0 mg; (ii) dans les autres cas : au plus proche multiple de 1 mg; b) lorsqu’elle est égale ou supérieure à 5 mg : au plus proche multiple de 5 mg. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.002

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.002

Colonne 1

Article

Colonne 2 Renseignemen ts Colonne 3 Nomenclature Colonne 4 Unité Règles d’écriture 9 Teneur en glucides « Glucides » ou « Total des glucides » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. 10 Teneur en fibres « Fibres » ou « Fibres alimentaires » La teneur est exprimée : a) en grammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 11 Teneur en sucres « Sucres » La teneur est exprimée : a) en grammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 12 Teneur en protéines « Protéines » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. 13 Teneur en potassium « Potassium » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 5 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 5 mg mais moins de 25 mg : au plus proche multiple de 5 mg; c) lorsqu’elle est égale ou supérieure à 25 mg mais moins de 250 mg : au plus proche multiple de 25 mg; d) lorsqu’elle est égale ou supérieure à 250 mg : au plus proche multiple de 50 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. Colonne 1

Article

14 Renseignements Teneur en calcium Colonne 2 Nomenclature « Calcium » Colonne 3 Unité La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. Colonne 4 Règles d'écriture b) dans les autres cas : au plus proche multiple de 1 %.

(1)

La teneur est arrondie : a) lorsqu'elle est inférieure à 5 mg : à 0 mg; b) lorsqu'elle est égale ou supérieure à 5 mg mais moins de 50 mg : au plus proche multiple de 5 mg; c) lorsqu'elle est égale ou supérieure à 50 mg mais moins de 250 mg : au plus proche multiple de 25 mg; d) lorsqu'elle est égale ou supérieure à 250 mg : au plus proche multiple de 50 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. Colonne 1

Article

15 Renseignements Teneur en fer Colonne 2 Nomenclature « Fer » Colonne 3 Unité La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. Colonne 4 Règles d'écriture

(1)

La teneur est arrondie : a) lorsqu'elle est inférieure à 0,05 mg : à 0 mg; b) lorsqu'elle est égale ou supérieure à 0,05 mg mais moins de 0,5 mg : au plus proche multiple de 0,05 mg; c) lorsqu'elle est égale ou supérieure à 0,5 mg mais moins de 2,5 mg : au plus proche multiple de 0,25 mg; d) lorsqu'elle est égale ou supérieure à 2,5 mg : au plus proche multiple de 0,5 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. Colonne 1

Article

16 Renseignements Énoncé interprétatif du % de la valeur quotidienne Colonne 2 Nomenclature « % 5 % ou moins c'est peu, 15 % ou plus c'est beaucoup » Colonne 3 Unité [non-applicable] Colonne 4 Règles d'écriture Le sous-titre « % valeur quotidienne » ou « % VQ » est suivi d'un astérisque qui signale l'énoncé interprétatif du % de la valeur quotidienne figurant dans le tableau des renseignements sur les aliments supplémentés. Colonne 1

Article

17 Renseignements Énoncé interprétatif du sous-titre « Supplément en » Colonne 2 Nomenclature « † Comprend les quantités naturelles et supplémentées » Colonne 3 Unité [non-applicable] Colonne 4 Règles d'écriture Le sous-titre « Supplément en » est suivi d'une croix qui signale l'énoncé interprétatif du sous-titre « Supplément en » figurant dans le tableau des renseignements sur les aliments supplémentés. Colonne 1

Article

18 Renseignements Teneur en ingrédient supplémentaire Colonne 2 Nomenclature La nomenclature de l'ingrédient supplémentaire est décrite conformément à la colonne 1 de la Liste des ingrédients supplémentaires autorisés. Colonne 3 Unité La teneur est exprimée : a) selon l'unité applicable prévue à la colonne 3 de la Liste des ingrédients supplémentaires autorisés par portion indiquée; b) s'il s'agit d'un élément nutritif ayant une valeur quotidienne, en pourcentage de la valeur quotidienne par portion indiquée. Colonne 4 Règles d'écriture

(1)

La teneur est arrondie au nombre entier le plus près et est exprimée de la manière visée à la colonne 3 et, le cas échéant, à la colonne 5 de la Liste des ingrédients supplémentaires autorisés.

(2)

Sauf selon une prévision de la colonne 5 de la Liste des ingrédients supplémentaires autorisés : a) lorsque la teneur déclarée est « 0 » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. TABLE | Column 1 | Column 2 | Column 3 | Column 4 | |----------|----------|----------|----------| | Item | Information | Description | Unit | Manner of expression | | 1 | Servings per package | "Servings per Container", "(number of units) per Container", "Servings per Package", "(number of units per Package", "Servings per (naming the package type)", or "(number of units) per (naming the package type)" | The quantity is expressed in number of servings. | (1) The quantity is rounded off | 2 | Energy value | "kilojoules" or "kJ" | The value is expressed in kilojoules per serving of stated size. | The value is rounded off to the nearest multiple of 10 kilojoules. | Column 1 Item 4 5 6 7 8 Column 2 Information Amount of omega-6 polyunsaturated fatty acids Amount of omega-3 polyunsaturated fatty acids Amount of monounsaturated fatty acids Amount of soluble fibre Amount of insoluble fibre Column 3 Description “Omega-6”, “Omega-6 Polyunsaturated Fat”, “Omega-6 Polyunsaturated Fatty Acids”, “Omega-6 Polyunsaturates” or “Omega-6 Polyunsaturated”

(2)

In all other cases: “Omega-6 Polyunsaturated Fat”, “Omega-6 Polyunsaturated Fatty Acids”, “Omega-6 Polyunsaturates” or “Omega-6 Polyunsaturated” “Omega-3”, “Omega-3 Polyunsaturated Fat”, “Omega-3 Polyunsaturated Fatty Acids”, “Omega-3 Polyunsaturates” or “Omega-3 Polyunsaturated”

(2)

In all other cases: “Omega-3 Polyunsaturated Fat”, “Omega-3 Polyunsaturated Fatty Acids”, “Omega-3 Polyunsaturates” or “Omega-3 Polyunsaturated” “Monounsaturated Fat”, “Monounsaturated Fatty Acids”, “Monounsaturates” or “Monounsaturated” “Soluble Fibre” or “Soluble Fiber” “Insoluble Fibre” or “Insoluble Fiber” Column 4 Unit Column 5 Manner of expression (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (b) if it is 0.5 g or more, to the nearest multiple of 1 g. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.003

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (d) if it is 250 µg or more, to the nearest multiple of 100 µg. (d) if it is 5 mg or more, to the nearest multiple of 1 mg. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Column 1 Item 14 15 16 Column 2 Information Amount of vitamin E Amount of thiamine Column 3 Description "Vitamin E" or "Vit E" "Vitamin K" or "Vit K" "Thiamine", "Thiamin", "Thiamine (Vitamin B1)", "Thiamine (Vit B1)", "Thiamin (Vitamin B1)" or "Thiamin (Vit B1)" Column 4 Unit Manner of expression (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 mg. (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 mg. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Column 1 Item 20 21 22 Column 2 Information Column 3 Description “Folate” “Vitamin B12” or “Vit B12” “Biotin” Column 4 Unit Column 4 Manner of expression (d) if it is 50 µg DFE or more, to the nearest multiple of 10 µg DFE. (d) if it is 0.25 µg or more, to the nearest multiple of 0.05 µg. (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (d) if it is 0.5 mg or more, to the nearest multiple of 0.1 mg. (d) if it is 50 mg or more, to the nearest multiple of 10 mg. (d) if it is 250 mg or more, to the nearest multiple of 50 mg. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (d) if it is 50 µg or more, to the nearest multiple of 10 µg. (d) if it is 50 mg or more, to the nearest multiple of 10 mg. (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Column 1 | Column 2 | Column 3 | Column 4 Item | Information | Description | Unit | Manner of expression (d) if it is 0.05 mg or more, to the nearest multiple of 0.01 mg. (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 mg. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Column 1 Item 33 34 Column 2 Information Amount of molybdenum Column 3 Description "Molybdenum" "Chloride" Column 4 Unit Manner of expression (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. (d) if it is 250 mg or more, to the nearest multiple of 50 mg. TABLEAU Renseignements complémentaires Colonne 1

Article

1 Colonne 2 Renseignements Portions par emballage Colonne 3 Nomenclature « Portions par contenant », « (nombre d’unités) par contenant », « Portions par emballage », « (nombre d’unités) par emballage », « portions par (type Colonne 4 Unité La quantité est exprimée en nombre de portions. Règles d’écriture

(1)

La quantité est arrondie : a) lorsqu’elle est inférieure à 2, au plus proche multiple de 1; b) lorsqu’elle est égale ou supérieure à 2 sans dépasser 5, au plus proche multiple de 0,5. PART B Foods DIVISION 24 Supplemented Foods Nutrition Labelling

Section B.29.003

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 24 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.003

Colonne 1

Article

Colonne 2 Renseignements Nomenclature Colonne 3 Unité Colonne 4 Règles d’écriture « (d’emballage) » ou « (nombre d’unités) par (type d’emballage) » 2 Valeur énergétique « kilojoules » ou « kJ » La valeur est exprimée en kilojoules par portion indiquée. La valeur est arrondie au plus proche multiple de 10 kilojoules. 3 Teneur en acides gras polyinsaturés « Acides gras polyinsaturés », « Lipides polyinsaturés » ou « polyinsaturés » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 1 g : au plus proche multiple de 0,1 g ; b) lorsqu’elle est égale ou supérieure à 1 g sans dépasser 5 g : au plus proche multiple de 0,5 g ; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. 4 Teneur en acides gras polyinsaturés oméga-6

(1)

Si le tableau des renseignements sur les aliments supplémentés indique la teneur en acides gras polyinsaturés oméga-6 : « Acides gras polyinsaturés oméga-6 », « Lipides polyinsaturés oméga-6 » ou « polyinsaturés oméga-6 »

(2)

Dans les autres cas : « Acides gras polyinsaturés oméga-6 », « Lipides polyinsaturés oméga-6 » ou « polyinsaturés oméga-6 » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 1 g : au plus proche multiple de 0,1 g ; b) lorsqu’elle est égale ou supérieure à 1 g sans dépasser 5 g : au plus proche multiple de 0,5 g ; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. 5 Teneur en acides gras polyinsaturés oméga-3

(1)

Si le tableau des renseignements sur les aliments supplémentés indique la teneur en acides gras polyinsaturés oméga-3 : « Acides gras polyinsaturés oméga-3 », « Lipides polyinsaturés oméga-3 » ou « polyinsaturés oméga-3 »

(2)

Dans les autres cas : « Acides gras polyinsaturés oméga-3 », « Lipides polyinsaturés oméga-3 » ou « polyinsaturés oméga-3 » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 1 g : au plus proche multiple de 0,1 g ; b) lorsqu’elle est égale ou supérieure à 1 g sans dépasser 5 g : au plus proche multiple de 0,5 g ; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. 6 Teneur en acides gras monoinsaturés « Acides gras monoinsaturés », « Lipides monoinsaturés » ou « monoinsaturés » La teneur est exprimée en grammes par portion indiquée. La teneur est arrondie : a) lorsqu’elle est inférieure à 1 g : au plus proche multiple de 0,1 g ; b) lorsqu’elle est égale ou supérieure à 1 g, sans dépasser 5 g : au plus proche multiple de 0,5 g ; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. PART B Foods DIVISION 24 Supplemented Foods Nutrition Labelling

Section B.29.003

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 24 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.003

Colonne 1 | Colonne 2 | Colonne 3 | Colonne 4

Article | Renseignements | Nomenclature | Unité | Règles d'écriture

7 | Teneur en fibres solubles | « Fibres solubles » | La teneur est exprimée en grammes par portion indiquée. | La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. 8 | Teneur en fibres insolubles | « Fibres insolubles » | La teneur est exprimée en grammes par portion indiquée. | La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. 9 | Teneur en polyalcools | (1) Si l’aliment supplémenté ne contient qu’un polyalcool : « Polyalcool », « Polyol » ou « (Nom du polyalcool) »

(2)

Dans les autres cas : « Polyalcools » ou « Polyols » | La teneur est exprimée en grammes par portion indiquée. | La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. 10 | Teneur en amidon | « Amidon » | La teneur est exprimée en grammes par portion indiquée. | La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. 11 | Teneur en vitamine A | « Vitamine A » ou « Vit A » | La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. | (1) La teneur est arrondie : a) lorsqu’elle est inférieure à 5 µg : à 0 µg; b) lorsqu’elle est égale ou supérieure à 5 µg mais moins de 50 µg : au plus proche multiple de 10 µg; c) lorsqu’elle est égale ou supérieure à 50 µg mais moins de 250 µg : au plus proche multiple de 50 µg; d) lorsqu’elle est égale ou supérieure à 250 µg : au plus proche multiple de 100 µg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est inférieure à 0,5 % : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 12 | Teneur en vitamine C | « Vitamine C » ou « Vit C » | La teneur est exprimée : a) en milligrammes par portion indiquée; | (1) La teneur est arrondie : a) lorsqu’elle est inférieure à 0,1 mg : à 0 mg; PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.003

Colonne 1

Article

Colonne 2 Renseignements Nomenclature Colonne 3 Unité Colonne 4 Règles d’écriture 13 Teneur en vitamine D « Vitamine D » ou « Vit D » La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,1 µg : à 0 µg; b) lorsqu’elle est égale ou supérieure à 0,1 µg mais moins de 1 µg : au plus proche multiple de 0,2 µg; c) lorsqu’elle est égale ou supérieure à 1 µg mais moins de 5 µg : au plus proche multiple de 0,5 µg; d) lorsqu’elle est égale ou supérieure à 5 µg : au plus proche multiple de 1 µg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est < 0 % : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 14 Teneur en vitamine E « Vitamine E » ou « Vit E » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,05 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,05 mg mais moins de 0,5 mg : au plus proche multiple de 0,1 mg; c) lorsqu’elle est égale ou supérieure à 0,5 mg mais moins de 2,5 mg : au plus proche multiple de 0,25 mg; d) lorsqu’elle est égale ou supérieure à 2,5 mg : au plus proche multiple de 0,5 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est < 0 % : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 15 Teneur en vitamine K « Vitamine K » ou « Vit K » La teneur est exprimée :

(1)

La teneur est arrondie : PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.003

Colonne 1

Article

Colonne 2 Renseignements Nomenclature Colonne 3 Unité Colonne 4 Règles d’écriture 16 Teneur en thiamine « Thiamine », « Thiamine (vitamine B1) » ou « Thiamine (vit B1) » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,005 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,005 mg mais moins de 0,05 mg : au plus proche multiple de 0,01 mg; c) lorsqu’elle est égale ou supérieure à 0,05 mg mais moins de 0,25 mg : au plus proche multiple de 0,025 mg; d) lorsqu’elle est égale ou supérieure à 0,25 mg : au plus proche multiple de 0,05 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 17 Teneur en riboflavine « Riboflavine », « Riboflavine (vitamine B2) » ou « Riboflavine (vit B2) » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,005 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,005 mg mais moins de 0,05 mg : au plus proche multiple de 0,01 mg; c) lorsqu’elle est égale ou supérieure à 0,05 mg mais moins de 0,25 mg : au plus proche multiple de 0,025 mg; d) lorsqu’elle est égale ou supérieure à 0,25 mg : au plus proche multiple de 0,05 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.003

Colonne 1 | Colonne 2 | Colonne 3 | Colonne 4

Article | Renseignements | Nomenclature | Unité | Règles d’écriture

18 | Teneur en niacine | « Niacine » | La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. | (1) La teneur est arrondie : a) lorsqu’elle est inférieure à 0,05 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,05 mg mais moins de 0,5 mg : au plus proche multiple de 0,1 mg; c) lorsqu’elle est égale ou supérieure à 0,5 mg mais moins de 2,5 mg : au plus proche multiple de 0,25 mg; d) lorsqu’elle est égale ou supérieure à 2,5 mg : au plus proche multiple de 0,5 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 19 | Teneur en vitamine B6 | « Vitamine B6 » ou « Vit B6 » | La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. | (1) La teneur est arrondie : a) lorsqu’elle est inférieure à 0,005 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,005 mg mais moins de 0,01 mg : au plus proche multiple de 0,01 mg; c) lorsqu’elle est égale ou supérieure à 0,01 mg mais moins de 0,25 mg : au plus proche multiple de 0,025 mg; d) lorsqu’elle est égale ou supérieure à 0,25 mg : au plus proche multiple de 0,05 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 20 | Teneur en folate | « Folate » | La teneur est exprimée : a) en microgrammes d’équivalents de folate alimentaire (ÉFA) par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. | (1) La teneur est arrondie : a) lorsqu’elle est inférieure à 1 µg ÉFA : à 0 µg ÉFA; b) lorsqu’elle est égale ou supérieure à 1 µg ÉFA mais moins de 10 µg ÉFA : au plus proche multiple de 1 µg ÉFA; c) lorsqu’elle est égale ou supérieure à 10 µg ÉFA mais moins de 50 µg ÉFA : au plus proche multiple de 5 µg ÉFA; d) lorsqu’elle est égale ou supérieure à 50 µg ÉFA : au plus proche multiple de 10 µg ÉFA. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.003

Colonne 1

Article

21 22 23 Colonne 2 Renseignements Teneur en vitamine B12 Teneur en biotine Teneur en acide pantothénique Colonne 3 Nomenclature « Vitamine B12 » ou « Vit B12 » « Biotine » « Acide pantothénique » ou « Pantothénate » Colonne 4 Unité La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. Règles d’écriture

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,005 µg à 0 µg; b) lorsqu’elle est égale ou supérieure à 0,005 µg mais moins de 0,05 µg, au plus proche multiple de 0,01 µg; c) lorsqu’elle est égale ou supérieure à 0,05 µg mais moins de 0,25 µg, au plus proche multiple de 0,05 µg; d) lorsqu’elle est égale ou supérieure à 0,25 µg, au plus proche multiple de 0,1 µg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 » µg EFA : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,05 µg à 0 µg; b) lorsqu’elle est égale ou supérieure à 0,05 µg mais moins de 0,5 µg, au plus proche multiple de 0,1 µg; c) lorsqu’elle est égale ou supérieure à 0,5 µg mais moins de 2,5 µg, au plus proche multiple de 0,25 µg; d) lorsqu’elle est égale ou supérieure à 2,5 µg, au plus proche multiple de 0,5 µg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 » µg : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,01 mg à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,01 mg mais moins de 0,1 mg, au plus proche multiple de 0,02 mg; c) lorsqu’elle est égale ou supérieure à 0,1 mg mais moins de PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.003

Colonne 1

Article

Renseignements Colonne 2 Nomenclature Colonne 3 Unité Colonne 4 Règles d’écriture 24 Teneur en choline « Choline » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. 0,5 mg : au plus proche multiple de 0,05 mg; d) lorsqu’elle est égale ou supérieure à 0,5 mg : au plus proche multiple de 0,1 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 25 Teneur en phosphore « Phosphore » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 5 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 5 mg mais moins de 50 mg : au plus proche multiple de 10 mg; c) lorsqu’elle est égale ou supérieure à 50 mg mais moins de 250 mg : au plus proche multiple de 25 mg; d) lorsqu’elle est égale ou supérieure à 250 mg : au plus proche multiple de 50 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 26 Teneur en iode « Iodure » ou « Iode » La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 1 µg : à 0 µg; b) lorsqu’elle est égale ou supérieure à 1 µg mais moins de 10 µg : au plus proche multiple de 2 µg; À jour au 11 novembre 2024 Dernière modification le 17 juin 2024 PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.003

Colonne 1

Article

Colonne 2 Renseignements Colonne 3 Nomenclature Colonne 4 Unité Colonne 4 Règles d'écriture 27 Teneur en magnésium « Magnésium » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 1 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 1 mg mais moins de 10 mg : au plus proche multiple de 1 mg; c) lorsqu’elle est égale ou supérieure à 10 mg mais moins de 50 mg : au plus proche multiple de 5 mg; d) lorsqu’elle est égale ou supérieure à 50 mg : au plus proche multiple de 10 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 28 Teneur en zinc « Zinc » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,05 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,05 mg mais moins de 0,5 mg : au plus proche multiple de 0,1 mg; c) lorsqu’elle est égale ou supérieure à 0,5 mg mais moins de 2,5 mg : au plus proche multiple de 0,25 mg; d) lorsqu’elle est égale ou supérieure à 2,5 mg : au plus proche multiple de 0,5 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 29 Teneur en sélénium « Sélénium » La teneur est exprimée : a) en microgrammes par portion indiquée;

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,1 µg : à 0 µg;

Article

Colonne 1 Renseignements Colonne 2 Nomenclature Colonne 3 Unité Colonne 4 Règles d'écriture 30 Teneur en cuivre « Cuivre » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,0015 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,0015 mg mais moins de 0,005 mg : au plus proche multiple de 0,002 mg; c) lorsqu’elle est égale ou supérieure à 0,005 mg mais moins de 0,025 mg : au plus proche multiple de 0,005 mg; d) lorsqu’elle est égale ou supérieure à 0,025 mg : au plus proche multiple de 0,01 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est < 0 mg : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 31 Teneur en manganèse « Manganèse » La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu’elle est inférieure à 0,005 mg : à 0 mg; b) lorsqu’elle est égale ou supérieure à 0,005 mg mais moins de 0,01 mg : au plus proche multiple de 0,01 mg; c) lorsqu’elle est égale ou supérieure à 0,01 mg mais moins de 0,025 mg : au plus proche multiple de 0,025 mg; d) lorsqu’elle est égale ou supérieure à 0,025 mg : au plus proche multiple de 0,05 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est < 0 mg : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 32 Teneur en chrome « Chrome » La teneur est exprimée :

(1)

La teneur est arrondie : PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.003

Article | Colonne 1 | Colonne 2 | Colonne 3 | Colonne 4

Renseignements | Nomenclature | Unité | Règles d'écriture a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée. a) lorsqu'elle est inférieure à 0,05 µg : à 0 µg; b) lorsqu'elle est égale ou supérieure à 0,05 µg mais moins de 0,5 µg : au plus proche multiple de 0,1 µg; c) lorsqu'elle est égale ou supérieure à 0,5 µg mais moins de 2,5 µg : au plus proche multiple de 0,25 µg; d) lorsqu'elle est égale ou supérieure à 2,5 µg : au plus proche multiple de 0,5 µg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 33 | Teneur en molybdène | « Molybdène » | La teneur est exprimée : a) en microgrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu'elle est inférieure à 0,05 µg : à 0 µg; b) lorsqu'elle est égale ou supérieure à 0,05 µg mais moins de 0,5 µg : au plus proche multiple de 0,1 µg; c) lorsqu'elle est égale ou supérieure à 0,5 µg mais moins de 2,5 µg : au plus proche multiple de 0,25 µg; d) lorsqu'elle est égale ou supérieure à 2,5 µg : au plus proche multiple de 0,5 µg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 µg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. 34 | Teneur en chlorure | « Chlorure » | La teneur est exprimée : a) en milligrammes par portion indiquée; b) en pourcentage de la valeur quotidienne par portion indiquée.

(1)

La teneur est arrondie : a) lorsqu'elle est inférieure à 5 mg : à 0 mg; b) lorsqu'elle est égale ou supérieure à 5 mg mais moins de 50 mg : au plus proche multiple de 5 mg; c) lorsqu'elle est égale ou supérieure à 50 mg mais moins de 250 mg : au plus proche multiple de 25 mg; d) lorsqu'elle est égale ou supérieure à 250 mg : au plus proche multiple de 50 mg.

(2)

Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %.

(3)

The information (ii) information — other than in respect of supplemental ingredients — for vitamins referred to in subsection D.01.002(1) must be expressed in the applicable unit referred to in subsection D.01.003(1) and for mineral nutrients referred to in paragraphs D.02.001(1)(a) to (j), (l) to (n) and (p) must be expressed in milligrams for sodium, potassium, calcium, phosphorus, magnesium, iron, zinc, chloride, copper and manganese and in micrograms for iodide, chromium, selenium and molybdenum, SOR/2022-169, s. 21. Basis of Information sodium, le potassium, le calcium, le phosphore, le magnésium, le fer, le zinc, le chlore, le cuivre et le manganèse et en microgrammes pour l’iode, le chrome, le sélénium et le molybdène, (A) par gramme ou 100 g de l’aliment supplémenté, dans le cas où la quantité nette de l’aliment est mentionnée en poids ou en nombre sur l’étiquette, (B) par millilitre ou 100 mL de l’aliment supplémenté, dans le cas où la quantité nette de l’aliment est mentionnée en volume sur l’étiquette, (iii) les renseignements concernant les autres éléments nutritifs ainsi que la valeur énergétique, figurant à la colonne 1 des tableaux des articles B.29.002 ou B.29.003, sont exprimés au moyen d’une unité visée à la colonne 3 : (A) par gramme ou 100 g de l’aliment supplémenté, dans le cas où la quantité nette de l’aliment est mentionnée en poids ou en nombre sur l’étiquette, (B) par millilitre ou 100 mL de l’aliment supplémenté, dans le cas où la quantité nette de l’aliment est mentionnée en volume sur l’étiquette, (iv) le pourcentage de la valeur quotidienne et les renseignements concernant la portion indiquée peuvent être omis, (v) les renseignements sont indiqués avec un degré de précision qui correspond à la précision des méthodes analytiques utilisées pour produire ces renseignements. DORS/2022-169, art. 21. Objet des renseignements B.29.005 (1) Sous réserve des paragraphes (2) à (5), le tableau des renseignements sur les aliments supplémentés indique les renseignements en fonction de l’aliment supplémenté tel qu’il est vendu.

(2)

Le tableau des renseignements sur les aliments supplémentés du tout produit préemballé contenant un assortiment d’aliments supplémentés d’un même type et dont la portion typique ne comprend qu’un de ces aliments indique les renseignements en fonction : a) de chaque aliment supplémenté dans le produit préemballé, lorsque les renseignements figurant à la colonne 1 du tableau de l’article B.29.002 sont différents pour chaque aliment supplémenté; (v) the information referred to in column 1 of item 18 of the table to section B.29.002, expressed using b) d’un aliment supplémenté dans le produit préemballé, lorsque les renseignements figurant à la colonne 1 du tableau de l’article B.29.002 sont les mêmes pour chaque aliment supplémenté.

(3)

Le tableau des renseignements sur les aliments supplémentés de tout produit préemballé contenant un assortiment d’aliments supplémentés de même type dont la portion typique comprend plus d’un de ces aliments indique les renseignements soit à la valeur de chaque aliment supplémenté, soit à une valeur composée.

(4)

Le tableau des renseignements sur les aliments supplémentés de tout aliment supplémenté à préparer selon des instructions fournies dans ou sur l’emballage, ou qui est normalement combiné avec d’autres ingrédients ou d’autres aliments ou qui avant d’être consommé, peut également indiquer les renseignements en fonction de l’aliment supplémenté une fois préparé, auquel cas a) le tableau indique les renseignements ci-après en fonction de l’aliment supplémenté préparé : (i) sauf dans le cas visé au sous-alinéa (ii), la quantité de l’aliment supplémenté exprimée en utilisant l’unité indiquée à la colonne 3 du sous-alinéa 1b)(i) du tableau de l’article B.29.002, soit « environ (la portion indiquée) » ou « environ (la portion indiquée) préparée », et, s’il y a lieu, aux moyens des règles d’écriture indiquées dans la colonne 4 des paragraphes 1c)(1) et (2), (ii) si l’aliment supplémenté est normalement combiné avec un autre aliment, la quantité de l’autre aliment exprimée en l’unité visée à la colonne 3 du sous-alinéa 1b)(ii) du tableau de l’article B.29.002, (iii) la valeur énergétique, exprimée au moyen de la nomenclature indiquée à la colonne 2 de l’article 2 du tableau de l’article B.29.002, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4, (iv) les renseignements visés à la colonne 1 des articles 3, 6 à 8, 10, 11 et 13 à 15 du tableau de l’article B.29.002 et à la colonne 1 des articles 11 à 34 du tableau de l’article B.29.003 qui sont indiqués en pourcentage de la valeur quotidienne dans le tableau des renseignements sur les aliments supplémentés en fonction de l’aliment supplémenté qu’il est vendu, exprimée au moyen de la nomenclature indiquée dans la colonne 2 de ces tableaux en pourcentage de la valeur quotidienne par portion indiquée et au moyen des règles d’écriture indiquées dans la colonne 4 de ceux-ci, (ii) the information set out in column 1 of items 3 to 10 of the table to section B.29.003, expressed using a description set out in column 2, in grams and in the manner specified in column 4, and (iii) the information set out in column 1 of items 3, 6 to 8, 10, 11 and 13 to 15 of the table to section (v) les renseignements visés à la colonne 1 de l’article 18 du tableau de l’article B.29.002, exprimés au moyen de la nomenclature visée à la colonne 2, de l’unité visée à la colonne 3 et des règles d’écriture visées à la colonne 4; b) le tableau peut également indiquer les renseignements ci-après en fonction des ingrédients ajoutés ou de l’autre aliment, s’ils sont déclarés dans le tableau des renseignements sur les aliments supplémentés de l’aliment supplémenté tel qu’il est vendu : (i) les renseignements visés à la colonne 1 des articles 3 à 5 et 7 à 12 du tableau de l’article B.29.002, exprimés au moyen de la nomenclature indiquée dans la colonne 2, en milligrammes pour ceux visés à la colonne 1 des articles 7 et 8 et en grammes pour ceux visés à la colonne 1 des articles 3 à 5 et 9 à 12 et au moyen des règles d’écriture indiquées dans la colonne 4, (ii) les renseignements visés à la colonne 1 des articles 3 à 10 du tableau de l’article B.29.003, exprimés au moyen de la nomenclature indiquée dans la colonne 2, en grammes et au moyen des règles d’écriture indiquées dans la colonne 4, (iii) les renseignements visés à la colonne 1 de l’article 2 du tableau de l’article B.29.002, exprimés au moyen de la nomenclature indiquée dans la colonne 2, de l’unité indiquée dans la colonne 3, par portion indiquée de l’aliment supplémenté préparé et au moyen des règles d’écriture indiquées dans la colonne 4.

(5)

Le tableau des renseignements sur les aliments supplémentés peut également indiquer les renseignements en fonction d’autres quantités de l’aliment supplémenté qui correspondent à différentes usages ou unités de mesure de l’aliment supplémenté, auquel cas : a) le tableau indique les renseignements ci-après pour chacune des autres quantités de l’aliment supplémenté : (i) la quantité exprimée selon une mesure domestique et une mesure métrique et au moyen des règles d’écriture indiquées dans la colonne 4 du tableau de l’article B.29.002, aux paragraphes 1(1) et (2), (ii) la valeur énergétique, exprimée au moyen de la nomenclature indiquée dans la colonne 2 de l’article 2 du tableau de l’article B.29.002, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4, SOR/2022-169, s. 21.

(3)

The characters in the supplemented food facts table SOR/2022-169, s. 21. B.29.007 (1) Subject to subsection (2), the supplemented food facts table must be displayed SOR/2022-169, s. 21. SOR/2022-169, s. 21. (a) the bilingual standard format in accordance with Figure 3.5(B), 3.6(B) or 3.7(B) of the Directory of SFFT Formats;

(2)

Sous réserve du paragraphe (3), le tableau des renseignements sur les aliments supplémentés est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(3)

Si le tableau des renseignements sur les aliments supplémentés ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible de l’aliment supplémenté, il est présenté selon l’une des façons suivantes : a) selon le modèle standard bilingue prévu aux figures 3.5(B), 3.6(B) ou 3.7(B) du Répertoire des modèles de TRAS; b) selon le modèle horizontal bilingue prévu aux figures 4.3(B), 4.4(B) ou 4.5(B) du Répertoire des modèles de TRAS; c) selon le modèle linéaire prévu aux figures 16.1(F) et (A) ou 16.2(F) et (A) du Répertoire des modèles de TRAS; d) selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si plus de 15 % de la surface exposée disponible de l’aliment supplémenté devrait être nécessaire pour présenter le tableau des renseignements sur les aliments supplémentés; e) d’une façon prévue à l’article B.29.017.

(4)

Pour l’application du présent article, afin d’établir si une version du tableau des renseignements sur les aliments supplémentés ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible de l’aliment supplémenté, il est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement.

(5)

Malgré les paragraphes (2) et (3), si le tableau des renseignements sur les aliments supplémentés est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues aux alinéas (3)a) à c) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2. TABLE PART 1 Standard Format Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use 1 1.1(E) and (F) 2 1.2(E) and (F) 3 1.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 4 1.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 5 1.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) 6 1.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) PART 2 Narrow Standard Format Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 1

2.1(E) and (F)

2

2.2(E) and (F)

3

2.3(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) 4

2.4(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) PART 3 Bilingual Standard Format Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 1

3.1(B)

2

3.2(B)

PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling Sections B.29.009-B.29.010 Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 3 3.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 4 3.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) PART 4 Bilingual Horizontal Format Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 1 4.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 2 4.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) SOR/2022-169, s. 21. Simplified Formats Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Articles B.29.009-B.29.010

Colonne 1 Figure du Répertoire des modèles de TRAS (version) Colonne 2 Condition d’utilisation

Article

3 3.3(B) (éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4 3.4(B) (éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

PARTIE 4

Modèle horizontal bilingue Colonne 1 Figure du Répertoire des modèles de TRAS (version) Colonne 2 Condition d’utilisation

Article

1 4.1(B) (éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 7 points) Les versions des parties 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 2 4.2(B) (éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 6 points) Les versions des parties 1 à 3 et de l’article 1 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. DORS/2022-169, art. 21. Modèles simplifiés B.29.010 (1) Le présent article s’applique à tout aliment supplémenté qui remplit la condition prévue au paragraphe B.29.002(4) et dont le tableau des renseignements sur les aliments supplémentés contient uniquement les renseignements visés aux alinéas B.29.002(4)a) à m).

(2)

Sous réserve du paragraphe (3), le tableau des renseignements sur les aliments supplémentés est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie. (a) the bilingual simplified standard format in accordance with Figure 6.5(B) or 6.6(B) of the Directory of SFFT Formats;

(3)

Si le tableau des renseignements sur les aliments supplémentés qui ne contient que les renseignements visés aux alinéas B.29.002(4)a) à m) ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible de l’aliment supplémenté, le tableau des renseignements sur les aliments supplémentés est présenté de l’une des façons suivantes : a) selon le modèle standard simplifié bilingue prévu aux figures 6.5(B) ou 6.6(B) du Répertoire des modèles de TRAS; b) selon le modèle horizontal simplifié bilingue prévu aux figures 7.3(B) ou 7.4(B) du Répertoire des modèles de TRAS; c) selon le modèle linéaire simplifié prévu aux figures 17.1(F) et (A) ou 17.2(F) et (A) du Répertoire des modèles de TRAS; d) selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau des renseignements sur les aliments supplémentés doit être présenté sur plus de 15 % de la surface exposée disponible; e) d’une façon prévue à l’article B.29.017.

(4)

Malgré les paragraphes (2) et (3), si le tableau des renseignements sur les aliments supplémentés est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues aux alinéas (3)a) à c) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2. TABLE PART 1 Simplified Standard Format Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 1

5.1(E) and (F)

2

5.2(E) and (F)

3

5.3(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 4

5.4(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 5

5.5(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) 6

5.6(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) PART 2 Bilingual Simplified Standard Format Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 1

6.1(B)

2

6.2(B)

3

6.3(B)

(nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 4

6.4(B)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) PART 3 Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 1

7.1(B)

(nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 2

7.2(B)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) SOR/2022-169, s. 21. (a) the bilingual simplified standard format in accordance with Figure 6.5.1(B) or 6.6.1(B) of the Directory of SFFT Formats; PART B Foods DIVISION 30 Supplemented Foods Nutrition Labelling

Section B.29.011

column 1 of the table to this section, without regard to any condition specified in column 2. TABLE PART 1 Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use 1

6.1.1(B)

2

6.2.1(B)

3

6.3.1(B)

(nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 4

6.4.1(B)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 30 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.011

présenté selon l’une des versions prévues aux alinéas (3)a) à c) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2. TABLEAU

PARTIE 1

Modèle standard simplifié bilingue — aliments supplémentés étant des produits préemballés à portion individuelle Colonne 1 Figure du Répertoire des modèles de TRAS (version) Colonne 2 Condition d’utilisation 1

6.1.1(B)

(éléments nutritifs et ingrédients supplémentaires figurant en caractères d’au moins 8 points) 2

6.2.1(B)

(éléments nutritifs et ingrédients supplémentaires figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3

6.3.1(B)

(éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4

6.4.1(B)

(éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART 2 Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 1

7.1.1(B)

2

7.2.1(B)

SOR/2022-169, s. 21. (a) the bilingual dual format in accordance with Figure 9.5(B) or 9.6(B) of the Directory of SFFT Formats; or TABLE PART 1 Column 1 | Column 2 Figure in Directory of SFFT Formats (Version) | Condition of use 1 | 8.1(E) and (F) 2 | 8.2(E) and (F) 3 | 8.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 4 | 8.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) TABLEAU

PARTIE 1

Modèle double — aliments supplémentés à préparer Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TRAS (version) | Condition d’utilisation 1 | 8.1(F) et (A) (éléments nutritifs et ingrédients supplémentaires figurant en caractères d’au moins 8 points) 2 | 8.2(F) et (A) (éléments nutritifs et ingrédients supplémentaires figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3 | 8.3(F) et (A) (éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4 | 8.4(F) et (A) (éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling

Section B.29.012

Column 1 Item 5

8.5(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) 6

8.6(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) Column 2 Condition of use PART 2 Column 1 Item 1

9.1(B)

2

9.2(B)

3

9.3(B)

(nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 4

9.4(B)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) Column 2 Condition of use SOR/2022-169, s. 21. Aggregate Format — Different Kinds of Supplemented Foods TABLE PART 1 Aggregate Format — Different Kinds of Supplemented Foods | Item | Column 1 Figure in Directory of SFFT Formats (Version) | Column 2 Condition of use | |------|-------------------------------------------------------|---------------------------|

(4)

Malgré les paragraphes (1) et (2), si le tableau des renseignements sur les aliments supplémentés du produit préemballé est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues au sous-alinéa 2(b)(i) ou du présent article, sans égard à toute condition prévue à la colonne 2. TABLEAU

PARTIE 1

Modèle composé — différents types d’aliments supplémentés | Article | Colonne 1 Figure du Répertoire des modèles de TRAS (version) | Colonne 2 Condition d’utilisation | |---------|-------------------------------------------------------------|-----------------------------------| | 1 | 10.1(F) et (A) | (éléments nutritifs et ingrédients supplément-taires figurant en caractères d’au moins 8 points) | | 2 | 10.2(F) et (A) | La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. | | 3 | 10.3(F) et (A) | Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. | | 4 | 10.4(F) et (A) | Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. | | 5 | 10.5(F) et (A) | Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. | PART B Foods DIVISION 24 Supplemented Foods Nutrition Labelling Sections B.29.013-B.29.014 Column 1 | Column 2 Figure in Directory of SFFT Formats (Version) | Condition of use Item 6 | 10.6(E) and (F) PART 2 Bilingual Aggregate Format — Different Kinds of Supplemented Foods Column 1 | Column 2 Figure in Directory of SFFT Formats (Version) | Condition of use Item 1 | 11.1(B) 2 | 11.2(B) 3 | 11.3(B) 4 | 11.4(B) SOR/2022-169, s. 21. Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 24 Aliments supplémentés

Étiquetage nutritionnel

Articles B.29.013-B.29.014

Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TRAS (version) | Condition d’utilisation

Article

6 | 10.6(F) et (A) (éléments nutritifs et ingrédients supplémentai­res figurant en caractères étroits d’au moins 6 points) | Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

PARTIE 2

Modèle composé bilingue — différents types d’aliments supplémentés Colonne 1 | Colonne 2 Figure du Répertoire des modèles de TRAS (version) | Condition d’utilisation

Article

1 | 11.1(B) (éléments nutritifs et ingrédients supplémentai­res figurant en caractères d’au moins 8 points) 2 | 11.2(B) (éléments nutritifs et ingrédients supplémentai­res figurant en caractères d’au moins 7 points) | La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3 | 11.3(B) (éléments nutritifs et ingrédients supplémentai­res figurant en caractères étroits d’au moins 7 points) | Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4 | 11.4(B) (éléments nutritifs et ingrédients supplémentai­res figurant en caractères étroits d’au moins 6 points) | Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. DORS/2022-169, art. 21. Modèle double — différentes quantités d’aliments supplémentés B.29.014 (1) Sous réserve du paragraphe (2), le tableau des renseignements sur les aliments supplémentés qui indique des renseignements distincts en fonction de différentes quantités de l’aliment supplémenté, tel qu’il est prévu à l’alinéa B.29.005(5)(a), sans indiquer les renseignements visés à l’alinéa B.29.005(5)(b), est présenté selon (a) the bilingual dual format in accordance with Figure 1.3.5(B) or 1.3.6(B) of the Directory of SFFT Formats; or l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(2)

Si le tableau des renseignements sur les aliments supplémentés ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible de l’aliment supplémenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté : a) soit selon le modèle double bilingue prévu aux figures 1.3.5(B) ou 1.3.6(B) du Répertoire des modèles de TRAS; b) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau des renseignements sur les aliments supplémentés devrait être présenté sur plus de 15 % de la surface exposée disponible.

(3)

Pour l’application du présent article, afin d’établir si une version du tableau des renseignements sur les aliments supplémentés ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible de l’aliment supplémenté, le tableau des renseignements sur les aliments supplémentés doit comprendre uniquement les renseignements exigés par le présent règlement pour chaque quantité d’aliment supplémenté pour laquelle des renseignements distincts y sont indiqués.

(4)

Malgré les paragraphes (1) et (2), si le tableau des renseignements sur les aliments supplémentés est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues à l’alinéa (2)a) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2. TABLE PART 1 Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 1

12.1(E) and (F)

2

12.2(E) and (F)

3

12.3(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 4

12.4(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 5

12.5(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) 6

12.6(E) and (F)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) PART 2 Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 1

13.1(B)

2

13.2(B)

3

13.3(B)

4

13.4(B)

SOR/2022-169, s. 21. TABLE PART 1 Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use 1

14.1(E) and (F)

2

14.2(E) and (F)

PART B Foods DIVISION 24 Supplemented Foods Nutrition Labelling

Section B.24.205

Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 3 14.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 4 14.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 5 14.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) 6 14.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) PART 2 Column 1 Figure in Directory of SFFT Formats (Version) Column 2 Condition of use Item 1 15.1(B) 2 15.2(B) Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 28 Aliments supplémentés

Étiquetage nutritionnel

Article B.29.205

Colonne 1 Figure du Répertoire des modèles de TRAS (version) Colonne 2 Condition d’utilisation

Article

2 14.2(F) et (A) (éléments nutritifs et ingrédients supplémentaires figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 3 14.3(F) et (A) (éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 4 14.4(F) et (A) (éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 7 points) Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 5 14.5(F) et (A) (éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. 6 14.6(F) et (A) (éléments nutritifs et ingrédients supplémentaires figurant en caractères étroits d’au moins 6 points) Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

PARTIE 2

Modèle composé bilingue — différentes quantités d’aliments supplémentés Colonne 1 Figure du Répertoire des modèles de TRAS (version) Colonne 2 Condition d’utilisation

Article

1 15.1(B) (éléments nutritifs et ingrédients supplémentaires figurant en caractères d’au moins 8 points) 2 15.2(B) (éléments nutritifs et ingrédients supplémentaires figurant en caractères d’au moins 7 points) La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling Sections B.29.015-B.29.016 Column 1 Item Figure in Directory of SFFT Formats (Version) 3

15.3(B)

(nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed)) 4

15.4(B)

(nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed)) Column 2 Condition of use SOR/2022-169, s. 21. Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Articles B.29.015-B.29.016

Colonne 1

Article

Figure du Répertoire des modèles de TRAS (version) 2

15.2(B)

(éléments nutritifs et ingrédients supplément-taires figurant en caractères d’au moins 7 points) 3

15.3(B)

(éléments nutritifs et ingrédients supplément-taires figurant en caractères étroits d’au moins 7 points) 4

15.4(B)

(éléments nutritifs et ingrédients supplément-taires figurant en caractères étroits d’au moins 6 points) Colonne 2 Condition d’utilisation La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible. DORS/2022-169, art. 21. Présentation des renseignements complémentaires B.29.016 (1) Les renseignements visés à la colonne 1 du tableau de l’article B.29.003 qui sont indiqués dans la version du tableau des renseignements sur les aliments supplémentés se composant d’un tableau en anglais et d’un tableau en français ou d’un tableau en anglais ou en français sont présentés : a) selon l’ordre, les retraits et les notes complémentaires indiqués aux figures 18.1(F) et (J) du Répertoire des modèles de TRAS; b) quant aux autres caractéristiques de présentation, selon le modèle prévu à la figure applicable du Répertoire des modèles de TRAS.

(2)

Les renseignements visés à la colonne 1 du tableau de l’article B.29.003 indiqués dans la version du tableau des renseignements sur les aliments supplémentés se composant d’un tableau en anglais et d’un tableau en français sont présentés : a) selon l’ordre, les retraits et les notes complémentaires indiqués à la figure 19.1(B) du Répertoire des modèles de TRAS; b) quant aux autres caractéristiques de présentation, selon le modèle prévu à la figure applicable du Répertoire des modèles de TRAS. PART B Foods DIVISION 29 Supplemented Foods Nutrition Labelling Sections B.29.016-B.29.017 SOR/2022-169, s. 21. B.29.017 (1) Despite section A.01.016 and subject to subsection (2), a supplemented food facts table that meets the conditions specified in subsection B.29.009(3), B.29.010(3) or B.29.011(3) or paragraph B.29.013(2)(a) may be set out on (a) a tag attached to the package; (b) a package insert; (c) the inner side of a label; (d) a fold-out label; or (e) an outer sleeve, overwrap or collar. Règlement sur les aliments et drogues

PARTIE B Aliments

TITRE 29 Aliments supplémentés

Étiquetage nutritionnel

Articles B.29.016-B.29.017

(3)

Malgré l’alinéa (1)a), les retraits indiqués aux figures 18.1(F) et (A) du Répertoire des modèles de TRAS ne s’appliquent pas si les renseignements visés à la colonne 1 du tableau de l’article sont présentés selon le modèle linéaire visé à l’alinéa B.29.009(3)c) ou le modèle linéaire simplifié visé à l’alinéa B.29.010(3)c). DORS/2022-169, art. 21. Autres modes de présentation B.29.017 (1) Malgré l’article A.01.016 et sous réserve du paragraphe (2), le tableau des renseignements sur les aliments supplémentés qui répond aux critères mentionnés aux paragraphes B.29.009(3), B.29.010(3) ou B.29.011(3) ou à l’alinéa B.29.013(2)a) peut être placé sur, selon le cas : a) une étiquette mobile attachée à l’emballage; b) une notice d’accompagnement; c) le verso d’une étiquette; d) une étiquette dépliante; e) un manchon, une surenveloppe ou un collier.

(2)

Le tableau des renseignements sur les aliments supplémentés ne peut être placé conformément aux alinéas (1)b) ou c) si une liste des mises en garde doit figurer sur l’étiquette de l’aliment supplémenté.

(3)

Si le tableau des renseignements sur les aliments supplémentés est placé conformément aux alinéas (1)b) ou c), le recto de l’étiquette indique l’endroit en caractères d’au moins 8 points.

(4)

Si le tableau des renseignements sur les aliments supplémentés est placé conformément au paragraphe (1), il est présenté : a) dans le cas de tout aliment supplémenté visé au paragraphe B.29.009(3), selon l’une des versions prévues aux alinéas B.29.009(3)a) à c) ou selon l’une des versions figurant à la colonne 1 du tableau de l’article B.29.009; b) dans le cas de tout aliment supplémenté visé au paragraphe B.29.010(3), selon l’une des versions prévues aux alinéas B.29.010(3)a) à c) ou selon l’une des versions figurant à la colonne 1 du tableau de l’article B.29.010; SOR/2022-169, s. 21. Small Packages (i) any declaration of the supplemented food’s energy value or the amount of a nutrient or supplemental ingredient contained in the supplemented food, c) dans le cas de tout aliment supplémenté visé au paragraphe B.29.011(3), selon l’une des versions prévues aux alinéas B.29.011(3)a) à c) ou selon l’une des versions figurant à la colonne 1 du tableau de l’article B.29.011; d) dans le cas de tout produit préemballé contenant un assortiment d’aliments supplémentés visé à l’alinéa B.29.013(2)a), selon l’une des versions prévues au sous-alinéa B.29.013(2)a)(i) ou selon l’une des versions figurant à la colonne 1 du tableau de l’article B.29.013. DORS/2022-169, art. 21. Petits emballages B.29.018 (1) Malgré l’article A.01.016 et sous réserve du paragraphe (2), l’étiquette de tout aliment supplémenté dont la surface exposée disponible est de moins de 100 cm² ne pas porter le tableau des renseignements sur les aliments supplémentés si son recto comporte des indications sur la manière dont l’acheteur ou le consommateur peut obtenir les renseignements qui devraient figurer dans le tableau.

(2)

Le paragraphe (1) ne s’applique pas : a) à l’aliment supplémenté lorsqu’une liste des mises en garde doit figurer sur son étiquette; b) à l’aliment supplémenté faisant l’objet de l’une des déclarations ci-après sur son étiquette ou encore dans l’annonce faite par le fabricant de l’aliment ou sous sa direction : (i) toute indication de la valeur énergétique de l’aliment ou de sa teneur en un élément nutritif ou en un ingrédient supplémentaire, (ii) toute déclaration indiquant expressément ou implicitement que l’aliment ou toute substance y contenue a des propriétés particulières liées à la nutrition ou à la santé, notamment une mention ou une allégation figurant à la colonne 4 du Tableau des mentions et allégations autorisées concernant les nutriments, à la colonne 1 du tableau suivant l’article B.01.603 ou aux articles B.01.311, D.01.006 ou D.02.004, (iii) toute mention, tout nom, logo, symbole ou sceau d’approbation ou toute marque concernant la santé.

(3)

Malgré l’alinéa (2)b), le paragraphe (1) s’applique à l’aliment supplémenté qui répond aux critères mentionnés à la colonne 2 de l’article 37 du Tableau des mentions (iv) displayed in a colour contrasting with the background of the label; (i) the list of ingredients, (iii) a declaration referred to in subsection B.01.010.4(1), or (iv) any statement referred to in subsection B.01.014(1); et des allégations autorisées concernant la teneur nutritive en regard du sujet « Sans sucres » figurant à la colonne 1 si les conditions ci-après sont réunies : a) l’aliment supplémenté ne fait l’objet d’aucune déclaration visée à l’alinéa (2)b), autre que : (i) les mentions ou les allégations figurant à la colonne 4 de l’article 37 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « Sans sucres » visé à la colonne 1, (ii) la valeur énergétique de l’aliment exprimée en Calories par portion indiquée, (iii) la teneur en polyalcools exprimée en grammes par portion indiquée; b) toute mention ou toute allégation figurant à la colonne 4 de l’article 37 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive en regard du sujet « Sans sucres » visé à la colonne 1 et figurant sur l’étiquette, à la fois : (i) est lisible sur l’espace principal, (ii) est en minuscules, à l’exception de la première lettre de chaque mot de la mention ou de l’allégation qui peut être majuscule, (iii) est de caractères de dimensions au moins égales et aussi bien en vue que les caractères utilisés dans la portion numérique de la déclaration de la quantité nette, comme l’exigent l’alinéa 229(1)a) et les paragraphes 229(2) et (3) du Règlement sur la salubrité des aliments au Canada, (iv) est d’une couleur faisant contraste avec le fond de l’étiquette; c) la valeur énergétique exprimée en Calories par portion indiquée et la teneur en polyalcools exprimée en grammes par portion indiquée figurent immédiatement après celui des éléments suivants qui figure en dernier sur l’étiquette : (i) la liste des ingrédients, (ii) la mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés au sens du paragraphe B.01.010.1(1), (iii) l’énoncé visé au paragraphe B.01.010.4(1), (iv) toute mention visée au paragraphe B.01.014(1); (d) the label of the supplemented food is not required to show a list of cautionary statements.

(4)

An indication referred to in subsection (1) (a) without charge; SOR/2022-169, s. 21. (d) the amount of any saturated fat, sugars or sodium if the amount meets or exceeds the applicable threshold set out in columns 2, 3, 5 or 6 of the table to section B.01.350; and SOR/2022-169, s. 21. Cautionary Statements (ii) “Attention”, “Attention :” or “Attention:” in the French version; DORS/2022-169, art. 21. (d) in regular or bold type; (f) separated by a bullet point or comma. (i) a list of ingredients, (iii) a declaration referred to in subsection B.01.014(1), (iv) any statement referred to in subsection B.01.014(1), (v) a nutrition facts table, or (vi) a supplemented food facts table. SOR/2022-169, art. 21. Presentation SOR/2022-169, s. 21. Placement B.29.022 (1) The supplemented food caution identifier must be displayed --- compact bilingue (CB), où figure l’identifiant dans les deux langues officielles.

(5)

L’identifiant des aliments supplémentés avec mise en garde doit être présenté conformément aux spécifications applicables prévues dans le Répertoire des spécifications sur l’identifiant des aliments supplémentés avec mise en garde.

(6)

Malgré le paragraphe (5), l’identifiant des aliments supplémentés avec mise en garde peut être d’une dimension plus grande que celles indiquées à la colonne 3 du tableau applicable du Répertoire des spécifications sur l’identifiant des aliments supplémentés avec mise en garde s’il est agrandi proportionnellement sur les plans vertical et horizontal.

(7)

Si, conformément au paragraphe B.01.012(3), les renseignements devant être indiqués aux termes du présent règlement sur l’étiquette d’un aliment supplémenté peuvent être uniquement en français ou uniquement en anglais et qu’ils y figurent dans la langue en cause, l’identifiant des aliments supplémentés avec mise en garde peut être présenté dans l’espace principal de l’aliment dans cette langue sur toute la surface exposée disponible.

(8)

Lorsque l’identifiant des aliments supplémentés avec mise en garde est présenté selon le modèle bilingue, l’ordre de présentation des langues indiqué dans l’identifiant applicable figurant à l’annexe K.2 peut être inversé.

(9)

Les caractères et les autres éléments de l’identifiant des aliments supplémentés avec mise en garde sont présentés de manière à ce qu’ils ne se touchent pas. DORS/2022-169, art. 21. Emplacement B.29.022 (1) L’identifiant des aliments supplémentés avec mise en garde est présenté : a) dans le cas d’un aliment supplémenté dont l’espace principal est moins haut que large, dans la moitié droite de l’espace principal; b) dans le cas de tout autre aliment supplémenté, dans la moitié supérieure de l’espace principal.

(2)

L’identifiant des aliments supplémentés avec mise en garde est entouré d’un espace de dégagement qui satisfait aux exigences suivantes : a) il a une largeur égale ou supérieure à celle prévue à la colonne 4 du tableau applicable du Répertoire des spécifications sur l’identifiant des aliments supplémentés avec mise en garde; SOR/2022-169, s. 21. Orientation SOR/2022-169, s. 21. SOR/2022-169, s. 21. SOR/2022-169, s. 21. SOR/2022-169, s. 21. élément nutritif contenu dans l’aliment supplémenté est généralement reconnu comme aidant à entretenir les fonctions de l’organisme nécessaires au maintien de la santé, si l’ingrédient supplémenté est un pour lequel une mise en garde figurant dans la liste des mises en garde est applicable.

(2)

Toutefois, de telles mentions ou de telles allégations sont permises sur l’étiquette ou dans l’annonce de tout aliment supplémenté si elles sont accompagnées d’une mention ou d’une allégation indiquant l’action ou les effets particuliers de l’ingrédient supplémentaire dans l’entretien des fonctions de l’organisme nécessaires au maintien de la santé.

(3)

Lorsque les mentions ou les allégations visées au paragraphe (1) figurent sur l’étiquette ou dans l’annonce de l’aliment supplémenté, ces mentions ou allégations ainsi que celles visées au paragraphe (2) : a) dans le cas où elles sont faites sur l’étiquette ou dans l’annonce, autre qu’une annonce radiophonique ou télévisée, de l’aliment supplémenté : (i) se précèdent ou se suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé entre elles, (ii) figurent en caractères de même taille et aussi bien en vue; b) dans le cas où elles sont faites dans une annonce radiophonique ou dans la composante audio d’une annonce télévisée de l’aliment supplémenté, se précèdent ou se suivent immédiatement; c) dans le cas où elles sont faites dans la composante visuelle de l’annonce télévisée de l’aliment supplémenté : (i) paraissent en même temps et pendant la même durée, (ii) se précèdent ou se suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, (iii) figurent en caractères de même taille et aussi bien en vue. DORS/2022-169, art. 21. B.29.027 Malgré toute disposition du présent règlement, sont interdites, sur l’étiquette ou dans l’annonce de tout aliment supplémenté, les mentions ou les allégations indiquant qu’un élément nutritif qui y est contenu est généralement reconnu comme aidant à entretenir les fonctions de l’organisme nécessaires à la croissance et au SOR/2022-169, s. 21.

(2)

Subsection (1) does not apply in respect of a declaration of a vitamin in a list of ingredients or supplemented food facts table, or in respect of a declaration of a mineral nutrient in a list of ingredients, nutrition symbol or supplemented food facts table. SOR/2022-169, s. 21. (a) if the representation is displayed on the principal display panel, (a) a declaration referred to in subsection B.01.301(1) or (2); SOR/2022-169, s. 21. Adulteration and Exemptions SOR/2022-169, s. 21. SOR/2022-169, s. 21. SOR/2022-169, s. 21. dépasse pas le double de la hauteur des lettres majuscules paraissant dans les mises en garde.

(2)

Pour l’application du paragraphe (1), les déclarations sont les suivantes : a) toute indication visée aux paragraphes B.01.301(1) ou (2); b) toute déclaration indiquant expressément ou implicitement que l’aliment supplémenté ou toute substance y étant contenue a des propriétés particulières liées à la nutrition ou à la santé, notamment une mention ou une allégation figurant à la colonne 4 du Tableau des mentions et des allégations autorisées concernant la teneur nutritive, à la colonne 1 du tableau suivant l’article B.01.603 ou aux articles B.01.311, D.01.006 ou D.02.004; c) toute mention, tout logo, symbole, sceau d’approbation ou toute marque concernant la santé.

(3)

Le présent article ne s’applique pas à la marque ou au nom de produit de l’aliment supplémenté. DORS/2022-169, art. 21. Falsification et exemptions B.29.030 Un produit préemballé, autre qu’un aliment supplémenté, est falsifié s’il contient un aliment supplémenté à titre d’ingrédient. DORS/2022-169, art. 21. B.29.031 Un produit préemballé, autre qu’un aliment supplémenté, est falsifié si une substance figurant à la colonne 1 de la Liste des ingrédients supplémentaires autorisés y a été ajoutée autrement que conformément au présent règlement. DORS/2022-169, art. 21. B.29.032 Un aliment supplémenté ne contient pas de substance toxique ou délétère, ou n’en est pas recouvert, pour l’application de l’alinéa 4(1)a) de la Loi ou n’est pas falsifié, pour l’application de l’alinéa 4(1)d) de cette dernière, pour la seule raison qu’un ingrédient supplémentaire y a été ajouté. DORS/2022-169, art. 21. PART C Drugs DIVISION 1

C

01.001 (1) In this Part acetaminophen product has the same meaning as in Division 9; (produit d’acétaminophène) adult standard dosage unit has, with reference to a drug, the same meaning as in Division 9; (dose normale pour adultes) adverse drug reaction means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; (réaction indésirable à une drogue) authorization holder [Repealed, SOR/2017-259, s. 1] children’s standard dosage unit has, with reference to a drug, the same meaning as in Division 9; (dose normale pour enfants) ---

PARTIE C

Drogues

TITRE 1

Dispositions générales

C

01.001 (1) Dans la présente partie, antibiotique désigne toute drogue ou tout mélange de drogues, tels ceux qui figurent aux articles C.01.410 à C.01.592, lesquels sont préparés à partir de certains micro-organismes, ou l’ont été antérieurement, mais sont maintenant fabriqués par synthèse, et sont doués de propriétés inhibitrices de la croissance d’autres micro-organismes; (antibiotic) arrêté d’urgence IVPD L’Arrêté d’urgence concernant l’importation, la vente et la publicité de drogues à utiliser relativement à la COVID-19, pris le 16 septembre 2020 par la ministre et publié le 3 octobre 2020 dans la Gazette du Canada, Partie I; (ISAD Interim Order) cesser s’entend, à l’égard de la vente d’une drogue par le fabricant à qui a été délivré le document prévu au paragraphe C.01.014.2(1) qui indique l’identification numérique attribuée à la drogue, du fait d’abandonner définitivement la vente de la drogue; (discontinue) COVID-19 La maladie à coronavirus 2019; (COVID-19) cuillère à thé désigne, aux fins du calcul d’une dose, un volume de cinq centimètres cubes; (teaspoon) date limite d’utilisation : a) S’agissant d’une drogue sous forme posologique, celles des dates ci-après qui est antérieure à l’autre, indiquée au moins par l’année et le mois : (i) la date jusqu’à laquelle la drogue conserve l’activité, la pureté et les propriétés physiques précisées sur l’étiquette, (ii) la date après laquelle le fabricant recommande de ne plus utiliser la drogue; b) s’agissant d’un ingrédient actif, celle des dates après qui s’applique, indiquée au moins par l’année et le mois : (i) la date de nouvelle analyse, COVID-19 means the coronavirus disease 2019; (COVID-19) (i) the retest date, or (ii) the date after which the manufacturer recommends that the active ingredient not be used; (date limite d’utilisation) flavour means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug solely to produce or mask a particular taste. It does not include an ingredient or combination of ingredients that impart only a sweet taste to the drug; (saveur) fragrance means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug to produce or mask a particular odour; (parfum) (ii) la date après laquelle le fabricant recommande de ne plus utiliser l’ingrédient actif; (expiration date) délai d’attente Intervalle entre le moment de la dernière administration d’une drogue à un animal et le moment où la concentration de tout résidu de la drogue présent dans les tissus ou les produits prélevés chez l’animal pour servir d’aliment ne présente vraisemblablement plus de risques pour la santé de l’être humain; (withdrawal period) dose normale pour adultes désigne, dans le cas d’une drogue, la dose prescrite au titre 9; (adult standard dosage unit) dose normale pour enfants désigne, dans le cas d’une drogue, la dose prescrite au titre 9; (children’s standard dosage unit) drogue contre la COVID-19 Drogue, à l’exception d’un produit de santé animale, fabriquée ou vendue en vue d’être utilisée relativement à la COVID-19 ou présentée comme devant l’être; (COVID-19 drug) drogue officielle désigne toute drogue a) pour laquelle une norme est fixée dans le présent règlement, ou b) pour laquelle une norme est fixée dans l’une des publications mentionnées à l’annexe B de la Loi, et non dans le présent règlement; (official drug) emballage protégé-enfants désigne un emballage qui répond aux exigences du paragraphe (2); (child resistant package) encre pharmaceutique Ingrédient non médicinal ou mélange d’ingrédients non médicinaux utilisé pour imprimer des marques ou des symboles sur la drogue; (pharmaceutical ink) fiche d’observation Rapport détaillé renfermant les données pertinentes concernant l’utilisation d’une drogue chez un sujet; (case report) groupe d’essai désigne un groupe qui répond aux exigences du paragraphe (3); (test group) ingrédient non médicinal Substance, autre qu’une drogue pharmacologiquement active, ajoutée à la drogue au cours de la fabrication et présente dans le produit fini; (non-medicinal ingredient) Liste A Document intitulé Liste de certains ingrédients actifs pharmaceutiques antimicrobiens publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (Liste A) Liste B Document intitulé Liste de certaines drogues pour usage vétérinaire qui peuvent être importées mais non vendues publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (Liste B) Liste C Document intitulé Liste des produits de santé animale publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (Liste C) Liste D Document intitulé Liste de certaines drogues sans ordonnance pouvant être distribuées à titre d’échantillons publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (Liste D) marque nominative Dans le cas d’une drogue, le nom en français ou en anglais, avec ou sans le nom d’un fabricant, d’une personne morale, d’une société de personnes ou d’un particulier: a) qui lui a été attribué par le fabricant; b) sous lequel elle est vendue ou fait l’objet de publicité; c) qui sert à l’identifier; (brand name) nom propre désigne, à l’égard d’une drogue, le nom en anglais ou en français a) attribué à ladite drogue à l’article C.01.002, b) figurant en caractères gras dans le présent règlement lorsqu’il est question de ladite drogue et, lorsque la drogue est désignée sous une autre appellation que celle qui est décrite dans la présente partie, le nom de la forme sous laquelle ladite drogue est distribuée, c) spécifié dans la licence canadienne, dans le cas des drogues comprises à l’annexe C ou à l’annexe D de la Loi, ou d) attribué, dans l’une des publications mentionnées à l’annexe B de la Loi, dans le cas des drogues non comprises aux alinéas a), b) ou c); (proper name) nom usuel Dans le cas d’une drogue, le nom en français ou en anglais sous lequel elle est: a) généralement connue; per cent means per cent by weight unless otherwise stated; (pour cent) pharmaceutical ink means a non-medicinal ingredient or combination of non-medicinal ingredients used to imprint the drug with marks or symbols; (encre pharmaceutique) (b) is practising pharmacy in that province; (pharmacien) (b) is practising as a pharmacy technician in that province; (technicien en pharmacie) (a) assigned to the drug in section C.01.002, b) désignée dans des revues scientifiques ou techniques autres que les publications dont le nom figure à l’annexe B de la Loi; (common name) ordonnance désigne un ordre délivré par un praticien, spécifiant une quantité donnée de quelque drogue ou mélange de drogues à dispenser à la personne nommée dans ladite ordonnance; (prescription) parfum Ingrédient non médicinal ou mélange d’ingrédients non médicinaux ajouté à la drogue pour produire ou masquer une odeur; (fragrance) pharmacien Personne qui : a) d’une part, est autorisée, notamment par un permis d’exercice, en vertu des lois d’une province à exercer la profession de pharmacien; b) d’autre part, exerce la profession de pharmacien dans cette province; (pharmacist) pour cent désigne le pourcentage en poids, à moins de précision contraire; (per cent) praticien Personne qui : a) d’une part, est autorisée en vertu des lois d’une province à traiter les patients au moyen d’une drogue sur ordonnance; b) d’autre part, exerce sa profession dans cette province; (practitioner) produit d’acétaminophène s’entend au sens du titre 9; (acetaminophen product) produit de salicylate s’entend au sens du titre 9; (salicylate product) produit de santé animale L’une des drogues ci-après qui est sous forme posologique et qui n’est pas fabriquée, vendue ou présentée comme pouvant servir au diagnostic, au traitement, à l’atténuation ou à la prévention d’une maladie, d’un désordre, d’un état physique anormal ou de leurs symptômes : a) une substance visée à la colonne I de la partie 1 de la Liste C qui correspond aux renseignements descriptifs visés aux colonnes II à V ou une combinaison de ces substances dont les ingrédients médicinaux sont des substances visées à la colonne I de la partie 1 de cette liste, si la combinaison correspond, pour chacun de ces substances, à la fois aux renseignements descriptifs visés aux colonnes II et III, et d’autre part à ceux visés aux colonnes IV et V, lesquels sont, au sein serious unexpected adverse drug reaction means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the drug; (réaction indésirable grave et imprévue à une drogue) teaspoon means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres; (cuillerée à thé) test group means a group that meets the requirements of subsection (3); (groupe d’essai) réaction indésirable à une drogue Réaction nocive et non intentionnelle à une drogue qui est provoquée par l’usage de celle-ci et qui ne nécessite ou prolonge l’hospitalisation, entraîne une malformation congénitale ou une invalidité ou incapacité persistante ou importante, met la vie en danger ou entraîne la mort; (serious adverse drug reaction) réaction indésirable grave à une drogue Réaction indésirable grave à une drogue, dont la nature, la gravité ou la fréquence n’est pas indiquée dans les mentions de risque figurant sur l’étiquette de la drogue; (serious unexpected adverse drug reaction) récipient immédiat Récipient qui est en contact direct avec la drogue; (immediate container) saveur Ingrédient non médicinal ou mélange d’ingrédients non médicinaux ajouté à la drogue pour produire ou masquer une saveur, à l’exclusion de ceux qui lui confèrent uniquement un goût sucré; (flavour) technicien en pharmacie Personne qui : a) d’une part, est autorisée, notamment par un permis d’exercice, en vertu des lois d’une province à exercer la profession de technicien en pharmacie; b) d’autre part, exerce la profession de technicien en pharmacie dans cette province; (pharmacy technician) titulaire de l’autorisation [Abrogé, DORS/2017-259, art. 1] usage interne signifie l’absorption par la bouche ou l’application, en vue d’une action fonctionnelle, à toute partie du corps dans laquelle ladite drogue vient en contact avec une muqueuse; (internal use) usage parentéral signifie l’administration d’une drogue au moyen d’une seringue hypodermique, d’une aiguille ou de quelque autre instrument, à travers ou dans la peau ou une muqueuse. (parenteral use) (1.1) Pour l’application de la Loi, réaction indésirable grave à une drogue s’entend au sens du paragraphe (1).

(2)

L’emballage protège-enfants est un emballage qui : a) soit, lorsqu’il est soumis à un essai selon une méthode acceptable, répond aux exigences suivantes : (i) dans le cas d’un groupe d’essai formé d’enfants, ne peut être ouvert : (A) d’une part, par au moins 85 pour cent de ces enfants, sans démonstration préalable de la méthode d’ouverture, (B) d’autre part, par au moins 80 pour cent de ces enfants, après démonstration de la méthode d’ouverture, (ii) dans le cas d’un groupe d’essai formé d’adultes : (A) peut être ouvert par au moins 90 pour cent de ces adultes, (B) s’il s’agit d’un emballage conçu pour être refermé de façon à répondre encore aux exigences du sous-alinéa (i), peut être ainsi refermé par au moins 90 pour cent de ces adultes; b) soit est conforme à l’une des normes suivantes : (i) la norme CAN/CSA-Z76.1-M90 de l’Association canadienne de normalisation intitulée Emballages de sécurité réutilisables pour enfants, publiée en janvier 1990, compte tenu de ses modifications successives, SOR/98-654, s. 1; SOR/98-665, s. 1; SOR/98-423, s. 1; SOR/98-484, s. 1; SOR/98-654, s. 1; SOR/98-423, s. 1; SOR/98-411, s. 1; SOR/98-423, s. 1; SOR/98-423, s. 1; SOR/2016-108, s. 5; SOR/2017-122, s. 30; SOR/2017-123, s. 30; SOR/2017-276, s. 1; SOR/2017-123, s. 1; SOR/2020-192, s. 1; SOR/2020-247, s. 1; SOR/2022-46, s. 1; SOR/2022-46, s. 1; SOR/2023-247, s. 1.

C

01.001A [Repealed, SOR/98-423, s. 1] TABLE A.1 | Acepromazine | 2-acetyl-10-(3-dimethylaminopropyl) iephenothiazine A.2 | Acetaminophen | p-Acetamidophenol, Paracetamol, p-Hydroxyacetanilide: N-acetyl-p-aminophenol A.3 | Acetanilide: Acetanilid | Acetylaminobenzene: Antifebrin: Phenylacetamide A.4 | Acetylsalicylic Acid | Acetylsalicylic acid A.5 | Allopurinol | 1H-Pyrazolo [3,4-d] pyrimidin-4-ol: 4-Hydroxypyrazolo [3,4-d] pyrimidine A.6 | Amantadine | 1-Adamantanamine A.7 | Aminocaproic acid | 6-Aminohexanoic acid A.8 | Aminopterin | N-[4-(2,4-diamino-6-pteridyl methyl) amino-benzoyl]-L-glutamic acid A.10 | Amitriptyline | 3-(3-Dimethylaminopropylidene)-2,4,5-dibenzocycloheptadiene-1,4-diene A.11 | Azacyclonol | 4-(2-diphenyl-4-piperidinoethanol) B.1 | Bemegride | 3-Ethyl-3-methylglutarimide B.2 | Benactyzine | Dimethylaminoethyl-1,1-diphenylglycolate B.3 | Bendroflumethiazide | 3-benzyl-3,4-dihydro-6-(trifluoro- methyl)-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide: Bendrofluazide (B.A.N.) B.5 | Bethanidine | N-Benzyl-N'N"-dimethylguanidine: 1-Benzyl-2,3-dimethylguanidine B.6 | Bretylium tosylate | N-2-Bromobenzyl-N-ethyl-N, N-dimethylammonium tosylate (Tosylic acid is trivial name for p-toluenesulphonic acid) B.7 | Bromisoval | 2-monobromoisovalerylurea: Bromisovalum: Bromvaletina

C

1 | Calcium Carbimide | Calcium cyanamide

C

2 | Captopidamine | 4-butythio-α-phenylbenzyl-2-dimethylaminoethylsulfide

C

3 | Carisoprodol | N-Isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate

C

4 | Carphenazine | 1-[10-(3/4/2-Hydroxyethyl)-1-piperazinyl)propyl) phenothiazin-2yl]-1-propanone

C

6 | Chloramzenone | 2-(4-chlorophenyl)-3-methyl-4-methathiazaone-1,1-dioxide: Chlormethazone: Chlormethazone

C

7 | Chlorotheophylline | N,N-dimethyl-N'-(2-pyridyl)-N'-(5-chloro-α-thenyl)-ethylenediamine: Chlorothen

C

8 | Chlorphentermine | 4-Chloro-α,α-dimethylphenethylamine

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9 Cinchocaine 2-butoxy-N-(2-diethylaminoethyl) cinchoninamide: Dibucaine

C

10 Cinchophen 2-phenylquinoline-4-carboxylic acid: Quinophan

C

11 Clofibrate Ethyl 2-(p-chlorophenoxy)-2-methylpropionate

C

12 Clomiphene 1-Chloro-2-[4-(2-diethylamino-ethoxy)phenyl]-1,2-diphenylethylene: 2-[p-(2-Chloro-1,2-diphenylvinyl)phenoxy] triethylamine

D

1 Desipramine 5-(3-Methylaminopropyl)-10,11-dihydro-5H-dibenz[b,f]azepine

D

2 Diazepam 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one

D

3 Diethylpropion 1-phenyl-2-diethylaminopropanone-1

D

4 Diphenidol 1,1-Diphenyl-4-piperidinobutan-1-ol

D

5 Disulfiram Tetraethylthiuram disulphide E.1 Ectylurea 2-ethyl-cis-crotonylurea E.2 Emylcamate 1-Ethyl-1-methylpropyl carbamate E.3 Ethacrynic Acid [2,3-Dichloro-4-(2-methylene)butenyl] phenoxy acetic acid: 2,3-Dichloro-4-(2-ethylacryloyl) phenoxyacetic acid E.4 Ethchlorvynol 3-(2-chlorovinyl)-1-pentyn-3-ol E.5 Ethinamate 1-ethynycyclohexyl carbamate E.6 Ethionamide 2-Ethylisonicotinamide E.7 Ethomoxane 2-n-Butylaminomethyl-8-ethoxy-benzo-1,4-dioxan E.9 Etryptamine 3-(2-Aminobutyl) indole E.10 Etymemazine 10-(3-Dimethylamino-2-methylpropyl)-2-ethylphenothiazine F.1 Fluphenazine 10-(3-[4-(2-Hydroxyethyl) piperazin-1-yl propyl)-2-tri-fluoromethylphenothiazine F.2 Furosemide 4-Chloro-N-furfuryl-5 sulphamoylanthranilic acid: Frusemide (B.A.N.) G.1 Glyburide 5-chloro-N-[2-[[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxy benzamide: 1-[4-[2-(5-chloro-2-methoxybenzamido)ethyl]phenyl]-sulfonyl-3-cyclohexylurea: Glibenclamide H.1 Haloperidol 4-(4-Chlorophenyl)-1-[3-(4-fluorobenzoyl)-propyl]-piperidin-4-ol: 4-[4-(p-Chlorophenyl)-4-hydroxy-piperidino]-4-fluoro-butyrophenone H.2 Hydroxychloroquine 7-Chloro-4[4-(N-ethyl-N-2-hydro-xyethylamino)-1-methylbutyl-amino] quinoline H.3 Hydroxyzine 1-(p-chloro-p-phenylbenzyl)-4-(2-hydroxy ethoxyethyl) piperazine

I

1 Idoxuridine 5-Iodo-2'-deoxyuridine

I

2 Imipramine 5-(3-dimethylaminopropyl)-10,11-dihydro-5H-dibenz[b,f]azepine

I

3 Indomethacin 1-(p-Chlorobenzoyl)-5-methoxy-2-methyl-indole-3-acetic acid

I

4 Iproniazid 1-isonicotinoyl-2-isopropylhydrazide

I

5 Isocarboxazid 3-N-Benzylhydrazinocarbonyl-5-methylisoxazole

I

6 Isoproterenol .............................................................. 3,4-Dihydroxy-α-[isopropylamino] methyl benzyl alcohol: Isoprenaline

L

1 Liothyronine ............................................................... Lα-Amino-3-[4-(4-hydroxy-3-iodophenoxy)-3,5-di-iodo- phenyl] propionic acid

M

1 Mefenamic acid ......................................................... N-(2,3-Xylyl) anthranilic acid

M

2 Melphalan ................................................................. 4-[Di-(2-chlorethyl)amino]-L-phenylalanine

M

4 Mephenesin ............................................................. 3-o-toloxy-1,2-propanediol

M

6 Meprobamate ......................................................... 2,2-di(carboamoylmethyl) pentane

M

7 Methaqualone ......................................................... 2-Methyl-3-o-tolylquinazolin-4-one: 2-Methyl-3-o- tolyl-4-quinazolone

M

8 Methisazone ............................................................ 1-Methylindoline-2,3-dione-3-thiosemicarbazone: N- Methylisatin-3-thiosemicarbazone

M

9 Methotrimeprazine .................................................. 10-[3-(2-Methyl)dimethylamino propyl]-2- methoxyphenothiazine: Levomepromazine

M

10 Methyldopa ............................................................. 1-3(3,4-Dihydroxyphenyl)-2-methylalanine

M

11 Methylparafynol ...................................................... 3-methyl-1-pentyn-3-ol: Methylpentynol

M

12 Methylphenidate ..................................................... Methyl-1-phenyl-1-(2-piperidyl) acetate

M

13 Methylprylon ........................................................... 3,3-diethyl-5-methyl-2,4-piperidinedione

M

14 Methysergide ......................................................... 1-(Hydroxymethyl)propylamide of 1-methyl-d-lysergic acid

M

15 Metyrapone ............................................................ 2-Methyl-1,2-di(3-pyridyl)propan-1-one N.1 Nalidixic Acid ........................................................... 1-Ethyl-7-methyl-4-oxo-1,8-naphthyridine-3-carboxylic acid N.2 Nialamide ................................................................. 1-[2-(benzcarbamyl)ethyl]-2-isonicotinoyl-hydrazine N.3 Nortriptyline ............................................................ 3-(3-Methylaminopropylidene)-1,2, 4,5- dibenzocyclohepta-1,4-diene O.2 Oxazepam ............................................................... 7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-1,4- benzodiazepin-2H-one O.3 Oxyphenbutazone ................................................... 4-n-Butyl-2-(4-hydroxyphenyl)-1-phenyl- pyrazolidine-3,5-dione P.1 Paramethadione ...................................................... 3,5-dimethyl-5-ethyl-2,4-oxazolidinedione P.2 Pargyline ................................................................. N-Benzyl-N-methylpro-2-ynylamine P.3 Pemoline ................................................................. 2-Imino-5-phenyloxazolidin-4-one P.4 Pentazocine ............................................................ 1,2,3,4,5,6-Hexahydro-6-hydroxy-6,11-dimethyl-3-(3- methyl-but-2-enyl)-2,6-methano-3-benzazocin-8-ol P.5 Pentolinium Tartrate ............................................... NN'-Pentamethylene-(methylpyrrolidinium hydrogen, tartrate) P.6 Perphenazine .......................................................... 2-chloro-10-[3-(1-(2-hydroxyethyl)-4- piperazinyl)propyl] phenothiazine P.7 Phacetoperane ....................................................... 1-Phenyl-1(2'-piperidyl)-1-acetoxymethane P.8 Phenacemide ......................................................... (Phenylacetyl)urea P.9 Phenacetin ............................................................. p-acetphenetidin: Acetphenetidin: Acetophenetidin: p- ethoxyacetanilid P.10 Phenalglycodol ...................................................... 2-p-chlorophenyl-3-methyl-2,3-butanediol P.12 Phenelzine ............................................................. 2-phenylethylhydrazine P.13 Phenformin ............................................................ N'-ß-phenethylformamidiniomurea P.16 Phentermine .......................................................... α, α-Dimethylphenethylamine: phenyl-tert-butylamine P.17 Phenylindanedione ................................................ 2-phenylindane-1,3-dione P.19 Pholedrine ............................................................. p-(4'-hydroxyphenyl)-isopropylmethylamine P.20 Piperilate ............................................................... 1-piperidine-ethan benzoate P.21 Pipradol ................................................................. Diphenyl-2-piperidylmethanol P.22 Prochlorperazine ................................................... 2-Chloro-10-[3-(1-methyl-4-piperazinyl) propyl]phenothiazine P.23 Prodilidine ............................................................. 1,2-Dimethyl-3-pyrrolidinyl propionate P.24 Propranolol ............................................................ 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol P.25 Protriptyline ........................................................... 9-(3-Dimethylaminopropyl)-10-thia-1,9-diaza-anthracene P.26 Protriptyline ........................................................... 7-(3-Methylaminopropyl)-1,2:5,6-dibenzocycloheptatrien: N-Methyl-5H-dibenzo [a, d] cycloheptene-5-propylamine P.27 Pyrazinamide ......................................................... Pyrazinoic acid amide S.01 Sodium Cromoglycate .......................................... 4H-1-Benzopyran-2-carboxylic acid, 5,5'-[2-hydroxy-1,3-propanediyl] bis(oxy)]bis[4-oxo-,disodium salt]: Disodium 5,5'-(2-hydroxytrimethylenedioxy) bis(4-oxo-4H-1-benzopyran-2- carboxylate): Disodium 4,4'-dioxo-5,5'-(2-hydroxytrimethylenedioxy)di (chromene-2-carboxylate): Cromolyn Sodium (USP): Disodium Cromoglycate S.1 Sulfameter ............................................................. 2-(4-Aminobenzenesulphonamido)-5-methoxypyrimidine: N'-(5-methoxy-2-pyrimidinyl) sulfanilamide: Sulfamethoxydiazine (B.A.N.) S.2 Sulfamethazine ...................................................... N'-(4,6-dimethyl-2- pyrimidyl)sulfanilamide: 2-(p-aminobenzenesulphonamide)-4,6-dimethylpyrimidine: sulphadimethine S.3 Sulfinpyrazone ....................................................... 1,2-diphenyl-4-[2-(phenylsulfinyl)ethyl]-3-pyrazolidinedione S.4 Sulfisoxazole ......................................................... 3,4-dimethyl-5-sulfanilamidisoxazole: Sulphafurazole T.1 Tetracaine .............................................................. 2-dimethylaminoethyl-p-n- butylaminobenzoate: Amethocaine T.2 Thiethylperazine .................................................... 2-Ethylthio-10-[3-(4- methylpiperazin-1-yl) propyl]phenothiazine T.3 Thiopropazate ......................................................... 2-chloro-10-[3-(1'-2-acetoxyethyl)-4-piperazinyl] propyl]phenothiazine T.4 Thioproperazine ..................................................... 2-Dimethylsulphamoyl-10-[3-(4-methylpiperazin-1-yl)-propyl]phenothiazine T.6 Tranylcypromine .............................................. Trans d, 1-2-phenylcyclopropyl-amine T.7 Triamterene ....................................................... 2,4,7-Triamino-6-phenylpteridine T.8 Triflupromazine ............................................... 10-(3-dimethylaminopropyl)-2-trifluoromethylphenothiazine: Fluopromazine T.10 Trimethadione ................................................ 3,5,5-trimethyl-2,4-oxazolidine-dione: Troxidone T.11 Trimipramine .................................................. 5-(3-Dimethylamino-2-methylpropyl)-10,11-dihydro-5H-dibenzo[b,f]azepine: 5-[3'-Dimethylamino-2'-methylpropyl]iminodibenzyl T.12 Tybamate ......................................................... 2-Methyl-2-propyltrimethylene butylcarbamate carbamate: 2-(Hydroxymethyl)-2-methyl-pentyl butylcarbamate carbamate TABLEAU Poste no Noms propres .............................................. Noms chimiques et synonymes A.1 Acépromazine .................................................. 2-acétyl-10-(3-diméthylaminopropyl) phénothiazine A.2 Acétaminophène .............................................. p-acétaminophénol, paracétamol, p-hydroxyacétanilide: N-acétyl-p aminophénol A.3 Acétanilide ....................................................... Acétylaminobenzène: antifébrile: phénylacétamide A.4 Acide acétylsalicylique .................................... Acide acétylsalicylique A.5 Allopurinol ......................................................... 1-H-Pyrazolo[3,4-d] pyrimidin-4-ol: 4-Hydroxypyrazolo(3,4-d) pyrimidine A.6 Amantadine ...................................................... 1-Adamantanamine A.7 Acide aminocaproïque .................................... ε-acide aminohéxanoïque A.8 Aminoptérine ................................................... N-4-(2,4-diamino-6-ptérydl méthyl) amino-benzoyl-L-acide glutamique A.9 Aminopyrine: amidopyrine ............................ 1,5-diméthyl-2-phényl-4-diméthylamino-3-pyrazolone: diméthylaminophénazone A.10 Amitriptyline ................................................... 3-(3-diméthylaminopropylidène)-1,2; 4,5-dibenzo(cyclohepta-1,4-diène A.11 Azacyclonol ..................................................... α,α-diphényl-4-pipéridine carbinol B.1 Bémégride ....................................................... 3-éthyl-3-méthylglutarimide B.2 Bénactyzine ..................................................... Diméthylaminoéthyl-1,1-diphénylglycolate B.3 Bendrofluméthiazide ..................................... 3-benzyl-3,4-dihydro-6-(trifluorométhyl)-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide: Bendrofluazide (B.A.N.) B.4 Bétahistine ....................................................... 2-[2-(Méthylamino)éthyl]pyridine B.5 Bétahindine ..................................................... N-Benzyl-N',N''-diméthylguanidine: 1-Benzyl-2,3-diméthylguanidine B.6 Brétylium (Tosylate de) .................................. Tosylate de N-2-bromobenzyl-N-éthyl-N,N-diméthylammonium (acide tosylique est le nom vulgaire de l'acide p-toluènesulfonique) B.7 Bromisoval ....................................................... 2-monobromo-isovalérylurée: bromisovalum: bromuré de méthylebutylurée

C

1 Calcium, carbimide de ................................... Cyanamide de calcium Poste no Noms propres Noms chimiques et synonymes

C

2 Captodiamine Sulfure de 4-butylthio-α-phénylbenzyl-2-diméthylaminoéthyl

C

3 Carisoprodol Dicarbamate de N-isopropyl-2-méthyl-2-propyl-1,3-propanediol

C

4 Carphénazine 1-10-[3(4-(2-hydroxyéthyl)-1-pipérazinyl) propyl] phénothiazine-2yl]-1-propanone

C

5 Céphaloridine 7-[2-Thiényl]acétamido-3-(1-pyridylméthyl)-3-céphèm-4-carboxylique acide bétainate

C

6 Chlormézanone 1-bioxyde de 2-(4-chlorophényl)-3-méthyl-4-méthiazalone-1: chlorméthazalone: chrométhazone

C

7 Chlorométhapyrilène N,N-diméthyl-N-[2-pyridyl]-N'-(5-chloro-2-éthynyl-éthyl)éthylènediamine: chlorothène

C

8 Chlorphénétermine 4-chloro-α,α-diméthylphénéthylamine

C

9 Cinchocaïne 2-butoxy-N-(2-diéthylaminoéthyl) cinchoninamide: dibucaïne

C

10 Cinchonphène Acide carboxylique de 2-phénylquinoléine-4-quinophénone

C

11 Clofibrate Éthyl 2-[p-Chlorophénoxy]-2-méthylpropionate

C

12 Clomiphène 1-Chloro-2-[4-(2-diéthylaminoéthoxy)phényl]-1,2-diphényléthylène: 2-[p-(2-Chloro-1,2-diphényléthyl)phénoxy]triéthylamine

D

1 Désipramine 5-(3-méthylamino-2-méthylpropyl)-10,11-dihydro-5H-dibenz[b,f]azépine

D

2 Diazépame 7-chloro-1,3-dihydro-1-méthyl-5-phényl-2H-1,4-benzodiazépine-2-one

D

3 Diéthylpropion 1-phényl-2-diéthylaminopropanone-1

D

4 Diphénidol 1,1-Diphényl-4-pipéridinobutan-1-ol

D

5 Disulfirame Bisulfure de tétraéthylthiurame E.1 Éctylurée 2-éthyl-cis-crotonylurée E.2 Émylcamate Carbamate de 2-éthyl-1-méthylpropyl E.3 Éthacrynique (Acide) [2,3-Dichloro-4-(2-méthylènebutyryl) phénoxy]acétique acide: 2,3-Dichloro-4-(2-éthylacryloyl)phénoxyacétique acide E.4 Ethchlorvynol 3-(2-chlorovinyl)-1-pentyn-3-ol E.5 Éthinamate Carbamate de 1-éthynylcyclohexyl E.6 Éthionamide 2-éthylisonicotinamide E.7 Éthomoxane 2-n-butylaminométhyl-8-éthoxybenzo-1,4-dioxane E.8 Éthyl (Trichloramate d') Carbamate d'éthyl [n-1-(2,2,2-trichloro-1-hydroxyéthyl)] E.9 Étryptamine 3-(2-aminobutyl) indole E.10 Étymémazine 10-(3-diméthylamino-2-méthylpropyl)-2-éthylphénothiazine F.1 Fluphénazine 10-[3-[4-(2-hydroxyéthyl)pipérazine-1-yl]propyl]-2-trifluorométhylphénothiazine F.2 Furosémide 4-Chloro-N-furfuryl-5-sulphamoylanthranilique acide: frusémide (B.A.N.) G.1 Glyburide [[chloro-5 méthoxy-2 benzamido]-2 éthyl]-4 phénylsulfonyl]-1-cyclohexyl-3 urée: Glibenclamide Poste no Noms propres Noms chimiques et synonymes H.1 Halopéridol 4-(4-Chlorophényl)-1-[3-(4-fluorobenzoyl) propyl]-pipéridine-4-ol-4-[4-(4-Chlorophényl)-4-hydroxypipéridinyl]-4-fluorobutyrophénone H.2 Hydroxychloroquine 7-chloro-4-[4-(N-éthyl-N-2-hydroxyéthylamino)-1-méthylbutyl-amino] quinoline H.3 Hydroxyzine 1-(p-chloro-α-phénylbenzyl)-4-(2-hydroxy éthoxyéthyl) pipérazine

I

1 Idoxuridine 5-iodo-2′-désoxyuridine

I

2 Imipramine 5-(3-diméthylaminopropyl)-10,11-dihydro-5H-dibenzo[b,f]azépine

I

3 Indométhacine Acide acétique de 1-(p-chlorobenzoyl)-5-méthoxy-2-méthylindole-3

I

4 Iproniazide 1-isonicotinoyl-2-isopropylhydrazine

I

5 Isocarboxazide 3-N-benzylhydrazinocarbonyl-5-méthylisoxazole

I

6 Isoprotérénol Alcool benzylique de 3,4-dihydroxy-α-(isopropylamino)methyl)-isoprotérénine

L

1 Liothyronine Acide propionique de L-α-amino-3-(4-hydroxy-3-iodophényl)-3-iodo-1-propanol

M

1 Méfénamique (Acide) Acide anthranilique de N-(2,3-xylil)

M

2 Méprobamate 2,2-di(carbamoylméthyl) pentane

M

3 Mépazine 10-(3′-m-3′-pipéridyl)phénylphénothiazine

M

4 Méphénésine 1-(o-crésyl)-2-méthoxyéthanol

M

5 Méphénoxalone 5-(o-méthoxyphénométhyl)-2-oxazolidinone

M

6 Méprobamate 2,2-di(carbamoylméthyl) pentane

M

7 Méthaqualone 2-méthyl-3-o-tolylquinazoline-4-one et 2-méthyl-3-o-tolyl-4-quinazolone

M

8 Méthisazone 1-Méthylindoline-2,3-dione-3-thiosemicarbazone: N-Méthylisatin-β-thiosemicarbazone

M

9 Méthotriméprazine 10-[3-(2-méthyl)diméthylamino propyl]-2-méthoxyphénothiazine: lévomépromazine

M

10 Méthyldopa 1-3-(3,4-dihydroxyphényl)-2-méthylalanine

M

11 Méthylparafynol 3-méthyl-1-pentyn-3-ol: méthylpentynol

M

12 Méthylphénidate Acétate de méthyl 1-phényl-1-[2-pipéridyl]

M

13 Méthylprylon 3,3-diéthyl-5-méthyl-2,4-pipéridinedione

M

14 Méthysergide Acide 1-méthyl-d-lysergique de 1-(hydroxyméthyl) propylamide

M

15 Métyrapone 2-méthyl-1,2-di(3′-pyridyl)propane-1-one N.1 Nalidixique (Acide) Acide carboxylique de 1-éthyl-7-méthyl-4-oxo-1,8-naphthyridine-3 N.2 Nialamide 1-(2-[benzylcarbonyl] éthyl)-2-isonicotinoylhydrazine N.3 Nortriptyline 3-(3-méthylaminopropylidène)-1,2:4,5-dibenzocyclohepta-1,4-diène O.1 Oxanamide 2-éthyl-3-propyl-glycicamide O.2 Oxazépam 7-chloro-1,3-dihydro-3-hydroxy-5-phényl-1,4-benzodiazépine-2-one O.3 Oxyphenbutazone 4-n-butyl-2(4-hydroxyphényl)-1-phénylpyrazolidine-3,5-dione P.1 Paraméthadione 3,5-diméthyl-5-éthyl-2,4-oxazolidinedione P.2 Pargyline N-benzyl-N-méthylprop-2-ynylamine Poste no Noms propres Noms chimiques et synonymes P.3 Pémoïne 2-imino-5-phényloxazolidine-4-one P.4 Pentazocine 1,2,3,4,5,6-Hexahydro-8-hydroxy-6,11-diméthyl-3-(3-méthylbut-2-ényl)-2,6-méthano-3-benzazocine : 1,2,3,4,5,6-Hexahydro-6,11-diméthyl-3-(3-méthyl-2-butényl)-2,6-méthano-3-benzazocine-8-ol P.5 Pentolinium (Tartrate de) NN’-pentaméthylènediiodure (tartrate d’hydrogène de méthylpyrrolidinium) P.6 Perphénazine 2-chloro-10-[3-[1-(2-hydroxyéthyl)-4-pipérazinyl]propyl] phénothiazine P.7 Phacétopérane 1-1-phényl-1-(2’-pipéridyl)-1-acétoxyméthane P.8 Phénacémide Phénylacétylurée P.9 Phénacétine p-acétphénétidine : acétphénétidine : acétophénétidine : p-éthoxy-acétanilide P.10 Phénalygcol 2-p-chlorophényl-3-méthyl-2,3-butanediol P.11 Phénédimétrazine 3,4-diméthyl-2 phénylmorpholine P.12 Phénélzine 2-phényléthylhydrazine P.13 Phénéformine N’-ß-phénylformamidinylniorurée P.14 Phéniprazine α-méthylphénylhydrazine P.15 Phénmétrazine Tétrahydro-3-méthyl-2-phényl-1,4-oxazine : 3-méthyl-2-phénylmorpholine P.16 Phénétermine α,α-diméthylphényléthylamine : phényl-tert-butylamine P.17 Phénmédinédione 2-méthyl-1,3-indandione P.18 Phénylotoxamine N,N-diméthyl-2-(α-phényl-o-tolyloxy) éthylamine P.19 Pholéridine p-(4-hydroxyphényl)-isopropylméthylamine P.20 Pipérilate Benzilate de 1-pipéridine-éthanol P.21 Pipradrol Diphényl-2-pipéridylméthanol P.22 Prochlorpérazine 2-chloro-10-[3-(1-méthyl-4-pipérazinyl)propyl]phénothiazine P.23 Prodilidine Propionate de 1,2-diméthyl-3-phényl-3-pyrrolidinyl P.24 Propranolol 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol P.25 Prothiépéndyl 9-(3-diméthylaminopropyl)-10-thia-1,9-diaza-anthracène P.26 Protriptyline 7-(3-Méthylaminopropyl)-1,2,5,6-dibenzo[c]heptatriène : N-Méthyl-5H-dibenzo [a,d] cycloheptène-5-propylamine P.27 Pyrazinamide Amide acido-pyrazinoïque R.1 Rifampin 3-[(4-méthyl-1-pipérazinyl)imino]méthyl rifamycine SV : Rifampicine (I.N.N.) (Rifamycine SV, antibiotique produit par le streptomyces mediterranei) S.01 Cromoglicate sodique Sel disodique de l’acide (hydroxy-2 triméthylène-dioxy-5,5’-bis(oxy)-5,5’-bis(oxo-4H) α-benzopyrane-carboxylique-2) : (Hydroxy-2 triméthylènedioxy)-5,5’-bis(oxo-4H) α-benzopyrane-carboxylate 2)-disodique : Dioxo-4,4’-(hydroxy-2 triméthylènedioxy)-5,5’-bis(benzopyrane-carboxylate-2) disodique : Cromolyn sodium (USP) : Cromoglicate disodique : bis(carboxylate-2 de sodium oxo-4 chroményl-5 oxy)-1,3 propanol-2. Poste no | Noms propres | Noms chimiques et synonymes ---|---|--- S.1 | Sulfameter | 2-(4-Aminobenzènesulphonamido)-5-méthoxypyrimidine : N'-(5-méthoxy-2-pyrimidinyl) sulfanilamide : Sulfaméthoxydiazine (B.A.N.) S.2 | Sulfaméthazine | N'-(4,6-diméthyl-2-pyrimidyl) sulfanilamide : 2-(p-aminobenzènesulfonamide)-4,6-diméthylpyrimidine : sulfadimédine S.3 | Sulfinpyrazone | 1,2-diphényl-4-(2-pyridylsulfinéthyl)-3,5-pyrazolidinedione S.4 | Sulfisoxazole | 3,4-diméthyl-5-sulfanilamidoisoxazole : sulfafurazole T.1 | Tétracaïne | 2-diméthylaminoéthyl-p-n-butylaminobenzoate : améthocaïne T.2 | Thiéthylpérazine | 2-éthylthio-10-[3-(4-méthylpipérazine-1-yl)propyl] phénothiazine T.3 | Thiopropazate | 2-chloro-10-[3-[1-(2-acétoxyéthyl)-4-pipérazinyl]propyl] phénothiazine T.4 | Thiopropérazine | 2-diméthylsulphamoyl-10-[3-(4-méthylpipérazine-1-yl)-propyl]phénothiazine T.5 | Thioridazine | 10-[2-[2-(1-méthylpipéridyl)] éthyl]-2-méthylthiophénothiazine T.6 | Tranylcypromine | trans d, 1-2-phénylcyclopropylamine T.7 | Trimetrexate | 2,4,7-triamino-6-éthylpteridine T.8 | Triflupromazine | 10-[3-(diméthylamino)propyl]-2-trifluorométhylphénothiazine T.9 | Triméprazine | 10-(3-diméthylamino-2-méthylpropyl)phénothiazine T.10 | Triméthadione | 3,5,5-triméthyl-2,4-oxazolidinedione : troxidone T.11 | Trimipramine | 5-(3-diméthylamino-2-méthylpropyl)-10,11-dihydro-5H-dibenz [b,f]azépine : 5-(3-diméthylamino-2'-méthylpropyl)iminodibenzyl T.12 | Tybamate | 2-méthyl-2-propyltriméthylène butylcarbamate : 2-(hydroxyméthyl)-2-méthylpentyl butylcarbamate carbamate

V

1 | Vinblastine | Alcaloïde dérivé du Vinca rosea

V

2 | Vincristine | Alcaloïde dérivé du Vinca rosea SOR/80-544, s. 1.

C

01.004 (1) The inner and outer labels of a drug shall show (a) on the principal display panel

C

01.003 Il est interdit de vendre une drogue qui n’est pas étiquetée selon le présent règlement. DORS/80-544, art. 1.

C

01.004 (1) Les étiquettes intérieure et extérieure d’une drogue doivent porter a) sur l’espace principal : (i) le nom propre, s’il y a lieu, de la drogue inscrit immédiatement avant ou après la marque nominative de celle-ci, en caractères d’une taille au moins égale à la moitié de celle des caractères de la marque nominative, (ii) le nom usuel de la drogue à défaut d’un nom propre, (b) on the upper left quarter of the principal display panel (iii) si une norme est prescrite pour la drogue au titre de la présente partie, une déclaration attestant que la drogue est conforme à la norme canadienne, pour laquelle l’abréviation D.N.C. peut être utilisée, (iv) si une norme n’est pas prescrite pour la drogue au titre de la présente partie mais figure dans une publication mentionnée à l’annexe B de la Loi, le nom de la publication qui contient cette norme ou son abréviation donnée à l’annexe B de la Loi, ou, s’il s’agit d’une norme du fabricant, une déclaration en ce sens, (v) en français et en anglais, la mention « stérile » « sterile » s’il s’agit d’une drogue dont l’état stérile est exigé par le présent règlement; b) sur le quart supérieur gauche de l’espace principal : (i) le symbole « Pr », s’il s’agit d’une drogue sur ordonnance, lequel symbole ne peut figurer sur l’étiquette d’aucune autre drogue, (ii) le symbole « C » inscrit clairement, d’une couleur et de dimensions bien visibles, s’il s’agit d’une drogue contrôlée autre qu’une drogue contrôlée contenue dans un implant agricole et mentionnée à la partie III de l’annexe de la partie G, (iii) le symbole « N » d’une couleur faisant contraste avec le reste de l’étiquette ou en caractères d’au moins la moitié de la taille de toute autre lettre utilisée sur l’étiquette, s’il s’agit d’un stupéfiant au sens du Règlement sur les stupéfiants, (iv) s’il s’agit d’une substance ciblée au sens de l’article 1 du Règlement sur les benzodiazépines et autres substances ciblées, le symbole suivant, d’une couleur contrastant avec le reste de l’étiquette et en caractères d’au moins la moitié de la taille de toute autre lettre utilisée sur l’espace principal : c) sur une partie quelconque : (i) le nom et l’adresse du fabricant de la drogue, (ii) le numéro de lot de la drogue, "HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS. SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN." (1.1) to (1.5) [Repealed, SOR/2014-158, s. 3] (iii) le mode d’emploi approprié de la drogue, sauf s’il s’agit d’une drogue à laquelle s’applique l’article C.01.004.02, (iv) une liste quantitative des ingrédients médicinaux de la drogue, désignés par leurs noms propres ou, à défaut, par leurs noms usuels, sauf s’il s’agit d’une drogue à laquelle s’applique l’article C.01.004.02, (v) la date limite d’utilisation de la drogue, (vi) dans le cas d’une drogue nouvelle pour usage exceptionnel à l’égard de laquelle un avis de conformité a été délivré en application de l’article C.08.004.01, la mention suivante, inscrite en majuscules et de façon lisible: « SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN. » (1.1) à (1.5) [Abrogés, DORS/2014-158, art. 3]

(2)

Outre les exigences du paragraphe (1), les renseignements ci-après figurent sur l’étiquette extérieure d’une drogue : a) le contenu net du contenant de la drogue, en termes de poids, de volume ou de nombre; b) dans le cas d’une drogue à usage parentéral, une liste quantitative de tous les agents de conservation incorporés à la drogue, désignés par leurs noms propres ou, à défaut, par leur nom usuel; c) dans le cas d’une drogue pour usage humain qui contient du mercure ou l’un de ses sels ou dérivés utilisé comme agent de conservation, une liste quantitative de tous les agents de conservation mercuriels incorporés à la drogue, désignés par leurs noms propres ou, à défaut, par leur nom usuel.

(3)

Lorsque le contenant d’une drogue est trop petit pour avoir une étiquette intérieure conforme aux exigences du présent règlement, la drogue est soustraite à ces exigences d’étiquetage : a) s’il y a une étiquette extérieure conforme aux dispositions d’étiquetage du présent règlement; et (b) the inner label shows (vi) the name of the manufacturer of the drug, (vii) the expiration date of the drug, and

(4)

[Repealed, SOR/92-654, s. 2] (a) a drug sold to a drug manufacturer; or

C

01.004.01 (1) Every label of a drug for human use in dosage form shall display the following: b) si l’étiquette intérieure indique (i) le nom propre de la drogue, à défaut, son nom usuel, ou la marque nominative s’il s’agit d’une drogue renfermant plus d’un ingrédient médicinal, (ii) l’activité de la drogue, sauf si, dans le cas d’une drogue renfermant plus d’un ingrédient médicinal, le nom utilisé conformément au sous-alinéa (i) est unique en ce qui a trait à une activité particulière de la drogue, (iii) le contenu net du récipient de la drogue, s’il ne s’agit pas d’une drogue sous une forme posologique déterminée, (iv) la voie d’administration si elle ne s’agit pas de la voie orale, (v) le numéro de lot de la drogue, (vi) le nom du fabricant de la drogue, (vii) la date limite d’utilisation de la drogue, (viii) l’indication de caractéristiques spéciales de la forme posologique si elles ne sont pas manifestes d’après le nom de la drogue visé au sous-alinéa (i) ou (ii).

(4)

[Abrogé, DORS/92-654, art. 2]

(5)

Le présent article ne s’applique pas a) à une drogue vendue à un fabricant de drogues; ni b) à une drogue vendue sur ordonnance si l’étiquette de la drogue porte la mode d’emploi propre à l’usage de la drogue et est conforme à l’article C.01.005.

C

01.004.01 (1) Toute étiquette d’une drogue pour usage humain sous forme posologique porte ce qui suit : a) le numéro de téléphone, l’adresse électronique, l’adresse du site Web ou l’adresse postale d’une personne-ressource au Canada, ou tout autre renseignement permettant de contacter cette personne-ressource; b) une mention que tout préjudice à l’égard de la santé d’une personne soupçonné d’être lié à l’utilisation de la drogue peut être porté à l’attention de cette personne-ressource.

(2)

Subsection (1) does not apply to SOR/2014-158, s. 4. (a) adequate directions for use of the drug; (d) the information referred to in subsection C.01.004.01(1). (a) in the case where a bilingual table referred to in subsection (1) is displayed, the expressions “flavour/ saveur”, “fragrance/parfum” and “pharmaceutical ink/ encre pharmaceutique”; or

(2)

Le paragraphe (1) ne s’applique pas : a) aux étiquettes d’une drogue mentionnée aux annexes C ou D de la Loi et qui est sous forme posologique; b) aux étiquettes intérieure et extérieure d’une drogue à laquelle s’applique l’article C.01.004.02. DORS/2014-158, art. 4.

C

01.004.02 (1) Outre les exigences de l’article C.01.004, l’étiquette extérieure d’une drogue pour usage humain sous forme posologique porte soit un tableau bilingue, placé sur un espace quelconque, qui ne présente que les renseignements ci-après en français et en anglais, soit un tableau en français et un tableau en anglais, chacun placé sur un espace quelconque, qui ne présentent que ces renseignements : a) le mode d’emploi approprié de la drogue; b) une liste quantitative des ingrédients médicinaux de la drogue, désignés par leurs noms propres ou, à défaut, par leurs noms usuels; c) la liste des ingrédients non médicinaux de la drogue, présentés par ordre alphabétique ou par ordre décroissant de leur proportion respective dans celle-ci, précédée d’une mention qui les distingue clairement des ingrédients médicinaux; d) les renseignements visés au paragraphe C.01.004.01(1).

(2)

Dans le cas où l’emballage est trop petit pour avoir une étiquette extérieure qui fournit soit un tableau bilingue qui donne la liste des ingrédients non médicinaux, soit deux tableaux unilingues qui donnent cette liste, celle-ci est présentée en français et en anglais sur une étiquette mobile, un ruban ou une carte attachés à l’emballage.

(3)

Dans le cas où une encre pharmaceutique, un parfum ou une saveur sont ajoutés à la drogue, les mentions ci-après peuvent remplacer, dans la liste des ingrédients non médicinaux, l’énumération de chacun des ingrédients en question, pour en indiquer l’ajout : a) s’agissant du tableau bilingue visé au paragraphe (1), les mentions « encre pharmaceutique/pharmaceutical ink », « parfum/fragrance » ou « saveur/ flavour »; b) s’agissant des tableaux unilingues visés au paragraphe (1) : (i) “encre pharmaceutique”, “parfum” and “saveur” in the table in French, and

(6)

Subsections (1) to (5) do not apply to (a) prescription drugs; SOR/2014-158, s. 5; SOR/2017-18, s. 23; SOR/2018-69, s. 13; SOR/2021-46, s. 5.

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01.004.03 In addition to the requirements of section C.01.004, the inner label of a drug to which section C.01.004.02 applies shall display on any panel (a) adequate directions for use of the drug; (i) pour ce qui est du tableau en français, les mentions « encre pharmaceutique », « parfum » ou « saveur », (ii) pour ce qui est du tableau en anglais, les mentions « flavour », « fragrance » ou « pharmaceutical ink ».

(4)

Dans le cas où la composition de la drogue varie de lot en lot relativement à ses ingrédients non médicinaux : a) s’agissant du tableau bilingue visé au paragraphe (1), ce tableau porte une mention de tout substitut d’ingrédient non médicinal susceptible de se trouver dans la drogue, précédée du symbole « +/- » ou « ± » ou de la mention « ou/ou » ou « peut contenir/may contain »; b) s’agissant des tableaux unilingues visés au paragraphe (1) : (i) pour ce qui est du tableau en français, ce tableau porte une mention de tout substitut d’ingrédient non médicinal susceptible de se trouver dans la drogue, précédée du symbole « +/- » ou « ± » ou de la mention « ou » ou « peut contenir », (ii) pour ce qui est du tableau en anglais, ce tableau porte une mention de tout substitut d’ingrédient non médicinal susceptible de se trouver dans la drogue, précédée du symbole « +/- » ou « ± » ou de la mention « or » ou « may contain ».

(5)

Pour l’application des alinéas (3)a) et (4)a), les termes anglais des mentions qui y sont prévues peuvent paraître en premier.

(6)

Les paragraphes (1) à (5) ne s’appliquent pas : a) aux drogues sur ordonnance; b) aux drogues qui peuvent être vendues sans ordonnance mais à administrer uniquement sous la surveillance d’un praticien; c) aux drogues qui sont présentées comme étant destinées exclusivement à la désinfection de surfaces dures non poreuses. DORS/2014-158, art. 5; DORS/2017-18, art. 23; DORS/2018-69, art. 13; DORS/2021-46, art. 5.

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01.004.03 Outre les exigences de l’article C.01.004, l’étiquette intérieure d’une drogue à laquelle s’applique l’article C.01.004.02 porte, sur un espace quelconque : a) le mode d’emploi approprié de la drogue; (c) the information referred to in subsection C.01.004.01(1). SOR/2014-158, s. 5. SOR/82-524, s. 1; SOR/93-475, s. 1; SOR/97-12, s. 2.

(2)

Subsection (1) does not apply to (iii) the name of the drug’s manufacturer.

(4)

and (5) [Repealed, SOR/81-248, s. 1] SOR/81-248, s. 1; SOR/93-202, s. 3; SOR/98-423, s. 2; SOR/2001-181, s. 4; SOR/2017-259, s. 2; SOR/2018-69, s. 2; SOR/2018-178, s. 1. (a) the opioid will be, or is, administered under the supervision of a practitioner; or SOR/2018-77, s. 2.

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01.008 [Repealed, SOR/80-544, s. 2] SOR/2017-18, s. 13. SOR/2013-122, s. 6; SOR/2014-158, s. 2; SOR/2017-18, art. 21(F); SOR/2018-69, s. 14(F); SOR/2021-46, s. 10.

(2)

[Repealed, SOR/93-243, s. 2] SOR/93-243, s. 2; SOR/2018-69, ss. 31(E), 32(F). SOR/89-455, s. 2; SOR/94-36, s. 1; SOR/2018-69, s. 27. SOR/2018-69, ss. 15, 27. SOR/2017-76, s. 2. SOR/81-248, s. 2; SOR/92-12, s. 3; SOR/2013-179, s. 1; SOR/2017-259, s. 3; SOR/2018-77, s. 3; SOR/2024-132, s. 85. (h) the name and quantity of each colouring ingredient that is not a medicinal ingredient; (j) the recommended dosage of the drug; SOR/2014-158, s. 2; SOR/2022-45, s. 4; SOR/2018-423, s. 3; SOR/2011-88, s. 2; SOR/2014-158, s. 7; SOR/2017-259, s. 4; SOR/2018-89, ss. 27, 33(F). (a) sets out (i) sets out (i) a new drug submission under section C.08.002, (ii) an abbreviated new drug submission under section C.08.002.1, or (iii) a supplement to a new drug submission or abbreviated new drug submission under section C.08.003. designated COVID-19 drug has the same meaning as in section C.08.001.1. (drogue désignée contre la COVID-19) SOR/2018-77, s. 4; SOR/2021-45, s. 2. SOR/81-248, s. 2; SOR/98-423, s. 6; SOR/2014-158, s. 8; SOR/2017-259, s. 6; SOR/2018-89, s. 27. (a) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(a) to (f) (b) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(g) to (k) SOR/81-248, s. 2; SOR/92-203, s. 2; SOR/98-423, s. 6; SOR/2016-139, s. 2; SOR/2018-89, s. 27. SOR/81-248, s. 2; SOR/2017-259, s. 7; SOR/2018-69, ss. 27, 39.

(4)

For greater certainty, the Minister’s power to cancel the assignment of a drug identification number SOR/81-248, s. 2; SOR/2016-139, s. 3; SOR/2017-259, s. 7; SOR/2018-69, ss. 27, 39; SOR/2018-84, ss. 1, 3; SOR/2020-262, s. 1. a) le fabricant à qui a été délivré le document prévu au paragraphe C.01.014.2(1) qui indique l’identification numérique contrevient à l’article C.01.014.5; b) le fabricant à qui a été délivré le document prévu au paragraphe C.01.014.2(1) qui indique l’identification numérique a été avisé, en application de l’article C.01.013, que les preuves qu’il a fournies concernant la drogue sont insuffisantes; c) la drogue est une drogue nouvelle pour laquelle l’avis de conformité a été suspendu en vertu de l’article C.08.006.

(3)

Le ministre peut annuler l’identification numérique attribuée à une drogue si, après qu’il a ordonné en vertu de l’article 21.31 de la Loi au titulaire d’une autorisation relative à un produit thérapeutique visée aux sous-alinéas C.01.052(1)a)(i) ou (iii) d’effectuer une évaluation de la drogue en vue de fournir des preuves établissant que les bénéfices liés à la drogue l’emportent sur les risques de préjudice à la santé, a) le titulaire ne se conforme pas à l’ordre; b) le titulaire se conforme à l’ordre, mais le ministre conclut que les résultats de l’évaluation ne sont pas suffisants pour établir que les bénéfices liés à la drogue l’emportent sur les risques de préjudice à la santé.

(4)

Il est entendu que le pouvoir du ministre d’annuler l’identification numérique attribuée à une drogue : a) en vertu de l’alinéa (2)b) n’a pas d’incidence sur son pouvoir d’annuler une telle identification en vertu du paragraphe (3); b) en vertu du paragraphe (3) n’a pas d’incidence sur son pouvoir d’annuler une telle identification en vertu de l’alinéa (2)b). DORS/81-248, art. 2; DORS/2016-139, art. 3; DORS/2017-259, art. 7; DORS/2018-69, art. 27 et 39; DORS/2018-84, art. 1 et 3; DORS/2020-262, art. 1. Pénuries de drogues et interruption et cessation de la vente de drogues

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01.014.7 Le fabricant à qui a été délivré le document prévu au paragraphe C.01.014.2(1) qui indique l’identification numérique attribuée à une drogue fournit au ministre, dans les trente jours suivant la cessation de la vente de cette drogue, les renseignements suivants : a) l’identification numérique attribuée à la drogue; b) la date à laquelle il a cessé la vente de la drogue; SOR/81-248, s. 8; SOR/2016-139, s. 5; SOR/2017-259, s. 8. SOR/2017-259, s. 8. SOR/2017-259, s. 8. (b) prescription drugs; SOR/2016-139, s. 5; SOR/2018-69, ss. 17, 40; SOR/2021-199, s. 1. (f) the drug’s strength; (g) the drug’s dosage form; (i) the drug’s route of administration; (l) the actual or anticipated reason for the shortage.

(2)

The manufacturer shall post the information les renseignements ci-après, en français et en anglais, sur un site Web exploité à cette fin par un contractant avec lequel Sa Majesté du chef du Canada a conclu un contrat pour rendre cette information disponible au public : a) son nom, ainsi que ses numéro de téléphone, adresse électronique, adresse de site Web ou adresse postale ou tout autre renseignement permettant de communiquer avec lui; b) l’identification numérique attribuée à la drogue; c) la marque nominative de la drogue et son nom propre ou, à défaut, son nom usuel; d) le nom propre des ingrédients médicinaux de la drogue ou, à défaut, leur nom usuel; e) la classification thérapeutique de la drogue dans le système de classification anatomique, thérapeutique et chimique (ATC), établi par le Centre collaborateur de l’Organisation mondiale de la Santé pour la méthodologie sur l’établissement des statistiques concernant les produits médicamenteux, à savoir sa description de niveau 3 son code de niveau 4; f) la concentration de la drogue; g) la forme posologique de la drogue; h) la quantité de drogue contenue dans l’emballage; i) la voie d’administration de la drogue; j) la date réelle ou prévue du début de la pénurie; k) la date à laquelle il est prévu que le fabricant sera capable de répondre à la demande pour la drogue, dans la mesure où ce dernier peut prévoir une telle date; l) la raison réelle ou prévue de la pénurie.

(2)

Le fabricant affiche les renseignements : a) s’il prévoit que la pénurie débutera dans plus de six mois, au moins six mois avant la date à laquelle il prévoit que la pénurie débutera; b) s’il prévoit que la pénurie débutera dans six mois ou moins, dans les cinq jours qui suivent la date où il établit cette prévision; c) s’il n’a pas prévu la pénurie, dans les cinq jours qui suivent la date où il en constate l’existence. SOR/2016-139, s. 5; SOR/2017-259, s. 9; SOR/2021-199, s. 2. (f) the drug’s strength; (g) the drug’s dosage form; (i) the drug’s route of administration; (k) the reason for the discontinuation of sale.

(2)

The manufacturer shall post the information

(3)

Si les renseignements affichés changent, le fabricant les met à jour sur le site Web dans les deux jours suivant la date à laquelle il fait ou constate le changement.

(4)

Dans les deux jours suivant la date à laquelle il est capable de répondre à la demande pour la drogue, le fabricant le signale sur le site Web.

(5)

Le présent article ne s’applique pas à l’égard de la pénurie d’une drogue qui résulte de la décision du fabricant d’en cesser la vente. DORS/2016-139, art. 5; DORS/2017-259, art. 9; DORS/2021-199, art. 2.

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01.014.10 (1) Si le fabricant à qui a été délivré le document prévu au paragraphe C.01.014.2(1) qui indique l’identification numérique attribuée à une drogue décide de cesser la vente de la drogue, il affiche les renseignements ci-après, en français et en anglais, sur le site Web visé au paragraphe C.01.014.9(1) : a) son nom, ainsi que son numéro de téléphone, adresse électronique, adresse de site Web ou adresse postale ou tout autre renseignement permettant de communiquer avec lui; b) l’identification numérique attribuée à la drogue; c) la marque nominative de la drogue et son nom propre ou, à défaut, son nom usuel; d) le nom propre des ingrédients médicinaux de la drogue ou, à défaut, leur nom usuel; e) la classification thérapeutique de la drogue dans le système de classification anatomique, thérapeutique et chimique (ATC), établi par le Centre collaborateur de l’Organisation mondiale de la Santé pour la méthodologie sur l’établissement des statistiques concernant les produits médicaux, à savoir sa description de niveau 3 et son code de niveau 4; f) la concentration de la drogue; g) la forme posologique de la drogue; h) la quantité de drogue contenue dans l’emballage; i) la voie d’administration de la drogue; j) la date à laquelle le fabricant cessera la vente de la drogue; k) la raison de la cessation de la vente.

(2)

Le fabricant affiche les renseignements : SOR/2016-139, s. 5; SOR/2017-259, s. 10. SOR/2016-139, s. 5; SOR/2017-259, s. 11.

(2)

The manufacturer or licensee shall provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. SOR/2021-199, s. 3. SOR/2021-199, s. 3. Tablet Disintegration Times (b) [Repealed, SOR/98-423, s. 7] SOR/89-428, s. 2; SOR/98-455, s. 3; SOR/94-36, s. 2; SOR/98-423, s. 7; SOR/2011-88, s. 4. SOR/95-521, s. 2; SOR/2011-31, s. 1. [SOR/2019-190, s. 1] SOR/95-521, s. 2; SOR/2011-31, s. 1. (a) the annual summary reports; SOR/2011-31, s. 1. SOR/2017-76, s. 4.

(3)

The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the

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01.019 (4) The manufacturer shall submit the report within the specified period. SOR/2011-31, s. 1; SOR/2017-18, s. 14. SOR/2017-76, s. 5. Maintenance of Records

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01.020 (1) The manufacturer shall maintain records of the reports and case reports referred to in sections C.01.017 to C.01.019. SOR/2011-31, s. 1. Provision of Information Under Section 21.8 of Act (d) the drug identification number assigned for the drug, if applicable; (e) the patient’s age and sex; (f) a description of the serious adverse drug reaction; d) l’identification numérique qui a été attribuée à la drogue, le cas échéant; e) l’âge et le sexe du patient; f) une description de la réaction indésirable grave à une drogue; g) la date de la première consignation de la réaction indésirable grave à une drogue; h) la date à laquelle le patient a utilisé la drogue pour la première fois et, le cas échéant, la date à laquelle il a cessé de l’utiliser; i) la date à laquelle la réaction indésirable grave à une drogue s’est produite pour la première fois et, le cas échéant, celle à laquelle l’état de santé du patient antérieur à la réaction a été rétabli; j) tout état pathologique du patient directement rattaché à la réaction indésirable grave à une drogue; k) tout produit thérapeutique utilisé de façon concomitante par le patient; l) l’effet de la réaction indésirable grave à une drogue sur la santé du patient.

(3)

L’hôpital est exempté de l’application de l’article 21.8 de la Loi à l’égard des renseignements visés au paragraphe (2) dans les cas suivants : a) les renseignements visés aux alinéas (2)b), c), e) et f) concernant la réaction indésirable grave à une drogue ne relèvent pas de l’hôpital; b) la réaction indésirable grave à une drogue met en cause seulement l’une des drogues suivantes : (i) le vaccin administré dans le cadre d’un programme provincial de vaccination systématique, (ii) la drogue dont la vente est autorisée sous le régime du titre 5 de la présente partie, (iii) la drogue vendue en vertu du paragraphe C.08.011(1).

(4)

Au présent article, hôpital s’entend de l’établissement qui, selon le cas : a) fait l’objet d’un permis délivré par une province ou a été approuvé ou désigné par elle à ce titre, en conformité avec ses lois, en vue d’assurer des soins ou des traitements aux personnes atteintes de toute forme de maladie ou d’affection; Limits of Drug Dosage (a) the quantitative content of the drug, (ii) preparations solely for children’s use; and 10 - 14 one-half TABLE Table of Limits of Drug Dosage for Adults |------|--------------|--------------| | | Per cent | Single | Daily | | Acetaminophen | — | 650 | 4.0 g | | Acetanilide and derivatives (except N-Acetyl-p-amino phenol) | — | 65 | 195 | PART C Drugs DIVISION 1 Limits of Drug Dosage

Section C.01.021

Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 1

Doses limites des drogues

Article C.01.021

Item | Maximum Limit | Per cent | Single | Daily Acetylsalicylic Acid | — | 650 | 4.0 g Adonis vernalis | — | 65 | 195 Amylocaine Hydrochloride, except when sold or recommended for ophthalmic use | 1.0 | 0.0 | 0.0 Benzene (Benzol) | — | — | — Benzocaine | 8.0 | 195 | 585 Beta-Naphthol | — | 195 | 585 Butacaine Sulphate, except when sold or recommended for ophthalmic use | 1.0 | 0.0 | 0.0 Cadexomer Iodine | — | — | — Cantharides, blisters only | 0.2 | 0.0 | 0.0 Cedar Oil | — | 25.0 | 0.0 Choline Salicylate | — | 870 | 5.22 g Cinchoicaine Hydrochloride, except suppositories | 1.0 | 0.0 | 0.0 Cinchoicaine Hydrochloride, suppositories only | — | 11 | 11 Croton Oil | — | 10.0 | 0.0 Hyoscyamine | 2.0 | — | — Hyoscine amoxidide hydrobromide | 0.5 | 0.325 | 0.975 PART C Drugs DIVISION 1 Limits of Drug Dosage

Section C.01.021

Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 1

Doses limites des drogues

Article C.01.021

Maximum Limit | Per cent | Single | Daily Magnesium Salicylate ............................................................... — | 650 | 4.0 g Methyl Salicylate ....................................................................... 30 | — | — Methylene Blue .......................................................................... — | 130 | 390 Phenacetin .................................................................................. — | 650 | 1.95 g Phenol ......................................................................................... 2.0 | 32.5 | 260 Phosphorus .................................................................................. — | 0.0 | 0.0 Podophyllin .................................................................................. 0.0 | 0.0 | 0.0 Potassium Chlorate ..................................................................... — | 325 | 975 Potassium Chlorate, gargle ....................................................... 2.5 | — | — Salicylamide ................................................................................ — | 975 | 2.925 g Santonin ...................................................................................... — | 65 | 130 Sodium Chlorate ......................................................................... — | 325 | 975 Sodium Fluoride ......................................................................... — | 0.1 | 0.1 Sodium Salicylate ....................................................................... — | 650 | 4.0 g Tannic Acid ................................................................................. — | 150 | 1 000 Thiocyanates ............................................................................... 0.0 | 0.0 | 0.0 Urethane ...................................................................................... 0.0 | 0.0 | 0.0 TABLEAU Tableau des doses limites des drogues pour adultes Usage externe | Usage interne Drogue | Dose maximum en milligrammes, sauf indication contraire | pour cent | Dose simple | Dose quotidienne Acétaminophène ......................................................................... — | 650 | 4,0 g PART C Drugs DIVISION 1 Limits of Drug Dosage

Section C.01.021

Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 1

Doses limites des drogues

Article C.01.021

Drogue Usage externe Usage interne Dose maximum Dose maximum en milligrammes, sauf indication contraire pour cent Dose simple Dose quotidienne Acétanilide et dérivés (exception faite de N-acétyl-p-aminophénol) ............ — 65 195 Acide acétylsalicylique ................................................................................ — 650 4,0 g Acide cyanhydrique (prussique) solution à 2 pour cent ............................... — 0,062 ml 0,31 ml Acide tannique ............................................................................................ — 150 1 000 Aconitine, ses préparations et dérivés ......................................................... 0,2 0,1 0,1 Adonis vernalis ............................................................................................ — 65 195 Amylocaine, ses sels et dérivés, lorsqu’ils sont vendus ou recommandés pour usage ophtalmique ............................................................................. 0,0 0,0 0,0 Antimoine (composés d’) ............................................................................ — 3,3 13 Atropine, méthylatropine, et leurs sels ....................................................... 1,0 0,13 0,44 Belladone et ses préparations, en alcaloïdes de la belladone .................... 0,375 0,13 0,44 Benzène (benzol) ......................................................................................... — — — Benzocaïne .................................................................................................. — 195 585 Bêta-naphtol ............................................................................................... — 130 390 Bleu de méthylène ....................................................................................... — 325 975 Bromure d’aminoxyde d’hyosine ................................................................. 0,5 0,325 0,975 Butacaïne, ses sels et dérivés, lorsqu’ils sont vendus ou recommandés pour usage ophtalmique ............................................................................. 0,0 0,0 0,0 Cadexomère iodé ........................................................................................ — 0,0 0,0 Cantharides, cantharidine et leurs préparations, basées sur la cantharidine, à l’exception des vésicatoires ............................................... 0,03 0,0 0,0 Cantharides, vésicatoires seulement .......................................................... 0,2 0,0 0,0 Chlorate de potassium ................................................................................ — 325 975 Chlorate de potassium (gargarisme) .......................................................... 2,5 — — Chlorate de sodium ..................................................................................... — 325 975 Chlorhydrate d’amylocaine, sauf lorsque vendu ou recommandé pour usage ophtalmique ..................................................................................... 1,0 0,0 0,0 Chlorhydrate de cinchocaïne, à l’exception des suppositoires ................... 1,0 0,0 0,0 Chlorhydrate de cinchocaïne (suppositoires seulement) ............................ — 11 11 Chlorobutanol (à toutes les 4 heures au plus) ............................................ — 325 975 Colchicine et ses sels .................................................................................. — 0,55 1,65 Colchicine et ses préparations, en colchicine ............................................ — 0,27 0,81 Cyproheptadine et ses sels, lorsqu’ils sont vendus ou recommandés pour augmenter le poids ..................................................................................... 0,0 0,0 0,0 Éphédrine et ses sels ................................................................................... — 11 32,5 Éphédrine et ses sels (vaporisations) ......................................................... 1,0 — — Épinéphrine et ses sels (vaporisations) ...................................................... 1,0 — — Gelsémine (gelsémine) et ses sels (à toutes les 4 heures au plus) ............ — 0,55 1,65 Gelsémine et ses préparations, en drogue brute ........................................ — 16,2 48,6 Huile de cèdre ............................................................................................. 25,0 0,0 0,0 Huile de croton ............................................................................................ 10,0 — — PART C Drugs DIVISION 1 Limits of Drug Dosage

Section C.01.021

Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 1

Doses limites des drogues

Article C.01.021

Usage externe | Usage interne Drogue | Dose maximum pour cent | Dose simple | Dose quotidienne Dose maximum en milligrammes, sauf indication contraire Hydroquinone ............................................................... 2,0 | — | — Hyoscine (scopolamine) et ses sels ........................................ 0,5 | 0,325 | 0,975 Hyoscyamine et ses sels .................................................. — | 0,325 | 0,975 Jusquiame et ses préparations, en alcaloïdes de jusquiame ........... — | 0,073 | 0,22 Lobélie et ses préparations, en drogue brute ............................ — | 130 | 390 Lobélien et ses sels ....................................................... — | 2,0 | 6,0 Phénacétine ................................................................. — | 650 | 1,95 g Phénazone et ses composés .............................................. — | 325 | 975 Phénol ....................................................................... 2,0 | 32,5 | 260 Phénylpropanolamine, lorsqu’elle est vendue ou recommandée comme déprimant de l’appétit .................................................. — | 0,0 | 0,0 Phosphore .................................................................. — | 0,0 | 0,0 Podophylline ............................................................... — | 0,0 | 0,0 Procaïne et ses sels ...................................................... — | 0,0 | 0,0 Proxymétacaïne, ses sels et dérivés, lorsqu’ils sont vendus ou recommandés pour usage ophtalmique ................................. — | 0,0 | 0,0 Salicylamide ............................................................... — | 975 | 2,925 g Santonine ................................................................... — | — | — Scille et ses préparations, en drogue brute ............................ — | 65 | 130 Sélénium et ses composés ............................................... — | 2,5 | 0,0 Sodium (fluorure de) .................................................... — | 32,5 | 97,5 Stramoine et ses préparations, en alcaloïdes de stramoine ........... — | 0,16 | 0,65 Strychnine et ses sels ................................................... — | — | — Sulfate de butacaïne, sauf lorsque vendu ou recommandé pour usage ophtalmique .............................................................. — | 0,0 | 0,0 Tétracaïne, ses sels et dérivés lorsqu’ils sont vendus ou recommandés pour usage ophtalmique ................................................ — | 0,0 | 0,0 Thiocyanates .............................................................. — | 0,0 | 0,0 Uréthane .................................................................... — | 0,0 | 0,0 Quand des drogues douées de propriétés physiologiques semblables sont en mélange, la dose de chacune doit être réduite proportionnellement. Les doses exactes peuvent être exprimées en unités métriques ou en unités impériales. Si la dose est exprimée en unités des deux systèmes, l’une des données peut n’être qu’approximative, mais cette valeur approximative doit précéder ou suivre la donnée exacte d’après laquelle le produit sera jugé, et elle doit être indiquée entre parenthèses. SOR/78-422, art. 1; SOR/80-544, art. 3; SOR/84-145, art. 1; SOR/85-715, art. 3; SOR/85-966, art. 2; SOR/88-94, s. 1; SOR/98-229, s. 2; SOR/98-548, s. 1.

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01.022 Notwithstanding paragraph C.01.021(b), the recommended single and daily dosage of a drug

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01.024 (1) Sections C.01.021 and C.01.022 do not apply to (a) a drug sold to a drug manufacturer; or (b) a drug sold on prescription.

(2)

Paragraph C.01.021(c) does not apply to (a) acetaminophen; (b) acetylsalicylic acid; (c) magnesium salicylate; (d) sodium salicylate; or (e) choline salicylate. TABLE Maximum Dose | Item | Column I Age | Column II Maximum Children's Dose (80 mg units) Acetaminophen Drops | Column III Maximum Children's Dose (80 mg units) Acetaminophen | Column IV Maximum Children's Dose (160 mg units) Acetaminophen | Column V Maximum Adult's Dose (325 mg units) | Column VI Maximum Single Dose (mg) | Column VII Maximum Daily Dose (mg) | |------|--------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------|----------------------------------|-----------------------|-----------------------| | 2 | 9 to under 11 years | 5 | 2.5 | 1.25 | 400 | 2 000 | PART C Drugs DIVISION 1 Limits of Drug Dosage

Section C.01.024

Réglément sur les aliments et drogues

PARTIE C Drogues

TITRE 1

Doses limites des drogues

Article C.01.024

Column I | Column II | Column III | Column IV | Column V | Column VI | Column VII 3 | 6 to under 9 years | — | 4 | 2 | 1 | 320 | 1 600 4 | 4 to under 6 years | — | 3 | 1.5 | — | 240 | 1 200 5 | 2 to under 4 years | — | 2 | 1 | — | 160 | 800 TABLEAU Doses maximales Colonne I | Colonne II | Colonne III | Colonne IV | Colonne V | Colonne VI | Colonne VII

Article | Âge | Dose maximale pour enfants en unités posologiques de 80 mg d’acétaminophène en gouttes | Dose maximale pour enfants en unités posologiques de 80 mg | Dose maximale pour enfants en unités posologiques de 160 mg d’acétaminophène | Dose maximale pour adultes en unités posologiques de 325 mg | Dose maximale simple (en mg) | Dose maximale quotidienne (en mg)

1 | 11 ans jusqu’à moins de 12 ans | — | 6 | 3 | 1,5 | 480 | 2 400 2 | 9 ans jusqu’à moins de 11 ans | — | 5 | 2,5 | 1,25 | 400 | 2 000 3 | 6 ans jusqu’à moins de 9 ans | — | 4 | 2 | 1 | 320 | 1 600 4 | 4 ans jusqu’à moins de 6 ans | — | 3 | 1,5 | — | 240 | 1 200 5 | 2 ans jusqu’à moins de 4 ans | — | 2 | 1 | — | 160 | 800 6 | 1 an jusqu’à moins de 2 ans | 1,5 ou selon les instructions du médecin | — | — | — | 120 | 600 7 | 4 mois jusqu’à moins de 1 an | 1 ou selon les instructions du médecin | — | — | — | 80 | 400 PART C Drugs DIVISION 1 Limits of Drug Dosage Sections C.01.024-C.01.026 Colonne I

Article

8 Âge 0 mois jusqu’à moins de 4 mois Colonne II Dose maximale pour enfants en unités posologiques de 80 mg d’acétaminophène en gouttes 0,5 ou selon les instructions du médecin Colonne III Dose maximale pour enfants en unités posologiques de 80 mg — Colonne IV Dose maximale pour enfants en unités posologiques de 160 mg d’acétaminophène — Colonne V Dose maximale pour adultes en unités posologiques de 325 mg — Colonne VI Dose maximale simple (en mg) 40 Colonne VII Dose maximale quotidienne (en mg) 200 TABLE MAXIMUM DOSE Age (Years) Under 2 Adult Dosage Units (435 mg) 1 ½ 1 ¼ 1 ¾ ½ Single Dose (mg) 660 550 440 330 220 Maximum Daily Dose (mg) 3 300 2 750 2 200 1 650 1 100 SOR/84-145, s. 2; SOR/90-587, s. 1.

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01.026 The provisions of section C.01.025 do not apply to (a) a drug sold on prescription, or (b) the inner label of a single-dose container. Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 1

Doses limites des drogues

Articles C.01.024-C.01.026

Colonne I

Article

8 Âge 0 mois jusqu’à moins de 4 mois Colonne II Dose maximale pour enfants en unités posologiques de 80 mg d’acétaminophène en gouttes 0,5 ou selon les instructions du médecin Colonne III Dose maximale pour enfants en unités posologiques de 80 mg — Colonne IV Dose maximale pour enfants en unités posologiques de 160 mg d’acétaminophène — Colonne V Dose maximale pour adultes en unités posologiques de 325 mg — Colonne VI Dose maximale simple (en mg) 40 Colonne VII Dose maximale quotidienne (en mg) 200

(4)

Lorsque le salicylate de choline est recommandé pour les enfants, il est interdit de vendre cette drogue pour administration humaine à moins qu’il ne soit indiqué sur les étiquettes intérieure et extérieure a) qu’il est recommandé de prendre cette drogue « selon les instructions du médecin »; ou b) qu’il est recommandé de ne pas prendre des doses supérieures à celles indiquées dans le tableau ci-après et de ne pas administrer de doses simples à moins de quatre heures d’intervalle. TABLEAU DOSE MAXIMUM Âge (Années) 11 à moins de 12 9 à moins de 11 6 à moins de 9 4 à moins de 6 2 à moins de 4 moins de 2 ans Unités posologiques adultes (435 mg) 1 ½ 1 ¼ 1 ¾ ½ selon les instructions du médecin Dose simple (en mg) 660 550 440 330 220 Dose maximale quotidienne (en mg) 3 300 2 750 2 200 1 650 1 100 DORS/84-145, art. 2; DORS/90-587, art. 1.

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01.025 Les étiquettes intérieure et extérieure d’une drogue portant une dose simple ou dose quotidienne recommandée, ou la déclaration d’une concentration dépassant les limites fixées à l’article C.01.021, doivent toutes deux porter une mise en garde signalant que le produit ne doit être employé que sur le conseil d’un médecin.

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01.026 Les dispositions de l’article C.01.025 ne s’appliquent pas a) à une drogue vendue sur ordonnance; ni b) à l’étiquette intérieure d’un récipient à dose unique. (a) acetaminophen; (b) acetylsalicylic acid; (c) choline salicylate; (d) magnesium salicylate; or (e) sodium salicylate.

(3)

[Repealed, SOR/94-409, s. 1] SOR/81-388, s. 1; SOR/84-145, s. 4(F); SOR/85-966, s. 3; SOR/93-202, s. 5; SOR/94-311, s. 1; SOR/94-409, s. 1. (d) phenacetin, either singly or in combination with other drugs, shall carry the following cautionary statement: (a) intended for parenteral use only; SOR/86-933, s. 2; SOR/88-323, s. 2(F); SOR/93-411, s. 2; SOR/2013-122, s. 7.

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01.029 (1) Subject to subsections C.01.031.2(1) and (2), the inner and outer labels of a drug (i) salicylic acid, a salt thereof or salicylamide, (iii) acetaminophen, or (iv) more than five per cent alkyl salicylates, (d) more than the equivalent of 250 mg of elemental iron, SOR/86-939, s. 2; SOR/87-484, s. 2; SOR/88-323, s. 3; SII; SOR/90-887, s. 2; SOR/93-468, s. 1; SOR/2018-132, s. 1.

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01.030 [Repealed, SOR/2003-196, s. 104]

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01.031 (1) Subject to section C.01.031.2,

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Subsection C.01.031.2(2) and paragraph C.01.031.2(3)(a) do not apply to a drug referred to in paragraph C.01.029(1)(a.1). SOR/86-939, s. 2; SOR/87-416, s. 1; SOR/93-468, s. 2; SOR/2018-132, s. 2.

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01.031.1 [Repealed, SOR/87-484, s. 3]

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01.031.2 (1) Sections C.01.029 to C.01.031 do not apply to a drug that is (b) intended for parenteral use only; (c) in effervescent or powder form; (d) in suppository form; forme octogonale et de couleur frappante sur fond de couleur contrastante. DORS/86-939, art. 2; DORS/87-484, art. 2; DORS/88-323, art. 3; SII; DORS/90-887, art. 2; DORS/93-468, art. 1; DORS/2018-132, art. 1.

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01.030 [Abrogé, DORS/2003-196, art. 104]

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01.031 (1) Sous réserve de l’article C.01.031.2, a) est interdite la vente d’une drogue mentionnée au paragraphe C.01.029(1) à moins (i) qu’elle ne soit emballée dans un emballage protégé-enfants lorsque la drogue est recommandée exclusivement pour les enfants, (ii) qu’elle ne soit offerte dans au moins un format d’emballage protégé-enfants lorsque la drogue n’est pas recommandée exclusivement pour les enfants, sauf s’il s’agit d’une drogue qui est visée au sous-alinéa (iii), (iii) qu’elle ne soit emballée dans un emballage protégé-enfants lorsque la drogue est un produit de vapotage visé à l’alinéa C.01.029(1)a.1); et b) lorsqu’une drogue mentionnée au paragraphe C.01.029(1) est emballée dans un emballage qui n’est pas un emballage protégé-enfants, l’étiquette extérieure doit indiquer que la drogue est disponible dans un emballage protégé-enfants.

(2)

Le paragraphe C.01.031.2(2) et l’alinéa C.01.031.2(3)a) ne s’appliquent pas à une drogue visée à l’alinéa C.01.029(1)a.1). DORS/86-939, art. 2; DORS/87-416, art. 1; DORS/93-468, art. 2; DORS/2018-132, art. 2.

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01.031.1 [Abrogé, DORS/87-484, art. 3]

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01.031.2 (1) Les articles C.01.029 à C.01.031 ne s’appliquent pas à : a) une drogue sur ordonnance ou une drogue qui doit être vendue conformément à une ordonnance aux termes de la partie G, du Règlement sur les benzodiazépines et autres substances ciblées ou du Règlement sur les stupéfiants; b) une drogue destinée exclusivement à l’usage parentéral; c) une drogue sous forme de préparation effervescente ou de poudre; d) une drogue sous forme de suppositoire; SOR/83-523, s. 2; SOR/88-484, s. 4; SOR/88-323, s. 5; FIF, SOR/93-468, s. 3; SOR/2013-122, s. 8.

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01.032 No person shall sell a corticosteroid drug for ophthalmic use unless Viral diseases of the cornea and conjunctiva; Side Effects and e) une drogue destinée à l’usage topique, sauf s’il s’agit d’une préparation liquide contenant plus de cinq pour cent de salicylate d’alkyle; f) une drogue emballée dans un emballage non refermable contenant au plus deux doses normales pour un adulte; g) une drogue sous forme de pâte dentifrice.

(2)

Les articles C.01.029 à C.01.031 ne s’appliquent pas à une drogue qui est remballée par un pharmacien ou un praticien au moment de la vente.

(3)

L’article C.01.031 ne s’applique pas à : a) une drogue vendue seulement dans un contenant muni d’un applicateur à bille ou d’un vaporisateur ou d’un applicateur à mèche fixé en permanence; b) une drogue vendue exclusivement à l’intention des animaux autres que les animaux familiers; c) une drogue réservée à l’usage des cabinets de dentistes ou présentée dans un emballage destiné uniquement aux hôpitaux. DORS/83-523, art. 2; DORS/88-484, art. 4; DORS/88-323, art. 5; FIF; DORS/93-468, art. 3; DORS/2013-122, art. 8.

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01.032 Est interdit de vendre toute drogue corticostéroïde pour usage ophtalmique, à moins a) que l’étiquette extérieure ou la notice d’accompagnement ne porte, comme partie du mode d’emploi, les déclarations ci-dessous : « Contre-indications Affections virales de la cornée et des conjonctives Tuberculose des yeux Affections fongiques des yeux Infections purulentes aiguës et non traitées des yeux, qui, à l’instar des autres affections causées par des micro-organismes, peuvent être masquées ou stimulées par la présence du stéroïde. Effets secondaires L’usage ophtalmique prolongé des drogues corticostéroïdes peut causer un accroissement de la pression intra-oculaire chez certains sujets et, dans les affections causant l’amincissement de la cornée, on a vu des perforations se produire. » et b) que l’étiquette intérieure ne porte les déclarations requises par l’alinéa a) ou les instructions de lire SOR/2018-69, s. 18(F). SOR/2013-122, s. 9.

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01.035 Sections C.01.032 and C.01.034 do not apply to a drug sold solely for veterinary use.

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01.036 (1) No manufacturer or importer shall sell (i) oxyphenisatin, (ii) oxyphenisatin acetate, or (iii) phenisatin; or l’étiquette extérieure ou la notice d’accompagnement pour se renseigner sur les contre-indications et les effets secondaires. DORS/2018-69, art. 18(F).

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01.033 L’article C.01.032 ne s’applique pas à une drogue corticostéroïde vendue par un pharmacien conformément à une ordonnance. DORS/2013-122, art. 9.

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01.034 Est interdit l’envoi, à un praticien, de matières publicitaires relatives aux drogues corticostéroïdes pour usage ophtalmique à moins que les déclarations requises par l’alinéa C.01.032a) ne soient incluses dans ces matières.

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01.035 Les articles C.01.032 et C.01.034 ne s’appliquent pas à une drogue vendue pour l’usage vétérinaire seulement. Divers

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01.036 (1) Il est interdit à un fabricant ou importateur de vendre a) une drogue qui contient de la phénacétine associée à un sel ou à un dérivé de l’acide salicylique; b) une drogue pour usage humain qui contient de l’oxyphénisatine, de l’acétate d’oxyphénisatine ou de la phénisatine; ou c) une drogue pour usage humain qui contient du mercure ou l’un de ses sels ou dérivés, sauf s’il s’agit de l’une des drogues suivantes dans laquelle le mercure ou l’un de ses sels ou dérivés est utilisé comme agent de conservation et pour laquelle le fabricant ou l’importateur a soumis au ministre des preuves démontrant que l’utilisation de cet agent de conservation est le seul moyen satisfaisant d’assurer la stérilité ou la stabilité de la drogue : (i) une drogue mentionnée aux annexes C ou D de la Loi, (ii) l’une des drogues suivantes : (A) une drogue ophtalmique ou une drogue pour usage dans la région oculaire, (B) une drogue pour administration par voie nasale, (C) une drogue pour administration par voie otique, SOR/78-423, s. 2; SOR/86-93, s. 3; SOR/89-229, s. 3; SOR/2018-69, s. 27. SOR/78-875, s. 1. (a) more than 1.92 g of salicylicamide or salicylic acid or the equivalent quantity of a salt of salicylic acid; (d) more than 1.92 g of acetaminophen in 80 mg dosage units. SOR/86-93, s. 4; SOR/87-484, s. 5; SOR/88-323, s. 6; SOR/90-587, s. 3. (b) extracts or tinctures of (i) Strychnos nux vomica, (ii) Strychnos Ignatii, or (d) Echimidine or any of its salts; or (i) Symphytum asperum, (ii) Symphytum x uplandicum, or (iii) any other plant species containing echimidine. SOR/95-512, s. 1; SOR/88-173, s. 1. SOR/97-12, s. 4. (a) chloroform; or SOR/89-229, s. 4; SOR/2013-113, s. 1. SOR/88-422, s. 2; SOR/89-801, s. 1; SOR/81-334, s. 2(F); SOR/89-176, s. 1; SOR/92-662, s. 1. Colouring Agents D & C (indication of the colour and the number) means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in drugs and cosmetics; (D&C (indication de la couleur et du numéro)) FD & C (indication of the colour and the number) means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in food, drugs and cosmetics. (FD&C (indication de la couleur et du numéro)) (a) ACID FUCHSIN D (D & C Red No. 33; C.I. No. 17200), ANTHOCYANIN DERIVED FROM JUICE EXPRESSED FROM FRESH EDIBLE FRUITS OR VEGETABLES, ß-APO-8'-CAROTENAL (C.I. No. 40820), BRILLIANT BLUE FCF AMMONIUM SALT (D & C Blue No. 4; C.I. No. 42090), CANTHAXANTHIN (C.I. No. 40850), CARAMEL, CARMINE (C.I. No. 75470), ß-CAROTENE (C.I. No. 40800), CHLOROPHYLL (C.I. No. 75810), IRON OXIDES (C.I. Nos. 77489, 77491, 77492, 77499), FD&C (indication de la couleur et du numéro) Désignation servant à identifier un colorant pouvant être utilisé aux États-Unis dans les aliments, les drogues et les cosmétiques, selon le Code of Federal Regulations des États-Unis. (FD & C (indication of the colour and the number))

(3)

Les colorants qui peuvent être employés dans les drogues à usage interne ou externe sont les suivants : a) AMARANTE (FD&C, Rouge nº 2, radié; C.I. nº 16185), ANTHOCYANINE PROVENANT DE JUS EXPRIMÉ DE FRUITS OU DE LÉGUMES COMESTIBLES FRAIS, ß-APO-8'-CAROTÉNAL (C.I. nº 40820), BLEU BRILLANT FCF, SEL D'AMMONIUM (D&C Bleu nº 4, C.I. nº 42090), BLEU BRILLANT FCF, SEL SODIQUE (FD&C Bleu nº 1, C.I. nº 42090), CANTHAXANTHINE (C.I. nº 40850), CARAMEL, CARBONE NOIR (C.I. nº 77266), CARMIN (C.I. nº 75470), CARMOISINE (Ext. D&C Rouge nº 10, radié; C.I. nº 14720), ß-CAROTÈNE (C.I. nº 40800), CHLOROPHYLLE (C.I. nº 75810), DIOXYDE DE TITANE (C.I. nº 77891), ÉOSINE YS, FORME ACIDE (D&C Rouge nº 21; C.I. nº 45380:2), ÉOSINE YS, SEL SODIQUE (D&C Rouge nº 22; C.I. nº 45380), ÉRYTHROSINE (FD&C Rouge nº 3; C.I. nº 45430), FUSCHINE ACIDE D (D&C Rouge nº 33; C.I. nº 17200), INDIGO (D&C Bleu nº 6; C.I. nº 73000), INDIGOTINE (FD&C Bleu nº 2; C.I. nº 73015), JAUNE DE QUINOLINE WS (D&C Jaune nº 10; C.I. nº 47005), JAUNE SOLEIL FCF (FD&C Jaune nº 6; C.I. nº 15985), LITHOL RUBINE B, SEL DE CALCIUM (D&C Rouge nº 7, C.I. nº 15850:1), LITHOL RUBINE B, SEL SODIQUE (D&C Rouge nº 6; C.I. nº 15850), NOIR DE FUMÉE (C.I. nº 77266), PONCEAU 4R (C.I. No. 16255), PONCEAU SX (FD & C Red No. 4; C.I. No. 14700), RIBOFLAVIN, TITANIUM DIOXIDE (C.I. No. 77891); (i) alumina, (ii) blanc fixe, (iii) gloss white, (iv) clay, (v) zinc oxide, (vi) talc, (vii) rosin, (viii) aluminum benzoate, (ix) calcium carbonate, or (c) preparations made by extending any sodium, potassium, aluminum, barium, calcium, strontium or zirconium salt of any of the colouring agents listed in paragraph (a) on a substratum of (i) alumina, (ii) blanc fixe, (iii) gloss white, OXYDES DE FER (C.I. nos 77489, 77491, 77492 et 77499), PHLOXINE B, FORME ACIDE (D&C Rouge no 27; C.I. no 45410:1), PHLOXINE B, SEL SODIQUE (D&C Rouge no 28; C.I. no 45410), PONCEAU SX (FD&C Rouge no 4; C.I. no 14700), PONCEAU 4R (C.I. no 16255), RIBOFLAVINE, ROSE HÉLINDONE CN (D&C Rouge no 30; C.I. no 73360), ROUGE ALLURA AC (FD&C Rouge no 40; C.I. no 16035), ROUGE FEU (D&C Rouge no 36; C.I. no 12085), TARTRAZINE (FD&C Jaune no 5; C.I. no 19140), VERT D’ALIZARINE CYANINE F (D&C Vert no 3; C.I. no 61570), VERT SOLIDE FCF (FD&C Vert no 3; C.I. no 42053); b) les préparations effectuées par l’addition d’un des colorants énumérés à l’alinéa a) à un substrat (i) d’alumine, (ii) de blanc fixe, (iii) de blanc lustré, (iv) d’argile, (v) d’oxyde de zinc, (vi) de talc, (vii) de colophane, (viii) de benzoate d’aluminium, (ix) de carbonate de calcium, ou (x) d’une combinaison des substances visées aux sous-alinéas (i) à (ix); et c) les préparations effectuées par l’addition d’un sel de sodium, de potassium, d’aluminium, de baryum, de calcium, de strontium ou de zirconium d’un des colorants énumérés à l’alinéa a) à un substrat (i) d’alumine, (ii) de blanc fixe, (iv) clay, (v) zinc oxide, (vi) talc, (vii) rosin, (viii) aluminum benzoate, (ix) calcium carbonate, or (x) any combination of the substances listed in sub-paragraphs (i) to (ix). (a) ACID VIOLET 43 (Ext. D & C Violet No. 2; C.I. No. 60730), ANNATTO (C.I. No. 75120), BISMUTH OXYCHLORIDE (C.I. No. 77163), CHROMIUM HYDROXIDE GREEN (PIGMENT GREEN 18; C.I. No. 77289), DIBROMOFLUORESCEIN (SOLVENT RED 72 (C.I. No. 45370:1); ORANGE No. 5 (D & C Orange No. 5)), FERRIC FERROCYANIDE (C.I. No. 77510), GUANINE (C.I. No. 75170), MICA (C.I. No. 77019), ORANGE II (D&C Orange No. 4; C.I. No. 15510), ZINC OXIDE (C.I. No. 77947); (iii) de blanc lustré, (iv) d’argile, (v) d’oxyde de zinc, (vi) de talc, (vii) de colophane, (viii) de benzoate d’aluminium, (ix) de carbonate de calcium, ou (x) d’une combinaison des substances visées aux sous-alinéas (i) à (ix).

(4)

Les colorants suivants peuvent être employés uniquement dans les drogues à usage externe : a) DIBROMOFLUORESCÉINE (ROUGE SOLVANT 72 (C.I. no 45370:1) ORANGE no 5 (D&C Orange no 5)), FERROCYANURE FERRIQUE (C.I. no 77510), GUANINE (C.I. no 75170), MARRON FONCÉ (D&C Rouge no 34; C.I. no 15880:1), MICA (C.I. no 77019), ORANGE II (D&C Orange no 4; C.I. no 15510), OXYCHLORURE DE BISMUTH (C.I. no 77163), OXYDE DE ZINC (C.I. no 77947), POURPRE D’ALIZUROL SS (D&C Violet no 2; C.I. no 60725), PYRANINE CONCENTRÉE (D&C Vert no 8; C.I. no 59040), ROCOU (C.I. no 75120), ROUGE TONEY (D&C Rouge no 17; C.I. no 26100), URANINE, FORME ACIDE (D&C Jaune no 7; C.I. no 45350:1), URANINE, SEL SODIQUE (D&C Jaune no 8; C.I. no 45350), VERT DE QUINIZARINE SS (D&C Vert no 6; C.I. no 61565), VERT D’HYDROXYDE DE CHROME (PIGMENT VERT 18 (C.I. no 77289)), VIOLET ACIDE 43 (Ext. D&C Violet no 2; C.I. no 60730), VIOLET DE MANGANÈSE (C.I. no 77742); (i) alumina, (ii) blanc fixe, (iii) gloss white, (iv) clay, (v) zinc oxide, (vi) talc, (vii) rosin, (viii) aluminum benzoate, (ix) calcium carbonate, or (c) preparations made by extending any sodium, potassium, aluminum, barium, calcium, strontium or zirconium salt of any of the colouring agents listed in paragraph (a) on a substratum of (i) alumina, (ii) blanc fixe, (iii) gloss white, (iv) clay, (v) zinc oxide, (vi) talc, (vii) rosin, (viii) aluminum benzoate, (ix) calcium carbonate, or (x) any combination of the substances listed in subparagraphs (i) to (ix). (a) titanium dioxide (C.I. No. 77891); (b) iron oxides (C.I. Nos. 77489, 77491, 77492, 77499); or (a) medical devices; SOR/84-949, s. 1; SOR/86-500, s. 1; SOR/94-460, s. 1; SOR/95-431, s. 1; SOR/2002-369, s. 1; SOR/2005-95, s. 1; SOR/2018-248, s. 1. Prescription Drugs SOR/2013-122, s. 10; SOR/2017-18, s. 21(F). SOR/2013-122, s. 10. SOR/2013-122, s. 10.

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01.041 (1) No person shall sell a prescription drug unless (d) the person’s name and the name of the practitioner who issued the prescription; and SOR/78-442, s. 2; SOR/80-543, s. 3; SOR/93-202, s. 6; SOR/93-407, s. 2; SOR/2013-122, s. 11.

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01.041.1 Subject to paragraph C.01.041.3(2)(b), a pharmacist or pharmacy technician may transfer to another pharmacist or pharmacy technician a prescription for a prescription drug. SOR/78-442, s. 3; SOR/2013-122, s. 11. SOR/78-442, s. 3; SOR/2013-122, s. 11. SOR/78-442, s. 3; SOR/2013-122, s. 11.

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01.041.4 [Repealed, SOR/2013-122, s. 11] (b) the date of each refill, if applicable; (d) the name of the person who sold the drug. SOR/2013-122, s. 11.

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01.043 (1) A person may sell a prescription drug to (a) a drug manufacturer; (b) a practitioner; (c) a wholesale druggist; (d) a pharmacist; or SOR/2013-122, s. 11. SOR/78-424, s. 5; SOR/93-202, s. 7; SOR/93-407, s. 3; SOR/2013-122, s. 11. (a) a practitioner; (b) a pharmacist; (c) a wholesale druggist; (b) a drug manufacturer; (c) a wholesale druggist; (d) a pharmacist; or (e) a resident of a foreign country while a visitor in Canada. SOR/93-407, s. 4; SOR/2013-122, s. 11.

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01.046 [Repealed, SOR/2013-122, s. 11]

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01.047 [Repealed, SOR/80-543, s. 4] [SOR/2020-74, s. 2] (c) [Repealed, SOR/2020-74, s. 3] (d) a prescription drug as defined in subsection 1(2) of the Cannabis Regulations. b) les fabricants de drogues; c) les pharmaciens en gros; d) les pharmaciens; e) les résidents d’un pays étranger, durant leur séjour au Canada. DORS/93-407, art. 4; DORS/2013-122, art. 11.

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01.046 [Abrogé, DORS/2013-122, art. 11]

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01.047 [Abrogé, DORS/80-543, art. 4] Distribution de drogues à titre d’échantillons [DORS/2020-74, art. 2]

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01.048 (1) La personne qui reçoit une commande signée par un praticien ou un pharmacien peut distribuer ou faire distribuer à celui-ci, à titre d’échantillon, une drogue sous forme posologique, autre que celles mentionnées ci-après, dont le nom propre ou le nom usuel, la marque nominative et la quantité sont précisés dans la commande, si la drogue est conforme aux exigences du présent règlement : a) un stupéfiant au sens du Règlement sur les stupéfiants; b) une drogue contrôlée au sens de l’article G.01.001; c) [Abrogé, DORS/2020-74, art. 3] d) une drogue sur ordonnance au sens du paragraphe 1(2) du Règlement sur le cannabis. (1.1) Il n’est permis, en vertu du paragraphe (1), de distribuer ou de faire distribuer une drogue sur ordonnance, à titre d’échantillon, à un praticien ou à un pharmacien que si celui-ci est autorisé à prescrire ou à dispenser la drogue en vertu des lois de la province où il exerce.

(2)

Une commande dont il est question au paragraphe (1) peut spécifier que ladite commande sera renouvelée à intervalles indiqués pendant une période d’au plus six mois.

(3)

Malgré le paragraphe (1), il est permis de distribuer ou de faire distribuer à un praticien ou à un pharmacien, à titre d’échantillon, une drogue sous forme posologique qui n’est pas une drogue sur ordonnance et qui appartient à une catégorie de drogues figurant à la colonne 1 de la Liste D, sans avoir pu obtenir une commande signée à cet égard, si les conditions suivantes sont réunies : a) la drogue ne contient, comme ingrédients médicinaux, que SOR/93-202, s. 9; SOR/97-228, s. 2; SOR/2018-144, s. 366; SOR/2019-171, s. 24; SOR/2020-74, s. 3. (a) maintain records showing (ii) the brand name, quantity and form of the drug distributed, and SOR/93-202, s. 10; SOR/2020-74, s. 4. SOR/93-202, art. 9; DORS/97-228, art. 2; DORS/2018-144, art. 366; DORS/2019-171, art. 24; DORS/2020-74, art. 3.

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01.049 La personne qui, au titre du paragraphe C.01.048(1), reçoit une commande à l’égard d’une drogue et la distribue ou la fait distribuer, à titre d’échantillon, doit : a) tenir des dossiers indiquant (i) le nom, l’adresse et les titres professionnels de toute personne à qui la drogue est distribuée, (ii) la marque nominative, la quantité et la forme de présentation de cette drogue, (iii) la date de distribution de ladite drogue; et b) conserver lesdits dossiers, ainsi que toutes les commandes reçues en vertu de l’article C.01.048, pendant au moins deux ans, à compter de la date à laquelle la distribution inscrite aux dossiers a eu lieu. DORS/93-202, art. 10; DORS/2020-74, art. 4.

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01.049.1 Il est permis de distribuer ou de faire distribuer aux consommateurs âgés de 18 ans ou plus, à titre d’échantillon, une drogue sous forme posologique qui n’est pas une drogue sur ordonnance et qui appartient à une catégorie de drogues visée à la colonne 1 de la Liste D, si les conditions suivantes sont réunies : a) la drogue contient comme seuls ingrédients médicinaux un ou plusieurs de ceux visés à la colonne 2 dont la quantité figure à la colonne 3 et elle correspond aux renseignements descriptifs visés aux colonnes 4 à 6; b) la date limite d’utilisation de la drogue est, selon le cas : (i) si elle est indiquée par le jour, le mois et l’année, au moins trente jours après la date à laquelle la drogue a été distribuée, (ii) si elle est indiquée uniquement par le mois et l’année, un mois quelconque suivant celui de la date à laquelle la drogue a été distribuée; c) la drogue est conforme aux exigences du présent règlement. SOR/2020-74, art. 5. Information — Serious Risk of Injury to Human Health (a) prescription drugs; SOR/2018-84, s. 2; SOR/2020-262, s. 2[F]. Recalls étrangère mentionnée dans la partie C de la liste visée à l’alinéa a).

(3)

Il fournit ces renseignements au ministre au plus tard soixante-douze heures après en avoir reçu communication ou en avoir eu connaissance, selon la première des deux éventualités à survenir.

(4)

Les catégories de drogues sont les suivantes : a) les drogues sur ordonnance; b) les drogues qui doivent être vendues conformément à une ordonnance aux termes de la partie G, du Règlement sur les benzodiazépines et autres substances ciblées ou du Règlement sur les stupéfiants; c) les drogues qui peuvent être vendues sans ordonnance, mais à administrer uniquement sous la surveillance d’un praticien.

(5)

Malgré le paragraphe (2), le titulaire d’une autorisation relative à un produit thérapeutique qui a fourni des renseignements en application : a) de l’alinéa (2)a) n’est pas tenu de fournir les mêmes renseignements de nouveau, en application de cet alinéa, dans le cas où il en a reçu communication ou en a connaissance relativement à une autorité réglementaire étrangère ou à une personne visées par cet alinéa; b) des alinéas (2)b) ou c) n’est pas tenu de fournir les mêmes renseignements de nouveau, en application de ces alinéas, dans le cas où il en a reçu communication ou en a connaissance relativement à une autorité réglementaire étrangère visée par cet alinéa.

(6)

Au présent article, autorité réglementaire étrangère s’entend de tout organisme gouvernemental ou de toute autre entité, ailleurs qu’au Canada, qui est habilité à contrôler la fabrication, l’utilisation ou la vente de drogues sur le territoire relevant de sa compétence et qui peut prendre les mesures d’exécution pour veiller à ce que les drogues qui y sont commercialisées satisfassent aux exigences légales qui s’appliquent. DORS/2018-84, art. 2; DORS/2020-262, art. 2[F]. Retrait du marché

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01.051 Un fabricant qui vend une drogue sous une forme posologique ou une personne qui importe et vend au Canada une drogue sous une forme posologique donnée, s’ils décident de retirer la drogue du marché, fournissent au ministre les renseignements suivants dès le début du retrait : (c) the quantity of the drug manufactured or imported; (d) the quantity of the drug distributed; (e) the quantity of the drug remaining on the premises of the manufacturer or importer; SOR/82-524, s. 2; SOR/93-202, s. 11; SOR/2018-69, s. 27. SOR/2018-84, s. 3; SOR/2020-262, s. 3. (A) importer la drogue, au sens du paragraphe C.01A.001(1), (B) manufacturer ou emballer-étiqueter la drogue à l’étranger, au sens du paragraphe C.01A.001(1), (C) analyser la drogue à l’étranger, (iii) s’agissant du titulaire de l’autorisation relative à un produit thérapeutique visée au sous-alinéa a)(ii) qui n’est pas un importateur, que la façon dont est menée une activité autorisée par l’autorisation peut constituer un risque de blessure ou de danger à la santé lié à la drogue.

(2)

Au terme de son examen des résultats d’une évaluation visant une drogue qu’il a ordonnée en vertu de l’article 21.31 de la Loi, le ministre : a) communique au titulaire de l’autorisation relative à un produit thérapeutique les résultats de l’examen; b) veille à ce qu’un résumé des résultats de l’examen, ainsi que la description des mesures qu’il a prises ou qu’il pourrait prendre à la suite de l’examen, soient publiés sur le site Web du gouvernement du Canada. DORS/2018-84, art. 3; DORS/2020-262, art. 3. Activités ordonnées en vertu de l’article 21.32 de la Loi

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01.053 Le pouvoir du ministre de donner un ordre visant une drogue en vertu de l’article 21.32 de la Loi est assujetti aux conditions suivantes : a) la personne à qui l’ordre est donné est titulaire de l’une des autorisations relatives à un produit thérapeutique ci-après à l’égard de la drogue : (i) l’identification numérique attribuée en application du paragraphe C.01.014.2(1), (ii) la licence d’établissement délivrée en application du paragraphe C.01A.008(1), (iii) l’avis de conformité délivré en application des articles C.08.004 ou C.08.004.01; b) le ministre a des motifs raisonnables de croire, à la (i) s’agissant du titulaire de l’une des autorisations relatives à un produit thérapeutique visées aux sous-alinéas a)(i) ou (iii), que les bénéfices ou les SOR/2018-84, s. 3; SOR/2020-262, s. 4.

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01.055 and C.01.056 [Repealed, SOR/82-524, s. 2] effets nocifs liés à la drogue font l’objet d’incertitudes importantes, (ii) s’agissant du titulaire de l’autorisation relative à un produit thérapeutique visée au sous-alinéa a)(ii) qui est un importateur, que la façon dont une ou plusieurs des activités ci-après sont menées a créé des incertitudes importantes en ce qui concerne les bénéfices ou les effets nocifs liés à la drogue : (A) importer la drogue, au sens du paragraphe C.01A.001(1), (B) manufacturer ou emballer-étiqueter la drogue à l’étranger, au sens du paragraphe C.01A.001(1), (C) analyser la drogue à l’étranger, (iii) s’agissant du titulaire de l’autorisation relative à un produit thérapeutique visée au sous-alinéa a)(ii) qui n’est pas un importateur, que la façon dont est menée une activité autorisée par l’autorisation a créé des incertitudes importantes en ce qui concerne les bénéfices ou les effets nocifs liés à la drogue, (iv) que le titulaire de l’autorisation relative à un produit thérapeutique n’est pas en mesure de fournir au ministre des renseignements suffisants pour gérer ces incertitudes, (v) que les exigences applicables du présent règlement ainsi que toute condition dont l’autorisation est assortie ne permettent pas de recueillir des renseignements suffisants pour gérer ces incertitudes; c) le ministre tient compte des éléments suivants : (i) la faisabilité des activités qu’il ordonnera au titulaire de l’autorisation relative à un produit thérapeutique de mener, (ii) l’existence de moyens moins exigeants de recueillir des renseignements supplémentaires quant aux effets de la drogue sur la santé ou la sécurité. DORS/2018-84, art. 3; DORS/2020-262, art. 4.

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01.055 et C.01.056 [Abrogés, DORS/82-524, art. 2] Limites de variabilité

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01.061 (1) Dans le cas d’une drogue dont la quantité nette contenue dans l’emballage n’est indiquée sur l’étiquette autrement qu’en nombre d’unités posologiques, la quantité nette moyenne, déterminée conformément à la méthode officielle DO-31 intitulée Détermination du PART C Drugs DIVISION 1 Sections C.01.061-C.01.062 TABLE Column I | Column II Item | 3 | 101 or more | the greater of one unit or 0.75% of the labelled number, rounded up to the next whole number SOR/82-429, s. 4; SOR/89-455, s. 4; SOR/97-228, s. 3; SOR/2019-171, s. 24.

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01.062 (1) Subject to subsections (2) to (5), no manufacturer shall sell a drug in dosage form where the amount of any medicinal ingredient therein, determined using an acceptable method, is (a) less than 90.0 per cent of the amount of the medicinal ingredient shown on the label; or Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 1

Limites de variabilité

Articles C.01.061-C.01.062

contenu net en date du 7 décembre 1988, pour tout groupe de 10 emballages de cette drogue choisis selon cette méthode, ne peut être inférieure à la quantité nette indiquée sur l’étiquette.

(2)

Dans le cas d’une drogue dont la quantité nette contenue dans l’emballage est indiquée sur l’étiquette en nombre d’unités posologiques, pour tout groupe de 10 emballages de cette drogue choisis conformément à la méthode officielle DO-31 intitulée *Détermination du contenu net en date du 7 décembre 1988*, lorsque le nombre d’unités posologiques de ce groupe est déterminé selon cette méthode : a) le nombre moyen d’unités posologiques pour les 10 emballages ne peut être inférieur au nombre d’unités posologiques indiqué sur l’étiquette; b) aucun emballage ne peut contenir un nombre d’unités posologiques inférieur à celui indiqué sur l’étiquette, sous réserve des écarts prévus au tableau du présent article; c) dans le cas d’une drogue contrôlée au sens de l’article G.01.001 ou d’un stupéfiant au sens du *Règlement sur les stupéfiants*, aucun emballage ne peut contenir un nombre d’unités posologiques supérieur à celui indiqué sur l’étiquette, sous réserve des écarts prévus au tableau du présent article. TABLEAU Colonne I | Colonne II Nombre d’unités posologiques indiqué sur l’étiquette, par emballage | Écart admissible par rapport au nombre indiqué sur l’étiquette

Article |

1 | 50 ou moins | 0 2 | Plus de 50, mais moins de 101 | 1 3 | 101 ou plus | le plus élevé des nombres suivants : une unité ou 0,75 % du nombre indiqué sur l’étiquette, arrondi au nombre entier supérieur DORS/82-429, art. 4; DORS/89-455, art. 4; DORS/97-228, art. 3; DORS/2019-171, art. 24.

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01.062 (1) Sous réserve des paragraphes (2) à (5), le fabricant ne peut vendre une drogue sous forme posologique lorsque la quantité de tout ingrédient médicinal qu’elle contient, déterminée selon une méthode acceptable, représente : a) moins de 90,0 pour cent de la quantité indiquée sur l’étiquette; (b) more than 110.0 per cent of the amount of the medicinal ingredient shown on the label. (a) not less than 85.0 per cent of the amount of the medicinal ingredient shown on the label; and (b) not more than 120.0 per cent of the amount of the medicinal ingredient shown on the label.

(5)

Subsections (1) to (4) do not apply in respect of (b) [Repealed, SOR/98-423, s. 8] (d) a drug described in Schedule C or D to the Act or Division 6 of Part C of these Regulations; or TABLE Column I Item 1 2 3 4 5 6 7 8 9 10 11 12 13 Vitamin thiamine riboflavin niacin or niacinamide pyridoxine d-pantothenic acid folic acid vitamin B12 vitamin C vitamin D vitamin E vitamin K biotin Column II Recommended daily dose 10 000 I.U.

4.5 mg

7.5 mg

45 mg 15 mg 15 mg

0.4 mg

14 µg 150 I.U. 400 I.U. 25 I.U.

0.0 mg

0.0 mg

Column III

90.0 - 165.0 %

90.0 - 145.0 %

90.0 - 125.0 %

90.0 - 125.0 %

90.0 - 125.0 %

90.0 - 125.0 %

90.0 - 135.0 %

90.0 - 135.0 %

90.0 - 145.0 %

90.0 - 145.0 %

90.0 - 125.0 %

90.0 - 125.0 %

90.0 - 135.0 %

Column IV

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

90.0 - 115.0 %

TABLEAU Colonne I

Article

1 Vitamine vitamine A (ou comme B-carotène) Colonne II Dose quotidienne recommandée 10 000 U.I. Colonne III Écart admissible lorsque la dose quotidienne recommandée indiquée sur l’étiquette est égale ou inférieure à celle de la colonne II 90,0 - 165,0 % Colonne IV Écart admissible lorsque la dose quotidienne recommandée indiquée sur l’étiquette est supérieure à celle de la colonne II 90,0 - 115,0 % PART C Drugs DIVISION 1 Sections C.01.062-C.01.065 Colonne I

Article

Vitamine Colonne II Dose quotidienne recommandée Colonne III Écart admissible lorsque la dose quotidienne recommandée indiquée sur l’étiquette est égale ou inférieure à celle de la colonne II Colonne IV Écart admissible lorsque la dose quotidienne recommandée indiquée sur l’étiquette est supérieure à celle de la colonne II 2 thiamine 4,5 mg 90,0 - 145,0 % 90,0 - 125,0 % 3 riboflavine 7,5 mg 90,0 - 125,0 % 90,0 - 125,0 % 4 niacine ou niacinamide 45 mg 90,0 - 125,0 % 90,0 - 125,0 % 5 pyridoxine 3 mg 90,0 - 125,0 % 90,0 - 125,0 % 6 acide d-panthothénique 15 mg 90,0 - 135,0 % 90,0 - 125,0 % 7 acide folique 0,4 mg 90,0 - 135,0 % 90,0 - 125,0 % 8 vitamine B12 14 µg 90,0 - 135,0 % 90,0 - 125,0 % 9 vitamine C 100 mg 90,0 - 145,0 % 90,0 - 125,0 % 10 vitamine D 400 U.I. 90,0 - 145,0 % 90,0 - 125,0 % 11 vitamine E 25 U.I. 90,0 - 125,0 % 90,0 - 125,0 % 12 vitamine K 0,0 mg 90,0 - 115,0 % - 13 biotine 0,0 mg 90,0 - 135,0 % - SOR/92-131, s. 1; SOR/92-591, s. 2; SOR/94-689, s. 2; SOR/95-500, s. 2; SOR/98-423, s. 8; SOR/2011-88, s. 8; SOR/2014-158, s. 8; SOR/2018-89, s. 19(F).

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01.063 [Repealed, SOR/96-399, s. 2] (b) shall not interfere with the therapeutic properties of the drug. SOR/90-586, s. 2. Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 1

Limites de variabilité

Articles C.01.062-C.01.065

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01.063 [Abrogé, DORS/96-399, art. 2]

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01.064 Si une drogue est préparée pour usage ophtalmique ou usage parentéral et que l’un de ses ingrédients est un agent de conservation, cet ingrédient a) doit être limité à la quantité nécessaire pour produire l’effet prévu sans entraîner de risques induits pour les personnes ou les animaux; b) ne doit pas nuire aux propriétés thérapeutiques de la drogue. DORS/90-586, art. 2.

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01.065 Il est interdit de vendre une drogue préparée pour usage ophtalmique ou usage parentéral, sauf si un échantillon représentatif de chaque lot de la drogue, dans son récipient immédiat : a) est soumis, selon une méthode acceptable, à une épreuve d’identité qui démontre que la drogue correspond à son nom propre, ou à défaut, à son nom usuel; (i) for living vaccines, or SOR/86-552, s. 1; SOR/90-586, s. 3; SOR/93-202, s. 12; SOR/96-399, s. 3; SOR/2018-69, s. 27. SOR/81-335, s. 1; SOR/96-399, s. 4. SOR/85-715, s. 5; SOR/92-654, s. 3. SOR/96-399, s. 5. **Mercuric Chloride Tablets** (i) of an irregular or angular shape, (ii) the word “Poison”. SOR/2001-181, s. 2.

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01.081 [Repealed, SOR/80-544, s. 4]

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01.085 [Repealed, SOR/80-544, s. 5] **Synthetic Sweeteners**

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01.101 (1) [Repealed, SOR/78-422, s. 3]

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01.121 and C.01.122 [Repealed, SOR/80-544, s. 6]

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01.131 No person shall sell Aminopyrine or Dipyrone (a derivative of Aminopyrine) for oral or parenteral use, unless (a) the inner label carries the statement: SOR/2018-69, s. 34(F). Coated Potassium Salts SOR/2018-69, s. 34(F).

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01.136 The provisions of sections C.01.134 and C.01.135 do not apply to coated tablets containing potassium salts with or without thiazide diuretics that (c) contain 100 milligrams or less of elemental potassium per tablet. Antibiotics (a) per gram in the case of solids or viscous liquids; (b) per millilitre in the case of other liquids; and SOR/80-544, s. 7; SOR/92-654, s. 4.

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01.402 [Repealed, SOR/92-654, s. 4]

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01.410 to C.01.412 [Repealed, SOR/80-544, s. 8]

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01.420 to C.01.422 [Repealed, SOR/80-544, s. 8] Chloramphenicol

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01.430 to C.01.432 [Repealed, SOR/80-544, s. 8] (a) the inner label carries a warning statement to the effect that SOR/2018-69, s. 35(F). SOR/2013-122, s. 12.

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01.436 The provisions of sections C.01.433 and C.01.435 do not apply to a drug sold solely for veterinary use.

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01.440 to C.01.442 [Repealed, SOR/80-544, s. 8]

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01.450 to C.01.452 [Repealed, SOR/80-544, s. 8]

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01.460 to C.01.462 [Repealed, SOR/80-544, s. 8]

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01.470 to C.01.472 [Repealed, SOR/80-544, s. 8]

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01.480 [Repealed, SOR/80-544, s. 8]

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01.490 to C.01.497 [Repealed, SOR/80-544, s. 8]

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01.510 to C.01.513 [Repealed, SOR/80-544, s. 8]

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01.520 to C.01.522 [Repealed, SOR/80-544, s. 8]

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01.530 to C.01.532 [Repealed, SOR/80-544, s. 8]

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01.540 to C.01.542 [Repealed, SOR/80-544, s. 8]

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01.550 to C.01.552 [Repealed, SOR/80-544, s. 8]

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01.560 to C.01.563 [Repealed, SOR/80-544, s. 8]

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01.570 to C.01.572 [Repealed, SOR/80-544, s. 8]

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01.580 [Repealed, SOR/80-544, s. 8]

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01.590 to C.01.592 [Repealed, SOR/80-544, s. 8] Veterinary Drugs

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01.601 [Repealed, SOR/93-407, s. 6] (i) International Units per gram or per millilitre for vitamin A, provitamin A, vitamin D, and vitamin E, (ii) milligrams per gram in the case of solids or viscous liquids, or per millilitre in the case of other liquids, for thiamine, riboflavin, niacin, niacinamide, pyridoxine, d-pantothenic acid, d-pantothenol, folic acid, ascorbic acid, and vitamin K, (iii) micrograms per gram in the case of solids or viscous liquids, or per millilitre in the case of other liquids, for biotin, and vitamin B12, (v) for vitamin products put up in individual dosage or dispensing form, the specified units per individual dosage or dispensing form; SOR/80-543, s. 6. (b) [Repealed, SOR/92-654, s. 5] SOR/80-543, s. 7; SOR/92-654, s. 5. SOR/88-378, s. 1; SOR/92-664, s. 2; SOR/93-467, s. 1; SOR/2018-69, s. 27. SOR/90-327, s. 1.

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01.607 Notwithstanding subparagraph C.01.004(1)(c)(ii), the declaration of a lot number is not required on the label of an animal feeding-stuff containing a drug. SOR/80-543, s. 8.

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01.608 The provisions of section C.01.604 do not apply to medicated feeds registered under the Feeds Act. SOR/2018-69, s. 20; SOR/2021-46, s. 6(F). (d) a 5-nitroimidazole compound; or SOR/85-839, s. 1; SOR/88-665, s. 2; SOR/91-546, s. 1; SOR/94-558, s. 2; SOR/97-510, s. 2; SOR/2003-229, s. 3. PROHIBITS THE ADMINISTRATION OF THIS PREPARATION TO ANIMALS THAT PRODUCE FOOD OR ANIMALS THAT ARE INTENDED FOR CONSUMPTION AS FOOD / MISE EN GARDE : EN VERTU DES LOIS FÉDÉRALES, IL EST INTERDIT D’ADMINISTRER CETTE PRÉPARATION AUX ANIMAUX QUI PRODUISENT DES ALIMENTS OU AUX ANIMAUX DESTINÉS À ÊTRE CONSOMMÉS COMME ALIMENTS”; (d) where the preparation is for oral use, the preparation SOR/91-546, s. 1. a) l’étiquette intérieure et l’étiquette extérieure de cette préparation portent la mise en garde suivante : « MISE EN GARDE : EN VERTU DES LOIS FÉDÉRALES, IL EST INTERDIT D’ADMINISTRER CETTE PRÉPARATION AUX ANIMAUX QUI PRODUISENT DES ALIMENTS OU AUX ANIMAUX DESTINÉS À ÊTRE CONSOMMÉS COMME ALIMENTS / WARNING : FEDERAL LAW PROHIBITS THE ADMINISTRATION OF THIS PREPARATION TO ANIMALS THAT PRODUCE FOOD OR ANIMALS THAT ARE INTENDED FOR CONSUMPTION AS FOOD »; b) s’il s’agit d’une préparation à usage parentéral, celle-ci contient au plus un gramme de chloramphénicol par ampoule sous forme de succinate sodique de chloramphénicol; c) s’il s’agit d’une préparation pour usage ophtalmique, celle-ci contient au plus 1 pour cent de chloramphénicol; d) s’il s’agit d’une préparation pour administration par voie orale, celle-ci, selon le cas : (i) est sous forme de comprimé ou de capsule et contient au plus un gramme de chloramphénicol par comprimé ou capsule, (ii) est sous forme de suspension de palmitate de chloramphénicol et contient au plus trois grammes de chloramphénicol par récipient. DORS/91-546, art. 1.

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01.611 (1) Le ministre peut, par écrit, exiger de temps à autre du fabricant d’une drogue recommandée pour administration aux animaux qui peuvent servir d’aliment a) une présentation relative à la drogue décrivant en détail les épreuves conduites pour vérifier qu’aucune substance mentionnée à la colonne II de la Liste visée par l’Autorisation de mise en marché - Limites maximales de résidus pour les drogues pour usage vétérinaire dans les aliments ne demeure dans un aliment mentionné à la colonne III de la Liste, sauf dans une quantité inférieure à la limite maximale de résidus prévue à la colonne IV pour cet aliment et cette substance; b) l’impression, dans l’espace principal de l’étiquette extérieure, sur l’étiquette intérieure et, le cas échéant, sur la notice jointe à l’emballage qui décrit la drogue, d’une mise en garde indiquant que les aliments provenant d’animaux auxquels a été administrée cette drogue ne peuvent être vendus pour consommation humaine que s’il s’est écoulé depuis cette administration le délai que fixe le ministre en se fondant sur une SOR/93-462, s. 2; SOR/2017-76, s. 14; SOR/2018-69, s. 27. SOR/2017-76, s. 6. SOR/2017-76, s. 6.

(2)

A veterinary health product shall display, on the principal display panel of the inner and outer label, the statement: “Veterinary Health Product / Produit de santé animale” or “Produit de santé animale / Veterinary Health Product”.

(3)

Section C.01.600 and paragraph C.01.604(b) do not apply in respect of a veterinary health product. SOR/2017-76, s. 6. (a) the name, mailing address, telephone number and email address of the manufacturer or importer; (d) the strength per dosage unit; (e) the route of administration; (f) a quantitative list of the medicinal ingredients and a qualitative list of the non-medicinal ingredients; SOR/2017-76, s. 6. SOR/2017-76, s. 6. SOR/2017-76, s. 6. Contraceptive Drugs SOR/2013-122, s. 13. DIVISION 1A Interpretation b) les renseignements et documents fournis par le fabricant ou l’importateur aux termes de l’article C.01.616 ne sont pas suffisants pour démontrer l’innocuité du produit; c) il a des motifs raisonnables de croire que la vente du produit enfreindrait la Loi ou le présent règlement.

(2)

Le ministre lève l’ordre de cessation de vente lorsque le fabricant ou l’importateur lui fournit les renseignements et documents établissant, selon le cas : a) que le produit est sûr, dans le cas d’un ordre de cessation de vente fondé sur les alinéas (1)a) ou b); b) que la vente du produit n’enfreindrait plus la Loi ou le présent règlement, dans le cas d’un ordre de cessation de vente fondé sur l’alinéa (1)c); c) que la situation donnant lieu à l’ordre de cessation de vente n’a pas existé. DORS/2017-76, art. 6. Drogues anticonceptionnelles

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01.625 Les drogues anticonceptionnelles qui sont fabriquées, vendues ou présentées pour la prévention de la conception et qui ne sont pas des drogues sur ordonnance peuvent faire l’objet de publicité auprès du grand public. DORS/2013-122, art. 13.

TITRE 1A

Licence d’établissement Définitions et interprétation

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01A.001 (1) Les définitions qui suivent s’appliquent au présent titre et aux titres 2 à 4. accord de reconnaissance mutuelle Accord international portant sur la reconnaissance mutuelle en matière de certification de la conformité aux bonnes pratiques de fabrication des drogues. (mutual recognition agreement) active pharmaceutical ingredient means an active ingredient that is used in the fabrication of a pharmaceutical. (ingrédient actif pharmaceutique) agent antimicrobien Drogue pouvant détruire les micro-organismes pathogènes et dont l’étiquette indique qu’elle est destinée à être utilisée dans la désinfection des surfaces de l’environnement ou des instruments médicaux, au sens du Règlement sur les instruments médicaux, qui : a) ne sont pas des instruments effractifs au sens de ce règlement; b) sont destinés à entrer en contact uniquement avec une peau intacte. (antimicrobial agent) autorité réglementaire Organisme public ou autre entité, de, dans un pays participant, qui est habilité à contrôler l’utilisation ou la vente de drogues dans ce pays et qui peut prendre des mesures d’exécution pour veiller à ce que les drogues commercialisées sur le territoire relevant de sa compétence satisfassent aux exigences légales. (regulatory authority) bâtiment reconnu À l’égard de la manufacture, de l’emballage-étiquetage ou de l’analyse d’une drogue, bâtiment qu’une autorité réglementaire, désignée aux termes du paragraphe C.01A.019(1) à l’égard de cette activité pour cette drogue, a reconnu comme satisfaisant à ses normes de bonnes pratiques de fabrication à l’égard de cette activité pour cette drogue. (recognized building) certificat de lot Certificat délivré par le manufacturier d’un lot d’une drogue ou d’un lot de fabrication de celle-ci qui, si est, importée dans le cadre d’un accord de reconnaissance mutuelle, soit visée à la liste de drogues vendues sans ordonnance et non soumises à certaines analyses, et dans lequel le manufacturier : a) identifie le document-type de production pour la drogue et atteste que le lot ou le lot de fabrication a été manufacturé, emballé-étiqueté et analysé conformément aux méthodes énoncées dans le document-type; b) fournit une description détaillée de la drogue, y compris : (i) la liste des propriétés et des qualités de la drogue, y compris l’identité, l’activité et la pureté de la drogue, (ii) une indication des tolérances relatives aux propriétés et aux qualités de la drogue; c) indique les méthodes d’analyse du lot ou lot de fabrication ainsi que les résultats analytiques détaillés obtenus; (a) lists the types and strengths of medicinal ingredients that may be contained in drugs of a specified class; and (b) sets out labelling and other requirements that apply to those drugs. (monographie de classe) dosage form class means a parenteral, tablet, capsule, solution, suspension, aerosol, powder, suppository, medical gas or drug premix, or any other dosage form class designated by the Minister. (classe de forme posologique) d) indique les adresses des bâtiments où le lot ou le lot de fabrication a été manufacturé, emballé-étiqueté et analysé; e) atteste que le lot ou le lot de fabrication a été manufacturé, emballé-étiqueté et analysé, selon le cas : (i) s’agissant de la drogue importée dans le cadre d’un accord de reconnaissance mutuelle, conformément aux bonnes pratiques de fabrication de l’autorité réglementaire qui a reconnu les bâtiments comme satisfaisant à ses normes de bonnes pratiques de fabrication, (ii) s’agissant de la drogue qui n’est pas importée dans le cadre d’un accord de reconnaissance mutuelle et qui est visée à la liste de drogues vendues sans ordonnance et non soumises à certaines analyses, conformément aux exigences de la section 2. (batch certificate) classe de forme posologique S’entend des parentéraux, comprimés, capsules, solutions, suspensions, aérosols, poudres, suppositoires, gaz médicaux, prémélanges médicamenteux ou de toute autre classe de forme posologique désignée par le ministre. (dosage form class) emballer-étiqueter Emballer une drogue dans son récipient immédiat ou apposer l’étiquette intérieure ou extérieure sur la drogue. (package/label) grossiste Personne, autre qu’un distributeur visé à l’article C.01A.003, qui vend une ou plusieurs des drogues ci-après autrement qu’au détail : a) toute drogue sans forme posologique visée aux annexes C ou D de la Loi, toute drogue qui est une drogue sur ordonnance ou toute drogue contrôlée au sens de l’article G.01.001; b) un ingrédient actif; c) un stupéfiant au sens du Règlement sur les stupéfiants; d) une drogue contenant du cannabis au sens du paragraphe 2(1) de la Loi sur le cannabis. L’expression « vendre en gros » a un sens correspondant. (wholesaler) importer Importer une drogue au Canada en vue de la vente. (import) ingrédient actif Drogue qui, lorsqu’elle est utilisée comme matière première dans la manufacture d’une PART C Drugs Interpretation Sections C.01A.001-C.01A.001 as amended from time to time. (Liste de drogues vendues sans ordonnance et non soumises à certaines analyses) pharmaceutical means a drug other than a drug listed in Schedule C or D to the Act. (produit pharmaceutique) site [Repealed, SOR/2002-368, s. 1] wholesale [Repealed, SOR/2013-74, s. 2] Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 1A Licence d’établissement

Définitions et interprétation

Articles C.01A.001-C.01A.001

drogue sous forme posologique, lui confère les effets recherchés. (active ingredient) ingrédient actif pharmaceutique Ingrédient actif utilisé dans la manufacture d’un produit pharmaceutique. (active pharmaceutical ingredient) Liste de drogues vendues sans ordonnance et non soumises à certaines analyses Liste de drogues figurant dans le document intitulé Liste de drogues vendues sans ordonnance pour lesquelles les analyses exigées en vertu des paragraphes C.02.019(1) et (2) du Règlement sur les aliments et drogues ne s’appliquent pas, publié par le gouvernement du Canada sur son site Web, avec ses modifications successives. (List of Non-prescription Drugs Not Subject to Certain Testing Requirements) manufacturer Préparer et conserver une drogue en vue de la vente. (fabricate) monographie de classe Document établi par le ministère de la Santé qui : a) présente les types et concentrations d’ingrédients médicinaux qui peuvent être contenus dans les drogues d’une classe donnée; b) énonce les exigences, notamment en matière d’étiquetage, applicables à ces drogues. (class monograph) pays ou régions reconnus Pays ou région figurant dans le document intitulé Liste des pays ou régions étrangers et de leurs organismes de réglementation pour l’application du paragraphe C.02.019(5) du Règlement sur les aliments et drogues, publié par le gouvernement du Canada sur son site Web, avec ses modifications successives. (recognized country or region) pays participant Pays participant à un accord de reconnaissance mutuelle avec le Canada. (MRA country) pays signataire [Abrogé, DORS/2002-368, art. 1] prémélange médicamenteux Drogue à usage vétérinaire qui a fait l’objet d’une identification numérique et dont l’étiquette porte qu’elle doit être combinée à un aliment au sens de l’article 2 de la Loi relative aux aliments du bétail. (drug premix) prémélange médicamenteux dilué Drogue à usage vétérinaire résultant de la combinaison d’un prémélange médicamenteux à un aliment, au sens de l’article 2 de la Loi relative aux aliments du bétail, et approuvée par les autorités compétentes pour cette drogue, au (b) an active ingredient; (d) a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act. (grossiste) moins 10 kg de la combinaison soit nécessaire pour médicamenter une tonne métrique d’un aliment complet, au sens du paragraphe 1(1) du Règlement de 2024 sur les aliments du détail. (dilute drug premix) produit intermédiaire en vrac Ingrédient actif utilisé dans la manufacture d’une drogue d’origine biologique visée à l’annexe C de la Loi ou d’une drogue visée à l’annexe D de la Loi. (bulk process intermediate) produit pharmaceutique Toute drogue non visée aux annexes C ou D de la Loi. (pharmaceutical) site [Abrogée, DORS/2022-368, art. 1] vendre en gros [Abrogée, DORS/2013-74, art. 2] (a) a dilute drug premix; Application (a) wholesaling a drug premix; (i) a pharmacist,

(2)

Au présent titre et au titre 2, le terme drogue ne vise pas : a) le prémélange médicamenteux dilué; b) l’aliment médicamenteux au sens du paragraphe 1(1) du Règlement de 2024 sur les aliments du détail; c) l’ingrédient actif pour usage vétérinaire qui n’est pas un ingrédient actif pharmaceutique; d) l’ingrédient actif pharmaceutique pour usage vétérinaire qui peut être vendu sans ordonnance et qui est également un produit de santé naturel au sens du paragraphe 1(1) du Règlement sur les produits de santé naturels; e) la drogue utilisée uniquement pour une étude expérimentale menée conformément au certificat délivré en vertu de l’article C.08.015.

(3)

Lorsque le ministre désigne d’autres classes de formes posologiques, il met la liste de ces classes à la disposition de quiconque en fait la demande. Application

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01A.002 (1) Le présent titre ne s’applique pas dans les cas suivants : a) la vente en gros d’un prémélange médicamenteux; b) sous réserve du paragraphe (3), l’importation ou la préparation, conformément à une ordonnance, de drogue qui n’est pas disponible sur le marché canadien par les personnes suivantes : (i) un pharmacien, (ii) a practitioner, and (i) homeopathic drugs, SOR/97-12, s. 5; SOR/2002-368, s. 2; SOR/2013-74, s. 3; SOR/2017-259, s. 12; SOR/2022-100, s. 2. (a) a distributor of an active ingredient; and SOR/97-12, s. 5; SOR/2002-368, s. 2; SOR/2013-74, s. 3; SOR/2017-259, s. 12. SOR/2022-100, s. 2. (a) fabricate, package/label or import a drug; (i) an active pharmaceutical ingredient, or (d) wholesale a drug other than (i) an active pharmaceutical ingredient, or SOR/97-12, s. 5; SOR/2002-368, s. 2; SOR/2013-74, s. 4; SOR/2017-259, s. 13; SOR/2018-144, s. 36; SOR/2019-171, s. 24; SOR/2022-100, s. 3. Application [SOR/2011-81, s. 1(E)] (d) each category of drugs set out in Table II to section C.01A.008 for which the licence is requested; le cas échéant, son numéro de télécopieur et son adresse électronique; c) chaque activité visée par la demande et figurant au tableau I de l’article C.01A.008; d) chaque catégorie de drogues visée par la demande et figurant au tableau II de l’article C.01A.008; e) chaque classe de forme posologique à l’égard de laquelle le demandeur se propose d’exercer une activité visée par sa licence et une mention indiquant s’il s’agit d’une forme posologique stérile; f) une mention indiquant si le demandeur se propose d’exercer une activité visée par sa licence à l’égard d’un ingrédient actif; g) l’adresse de chacun des bâtiments au Canada où le demandeur se propose de manufacturer, d’emballer-étiqueter, d’effectuer des analyses exigées au titre 2 ou d’entreposer des drogues, avec indication, pour chaque bâtiment, des activités et des catégories de drogues ainsi que, pour chaque catégorie de drogues, la classe de forme posologique, le cas échéant, et une mention indiquant si une drogue sera sous forme stérile; h) l’adresse de chacun des bâtiments au Canada où seront conservés les dossiers; i) pour tout bâtiment visé aux alinéas g) ou h), une mention indiquant s’il s’agit d’une maison d’habitation; j) l’identification numérique, le cas échéant, ou le nom qui identifie clairement la drogue s’il s’agit : (i) d’un stupéfiant au sens du Règlement sur les stupéfiants, d’une drogue contrôlée au sens de l’article G.01.001 ou d’une drogue contenant du cannabis au sens du paragraphe 2(1) de la Loi sur le cannabis, pour lequel la licence est demandée, (ii) de toute autre drogue d’une catégorie visée par la demande, à moins que la licence ne vise des analyses effectuées conformément au titre 2, la distribution visée à l’alinéa a), de la présente règle (C.01A.003a) ou la vente en gros; k) la date de la dernière inspection des bâtiments visés à l’alinéa g), le cas échéant, effectuée aux termes de la Loi ou du présent règlement; l) la preuve que les bâtiments, l’équipement et les méthodes et pratiques que le demandeur propose satisfont aux exigences applicables des titres 2 à 4; (o) in the case of an importer referred to in paragraph (n), m) dans le cas de l’importateur d’une drogue qui, dans un pays participant, est manufacturée, emballée-étiquetée ou analysée dans un bâtiment reconnu : (i) les nom et adresse de chaque manufacturier, emballeur-étiqueteur et analyste ainsi que l’adresse de chaque bâtiment où la drogue est manufacturée, emballée-étiquetée ou analysée, avec indication, pour chaque bâtiment, de l’activité et de la catégorie de drogues ainsi que, pour chaque catégorie de drogues, la classe de forme posologique, le cas échéant, et une mention indiquant s’il s’agit d’une drogue stérile, (ii) à l’égard de chaque activité qui, dans un pays participant, est effectuée dans un bâtiment reconnu, le nom de l’autorité réglementaire désignée aux termes du paragraphe C.01A.019(1) à l’égard de cette activité pour cette drogue qui reconnaît ce bâtiment comme satisfaisant à ses normes de bonnes pratiques de fabrication qui ont trait à cette activité pour cette drogue, (iii) à l’égard des autres activités, selon le cas : (A) le certificat d’un inspecteur canadien indiquant que les bâtiments, l’équipement, les méthodes et pratiques du manufacturier, de l’emballeur-étiqueteur ou de l’analyste satisfont aux exigences applicables des titres 2 à 4, (B) toute autre preuve établissant que les bâtiments, l’équipement et les méthodes et pratiques du manufacturier, de l’emballeur-étiqueteur ou de l’analyste satisfont aux exigences applicables des titres 2 à 4; n) dans le cas de tout autre importateur, les nom et adresse du manufacturier, de l’emballeur-étiqueteur et de l’analyste de qui il se propose d’importer la drogue, l’adresse de chaque bâtiment où elle sera manufacturée, emballée-étiquetée et analysée, avec indication, pour chaque bâtiment, de l’activité et de la catégorie de drogues ainsi que, pour chaque catégorie de drogues, la classe de forme posologique, le cas échéant, et une mention indiquant s’il s’agit d’une drogue stérile; o) dans le cas de l’importateur visé à l’alinéa (n), selon le cas : (i) le certificat d’un inspecteur canadien indiquant que les bâtiments, l’équipement et les méthodes et pratiques du manufacturier, de l’emballeur-étiqueteur et de l’analyste satisfont aux exigences applicables des titres 2 à 4, SOR/97-12, s. 5; SOR/2000-120, s. 2; SOR/2002-368, s. 4; SOR/2011-81, s. 2; SOR/2013-74, s. 5; SOR/2018-144, s. 389; SOR/2019-171, s. 24; SOR/2021-45, s. 3. (d) in addition to the matters set out in paragraphs (a) to (c), in the case of an importer, (i) to add a fabricator, packager/labeller or tester of a drug, (ii) une autre preuve établissant que les bâtiments, l’équipement et les méthodes et pratiques du manufacturier, de l’emballeur-étiqueteur et de l’analyste satisfont aux exigences applicables des titres 2 à 4.

(2)

En plus des renseignements et du matériel visés au paragraphe (1), la personne qui présente une demande de licence d’établissement qui vise l’une ou plusieurs des activités figurant au tableau I de l’article C.01A.008 et exercées à l’égard d’une catégorie de drogues figurant au tableau II de cet article qui inclut une drogue contre la COVID-19 peut inclure dans la demande une mention à cet égard. DORS/97-12, art. 5; DORS/2000-120, art. 2; DORS/2002-368, art. 4; DORS/2011-81, art. 2; DORS/2013-74, art. 5; DORS/2018-144, art. 389; DORS/2019-171, art. 24; DORS/2021-45, art. 3.

C

01A.006 (1) Toute demande de modification d’une licence d’établissement est présentée au ministre, en la forme établie par celui-ci, et contient les renseignements et documents visés à l’article C.01A.005 relativement à la modification demandée. (1.1) En plus des renseignements et du matériel visés au paragraphe (1), la personne qui présente une demande de modification d’une licence d’établissement qui vise l’une ou plusieurs des activités figurant au tableau I de l’article C.01A.008 et exercées à l’égard d’une catégorie de drogues figurant au tableau II de cet article qui inclut une drogue contre la COVID-19 peut inclure dans la demande une mention à cet égard.

(2)

Une licence d’établissement doit faire l’objet d’une modification lorsque le titulaire se propose : a) d’ajouter une ou plusieurs activités ou une catégorie de drogues visées aux tableaux de l’article C.01A.008; b) à l’égard d’une catégorie de drogues et d’une activité visées par la licence, d’autoriser des formes posologiques stériles; c) d’ajouter un ou plusieurs bâtiments au Canada où il est autorisé de fabriquer, d’emballer-étiqueter, d’analyser conformément au titre 2 ou d’entreposer une drogue ou, pour un bâtiment existant, d’ajouter l’autorisation de manufacturer, d’emballer-étiqueter, d’analyser ou d’entreposer une catégorie de drogues ou des formes posologiques stériles de celle-ci; d) dans le cas de tout importateur, en plus des éléments visés aux alinéas a) à c) : (i) d’ajouter le nom d’un manufacturier, emballeur-étiqueteur ou analyste, SOR/97-12, s. 5; SOR/2011-81, s. 3; SOR/2021-45, s. 4. SOR/97-12, s. 5; SOR/2011-81, s. 4; SOR/2021-45, s. 5(F). Issuance

(2)

The establishment licence shall indicate (d) [Repealed, SOR/2002-368, s. 5] TABLE I 1 Fabricate 2 Package/label tableaux I et II du présent article, respectivement, et précise pour chaque activité et catégorie de drogues, si des formes posologiques stériles sont autorisées; b) l’adresse de chacun des bâtiments au Canada où il est autorisé à manufacturer, à emballer-étiqueter, à analyser conformément au titre 2 ou à entreposer une catégorie de drogues figurant au tableau II du présent article et pour chacun d’eux, l’activité et la catégorie de drogues, et si des formes posologiques stériles sont autorisées; c) dans le cas de tout importateur, en plus des indications visées aux alinéas a) et b) : (i) le nom et adresse de chaque manufacturier, emballeur-étiqueteur et analyseur auprès de qui il est autorisé à obtenir la drogue pour l’importation, (ii) l’adresse de chaque bâtiment où la drogue est autorisée la manufacture, l’emballage-étiquetage ou l’analyse de la drogue avec indication, pour chacun d’eux, des activités et de la catégorie de drogues autorisées figurant au tableau II du présent article, et si des formes posologiques stériles sont autorisées. d) [Abrogé, DORS/2002-368, art. 5]

(3)

Le ministre peut indiquer dans la licence d’établissement toute période pendant laquelle les dossiers doivent être conservés sous le régime du titre 2 et qui, selon le profil de sûreté de la drogue ou des matériaux, est suffisante pour assurer la protection du consommateur.

(4)

Lorsqu’il délivre une licence d’établissement, le ministre peut l’assortir de conditions portant sur : a) les analyses à effectuer à l’égard de la drogue et l’équipement à utiliser afin que la drogue puisse être utilisée sans danger; b) tout autre élément nécessaire pour prévenir le risque pour la santé des consommateurs, notamment les conditions dans lesquelles la drogue est manufacturée, emballée-étiquetée ou analysée. TABLEAU I

Article Activité

1 Manufacturer 2 Emballer-étiqueter 3 Analyser, y compris examiner, conformément au titre 2 PART C Drugs Issuance Sections C.01A.008-C.01A.009 (a) an active pharmaceutical ingredient; or 6 Import (a) an active pharmaceutical ingredient; or TABLE II Item Categories of drugs 1 Pharmaceutical

1.1 Active ingredients

2 Vaccines 3 [Repealed, SOR/2013-179, s. 2] SOR/97-12, s. 5; SOR/2000-120, s. 2; SOR/2002-368, s. 5; SOR/2013-74, s. 6; SOR/2013-179, s. 2; SOR/2017-6, s. 8; SOR/2017-251, s. 4; SOR/2018-144, s. 4; SOR/2019-171, s. 24; SOR/2021-46, s. 6; SOR/2021-46, s. 11(E); SOR/2022-100, s. 4. Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 1A Licence d’établissement

Délivrance

Articles C.01A.008-C.01A.009

Article Activité

4 Distribuer à titre de distributeur visé à l’alinéa C.01A.003a) un ingrédient actif autre que : a) l’ingrédient actif pharmaceutique b) l’ingrédient actif utilisé dans la manufacture d’une drogue d’origine non biologique visée à l’annexe C de la Loi 5 Distribuer à titre de distributeur visé à l’alinéa C.01A.003b) 6 Importer 7 Vendre en gros une drogue autre que : a) l’ingrédient actif pharmaceutique b) l’ingrédient actif utilisé dans la manufacture d’une drogue d’origine non biologique visée à l’annexe C de la Loi TABLEAU II

Article Catégorie de drogues

1 Produit pharmaceutique

1.1 Ingrédient actif

2 Vaccin 3 [Abrogé, DORS/2013-179, art. 2] 4 Drogue, autre qu’un vaccin, visée à l’annexe D de la Loi 5 Drogue visée à l’annexe C de la Loi 6 Drogue qui est une drogue sur ordonnance, drogue contrôlée au sens de l’article G.01.001, stupéfiant au sens du Règlement sur les stupéfiants, et drogue contenant du cannabis au sens du paragraphe 2(1) de la Loi sur le cannabis 7 Ingrédient actif pharmaceutique figurant dans la Liste A qui est destiné à un usage vétérinaire DORS/97-12, art. 5; DORS/2000-120, art. 2; DORS/2002-368, art. 5; DORS/2013-74, art. 6; DORS/2013-179, art. 2; DORS/2017-6, art. 8; DORS/2017-251, art. 4; DORS/2018-144, art. 4; DORS/2019-171, art. 24; DORS/2021-46, art. 6; DORS/2021-46, art. 11(A); DORS/2022-100, art. 4. Examen annuel de la licence

C

01A.009 (1) Le titulaire d’une licence d’établissement qui n’est pas suspendue doit, avant le 1er avril de chaque année, présenter au ministre la demande d’examen de sa licence accompagnée des renseignements et documents visés à l’article C.01A.005. SOR/97-12, s. 5; SOR/97-298, s. 1; SOR/2011-81, s. 5. SOR/97-12, s. 5. (b) the applicable requirements of Divisions 2 to 4.

(2)

[Repealed, SOR/2000-120, s. 4] SOR/97-12, s. 5; SOR/2000-120, s. 4; SOR/2021-45, s. 7. SOR/97-12, s. 5; SOR/2021-45, s. 8; SOR/2021-46, s. 11(E). SOR/2021-45, s. 9. SOR/2021-45, s. 9. SOR/97-12, s. 5; SOR/2017-18, s. 15; SOR/2021-45, s. 10.

(2)

Le ministre donne au titulaire de la licence d’établissement un préavis écrit, d’au moins quinze jours indiquant la modification envisagée, les motifs de celle-ci et sa date d’entrée en vigueur. DORS/97-12, art. 5; DORS/2021-45, art. 8; DORS/2021-46, art. 11(A).

C

01A.012.1 (1) Malgré le paragraphe C.01A.008(4), le ministre peut, à tout moment, notamment lors de la délivrance, assortir de conditions la licence d’établissement qu’il délivre ou modifie en vertu de l’article C.01A.008 en réponse à la demande visée aux paragraphes C.01A.005(2) ou C.01A.006.1(1) qui contient la mention visée à celui de ces paragraphes qui s’applique.

(2)

Il est entendu que les conditions dont le ministre peut assortir la licence d’établissement en vertu du paragraphe (1) ne se limitent pas à celles visées au paragraphe C.01A.008(4). DORS/2021-45, art. 9.

C

01A.012.2 Le ministre peut, à tout moment, modifier les conditions dont il a assorti une licence d’établissement en vertu du paragraphe C.01A.012.1(1). DORS/2021-45, art. 9. Avis de modification

C

01A.013 Le titulaire d’une licence d’établissement doit aviser, par écrit, le ministre au plus tard le 15e jour suivant, selon le cas : a) la modification des renseignements visés aux alinéas C.01A.005(1)a), b) et e) à i); b) la survenance d’un fait susceptible d’avoir un effet sur la qualité, l’innocuité ou l’efficacité d’une drogue manufacturée, emballée-étiquetée, analysée conformément au titre 2 ou entreposée par lui qui entraîne le non-respect des exigences visées aux titres 2 à 4. DORS/97-12, art. 5; DORS/2017-18, art. 15; DORS/2021-45, art. 10.

C

01A.014 (1) Il est interdit au titulaire d’une licence d’établissement d’exercer une activité visée par sa licence à l’égard d’une catégorie de drogues, si une modification visée au paragraphe (2) est apportée, sauf : a) s’il a déposé auprès du ministre un avis contenant les renseignements nécessaires pour permettre à celui-ci d’évaluer l’innocuité de la drogue nouvelle eu égard à la modification; b) si le ministre lui a fait parvenir une lettre indiquant que les renseignements feront l’objet d’un examen, et qu’il ne lui a pas, dans les 90 jours suivant la date de SOR/97-12, s. 5; SOR/2000-120, s. 5; SOR/2002-368, s. 6. SOR/97-12, s. 5; SOR/2000-120, s. 6; SOR/2002-368, s. 7. Suspension SOR/97-12, s. 5; SOR/2018-84, s. 4; SOR/2021-46, s. 7. SOR/2018-84, s. 6; SOR/2021-45, s. 11. a) les antécédents du titulaire pour ce qui est de la conformité aux dispositions de la Loi ou du présent règlement; b) le risque que présenterait le maintien de la licence pour la santé des consommateurs.

(3)

Le ministre ne peut suspendre la licence d’établissement que si, à la fois : a) il a envoyé au titulaire un avis écrit précisant les motifs de la suspension et, le cas échéant, les mesures correctives qui s’imposent ainsi que le délai accordé pour les prendre; b) lorsque l’avis prévoit des mesures correctives, le titulaire ne les a pas prises dans le délai prévu; c) le titulaire a eu la possibilité de se faire entendre à l’égard de la suspension. DORS/97-12, art. 5; DORS/2018-84, art. 4; DORS/2021-46, art. 7.

C

01A.017 (1) Le ministre peut suspendre une licence d’établissement à l’égard de toute indication visée au paragraphe C.01A.008(2) si, après qu’il a ordonné en vertu de l’article 21.31 de la Loi au titulaire de la licence d’effectuer une évaluation en vue de fournir des preuves établissant que ses bâtiments, son équipement ou ses méthodes et pratiques, selon le cas, remplissent toujours les exigences prévues à l’alinéa C.01A.005(1)l), aux sous-alinéas C.01A.005(1)m)(ii) ou (iii) ou à l’alinéa C.01A.005(1)o) : a) le titulaire ne se conforme pas à l’ordre; b) le titulaire se conforme à l’ordre, mais le ministre conclut que les résultats de l’évaluation sont insuffisants pour établir que ces exigences sont toujours remplies. DORS/2018-84, art. 6; DORS/2021-45, art. 11. SOR/97-12, s. 5; SOR/2018-84, s. 6. SOR/2011-81, s. 6; SOR/2018-84, s. 7. SOR/2018-84, s. 7. SOR/97-12, s. 7; SOR/2000-120, s. 7; SOR/2002-368, s. 8; SOR/2024-136, s. 2. DIVISION 2 Good Manufacturing Practices

C

02.001 [Repealed, SOR/97-12, s. 5.1]

C

02.002 In this Division, drug [Repealed, SOR/97-12, s. 6] importer [Repealed, SOR/97-12, s. 6] packaging material includes a label; (matériel d’emballage) produce [Repealed, SOR/97-12, s. 6] quality control department [Repealed, SOR/2010-95, s. 1] SOR/82-524, s. 3; SOR/85-754, s. 1; SOR/89-174, s. 1; SOR/97-12, s. 6; SOR/2010-95, s. 1. SOR/2004-282, s. 3.

C

02.002.2 In this Division,

TITRE 2

Bonnes pratiques de fabrication

C

02.001 [Abrogé, DORS/97-12, art. 5.1]

C

02.002 Dans le présent titre, drogue [Abrogée, DORS/97-12, art. 6] importateur [Abrogé, DORS/97-12, art. 6] gaz médical désigne tout gaz ou mélange de gaz fabriqué ou vendu pour servir de drogue ou présenté comme pouvant servir de drogue; (medical gas) matériel de conditionnement [Abrogé, DORS/89-174, art. 1] matériel d’emballage comprend une étiquette; (packaging material) produire [Abrogé, DORS/97-12, art. 6] service du contrôle de la qualité [Abrogé, DORS/2010-95, art. 1] spécifications s’entend de la description détaillée d’une drogue, de la matière première utilisée dans cette drogue ou du matériel d’emballage de la drogue, y compris : a) la liste des propriétés et des qualités de la drogue, de la matière première ou du matériel d’emballage qui ont trait à la fabrication, à l’emballage et à l’emploi de la drogue, y compris l’identité, l’activité et la pureté de la drogue, de la matière première ou du matériel d’emballage, b) une description détaillée des méthodes d’analyse et d’examen de la drogue, de la matière première ou du matériel d’emballage, c) une indication des tolérances relatives aux propriétés et aux qualités de la drogue, de la matière première ou du matériel d’emballage. (specifications) DORS/82-524, art. 3; DORS/85-754, art. 1; DORS/89-174, art. 1; DORS/97-12, art. 6; DORS/2010-95, art. 1.

C

02.002.1 Le présent titre ne s’applique pas aux activités visant à manufacturer, à emballer-étiqueter, à analyser, à entreposer ou à importer un agent antimicrobien. DORS/2004-282, art. 3.

C

02.002.2 Dans le présent titre : a) toute mention des spécifications d’une drogue destinée à la consommation ou à l’usage à l’extérieur du SOR/2022-100, s. 5. Sale SOR/82-524, s. 3; SOR/97-12, s. 7; SOR/2000-120, s. 8; SOR/2010-105, s. 2(F). DORS/2013-74, s. 7. SOR/2013-74, s. 7. SOR/2013-74, s. 7. Canada, de la matière première utilisée dans cette drogue ou du matériel d’emballage de la drogue constitue un renvoi aux spécifications auxquelles la drogue, la matière première ou le matériel d’emballage est tenu de se conformer dans le pays dans lequel la drogue est destinée à être consommée ou utilisée; b) la définition de date limite d’utilisation au paragraphe C.01.001(1) ne s’applique pas à l’égard d’une drogue destinée à la consommation ou à l’usage à l’extérieur du Canada. DORS/2022-100, art. 5. Vente

C

02.003 Il est interdit au distributeur visé à l’alinéa C.01A.003b) et à l’importateur de vendre une drogue qui n’a pas été manufacturée, emballée-étiquetée, analysée et entreposée conformément aux exigences du présent titre. DORS/82-524, art. 3; DORS/97-12, art. 7; DORS/2000-120, art. 8; DORS/2010-105, art. 2(F).

C

02.003.1 Il est interdit à la personne qui manufacture, emballe-étiquette, analyse ou entrepose une drogue de la vendre à moins de l’avoir manufacturée, emballée-étiquetée, analysée et entreposée conformément aux exigences du présent titre. DORS/2013-74, art. 7.

C

02.003.2 (1) Il est interdit d’importer un ingrédient actif en vue de le vendre à moins qu’une personne ne soit responsable au Canada de sa vente.

(2)

Il est interdit à toute personne qui importe un ingrédient actif d’en vendre un lot ou un lot de fabrication, à moins que les renseignements suivants ne figurent sur l’étiquette : a) les nom et adresse municipale de cette personne; b) les nom et adresse du principal établissement au Canada de la personne responsable de la vente. DORS/2013-74, art. 7. Utilisation pour la manufacture

C

02.003.3 Il est interdit d’utiliser dans la manufacture d’une drogue tout ingrédient actif qui n’a pas été manufacturé, emballé-étiqueté, analysé et entreposé conformément aux exigences du présent titre. DORS/2013-74, art. 7. Premises SOR/82-524, s. 3; SOR/97-12, s. 8; SOR/2010-95, s. 3. SOR/82-524, s. 3; SOR/97-12, s. 9. Personnel SOR/82-524, s. 3; SOR/85-754, s. 2; SOR/97-12, s. 2; SOR/2018-69, s. 27. Sanitation PART C Drugs DIVISION 2 Good Manufacturing Practices Sanitation Sections C.02.007-C.02.009 SOR/82-524, s. 3; SOR/97-12, ss. 10, 53. SOR/82-524, s. 3; SOR/97-12, s. 11. Raw Material Testing (a) be in writing; Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 2 Bonnes pratiques de fabrication

Hygiène

Articles C.02.007-C.02.009

a) les méthodes de nettoyage des locaux où la drogue est manufacturée ou emballée-étiquetée et de l'équipement servant à ces fins; b) des instructions pour manufacturer et emballer- étiqueter les drogues dans des conditions hygiéniques et pour manutentionner le matériel utilisé à ces fins. DORS/82-524, art. 3; DORS/97-12, art. 10 et 53.

C

02.008 (1) Le manufacturier et l'emballeur-étiqueteur d'une drogue doivent avoir, par écrit, les exigences minimales relatives à la santé ainsi qu'au comportement et aux vêtements du personnel afin de garantir une manufacture et emballée-étiquetée des conditions hygiéniques.

(2)

L'accès à une zone où est exposée une drogue à l'étape où elle est manufacturée ou emballée-étiquetée est interdit à la personne : a) qui est atteinte ou porteuse d'une maladie transmissible; b) qui présente une plaie ouverte sur une surface exposée de son corps. DORS/82-524, art. 3; DORS/97-12, art. 11. Analyse des matières premières

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02.009 (1) Un lot ou un lot de fabrication d'une matière première doit être analysé en fonction des spécifications de cette matière première, avant d'être utilisé pour manufacturer une drogue.

(2)

Un lot ou un lot de fabrication d'une matière première ne peut être utilisé pour manufacturer une drogue que s'il est conforme aux spécifications de cette matière première.

(3)

Nonobstant le paragraphe (1), l'eau peut, avant la fin de l'analyse visée à ce paragraphe, être utilisée pour manufacturer une drogue.

(4)

Si une propriété d'une matière première est susceptible de s'altérer au cours de l'entreposage, aucun lot ou lot de fabrication de cette matière ne peut être utilisé, après avoir été entreposé, pour manufacturer une drogue, à moins que la propriété n'ait été à nouveau analysée après un intervalle approprié et trouvée conforme aux spécifications établies pour cette propriété.

(5)

Si les spécifications visées aux paragraphes (1), (2) et (4) ne sont pas prescrites, elles doivent a) être par écrit; (i) the fabricator SOR/82-524, s. 3; SOR/97-12, ss. 12, 60; SOR/2018-69, s. 27. Manufacturing Control SOR/82-524, s. 3; SOR/97-12, s. 13.

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02.012 (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler of a drug shall maintain SOR/82-524, s. 3; SOR/88-174, s. 8(F); SOR/97-12, ss. 14, 15; SOR/2010-95, s. 5; SOR/ 2013-74, s. 9. SOR/82-524, s. 3; SOR/97-12, s. 15; SOR/2010-95, s. 6. Packaging Material Testing

(3)

The specifications referred to in subsections (1) and (2) shall (a) be in writing; SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/2018-69, s. 27. SOR/82-524, s. 3; SOR/89-174, ss. 2(F), 8(F); SOR/97-12, s. 56(F); SOR/2018-69, s. 27.

(3)

The specifications referred to in subsections (1) and (2) shall (a) be in writing; SOR/82-524, s. 3; SOR/2013-74, s. 10. (i) the packager/labeller, distributor or importer constante selon les spécifications établies pour celle-ci et qu’elle est invariablement conforme à ces spécifications, (B) effectue des analyses de vérification complètes à une fréquence acceptable selon le ministre, (ii) la drogue n’a pas été transportée ou entreposée dans des conditions pouvant faire en sorte qu’elle ne soit plus conforme aux spécifications établies à son égard.

(2)

Chaque lot ou lot de fabrication d’une drogue reçu au Canada dans les locaux de l’emballeur-étiqueteur, du distributeur ou de l’importateur doit, lorsque la période de vie utile de cette drogue est de plus de 30 jours, être soumis à une analyse d’identité, celle-ci devant être confirmée par l’emballeur-étiqueteur après l’emballage-étiquetage.

(3)

Les paragraphes (1) et (2) ne s’appliquent pas au distributeur si la drogue est manufacturée, emballée-étiquetée et testée au Canada par le titulaire d’une licence d’établissement autorisant ces activités à l’égard de cette drogue.

(4)

Les paragraphes (1) et (2) ne s’appliquent pas au distributeur ni à l’importateur si la drogue est manufacturée, emballée-étiquetée et analysée dans un bâtiment reconnu d’un pays participant et s’ils conservent une copie du certificat de lot pour chaque lot de la drogue, ou chaque lot de fabrication de celle-ci qu’ils reçoivent. (4.1) Les paragraphes (1) et (2) ne s’appliquent ni au distributeur ni à l’importateur d’une drogue contre la COVID-19 si celle-ci fait l’objet d’une demande écrite au titre de l’article C.04.015. (4.2) Le paragraphe (1) ne s’applique ni à l’emballeur-étiqueteur, ni au distributeur, ni à l’importateur, si les conditions ci-après sont réunies : a) la drogue est un produit pharmaceutique radioactif ou un générateur de radionucléides au sens de l’article C.03.001 et elle a une période de vie utile d’au plus trente jours; b) l’emballeur-étiqueteur, le distributeur ou l’importateur, selon le cas, conserve une preuve à la ministre jugée satisfaisante démontrant à la fois que : (i) la drogue a été analysée en fonction des spécifications établies à son égard, (ii) la drogue n’a été ni transportée ni entreposée dans des conditions pouvant faire en sorte qu’elle ne soit plus conforme à ces spécifications. (i) for human use, (ii) in dosage form, (4.3) Les paragraphes (1) et (2) ne s’appliquent ni à l’emballeur-étiqueteur, ni au distributeur, ni à l’importateur, si les conditions ci-après sont réunies : a) la drogue satisfait aux exigences suivantes : (i) elle est destinée à l’usage des humains; (ii) elle est sous forme posologique; (iii) elle est visée à l’annexe D de la Loi; (iv) elle n’est pas un vaccin; (v) elle est composée de cellules humaines nucléées autologues génétiquement modifiées ou elle atteint les cellules à l’aide d’un vecteur de virus adéno-associé; b) l’emballeur-étiqueteur, le distributeur ou l’importateur, selon le cas, conserve une preuve que le ministre juge satisfaisante démontrant à la fois que : (i) la drogue a été analysée en fonction des spécifications établies à son égard, (ii) elle n’a pas été transportée ni entreposée dans des conditions pouvant modifier sa conformité aux spécifications établies à son égard.

(5)

Les paragraphes (1) et (2) ne s’appliquent ni au distributeur ni à l’importateur d’une drogue qui peut être vendue sans ordonnance et qui appartient à une catégorie de drogues figurant à la colonne 1 de la liste de drogues vendues sans ordonnance et non soumises à certaines analyses, si les conditions ci-après sont réunies : a) la drogue contient comme seuls ingrédients actifs un ou plusieurs de ceux visés à la colonne 2 pour cette catégorie de drogues, chacun en une quantité figurant à la colonne 3, et les éléments descriptifs visés aux colonnes 4 à 6 s’appliquent à la drogue; b) la drogue satisfait aux exigences suivantes : (i) elle est manufacturée soit au Canada, soit dans des pays ou régions reconnus; (ii) elle est emballée-étiquetée soit au Canada, soit dans des pays ou régions reconnus; (iii) elle fait l’objet de l’analyse dans des pays ou régions reconnus. SOR/82-524, s. 3; SOR/83-174, s. 8(F); SOR/97-12, ss. 16, 57; SOR/2000-120, s. 11; SOR/2002-368, s. 10; SOR/2013-74, s. 11; SOR/2018-69, s. 27; SOR/2020-73, s. 2; SOR/2021-45, s. 12; SOR/2024-136, s. 4. Records SOR/82-524, s. 3; SOR/89-174, ss. 31, 48, 89(F); SOR/97-12, ss. 17, 52, 60; SOR/2013-74, s. 11; SOR/2017-259, s. 15; SOR/2018-69, s. 27.

(2)

Le distributeur visé à l’alinéa C.01A.003b) et l’importateur fournissent au ministre, sur demande, les résultats des analyses des matières premières et des matériaux d’emballage-étiquetage effectuées pour chaque lot ou lot de fabrication d’une drogue qu’ils distribuent ou importent.

(3)

Le manufacturier conserve dans ses locaux les spécifications écrites relatives à ces matières ainsi qu’une preuve satisfaisante des analyses prévues à l’article C.02.009 et les résultats de celles-ci.

(4)

La personne qui emballe une drogue conserve dans ses locaux les spécifications écrites relatives au matériel d’emballage ainsi qu’une preuve satisfaisante des examens ou analyses prévus à l’article C.02.016 et les résultats de ceux-ci.

(5)

Le manufacturier, l’emballeur-étiqueteur et l’analyste conservent dans leurs locaux au Canada les plans et devis détaillés de chacun des bâtiments au Canada où la drogue est manufacturée, emballée-étiquetée ou analysée ainsi qu’une description de la conception et de la construction de ces bâtiments.

(6)

Le manufacturier, l’emballeur-étiqueteur et l’analyste conservent dans leurs locaux au Canada un dossier pour chaque membre de son personnel supervisant les opérations visant à manufacturer, emballer-étiqueter et analyser la drogue, notamment son titre, ses responsabilités, ses qualifications, son expérience et sa formation. DORS/82-524, art. 3; DORS/89-174, art. 31 et 48(F); DORS/97-12, art. 17, 52 et 60; DORS/2013-74, art. 11; DORS/2017-259, art. 15; DORS/2018-69, art. 27.

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02.021 (1) Les dossiers et les preuves exigés par le présent titre pour les opérations visant à manufacturer, emballer-étiqueter, analyser le produit fini aux termes de l’article C.02.018 et entreposer une drogue sous forme posologique doivent être conservés pendant au moins une (1) année suivant la date limite d’utilisation de la drogue, à moins que la licence d’établissement de l’intéressé ne prévoie une autre période.

(2)

Sous réserve du paragraphe (4), les dossiers et les preuves exigés par le présent titre pour les opérations visant à manufacturer, emballer-étiqueter, analyser le produit fini aux termes de l’article C.02.018 et entreposer un ingrédient actif doivent être conservés, pour chaque lot ou lot de fabrication de l’ingrédient actif, pendant celle des périodes ci-après qui s’applique, à moins que la licence d’établissement de l’intéressé ne prévoie une autre période : a) dans le cas d’un ingrédient actif ayant une date de nouvelle analyse, trois ans après la distribution complète du lot ou du lot de fabrication; SOR/82-524, s. 3; SOR/98-174, s. 8(F); SOR/92-654, s. 6; SOR/97-12, s. 18; SOR/2013-74, s. 11. SOR/82-524, s. 3; SOR/92-654, s. 7; SOR/97-12, s. 18; SOR/2013-74, s. 11. (a) the results of any investigation carried out under subsection C.02.015(2) and, if applicable, the corrective action taken; or b) dans les autres cas, un an après la date limite d'utilisation du lot ou du lot de fabrication.

(3)

Sous réserve du paragraphe (4), les dossiers et les preuves exigés par le présent titre au sujet de l'analyse des matières premières visées à l'article C.02.009 et des matériaux d'emballage-étiquetage doivent être conservés pendant cinq ans après leur dernière utilisation au cours des opérations visant à manufacturer ou à emballer-étiqueter la drogue à moins que la licence d'établissement de l'intéressé ne prévoie une autre période.

(4)

Si le manufacturier doit conserver des dossiers et des preuves à l'égard d'un même ingrédient actif aux termes des paragraphes (2) et (3), il les conserve pendant la plus longue période applicable. DORS/82-524, art. 3; DORS/98-174, art. 8(F); DORS/92-654, art. 6; DORS/97-12, art. 18; DORS/2013-74, art. 11.

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02.022 (1) Le grossiste, le distributeur visé à l'article C.01A.003 et l'importateur d'une drogue sous forme posologique conservent les dossiers sur la vente de chaque lot ou lot de fabrication de la drogue qui leur permettent de retirer ce lot ou lot de fabrication du marché pendant un an après la date limite d'utilisation de ce lot ou lot de fabrication, à moins que la licence d'établissement de l'intéressé ne prévoie une autre période.

(2)

Le distributeur d'un ingrédient actif visé à l'alinéa C.01A.003(a) et le grossiste et l'importateur d'un ingrédient actif conservent les dossiers sur la vente de chaque lot ou lot de fabrication de l'ingrédient actif qui leur permettent de retirer du marché le lot ou lot de fabrication pendant celle des périodes ci-après qui s'applique, à moins que l'intéressé ne détienne une licence d'établissement qui prévoit une autre période: a) dans le cas d'un ingrédient actif ayant une date de nouvelle analyse, trois ans après la distribution complète du lot ou du lot de fabrication; b) dans les autres cas, un an après la date limite d'utilisation du lot ou du lot de fabrication. DORS/82-524, art. 3; DORS/92-654, art. 7; DORS/97-12, art. 18; DORS/2013-74, art. 11.

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02.023 (1) Sur réception d'une plainte ou de renseignements sur la qualité d'une drogue ou sur des défauts ou dangers qu'elle comporte, le manufacturier, l'emballeur-étiqueteur, le grossiste, le distributeur visé à l'article C.01A.003 et l'importateur de la drogue en consignent les détails dans un dossier dans lequel figurent les renseignements suivants, le cas : a) les résultats des enquêtes qu'ils ont menées à cet égard aux termes du paragraphe C.02.015(2) et, le cas échéant, les mesures correctives prises; (b) in the case of an active ingredient, SOR/82-524, s. 3; SOR/92-654, s. 7; SOR/97-12, s. 18; SOR/2010-95, s. 7; SOR/2013-74, s. 11.

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02.024 (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler shall

(2)

Every person who fabricates or packages/labels a drug shall SOR/82-524, s. 3; SOR/97-12, ss. 19, 53. (d) the lot number. SOR/2013-74, s. 12. Samples SOR/82-524, s. 3; SOR/88-174, s. 4(F); SOR/92-654, s. 8; SOR/97-12, s. 20; SOR/2013-74, s. 13; SOR/2021-46, s. 8. SOR/82-524, s. 3. SOR/82-524, s. 3; SOR/97-12, s. 58; SOR/2013-74, s. 14. SOR/82-524, s. 3; SOR/97-12, s. 58; SOR/2013-74, s. 14. (a) in separate and enclosed areas; SOR/82-524, s. 3; SOR/97-12, s. 21. Medical Gases

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02.030 The provisions of sections C.02.025, C.02.027 and C.02.028 do not apply to medical gases. SOR/85-754, s. 3. DIVISION 3 Schedule C Drugs

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03.001 In this Division, licence or Canadian licence [Repealed, SOR/97-12, s. 22] manufacturer [Repealed, SOR/97-12, s. 22] (a) contained in an ion-exchange column, or (d) a solvent extraction procedure. (générateur de radionucléide) SOR/97-12, s. 22; SOR/2013-74, s. 15. SOR/97-12, s. 23.

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03.002 to C.03.005 [Repealed, SOR/97-12, s. 24]

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03.006 [Repealed, SOR/97-12, s. 67]

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03.007 to C.03.011 [Repealed, SOR/97-12, s. 26] SOR/97-12, s. 27; SOR/2018-69, s. 27. SOR/97-12, s. 27.

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03.014 (1) Section C.01.004 does not apply to a drug.

(2)

and (3) [Repealed, SOR/97-12, s. 28] SOR/79-236, s. 1; SOR/93-202, s. 15; SOR/97-12, s. 28.

(2)

Subsection (1) does not apply to (a) a drug sold to a drug fabricator; (b) a drug sold under a prescription; (d) a component or kit as defined in section C.03.205. SOR/80-543, s. 9; SOR/97-12, s. 16; SOR/2001-181, s. 4; SOR/2013-122, s. 16.

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03.030 to C.03.045 [Repealed, SOR/81-335, s. 2] SOR/97-12, s. 29.

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03.202 (1) Every package containing a radiopharmaceutical, other than a radionuclide generator, shall carry, (iv) the drug identification number assigned for the radiopharmaceutical, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”; and (v) [Repealed, SOR/2017-259, s. 16] (viii) the names and a statement of the amounts of all other non-radioactive contents of the drug, (ix) a statement of the total radioactivity content of the drug including overfill, (A) units of radioactivity per capsule or (B) units of radioactivity per unit volume, (xii) a statement of the specific activity of the drug expressed as units of radioactivity per unit weight of carrier present or the statement “carrier-free” or “sans entraîneur”, whichever is applicable, (b) sold under a prescription, if the radiopharmaceutical’s label indicates

(4)

Section C.01.005 does not apply to a radiopharmaceutical. SOR/79-286, s. 2; SOR/93-202, s. 16; SOR/97-12, ss. 54, 58, 62; SOR/2001-203, s. 2; SOR/2012-129, s. 2; SOR/2017-259, s. 16; SOR/2018-69, s. 35(F).

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03.203 (1) Every radionuclide generator shall carry on the inner label (e) the drug identification number assigned for the radionuclide generator, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”; (g) a statement of the total parent radioactivity contained in the radionuclide generator; (k) a statement of special storage requirements with reference to temperature or shielding;

(3)

Section C.01.005 does not apply to a radionuclide generator. SOR/79-236, s. 3; SOR/93-202, s. 17; SOR/97-12, ss. 54, 58, 62; SOR/2012-129, s. 3; SOR/2017-259, s. 18(F); SOR/2018-69, ss. 21(F), 22(F). SOR/97-12, s. 30; SOR/2012-129, s. 4. [SOR/2017-259, s. 18(F)] (b) an empty vial or other accessory item in a kit. (constituant) (b) may contain empty vials or other accessory items. (trousse) SOR/79-236, s. 4; SOR/2017-259, s. 19.

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03.206 Sections C.01.005 and C.04.019 do not apply to a component or kit. SOR/79-236, s. 4.

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03.207 (1) Every component shall be labelled to show (d) the lot number;

(2)

The component of a kit that is intended to contain the prepared radiopharmaceutical shall be labelled to display the drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”. SOR/79-798, s. 4; SOR/97-12, s. 8; SOR/2017-259, s. 20; SOR/2018-69, s. 23(F).

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03.208 Every kit shall be labelled to show (d) the name and address of the distributor referred to in paragraph C.01A.003(b); (e) the drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”; (f) the lot number; (j) a statement of the sterility and apyrogenicity of the components; (l) a statement of the duration of the useful life of the prepared radiopharmaceutical; (m) a statement of the storage requirements for the prepared radiopharmaceutical; (o) a statement of the route of administration of the prepared radiopharmaceutical. (p) [Repealed, SOR/2001-203, s. 3] (b) a list of the contents of the kit; (d) identification of the radionuclides that can be used to prepare the radiopharmaceutical; (f) a statement of the duration of the useful life of the prepared radiopharmaceutical; (g) a description of the biological actions of the prepared radiopharmaceutical; (l) the radiation dosimetry in respect of the prepared radiopharmaceutical; SOR/79-236, s. 4; SOR/93-202, ss. 19, SOR/97-12, s. 58; SOR/2018-68, s. 36(F). Positron-emitting Radiopharmaceuticals Interpretation g) une description des effets biologiques du produit pharmaceutique radioactif préparé; h) les indications et contre-indications du produit pharmaceutique radioactif préparé; i) les mises en garde et les précautions relatives aux constituants et au produit pharmaceutique radioactif préparé; j) les effets nocifs, liés, le cas échéant, au produit pharmaceutique radioactif préparé; k) lorsqu’il y a lieu, la pharmacologie et la toxicologie du produit pharmaceutique radioactif préparé ou une mention indiquant que ces renseignements sont disponibles sur demande; l) la dosimétrie des rayonnements pour le produit pharmaceutique radioactif préparé; m) une déclaration de l’usage recommandé pour le produit pharmaceutique radioactif recommandé pour cet usage; n) une déclaration de la voie d’administration prévue pour le produit pharmaceutique radioactif préparé; et o) une recommandation selon laquelle la pureté radiochimique et le teneur radioactive du produit pharmaceutique radioactif préparé doivent être vérifiées avant l’administration. DORS/79-236, art. 4; DORS/93-202, art. 19; DORS/97-12, art. 58; DORS/2018-68, art. 36(F). Produits pharmaceutiques radioactifs émetteurs de positrons Définitions

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03.301 Les définitions qui suivent s’appliquent au présent article et aux articles C.03.302 à C.03.319. autre personne Tout individu qui entre en contact physique avec un sujet de l’étude. (other person) bonnes pratiques cliniques Pratiques cliniques généralement reconnues visant à protéger les droits, la sécurité et le bien-être des sujets de l’étude et de toute autre personne. (good clinical practices) chercheur qualifié Médecin, membre en règle d’une association médicale canadienne, chargé par le promoteur de veiller au bon déroulement d’une étude dans un lieu d’étude donné et exerçant à ce titre selon les lois de la province où se trouve ce lieu. (qualified investigator) research ethics board means a body described in section C.03.306. (comité d’éthique de la recherche) (b) a congenital malformation; (d) a life-threatening condition; or (e) death. (réaction indésirable grave) study drug means a positron-emitting radiopharmaceutical that is used in a study. (drogue destinée à l’étude) SOR/2012-129, s. 5. Application

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03.302 (1) Sections C.03.303 to C.03.319 apply to the sale and importation of study drugs.

(2)

Sections C.03.001 to C.03.209 and Divisions 5 and 8 do not apply to study drugs. SOR/2012-129, s. 5. (d) the sponsor is authorized under section C.03.309 to sell or import the study drug; and (e) the sponsor complies with sections C.03.310 to C.03.316. SOR/2012-129, s. 5. Purpose of Study (a) the pharmacokinetics or metabolism of the study drug; (b) normal human biochemistry or physiology; or (a) discover, identify or verify the pharmacodynamic effects of the study drug; (c) fulfil an immediate therapeutic or diagnostic purpose; or (d) ascertain the safety or efficacy of the study drug. SOR/2012-129, s. 5. Requirements (f) female study subjects shall SOR/2012-129, s. 5. Exigences

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03.305 (1) L’étude satisfait aux critères suivants : a) elle est réalisée à partir d’une drogue destinée à l’étude dont l’innocuité a été établie à l’égard de l’humain — sur la base de données suffisantes, obtenues dans le cadre d’essais effectués sur des animaux et des êtres humains — avant son utilisation dans le cadre de l’étude; b) il a été établi que la quantité ou la combinaison des ingrédients actifs de la drogue destinée à l’étude ne provoquent chez les êtres humains aucun effet pharmacodynamique qui puisse être détecté sur le plan clinique; c) la dose annuelle totale de rayonnement que recevra chaque sujet, notamment par suite de multiples administrations de la drogue destinée à l’étude, de l’exposition à des impuretés ou à des contaminants importants et des autres procédures utilisées pour les besoins de l’étude, ne dépassera pas 50 mSv; d) le cas échéant, toute drogue utilisée de façon concomitante dans le cadre de l’étude s’est vu attribuer une identification numérique aux termes du paragraphe C.01.014.2(1) ou, s’agissant d’une drogue nouvelle, s’est vu délivrer un avis de conformité aux termes de l’article C.08.004; e) les sujets de l’étude ont au moins dix-huit ans et possèdent la capacité juridique au moment de l’étude; f) chaque sujet d’étude féminin : (i) a passé un test de grossesse confirmant qu’elle n’est pas enceinte au moment de l’étude ou a fourni une déclaration écrite confirmant ce fait, (ii) est avisée, si elle allait au moment de l’étude, de suspendre l’allaitement pendant vingt-quatre heures après l’administration de la drogue; g) l’étude porte sur au plus trente sujets.

(2)

Malgré l’alinéa (1)g), l’étude peut porter sur plus de trente sujets d’étude si le promoteur fournit au ministre les motifs scientifiques justifiant cette augmentation et que ce dernier l’approuve. DORS/2012-129, art. 5. SOR/2012-129, s. 5. (a) the use of the study drug will not endanger the health of any study subject or other person; (a) the title of the study and the protocol code or identification; (c) the number of study subjects; (d) the brand name, if any, of the study drug; (e) the chemical or generic name of the active ingredients in the study drug; (f) a qualitative list of the non-active ingredients of the study drug; (g) the maximum mass of the study drug to be administered to each study subject; (h) the radioactive dose range of the study drug, expressed in MBq or mCi; (i) the effective dose or effective dose equivalent of the study drug, expressed in mSv/MBq or rem/mCi; (m) the name and civic address of each study site; (n) for each study site, the name, civic address, telephone number, fax number and email address of the qualified investigator; (b) l’étude n’ira pas à l’encontre des intérêts des sujets de l’étude; (c) les objectifs de l’étude sont raisonnablement réalisables.

(2)

La demande d’autorisation contient les renseignements et documents suivants : a) le titre de l’étude et le code ou l’identification du protocole; b) l’objectif et une brève description de l’étude; c) le nombre de sujets de l’étude; d) la marque nominative de la drogue destinée à l’étude, s’il y a lieu; e) le nom chimique ou générique des ingrédients actifs de la drogue destinée à l’étude; f) la liste qualitative des ingrédients non actifs de la drogue destinée à l’étude; g) la masse maximale de la drogue destinée à l’étude qui sera administrée à chaque sujet de l’étude; h) l’amplitude de la dose radioactive de la drogue destinée à l’étude, exprimée en MBq ou en mCi; i) la dose efficace ou l’équivalent de dose efficace de la drogue destinée à l’étude, exprimés en mSv/MBq ou en rem/mCi; j) les nom et adresse municipale du promoteur, son adresse postale si elle est différente, ainsi que ses numéro de téléphone, numéro de télécopieur et adresse électronique; k) les nom et adresse municipale du fabricant, son adresse postale si elle est différente, ainsi que ses numéro de téléphone, numéro de télécopieur et adresse électronique; l) dans le cas d’une demande d’importation, les nom et adresse municipale, l’adresse postale si elle est différente, ainsi que les numéro de téléphone, numéro de télécopieur et adresse électronique du représentant du fabricant au Canada qui est responsable de la vente de la drogue destinée à l’étude; m) les nom et adresse municipale de chaque lieu d’étude; n) pour chaque lieu d’étude, les nom, adresse municipale, numéro de téléphone, numéro de télécopieur et adresse électronique du chercheur qualifié; SOR/2012-129, s. 5. SOR/2012-129, s. 5. SOR/2012-129, s. 5. Notice SOR/2012-129, s. 5. Good Clinical Practices (d) at each study site, there is only one qualified investigator; SOR/2012-129, s. 5. Labelling (i) the unique batch number for the study drug, and (ii) the chemical or generic name of the active ingredients in the study drug, (iii) the name and civic address of the manufacturer, (v) the code or other identification of the protocol, SOR/2012-129, s. 5; SOR/2018-69, art. 24(F); SOR/2021-46, s. 9(F). **Submission of Information** (a) the use of the study drug may endanger the health of a study subject or other person; (d) information submitted in respect of the study drug or study is false or misleading. SOR/2012-129, s. 5.

(3)

Sections C.01.016 to C.01.020 do not apply to study drugs. SOR/2012-129, s. 5. Records SOR/2012-129, s. 5. Discontinuance of a Study SOR/2012-129, s. 5. Suspension (d) the sponsor contravenes a provision of these Regulations or any provision of the Act in relation to the study drug. pour la santé des sujets de l’étude ou celle de toute autre personne.

(2)

S’il est mis fin à l’étude pour des raisons de santé ou sécurité pouvant affecter des sujets de l’étude ou d’autres personnes, le promoteur en avise le ministre par écrit dans les quinze jours suivant la cessation de l’étude et indique dans l’avis les motifs de la cessation et l’incidence de cette cessation sur des autres études qui sont prévues ou en cours au Canada relativement à la drogue destinée à l’étude. DORS/2012-129, art. 5. Suspension

C

03.317 (1) Le ministre suspend — en totalité ou à l’égard d’un lieu d’étude donné — l’autorisation de vendre ou d’importer la drogue destinée à l’étude dans les cas suivants : a) l’un des renseignements ou documents fournis en application des articles C.03.307, C.03.308 ou C.03.313 s’avère inexact ou incomplet; b) le promoteur ne fournit pas, sur demande écrite du ministre en vertu de l’article C.03.313, au plus tard à la date précisée dans celle-ci, de renseignements suffisants pour établir l’innocuité de la drogue destinée à l’étude; c) le promoteur a omis d’informer le ministre des réactions indésirables visées à l’article C.03.314 ou de lui remettre un rapport à cet effet conformément à cet article; d) le promoteur a contrevenu à toute disposition du présent règlement ou de la Loi relative à la drogue destinée à l’étude.

(2)

Pour décider s’il suspend l’autorisation dans sa totalité ou à l’égard d’un lieu d’étude donné, le ministre vérifie si le motif de la suspension s’applique à l’étude dans sa totalité ou seulement à un lieu d’étude donné.

(3)

Avant de suspendre l’autorisation, le ministre envoie au promoteur un préavis qui contient les précisions suivantes : a) les motifs de la suspension envisagée, si elle vise la totalité de l’autorisation ou uniquement un lieu d’étude donné et sa date de prise d’effet; b) son obligation de prendre les mesures correctives qui s’imposent, le cas échéant, au plus tard à la date précisée; SOR/2012-129, s. 5. Reinstatement (b) in the case of a suspension under subsection C.03.317(4), the period specified in the notice sent under subsection C.03.317(5). SOR/2012-129, s. 5. SOR/2012-129, s. 5. DIVISION 4 Schedule D Drugs

C

04.001 In this Division, licence or Canadian licence [Repealed, SOR/97-12, s. 31] manufacturer [Repealed, SOR/97-12, s. 31; SOR/2013-74, s. 16] SOR/97-12, s. 32 SOR/97-12, s. 33

C

04.004 to C.04.006 [Repealed, SOR/97-12, s. 34]

C

04.007 [Repealed, SOR/97-12, s. 67]

C

04.008 to C.04.012 [Repealed, SOR/97-12, s. 36] SOR/97-12, s. 63. SOR/97-12, s. 37. SOR/97-12, s. 37; SOR/2018-69, s. 27. SOR/97-12, s. 38. SOR/97-12, s. 61. SOR/97-12, s. 61. (iii) the potency of the drug, where applicable, (iv) the recommended dose of the drug, (v) the lot number, (vi) the expiration date except upon the inner label of a single-dose container, and (vii) adequate direction for use; and (ii) [Repealed, SOR/2013-179, s. 3] PART C Drugs DIVISION 4 Schedule D Drugs Sections C.04.010-C.04.052 "HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS." SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN. SOR/98-424, s. 7; SOR/93-202, s. 21; SOR/97-12, ss. 39, 54, 58; SOR/2011-88, s. 6; SOR/2013-122, s. 3. (b) a drug sold under a prescription. SOR/80-543, s. 10; SOR/97-12, s. 40; SOR/2001-181, s. 4; SOR/2013-122, s. 17. Bacterial Vaccines, Products Analogous to Bacterial Vaccines SOR/97-12, s. 61. SOR/97-12, s. 61. (a) the number of bacteria per millilitre, or the weight of dried substance of bacteria per millilitre, (b) the number of bacteria per millilitre, or the weight of dried substance of bacteria per millilitre, of each species or immunogenic type for a vaccine that contains a number of different species or immunogenic types of bacteria, (d) the recommended dose, Typhoid Vaccine Pertussis Vaccine SOR/90-217, s. 1; SOR/97-12, s. 61. B.C.G. (Bacille Calmette-Guérin) Vaccine SOR/2018-69, s. 27. SOR/97-12, s. 61. SOR/97-12, s. 41. SOR/97-12, s. 61. SOR/97-12, s. 65. SOR/97-12, s. 62. SOR/97-12, s. 63. SOR/97-12, s. 61. SOR/97-12, s. 63. SOR/97-12, s. 61.

C

04.082 No inner label shall be required for fluid B.C.G. vaccine in single-dose containers.

C

04.083 The label of fluid B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of (a) the weight of bacteria per millilitre; and

C

04.084 The label of freeze-dried B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of (a) the amount of bacteria per vial or per dose; and

C

04.085 The provisions of subparagraph C.04.019(b)(iv) do not apply to freeze-dried B.C.G. vaccine. Products Analogous to Bacterial Vaccines

C

04.090 A product analogous to a bacterial vaccine shall be Virus and Rickettsial Vaccines

C

04.100 A virus vaccine, rickettsial vaccine, shall be a suspension of, or prepared from, living or killed viruses or rickettsiae. SOR/87-12, s. 2; SOR/97-12, s. 42. SOR/97-12, s. 63; SOR/2018-69, s. 27. Smallpox Vaccine

C

04.110 Smallpox vaccine (a) shall be a virus vaccine; (ii) specifically infected membranes of chick embryos, or SOR/2006-2, s. 1. SOR/97-12, s. 43. SOR/97-12, s. 43. SOR/97-12, s. 63. (a) spore-forming anaerobic micro-organisms; (b) coagulase positive staphylococci; (c) haemolytic streptococci; and (d) any other contaminating pathogenic micro-organisms. SOR/97-12, s. 63. SOR/97-12, s. 63. (b) meets the potency of equal to or greater than 10⁸ pockforming units per millilitre, as determined using chick embryo chorioallantoic membranes. SOR/2006-2, s. 2.

C

04.117 No person shall sell smallpox vaccine unless SOR/97-12, s. 44. SOR/2006-2, s. 3. Poliomyelitis Vaccine

C

04.122 Poliomyelitis vaccine shall be an aqueous suspension of killed poliomyelitis viruses, Types I, II, and III. SOR/85-715, art. 6; SOR/2018-69, s. 27. Poliovirus Vaccine, Live, Oral (d) are proved to be capable of multiplying in the human alimentary tract and of producing type specific neutralizing antibodies when administered orally; and SOR/2018-69, s. 27. SOR/97-12, s. 61. SOR/97-12, s. 61; SOR/2018-69, s. 27.

C

04.132 Poliovirus vaccine, live, oral shall be prepared only SOR/2018-69, s. 27. SOR/97-12, s. 61. SOR/97-12, s. 61; SOR/2018-69, s. 27. SOR/97-12, s. 61. SOR/97-12, s. 61. Bacteriophage Toxins, Toxoids Schick Test Reagents

C

04.140 Schick test reagents for the diagnosis of susceptibility to diphtheria shall be (a) diphtheria toxin for Schick test; (a) diphtheria toxoid; or Diphtheria Toxoid

C

04.160 Liquid diphtheria toxoid shall be sterile, formalized, detoxified diphtheria toxin and shall not contain more than 0.02 per cent free formaldehyde.

C

04.161 Diphtheria toxoid alum precipitated shall be prepared from diphtheria toxoid, and shall not contain more than 15 milligrams of alum per human dose.

C

04.162 The alum used in the preparation of diphtheria toxoid alum precipitated shall contain not less than 99.5 per cent pure potassium alum, Al K(SO4)2,12H2O. SOR/97-12, s. 61. SOR/97-12, s. 61. SOR/97-12, s. 61. Tetanus Toxoid

C

04.180 Liquid tetanus toxoid shall be sterile, formalized, detoxified tetanus toxin, and shall not contain more than 0.02 per cent free formaldehyde.

C

04.181 Tetanus toxoid alum precipitated shall be prepared from tetanus toxoid, and shall not contain more than 15 milligrams of alum per human dose.

C

04.182 The alum used in the preparation of tetanus toxoid alum precipitated shall contain not less than 99.5 per cent pure potassium alum, Al K(SO₄)₂, 12H₂O. SOR/97-12, s. 61. SOR/97-12, s. 65. SOR/97-12, s. 61. Antitoxins, Antisera

C

04.212 Liquid diphtheria antitoxin shall have a potency of not less than 500 International Units per millilitre.

C

04.213 Liquid tetanus antitoxin shall have a potency of not less than 400 International Units per millilitre.

C

04.214 A liquid antitoxin or antiserum shall contain not more than 20 per cent solids.

C

04.216 A dried antitoxin or antiserum shall not contain more than one per cent moisture when determined by an acceptable method.

C

04.219 In respect of antitoxins, the expiration date shall be

C

04.220 In respect of antisera, the expiration date shall be SOR/97-12, s. 61. SOR/97-12, s. 61. SOR/97-12, s. 61.

C

04.235 (1) Subject to subsections (2) and (3), dried human serum, dried human plasma or dried fractions of either shall not contain more than one per cent moisture when determined by an acceptable method.

(2)

Dried Rh(D) Immune Human globulin shall not contain more than three per cent moisture when determined by an acceptable method.

(3)

Dried Antihemophilic Factor Human shall not contain more than two per cent moisture when determined by an acceptable method. SOR/81-334, s. 3. SOR/97-12, s. 61. SOR/97-12, s. 61.

C

04.241 The date of manufacture of preparations from human sources shall be the date of bleeding the donor.

C

04.300 and C.04.301 [Repealed, SOR/81-335, s. 3]

C

04.400 [Repealed, SOR/2013-179, s. 4]

C

04.401 [Repealed, SOR/2013-179, s. 4]

C

04.402 [Repealed, SOR/2013-179, s. 4]

C

04.403 [Repealed, SOR/2013-179, s. 4]

C

04.404 [Repealed, SOR/2013-179, s. 4]

C

04.405 [Repealed, SOR/2013-179, s. 4]

C

04.406 [Repealed, SOR/2013-179, s. 4]

C

04.407 [Repealed, SOR/2013-179, s. 4]

C

04.408 [Repealed, SOR/2013-179, s. 4]

C

04.409 [Repealed, SOR/2013-179, s. 4]

C

04.410 [Repealed, SOR/2013-179, s. 4]

C

04.411 [Repealed, SOR/2013-179, s. 4]

C

04.412 [Repealed, SOR/2013-179, s. 4]

C

04.413 [Repealed, SOR/2013-179, s. 4]

C

04.414 [Repealed, SOR/2013-179, s. 4]

C

04.415 [Repealed, SOR/2013-179, s. 4]

C

04.416 [Repealed, SOR/2013-179, s. 4]

C

04.417 [Repealed, SOR/2013-179, s. 4]

C

04.418 [Repealed, SOR/2013-179, s. 4]

C

04.419 [Repealed, SOR/2013-179, s. 4]

C

04.420 [Repealed, SOR/2013-179, s. 4]

C

04.421 [Repealed, SOR/2013-179, s. 4]

C

04.422 [Repealed, SOR/2013-179, s. 4]

C

04.423 [Repealed, SOR/2013-179, s. 4]

C

04.424 [Repealed, SOR/2006-353, s. 1]

C

04.425 [Repealed, SOR/2006-353, s. 1]

C

04.426 [Repealed, SOR/2006-353, s. 1]

C

04.427 [Repealed, SOR/97-12, s. 50]

C

04.428 [Repealed, SOR/2006-353, s. 1] Insulin Preparations [SOR/82-769, s. 4]

(4)

The potency of an insulin preparation shall be expressed in units per cubic centimetre and each unit per cubic centimetre shall provide one International Unit of insulin per cubic centimetre. SOR/82-769, s. 4. SOR/82-769, s. 4. (b) on the dry basis, not less than 0.30 per cent and not more than 0.90 per cent zinc. SOR/82-769, s. 4. Insulin Injection or Insulin (a) weight by volume, (i) not less than 0.1 per cent and not more than 0.25 per cent of either phenol or cresol, and (ii) not less than 1.4 per cent and not more than 1.8 per cent glycerin; and SOR/82-769, s. 4; SOR/85-715, s. 7.

C

04.554 No person shall sell Insulin Injection unless, (i) 40 International Units of insulin, (ii) 80 International Units of insulin, or (iii) 100 International Units of insulin; and

C

04.555 (1) A fabricator shall not sell Insulin Injection unless he SOR/82-769, s. 4; SOR/97-12, s. 61. Insulin Zinc Suspension — Rapid (a) weight by volume, (i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2·3H2O), (ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and (iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and SOR/80-545, s. 1; SOR/82-769, s. 4; SOR/85-715, s. 8. SOR/82-769, s. 4.

C

04.560 No person shall sell Insulin Zinc Suspension — Rapid unless (i) 40 International Units of insulin, (ii) 80 International Units of insulin, or (iii) 100 International Units of insulin. SOR/82-769, s. 4.

C

04.561 (1) A fabricator shall not sell Insulin Zinc Suspension — Rapid unless he (d) [Repealed, SOR/95-203, s. 3] SOR/82-769, s. 4; SOR/95-203, s. 3; SOR/97-12, s. 6; SOR/2018-69, ss. 27, 31(E), 32(F). (a) weight by volume, (i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2·3H2O), (ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and (iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and SOR/82-769, s. 4. SOR/82-769, s. 4.

C

04.566 No person shall sell Insulin Zinc Suspension-Medium unless (i) 40 International Units of insulin, (ii) 80 International Units of insulin, or (iii) 100 International Units of insulin. SOR/82-769, s. 4.

C

04.567 (1) A fabricator shall not sell Insulin Zinc Suspension-Medium unless he (ii) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin, (iii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin, SOR/82-769, s. 4. Insulin Zinc Suspension — Prolonged (a) weight by volume, (i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2·3H2O), (ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and (iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and SOR/80-546, s. 3; SOR/82-769, s. 4; SOR/85-715, s. 10. SOR/82-769, s. 4.

C

04.572 No person shall sell Insulin Zinc Suspension — Prolonged unless (i) 40 International Units of insulin, (ii) 80 International Units of insulin, or (iii) 100 International Units of insulin. SOR/82-769, s. 4.

C

04.573 (1) A fabricator shall not sell Insulin Zinc Suspension — Prolonged unless he (ii) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin, (iii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin, SOR/82-769, s. 4. (i) not less than 0.15 per cent and not more than 0.20 per cent cresol, or (ii) not less than 0.20 per cent and not more than 0.26 per cent phenol, and SOR/82-769, s. 4. SOR/82-769, s. 4. SOR/82-769, s. 4. SOR/82-769, s. 4; SOR/97-12, s. 64; SOR/2018-69, ss. 31(E), 32(F). (b) each cubic centimetre thereof provides, (i) 40 International Units of insulin, or (ii) 80 International Units of insulin. SOR/82-769, s. 4. (ii) zinc in grams, or in milligrams, per 1,000 International Units of insulin, (iv) the volume of the preparation in cubic centimetres or litres; (d) for the trial mixture of Globin Insulin with Zinc, (ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(2)

Une présentation soumise en exécution du paragraphe (1) doit contenir au moins, a) à l’égard de chaque maître-lot d’insuline ou de cristaux d’insuline-zinc ayant servi à la fabrication de l’insuline-globine avec zinc, (i) les protocoles du titrage de l’activité exprimée en unités internationales par centimètre cube, dans le cas de l’insuline, et en unités internationales par milligramme, dans le cas des cristaux d’insuline-zinc, (ii) un rapport de la teneur en humidité, exprimée en pourcentage et déterminée par dessiccation à poids constant à 100 °C, dans le cas des cristaux d’insuline-zinc, et (iii) des rapports du dosage de la teneur en azote en milligrammes et de la teneur en zinc en milligrammes par 1 000 unités internationales d’insuline; b) à l’égard du maître-lot de chlorhydrate de globine ayant servi à la préparation de l’insuline-globine avec zinc, des rapports de titrage de (i) la teneur en azote exprimée en pourcentage et calculée sur la matière desséchée et exempte de cendres et d’acide chlorhydrique, (ii) la teneur en chlorure exprimée en pourcentage et calculée comme chlorhydrate, et (iii) la teneur en cendres, exprimée en pourcentage; c) à l’égard des composants ayant servi à la préparation du mélange d’essai de l’insuline-globine avec zinc, un rapport sur (i) la quantité d’insuline, en grammes ou en unités internationales, (ii) la quantité de zinc, en grammes ou en milligrammes, par 1 000 unités internationales d’insuline, (iii) la quantité de chlorhydrate de globine, en grammes ou en milligrammes, par 1 000 unités internationales d’insuline, et (iv) le volume de la préparation, en centimètres cubes ou en litres; d) à l’égard du mélange d’essai de l’insuline-globine avec zinc, [Repealed, SOR/95-203, s. 6] SOR/82-769, s. 4; SOR/95-203, s. 6; SOR/97-12, s. 61; SOR/2018-69, ss. 27, 31(E), 32(F). SOR/82-769, s. 4. (a) weight by volume, not less than 0.15 per cent and not more than 0.25 per cent anhydrous disodium phosphate, and either (i) not less than 1.4 per cent and not more than 1.8 per cent glycerin and not less than 0.15 per cent and (ii) not less than 0.40 per cent and not more than 0.45 per cent sodium chloride and not less than 0.7 per cent and not more than 0.9 per cent glycerin and not less than 0.18 per cent and not more than 0.22 per cent metacresol; and SOR/82-769, s. 4; SOR/85-715, s. 11. SOR/82-769, s. 4. SOR/82-769, s. 4. SOR/82-769, s. 4.

C

04.587 No person shall sell NPH Insulin unless (b) each cubic centimetre thereof provides, (i) 40 International Units of insulin, (ii) 80 International Units of insulin, or (iii) 100 International Units of insulin. SOR/82-769, s. 4.

C

04.588 (1) A fabricator shall not sell NPH Insulin unless he (ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin, (iii) a report of the insulin content in International Units per cubic centimetre of the supernatant liquid after removal of the suspended precipitate, (v) a report on the microscopic examination of the precipitate; (ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin, (vi) [Repealed, SOR/95-203, s. 7] SOR/82-769, s. 4; SOR/95-203, s. 7; SOR/97-12, s. 61; SOR/2018-69, ss. 27, 31(E), 32(F). SOR/82-769, s. 4. Protamine Zinc Insulin (a) weight by volume, (i) not less than 0.15 per cent and not more than 0.25 per cent anhydrous disodium phosphate, (ii) not less than 1.4 per cent and not more than 1.8 per cent glycerin, and (iii) either not less than 0.18 per cent and not more than 0.22 per cent cresol, or not less than 0.22 per cent and not more than 0.28 per cent phenol; and SOR/82-769, s. 4. SOR/82-769, s. 4. SOR/82-769, s. 4. SOR/82-769, s. 4; SOR/97-12, ss. 6,4; SOR/2018-69, ss. 31(E), 32(F).

C

04.594 No person shall sell Protamine Zinc Insulin unless (b) each cubic centimetre thereof provides (i) 40 International Units of insulin, (ii) 80 International Units of insulin, or (iii) 100 International Units of insulin. SOR/82-769, s. 4.

C

04.595 (1) A fabricator shall not sell Protamine Zinc Insulin unless he (ii) zinc in grams or in milligrams, per 1,000 International Units of insulin, (iv) the volume of the preparation in cubic centimetres or litres; (c) for the trial mixture of Protamine Zinc Insulin, (ii) a report of assay of its zinc content in milligrams per cubic centimetre per 1,000 International Units of insulin, (iv) [Repealed, SOR/95-203, s. 8] SOR/82-769, s. 4; SOR/95-203, s. 8; SOR/97-12, s. 61; SOR/2018-69, ss. 27, 31(E), 32(F). SOR/82-769, s. 4. (a) weight by volume, (i) not less than 0.6 per cent and not more than 1.0 per cent sodium chloride, and (ii) not less than 0.2 per cent and not more than 0.3 per cent phenol; and SOR/82-769, s. 4. SOR/82-769, s. 4. SOR/82-769, s. 4. SOR/82-769, s. 4.

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04.601 (1) A fabricator shall not sell Sulphated Insulin unless he (vii) [Repealed, SOR/95-203, s. 9] SOR/82-769, s. 4; SOR/95-203, s. 9; SOR/97-12, s. 61; SOR/2018-69, ss. 27, 31(E), 32(F). SOR/80-546, s. 4; SOR/82-769, s. 4. [SOR/82-769, s. 8] SOR/82-769, s. 7; SOR/97-12, s. 65. TABLE | Column I | Column II | Column III | |----------|-----------|------------| | | | (b) 80 units per cc. | (b) black ink on green stock. | | | | (c) 100 units per cc. | (c) black ink on white stock. | | | | (b) 80 units per cc. | (b) green ink on grey stock. | | | | (c) 100 units per cc. | (c) black ink on white stock. | | 3 | Insulin Zinc Suspension — Rapid, Insulin Zinc Suspension — Medium and Insulin Zinc Suspension — Prolonged. | (a) 40 units per cc. | (a) red ink on lavender stock plus a distinguishing mark or design. | | | | (b) 80 units per cc. | (b) green ink on lavender stock plus a distinguishing mark or design. | | | | (c) 100 units per cc. | (c) black ink on white stock. | PART C Drugs DIVISION 4

Section C.04.651

Column I Item Insulin Preparation 5 NPH Insulin. 6 Protamine Zinc Insulin. 7 Sulphated Insulin. Column II (a) 40 units per cc. (b) 80 units per cc. (c) 100 units per cc. (a) 40 units per cc. (b) 80 units per cc. (c) 100 units per cc. 100 units per cc. Column III (a) red ink on blue stocks. (b) green ink on blue stock. (a) red ink on white stock. (b) green ink on white stock. black ink on white stock plus the statement “Warning... Not for Ordinary Use... See Package Leaflet”. TABLEAU Colonne I Poste n° Préparation insulinique 1 Injection insulinique non étiquetée de la façon indiquée au poste 2 2 Injection insulinique dont l’étiquette porte : « Insuline faite avec des cristaux d’insuline... zinc » 3 Suspension d’insuline-zinc d’absorption rapide, suspension d’insuline-zinc d’absorption moyenne et suspension d’insuline-zinc d’absorption prolongée 4 Insuline-globine avec zinc 5 Insuline NPH 6 Insuline-zinc-protamine Colonne II Activité de la préparation a) 40 unités par cc b) 80 unités par cc c) 100 unités par cc a) 40 unités par cc b) 80 unités par cc c) 100 unités par cc a) 40 unités par cc b) 80 unités par cc c) 100 unités par cc a) 40 unités par cc b) 80 unités par cc a) 40 unités par cc b) 80 unités par cc c) 100 unités par cc a) 40 unités par cc b) 80 unités par cc c) 100 unités par cc Colonne III Nécessités d’impression pour l’étiquette a) caractères noirs sur fond jaune b) caractères noirs sur fond vert c) caractères noirs sur fond blanc a) caractères rouges sur fond gris b) caractères verts sur fond gris c) caractères noirs sur fond blanc a) caractères rouges sur fond lavande ainsi qu’une marque ou un symbole distinctifs b) caractères verts sur fond lavande ainsi qu’une marque ou un symbole distinctifs c) caractères noirs sur fond blanc a) caractères rouges sur fond brun, sauf que l’expression « 40 unités par centimètre cube » peut être imprimée en caractères blancs sur fond rouge b) caractères verts sur fond brun, sauf que l’expression « 80 unités par centimètre cube » peut être imprimée en caractères blancs sur fond vert a) caractères rouges sur fond bleu b) caractères verts sur fond bleu c) caractères noirs sur fond blanc a) caractères rouges sur fond blanc b) caractères verts sur fond blanc c) caractères noirs sur fond blanc SOR/82-769, s. 7; SOR/97-12, s. 65. SOR/82-769, s. 7; SOR/97-12, s. 65. SOR/82-769, s. 7, 9; SOR/97-12, s. 65. (a) a statement that (iii) que les directives du médecin au sujet du régime alimentaire, de la posologie, du repos et de l’exercice doivent être suivies minutieusement; b) une description de la méthode à suivre pour retirer la préparation insulinique de la fiole, y compris le mode de stérilisation de la seringue et de l’aiguille, du bouchon de la fiole et du point d’injection; c) un avertissement expliquant que les injections doivent être sous-cutanées, et non pas intraveineuses ni intramusculaires, et une mise en garde contre des injections successives au même endroit; d) un avertissement disant que les doses sont spécifiées en termes d’unités d’activité par centimètre cube et que le volume de chaque dose dépend de l’activité en unités par centimètre cube énoncée sur l’étiquette de la préparation insulinique et que, pour ces raisons, il importe que le malade comprenne bien la graduation des seringues; e) une brève explication de l’hypoglycémie ainsi que des mesures d’urgence que peuvent prendre les malades et ceux qui les soignent en cas de réactions hypoglycémiques; f) un avertissement sur l’apparition possible de réactions indésirables par suite de maladie ou d’infection, de l’omission d’un repas et d’un manque de la préparation insulinique; g) un avertissement de n’employer aucune autre sorte de préparation insulinique que celle qui a été prescrite par le médecin; h) un avertissement de ne pas commencer à se servir d’un emballage après la date limite d’utilisation imprimée sur l’emballage; i) un avertissement recommandant d’employer le contenu d’une façon aussi continue que possible et de jeter toute fiole entamée qui n’a pas servi depuis plusieurs semaines; j) un avertissement signalant l’importance de consulter régulièrement un médecin et de suivre fidèlement ses directives; k) dans le cas de préparations insulinique consistant en une solution limpide, incolore ou presque incolore, exempte de turbidité et matière insoluble, un avertissement disant que, si le contenu d’une fiole devient brouillé ou trouble, il faut cesser d’utiliser cette fiole; l) dans le cas de préparations insulinique consistant en un précipité en suspension dans un milieu aqueux SOR/82-769, ss. 7, 10. (a) contains an excess volume sufficient to permit withdrawal of 20 cubic centimetres, and (b) provides 500 International Units of insulin per cubic centimetre, if (d) both the inner and the outer labels carry the statement “Warning — High Potency — Not for Ordinary Use”; and tamponné, un avertissement expliquant qu’il est nécessaire d’agiter la fiole avec soin avant d’en retirer une dose et signalant que, si le contenu prend une apparence granuleuse ou granulaire ou s’il s’est formé un dépôt de particules sur la paroi du contenant, il faut cesser d’utiliser cette fiole; m) des directives demandant de garder la préparation insulinique au réfrigérateur à une température comprise entre 35° et 50 °F (2° et 10 °C) et de ne pas l’exposer à être congelée; et n) dans le cas de l’insuline sulfurisée, un avertissement expliquant que cette préparation insulinique n’est pas destinée à l’usage courant mais est une insuline chimiquement modifiée qui peut être plus efficace que les préparations insulinique usuelles chez certains diabétiques résistants ou allergiques à l’insuline. DORS/82-769, art. 7 et 10.

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04.656 (1) Nonobstant l’article C.04.554, un titulaire de licence d’établissement peut vendre de l’injection insulinique faite avec des cristaux d’insuline-zinc et offerte dans des fioles d’une capacité approximative de 20 centimètres cubes, et a) contient un excédent de volume permettant d’en retirer 20 centimètres cubes, et b) fournit 500 unités internationales d’insuline par centimètre cube, si c) nonobstant l’article C.04.651, les étiquettes intérieure et extérieure sont toutes deux imprimées en caractères noirs sur fond blanc et portent en surcharge d’étroites bandes diagonales brunes et blanches, en nombre d’au moins cinq et d’au plus 20 au pouce; d) les étiquettes intérieure et extérieure portent toutes deux la mention « Avertissement — Activité Élevée — Ne pas employer aux fins ordinaires »; et e) chaque emballage contient un prospectus explicatif conforme aux exigences de l’article C.04.655 et portant de plus : (i) au début du prospectus, l’avertissement : « Mise en garde — Cette préparation insulinique contient 500 unités internationales d’insuline par centimètre cube. Mettre un soin extrême à mesurer les doses, car une dose excessive donnée par inadvertance peut provoquer un état de choc irréversible. L’employer autrement que sous la surveillance constante d’un médecin peut avoir de graves conséquences. À moins que cette used by patients to replace use of any other insulin preparations.”,

(2)

[Repealed, SOR/95-203, s. 10] SOR/82-769, ss. 7, 11; SOR/95-203, s. 10; SOR/97-12, s. 64. Anterior Pituitary Extracts [SOR/82-769, s. 14] (a) Adrenocorticotrophic Hormone, Corticotrophin, (b) Thyrotrophic Hormone, Thyrotrophin, (c) Growth Hormone Pituitary, Somatotrophin, (d) Lactogenic Hormone, Prolactin, and if unpurified anterior pituitary extract SOR/82-769, s. 13.

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04.676 Reference standards for anterior pituitary extract shall be (a) the International Standard, préparation ne soit spécifiquement prescrite, les malades ne devraient jamais l’employer à la place de quelque autre préparation insulinique. », (ii) un avertissement de ne pas administrer par voie intraveineuse de l’insuline faite avec des cristaux d’insuline-zinc à 500 unités internationales par centimètre cube, et (iii) un exposé des renseignements nécessaires au médecin pour l’administration sûre et efficace de ladite drogue dans le traitement par choc insulinique et dans le traitement des diabétiques offrant une grande résistance à l’insuline (besoin quotidien de plus de 200 unités internationales d’insuline).

(2)

[Abrogé, DORS/95-203, art. 10] DORS/82-769, art. 7 et 11; DORS/95-203, art. 10; DORS/97-12, art. 64. Extraits hypophysaires (lobe antérieur) [DORS/82-769, art. 14]

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04.675 L’extrait hypophysaire (lobe antérieur) doit inclure tous les produits naturels préparés à partir du lobe antérieur de la glande hypophysaire d’animaux, et possédant des propriétés physiologiques associées aux hormones du lobe antérieur de la glande hypophysaire, et leurs noms propres doivent être a) Hormone adénocorticotrope, Corticotrophine, b) Hormone thyrotrope, Thyrotrophine, c) Hormone pituitaire de la croissance, Somatotrophine, d) Hormone lactogène, Prolactine, e) Hormone gonadotrope, Gonadotrophine, suivi de qualificatifs pour indiquer l’activité gonadotrope associée à l’extrait, et, s’il s’agit d’extrait hypophysaire (lobe antérieur) non purifié, f) Extrait hypophysaire (lobe antérieur) suivi de qualificatifs qui indiquent les propriétés physiologiques attribuées à l’extrait. DORS/82-769, art. 13.

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04.676 Les étalons de l’extrait hypophysaire (lobe antérieur) doivent être a) l’étalon international; SOR/82-769, s. 13; SOR/97-12, s. 58; SOR/2018-69, s. 27. SOR/82-769, s. 13; SOR/97-12, s. 58; SOR/97-543, s. 6. SOR/82-769, s. 13; SOR/97-12, s. 64. SOR/82-769, s. 13. SOR/82-769, s. 13; SOR/93-202, s. 22.

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04.681 The outer label of an anterior pituitary extract or mixture of anterior pituitary extracts shall carry a statement SOR/82-769, s. 13.

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04.682 Both the inner and outer labels of adrenocorticotrophic hormone shall carry a statement indicating the route of administration, in addition to meeting the requirements of paragraphs C.04.681(a) and (b). SOR/82-769, ss. 13, 15.

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04.683 The expiration date for an anterior pituitary extract or mixture of anterior pituitary extracts shall be not more than two years after the date of passing a potency test. SOR/82-769, ss. 13, 15. DIVISION 5 Interpretation adverse drug reaction means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. (réaction indésirable à une drogue) Règlement sur les aliments et drogues

PARTIE C

TITRE 4

Extraits hypophysaires (lobe antérieur)

Articles C.04.681-C.05.001

a) donnant le nom de l’espèce d’animal dont proviennent les glandes ayant servi à la préparation de l’extrait hypophysaire (lobe antérieur); b) avertissant que le produit doit être conservé à la température du réfrigérateur; et c) sauf dans le cas des hormones gonadotropes, de n’employer ce produit que sur l’avis ou l’ordonnance d’un médecin. DORS/82-769, art. 13.

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04.682 Les étiquettes intérieure et extérieure d’une hormone adrénocorticotrope doivent toutes deux porter une déclaration de la voie d’administration, en plus d’être conformes aux dispositions des alinéas C.04.681a) et b). DORS/82-769, art. 13 et 15.

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04.683 La date limite d’utilisation d’un extrait hypophysaire (lobe antérieur) ou d’un mélange d’extraits hypophysaires (lobe antérieur) ne doit pas dépasser deux ans après la date d’épreuve satisfaisante de son activité. DORS/82-769, art. 13 et 15.

TITRE 5

Drogues destinées aux essais cliniques sur des sujets humains Définitions

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05.001 Les définitions qui suivent s’appliquent au présent titre. bonnes pratiques cliniques Pratiques cliniques généralement reconnues visant à assurer la protection des droits, la sûreté et le bien-être des sujets d’essai clinique et d’autres personnes ainsi que la fiabilité des données visées à l’article C.05.010. (good clinical practices) brochure du chercheur Document dans lequel figurent les données précliniques et cliniques d’une drogue visées à l’alinéa C.05.005e). (investigator’s brochure) chercheur qualifié La personne qui est responsable auprès du promoteur de la conduite de l’essai clinique à un lieu d’essai clinique, qui est habilitée à dispenser des soins de santé en vertu des lois de la province où a lieu l’essai clinique et qui est soit : a) dans le cas d’un essai clinique portant sur une drogue destinée à être utilisée exclusivement en médecine dentaire, un médecin ou un dentiste, membre en drogue Drogue pour usage humain destinée à faire l’objet d’un essai clinique. (drug) essai clinique Recherche sur des sujets humains dont l’objet est soit de découvrir ou de vérifier les effets cliniques, pharmacologiques ou pharmacodynamiques serious unexpected adverse drug reaction means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out in the investigator’s brochure or on the label of the drug. (réaction indésirable grave et imprévue à une drogue) SOR/2001-203, s. 4; 2001, c. 27, s. 273; SOR/2012-16, s. 1; SOR/2013-65, s. 1(F). Application

(2)

Except for paragraph C.05.003(a), subsections C.05.006(2) and (3), paragraphs C.05.010(a) to (d), section C.05.011, subsections C.05.012(1) and (2), paragraphs C.05.012(3)(a) to (d) and (f) to (h), subsection C.05.012(4) and sections C.05.013, C.05.016 and C.05.017, this Division does not apply to the sale or importation of a drug d’une drogue pour usage humain, soit de déceler les incidents thérapeutiques liés à cette drogue, soit d’en étudier l’absorption, la distribution, le métabolisme et l’élimination ou soit d’en établir l’innocuité ou l’efficacité. (clinical trial) importer Importer une drogue au Canada pour la vendre dans le cadre d’un essai clinique. (import) incident thérapeutique Événement indésirable affectant la santé d’un sujet d’essai clinique à qui une drogue a été administrée — qui peut ou non être causé par l’administration de la drogue — y compris toute réaction indésirable à une drogue. (adverse event) promoteur Personne physique ou morale, établissement ou organisme qui mène un essai clinique. (sponsor) protocole Document qui expose les objectifs, le plan de travail, la méthodologie, les considérations statistiques et l’organisation d’un essai clinique. (protocol) réaction indésirable à une drogue Réaction nocive et non intentionnelle à une drogue qui est causée par l’administration de toute dose de celle-ci. (adverse drug reaction) réaction indésirable grave à une drogue Réaction indésirable à une drogue qui nécessite ou prolonge l’hospitalisation, entraîne une malformation congénitale ou une invalidité ou incapacité persistante ou importante, met la vie en danger ou entraîne la mort. (serious adverse drug reaction) réaction indésirable grave et imprévue à une drogue Réaction indésirable grave à une drogue dont la nature, la sévérité ou la fréquence ne sont pas mentionnées dans les renseignements sur les risques qui figurent dans la brochure du chercheur ou sur l’étiquette de la drogue. (serious unexpected adverse drug reaction) DORS/2001-203, art. 4; 2001, ch. 27, art. 273; DORS/2012-16, art. 1; DORS/2013-65, art. 1(F). Champ d’application

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05.002 (1) Sous réserve du paragraphe (2), le présent titre s’applique à la vente et à l’importation d’une drogue destinée à être utilisée dans des essais cliniques sur des sujets humains.

(2)

À l’exception de l’alinéa C.05.003a), des paragraphes C.05.006(2) et (3), des alinéas C.05.010a) à d), de l’article C.05.011, des paragraphes C.05.012(1) et (2), des alinéas C.05.012(3)a) à d) et f) à h), du paragraphe C.05.012(4) et des articles C.05.013, C.05.016 et C.05.017, le présent titre ne s’applique ni à la vente ni à l’importation d’une drogue for the purposes of a clinical trial authorized under subsection C.05.006(2). SOR/2001-203, s. 4.

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05.003 Despite sections C.01.014, C.08.002, C.08.002.02 and C.08.003, no person shall sell or import a drug for the purposes of a clinical trial unless (b) the person complies with this Division and sections C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136, and C.01.435; and SOR/2001-203, s. 4; SOR/2011-88, s. 7. SOR/2001-203, s. 4. (a) a copy of the protocol for the clinical trial; (iii) the therapeutic and pharmacological classifications of the drug, (iv) the medicinal ingredients of the drug, (v) the non-medicinal ingredients of the drug, (vi) the dosage form of the drug, (xi) a statement e) la brochure du chercheur qui contient les renseignements suivants : (i) les propriétés physiques, chimiques et pharmaceutiques de la drogue, (ii) les aspects pharmacologiques de la drogue, y compris ses métabolites observés chez les espèces animales testées, (iii) le comportement pharmacocinétique de la drogue et le métabolisme de celle-ci, y compris la façon dont elle est transformée biologiquement chez les espèces animales testées, (iv) le cas échéant, les effets toxicologiques de la drogue observés chez les espèces animales testées lors d'études à dose unique, d'études à dose répétée ou d'études spéciales, (v) le cas échéant, les résultats des études de carcinogénicité chez les espèces animales testées à l'égard de la drogue, (vi) le cas échéant, les résultats des études cliniques sur le comportement pharmacocinétique de la drogue, (vii) le cas échéant, lorsque des essais cliniques ont déjà été menés sur des sujets humains, les renseignements suivants obtenus lors de ces essais : l'innocuité de la drogue, son comportement pharmacodynamique, son efficacité et ses doses-réponses, (viii) si la drogue est un produit pharmaceutique radioactif au sens de l'article C.03.201, les renseignements sur le mode de préparation du produit ainsi que sur la dosimétrie des rayonnements pour le produit préparé et les conditions d'emmagasinage une fois préparé; f) si la drogue contient un excipient d'origine humaine, y compris toute utilisation dans un placebo : (i) la mention, le cas échéant, que l'excipient a fait l'objet d'une identification numérique en vertu du paragraphe C.01.014.2(1) ou, s'agissant d'une drogue nouvelle, d'un avis de conformité en vertu du paragraphe C.08.004(1), (ii) dans les autres cas, des renseignements suffisants pour établir l'identité, la pureté, la puissance, la stabilité et l'innocuité de l'excipient d'origine humaine; g) si la drogue n'a pas fait l'objet d'une identification numérique en vertu du paragraphe C.01.014.2(1) ou, s'agissant d'une drogue nouvelle, d'un avis de conformité n'a pas été délivré en vertu des articles C.08.004 ou C.08.004.01, les renseignements sur la chimie et la fabrication de la drogue, y compris le site de fabrication; SOR/2001-203, s. 4; SOR/2011-88, s. 8; SOR/2012-16, s. 2(F). (ii) dans tout autre cas, les renseignements justifiant l’identité, la pureté, l’activité, la stabilité et l’innocuité de l’excipient; g) s’il s’agit d’une drogue à l’égard de laquelle aucune identification numérique n’a été attribuée en vertu du paragraphe C.01.014.2(1) ou s’il s’agit d’une drogue nouvelle à l’égard de laquelle aucun avis de conformité n’a été délivré en application des articles C.08.004 ou C.08.004.01, les renseignements sur la chimie et la fabrication de la drogue, y compris le lieu de fabrication; h) la date projetée du début de l’essai clinique à chaque lieu d’essai clinique, si ce renseignement est connu au moment de la présentation de la demande. DORS/2001-203, art. 4; DORS/2011-88, art. 8; DORS/2012-16, art. 2(F). Autorisation

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05.006 (1) Sous réserve du paragraphe (3), le promoteur peut vendre ou importer une drogue destinée à un essai clinique, autre qu’une drogue visée au paragraphe (2), si les conditions suivantes sont réunies : a) il a présenté au ministre une demande conforme à l’article C.05.005; b) le ministre ne lui a pas envoyé, dans les trente jours suivant la date de réception de la demande, un avis lui indiquant qu’il ne peut vendre ou importer la drogue pour l’un des motifs suivants : (i) les renseignements et documents à l’égard de la demande, selon le cas : (A) n’ont pas été fournis conformément au présent règlement, (B) ne sont pas suffisants pour permettre au ministre d’évaluer l’innocuité et les risques de la drogue ou la sûreté et les risques de l’essai clinique, (ii) le ministre a des motifs raisonnables de croire, d’après l’examen de la demande ou des renseignements fournis en vertu de l’article C.05.009, ou d’après l’évaluation de tout autre renseignement, que l’une des conditions suivantes existe : (A) l’utilisation de la drogue destinée à l’essai clinique met en danger la santé d’un sujet d’essai clinique ou celle d’une autre personne, (B) l’essai clinique va à l’encontre de l’intérêt d’un sujet d’essai clinique, SOR/2001-203, s. 4; SOR/2012-16, s. 3(F). (c) les objectifs de l’essai clinique ne seront pas atteints; c) pour chaque lieu d’essai clinique, le promoteur a obtenu l’approbation du comité d’éthique de la recherche à l’égard du protocole visé à l’alinéa C.05.005a) et à l’égard d’une formule de consentement éclairé contenant la déclaration visée à l’alinéa C.05.005b); d) avant la vente ou l’importation de la drogue à un lieu d’essai clinique, le promoteur a fourni au ministre les renseignements visés aux sous-alinéas C.05.005c)(ix) et (x) et aux alinéas C.05.005d) et h) qui n’ont pas été fournis à l’égard de ce lieu au moment de la présentation de la demande.

(2)

Sous réserve du paragraphe (3), le promoteur peut vendre ou importer une drogue destinée à un essai clinique lorsque : a) s’agissant d’une drogue nouvelle à l’égard de laquelle un avis de conformité a été délivré en vertu du paragraphe C.08.004(1), l’essai clinique porte sur les fins ou le mode d’emploi pour lesquels l’avis de conformité a été délivré; b) s’agissant d’une drogue, autre qu’une drogue nouvelle, à l’égard de laquelle une identification numérique a été attribuée en vertu du paragraphe C.01.014.2(1), l’essai clinique porte sur l’usage ou les fins pour lesquels l’identification numérique a été attribuée.

(3)

Le promoteur ne peut vendre ou importer la drogue destinée à un essai clinique : a) durant la période de la suspension ordonnée en vertu des articles C.05.016 ou C.05.017; b) après l’annulation ordonnée en vertu des articles C.05.016 ou C.05.017. DORS/2001-203, art. 4; DORS/2012-16, art. 3(F).

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05.007 Lorsque la vente ou l’importation d’une drogue est autorisée sous le régime du présent titre, le promoteur peut apporter un ou plusieurs des changements suivants s’il en avise le ministre par écrit dans les quinze jours suivant la date du changement : a) tout changement apporté aux renseignements sur la chimie et la fabrication de la drogue qui n’a aucune incidence sur la qualité ou l’innocuité de celle-ci, autre qu’un changement pour lequel une modification est exigée par l’article C.05.008; SOR/2001-203, s. 4; SOR/2012-16, s. 4(F). (d) before the sale or importation of the drug, the sponsor maintains records concerning (i) the information referred to in paragraph C.05.005(h), and (d) amendments to the protocol that affect the safety evaluation of the drug; SOR/2001-203, s. 4; SOR/2012-16, s. 5. PART C Drugs Sections C.05.009-C.05.010 SOR/2001-203, s. 4; SOR/2012-16, s. 6(F). Good Clinical Practices (d) for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site; Règlement sur les aliments et drogues

PARTIE C Drogues

TITRE 5 Drogues destinées aux essais cliniques sur des sujets humains

Renseignements complémentaires et échantillons

Articles C.05.009-C.05.010

ne sont pas suffisants pour permettre au ministre de déterminer si l’un des motifs visés aux alinéas C.05.006(1)b) ou C.05.008(1)b) existe, le ministre peut exiger que le promoteur lui fournisse, dans les deux jours suivant la réception de la demande du ministre, les renseignements complémentaires concernant la drogue ou l’essai clinique ou les échantillons de la drogue qui lui sont nécessaires pour faire cette détermination. DORS/2001-203, art. 4; DORS/2012-16, art. 6(F). Obligations du promoteur Bonnes pratiques cliniques

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05.010 Le promoteur doit veiller à ce que tout essai clinique soit mené conformément aux bonnes pratiques cliniques et, en particulier, veiller à ce que : a) l’essai clinique soit fondé sur le plan scientifique et clairement décrit dans un protocole; b) l’essai clinique soit mené et la drogue utilisée en conformité avec le protocole de l’essai clinique et le présent titre; c) des systèmes et des procédures visant à assurer la qualité de tous les aspects de l’essai clinique soient mis en œuvre; d) pour chaque lieu d’essai clinique, l’approbation d’un comité d’éthique de la recherche soit obtenue avant le début de l’essai clinique à ce lieu; e) à chaque lieu d’essai clinique, il n’y ait au plus un chercheur qualifié; f) à chaque lieu d’essai clinique, les soins de santé et les décisions médicales dans le cadre de l’essai clinique relèvent du chercheur qualifié; g) chaque individu collaborant à la conduite de l’essai clinique soit qualifié, par ses études, sa formation et son expérience, pour accomplir les tâches qui lui sont confiées; h) le consentement éclairé — donné conformément aux règles de droit régissant les consentements — soit obtenu par écrit de chaque personne avant qu’elle participe à l’essai clinique mais seulement après qu’elle a été informée de ce qui suit : (i) des risques et bénéfices prévus pour sa santé résultant de sa participation à l’essai clinique, SOR/2001-203, s. 4; SOR/2012-16, s. 7(F). Labelling (b) the name, number or identifying mark of the drug; (d) the recommended storage conditions for the drug; (f) the name and address of the sponsor; SOR/2001-203, s. 4; SOR/2012-16, s. 8(F). Records (iii) de tout autre aspect de l’essai clinique nécessaire à la prise de sa décision de participer à l’essai clinique; i) les exigences relatives aux renseignements et registres prévues à l’article C.05.012 soient respectées; j) la drogue soit fabriquée, manutentionnée et emmagasinée conformément aux bonnes pratiques de fabrication visées aux titres 2 à 4, à l’exception des articles C.02.019, C.02.025 et C.02.026. DORS/2001-203, art. 4; DORS/2012-16, art. 7(F). Étiquetage

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05.011 Malgré les autres dispositions du présent règlement relatives à l’étiquetage, le promoteur doit veiller à ce que la drogue porte une étiquette sur laquelle figurent, dans les deux langues officielles, les renseignements suivants : a) une mention indiquant que la drogue est de nature expérimentale et ne doit être utilisée que par un chercheur qualifié; b) le nom, le numéro ou la marque d’identification de la drogue; c) la date limite d’utilisation de la drogue; d) les conditions d’entreposage recommandées de la drogue; e) le numéro de lot de la drogue; f) les nom et adresse du promoteur; g) le code ou l’identification du protocole; h) si la drogue est un produit pharmaceutique radioactif au sens de l’article C.03.201, les renseignements exigés par le sous-alinéa C.03.202(1)b)(vi). DORS/2001-203, art. 4; DORS/2012-16, art. 8(F). Registres

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05.012 (1) Le promoteur doit consigner dans des registres, traiter et conserver les renseignements relatifs à un essai clinique de façon à permettre la présentation de rapports complets et exacts sur ceux-ci ainsi que leur interprétation et leur vérification.

(2)

Le promoteur doit tenir des registres complets et précis afin de démontrer que l’essai clinique est mené conformément aux bonnes pratiques cliniques et au présent règlement. (a) a copy of all versions of the investigator’s brochure for the drug; SOR/2001-203, s. 4; SOR/2022-18, s. 55. (d) a qualified investigator is not respecting the undertaking referred to in paragraph C.05.012(3)(f); or SOR/2001-203, s. 4; SOR/2012-16, s. 9(F).

(3)

Sections C.01.016 to C.01.020 do not apply to drugs used for the purposes of a clinical trial. SOR/2001-203, s. 4; SOR/2017-18, s. 16. Discontinuance of a Clinical Trial SOR/2001-203, s. 4. (d) the sponsor has failed to provide (ii) information or a report under section C.05.014. SOR/2001-203, s. 4; SOR/2012-16, s. 10. SOR/2001-203, s. 4; SOR/2012-16, s. 11. DIVISION 6 Conjugated Estrogens Conjugated Estrogens for Injection Conjugated Estrogens Tablets Digitoxin Digitoxin Tablets Digoxin Digoxin Elixir Digoxin Injection Digoxin Tablets Esterified Estrogens Esterified Estrogens Tablets Gelatin Thyroid SOR/80-544, s. 11.

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06.001 In this Division, Conjugated Estrogens SOR/82-429, s. 5. Conjugated Estrogens for Injection

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06.003 [S]. Conjugated estrogens for injection shall be the drug conjugated estrogens for injection described in The Pharmacopeia of the United States of America, XVIII (1970), except that SOR/82-429, s. 6. Conjugated Estrogens Tablets

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06.004 [S]. Conjugated estrogens tablets shall be the drug conjugated estrogens tablets described in The Pharmacopeia of the United States of America, XVIII (1970), except that SOR/82-429, s. 7.

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06.100 and C.06.101 [Repealed, SOR/80-544, s. 12] Digitoxin Digitoxin Tablets Digoxin Digoxin Elixir selon la méthode officielle DO-29, (Œstrogènes conjugués, du 15 octobre 1981; et que b) l’épreuve d’identité qui y est décrite est effectuée selon la méthode officielle DO-29, (Œstrogènes conjugués, du 15 octobre 1981. DORS/82-429, art. 6. Comprimés d’œstrogènes conjugués

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06.004 [N]. Les comprimés d’œstrogènes conjugués doivent être la drogue décrite dans la Pharmacopée of the United States of America, XVIII (1970), sauf que a) la solution A diluée, les solutions A et B, ainsi que le réactif de l’équilibrant qui y sont décrits sont préparés selon la méthode officielle DO-29, (Œstrogènes conjugués, du 15 octobre 1981; et que b) l’épreuve d’identité qui y est décrite est effectuée selon la méthode officielle DO-29, (Œstrogènes conjugués, du 15 octobre 1981. DORS/82-429, art. 7.

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06.100 et C.06.101 [Abrogés, DORS/80-544, art. 12] Digitoxine

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06.120 [N]. La digitoxine doit être la drogue digitoxin décrite dans la Pharmacopée of the United States of America. Comprimés de digitoxine

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06.121 [N]. Les comprimés de digitoxine doivent être la drogue digitoxin tablets décrite dans la Pharmacopée of the United States of America. Digoxine

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06.130 [N]. La digoxine doit être la drogue digoxin décrite dans la Pharmacopée of the United States of America. Élixir de digoxine

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06.131 [N]. L’élixir de digoxine doit être la drogue digoxin elixir décrite dans la Pharmacopée of the United States of America. Digoxin Injection Digoxin Tablets

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06.140 to C.06.142 [Repealed, SOR/80-544, s. 12]

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06.150 to C.06.153 [Repealed, SOR/80-544, s. 12]

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06.154 to C.06.156 [Repealed, SOR/80-544, s. 12]

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06.157 to C.06.160 [Repealed, SOR/80-544, s. 12] Esterified Estrogens

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06.161 [S]. Esterified estrogens shall be the drug esterified estrogens described in the Pharmacopeia of the United States of America. Esterified Estrogens Tablets

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06.162 [S]. Esterified estrogens tablets shall be the drug esterified estrogens tablets described in the Pharmacopeia of the United States of America. Gelatin

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06.180 to C.06.183 [Repealed, SOR/80-544, s. 12]

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06.230 to C.06.233 [Repealed, SOR/80-544, s. 12]

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06.240 to C.06.242 [Repealed, SOR/80-544, s. 12] Thyroid Description, — (ii) Moisture, — thyroid loses not more than six per cent moisture.

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06.251 Thyroid shall be SOR/82-429, s. 8.

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06.252 [Repealed, SOR/80-544, s. 12]

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06.260 to C.06.264 [Repealed, SOR/80-544, s. 12]

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06.270 to C.06.280 [Repealed, SOR/80-544, s. 12] DIVISION 7 Interpretation General Council Decision has the meaning assigned by subsection 30(6) of the Act. (décision du Conseil général) SOR/2005-141, s. 1. Application SOR/2005-141, s. 1. b) conservée au frais dans des récipients hermétiquement bouchés. DORS/82-429, art. 8.

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06.252 [Abrogé, DORS/80-544, art. 12]

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06.260 à C.06.264 [Abrogés, DORS/80-544, art. 12]

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06.270 à C.06.280 [Abrogés, DORS/80-544, art. 12]

TITRE 7

Vente de drogues aux fins de mise en œuvre de la décision du Conseil général Définitions

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07.001 Les définitions qui suivent s’appliquent au présent titre. commissaire aux brevets Le commissaire aux brevets nommé en vertu du paragraphe 4(1) de la Loi sur les brevets. (Commissioner of Patents) décision du Conseil général S’entend au sens du paragraphe 30(6) de la Loi. (General Council Decision) DORS/2005-141, art. 1. Champ d’application

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07.002 Le présent titre s’applique à la vente de drogues aux fins de mise en œuvre de la décision du Conseil général. DORS/2005-141, art. 1. Demande d’autorisation

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07.003 La demande d’autorisation pour la vente d’une drogue sous le régime du présent titre est présentée au ministre par le fabricant et comporte les renseignements et documents suivants : a) une déclaration du fabricant portant qu’il a l’intention de présenter une demande au commissaire aux brevets aux termes de l’article 21.04 de la Loi sur les brevets; b) dans le cas d’une drogue nouvelle, le numéro et la date de dépôt de la présentation de drogue nouvelle ou de la présentation abrégée de drogue nouvelle déposées respectivement aux termes des articles C.08.002 et C.08.002.1, ainsi que de tout supplément à l’une de SOR/2005-141, s. 1. l'autre présentation déposée aux termes de l'article C.08.003; c) dans le cas d'une drogue autre qu'une drogue nouvelle : (i) soit le numéro et la date de dépôt de la demande d'identification numérique présentée à l'égard de la drogue aux termes de l'article C.01.014.1, (ii) soit l'identification numérique attribuée à la drogue, le cas échéant, aux termes de l'article C.01.014.2; d) dans le cas où la drogue se présente sous une forme posologique solide, la manière dont elle est marquée conformément à l'alinéa C.07.008a) ainsi qu'une preuve établissant que cette méthode n'a aucune incidence sur son innocuité et efficacité; e) dans le cas où la drogue se présente sous une forme posologique non solide, la manière dont le récipient immédiat est marqué conformément à l'alinéa C.07.008a); f) un échantillon de l'étiquette de la drogue, lequel contient les renseignements prévus à l'alinéa C.07.008c). DORS/2005-141, art. 1. Autorisation

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07.004 Le ministre avise le fabricant et le commissaire aux brevets, pour l'application de l'alinéa 21.04(3)b) de la Loi sur les brevets, que la drogue en cause satisfait aux exigences de la Loi et du présent règlement si les conditions suivantes sont réunies : a) le fabricant a présenté au ministre une demande conforme à l'article C.07.003 et il a fourni à ce dernier un exemplaire de la demande qu'il a présentée au commissaire aux brevets aux termes de l'article 21.04 de la Loi sur les brevets; b) dans le cas d'une drogue nouvelle, le ministre conclut que la présentation de drogue nouvelle, la présentation abrégée de drogue nouvelle ou le supplément à l'une ou l'autre présentation est conforme aux articles C.08.002, C.08.002.1 ou C.08.003, le cas échéant, et à l'article C.08.005.1; c) dans le cas d'une drogue autre qu'une drogue nouvelle, une identification numérique a été attribuée à la drogue aux termes de l'article C.01.014.2;

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07.005 Despite sections C.01.014, C.08.002 and C.08.003, a manufacturer may sell a drug under this Division if SOR/2005-141, s. 1.

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07.006 Sections C.01.005 and C.01.014.1 to C.01.014.4 do not apply to new drugs sold under this Division. SOR/2005-141, s. 1. SOR/2005-141, s. 1. SOR/2005-141, s. 1. Records SOR/2005-141, s. 1; SOR/2014-125, s. 1. SOR/2005-141, s. 1. DIVISION 8 New Drugs SOR/95-172, s. 2; SOR/2017-76, s. 10. (c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a); (produit de référence canadien) designated COVID-19 drug means a new drug for which the purpose and conditions of use recommended by the manufacturer relate to COVID-19; (drogue désignée contre la COVID-19) pharmaceutical equivalent means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; (équivalent pharmaceutique) b) qui entre dans une association de deux drogues ou plus, avec ou sans autre ingrédient, qui n’a pas été vendue dans cette association particulière, ou dans les proportions de ladite association pour ces drogues particulières, pendant assez longtemps et en quantité suffisante pour établir, au Canada, l’innocuité et l’efficacité de cette association ou de ces proportions employées comme drogue; ou c) pour laquelle le fabricant prescrit, recommande, propose ou déclare un usage comme drogue ou un mode d’emploi comme drogue, y compris la posologie, la voie d’administration et la durée d’action, et qui n’a pas été vendue pour cet usage ou selon ce mode d’emploi au Canada pendant assez longtemps et en quantité suffisante pour établir, au Canada, l’innocuité et l’efficacité de cet usage ou de ce mode d’emploi pour cette drogue. DORS/95-172, art. 2; DORS/2017-76, art. 10.

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08.001.1 Les définitions qui suivent s’appliquent au présent titre. drogue désignée contre la COVID-19 Drogue nouvelle dont les fins et le mode d’emploi recommandés par le fabricant ont trait à la COVID-19; (designated COVID-19 drug) équivalent pharmaceutique S’entend d’une drogue nouvelle qui, par comparaison à une autre drogue, contient les mêmes quantités d’ingrédients médicinaux identiques, sous des formes posologiques comparables, mais pas nécessairement les mêmes ingrédients non médicinaux. (pharmaceutical equivalent) produit de référence canadien Selon le cas : a) une drogue à l’égard de laquelle un avis de conformité a été délivré en application des articles C.08.004 ou C.08.004.01 et qui est commercialisée au Canada par son innovateur; b) une drogue jugée acceptable par le ministre et qui peut être utilisée pour la démonstration de la bioéquivalence d’après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, lorsqu’une drogue à l’égard de laquelle un avis de conformité a été délivré en application des articles C.08.004 ou C.08.004.01 ne peut être utilisée à cette fin parce qu’elle n’est plus commercialisée au Canada; c) une drogue jugée acceptable par le ministre qui peut être utilisée pour la démonstration de la bioéquivalence d’après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de SOR/95-411, s. 3; SOR/2011-88, s. 9; SOR/2021-45, s. 13.

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08.002 (1) No person shall sell or advertise a new drug unless (d) [Repealed, SOR/2014-158, s. 10] (c) a list of the ingredients of the new drug, stated quantitatively, and the specifications for each of those ingredients; biodisponibilité, par comparaison à une drogue visée à l’alinéa a). (Canadian reference product) spécifications S’entend de la description détaillée d’une drogue nouvelle et de ses ingrédients, notamment : a) la liste des propriétés et des qualités des ingrédients qui ont trait à la fabrication et à l’emploi de la drogue nouvelle, y compris leur identité, leur activité et leur pureté; b) la description détaillée des méthodes d’analyse et d’examen des ingrédients; c) la liste des tolérances relatives aux propriétés et aux qualités des ingrédients. (specifications) DORS/95-411, art. 3; DORS/2011-88, art. 9; DORS/2021-45, art. 13.

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08.002 (1) Il est interdit de vendre ou d’annoncer une drogue nouvelle, à moins que les conditions suivantes ne soient réunies : a) le fabricant de la drogue nouvelle, relativement à celle-ci, dépose auprès du ministre une présentation de drogue nouvelle, une présentation de drogue nouvelle pour usage exceptionnel, une présentation abrégée de drogue nouvelle ou une présentation abrégée de drogue nouvelle pour usage exceptionnel que celui-ci juge acceptable; b) le ministre a délivré au fabricant de la drogue nouvelle, en application des articles C.08.004 ou C.08.004.01, un avis de conformité relativement à la présentation; c) l’avis de conformité relatif à la présentation n’a pas été suspendu en vertu de l’article C.08.006. d) [Abrogé, DORS/2014-158, art. 10]

(2)

La présentation de drogue nouvelle doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d’évaluer l’innocuité et l’efficacité de la drogue nouvelle, notamment : a) une description de la drogue nouvelle et une mention de son nom propre ou, à défaut, de son nom usuel; b) une mention de la marque nominative de la drogue nouvelle ou du nom ou code d’identification projeté pour celle-ci; c) la liste quantitative des ingrédients de la drogue nouvelle et les spécifications relatives à chaque ingrédient; (d) a description of the plant and equipment to be used in the manufacture, preparation and packaging of the new drug; (2.4) Subsections (2.1) to (2.3) apply if (b) samples of the ingredients of the new drug; (d) any additional information or material respecting the safety and effectiveness of the new drug.

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08.002.01 (1) A manufacturer of a new drug may file an extraordinary use new drug submission for the new drug if (b) the requirements set out in paragraphs C.08.002(2)(g) and (h) cannot be met because

(2)

Subject to subsections (3) and (5), an extraordinary use new drug submission shall contain (i) the information and material described in paragraphs C.08.002(2)(a) to (f), (i) to (m) and (o), ou un état physiologique anormal graves — mettant notamment la vie en danger —, ou leurs symptômes, qui résultent — ou résulteraient vraisemblablement — d’une telle exposition, (ii) en tant que mesure préventive chez toute personne qui pourrait être exposée à une substance chimique, biologique, radiologique ou nucléaire qui risque d’entraîner une incapacité permanente ou la mort; b) il est impossible de remplir les exigences prévues aux alinéas C.08.002(2)g) et h) pour les raisons suivantes : (i) l’exposition de volontaires humains à la substance visée à l’alinéa a) risque d’entraîner une incapacité permanente ou la mort, (ii) les circonstances de l’exposition à la substance ne se produisent que de façon sporadique et il est peu fréquent.

(2)

Sous réserve des paragraphes (3) et (5), la présentation de drogue nouvelle pour usage exceptionnel doit contenir : a) une attestation, signée et datée par le premier dirigeant au Canada du fabricant qui dépose la présentation et par son directeur médical ou scientifique, portant que les conditions prévues aux alinéas (1)a) et b) sont remplies, accompagnée de suffisamment de renseignements à l’appui pour permettre au ministre de conclure que ces conditions sont remplies; b) suffisamment de renseignements et de matériel pour permettre au ministre d’évaluer l’innocuité et l’efficacité de cette drogue nouvelle, notamment : (i) les renseignements et le matériel visés aux alinéas C.08.002(2)a) à f), i) à m) et o), (ii) des renseignements concernant le processus pathophysiologique de la toxicité de la substance chimique, biologique, radiologique ou nucléaire et décrivant la capacité de la drogue nouvelle de traiter, d’atténuer ou de prévenir ce processus, (iii) des rapports détaillés d’études in vitro effectuées relativement à la toxicité et à l’activité de la drogue nouvelle aux fins recommandées, (iv) des rapports détaillés d’études, effectuées sur une espèce animale dont les réactions devraient permettre de prédire celles chez l’être humain, établissant l’innocuité de la drogue nouvelle et fournissant des preuves substantielles de ses effets (b) samples of the ingredients of the new drug; (d) any information omitted by virtue of subsection (3). lorsqu’elle est utilisée aux fins et selon le mode d’emploi recommandés, (v) des renseignements confirmant que le résultat d’études sur les animaux est clairement relié aux avantages recherchés chez l’être humain, (vi) des renseignements indiquant une connaissance suffisante de la pharmacocinétique et de la pharmacodynamie de la drogue nouvelle chez l’animal et l’être humain pour en tirer des conclusions permettant de déterminer une dose thérapeutique chez l’être humain, (vii) des renseignements concernant l’innocuité de la drogue nouvelle chez l’être humain, notamment des rapports détaillés de tout essai clinique établissant l’innocuité de la drogue nouvelle, (viii) tout renseignement concernant l’efficacité de la drogue nouvelle chez l’être humain aux fins et selon le mode d’emploi recommandés, (ix) un plan visant à surveiller et à établir l’innocuité et l’efficacité de la drogue nouvelle aux fins et selon le mode d’emploi recommandés, qui contient les procédures de collecte et d’analyse des données, (x) tout rapport d’évaluation disponible concernant la drogue nouvelle, préparé par toute autorité réglementaire dans tout pays autre que le Canada.

(3)

Il n’est pas nécessaire de fournir les rapports visés au sous-alinéa (2)(b)(iii) ou les renseignements visés au sous-alinéa (2)(b)(vi) si la présentation de drogue nouvelle pour usage exceptionnel contient une explication scientifique détaillée de la raison pour laquelle ils ne sont pas disponibles.

(4)

Tout renseignement ou matériel nécessaire pour permettre au ministre d’évaluer l’innocuité et l’efficacité de la drogue nouvelle doit être ajouté, à la demande du ministre, à la présentation de drogue nouvelle pour usage exceptionnel, notamment : a) les nom et adresse des fabricants de chaque ingrédient de la drogue nouvelle ainsi que ceux des fabricants de la drogue nouvelle sous la forme posologique proposée pour la vente; b) des échantillons des ingrédients de la drogue nouvelle; c) des échantillons de la drogue nouvelle sous la forme posologique proposée pour la vente; d) tout renseignement omis en vertu du paragraphe (3). SOR/2011-88, s. 11; SOR/2014-158, s. 11. SOR/2011-88, s. 11. (d) the conditions of use for the new drug fall within the conditions of use for the Canadian reference product. (d) the quantitative list of the medicinal ingredients of the new drug and of the Canadian reference product; (e) the qualitative list of the non-medicinal ingredients of the new drug and of the Canadian reference product; (k) the results of the comparative pharmacodynamic studies; (z) the results of the comparative studies on the pharmacokinetics; (kk) the results of the comparative studies on the clinical pharmacodynamics; (uu) the results of the comparative studies on the clinical pharmacodynamics; (zz) the results of the comparative studies on the clinical pharmacodynamics; (kkk) the results of the comparative studies on the clinical toxicological properties; (uuu) the results of the comparative studies on the clinical toxicological properties; (zzz) the results of the comparative studies on the clinical toxicological properties; (aaaa) the results of the comparative studies on the clinical therapeutic properties; (kkkk) the results of the comparative studies on the clinical therapeutic properties; (nnnn) the results of the comparative studies on the clinical pharmacodynamics; (pppp) the results of the comparative studies on the clinical therapeutic properties; (uuuu) the results of the comparative studies on the clinical therapeutic properties; (zzzz) the results of the comparative studies on the clinical therapeutic properties; (kkkkk) the results of the comparative studies on the clinical pharmacological properties; (nnnnn) the results of the comparative studies on the clinical toxicological properties; (uuuuu) the results of the comparative studies on the clinical pharmacological properties; (yyyyy) the results of the comparative studies on the clinical therapeutic properties; (zzzzz) the results of the comparative studies on the clinical pharmacological properties; (aaaaaa) the results of the comparative studies on the clinical pharmacokinetics; (dddddd) the results of the comparative studies on the clinical therapeutic properties; (iiiiii) the results of the comparative studies on the clinical therapeutic properties; (kkkkkk) the results of the comparative studies on the clinical pharmacokinetics; (nnnnnn) the results of the comparative studies on the clinical therapeutic properties; (uuuuuu) the results of the comparative studies on the clinical pharmacokinetics; (yyyyyy) the results of the comparative studies on the clinical pharmacological properties; (zzzzzz) the results of the comparative studies on the clinical pharmacokinetics; (aaaaaaa) the results of the comparative studies on the clinical pharmacodynamics; (kkkkkkk) the results of the comparative studies on the clinical pharmacodynamics; (uuuuuuu) the results of the comparative studies on the clinical pharmacodynamics; (yyyyyyy) the results of the comparative studies on the clinical pharmacokinetics; (zzzzzzz) the results of the comparative studies on the clinical pharmacodynamics; (aaaaaaa) the results of the comparative studies on the clinical toxicological properties; (kkkkkkk) the results of the comparative studies on the clinical toxicological properties; (uuuuuuu) the results of the comparative studies on the clinical toxicological properties; (vvvvvvv) the results of the comparative studies on the clinical therapeutic properties; (yyyyyyy) the results of the comparative studies on the clinical pharmacodynamics; (zzzzzzz) the results of the comparative studies on the clinical toxicological properties; (aaaaaaa) the results of the comparative studies on the clinical therapeutic properties; (iiiiiii) the results of the comparative studies on the clinical pharmacodynamics; (kkkkkkk) the results of the comparative studies on the clinical therapeutic properties; (nnnnnnn) the results of the comparative studies on the clinical pharmacodynamics; (ppppppp) the results of the comparative studies on the clinical therapeutic properties; (uuuuuuu) the results of the comparative studies on the clinical therapeutic properties; (yyyyyyy) the results of the comparative studies on the clinical toxicological properties; (zzzzzzz) the results of the comparative studies on the clinical therapeutic properties; (aaaaaaa) the results of the comparative studies on the clinical pharmacological properties; (g (i) paragraphs C.08.002(2)(a) to (f), (j) to (l) and (o), in the case of an abbreviated new drug submission, and (ii) paragraphs C.08.002(2)(a) to (f), (j) to (l) and (o), and subparagraphs C.08.002.01(2)(b)(ix) and (x), in the case of an abbreviated extraordinary use new drug submission; (b) samples of the ingredients of the new drug; a) les renseignements et le matériel visés : (i) aux alinéas C.08.002(2)a) à f), j) à l) et o), dans le cas d’une présentation abrégée de drogue nouvelle, (ii) aux alinéas C.08.002(2)a) à f), j) à l) et o) et aux sous-alinéas C.08.002.01(2)b)(ix) et (x), dans le cas d’une présentation abrégée de drogue nouvelle pour usage exceptionnel; b) les renseignements permettant d’identifier le produit de référence canadien utilisé pour les études comparatives menées dans le cadre de la présentation; c) les éléments de preuve, provenant des études comparatives menées dans le cadre de la présentation, établissant que la drogue nouvelle est : (i) d’une part, un équivalent pharmaceutique du produit de référence canadien, (ii) d’autre part, si le ministre l’estime nécessaire d’après les caractéristiques pharmaceutiques et, le cas échéant, d’après les caractéristiques de la biodisponibilité de celle-ci, bioéquivalente au produit de référence canadien selon les résultats d’études de biodisponibilité, d’études pharmacodynamiques ou des études cliniques; d) les éléments de preuve établissant que les lots d’essai de la drogue nouvelle ayant servi aux études menées dans le cadre de la présentation ont été fabriqués et contrôlés d’une manière représentative de la production destinée au commerce; e) dans le cas d’une drogue destinée à être administrée à des animaux producteurs de denrées alimentaires, les renseignements permettant de confirmer que le délai d’attente est identique à celui du produit de référence canadien.

(3)

Le fabricant de la drogue nouvelle doit, à la demande du ministre, lui fournir, selon ce celui-ci estime nécessaire pour évaluer l’innocuité et l’efficacité de la drogue dans le cadre de la présentation abrégée de drogue nouvelle ou de la présentation abrégée de drogue nouvelle pour usage exceptionnel, les renseignements et le matériel suivants : a) les nom et adresse des fabricants de chaque ingrédient de la drogue nouvelle et les nom et adresse des fabricants de la drogue nouvelle sous sa forme posologique proposée pour la vente; b) des échantillons des ingrédients de la drogue nouvelle; (d) any additional information or material respecting the safety and effectiveness of the new drug. SOR/85-411, s. 5; SOR/2011-88, s. 12; SOR/2014-158, s. 12. (d) [Repealed, SOR/2014-158, s. 13] (a) the description of the new drug; (c) the specifications of the ingredients of the new drug; (d) the plant and equipment used in manufacturing, preparation and packaging the new drug; c) des échantillons de la drogue nouvelle sous sa forme posologique proposée pour la vente; d) tout renseignement ou matériel supplémentaire se rapportant à l’innocuité et à l’efficacité de la drogue nouvelle.

(4)

Pour l’application du présent article, dans le cas d’une présentation abrégée de drogue nouvelle, la drogue nouvelle pour usage exceptionnel à l’égard de laquelle un avis de conformité a été délivré en application de l’article C.08.004.01 n’est pas un produit de référence canadien. DORS/85-411, art. 5; DORS/2011-88, art. 12; DORS/2014-158, art. 12.

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08.003 (1) Malgré l’article C.08.002, il est interdit de vendre une drogue nouvelle à l’égard de laquelle un avis de conformité a été délivré à son fabricant et n’a pas été suspendu en vertu de l’article C.08.006 lorsqu’un des éléments visés au paragraphe (2) diffère sensiblement des renseignements ou du matériel contenus dans la présentation de drogue nouvelle, la présentation de drogue nouvelle pour usage exceptionnel, la présentation abrégée de drogue nouvelle ou la présentation abrégée de drogue nouvelle pour usage exceptionnel, à moins que les conditions ci-après ne soient réunies : a) le fabricant de la drogue nouvelle a déposé auprès du ministre un supplément à la présentation; b) le ministre a délivré au fabricant un avis de conformité relativement au supplément; c) l’avis de conformité relatif au supplément n’a pas été suspendu en vertu de l’article C.08.006. d) [Abrogé, DORS/2014-158, art. 13]

(2)

Pour l’application du paragraphe (1), les éléments ayant trait à la drogue nouvelle sont les suivants : a) sa description; b) sa marque nominative ou le nom ou code sous lequel il est proposé de l’identifier; c) les spécifications de ses ingrédients; d) les installations et l’équipement à utiliser pour sa fabrication, sa préparation et son emballage; e) la méthode de fabrication et les mécanismes de contrôle à appliquer pour sa fabrication, sa préparation et son emballage; f) les analyses effectuées pour contrôler son activité, sa pureté, sa stabilité et son innocuité; (ii) the dosage of the new drug, (a) if, due to a matter specified in subsection (2) — other than the brand name of a new drug for human use — that the supplement concerns, it is necessary to modify a new drug’s labels: (b) if the supplement concerns the brand name of a new drug for human use: g) les étiquettes à utiliser pour la drogue nouvelle; g.1) dans le cas d’une drogue nouvelle pour usage humain, les emballages de celle-ci; h) les observations faites relativement : (i) à la voie d’administration recommandée pour la drogue nouvelle, (ii) à sa posologie, (iii) aux propriétés qui lui sont attribuées, (iv) à ses contre-indications et à ses effets secondaires, (v) au délai d’attente applicable à celle-ci; i) sa forme posologique proposée pour la vente.

(3)

Le supplément à toute présentation visée au paragraphe (1) contient, à l’égard des éléments qui diffèrent sensiblement de ce qui figure dans la présentation, suffisamment de renseignements et de matériel pour permettre au ministre d’évaluer l’innocuité et l’efficacité de la drogue nouvelle relativement à ces éléments. (3.1) Le supplément à toute présentation visée au paragraphe (1) contient, selon le cas, ce qui suit : a) si, en raison de l’élément visé au paragraphe (2) — autre que la marque nominative d’une drogue nouvelle pour usage humain — sur lequel porte le supplément, il est nécessaire de modifier les étiquettes de la drogue nouvelle : (i) dans le cas d’une drogue nouvelle pour usage vétérinaire, une esquisse de toute étiquette à utiliser relativement à la drogue nouvelle, y compris toute notice d’accompagnement et tout document supplémentaire sur l’emploi de la drogue nouvelle qui est fourni sur demande, (ii) dans le cas d’une drogue nouvelle pour usage humain, des maquettes de toute étiquette à utiliser relativement à la drogue nouvelle — y compris toute notice d’accompagnement et tout document supplémentaire sur l’emploi de la drogue nouvelle qui est fourni sur demande — ainsi que des maquettes des emballages de la drogue nouvelle; b) si le supplément porte sur la marque nominative d’une drogue nouvelle pour usage humain :

(4)

If a supplement to an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission concerns a matter specified in subparagraph (2)(h)(iii), the supplement shall contain the attestation and supporting information referred to in paragraph C.08.002.01(2)(a). (d) an abbreviated extraordinary use new drug submission that is filed under section C.08.002.1. (présentation) SOR/2021-45, s. 15. SOR/95-411, s. 6; SOR/2001-203, art. 5; SOR/2011-88, s. 14.

(3)

Sous réserve de l’article C.08.004.1, après avoir terminé l’examen des renseignements et du matériel supplémentaires déposés relativement à une présentation de drogue nouvelle, à une présentation abrégée de drogue nouvelle ou à un supplément à l’une de ces présentations, le ministre : a) si la présentation ou le supplément est conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, et à l’article C.08.005.1, délivre un avis de conformité; b) si la présentation ou le supplément n’est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1, délivre un avis à cet effet au fabricant.

(4)

L’avis de conformité délivré à l’égard d’une drogue nouvelle d’après les renseignements et le matériel contenus dans la présentation déposée conformément à l’article C.08.002.1 indique le nom du produit de référence canadien mentionné dans la présentation et constitue une déclaration d’équivalence de cette drogue.

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08.004.01 (1) Sous réserve de l’article C.08.004.1, le ministre, après avoir terminé l’examen d’une présentation de drogue nouvelle pour usage exceptionnel, d’une présentation abrégée de drogue nouvelle pour usage exceptionnel ou d’un supplément à l’une de ces présentations, a) si la présentation ou le supplément est conforme aux articles C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, et à l’article C.08.005.1, délivre un avis de conformité; b) si la présentation ou le supplément n’est pas conforme aux articles C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1, délivre un avis à cet effet au fabricant.

(2)

Le fabricant qui a déposé une présentation de drogue nouvelle pour usage exceptionnel, une présentation abrégée de drogue nouvelle pour usage exceptionnel ou un supplément à l’une de ces présentations non conformes aux articles C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1, peut modifier la présentation ou le supplément en déposant des renseignements ou du matériel supplémentaires dans les quatre-vingt-dix jours suivant la date à laquelle le ministre lui délivre un avis en application de l’alinéa C.08.004.01(1)b) ou dans tout délai plus long imparti par le ministre.

(3)

Sous réserve de l’article C.08.004.1, après avoir terminé l’examen des renseignements et du matériel DORS/2011-88, art. 15; DORS/2019-62, art. 2. abbreviated new drug submission includes an abbreviated extraordinary use new drug submission. (présentation abrégée de drogue nouvelle) new drug submission includes an extraordinary use new drug submission. (présentation de drogue nouvelle) suppléments déposés relativement à une présentation de drogue nouvelle pour usage exceptionnel, à une présentation abrégée de drogue nouvelle pour usage exceptionnel ou à un supplément à l’une de ces présentations, le ministre : a) si la présentation ou le supplément est conforme aux articles C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, et à l’article C.08.005.1, délivre un avis de conformité; b) si la présentation ou le supplément n’est pas conforme aux articles C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1, délivre un avis à cet effet au fabricant.

(4)

L’avis de conformité délivré à l’égard d’une drogue nouvelle pour usage exceptionnel d’après les renseignements et le matériel contenus dans la présentation déposée aux termes de l’article C.08.002.1 indique le nom du produit de référence canadien mentionné dans la présentation et constitue la déclaration d’équivalence de cette drogue nouvelle. DORS/2011-88, art. 15; DORS/2019-62, art. 2.

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08.004.1 (1) Les définitions qui suivent s’appliquent au présent article. présentation abrégée de drogue nouvelle S’entend également d’une présentation abrégée de drogue nouvelle pour usage exceptionnel. (abbreviated new drug submission) drogue innovante S’entend de toute drogue qui contient un ingrédient médicinal non déjà approuvé dans une drogue par le ministre et qui ne constitue pas une variante d’un ingrédient médicinal déjà approuvé tel un changement de sel, d’ester, d’énantiomère, de solvate ou de polymorphe. (innovative drug) population pédiatrique S’entend de chacun des groupes suivants : les bébés prématurés nés avant la 37e semaine de gestation, les bébés nés à terme et âgés de 0 à 27 jours, tous les enfants âgés de 28 jours à deux ans, ceux âgés de deux ans et un jour à 11 ans et ceux âgés de 11 ans et un jour à 18 ans. (pediatric populations) présentation de drogue nouvelle S’entend également d’une présentation de drogue nouvelle pour usage exceptionnel. (new drug submission) (1.1) Pour l’application de la définition de drogue innovante au paragraphe (1), un ingrédient médicinal n’est pas considéré comme étant approuvé dans une drogue du fait que le ministre a délivré ou modifié, en vertu de

(4)

The period specified in paragraph (3)(b) is lengthened to eight years and six months if l’arrêté d’urgence IVPD, une autorisation à l’égard d’une drogue contre la COVID-19 qui le contient.

(2)

L’objet du présent article est de mettre en œuvre les articles 20.48 et 20.49 de l’Accord entre le Canada, les États-Unis d’Amérique et les États-Unis du Mexique, au sens de l’Accord à l’article 2 de la Loi de mise en œuvre de l’Accord Canada–États-Unis–Mexique, et le paragraphe 3 de l’article 39 de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce figurant à l’annexe 1C de l’Accord instituant l’Organisation mondiale du commerce, au sens de l’Accord au paragraphe 2(1) de la Loi de mise en œuvre de l’Accord sur l’Organisation mondiale du commerce.

(3)

Lorsque le fabricant demande la délivrance d’un avis de conformité pour une drogue nouvelle sur la base d’une comparaison directe ou indirecte entre celle-ci et la drogue innovante : a) le fabricant ne peut déposer pour cette drogue nouvelle une présentation de drogue nouvelle, de présentation de drogue nouvelle modifiée ou un supplément à l’une de ces présentations avant l’expiration d’un délai de six ans suivant la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante; b) le ministre ne peut approuver une telle présentation ou un tel supplément et ne peut délivrer d’avis de conformité pour cette nouvelle drogue avant l’expiration d’un délai de huit ans suivant la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante.

(4)

Le délai prévu à l’alinéa (3)(b) est porté à huit ans et six mois si, à la fois : a) l’innovateur fournit au ministre la description et les résultats des essais cliniques concernant l’utilisation de la drogue innovante dans les populations pédiatriques concernées dans sa première présentation de drogue nouvelle à l’égard de la drogue innovante ou dans tout supplément à la présentation déposé au cours des cinq années suivant la délivrance du premier avis de conformité à l’égard de cette drogue innovante; b) le ministre conclut, avant l’expiration du délai de six ans suit la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante, que les essais cliniques ont été conçus et menés en vue d’élargir les connaissances sur l’utilisation de cette drogue dans les populations pédiatriques visées et que ces connaissances se traduiraient par des avantages pour la santé des membres de celles-ci.

(8)

Paragraph (3)(b) does not apply to a manufacturer if the innovator consents to the issuance of a notice of compliance to the manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4). SOR/95-411, s. 6; SOR/2006-241, s. 1; SOR/2011-88, s. 16; SOR/2014-124, s. 1; SOR/2020-74, s. 6; SOR/2021-45, s. 16. (iii) the source of the new drug,

(5)

Le paragraphe (3) ne s’applique pas si la drogue innovante n’est pas commercialisée au Canada.

(6)

L’alinéa (3)a) ne s’applique pas au fabricant dans le cas où l’innovateur consent à ce qu’il dépose une présentation de drogue nouvelle, une présentation abrégée de drogue nouvelle ou un supplément à l’une de ces présentations avant l’expiration du délai de six ans prévu à cet alinéa.

(7)

L’alinéa (3)a) ne s’applique pas au fabricant s’il dépose une demande d’autorisation pour vendre cette drogue nouvelle aux termes de l’article C.07.003.

(8)

L’alinéa (3)b) ne s’applique pas au fabricant dans le cas où l’innovateur consent à ce que soit délivré un avis de conformité avant l’expiration du délai de huit ans prévu à cet alinéa ou de huit ans et six mois prévu au paragraphe (4).

(9)

Le ministre tient un registre des drogues innovantes, lequel contient les renseignements relatifs à l’application des paragraphes (3) et (4). DORS/95-411, art. 6; DORS/2006-241, art. 1; DORS/2011-88, art. 16; DORS/2014-124, art. 1; DORS/2020-74, art. 6; DORS/2021-45, art. 16.

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08.005 (1) Sous réserve du paragraphe (1.1) et par dérogation aux articles C.08.002 et C.08.003, le fabricant d’une drogue nouvelle peut vendre celle-ci à un chercheur qualifié à la seule fin d’effectuer un essai clinique pour obtenir des preuves sur l’innocuité, la posologie et l’efficacité de la drogue nouvelle, si les conditions suivantes sont réunies : (a) le fabricant, avant la vente, déposé auprès du ministre, conformément à l’article C.08.005.1, une présentation préclinique contenant des renseignements et du matériel se rapportant à ce qui suit : (i) la marque nominative de la drogue nouvelle ou le nom ou code d’identification projeté pour celle-ci, (ii) la structure chimique ou tout autre détail spécifique qui permet de déterminer la composition de la drogue nouvelle, (iii) la provenance de la drogue nouvelle, (iv) un protocole détaillé de l’essai clinique, (v) les résultats des recherches effectuées pour motiver l’usage clinique de la drogue nouvelle, (vi) les contre-indications et les précautions connues relativement à la drogue nouvelle, ainsi (vii) all ingredients of the new drug, stated quantitatively, (i) “Investigational Drug” or “Drogue de recherche”, and (ii) “To Be Used By Qualified Investigators Only” or “Réservée uniquement à l’usage de chercheurs compétents”; (d) before the sale, the manufacturer ascertains that every qualified investigator to whom the new drug is to be sold SOR/79-236, s. 6; SOR/85-141, s. 4; SOR/87-611, s. 1; SOR/93-202, s. 26; SOR/95-411, s. 7; SOR/2001-203, s. 6; SOR/2018-69, s. 27. (a) [Repealed, SOR/2018-84, s. 10] (d) a submission certificate in respect of all information and material contained in the submission or supplement and any additional information or material filed to amend the submission or supplement. (i) a summary of the data, (ii) a cross-referencing of the data to the relevant portions of the sectional report,

(4)

The submission certificate referred to in paragraph (1)(d) shall

(5)

[Repealed, SOR/2018-84, s. 10] SOR/85-143, s. 5; SOR/92-543, s. 1; SOR/94-689, s. 2(F); SOR/95-411, s. 8; SOR/2001-203, s. 7; SOR/2011-88, s. 17; SOR/2018-84, s. 10. dans la présentation ou le supplément ou auxquels il est fait renvoi; b) être datée et signée à la fois par : (i) le premier dirigeant au Canada du fabricant qui dépose la présentation ou le supplément, (ii) le directeur médical ou scientifique du fabricant.

(5)

[Abrogé, DORS/2018-84, art. 10]

(6)

Le fabricant qui a déposé une présentation de drogue nouvelle, une présentation de drogue nouvelle pour usage exceptionnel, une présentation abrégée de drogue nouvelle, une présentation abrégée de drogue nouvelle pour usage exceptionnel, un supplément à l’une de ces présentations ou une présentation pour l’essai clinique d’une drogue nouvelle pour usage vétérinaire sans y inclure les fiches d’observations cliniques ou les données brutes y ayant trait doit conserver ces fiches ou ces données et les soumettre au ministre, sur réception d’une demande écrite, dans les trente jours suivant la réception de celle-ci. DORS/85-143, art. 5; DORS/92-543, art. 1; DORS/94-689, art. 2(F); DORS/95-411, art. 8; DORS/2001-203, art. 7; DORS/2011-88, art. 17; DORS/2018-84, art. 10.

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08.006 (1) Pour l’application du paragraphe (2), les éléments de preuve ou les nouveaux renseignements obtenus par le ministre comprennent les renseignements ou le matériel que lui présente toute personne au titre d’un des articles C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 ou C.08.005.1.

(2)

Le ministre peut suspendre, pour une période déterminée ou indéterminée, l’avis de conformité délivré à un fabricant à l’égard d’une présentation de drogue nouvelle, d’une présentation de drogue nouvelle pour usage exceptionnel, d’une présentation abrégée de drogue nouvelle, d’une présentation abrégée de drogue nouvelle pour usage exceptionnel ou d’un supplément à l’une de ces présentations, en envoyant au fabricant une notification indiquant que cette mesure est nécessaire, s’il estime : a) que la drogue n’est pas sans danger aux fins spécifiées dans la présentation ou le supplément, en s’appuyant sur des éléments de preuve : (i) soit d’essais cliniques ou autres expériences qui ne sont pas signalés dans la présentation ou le supplément ou qui ne lui étaient accessibles au moment de la délivrance de l’avis de conformité, (c) that the submission or supplement contained an untrue statement of material fact; (i) [Repealed, SOR/95-521, s. 3] b) le titulaire se conforme à l’ordre, mais le ministre conclut que les résultats de l’évaluation sont insuffisants pour établir que les bénéfices liés à la drogue l’emportent sur les risques de préjudice à la santé. DORS/95-411, art. 9; DORS/2001-203, art. 8; DORS/2011-88, art. 18; DORS/2018-69, art. 27; DORS/2018-84, art. 11; DORS/2020-262, art. 5.

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08.007 (1) Lorsqu’un fabricant a reçu un avis de conformité à l’égard d’une présentation de drogue nouvelle, d’une présentation de drogue nouvelle pour usage exceptionnel, d’une présentation abrégée de drogue nouvelle, d’une présentation abrégée de drogue nouvelle pour usage exceptionnel ou d’un supplément à l’une de ces présentations, il doit établir et tenir, de façon à en permettre la vérification, des registres concernant ce qui suit : a) les expériences animales et les épreuves cliniques, les études, recherches et tests, effectués par le fabricant ou qui lui sont rapportés par toute autre personne, au sujet de cette drogue nouvelle; b) les rapports publiés dans la documentation scientifique, ou la bibliographie scientifique dont il dispose, au sujet de cette drogue nouvelle; c) les expériences, recherches, études et tests, au sujet des propriétés chimiques ou physiques, ou de toute autre propriété de cette drogue nouvelle; d) toute substitution d’une autre substance pour cette drogue nouvelle, et tout mélange d’une autre substance avec cette drogue nouvelle; e) toute erreur dans l’étiquetage de cette drogue nouvelle, ou dans l’usage des étiquettes destinées à cette drogue nouvelle; f) toute modification ou détérioration importante de nature physique ou chimique, tout changement au point de vue bactériologique, et toute autre modification ou détérioration, dans n’importe quel lot de cette drogue nouvelle; g) toute occasion où un ou plusieurs lots distribués de cette drogue nouvelle n’étaient pas conformes aux spécifications établies dans la présentation ou le supplément; h) tout cas inhabituel où la drogue nouvelle ne produit pas l’effet prévu. i) [Abrogé, DORS/95-521, art. 3] (1.1) Le fabricant conserve tout registre relatif aux renseignements visés au paragraphe (1) durant une période SOR/85-411, s. 10; SOR/95-521, s. 13; SOR/2011-88, s. 19; SOR/2014-125, s. 2. SOR/85-411, s. 11; SOR/95-521, s. 14; SOR/2014-125, s. 3; SOR/2018-84, s. 12. (a) shall adhere to the plan referred to in subparagraph C.08.002.01(2)(b)(ix); and SOR/2011-88, s. 20. (b) to suspend a notice of compliance issued under section C.08.004 or C.08.004.01, SOR/85-411, s. 12; SOR/2001-203, s. 9; SOR/2011-88, s. 21. Pre-positioning of Designated COVID-19 Drugs

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08.009.01 The following definitions apply in sections C.08.009.03 to C.08.009.05. Chief Public Health Officer means the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act. (administrateur en chef de la santé publique) SOR/2021-45, s. 17. SOR/2021-45, s. 17. (ii) the name of the designated COVID-19 drug and a description of it, (iii) the name and contact information of the designated COVID-19 drug’s manufacturer, (iv) information specifying the quantity of the designated COVID-19 drug to be imported, (A) ou bien la drogue désignée contre la COVID-19 fait l’objet d’une présentation de drogue nouvelle déposée en application de l’article C.08.002, (B) ou bien une demande d’autorisation de vente a été présentée à une autorité réglementaire étrangère à l’égard de la drogue désignée contre la COVID-19, (ii) le nom et la description de la drogue désignée contre la COVID-19, (iii) les nom et coordonnées du fabricant de la drogue désignée contre la COVID-19, (iv) de l’information quant à la quantité de la drogue désignée contre la COVID-19 à importer, (v) les nom et coordonnées de tout titulaire de licence d’établissement envisagé pour l’importation de la drogue désignée contre la COVID-19, et (vi) l’adresse municipale du lieu où la drogue désignée contre la COVID-19 sera entreposée après l’importation; b) le titulaire de licence fournit au ministre : (i) les nom et coordonnées de chaque manufacturier, emballeur-étiqueteur et analyste de la drogue désignée contre la COVID-19 et l’adresse municipale de chaque bâtiment où celle-ci sera manufacturée, emballée-étiquetée ou analysée, avec indication, pour chaque bâtiment, de ce qui suit : (A) les activités mentionnées au tableau I de l’article C.01A.008 qui s’appliquent à la drogue désignée contre la COVID-19, (B) les catégories mentionnées au tableau II de cet article qui s’appliquent à la drogue désignée contre la COVID-19, (C) pour chacune de ces catégories, la classe de forme posologique, le cas échéant, et si la drogue désignée contre la COVID-19 sera sous une forme stérile, (ii) le certificat d’un inspecteur indiquant que les bâtiments, l’équipement et les méthodes et pratiques de chaque manufacturier, emballeur-étiqueteur et analyste satisfont aux exigences des divisions 2 à 4 ou, à défaut, toute autre preuve établissant qu’il est satisfait à ces exigences; c) le titulaire de licence est l’un de ceux que l’administrateur en chef de la santé publique mentionne dans SOR/2021-45, s. 17. (b) subsection C.02.012(1); (c) sections C.02.013 and C.02.014; (d) section C.02.015, as it applies to the storage and transportation of the designated COVID-19 drug by the holder; (f) subsection C.02.022(1); (g) section C.02.023; (h) subsection C.02.024(1); (i) section C.03.013; and SOR/2021-45, s. 17. SOR/2021-45, s. 17. SOR/2019-62, s. 3. (a) the Minister issues a notice of compliance under section C.08.004 or C.08.004.01; (b) in the case where the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(1)(b) and the manufacturer does not amend the submission or supplement under subsection C.08.004(2) or C.08.004.01(2), the applicable period referred to in the relevant subsection expires;

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08.009.05 Malgré toute disposition du présent règlement, le titulaire d’une licence d’établissement peut distribuer une drogue contre la COVID-19 qu’il a importée en vertu de l’article C.08.009.03 si les conditions suivantes sont réunies : a) l’administrateur en chef de la santé publique fournit au ministre le nom de la drogue désignée contre la COVID-19 et l’adresse municipale du lieu où elle sera entreposée après la distribution; b) la drogue désignée contre la COVID-19 est distribuée à une personne qui l’entreposera dans ce lieu. DORS/2021-45, art. 17. Communication de renseignements relatifs à des essais cliniques

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08.009.1 (1) Aux articles C.08.009.2 et C.08.009.3, renseignements relatifs à un essai clinique s’entend des renseignements relatifs à un essai clinique, au sens de l’article C.05.001, qui sont contenus dans une présentation de drogue nouvelle, une présentation de drogue nouvelle pour usage exceptionnel, une présentation abrégée de drogue nouvelle ou une présentation abrégée de drogue nouvelle pour usage exceptionnel déposée en application de la présente section ou des articles C.08.002, C.08.002.01 ou C.08.003 ou dans un supplément à l’une de ces présentations déposée aux termes de l’article C.08.003.

(2)

Il est entendu que la définition de renseignements relatifs à un essai clinique vise notamment les renseignements qui sont contenus dans une présentation ou un supplément visés dans cette définition et qui sont relatifs à un essai clinique sur des sujets humains relativement auquel une demande a été déposée en application du présent titre avant le 1er septembre 2001. DORS/2019-62, art. 3.

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08.009.2 (1) Les renseignements relatifs à un essai clinique qui sont des renseignements commerciaux confidentiels cessent d’être des renseignements commerciaux confidentiels dans l’un ou l’autre des cas ci-après survenus relativement à la présentation ou au supplément : a) le ministre délivre un avis de conformité en application des articles C.08.004 ou C.08.004.01; b) dans les cas où le ministre délivre un avis au fabricant, en application des alinéas C.08.004(1)b) ou C.08.004.01(1)b), et que le fabricant ne modifie pas la présentation ou le supplément en vertu des paragraphes C.08.004(2) ou C.08.004.01(2), celui des délais visés au paragraphe pertinent qui s’applique expire; (c) the Minister issues a notice to the manufacturer under paragraph C.08.004(3)(b) or C.08.004.01(3)(b). SOR/2019-62, s. 3. SOR/2019-62, s. 3. [SOR/2020-212, s. 1(F)] (b) the practitioner agrees to (d) in the case of a new drug for veterinary use, the person referred to in subparagraph (a)(iv) is a practitioner, a pharmacist or a person who may sell a medicated feed pursuant to section C.08.012.

(3)

[Repealed, SOR/2021-271, s. 4] (a) the name of the practitioner to whom the new drug may be sold; (d) the quantity of the new drug that may be sold to the practitioner to address the medical emergency. (i) à fournir au fabricant de la drogue nouvelle et au ministre un rapport sur les résultats obtenus à la suite de l’utilisation de la drogue pour traiter l’urgence médicale, notamment les renseignements concernant toute réaction indésirable à la drogue qu’il aura observée, (ii) à rendre compte au ministre, sur demande, de toutes les quantités de la drogue nouvelle reçues; c) dans le cas d’une drogue nouvelle pour usage humain, la personne visée au sous-alinéa (a)(iv) est un praticien ou un pharmacien; d) dans le cas d’une drogue nouvelle pour usage vétérinaire, la personne visée au sous-alinéa (a)(iv) est un praticien, un pharmacien ou une personne autorisée à vendre un aliment médicamenteux en vertu de l’article C.08.012.

(2)

Le sous-alinéa (1)(a)(iii) ne s’applique pas si les conditions suivantes sont réunies : a) la vente de la drogue nouvelle a été autorisée à au moins une reprise en vertu du paragraphe (1) pour traiter la même urgence médicale; b) l’Agence européenne des médicaments ou le Secrétariat américain aux produits alimentaires et pharmaceutiques aux États-Unis a autorisé la vente de la drogue nouvelle, sans conditions, pour le même usage dans le territoire relevant de sa compétence; c) le ministre n’a pas, en vertu des alinéas C.01.014.6(2)(b) ou c) ou du paragraphe C.01.014.6(3), annulé l’identification numérique attribuée à la drogue nouvelle.

(3)

[Abrogé, DORS/2021-271, art. 4]

(4)

La lettre d’autorisation délivrée contient : a) le nom du praticien auquel la drogue nouvelle peut être vendue; b) le nom et l’adresse municipale de la personne à qui la drogue nouvelle peut être expédiée; c) le nom de la drogue nouvelle et l’urgence médicale pour laquelle la drogue nouvelle peut être vendue; d) la quantité de la drogue nouvelle qui peut être vendue au praticien pour traiter l’urgence médicale.

(5)

Pour l’application du présent article, le praticien n’a pas à connaître l’identité de l’animal ou de la personne SOR/2013-172, s. 11; SOR/2018-69, ss. 31(E), 32(F); SOR/2020-212, s. 2; SOR/2021-271, s. 4. SOR/2020-212, s. 2; SOR/2023-247, s. 3. (ii) the quantity of the new drug to be imported, (iii) the name of the holder of an establishment licence who will import the new drug, qu’il traite à titre professionnel au moment de la délivrance de la lettre d’autorisation. DORS/2013-172, art. 11; DORS/2018-69, art. 31 à 32(F); DORS/2020-212, art. 2; DORS/2021-271, art. 4.

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08.011 (1) Malgré l’article C.08.002, le fabricant peut vendre une drogue nouvelle conformément à une lettre d’autorisation délivrée en vertu du paragraphe C.08.010(1).

(2)

En cas de vente faite en conformité avec le paragraphe (1) d’une drogue nouvelle pour usage vétérinaire qui contient un ingrédient pharmaceutique actif figurant dans la Liste A et qui n’a pas été importée en vertu de l’article C.08.012.1, un rapport annuel indiquant la quantité totale de la drogue nouvelle qui a été vendue, y compris une estimation de la quantité vendue à l’égard de chaque espèce animale auxquelles la drogue est destinée, est soumis au ministre par le fabricant, dans le cas où la drogue nouvelle se trouvait au Canada au moment de la vente, ou dans le cas contraire, par le praticien.

(3)

La vente d’une drogue nouvelle faite en conformité avec le paragraphe (1) est exemptée de l’application de la Loi et du présent règlement, à l’exception du présent article.

(4)

Le rapport visé au paragraphe (2) porte sur toute année civile — à commencer par la première année civile complète pendant laquelle la drogue a été vendue pour la première fois — et est présenté au plus tard le 31 mars de l’année civile qui suit celle qui est visée par le rapport. DORS/2020-212, art. 2; DORS/2023-247, art. 3.

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08.011.1 (1) Le ministre peut, si les conditions ci-après sont réunies, délivrer au fabricant d’une drogue nouvelle une lettre d’autorisation permettant au titulaire d’une licence d’établissement d’importer, pour usage humain ou vétérinaire, une quantité déterminée de cette drogue : a) le fabricant fournit au ministre les renseignements suivants : (i) le nom de la drogue nouvelle et des précisions concernant l’urgence médicale pour laquelle la drogue nouvelle sera importée, (ii) la quantité de la drogue nouvelle qui sera importée, (iii) le nom du titulaire d’une licence d’établissement qui l’importera, (iv) l’adresse municipale du lieu où la drogue nouvelle sera entreposée au Canada,

(2)

[Repealed, SOR/2021-271, s. 5] (d) the civic address of the facility where the new drug is to be stored in Canada.

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08.011.2 (1) Despite subsection C.01A.004(1), the holder of an establishment licence may import a new drug in accordance with a letter issued under subsection C.08.011.1(1). (c) subsection C.02.012(1); (d) sections C.02.013 and C.02.014; (g) subsection C.02.022(1); (h) section C.02.023; (i) subsection C.02.024(1); (j) section C.03.013; and SOR/2020-212, s. 2.

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08.011.3 (1) Despite section C.08.002, the holder of an establishment licence who imports a new drug under section C.08.011.2 may distribute a new drug in accordance with a letter of authorization issued under subsection C.08.010(1). SOR/2020-212, s. 2; SOR/2023-247, s. 5. (ii) the sale is permitted by section C.08.005, C.08.011 or C.08.013; (A) feeding instructions, SOR/80-274, s. 1; SOR/92-130, s. 1; SOR/93-202, s. 27; SOR/2018-69, s. 27; SOR/2024-132, s. 88. Experimental Studies Conditions of Sale

(2)

For the purposes of this section and sections C.08.014 to C.08.018, experimental studies certificate means a certificate issued pursuant to subsection C.08.015(1); (certificat d’études expérimentales) experimental studies investigator means a person named as the investigator in an experimental studies certificate; (expert en études expérimentales) experimental study means a limited test of a new drug in animals carried out by an experimental studies investigator. (étude expérimentale) SOR/81-333, s. 1; SOR/2018-69, s. 27. Experimental Studies Certificate (d) the name and address of the manufacturer of the new drug; (f) a description of the facilities to be used to conduct the experimental study; études expérimentales, une quantité spécifiée par le ministre, de drogues nouvelles d’application vétérinaire destinées à l’exécution d’une étude expérimentale chez l’animal si, a) l’expert en études expérimentales a reçu un certificat d’études expérimentales selon le paragraphe C.08.015(1) et si le certificat n’a pas été suspendu ou annulé selon l’article C.08.018; et b) la drogue est étiquetée conformément au paragraphe C.08.016(1).

(2)

Aux fins des articles C.08.013 à C.08.018, certificat d’études expérimentales désigne un certificat délivré selon le paragraphe C.08.015(1); expert en études expérimentales désigne la personne visée dans un certificat d’études expérimentales; étude expérimentale désigne un test limité effectué par un expert en études expérimentales sur des animaux auxquels on a administré une drogue nouvelle. DORS/81-333, art. 1; DORS/2018-69, art. 27. Certificat d’études expérimentales

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08.014 (1) Afin d’obtenir un certificat d’études expérimentales, un requérant doit présenter au ministre, par écrit, les renseignements et pièces suivants : a) la marque nominative de la drogue nouvelle ou le nom ou code d’identification projeté pour celle-ci; b) les objectifs et le protocole du projet d’étude expérimentale de la drogue nouvelle; c) l’espèce, le nombre et le type de production des animaux auxquels la nouvelle drogue doit être administrée; d) le nom et l’adresse du fabricant de la drogue nouvelle; e) l’adresse de l’établissement où l’étude expérimentale doit être effectuée; f) une description des installations devant servir à l’étude expérimentale; g) le nom, l’adresse et les qualifications de l’expert en études expérimentales proposé; SOR/81-333, s. 1; SOR/93-202, s. 28; SOR/2018-69, s. 27. SOR/81-333, s. 1; SOR/2018-69, ss. 25, 27; SOR/2022-197, s. 9; SOR/2023-247, s. 6. Labelling (d) the name and address of the manufacturer of the drug; and SOR/81-333, s. 1; SOR/88-378, s. 2; SOR/93-202, s. 29. Conditions of Experimental Study

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08.017 An experimental studies investigator shall (d) return to the manufacturer, on request, all quantities of the new drug not used in the experimental study;

(2)

Lorsque, à la réception des renseignements et pièces fournis aux termes de l’article C.08.014, le ministre conclut que les exigences des alinéas (1)a), b) et c) n’ont pas été satisfaites, il refuse de délivrer le certificat d’études expérimentales. DORS/81-333, art. 1; DORS/2018-69, art. 25 et 27; DORS/2022-197, art. 9; DORS/2023-247, art. 6. Étiquetage

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08.016 (1) L’étiquette d’une drogue nouvelle, vendue selon l’article C.08.013, doit porter : a) la marque nominative de la drogue nouvelle ou le nom ou code d’identification projeté pour celle-ci; b) une mise en garde indiquant que ladite drogue ne doit être utilisée que pour les études expérimentales effectuées sur les animaux; c) le numéro de lot; d) le nom et l’adresse du fabricant; et e) le nom de la personne à qui la drogue a été fournie.

(2)

Les articles C.01.004, C.01.005 et C.01.014 ne s’appliquent pas à une drogue qui est vendue selon l’article C.08.013 et étiquetée conformément au paragraphe (1). DORS/81-333, art. 1; DORS/88-378, art. 2; DORS/93-202, art. 29. Conditions applicables aux études expérimentales

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08.017 Un expert en études expérimentales doit a) utiliser la drogue nouvelle conformément au protocole de l’étude expérimentale; b) signaler immédiatement au ministre toute réaction indésirable grave liée à l’utilisation de la drogue nouvelle; c) communiquer rapidement au ministre, sur demande, les résultats de l’étude expérimentale; d) retourner au fabricant, sur demande, toute quantité de la drogue nouvelle non utilisée dans l’étude expérimentale; e) conserver tous les dossiers de l’étude expérimentale pendant au moins deux ans suivant la fin de l’étude et, sur demande, les mettre à la disposition du ministre; f) signaler rapidement au ministre tout cas où l’on dispose, contrairement aux termes de l’engagement SOR/81-333, s. 1; SOR/2001-203, s. 10; SOR/2018-69, s. 27. Suspension or Cancellation of Experimental Studies Certificate SOR/81-333, s. 1; SOR/2018-69, ss. 26, 27. DIVISION 9 Non-prescription Drugs mentionné au paragraphe C.08.014(2), d’animaux servant d’une manière quelconque dans une étude expérimentale, ou de leurs produits; et g) rendre compte au ministre, sur demande, de toutes les quantités de la drogue nouvelle qu’il aura reçues. DORS/81-333, art. 1; DORS/2001-203, art. 10; DORS/2018-69, art. 27. Suspension ou annulation du certificat d’études expérimentales

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08.018 (1) Lorsque le ministre conclut qu’il est nécessaire de sauvegarder la santé de l’animal ou la santé publique ou d’assurer la sécurité publique, il peut suspendre un certificat d’études expérimentales pour une période définie ou indéfinie, ou encore l’annuler.

(2)

Sans restreindre la portée générale du paragraphe (1), le ministre peut suspendre ou annuler un certificat d’études expérimentales si a) les renseignements et pièces soumis selon l’article C.08.014 comportent une fausse déclaration ou une omission concernant les propriétés de la drogue nouvelle, que celles-ci étaient connues ou auraient dû l’être, soit du fabricant ou de l’expert en études expérimentales; b) l’étiquetage de la drogue nouvelle est, à n’importe quel moment, faux, mensonger, trompeur ou incomplet; c) l’expert en études expérimentales n’a pas les qualifications voulues; d) il existe des preuves que l’expert en études expérimentales n’a pas satisfait aux conditions mentionnées à l’article C.08.017; ou e) une activité du fabricant, relative à la drogue nouvelle, a entraîné la condamnation dudit fabricant pour infraction à l’article C.08.002. DORS/81-333, art. 1; DORS/2018-69, art. 26 et 27.

TITRE 9

Médicaments vendus sans ordonnance

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09.001 Le présent titre ne s’applique pas a) à une drogue qui doit être vendue sur ordonnance aux termes du présent règlement ou du Règlement sur les stupéfiants; Analgesics SOR/84-145, s. 4. SOR/84-145, s. 4; SOR/86-589, s. 1. SOR/84-145, s. 4. Acetaminophen

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09.020 (1) The adult standard dosage unit of acetaminophen shall be 325 mg.

(2)

The children’s standard dosage units of acetaminophen shall be 80 mg or 160 mg. SOR/84-145, s. 4; SOR/90-857, s. 4.

(3)

[Repealed, SOR/90-587, s. 5]

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09.022 (1) Subject to subsections (2) to (4), an acetaminophen product sold in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of acetaminophen per individual dosage form. Salicylates

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09.030 (1) The adult standard dosage unit of a salicylate shall be

(2)

The children’s standard dosage unit of a salicylate shall be SOR/84-145, s. 4. (d) a salt or derivative of salicylic acid in combination with caffeine and one or more buffering agents or antacids. SOR/84-145, s. 4; SOR/85-96, s. 5(E).

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09.032 (1) Subject to subsections (2) and (3) and section C.09.035, a salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of a salicylate per individual dosage form. (a) 500 mg of acetylsalicylic acid, sodium salicylate or magnesium salicylate, or (b) 670 mg of choline salicylate SOR/84-145, s. 4; SOR/85-966, s. 6.

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09.033 (1) Subject to subsection (2), a salicylate product in the form of a liquid shall contain one adult standard dosage unit of a salicylate per teaspoon. SOR/84-145, s. 4. SOR/84-145, s. 4. SOR/84-145, s. 4. DIVISION 10 Access to Drugs in Exceptional Circumstances foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction. (autorité réglementaire étrangère) (d) the Chief Medical Officer of Public Health for the Department of Indigenous Services. (responsable de la santé publique) (ii) the intended use or purpose of the drug; (i) brand name, (ii) medicinal ingredients, (iii) dosage form, (iv) strength, (b) section C.02.006; (c) subsection C.02.012(1); (d) sections C.02.013 and C.02.014; b) la vente de la drogue est autorisée par une autorité réglementaire étrangère relevant des États-Unis, de la Suisse ou de l’Union européenne pour être utilisée pour le même usage ou aux mêmes fins que ceux visés au sous-alinéa a)(ii); c) la drogue fait partie de la même catégorie que celle visée par la licence; d) la drogue est importée directement du pays dans lequel sa vente a été autorisée par l’autorité réglementaire étrangère en cause; e) les renseignements ci-après concernant la drogue figurent dans la Liste des drogues utilisées pour des besoins urgents en matière de santé publique, publiée par le gouvernement du Canada sur son site Web, avec ses modifications successives : (i) la marque nominative, (ii) les ingrédients médicinaux, (iii) la forme posologique, (iv) la concentration, (v) la voie d’administration, (vi) tout code ou numéro d’identification qui lui est attribué dans le pays où sa vente a été autorisée.

(3)

Les articles C.01A.006 et C.01A.007 ne s’appliquent pas à l’égard de l’importation d’une drogue effectuée en vertu du paragraphe (2).

(4)

Il est entendu que, malgré le paragraphe C.01A.004(1), le titulaire peut importer une drogue en vertu du paragraphe (2) sans avoir fait modifier sa licence au titre de l’article C.01A.006.

(5)

Les titres 2 à 4, à l’exception des dispositions ci-après, ne s’appliquent pas à l’égard de l’importation d’une drogue effectuée en vertu du paragraphe (2) : a) les articles C.02.003.1 et C.02.004 en ce qui a trait à l’entreposage de la drogue par le titulaire; b) l’article C.02.006; c) le paragraphe C.02.012(1); d) les articles C.02.013 et C.02.014; PART C Drugs DIVISION 10 Access to Drugs in Exceptional Circumstances Sections C.10.001-C.10.002 (g) subsection C.02.022(1); (h) section C.02.023; (i) subsections C.02.024(1) and C.02.025(1); (j) section C.03.013; and SOR/2017-133, s. 2; SOR/2023-18, s. 2. (c) subsection C.02.012(1); (d) section C.02.013; (f) subsection C.02.022(1); (f.1) [Repealed, SOR/2023-247, s. 7] (g) section C.02.023; and (h) subsection C.02.024(1). SOR/2017-133, s. 2; SOR/2022-197, s. 10; SOR/2023-247, s. 7. (b) the brand name of the drug; (e) the total quantity of the drug imported. SOR/2017-133, s. 2; SOR/2023-18, s. 3. (b) prescription drugs; foreign regulatory authority has the same meaning as in subsection C.10.001(1). (autorité réglementaire étrangère) SOR/2021-199, s. 5. SOR/2021-199, s. 5. (i) the licensee’s name and contact information, (i) the licensee’s name, (ii) the information referred to in clauses (a)(iii)(A) to (F), (f) the total quantity of the designated drug that the licensee imports does not exceed the maximum limit specified in the list referred to in paragraph (d) in respect of the drug, if applicable; (a) a Saturday; or (G) une description détaillée de son mode d’emploi, (iv) le point d’entrée prévu au Canada, (v) la date d’arrivée prévue de la cargaison de la drogue désignée, (vi) la quantité totale de la drogue désignée devant être importée à la date visée au sous-alinéa (v); b) la vente de la drogue désignée est autorisée par une autorité réglementaire étrangère dans l’exercice de sa compétence; c) la drogue désignée appartient à la même catégorie de drogues que celle pour laquelle la licence d’établissement a été délivrée; d) les renseignements ci-après concernant la drogue désignée figurent sur la Liste des drogues destinées aux importations et ventes exceptionnelles : (i) le nom du titulaire, (ii) les renseignements visés aux divisions a)(iii)(A) à (F), (iii) le nom de l’autorité réglementaire étrangère visée à l’alinéa b), (iv) la date après laquelle elle ne peut plus être importée; e) le numéro de lot de la drogue désignée figure sur la liste visée à l’alinéa d), le cas échéant; f) la quantité totale de la drogue désignée que le titulaire importe n’excède pas la limite maximale figurant sur la liste visée à l’alinéa d) à l’égard de cette drogue, le cas échéant; g) la drogue désignée est importée à la date visée au sous-alinéa d)(iv) ou avant cette date; h) le titulaire a établi un plan qui prévoit les mesures envisagées pour se conformer aux exigences de l’article C.10.011.

(2)

Au paragraphe (1), jour ouvrable désigne un jour autre que : a) le samedi; SOR/2021-199, s. 5. (a) sections A.01.015, A.01.017 and A.01.051; and (i) sections C.01.016, C.01.017, C.01.019 to C.01.020.1, C.01.040.3 to C.01.049.1 and C.01.051, (iii) this section and sections C.10.009 to C.10.011. SOR/2021-199, s. 5. SOR/2021-199, s. 5.

(2)

The Minister may request that the licensee provide to the Minister any of the records referred to in paragraphs C.02.020(1)(a), (b) or (d) in respect of the designated drug. SOR/2021-199, s. 5. SOR/2021-199, s. 5. DIVISION 11 foreign regulatory authority has the same meaning as in subsection C.10.001(1). (autorité réglementaire étrangère) initial public health official means the public health official named in an authorization issued under subsection C.11.003(1). (responsable de la santé publique initial) (d) the Surgeon General of the Canadian Armed Forces; or (e) the Chief Medical Officer of Public Health for the Department of Indigenous Services. (responsable de la santé publique)

C

10.011 (1) Le titulaire d’une licence d’établissement ne peut vendre une drogue désignée qu’il a importée en vertu de l’article C.10.006 à moins de veiller à ce que les renseignements visés à la division C.10.006(1)a)(iii)(G) soient disponibles en français et en anglais de façon à permettre l’utilisation sécuritaire de la drogue.

(2)

Le titulaire veille à ce que les renseignements soient disponibles conformément au paragraphe (1) au moins jusqu’à la fin de la journée à la date limite d’utilisation la plus tardive attribuée à la drogue désignée qu’il a importée. DORS/2021-199, art. 5.

TITRE 11

Urgences en matière de santé touchant le public ou les Forces armées canadiennes — usage immédiat ou mise en réserve de drogues

C

11.001 (1) Les définitions qui suivent s’appliquent au présent titre. autorité réglementaire étrangère S’entend au sens du paragraphe C.10.001(1). (foreign regulatory authority) responsable de la santé publique L’une des personnes suivantes : a) l’administrateur en chef de la santé publique nommé en application du paragraphe 6(1) de la Loi sur l’Agence de la santé publique du Canada; b) le médecin hygiéniste en chef d’une province ou toute personne exerçant une fonction équivalente; c) le médecin hygiéniste d’une municipalité ou toute personne exerçant une fonction équivalente; d) le médecin général des Forces armées canadiennes; e) le médecin en chef de la santé publique du ministère des Services aux Autochtones. (public health official) responsable de la santé publique initial Le responsable de la santé publique nommé dans l’autorisation délivrée en vertu du paragraphe C.11.003(1). (initial public health official) subsequent public health official means any public health official, other than the initial public health official, who obtains the quantity of a drug, or a portion of the quantity, that is specified in an authorization issued under subsection C.11.003(1). (responsable de la santé publique subséquent) SOR/2023-188, s. 4. (d) state whether the drug is for immediate use or stockpiling or both; (ii) its medicinal ingredients, (h) specify the quantity of the drug required to address the emergency, event or incident; (iii) sa concentration, (iv) sa forme posologique, (v) la posologie recommandée pour l’usage précisé en application de l’alinéa e), (vi) la voie d’administration recommandée, (vii) les indications approuvées par toute autorité réglementaire étrangère, le cas échéant, (viii) toute contre-indication, (ix) le résumé de son profil d’innocuité, (x) les conditions d’entreposage recommandées; h) une mention indiquant la quantité de drogue requise pour parer à l’urgence, à l’événement ou à l’incident; i) une déclaration du responsable de la santé publique, avec renseignements et documents à l’appui, attestant les faits suivants : (i) il existe une urgence, un événement ou un incident réels, imminents ou éventuels en matière de santé publique ou touchant la santé des membres des Forces armées canadiennes qui est vraisemblablement cause chez l’humain ou malaise, un désordre ou un état physique anormal grave ou mettant la vie en danger, (ii) une mesure immédiate est requise — ou risque vraisemblablement de l’être, — pour diagnostiquer, traiter, atténuer ou prévenir la maladie, le désordre ou l’état physique anormal ou leurs symptômes, (iii) les traitements conventionnels, le cas échéant, ont échoué, ne conviennent pas ou ne sont pas disponibles au Canada au moment où la demande est présentée, (iv) les bénéfices connus et potentiels liés à l’usage précisé en application de l’alinéa e) l’emportent sur les risques connus et potentiels liés à cet usage; j) tout renseignement ou document dont dispose le responsable de la santé publique concernant l’innocuité, l’efficacité et la qualité de la drogue au regard de l’usage précisé en application de l’alinéa e), notamment tout renseignement publié dans une revue médicale ou scientifique; k) les renseignements ci-après, s’ils sont connus du responsable de la santé publique : SOR/2023-18, s. 4. (a) set out the date of issue; (d) describe the emergency, event or incident;

C

11.003 (1) Le ministre peut, au terme de l’examen de la demande, délivrer au fabricant une autorisation permettant à celui-ci de vendre au responsable de la santé publique une quantité déterminée de la drogue pour les usages précisés dans la demande.

(2)

Lors de l’examen de la demande, le ministre tient compte de l’existence d’un autre mécanisme pour parer à l’urgence, à l’événement ou à l’incident.

(3)

L’autorisation contient les renseignements suivants : a) la date de délivrance; b) les nom et coordonnées du responsable de la santé publique; c) les nom et coordonnées du fabricant; d) une description de l’urgence, de l’événement ou de l’incident; e) une mention indiquant si la drogue est requise pour usage immédiat, mise en réserve ou les deux; f) une description de l’usage pour lequel la vente de la drogue est autorisée pour parer à l’urgence, à l’événement ou à l’incident; (ii) its medicinal ingredients, (i) specify the quantity of the drug that may be sold. SOR/2023-18, s. 4. SOR/2023-18, s. 4. SOR/2023-18, s. 4. (a) the name and civic address of the drug’s manufacturer; (d) the drug’s brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark; (e) the drug’s medicinal ingredients; (f) the drug’s strength; (g) the drug’s dosage form; (b) to the persons who administer the drug, the information referred to in paragraphs C.11.002(2)(a), (b) and (e) and subparagraphs C.11.002(2)(g)(v), (vii) and (viii), if that information is not set out on the drug’s label or accompanying document. SOR/2023-18, s. 4. SOR/2023-18, s. 4. SOR/2023-18, s. 4. SOR/2023-18, s. 4. SOR/2023-18, s. 4. SOR/2023-18, s. 4. PART D

D

01.001 (1) In this Part, advertise means to advertise to the general public; (faire de la publicité) (nom usuel) recommended daily intake [Repealed, SOR/2016-305, s. 61] supplemental ingredient has the same meaning as in section B.01.001; (ingrédient supplémentaire) supplemented food facts table has the same meaning as in subsection B.01.001(1); (tableau des renseignements sur les aliments supplémentés) Table of Daily Values has the same meaning as in subsection B.01.001(1); (Tableau des valeurs quotidiennes) Table of Reference Amounts has the same meaning as in subsection B.01.001(1); (Tableau des quantités de référence) weighted recommended nutrient intake means, in respect of a vitamin or mineral nutrient, the amount of the vitamin or mineral nutrient set out in Table II to Division 1 and Table II to Division 2. (apport nutritionnel recommandé pondéré) fabricant, d’une personne morale, d’une société de personnes ou d’un particulier : a) qui lui a été attribué par le fabricant; b) sous lequel elle est vendue ou fait l’objet de publicité; c) qui sert à l’identifier; (brand name) nom usuel Dans le cas d’un sel ou d’un dérivé d’une vitamine, le nom en français ou en anglais sous lequel il est : a) généralement connu; b) désigné dans des revues scientifiques ou techniques; (common name) produit préemballé désigne un aliment contenu dans un emballage qui est celui dans lequel l’aliment est normalement vendu, utilisé ou acheté; (prepackaged product) ration quotidienne normale, lorsqu’il s’agit d’une substance alimentaire dont le nom ne figure pas à la colonne I de l’annexe K, s’entend de la quantité de cette substance alimentaire précisée à la colonne II en regard de cet article; (reasonable daily intake) succédané de lait humain S’entend au sens de l’article B.25.001; (human milk substitute) Tableau des quantités de référence S’entend au sens du paragraphe B.01.001(1); (Table of Reference Amounts) tableau des renseignements sur les aliments supplémentés S’entend au sens du paragraphe B.01.001(1); (supplemented food facts table) Tableau des valeurs quotidiennes S’entend au sens du paragraphe B.01.001(1); (Table of Daily Values) témoignage, lorsqu’il s’agit d’un aliment ou d’une drogue présentée comme contenant une vitamine, un minéral nutritif ou un minéral, signifie toute représentation, présentée de façon dramatique ou non, sous forme picturale, écrite ou orale, quant à l’effet que produit, a produit ou peut produire l’addition, au régime alimentaire d’une personne, de cette vitamine, de ce minéral nutritif ou de ce minéral, selon le cas. (testimonial)

(2)

Pour l’application de la présente partie, la portion indiquée d’un aliment est : SOR/88-559, s. 31; SOR/93-202, s. 31; SOR/96-259, s. 2; SOR/2003-11, s. 27; SOR/2016-305, s. 61; SOR/2021-57, s. 17; SOR/2022-169, s. 17.

D

01.001.1 (1) The daily value of a vitamin or mineral nutrient set out in column 1 of Part 2 of the Table of Daily Values is, in respect of a food, the quantity a) établie en fonction de l’aliment tel qu’il est vendu; b) dans l’un ou l’autre des cas ci-après, la quantité nette de l’aliment dans l’emballage lorsque : (i) cette quantité peut être raisonnablement consommée par une personne en une seule fois, (ii) l’emballage contient moins de 200 % de la quantité de référence de l’aliment; c) dans les autres cas, la quantité établie selon les critères énoncés à la colonne 3A du Tableau des quantités de référence pour cet aliment.

(3)

La portion indiquée d’un aliment est exprimée de la façon suivante : a) dans le cas d’un produit préemballé à portion individuelle auquel l’alinéa (2)(b) s’applique, par emballage et selon les unités suivantes : (i) en grammes, lorsque la quantité nette de l’aliment est mentionnée en poids ou en nombre sur l’étiquette, (ii) en millilitres, lorsque la quantité nette de l’aliment est mentionnée en volume sur l’étiquette; b) dans le cas d’un produit préemballé à portions multiples auquel l’alinéa (2)(c) s’applique, selon les unités ci-après indiquées à la colonne 3B du Tableau des quantités de référence et de la manière dont elles y sont présentées : (i) la mesure domestique applicable au produit, (ii) la mesure métrique applicable au produit. DORS/88-559, art. 31; DORS/93-202, art. 31; DORS/96-259, art. 2; DORS/2003-11, art. 27; DORS/2016-305, art. 61; DORS/2021-57, art. 17; DORS/2022-169, art. 17.

D

01.001.1 (1) La valeur quotidienne d’une vitamine ou d’un minéral nutritif figurant à la colonne 1 de la partie 2 du Tableau des valeurs quotidiennes est, à l’égard d’un aliment, la quantité de vitamine ou de minéral nutritif figurant : a) à la colonne 2, dans le cas d’un aliment destiné exclusivement aux bébés âgés d’au moins six mois mais de moins d’un an; b) à la colonne 3, dans le cas d’un aliment destiné aux bébés âgés d’au moins six mois mais de moins d’un an ou aux enfants âgés d’au moins un an mais de moins de quatre ans; c) à la colonne 4, dans les autres cas. (a) a human milk fortifier; or SOR/2016-305, s. 62; SOR/2021-57, s. 18.

D

01.001.2 If both a nutrition symbol, as defined in subsection B.01.001(1), and a statement or claim referred to in any of sections D.01.004 to D.01.007 and D.02.002 to D.02.005 appear on the principal display panel of a prepackaged product, SOR/2022-168, s. 45. DIVISION 1 (a) vitamin A; (b) vitamin D; (c) vitamin E; (d) vitamin K; (e) vitamin C; (f) thiamin, thiamine or vitamin B₁; (g) riboflavin or vitamin B₂; (h) niacin; (i) vitamin B₆; (j) folacin or folate; k) vitamin B12; l) pantothenic acid or pantothenate; m) biotin; and n) choline. (vitamine) SOR/88-559, s. 32; SOR/2003-11, s. 28; SOR/2016-305, s. 63. (ii) 1 RAE = 12 micrograms of beta-carotene; (ii) one milligram dl-alpha-tocopherol = 0.74 milligram vitamin E; (d) in the case of vitamin K, in terms of the content of phylloquinone and menaquinones, expressed in micrograms; SOR/88-559, s. 32; SOR/90-830, s. 7; SOR/2016-305, s. 64; SOR/2021-57, s. 19; SOR/2022-197, s. 11. une source ou d’une source autre que le lait, la viande, la volaille, le poisson ou les œufs; b) 1,3 pour cent des protéines, lorsque celles-ci proviennent du lait, de la viande, de la volaille ou du poisson; c) 1,5 pour cent des protéines, lorsque celles-ci proviennent des œufs. DORS/88-559, art. 32; DORS/90-830, art. 7; DORS/2016-305, art. 64; DORS/2021-57, art. 19; DORS/2022-197, art. 11.

D

01.004 (1) Il est interdit, sur l’étiquette ou dans l’annonce d’un aliment, autre qu’une préparation pour régime liquide, un fortifiant pour lait humain, un succédané de lait humain ou un aliment présenté comme contenant un succédané de lait humain, toute mention ou allégation relative à sa teneur en vitamine, à moins que les conditions suivantes ne soient réunies : a) il s’agit d’une vitamine figurant à la colonne 1 de la partie 2 du Tableau des valeurs quotidiennes; b) le pourcentage de la valeur quotidienne pour cette vitamine, par portion indiquée, est de 5 % ou plus; c) la teneur en vitamine est indiquée, sur l’étiquette ou dans l’annonce, en pourcentage de la valeur quotidienne, par portion indiquée. (1.1) La condition visée à l’alinéa (1)c) n’a pas à être remplie si la mention ou l’allégation visée au paragraphe (1) est faite sur l’étiquette ou dans l’annonce d’un légume frais, d’un fruit frais ou d’un mélange quelconque de légumes frais ou de fruits frais sans ingrédient ajouté, d’une orange à laquelle un colorant alimentaire a été ajouté et d’un légume frais ou d’un fruit frais enrobé d’huile minérale, de paraffine, de vaseline ou de tout autre enduit protecteur.

(2)

Si la mention ou l’allégation visée au paragraphe (1) est faite dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé faite par une personne autre que le fabricant du produit ou en son nom, le pourcentage de la valeur quotidienne, par portion indiquée, répond aux critères suivants : a) dans le cas d’une annonce autre qu’une annonce radiophonique ou télévisée : (i) d’une part, il précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation lorsqu’elle est faite une seule fois, ou la mention ou l’allégation est répétée, celle qui est la plus en évidence, SOR/84-300, s. 2; SOR/88-159, s. 32; SOR/90-830, s. 8; SOR/96-259, s. 9; SOR/ 2003-11, s. 29; SOR/2016-305, ss. 65, 66; SOR/2021-57, s. 2; SOR/2022-169, s. 23.

D

01.005 [Repealed, SOR/2003-11, s. 29] (ii) d’autre part, il figure en caractères d’une taille au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence; b) dans le cas d’une annonce radiophonique ou de la composante audio d’une annonce télévisée, il précède ou suit immédiatement la mention ou l’allégation; c) dans le cas d’une annonce télévisée, il est communiqué : (i) en mode audio, si la mention ou l’allégation fait partie uniquement de la composante audio de l’annonce ou, à la fois, des composantes audio et visuelle de celle-ci, (ii) en mode audio ou en mode visuel, si la mention ou l’allégation fait partie uniquement de la composante visuelle de l’annonce.

(3)

Le pourcentage de la valeur quotidienne, par portion indiquée, qui est communiqué en mode visuel dans une annonce télévisée conformément au sous-alinéa (2)c)(ii), à la fois : a) paraît en même temps et pendant au moins la même durée que la mention ou l’allégation; b) précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence; c) figure en caractères d’une taille qui est au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence.

(4)

L’alinéa (1)b) ne s’applique pas à l’indication de la teneur en une vitamine dans tout tableau de la valeur nutritive ou tout tableau des renseignements sur les aliments supplémentés.

(5)

L’alinéa (1)c) ne s’applique pas à l’indication de la teneur en biotine exigée par le sous-alinéa B.24.202a)(vi). DORS/84-300, art. 2; DORS/88-159, art. 32; DORS/90-830, art. 8; DORS/96-259, art. 9; DORS/2003-11, art. 29; DORS/2016-305, art. 65 et 66; DORS/2021-57, art. 2; DORS/2022-169, art. 23.

D

01.005 [Abrogé, DORS/2003-11, art. 29]

D

01.006 Est interdite sur l’étiquette ou dans les annonces d’un aliment toute allégation concernant l’action SOR/88-559, s. 32. (b) all components of the ingredient are declared. SOR/88-559, s. 32; SOR/2003-11, s. 30; SOR/2011-28, s. 7; SOR/2016-305, s. 66.

D

01.008 (1) Sections D.01.009, D.01.010 and D.01.011 do not apply to a human milk fortifier.

(2)

Sections D.01.009 and D.01.011 do not apply to a supplemented food. SOR/2021-57, s. 21; SOR/2022-169, s. 24. (a) in the case of vitamin A, 1,600 International Units; (b) in the case of thiamine, 0.6 milligram; (d) in the case of niacin or niacinamide, six milligrams; ou les effets d’une vitamine que contient l’aliment, sauf celle indiquant que la vitamine : a) contribue au maintien de la santé; b) est généralement reconnue comme aidant à entretenir les fonctions de l’organisme nécessaires au maintien de la santé et à la croissance et au développement normaux. DORS/88-559, art. 32.

D

01.007 (1) Si un constituant d’un ingrédient d’un produit préemballé mentionné au tableau du paragraphe B.01.009(1) est une vitamine, il est interdit, sur l’étiquette ou dans l’annonce de ce produit préemballé, toute mention ou allégation selon laquelle la vitamine est un constituant de cet ingrédient, à moins que les conditions suivantes soient remplies : a) malgré le paragraphe B.01.008.2(6), la vitamine est désignée par son nom usuel, lequel figure entre parenthèses immédiatement après l’ingrédient dont elle est un constituant, cependant, dans le cas où, en application de l’alinéa B.01.010.1(8)a), la source d’un allergène alimentaire ou de gluten doit figurer immédiatement après cet ingrédient, le nom usuel de la vitamine doit plutôt figurer immédiatement après cette source; b) tous les constituants de l’ingrédient sont indiqués.

(2)

L’alinéa (1)b) ne s’applique pas à la farine utilisée comme ingrédient dans la fabrication de tout produit préemballé visé au paragraphe (1). DORS/88-559, art. 32; DORS/2003-11, art. 30; DORS/2011-28, art. 7; DORS/2016-305, art. 66.

D

01.008 (1) Les articles D.01.009, D.01.010 et D.01.011 ne s’appliquent pas aux fortifiants pour lait humain.

(2)

Les articles D.01.009 et D.01.011 ne s’appliquent pas aux aliments supplémentés. DORS/2021-57, art. 21; DORS/2022-169, art. 24.

D

01.009 Sous réserve de l’article D.01.010, il est interdit de vendre un aliment auquel l’une des vitamines ci-après a été ajoutée, à moins qu’une ration quotidienne normale de cet aliment entraîne une prise quotidienne normale de cette vitamine d’une quantité d’au moins les suivantes : a) dans le cas de la vitamine A, au moins 1 600 unités internationales; b) dans le cas de la thiamine, au moins 0,6 milligramme; c) dans le cas de la riboflavine, au moins un milligramme; SOR/2022-168, s. 46. (a) in the case of vitamin A, 1,000 International Units; (d) in the case of niacin or niacinamide, four milligrams; (e) in the case of pyridoxine, 0.6 milligram; (f) in the case of ascorbic acid, 20 milligrams; (h) in the case of vitamin E, five International Units. SOR/2022-168, s. 47. (a) in the case of vitamin A, 2,500 International Units; (d) in the case of niacin or niacinamide, 20 milligrams; (e) in the case of pyridoxine, 1.5 milligrams; (f) in the case of ascorbic acid, 60 milligrams; (h) in the case of vitamin E, 15 International Units. SOR/2022-168, s. 48.

D

01.011.1 Sections D.01.009, D.01.010 and D.01.011 do not apply in respect of vitamin D in SOR/2022-168, s. 49.

D

01.013 [Repealed, SOR/2003-11, s. 31] TABLE I [Repealed, SOR/2016-305, s. 67] TABLE II Weighted Recommended Nutrient Intake | Item | Column I Vitamin | Column II Units | Column III Amount | |------|------------------|-----------------|-------------------| | 1 | Biotin | micrograms | 90 | | 2 | Folacin | micrograms | 195 | | 3 | Niacin | niacin equivalents | 16 | Sections D.01.013-D.02.001 Column I | Column II | Column III 4 | Pantothenic Acid | milligrams | 5.0 5 | Riboflavin | milligrams | 1.2 6 | Thiamine | milligrams | 1.0 7 | Vitamin A | retinol equivalents | 870 8 | Vitamin B₆ | milligrams | 1.0 9 | Vitamin B₁₂ | micrograms | 1.0 10 | Vitamin C | milligrams | 34 11 | Vitamin D | micrograms | 3.0 12 | Vitamin E | milligrams | 7.0 TABLEAU II Apport nutritionnel recommandé pondéré Colonne I | Colonne II | Colonne III

Article | Vitamine | Unités | Quantité

1 | Biotine | microgrammes | 90 2 | Folacine | microgrammes | 195 3 | Niacine | équivalents de niacine | 16 4 | Acide pantothénique | milligrammes | 5,0 5 | Riboflavine | milligrammes | 1,2 6 | Thiamine | milligrammes | 1,0 7 | Vitamine A | équivalents de rétinol | 870 8 | Vitamine B₆ | milligrammes | 1,0 9 | Vitamine B₁₂ | microgrammes | 1,0 10 | Vitamine C | milligrammes | 34 11 | Vitamine D | microgrammes | 3,0 12 | Vitamine E | milligrammes | 7,0 SOR/96-259, s. 5. DIVISION 2

TITRE 2

Minéraux nutritifs dans les aliments

D

02.001 (1) Dans le présent titre, minéral nutritif désigne l’un des éléments chimiques suivants, soit seul, soit (a) sodium; (b) potassium; (c) calcium; (d) phosphorus; (e) magnesium; (f) iron; (g) zinc; (h) iodide; (i) chloride; (j) copper; (k) fluoride; (l) manganese; (m) chromium; (n) selenium; (o) cobalt; (p) molybdenum; (q) tin; (r) vanadium; (s) silicon; and SOR/88-559, s. 34; SOR/90-830, s. 9(F). en combinaison avec un ou plusieurs autres éléments chimiques : a) sodium; b) potassium; c) calcium; d) phosphore; e) magnésium; f) fer; g) zinc; h) iode; i) chlore; j) cuivre; k) fluor; l) manganèse; m) chrome; n) sélénium; o) cobalt; p) molybdène; q) étain; r) vanadium; s) silicium; t) nickel. (minéral nutritif)

(2)

Le présent titre ne s’applique qu’aux aliments présentés comme contenant un minéral nutritif destiné à être utilisé dans l’alimentation humaine. DORS/88-559, art. 34; DORS/90-830, art. 9(F).

D

02.002 (1) Est interdite, sur l’étiquette ou dans l’annonce d’un aliment, autre que du sel de table ou d’usage domestique général contenant de l’iodure ajouté, de l’eau ou de la glace préemballées, une préparation pour régime liquide, un fortifiant pour lait humain, un succédané de lait humain ou un aliment présenté comme contenant un succédané de lait humain, toute mention ou allégation relative à sa teneur en un minéral nutritif, à moins que les conditions suivantes ne soient réunies : a) il s’agit d’un minéral nutritif figurant à la colonne 1 de la partie 2 du Tableau des valeurs quotidiennes; b) le pourcentage de la valeur quotidienne pour ce minéral nutritif, par portion indiquée, est de 5 % ou plus; c) la teneur en ce minéral nutritif est indiquée, sur l’étiquette ou dans l’annonce, en pourcentage de la valeur quotidienne, par portion indiquée. (1.1) La condition visée à l’alinéa (1)c) n’a pas à être remplie si la mention ou l’allégation visée au paragraphe (1) est faite sur l’étiquette ou dans une annonce d’un légume frais, d’un fruit frais ou d’un mélange quelconque de légumes frais ou de fruits frais sans ingrédient ajouté, d’une orange à laquelle un colorant alimentaire a été ajouté et d’un légume frais ou d’un fruit frais enrobé d’huile minérale, de paraffine, de vaseline ou de tout autre enduit protecteur.

(2)

Si la mention ou l’allégation visée au paragraphe (1) est faite dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres, le pourcentage de la valeur quotidienne, par portion indiquée, répond aux critères suivants : a) dans le cas d’une annonce autre qu’une annonce radiophonique ou télévisée : (i) d’une part, il précède ou suit, sans qu’aucun texte imprimé, écrit ou image graphique ne soit intercalé, la mention ou l’allégation apparaissant qu’une seule fois, ou si la mention ou l’allégation est répétée, celle qui est la plus en évidence, (ii) d’autre part, il figure en caractères d’une taille au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, ceux de celle qui est la plus en évidence; b) dans le cas d’une annonce radiophonique ou de la composante audio d’une annonce télévisée, il précède ou suit immédiatement la mention ou l’allégation; c) dans le cas d’une annonce télévisée, il est communiqué : (i) en mode audio, si la mention ou l’allégation fait partie uniquement de la composante audio de l’annonce ou, à la fois, des composantes audio et visuelle de celle-ci, SOR/84-300, s. 60; SOR/88-559, s. 34; SOR/90-830, s. 10; SOR/96-259, s. 9; SOR/2003-11, s. 34; SOR/2016-305, ss. 68, 69; SOR/2017-15, s. 27; SOR/2022-169, s. 25.

D

02.003 [Repealed, SOR/2003-11, s. 34] SOR/84-300, s. 61(E); SOR/88-559, s. 34.

(3)

Le pourcentage de la valeur quotidienne, par portion indiquée, qui est communiqué en mode visuel dans une annonce télévisée conformément au sous-alinéa (2)c)(ii), à la fois : a) paraît en même temps et pendant au moins le même durée que la mention ou l’allégation; b) précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois, ou si la mention ou l’allégation est répétée, celle qui est la plus en évidence; c) figure en caractères d’une taille qui est au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, de ceux de celle qui est la plus en évidence.

(4)

Le paragraphe (1) ne s’applique pas aux mentions ou allégations relatives à la teneur en sodium ou en potassium.

(5)

Les alinéas (1)a) et c) ne s’appliquent pas à l’indication de la teneur totale en ion fluorure exigée par les articles B.12.002 et B.12.008.

(6)

L’alinéa (1)b) ne s’applique pas à l’indication de la teneur en un minéral nutritif dans toute tableau de la valeur nutritive ou tout tableau des renseignements sur les aliments supplémentés.

(7)

L’alinéa (1)c) ne s’applique pas à l’indication de la teneur en chrome, en cuivre, en manganèse, en molybdène et en sélénium exigée par le sous-alinéa B.24.202a)(v). DORS/84-300, art. 61A; DORS/88-559, art. 34; DORS/96-259, art. 9; DORS/2003-11, art. 34; DORS/2016-305, art. 68, 69; DORS/2017-15, art. 27; DORS/2022-169, art. 25.

D

02.003 [Abrogé, DORS/2003-11, art. 34]

D

02.004 Il est interdit sur l’étiquette ou dans les annonces d’un aliment toute allégation concernant l’action ou les effets d’un minéral nutritif que contient l’aliment, sauf celle indiquant uniquement que le minéral nutritif a) contribue au maintien de la santé; b) est généralement reconnu comme aidant à entretenir les fonctions de l’organisme nécessaires au maintien de la santé et à la croissance et au développement normaux. DORS/84-300, art. 61A; DORS/88-559, art. 34. (b) all components of the ingredient are declared. SOR/88-559, s. 34; SOR/2003-11, s. 35; SOR/2011-28, s. 8; SOR/2016-305, s. 69.

D

02.006 [Repealed, SOR/2003-11, s. 35]

D

02.007 [Repealed, SOR/88-559, s. 34] (a) in the case of calcium, 300 milligrams; (d) in the case of iodine, 0.10 milligram. SOR/2021-57, s. 23; SOR/2022-168, s. 50; SOR/2022-169, s. 26. (i) Iron, Carbonyl, (ii) Iron, Electrolytic, or (iii) Iron, Reduced, SOR/84-303, s. 1. SOR/84-303, s. 1; SOR/2018-69, s. 27. TABLE I [Repealed, SOR/2016-305, s. 70] TABLE II Weighted Recommended Nutrient Intake Column I | Column II | Column III Mineral Nutrient | Units | Amount 1 | Calcium | milligrams | 780 2 | Iodide | micrograms | 155 3 | Iron | milligrams | 10 4 | Phosphorus | milligrams | 885 5 | Magnesium | milligrams | 210 6 | Zinc | milligrams | 10 TABLEAU I [Abrogé, DORS/2016-305, art. 70] TABLEAU II Apport nutritionnel recommandé pondéré Colonne I | Colonne II | Colonne III Minéral nutritif | Unités | Quantité 1 | Calcium | milligrammes | 780 2 | Iode | microgrammes | 155 3 | Fer | milligrammes | 10 4 | Phosphore | milligrammes | 885 5 | Magnésium | milligrammes | 210 6 | Zinc | milligrammes | 10 SOR/96-259, s. 7. DORS/96-259, art. 7. DIVISION 3

TITRE 3

Addition de vitamines, de minéraux nutritifs ou d’acides aminés aux aliments

D

03.001 (1) Dans le présent titre, les expressions vitamine et minéral nutritif ont le même sens que dans les titres 1 et 2 respectivement. SOR/88-559, s. 35. TABLE | Column I | Column II | |---------|-----------| | Food | Vitamin, Mineral Nutrient or Amino Acid | | 1 Breakfast cereals | Thiamine, niacin, vitamin B6, folic acid, pantothenic acid, magnesium, iron and zinc. | | 3 Infant cereal products | Thiamine, riboflavin, niacin or niacinamide, calcium, phosphorus, iron, iodine. | | 5 Alimentary pastes | Thiamine, riboflavin, niacin or niacinamide, folic acid, pantothenic acid, vitamin B6, iron, magnesium | | 6 Human milk fortifiers, infant formulas and formulated liquid diets | Amino acids — alanine, arginine, aspartic acid, cystine, glutamic acid, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine; Minerals — calcium, chloride, chromium, copper, iodide, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc; Vitamins — alpha-tocopherol, biotin, choline, d-pantothenic acid, folic acid, niacin, riboflavin, thiamin, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K. | Column I Food 16 [Repealed, SOR/94-689, s. 2] 17 Table salt, table salt substitutes 20 [Repealed, SOR/90-830, s. 11] 21 Goat’s milk, goat’s milk powder Column II Vitamin, Mineral Nutrient or Amino Acid Vitamins — alpha-tocopherol, biotin, d-pantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K Minerals — calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc Vitamin A, thiamine, niacin or niacinamide, vitamin C Thiamine, riboflavin, niacin, pyridoxine, d-pantothenic acid, folic acid, vitamin B12, iron, magnesium, potassium, zinc, copper, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine. Vitamins — alpha-tocopherol, biotin, d-pantothenic acid, folic acid, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D Minerals — calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc Vitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin C, iron Vitamin D Vitamin A, vitamin D Vitamin A, vitamin D Vitamin C, vitamin D Vitamin A, vitamin C, vitamin D Vitamin C Thiamine, riboflavin, niacin, vitamin B6, folic acid, d-pantothenic acid, calcium, iron, magnesium. Iodine. Vitamin C. Vitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin B6, d-pantothenic acid, folic acid, vitamin B12, alphatocopherol, calcium, iron, zinc, potassium. Vitamin D DIVISION 3 Addition of Vitamins, Mineral Nutrients or Amino Acids to Foods

Section D.03.002

Column I Food 27 Liquid whole egg, dried whole egg, frozen whole egg, liquid yolk, dried yolk, frozen yolk, liquid egg-white, (liquid albumen), dried egg-white (dried albumen), frozen egg-white (frozen albumen), liquid whole egg mix, dried whole egg mix, frozen whole egg mix, liquid yolk mix, dried yolk mix, frozen yolk mix Column II Vitamin, Mineral Nutrient or Amino Acid Vitamins C, D, folic acid Vitamins A, C, D, folic acid Thiamine, niacin, vitamin B6, folic acid, pantothenic acid, iron Fluorine Vitamin A, Vitamin D, Vitamin E, thiamine, riboflavin, niacin, vitamin B6, folacin, vitamin B12, pantothenic acid, calcium, phosphorus, magnesium, potassium, iron, zinc TABLEAU Colonne I Aliment 1 Céréales à déjeuner 2 Nectars de fruits, boissons aux légumes, bases et mélanges pour boissons aux légumes et mélanges de jus de légumes

2.1 Boissons à arôme de fruit qui répondent aux exigences de l’article B.11.150

2.2 Bases, concentrés et mélanges pour préparer les boissons à arôme de fruit qui répondent aux exigences de l’article B.11.151

3 Produits céréaliers pour bébés 4 Margarine et autres succédanés similaires du beurre 5 Pâtes alimentaires 6 Fortifiants pour lait humain, préparations pour nourrissons et préparations pour régime liquide Colonne II Vitamine, minéral nutritif ou acide aminé Thiamine, niacine, vitamine B6, acide folique, acide pantothénique, magnésium, fer et zinc Vitamine C Vitamines C, acide folique, thiamine, fer, potassium Vitamine C, acide folique, thiamine, fer, potassium Thiamine, riboflavine, niacine ou niacinamide, calcium, phosphore, fer, iode Vitamine A, vitamine D, alphatocophérol Thiamine, riboflavine, niacine ou niacinamide, acide folique, acide pantothénique, vitamine B6, fer, magnésium Acides aminés — acide aspartique, acide glutamique, alanine, arginine, cystine, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, méthionine, phénylalanine, proline, sérine, taurine, thréonine, tryptophane, tyrosine, valine; Minéraux — calcium, chlore, chrome, cuivre, iode, fer, magnésium, manganèse, molybdène, phosphore, potassium, sélénium, sodium, zinc; Vitamines — acide folique, acide d-pantothénique, alpha-tocophérol, biotine, choline, niacine, riboflavine, thiamine, vitamine A, vitamine B6, vitamine B12, vitamine C, vitamine D, vitamine K. Colonne I Aliment

6.1 Aliments présentés comme étant conçus pour régimes à très faible teneur en énergie

7 Mélanges et bases aromatisés qu’il est recommandé d’ajouter au lait 8 Simili-produits de viande, simili-produits de volaille, allongeurs de produits de viande et allongeurs de produits de volaille 9 Substituts de repas et suppléments nutritifs

9.1 Déjeuner tout prêt, déjeuner instantané et autres aliments semblables de remplacement du déjeuner tel qu’en fait la description

10 Lait condensé, lait, poudre de lait, lait stérilisé, lait (indication de l’arôme) 11 Lait écrémé additionné de solides du lait, lait partiellement écrémé additionné de solides du lait, lait écrémé (indication de l’arôme), lait partiellement écrémé (indication de l’arôme), lait écrémé à (indication de l’arôme) additionné de solides du lait, lait partiellement écrémé à (indication de l’arôme) additionné de solides du lait, lait écrémé, lait partiellement écrémé, poudre de lait écrémé 12 Lait évaporé 13 Lait écrémé évaporé, lait écrémé concentré, lait partiellement écrémé évaporé, lait partiellement écrémé concentré 14 Jus de pomme, jus de pomme reconstitué, jus de raisin, jus de raisin reconstitué, jus d’ananas, jus d’ananas reconstitué, jus de pomme et de (nom du fruit) visé à l’article B.11.132, jus de fruit concentré ou jus de fruit congelé 15 Farine, farine blanche, farine enrichie ou farine enrichie au fer 16 [Abrogé, DORS/94-689, art. 2] 17 Sel de table, succédanés du sel de table 18 Pommes de terre séchées 19 Produits limitant l’œuf entier 20 [Abrogé, DORS/90-830, art. 11] --- Colonne II Vitamine, minéral nutritif ou acide aminé Vitamines — acide d-pantothénique, acide folique, alpha-tocophérol, biotine, niacine, riboflavine, thiamine, vitamine A, vitamine B₆, vitamine B₁₂, vitamine C, vitamine D, vitamine K Minéraux — calcium, cuivre, chrome, cuivre, fer, iode, magnésium, manganèse, molybdène, phosphore, potassium, sélénium, sodium, zinc Vitamine A, thiamine, niacine ou niacinamide, vitamine C, fer Thiamine, riboflavine, niacine, pyridoxine, acide d-pantothénique, acide folique, vitamine B₁₂, fer, magnésium, potassium, zinc, protéines, acides aminés isolucine, leucine, lysine, méthionine, phénylalanine, thréonine, tryptophane, valine Vitamines — acide folique, acide d-pantothénique, alpha-tocophérol, biotine, niacine, riboflavine, thiamine, vitamine A, vitamine B₆, vitamine B₁₂, vitamine C, vitamine D Minéraux — calcium, cuivre, chrome, fer, iode, magnésium, manganèse, molybdène, phosphore, potassium, sélénium, sodium, zinc Vitamine D Vitamine A, vitamine D Vitamine C, vitamine D Vitamine A, vitamine C, vitamine D Vitamine C Thiamine, riboflavine, niacine, vitamine B₆, acide folique, acide d-pantothénique, calcium, fer, magnésium Iode Vitamine C Vitamine A, thiamine, riboflavine, niacine ou niacinamide, vitamine B₆, acide d-pantothénique, acide folique, vitamine B₁₂, alphatocophérol, calcium, fer, zinc, potassium DIVISION 3 Addition of Vitamins, Mineral Nutrients or Amino Acids to Foods Sections D.03.002-D.03.003 Colonne I Aliment 21 Lait de chèvre, lait de chèvre en poudre 22 Lait de chèvre partiellement écrémé, lait de chèvre écrémé, lait de chèvre partiellement écrémé en poudre, lait de chèvre écrémé en poudre 23 Lait de chèvre concentré Lait de chèvre concentré partiellement écrémé, lait de chèvre concentré écrémé 25 Riz précuit, au sens du paragraphe B.13.010(1.1) 26 Eau minérale, eau de source, eau en contenants scellés, glace pré-emballée 27 Œuf entier liquide, poudre d’œuf entier, œuf entier congelé, jaune d’œuf liquide, poudre de jaune d’œuf, jaune d’œuf congelé, blanc d’œuf liquide (albumen liquide), poudre de blanc d’œuf (poudre d’albumen), blanc d’œuf congelé (albumen congelé), mélange liquide d’œufs entiers, mélange de poudre d’œufs entiers, mélange congelé d’œufs entiers, mélange liquide de jaunes d’œufs, mélange de poudre de jaunes d’œufs, mélange congelé de jaunes d’œufs Colonne II Vitamine, minéral nutritif ou acide aminé vitamine D vitamines A et D vitamines C, D, acide folique vitamines A, C, D, acide folique Thiamine, niacine, vitamine B6, acide folique, acide pantothénique, fer Fluor Vitamine A, vitamine D, vitamine E, thiamine, riboflavine, niacine, vitamine B6, folacine, vitamine B12, acide pantothénique, calcium, phosphore, magnésium, potassium, fer, zinc (i) a gluten-free food referred to in paragraph B.24.003(1)(g), or DIVISION 4 [Repealed, SOR/2003-196, s. 105] Règlement sur les aliments et drogues

PARTIE D Vitamines, minéraux et acides aminés

TITRE 3 Addition de vitamines, de minéraux nutritifs ou d’acides aminés aux aliments

Articles D.03.002-D.03.003

D

03.003 L’article D.03.002 ne s’applique pas à l’aliment — autre qu’un aliment supplémenté — qui répond aux exigences suivantes : a) l’aliment est : (i) soit un aliment sans gluten visé à l’alinéa B.24.003(1)g), (ii) soit présenté comme étant destiné à un usage diététique spécial visé aux alinéas B.24.003(1)h) ou i); b) il n’y a pas de normes applicables dans ce règlement pour l’aliment; c) l’aliment n’est pas annoncé.

TITRE 4

[Abrogé, DORS/2003-196, art. 105] DIVISION 5

D

05.001 to D.05.007 [Repealed, SOR/2003-196, s. 106] SOR/81-196, s. 2.

D

05.010 [Repealed, SOR/2003-196, s. 107] PART E Cyclamate Sweeteners [SOR/2016-74, s. 11] SOR/78-422, s. 4; SOR/2016-74, s. 12. Sale SOR/78-422, s. 4; SOR/2016-74, s. 13. SOR/78-422, s. 4; SOR/2016-74, s. 14. Labelling SOR/78-422, s. 4; SOR/2016-74, s. 15. E.01.005 Every cyclamate sweetener shall be labelled to show SOR/78-422, s. 4; SOR/2016-74, s. 16. PART G DIVISION 1 Definitions (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d). (infraction désignée en matière criminelle) Directive en matière de sécurité La Directive sur les exigences en matière de sécurité physique pour les substances désignées et les drogues contenant du cannabis, avec ses modifications successives, publiée par le gouvernement du Canada sur son site Web. (Security Directive) distributeur autorisé Titulaire d’une licence délivrée au titre de l’article G.02.007. (licensed dealer) drogue contrôlée S’entend de l’une des substances suivantes : a) toute substance désignée qui est visée à l’annexe de la présente partie; b) s’agissant d’une sage-femme, d’un infirmier praticien ou d’un podiatre, toute substance désignée qui est visée à l’annexe de la présente partie et que ce praticien peut, au titre des articles 3 et 4 du Règlement sur les nouvelles catégories de praticiens, prescrire ou avoir en sa possession ou relativement à laquelle il peut, au titre de ces articles, livrer à l’une ou l’autre des activités. (controlled drug) emballage Vise notamment toute chose dans laquelle une drogue contrôlée est, en tout ou en partie, contenue, placée ou empaquetée. (package) étiquette S’entend au sens de l’article 2 de la Loi sur les aliments et drogues. (label) hôpital L’établissement, selon le cas : a) qui peut, au titre d’une licence, d’une autorisation ou d’une désignation délivrée par une province sous le régime de ses lois, fournir des soins ou des traitements aux personnes ou aux animaux atteints d’une maladie ou d’une affection; b) qui fournit des services de santé et qui soit appartenant au gouvernement du Canada ou au gouvernement d’une province, soit est exploité par lui. (hospital) infirmier praticien S’entend au sens de l’article 1 du Règlement sur les nouvelles catégories de praticiens. (nurse practitioner) infraction désignée en matière criminelle S’entend des infractions suivantes : a) infraction relative au financement du terrorisme visée aux articles 83.02 à 83.04 du Code criminel; b) infraction de fraude visée à l’un des articles 380 à 382 du Code criminel; licensed dealer means the holder of a licence issued under section G.02.007. (distributeur autorisé) qualified person in charge means the individual designated under subsection G.02.004(1). (responsable qualifié) c) infraction de recyclage des produits de la criminalité visée à l’article 462.31 du Code criminel; d) infraction relative à une organisation criminelle visée à l’un des articles 467.11 à 467.13 du Code criminel; e) tentative ou complot en vue de commettre une infraction visée aux alinéas a) à d), complicité après le fait à son égard ou fait de conseiller de la commettre. (designated criminal offence) Loi La Loi réglementant certaines drogues et autres substances. (Act) nécessaire d’essai Nécessaire qui a les caractéristiques suivantes : a) il contient d’une part une drogue contrôlée et d’autre part un réactif ou une substance tampon; b) il est utilisé dans un processus chimique ou analytique de dépistage ou de quantification d’une drogue contrôlée à des fins médicales, industrielles, de recherche scientifique, pour les travaux de laboratoire ou de recherche ou pour l’application ou l’exécution de la loi; c) son contenu n’est pas destiné à être consommé par une personne ou un animal, ni à leur être administré, et il n’est pas susceptible de l’être. (test kit) obligation internationale Toute obligation relative à une drogue contrôlée prévue par une convention, un traité ou un autre instrument multilatéral ou bilatéral que le Canada a ratifié ou auquel il adhère. (international obligation) ordonnance À l’égard d’une drogue contrôlée, l’autorisation d’un praticien d’en dispenser une quantité déterminée pour la personne qui y est nommée ou pour l’animal qui y est identifié. (prescription) pharmacien Personne qui est autorisée en vertu des lois d’une province à exercer la profession de pharmacien et qui l’exerce. (pharmacist) podiatre S’entend au sens de l’article 1 du Règlement sur les nouvelles catégories de praticiens. (podiatrist) préparation Drogue qui contient d’une part une drogue contrôlée et d’autre part un ingrédient actif de nature médicinale en dose thérapeutique reconnue qui n’est pas une drogue contrôlée. (preparation) (c) the contents of which are not intended or likely to be consumed by, or administered to, a person or an animal. (nécessaire d’essai) SOR/78-220, s. 1; SOR/85-550, s. 1; SOR/86-91, s. 1; SOR/90-281, s. 1(F); SOR/92-386, s. 1; SOR/97-228, s. 7; SOR/97-515, s. 2; SOR/2003-135, s. 2; SOR/2004-238, s. 1; SOR/2012-230, s. 6; SOR/2018-147, s. 29; SOR/2019-171, s. 1. publicité S’entend notamment de la présentation, par tout moyen, d’une drogue contrôlée en vue d’en promouvoir directement ou indirectement la disposition, notamment par vente. (advertisement) responsable principal L’individu désigné en application de l’article G.02.003. (senior person in charge) responsable qualifié L’individu désigné en application du paragraphe G.02.004(1). (qualified person in charge) sage-femme S’entend au sens de l’article 1 du Règlement sur les nouvelles catégories de praticiens. (midwife) DORS/78-220, art. 1; DORS/85-550, art. 1; DORS/86-91, art. 1; DORS/90-281, art. 1(F); DORS/97-228, art. 7; DORS/97-515, art. 2; DORS/2003-135, art. 2; DORS/2004-238, art. 1; DORS/2012-230, art. 6; DORS/2018-147, art. 29; DORS/2019-171, art. 1. Application Agricultural implants Definition of agricultural implant SOR/97-515, s. 3; SOR/98-125, art. 1; SOR/2003-34, s. 1; SOR/2003-413, s. 1; SOR/2018-69, ss. 67, 68; SOR/2019-171, s. 1. G.01.002.1 [Repealed, SOR/2019-171, s. 1] SOR/80-543, s. 11; SOR/2004-238, s. 2(F); SOR/2019-171, s. 1. SOR/92-386, s. 2; SOR/97-228, s. 8; SOR/2019-171, s. 1. Possession Authorized persons (ii) a pharmacist, or Agent or mandatory Agent or mandatory — person referred to in paragraph (1)(g) SOR/2019-171, s. 1. Test Kits (i) the name of the manufacturer, (iii) the registration number; and SOR/2019-171, s. 1. SOR/2019-171, s. 1. Issuance of registration number SOR/2019-171, s. 1. Cancellation of registration number SOR/2019-171, s. 1. G.01.010 [Repealed, SOR/2019-171, s. 1] DIVISION 2 Authorized Activities médicales, industrielles ou éducatives, pour des travaux de laboratoire ou de recherche ou pour l’application ou l’exécution de la loi : a) il contient une drogue contrôlée et un agent d’adultération ou un dénaturant, mélangés de telle manière et en quantités, proportions ou concentrations telles que la préparation ou le mélange ne présente pas un risque notable de toxicomanie; b) il contient des quantités ou des concentrations d’une drogue contrôlée si infimes qu’il ne présente pas un risque notable de toxicomanie. DORS/2019-171, art. 1. Numéro d’enregistrement — annulation G.01.009 Le ministre annule le numéro d’enregistrement d’un nécessaire d’essai dans les cas suivants : a) le fabricant retire le nécessaire d’essai du marché; b) le ministre a des motifs raisonnables de croire que le nécessaire d’essai n’est pas utilisé à des fins médicales, industrielles ou éducatives, pour des travaux de laboratoire ou de recherche ou pour l’application ou l’exécution de la loi; c) le ministre a des motifs raisonnables de croire que l’annulation est nécessaire pour protéger la sécurité ou la santé publiques, notamment pour prévenir le détournement d’une drogue contrôlée vers un marché ou un usage illicites. DORS/2019-171, art. 1. G.01.010 [Abrogé, DORS/2019-171, art. 1]

TITRE 2

Distributeurs autorisés Opérations autorisées Général G.02.001 (1) Le distributeur autorisé peut produire, assembler, vendre, fournir, transporter, expédier, livrer, importer ou exporter une drogue contrôlée s’il se conforme à la présente partie ainsi qu’aux conditions de sa licence de distributeur autorisé et de tout permis délivré en vertu de la présente partie. Présence d’un responsable qualifié

(2)

Le distributeur autorisé ne peut effectuer à son installation une opération relative à une drogue contrôlée Permit — import and export SOR/2004-238, s. 3; SOR/2019-171, s. 1. G.02.001.1 [Repealed, SOR/2019-171, s. 1] G.02.001.2 [Repealed, SOR/2019-171, s. 1] Dealer’s Licences Preliminary Requirements Eligible persons (a) an individual who ordinarily resides in Canada; SOR/2019-171, s. 1. G.02.002.1 [Repealed, SOR/2019-171, s. 1] SOR/2004-238, s. 4; SOR/2010-222, s. 8; SOR/2014-260, ss. 1, 16(F); SOR/2019-171, s. 1. G.02.003.1 [Repealed, SOR/2019-171, s. 1] G.02.003.2 [Repealed, SOR/2019-171, s. 1] G.02.003.3 [Repealed, SOR/2019-171, s. 1] G.02.003.4 [Repealed, SOR/2019-171, s. 1] --- que si le responsable qualifié ou un responsable qualifié suppléant est présent à l’installation. Permis — importation et exportation

(3)

Le distributeur autorisé est tenu d’obtenir un permis pour importer ou exporter une drogue contrôlée. Possession à des fins d’exportation

(4)

Le distributeur autorisé peut avoir en sa possession une drogue contrôlée en vue de son exportation s’il l’a obtenue conformément à la présente partie. DORS/2004-238, art. 3; DORS/2019-171, art. 1. G.02.001.1 [Abrogé, DORS/2019-171, art. 1] G.02.001.2 [Abrogé, DORS/2019-171, art. 1] Licences de distributeur autorisé Exigences préalables Personnes admissibles G.02.002 Les personnes ci-après peuvent demander une licence de distributeur autorisé : a) l’individu qui réside de façon habituelle au Canada; b) la personne morale qui a son siège social au Canada ou qui y exploite une succursale; c) le titulaire d’un poste qui est responsable des questions relatives aux drogues contrôlées pour le compte du gouvernement du Canada ou d’un gouvernement provincial, d’un service de police, d’un hôpital ou d’une université au Canada. DORS/2019-171, art. 1. G.02.002.1 [Abrogé, DORS/2019-171, art. 1] Responsable principal G.02.003 La personne qui demande une licence de distributeur autorisé désigne un seul individu à titre de responsable principal, le demandeur pouvant se désigner lui-même s’il est un individu, qui est responsable de la gestion de l’ensemble des activités relatives aux drogues contrôlées précisées dans la demande de licence. DORS/2004-238, art. 4; DORS/2010-222, art. 8; DORS/2014-260, art. 1 et 16(F); DORS/2019-171, art. 1. G.02.003.1 [Abrogé, DORS/2019-171, art. 1] G.02.003.2 [Abrogé, DORS/2019-171, art. 1] G.02.003.3 [Abrogé, DORS/2019-171, art. 1] G.02.003.4 [Abrogé, DORS/2019-171, art. 1] G.02.003.5 [Repealed, SOR/2019-171, s. 1] G.02.003.6 [Repealed, SOR/2019-171, s. 1] G.02.003.7 [Repealed, SOR/2019-171, s. 1] G.02.003.8 [Repealed, SOR/2019-171, s. 1] G.02.003.9 [Repealed, SOR/2019-171, s. 1] G.02.003.91 [Repealed, SOR/2019-171, s. 1] Qualifications (a) they work at the site specified in the dealer’s licence; Exception SOR/2004-238, s. 4; SOR/2019-171, s. 1. Ineligibility gestion des chaînes d’approvisionnement, les techniques en pharmacie ou les techniques de laboratoire, (iii) soit titulaire d’un diplôme, d’un certificat ou d’une attestation décerné par un établissement d’enseignement étranger dans l’un des domaines visés au sous-alinéa (ii) et titulaire de l’une des attestations suivantes : (A) une attestation d’équivalence, au sens du paragraphe 73(1) du Règlement sur l’immigration et la protection des réfugiés, (B) une attestation d’équivalence délivrée par une institution ou une organisation chargée de faire de telles attestations et reconnue par une province; c) il possède des connaissances et une expérience relatives à l’utilisation et à la manutention des drogues contrôlées précisées dans la licence de distributeur autorisé qui sont suffisantes pour lui permettre de bien exercer ses fonctions; d) il possède une connaissance suffisante des dispositions de la Loi et de la présente partie qui s’appliquent aux opérations précisées dans la licence de distributeur autorisé pour lui permettre de bien exercer ses fonctions. Exception

(4)

La personne qui demande une licence de distributeur autorisé peut désigner à titre de responsable qualifié ou de responsable qualifié suppléant un individu qui ne satisfait à aucune des exigences prévues à l’alinéa (3)(b) si les conditions ci-après sont réunies : a) aucun autre individu travaillant à l’installation ne satisfait à l’une de ces exigences; b) ces exigences ne sont pas nécessaires pour effectuer les opérations précisées dans la licence; c) l’individu possède des connaissances suffisantes acquises par la combinaison de ses études, de sa formation ou de son expérience de travail pour lui permettre de bien exercer ses fonctions. DORS/2004-238, art. 4; DORS/2019-171, art. 1. Inadmissibilité G.02.005 Ne peut être désigné à titre de responsable principal, de responsable qualifié ou de responsable qualifié suppléant l’individu qui, dans les dix années précédant la date de présentation de la demande de licence de distributeur autorisé : SOR/2019-171, s. 1. Issuance of Licence Application (i) an individual, the individual’s name, Documents (i) a copy of the person’s diploma, certificate or credential referred to in subparagraph G.02.004(3)(b)(ii) or (iii), or SOR/2019-171, s. 1. Issuance (a) the licence number; (d) the municipal address of the site at which the dealer may conduct the authorized activities; (f) the effective date of the licence; SOR/2019-171, s. 1. Validity SOR/2019-171, s. 1. Refusal (a) the applicant may not apply for a licence under section G.02.002; Refus G.02.009 (1) Le ministre refuse de délivrer une licence de distributeur autorisé dans les cas suivants : a) le demandeur ne peut pas demander une licence en vertu de l’article G.02.002; b) le demandeur a contrevenu, dans les dix années précédant la présentation de la demande de licence : (i) soit à une disposition de la Loi, de la Loi sur le cannabis ou de leurs règlements, (ii) soit à une condition d’une licence ou d’un permis qui lui a été délivré en vertu d’un règlement pris en vertu de la Loi ou qui lui a été délivré en vertu de la Loi sur le cannabis ou de ses règlements; c) dans les dix années précédant la présentation de la demande de licence, le responsable principal, le responsable qualifié ou tout responsable qualifié suppléant proposé a fait l’objet d’une condamnation visée aux sous-alinéas G.02.005a)(i) ou b)(i) ou s’est vu imposer une peine visée aux sous-alinéas G.02.005a)(ii) ou b)(ii); d) l’une des opérations pour lesquelles la licence est demandée entraînerait la violation d’une obligation internationale; e) le demandeur n’a pas mis en place à l’installation les mesures de sécurité prévues dans la Directive en matière de sécurité à l’égard d’une opération pour laquelle la licence est demandée; f) la méthode visée à l’alinéa G.02.006(1)j) ne permet pas la consignation des renseignements conformément à l’article G.02.071; g) soit le demandeur ne s’est pas conformé aux exigences prévues au paragraphe G.02.006(4), soit il s’y est conformé, mais les renseignements ou documents fournis sont insuffisants pour terminer l’examen de la demande de licence; h) le ministre a des motifs raisonnables de croire que le demandeur a fourni, dans sa demande de licence ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; i) le ministre a des motifs raisonnables de croire, sur le fondement de renseignements reçus d’une autorité compétente ou de l’Organisation des Nations Unies, que le demandeur a participé au détournement d’une drogue contrôlée vers un marché ou un usage illicites ou qu’il a participé à des opérations qui ont entraîné la violation d’une obligation internationale; Exceptions Notice SOR/2019-171, s. 1. Renewal of Licence Application j) le ministre a des motifs raisonnables de croire que la délivrance de la licence risquerait vraisemblablement de porter atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement d’une drogue contrôlée vers un marché ou un usage illicites. Exceptions

(2)

Le ministre ne peut, dans les cas visés aux alinéas (1)b) ou h), refuser de délivrer la licence si le demandeur remplit les conditions ci-après, sauf s’il a des motifs raisonnables de croire que le refus est nécessaire pour protéger la sécurité ou la santé publiques, notamment pour prévenir le détournement d’une drogue contrôlée vers un marché ou un usage illicites : a) le demandeur n’a pas d’antécédents de contravention à la Loi, à la Loi sur le cannabis ou à leurs règlements; b) il a soit pris les mesures correctives nécessaires pour veiller à respecter la Loi, la Loi sur le cannabis et leurs règlements, soit signé un engagement à cet égard. Préavis

(3)

Le ministre, avant de refuser de délivrer la licence, envoie au demandeur un préavis motivé l’informant qu’il peut présenter ses observations à cet égard. DORS/2019-171, art. 1. Renouvellement de la licence Demande G.02.010 (1) Le distributeur autorisé présente au ministre, pour obtenir le renouvellement de sa licence de distributeur autorisé, une demande qui contient les renseignements et documents visés aux paragraphes G.02.006(1) et (2). Signature et attestation

(2)

La demande satisfait aux exigences suivantes : a) elle est signée et datée par le responsable principal de l’installation précisée dans la demande; b) elle comprend une attestation de celui-ci portant sur les faits suivants : (i) à sa connaissance, tous les renseignements et documents fournis à l’appui de la demande sont exacts et complets, (ii) il est habilité à lier le distributeur autorisé. SOR/2019-171, s. 1. Renewal SOR/2004-238, s. 5; SOR/2010-222, s. 7; SOR/2019-171, s. 1. G.02.011.1 [Repealed, SOR/2019-171, s. 1] G.02.011.2 [Repealed, SOR/2019-171, s. 1] Validity SOR/2004-238, art. 5; SOR/2019-171, s. 1. Refusal Exceptions Notice SOR/2019-171, s. 1. Application SOR/78-427, s. 1; SOR/87-228, s. 10; SOR/2004-238, s. 6; SOR/2010-222, s. 8; SIEI; SOR/2019-171, s. 1. SOR/78-427, s. 2; SOR/2004-238, s. 7; SOR/2010-222, s. 9; SOR/2019-171, s. 1. Validity SOR/2019-171, s. 1. Refusal à cet effet, tout renseignement ou document que le ministre juge nécessaire pour compléter l’examen de la demande de modification. DORS/78-427, art. 1; DORS/87-228, art. 10; DORS/2004-238, art. 6; DORS/2010-222, art. 8; DORS/2019-171, art. 1. G.02.015 (1) Le ministre, au terme de l’examen de la demande de modification et sous réserve de l’article G.02.017, modifie la licence de distributeur autorisé. Conditions

(2)

Le ministre peut, lorsqu’il modifie la licence du distributeur autorisé, ajouter toute condition à la licence, en modifier les conditions ou supprimer l’une de celles-ci s’il a des motifs raisonnables de le croire nécessaire pour atteindre l’une des fins suivantes : a) le respect d’une obligation internationale; b) la conformité aux exigences associées au niveau de sécurité précisé dans la licence ou au nouveau niveau qui s’impose à la suite de la modification; c) la réduction d’un risque à l’atteinte à la sécurité ou à la santé publiques, notamment le risque de détournement d’une drogue contrôlée vers un marché ou un usage illicites. DORS/78-427, art. 2; DORS/2004-238, art. 7; DORS/2010-222, art. 9; DORS/2019-171, art. 1. Validité G.02.016 La licence de distributeur autorisé modifiée est valide jusqu’à la date d’expiration qui y est indiquée ou, si elle est antérieure, jusqu’à la date de sa suspension ou de sa révocation au titre des articles G.02.027 ou G.02.028. DORS/2019-171, art. 1. Refus G.02.017 (1) Le ministre refuse de modifier la licence de distributeur autorisé dans les cas suivants : a) l’une des opérations pour lesquelles la modification est demandée entraînerait la violation d’une obligation internationale; b) le distributeur autorisé n’a pas mis en place à l’installation les mesures de sécurité prévues dans la Directive en matière de sécurité à l’égard d’une opération pour laquelle la demande est faite; c) la méthode visée à l’alinéa G.02.006(1)j) ne permet pas la consignation des renseignements conformément à l’article G.02.071; Exceptions Notice SOR/2019-171, s. 1. Application (a) a change affecting the security measures at the site specified in the dealer’s licence; d) soit le distributeur autorisé ne s’est pas conformé aux exigences prévues au paragraphe G.02.014(3), soit il s’y est conformé, mais les renseignements ou documents fournis sont insuffisants pour terminer l’examen de la demande de modification; e) le ministre a des motifs raisonnables de croire que le distributeur autorisé a fourni, dans sa demande de modification ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; f) le ministre a des motifs raisonnables de croire que la modification de la licence risquerait vraisemblablement de porter atteinte à la santé publique ou à la sécurité publiques, notamment en raison du risque de détournement d’une drogue contrôlée vers un marché ou un usage illicites. Exceptions

(2)

Le ministre ne peut, dans le cas visé à l’alinéa (1)e), refuser de modifier la licence si le distributeur autorisé remplit les conditions ci-après, sauf s’il a des motifs raisonnables de croire que le refus est nécessaire pour protéger la sécurité ou la santé publiques, notamment pour prévenir le détournement d’une drogue contrôlée vers un marché ou un usage illicites : a) le distributeur autorisé n’a pas d’antécédents de contravention à la Loi, à la Loi sur le cannabis ou à leurs règlements; b) il a soit pris les mesures correctives nécessaires pour veiller à respecter la Loi, la Loi sur le cannabis et leurs règlements, soit signé un engagement à cet effet. Préavis

(3)

Le ministre, avant de refuser de modifier la licence, envoie au distributeur autorisé un préavis motivé l’informant qu’il peut présenter ses observations à cet égard. DORS/2019-171, art. 1. Changements exigeant une approbation préalable du ministre Demande G.02.018 (1) Le distributeur autorisé doit obtenir l’approbation du ministre, en lui présentant une demande écrite, avant de procéder à l’un des changements suivants : a) toute modification ayant une incidence sur les mesures de sécurité mises en place à l’installation précisée dans sa licence; (d) the replacement or addition of an alternate qualified person in charge. (i) the information specified in paragraph G.02.006(1)(c), and (ii) the declaration specified in paragraph G.02.006(2)(b) and the documents specified in paragraphs G.02.006(2)(c) and (d); and (i) the information specified in paragraph G.02.006(1)(d), and (ii) the declarations specified in paragraphs G.02.006(2)(b) and (e) and the documents specified in paragraphs G.02.006(2)(c), (d) and (f). Approval b) le remplacement du responsable principal; c) le remplacement du responsable qualifié; d) le remplacement ou l’adjonction de tout responsable qualifié suppléant. Renseignements et documents

(2)

Le distributeur autorisé fournit au ministre, pour tout changement visé au paragraphe (1), ce qui suit : a) les précisions concernant la modification ayant une incidence sur les mesures de sécurité mises en place à l’installation précisée dans sa licence; b) s’agissant du responsable principal : (i) les renseignements visés à l’alinéa G.02.006(1)c), (ii) la déclaration visée à l’alinéa G.02.006(2)b) et les documents visés aux alinéas G.02.006(2)c) et d); c) s’agissant du responsable qualifié ou d’un responsable qualifié suppléant : (i) les renseignements visés à l’alinéa G.02.006(1)d), (ii) les déclarations visées aux alinéas G.02.006(2)b) et e) ainsi que les documents visés aux alinéas G.02.006(2)c), d) et f). Renseignements et documents complémentaires

(3)

Le distributeur autorisé fournit au ministre, au plus tard à la date précisée dans la demande écrite de celui-ci à cet effet, tout renseignement ou document que le ministre juge nécessaire pour compléter l’examen de la demande d’approbation. Approbation G.02.019 (1) Le ministre, au terme de l’examen de la demande d’approbation et sous réserve de l’article G.02.020, approuve le changement. Conditions

(2)

Le ministre peut, lorsqu’il approuve le changement, ajouter toute condition à la licence du distributeur autorisé, en modifier les conditions ou supprimer l’une de celles-ci s’il a des motifs raisonnables de le croire nécessaire pour atteindre l’une des fins suivantes : a) le respect d’une obligation internationale; Dealer’s Licences Sections G.02.019-G.02.020 SOR/88-482, s. 2; SOR/2019-171, s. 1. Refusal Exception Notice Règlement sur les aliments et drogues

PARTIE G Drogues contrôlées

SECTION 2 Distributeurs autorisés

Licences de distributeur autorisé

Articles G.02.019-G.02.020

b) la conformité aux exigences associées au niveau de sécurité précisé dans la licence; c) la réduction d’un risque d’atteinte à la sécurité ou à la santé publiques, notamment le risque de détournement d’une drogue contrôlée vers un marché ou un usage illicites. DORS/88-482, art. 2; DORS/2019-171, art. 1. Refus G.02.020 (1) Le ministre refuse d’approuver le changement dans les cas suivants : a) dans les dix années précédant la présentation de la demande d’approbation de changement, le responsable principal, la personne qualifiée ou tout responsable qualifié suppléant proposé a fait l’objet d’une condamnation visée aux sous-alinéas G.02.005a)(i) ou b)(i) ou s’est vu imposer une peine visée aux sous-alinéas G.02.005a)(ii) ou b)(ii); b) soit le distributeur autorisé ne s’est pas conformé aux exigences prévues au paragraphe G.02.018(3), soit il s’y est conformé, mais les renseignements et documents fournis sont insuffisants pour terminer l’examen de la demande d’approbation de changement; c) le ministre a des motifs raisonnables de croire que le distributeur autorisé a fourni, dans sa demande d’approbation de changement ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; d) le ministre a des motifs raisonnables de croire que le changement risquerait vraisemblablement de porter atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement d’une drogue contrôlée vers un marché ou un usage illicites. Exceptions

(2)

Le ministre ne peut, dans le cas visé à l’alinéa (1)c), refuser d’approuver le changement si le distributeur autorisé a pris les mesures correctrices nécessaires pour veiller à respecter la Loi, la Loi sur le cannabis et leurs règlements ou a signé un engagement à cet effet, sauf s’il a des motifs raisonnables de croire que le refus est nécessaire pour protéger la sécurité ou la santé publiques, notamment pour prévenir le détournement d’une drogue contrôlée vers un marché ou un usage illicites. Préavis

(3)

Le ministre, avant de refuser d’approuver le changement, envoie au distributeur autorisé un préavis motivé SOR/2019-171, s. 1. Prior notice SOR/2019-171, s. 1. Notice — five days SOR/2019-171, s. 1. Notice — 10 days SOR/2019-171, s. 1. Content of notice Update SOR/78-820, s. 3; SOR/85-505, s. 2; SOR/98-126, s. 2; SOR/2004-238, s. 9; SOR/2010-222, s. 11; SOR/2012-230, s. 9; SOR/2019-171, s. 1. G.02.024.1 [Repealed, SOR/2019-171, s. 1] G.02.024.2 [Repealed, SOR/2019-171, s. 1] Notice Urgent circumstances Urgent circumstances — notice Notice SOR/2004-238, s. 12; SOR/2010-222, s. 13(F); SOR/2014-260, s. 7; SOR/2019-171, s. 1. Suspension Notice Reinstatement of licence SOR/2019-171, s. 1. (d) the licensed dealer does not take the corrective measures specified in an undertaking or notice; Exceptions Notice SOR/2019-171, s. 1. Return of licence SOR/2019-171, s. 1. Import Permits Application SOR/2019-171, s. 1. Issuance (a) the permit number; (b) the information set out in subsection G.02.030(1); (d) the expiry date of the permit, being the earlier of (ii) the expiry date of the dealer’s licence; and SOR/2019-171, s. 1. Validity (a) the expiry date set out in the permit, (b) the date of the suspension or revocation of the permit under section G.02.037 or G.02.038, (c) the date of the suspension or revocation of the dealer’s licence under section G.02.027 or G.02.028, and SOR/2019-171, s. 1. Return of permit SOR/2019-171, s. 1. Refusal b) la date de sa suspension ou de sa révocation au titre des articles G.02.037 ou G.02.038; c) la date de suspension ou de révocation, au titre des articles G.02.027 ou G.02.028, de la licence du distributeur autorisé; d) la date de suspension ou de révocation du permis d’exportation délivré par l’autorité compétente du pays d’exportation à l’égard de la drogue contrôlée à importer. DORS/2019-171, art. 1. Retour du permis G.02.033 Le distributeur autorisé dont le permis d’importation expire retourne l’original de celui-ci au ministre dans les quinze jours suivant la date d’expiration. DORS/2019-171, art. 1. Refus G.02.034 (1) Le ministre refuse de délivrer un permis d’importation dans les cas suivants : a) la licence du distributeur autorisé ne l’autorise pas à importer la drogue contrôlée visée ou elle expirera avant la date de l’importation; b) le ministre a des motifs raisonnables de croire que l’importation entraînerait la violation d’une obligation internationale; c) le distributeur autorisé n’a pas mis en place à l’installation les mesures de sécurité prévues dans la Directive en matière de sécurité à l’égard de l’importation; d) soit le distributeur autorisé ne s’est pas conformé aux exigences prévues au paragraphe G.02.030(3), soit il s’y est conformé, mais les renseignements ou documents fournis sont insuffisants pour terminer l’examen de la demande de permis; e) le ministre a des motifs raisonnables de croire que le distributeur autorisé a fourni, dans sa demande de permis ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; f) le distributeur autorisé a été avisé que la demande de renouvellement de sa licence de distributeur autorisé ou la demande de modification de celle-ci sera refusée; g) le ministre a des motifs raisonnables de croire que l’importation contreviendrait aux règles de droit du pays d’exportation, de tout pays de transit ou de tout pays de transbordement; Notice SOR/2019-171, s. 1. Providing copy of permit SOR/2019-171, s. 1. Declaration SOR/2019-171, s. 1. Suspension Notice Reinstatement of permit SOR/2019-171, s. 1. G.02.038 (1) Subject to subsection (2), the Minister must revoke an import permit if SOR/2019-171, s. 1. Exceptions Notice SOR/2019-171, s. 1. Return of permit SOR/2019-171, s. 1. Export Permits Application d) le ministre a des motifs raisonnables de croire que le distributeur autorisé a fourni, dans sa demande de permis ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; e) le ministre a des motifs raisonnables de croire, sur le fondement de renseignements reçus d’une autorité compétente ou de l’Organisation des Nations Unies, que le distributeur autorisé a participé au détournement d’une drogue contrôlée vers un marché ou un usage illicites; f) la licence du distributeur autorisé a été révoquée. Exceptions

(2)

Le ministre ne peut, dans les cas visés aux alinéas (1)d) ou G.02.028(1)e) ou g), révoquer le permis d’importation si le distributeur autorisé remplit les conditions ci-après, sauf s’il a des motifs raisonnables de croire que la révocation est nécessaire pour protéger la sécurité ou la santé publiques, notamment pour prévenir le détournement d’une drogue contrôlée vers un marché ou un usage illicites : a) le distributeur autorisé n’a pas d’antécédents de non-conformité à la Loi, à la Loi sur le cannabis et leurs règlements; b) il a soit pris les mesures correctives nécessaires pour veiller à respecter la Loi, la Loi sur le cannabis et leurs règlements, soit signé un engagement à cet effet. Préavis

(3)

Le ministre, avant de révoquer le permis d’importation, envoie au distributeur autorisé un préavis motivé l’informant qu’il peut présenter ses observations à cet égard. DORS/2019-171, art. 1. Retour du permis G.02.039 Le distributeur autorisé retourne au ministre l’original du permis d’importation dans les quinze jours suivant la date de prise d’effet de la révocation. DORS/2019-171, art. 1. Permis d’exportation Demande G.02.040 (1) Le distributeur autorisé présente au ministre, pour chaque exportation prévue de drogues contrôlées, une demande de permis d’exportation qui contient les renseignements et documents suivants : (d) the name and municipal address of the importer in the country of final destination; SOR/2019-171, s. 1. Issuance (a) the permit number; (b) the information set out in paragraphs G.02.040(1)(a) to (f); (d) the expiry date of the permit, being the earliest of (ii) the expiry date of the dealer’s licence, and SOR/2019-171, s. 1. Validity (a) the expiry date set out in the permit, (b) the date of the suspension or revocation of the permit under section G.02.047 or G.02.048, (c) the date of the suspension or revocation of the dealer’s licence under section G.02.027 or G.02.028, and SOR/2019-171, s. 1. Return of permit SOR/2019-171, s. 1. Refusal b) la date de sa suspension ou de sa révocation au titre des articles G.02.047 ou G.02.048; c) la date de suspension ou de révocation, au titre des articles G.02.027 ou G.02.028, de la licence du distributeur autorisé; d) la date d’expiration, de suspension ou de révocation du permis d’importation délivré par l’autorité compétente du pays de destination finale à l’égard de la drogue contrôlée à exporter. DORS/2019-171, art. 1. Retour du permis G.02.043 Le distributeur autorisé dont le permis d’exportation expire retourne l’original de celui-ci au ministre dans les quinze jours suivant la date d’expiration. DORS/2019-171, art. 1. Refus G.02.044 (1) Le ministre refuse de délivrer un permis d’exportation dans les cas suivants : a) la licence du distributeur autorisé ne l’autorise pas à exporter la drogue contrôlée visée ou elle expirera avant la date d’exportation; b) le ministre a des motifs raisonnables de croire que l’exportation entraînerait la violation d’une obligation internationale; c) soit le distributeur autorisé ne s’est pas conformé aux exigences prévues au paragraphe G.02.040(3), soit il s’y est conformé, mais les renseignements ou documents fournis sont insuffisants pour terminer l’examen de la demande de permis; d) le ministre a des motifs raisonnables de croire que le distributeur autorisé a fourni, dans sa demande de permis ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; e) le distributeur autorisé a été avisé que la demande de renouvellement ou de modification de sa licence de distributeur autorisé sera refusée; f) le ministre a des motifs raisonnables de croire que l’exportation ne serait pas conforme au permis d’importation délivré par l’autorité compétente du pays de destination finale; g) le ministre a des motifs raisonnables de croire que l’exportation contreviendrait aux règles de droit du pays de destination finale, de tout pays de transit ou de tout pays de transbordement; Notice SOR/2019-171, s. 1. Providing copy of permit SOR/2019-171, s. 1. Declaration SOR/2019-171, s. 1. Suspension Notice Reinstatement of permit SOR/2019-171, s. 1. Exceptions Notice SOR/2019-171, s. 1. Return of permit SOR/2019-171, s. 1. Name SOR/2019-171, s. 1. e) le ministre a des motifs raisonnables de croire, sur le fondement de renseignements reçus d’une autorité compétente ou de l’Organisation des Nations Unies, que le distributeur autorisé a participé au détournement d’une drogue contrôlée vers un marché ou un usage illicites; f) la licence du distributeur autorisé a été révoquée. Exceptions

(2)

Le ministre ne peut, dans les cas visés aux alinéas (1)d) ou G.02.028(1)e) ou g), révoquer le permis d’exportation si le distributeur autorisé remplit les conditions ci-après, sauf s’il a des motifs raisonnables de croire que la révocation est nécessaire pour protéger la santé et la sécurité publiques, notamment pour prévenir le détournement d’une drogue contrôlée vers un marché ou un usage illicites : a) le distributeur autorisé n’a pas d’antécédents de contravention à la Loi, à la Loi sur le cannabis ou à leurs règlements; b) il a pris les mesures correctives nécessaires pour veiller à respecter la Loi, la Loi sur le cannabis et leurs règlements, ou s’est engagé à le faire. Préavis

(3)

Le ministre, avant de révoquer le permis d’exportation, envoie au distributeur autorisé un préavis motivé l’informant qu’il peut présenter ses observations à cet égard. DORS/2019-171, art. 1. Retour du permis G.02.049 Le distributeur autorisé retourne au ministre l’original du permis d’exportation dans les quinze jours suivant la date de prise d’effet de la révocation. DORS/2019-171, art. 1. Nom G.02.050 Le distributeur autorisé veille à ce que son nom, tel qu’il apparaît sur sa licence, figure sur tout ce qu’il utilise pour s’identifier lors de ses opérations à l’égard des drogues contrôlées, notamment les étiquettes, les bons de commande, les documents d’expédition, les factures et les publicités. DORS/2019-171, art. 1. SOR/2019-171, s. 1. Sale to pharmacist SOR/2019-171, s. 1. Sale to practitioner G.02.053 (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a practitioner. SOR/2019-171, s. 1. Provision to hospital employee SOR/2019-171, s. 1. Sale to exempted person SOR/2019-171, s. 1. SOR/2019-171, s. 1. SOR/2019-171, s. 1. Verbal order Receipt SOR/2019-171, s. 1. (a) the number of sales or provisions, not exceeding four; (b) the specific quantity for each sale or provision; and Multiple sales — insufficient stock SOR/2019-171, s. 1. Exception SOR/2019-171, s. 1. (d) in the case of a drug to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported. Exception SOR/2019-171, s. 1. SOR/2019-171, s. 1. Theft or loss — licence and permit SOR/2019-171, s. 1. Theft or unexplainable loss — controlled drug SOR/2019-171, s. 1. Suspicious transaction Good faith SOR/2019-171, s. 1. SOR/2019-171, s. 1. Destruction of Controlled Drugs SOR/2019-171, s. 1. SOR/2019-171, s. 1. (d) a brief description of the method of destruction; SOR/2019-171, s. 1. Approval SOR/2019-171, s. 1. Documents SOR/2019-171, s. 1. Information — general SOR/2019-171, s. 1. Verbal order SOR/2019-171, s. 1. (d) the explanation for the loss. SOR/2019-171, s. 1. Destruction (a) the municipal address of the place of destruction; (d) the date of destruction. SOR/2019-171, s. 1. SOR/2019-171, s. 1. SOR/2019-171, s. 1. Retention period SOR/2019-171, s. 1. SOR/2019-171, s. 1. SOR/2019-171, s. 1. DIVISION 3 [SOR/2019-171, s. 2(F)] [SOR/2019-171, s. 2] General information Record

(2)

The record of information referred to in subsection (1) shall be kept Exception SOR/78-427, s. 5; SOR/85-550, art. 4; SOR/86-881, s. 2(F); SOR/90-261, s. 3(F); SOR/97-228, s. 12; SOR/2004-238, s. 13; SOR/2010-222, s. 14(E). [SOR/2019-171, s. 3] No sale without prescription SOR/2004-238, s. 14. G.03.002.1 Subject to section G.03.002.2 and notwithstanding sections G.03.002, G.03.003 and G.03.005, no pharmacist shall SOR/2003-135, ss. 7, 8; SOR/2004-238, s. 15; SOR/2019-171, s. 4(F). Exception — notice of retraction SOR/2003-135, s. 4. Sale to practitioner — order a) si l’ordonnance est écrite, s’assurer qu’elle est signée et datée par le praticien dont elle émane et vérifier lui-même toute signature qu’il ne connaît pas; b) si l’ordonnance est verbale, prendre les précautions raisonnables pour s’assurer que la personne la prescrivant est bien un praticien. DORS/2004-238, art. 14. Interdiction — pharmacien ou praticien nommé dans un avis G.03.002.1 Sous réserve de l’article G.03.002.2 et nonobstant les articles G.03.002, G.03.003 et G.03.005, il est interdit à un pharmacien de a) vendre ou fournir une drogue contrôlée, autre qu’une préparation, à un pharmacien nommé dans un avis communiqué par le ministre selon l’article G.03.017.2; b) vendre ou fournir une préparation à un pharmacien nommé dans un avis communiqué par le ministre selon l’article G.03.017.2; c) dispenser, vendre ou fournir une drogue contrôlée, autre qu’une préparation, soit à un praticien, soit en vertu d’une ordonnance ou d’une commande faite par un praticien nommé dans un avis communiqué par le ministre en application de l’article G.04.004.2; d) dispenser, vendre ou fournir une préparation soit à un praticien, soit en vertu d’une ordonnance ou d’une commande faite par un praticien nommé dans un avis communiqué par le ministre en application de l’article G.04.004.2. DORS/2003-135, art. 7 et 8; DORS/2004-238, art. 15; DORS/2019-171, art. 4(F). Exception — avis de rétractation G.03.002.2 L’article G.03.002.1 ne s’applique pas au pharmacien auquel le ministre a donné un avis de rétractation de l’avis : a) selon l’article G.03.017.3, à l’égard de tout pharmacien nommé dans un avis donné par le ministre selon l’article G.03.017.2; b) selon l’article G.04.004.3, à l’égard de tout praticien nommé dans un avis donné par le ministre selon l’article G.04.004.2. DORS/2003-135, art. 4. Vente à un praticien — commande G.03.003 (1) Le pharmacien peut vendre ou fournir une drogue contrôlée à un praticien pour l’usage de sa pratique professionnelle dans l’une des circonstances suivantes :

(2)

[Repealed, SOR/2019-171, s. 5] SOR/85-550, s. 6; SOR/2004-238, s. 16; SOR/2012-230, s. 11; SOR/2019-171, s. 5. Prescription file SOR/2004-238, s. 17. Provision to hospital SOR/85-550, s. 6; SOR/2004-238, s. 18(E); SOR/2019-171, s. 6. Refilling prescription G.03.006 A pharmacist shall not refill a prescription for a controlled drug unless SOR/78-427, s. 6; SOR/97-228, s. 13. Records Written order or prescription (d) the name, form and quantity of the controlled drug dispensed; (f) the number assigned to the order or prescription. SOR/78-427, s. 7; SOR/81-356, s. 11(F); SOR/91-228, s. 14; SOR/2004-238, s. 19; SOR/2019-171, s. 7. Verbal order or prescription (d) the name, form and quantity of the controlled drug; SOR/85-550, s. 7; SOR/2004-238, s. 20; SOR/2019-171, s. 7. SOR/2019-171, s. 7. Retention period General Obligations of Pharmacist [SOR/2019-171, s. 8] G.03.011 A pharmacist shall (d) permit an inspector to check all stocks of controlled drugs on his premises. Loss or theft — protective measures SOR/85-550, s. 8. [SOR/2019-171, s. 9] SOR/81-589, s. 2; SOR/85-550, s. 9; SOR/99-125, s. 3; SOR/2004-238, s. 21; SOR/2014-260, s. 8; SOR/2018-69, s. 65; SOR/2019-171, s. 10. Record SOR/85-550, s. 10; SOR/2004-238, s. 22. (C) contravened this Part; or SOR/86-881, s. 1; SOR/97-228, s. 15; SOR/2003-135, s. 5; SOR/2010-222, s. 15; SOR/2019-171, s. 11. SOR/2003-135, s. 5. (i) soit l’autorité soumet au ministre une demande écrite qui précise les nom et adresse du pharmacien, la nature des renseignements demandés et une déclaration portant que les renseignements sont nécessaires pour l’aider à mener une enquête licite, (ii) soit le ministre a des motifs raisonnables de croire à l’existence de l’un des faits ci-après concernant le pharmacien : (A) il a contrevenu à une règle de conduite établie par l’autorité, (B) il a été condamné pour une infraction désignée, (C) il a contrevenu à la présente partie; b) s’agissant de l’autorité d’une province où le pharmacien n’est pas autorisé à exercer, l’autorité soumet au ministre les documents suivants : (i) une demande écrite qui précise les nom et adresse du pharmacien ainsi que la nature des renseignements demandés, (ii) un document qui démontre : (A) soit que le pharmacien a demandé à l’autorité l’autorisation d’exercer dans cette province, (B) soit que l’autorité a des motifs raisonnables de croire que le pharmacien exerce dans cette province sans autorisation. DORS/86-881, art. 1; DORS/97-228, art. 15; DORS/2003-135, art. 5; DORS/2010-222, art. 15; DORS/2019-171, art. 11. Avis d’interdiction de vente Demande du pharmacien G.03.017.1 Tout pharmacien peut demander par écrit au ministre d’envoyer aux personnes et aux autorités visées au paragraphe G.03.017.2(3) un avis, émis conformément à l’article G.03.017.2, les informant que les destinataires de l’avis ne doivent pas lui vendre ou fournir toute drogue contrôlée autre qu’une préparation, toute préparation, ou les deux. DORS/2003-135, art. 5. Avis par le ministre G.03.017.2 (1) Le ministre envoie, dans les cas prévus au paragraphe (2), un avis aux destinataires visés au paragraphe (3) les informant que les pharmaciens qui exercent dans les pharmacies ayant reçu l’avis et les distributeurs autorisés ne peuvent pas vendre ou fournir de Circumstances requiring a notice Recipients Other circumstances drogues contrôlées autres que des préparations ou de préparations au pharmacien nommé dans l’avis. Cas exigeant l’avis

(2)

Les cas exigeant l’avis sont les suivants : a) le pharmacien nommé dans l’avis en fait la demande au ministre en vertu de l’article G.03.017.1; b) il a contrevenu à une règle de conduite établie par l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où il exerce et l’autorité a demandé au ministre par écrit d’envoyer l’avis; c) il a été condamné pour une infraction désignée ou pour une contravention au présent règlement. Destinataires

(3)

Les destinataires de l’avis sont les suivants : a) tous les distributeurs autorisés; b) les pharmacies de la province où le pharmacien nommé dans l’avis, d’une part, est autorisé à exercer des lois de celle-ci à exercer sa profession et, d’autre part, l’y exerce; c) l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où le pharmacien nommé dans l’avis est autorisé à exercer; d) les pharmacies d’une province adjacente qui pourraient exécuter une commande faite par le pharmacien nommé dans l’avis; e) l’autorité provinciale attributive de licences en matière d’activités professionnelles d’une autre province qui en a fait la demande par écrit au ministre. Autres cas

(4)

Le ministre peut envoyer l’avis visé au paragraphe (1) au destinataire visé au paragraphe (3) s’il a pris les mesures prévues au paragraphe (5) et s’il a des motifs raisonnables de croire que le pharmacien nommé dans l’avis se trouve dans l’un des cas suivants : a) il a contrevenu à une disposition de la Loi ou du présent règlement; b) il s’est administré à plus d’une reprise une drogue contrôlée autre qu’une préparation autrement que de façon non conforme aux pratiques pharmaceutiques reconnues; Measures before sending notice SOR/2003-135, s. 5; SOR/2010-222, ss. 16, 36(F); SOR/2019-171, s. 12. Notice of retraction SOR/2003-135, s. 5; SOR/2010-222, s. 17; SOR/2019-171, s. 12. G.03.017.4 and G.03.017.5 [Repealed, SOR/2003-135, s. 5] DIVISION 4 Practitioners Conditions (a) in the case of persons, (i) narcolepsy, b) dans les cas visés aux alinéas G.03.017.2(2)b) et c) et (4)a) à f), le pharmacien nommé dans l’avis a satisfait aux exigences suivantes : (i) il lui a demandé par écrit d’envoyer un avis de rétractation de l’avis, (ii) il lui a fourni une lettre de l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où il est autorisé à exercer, dans laquelle l’autorité accepte la rétractation de l’avis d’interdiction. DORS/2003-135, art. 5; DORS/2010-222, art. 17; DORS/2019-171, art. 12. G.03.017.4 et G.03.017.5 [Abrogés, DORS/2003-135, art. 5]

TITRE 4

Praticiens Administration de drogues désignées et autres drogues contrôlées G.04.001 (1) Le praticien ne peut, sous réserve des paragraphes (2) et (3) ainsi que d’une exemption relative à l’administration de la drogue contrôlée que l’exemption précise et accordée en vertu de l’article 56 de la Loi, administrer une drogue contrôlée à une personne ou à un animal. Conditions

(2)

Le praticien peut administrer à une personne ou à un animal une drogue contrôlée, autre qu’une drogue désignée, si les conditions ci-après sont remplies : a) le praticien traite la personne ou l’animal à titre professionnel; b) la drogue contrôlée est nécessaire pour traiter l’état de la personne ou de l’animal. Fins visées

(3)

Le médecin, le dentiste, le vétérinaire ou l’infirmier praticien peut administrer une drogue désignée à une personne ou à un animal qu’il traite à titre professionnel si la drogue est destinée au traitement de l’un des états suivants : a) s’agissant d’une personne : (i) la narcolepsie, (ii) hyperkinetic disorders in children, (iii) epilepsy, (iv) parkinsonism, or Definitions (d) phendimetrazine and its salts; or (e) phendimetrazine and its salts. (drogue désignée) SOR/99-125, s. 4; SOR/2004-238, s. 23; SOR/2012-230, s. 12; SOR/2019-171, s. 13. Records (ii) les troubles hypercinétiques chez l’enfant, (iii) l’épilepsie, (iv) le syndrome parkinsonien, (v) l’hypotension liée à l’anesthésie; b) s’agissant d’un animal, la dépression des centres cardiaques et respiratoires. Définitions

(4)

Les définitions qui suivent s’appliquent au présent article. administrer Est assimilé au fait d’administrer une drogue celui de la prescrire, de la vendre ou de la fournir. (administer) drogue désignée S’entend des drogues contrôlées suivantes : a) amphétamine et ses sels; b) benzphétamine et ses sels; c) méthamphétamine et ses sels; d) phénmétrazine et ses sels; e) phendimétrazine et ses sels. (designated drug) DORS/99-125, art. 4; DORS/2004-238, art. 23; DORS/2012-230, art. 12; DORS/2019-171, art. 13. Documents Registre des drogues contrôlées vendues et fournies G.04.002 (1) Tout praticien qui vend ou fournit à une personne une drogue contrôlée qu’elle s’administrera à elle-même ou qu’il administrera à un animal, qu’il la facture ou non, consigne le nom et la quantité de la drogue contrôlée vendue ou fournie, les nom et adresse de la personne à laquelle elle a été vendue ou fournie et la date de la transaction, s’il s’agit d’une quantité : a) supérieure à trois fois la dose quotidienne maximale recommandée par le fabricant ou l’assembleur de la drogue contrôlée; b) supérieure à trois fois la dose thérapeutique quotidienne maximale généralement admise pour cette drogue contrôlée, si le fabricant ou l’assembleur n’a pas spécifié de dose quotidienne maximale. Accessibility of record SOR/88-482, s. 4(F); SOR/2004-238, s. 24; SOR/2019-171, s. 14. General Obligations of Practitioner [SOR/2019-171, s. 15] Requirements G.04.002A A practitioner shall (d) permit an inspector to check all stocks of controlled drugs on the practitioner’s premises; SOR/2004-238, s. 25. G.04.003 [Repealed, SOR/2010-222, s. 18] (C) contravened this Part; or SOR/96-881, s. 2; SOR/97-228, s. 17; SOR/2003-135, s. 6; SOR/2010-222, s. 19; SOR/2019-171, s. 16. (d) pharmacists practising in the notified pharmacies must not fill a prescription or order for a preparation from that practitioner. SOR/2003-135, s. 6. Circumstances requiring a notice Recipients Other circumstances et l’autorité a demandé au ministre par écrit d’envoyer l’avis; c) il a été condamné pour une infraction désignée ou pour une contravention à la présente partie. Destinataires

(3)

Les destinataires de l’avis sont les suivants : a) tous les distributeurs autorisés; b) les pharmacies de la province où le praticien nommé dans l’avis, d’une part, est inscrit et autorisé en vertu des lois de celle-ci à exercer sa profession et, d’autre part, l’y exerce; c) l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où le praticien nommé dans l’avis est inscrit et autorisé à exercer; d) les pharmacies d’une province adjacente qui pourraient exécuter une commande ou une ordonnance faites par le praticien nommé dans l’avis; e) l’autorité provinciale attributive de licences en matière d’activités professionnelles d’une autre province qui en a fait la demande par écrit au ministre. Autres cas

(4)

Le ministre peut envoyer l’avis visé au paragraphe (1) au destinataire visé au paragraphe (3) s’il a pris les mesures prévues au paragraphe (5) et s’il a des motifs raisonnables de croire que le praticien nommé dans l’avis se trouve dans l’un des cas suivants : a) il a contrevenu à une disposition de la Loi ou du présent règlement; b) il s’est administré à plus d’une reprise une drogue contrôlée, autre qu’une préparation, obtenue sur commande ou ordonnance faites par lui ou, à défaut de commande ou d’ordonnance, d’une façon non conforme aux pratiques professionnelles reconnues; c) il s’est administré à plus d’une reprise une préparation obtenue sur commande ou ordonnance faites par lui ou, à défaut de commande ou d’ordonnance, d’une façon non conforme aux pratiques professionnelles reconnues; d) il a, à plus d’une reprise, fait une ordonnance pour une drogue contrôlée autre qu’une préparation, la fournie ou l’a administrée à son époux ou conjoint de fait, à son père, à sa mère ou à son enfant, y compris Measures before sending notice SOR/2003-135, s. 6; SOR/2010-222, ss. 20, 35(F); SOR/2019-171, s. 17. Notice of retraction G.04.004.4 and G.04.004.5 [Repealed, SOR/2003-135, s. 6] DIVISION 5 Hospitals Record — controlled drugs (d) the name of the patient for whom a controlled drug was dispensed; (e) the name of the practitioner ordering or prescribing a controlled drug; and

(2)

Subject to subsections (3) and (4), the record of information referred to in subsection (1) shall be kept Exception — preparation

(3)

The information referred to in paragraphs (1)(d) to (f) may, with respect to a preparation, be kept in a form other than that specified in paragraph (2)(b). Exception — Part II or III of schedule SOR/87-472, s. 8; SOR/85-500, s. 11; SOR/88-482, s. 18; SOR/97-228, s. 18; SOR/2004-238, s. 22; SOR/2019-171, s. 18(F). (d) permit an inspector to check all stocks of controlled drugs in the hospital. SOR/2019-171, s. 26(F). Emergency — pharmacist Signature SOR/85-550, s. 12; SOR/88-482, s. 7; SOR/2004-238, s. 28; SOR/2010-222, s. 22(F); SOR/2019-171, s. 15(F); SOR/2019-171, s. 25(F). Loss or theft SOR/78-427, s. 9. DIVISION 6 (a) the name and municipal address of the pharmacy or pharmacist; fourni pour une urgence à un employé d’un autre hôpital ou à un praticien exerçant dans un autre hôpital, sur réception d’une commande écrite, signée et datée par le pharmacien de l’autre hôpital ou par le praticien autorisé par le responsable de l’autre hôpital à signer une telle commande. Urgence — pharmacien

(4)

Sous réserve du paragraphe (6), le responsable d’un hôpital peut permettre qu’une drogue contrôlée soit vendue ou fournie à un pharmacien pour une urgence, sur réception d’une commande écrite, signée et datée par ce pharmacien. Recherche

(5)

Le responsable d’un hôpital peut permettre qu’une drogue contrôlée soit fournie, à des fins de recherches, à un employé d’un laboratoire de recherche de cet hôpital. Signature

(6)

Il est interdit au responsable d’un hôpital de permettre que la drogue contrôlée soit vendue ou fournie en vertu des paragraphes (3) ou (4) à moins que la personne qui vend ou fournit la drogue contrôlée ne reconnaisse la signature du pharmacien de l’autre hôpital ou du praticien autorisé à signer une commande par le responsable de l’autre hôpital ou ne l’ait vérifiée. DORS/85-550, art. 12; DORS/88-482, art. 7; DORS/2004-238, art. 28; DORS/2010-222, art. 22(F); DORS/2019-171, art. 15(F); DORS/2019-171, art. 25(F). Pertes et vols G.05.004 Le responsable d’un hôpital doit prendre toutes les mesures nécessaires pour empêcher, dans son établissement, la perte ou le vol de drogues contrôlées et doit signaler au ministre toute perte ou tout vol dans les 10 jours en suivant la découverte. DORS/78-427, art. 9.

TITRE 6

Dispositions générales Étiquetage — drogue dispensée conformément à une ordonnance G.06.001 L’article C.01.004 ne s’applique pas à la drogue contrôlée dispensée par un pharmacien conformément à une ordonnance, mais les renseignements ci-après doivent figurer sur l’étiquette de l’emballage de la drogue contrôlée : a) les nom et adresse municipale de la pharmacie ou du pharmacien; (b) the date and number of the prescription; (d) the name of the practitioner; SOR/89-125, s. 6; SOR/2004-238, s. 29; SOR/2018-69, ss. 67, 69; SOR/2019-171, s. 20. Labelling — test kit SOR/85-550, s. 13; SOR/88-482, s. 8(F); SOR/89-125, s. 6; SOR/2019-171, s. 20. G.06.002.1 [Repealed, SOR/2019-171, s. 20] G.06.002.2 [Repealed, SOR/2019-171, s. 20] G.06.002.3 [Repealed, SOR/2019-171, s. 20] G.06.002.4 [Repealed, SOR/2019-171, s. 20] (a) a practitioner of medicine; or Agent or mandatary of practitioner of medicine (a) the practitioner; or (b) the Minister. Practitioner of medicine b) la date et le numéro de l’ordonnance; c) le nom de la personne pour laquelle la drogue contrôlée est dispensée; d) le nom du praticien; e) le mode d’emploi; f) tout autre renseignement devant figurer, conformément à l’ordonnance, sur l’étiquette. DORS/89-125, art. 5; DORS/2004-238, art. 29; DORS/2018-69, art. 67 et 69; DORS/2019-171, art. 20. Étiquetage — nécessaire d’essai G.06.002 L’article C.01.004 ne s’applique pas au nécessaire d’essai qui contient une drogue contrôlée et auquel un numéro d’enregistrement a été attribué. DORS/85-550, art. 13; DORS/88-482, art. 8(F); DORS/89-125, art. 6; DORS/2019-171, art. 20. G.06.002.1 [Abrogé, DORS/2019-171, art. 20] G.06.002.2 [Abrogé, DORS/2019-171, art. 20] G.06.002.3 [Abrogé, DORS/2019-171, art. 20] G.06.002.4 [Abrogé, DORS/2019-171, art. 20] Identification ou analyse de drogues contrôlées G.06.003 (1) Toute personne peut, malgré toute disposition de la présente partie, fournir ou livrer une drogue contrôlée à des fins d’identification ou d’analyse aux personnes suivantes : a) le médecin; b) le mandataire d’un médecin, si le mandataire bénéficie d’une exemption relative à la possession de cette drogue à ces fins et accordée en vertu de l’article 56 de la Loi. Mandataire d’un médecin

(2)

Le mandataire d’un médecin qui reçoit la drogue contrôlée la fournit ou la livre immédiatement à l’une des personnes suivantes : a) le médecin; b) le ministre. Médecin

(3)

Le médecin qui reçoit la drogue contrôlée la fournit ou la livre immédiatement à l’une des personnes suivantes : DIVISION 6 General Sections G.06.003-G.06.005 (b) to the Minister. SOR/2019-171, s. 20. SOR/2019-171, s. 20. (iii) details of the use of the controlled drug; SOR/2019-171, s. 20. Règlement sur les aliments et drogues

PARTIE G Drogues contrôlées

TITRE 6 Dispositions générales

Articles G.06.003-G.06.005

a) la personne qui bénéficie d’une exemption relative à la possession de cette drogue à ces fins et accordée en vertu de l’article 56 de la Loi si la drogue lui est fournie ou livrée à des fins d’identification ou d’analyse; b) le ministre. DORS/2019-171, art. 20. Publicité G.06.004 Il est interdit, à l’égard d’une drogue contrôlée: a) d’en faire la publicité auprès du grand public; b) d’en faire la publicité par écrit, sauf si le symbole ci-après figure de façon bien visible, par sa couleur et sa taille, sur le quart supérieur gauche de la première page de la publicité: DORS/2019-171, art. 20. Conservation des documents — cas spécifiques G.06.005 La personne qui bénéficie d’une exemption relative à la possession ou à l’administration d’une drogue contrôlée et accordée en vertu de l’article 56 de la Loi ainsi le médecin qui a reçu une drogue contrôlée en vertu des paragraphes G.06.003(1) ou (2) et le mandataire d’un médecin qui a reçu une drogue contrôlée en vertu du paragraphe G.06.003(1) doivent satisfaire aux exigences suivantes: a) ils consignent dans un registre les renseignements ci-après et les conservent pendant une période de deux ans suivant la date de leur consignation: (i) le nom et la quantité de toute drogue contrôlée achetée ou reçue ainsi que la date de l’achat ou de la réception, (ii) les nom et adresse de la personne de qui ils ont acheté et de qui ils ont reçu la drogue contrôlée, (iii) les précisions concernant l’utilisation de la drogue contrôlée; b) ils fournissent au ministre tout renseignement que celui-ci exige à l’égard de la drogue contrôlée; c) ils donnent accès aux registres dont la tenue est requise par la présente partie. DORS/2019-171, art. 20. Definitions SOR/2019-171, s. 20. Content of notification

(2)

The notification must specify SOR/2019-171, s. 20. G.07.001 [Repealed, SOR/2019-171, s. 20] G.07.002 [Repealed, SOR/2019-171, s. 20] SCHEDULE (Sections G.01.001 and G.01.002, subsections G.01.005(1) and G.02.058(1), section G.02.073, subsection G.03.001(3), paragraph G.03.006(a), section G.03.007 and subsection G.05.001(4)) PART I

(1)

amphetamine (α-methylbenzeneethanamine)

(2)

methamphetamine (N,α-dimethylbenzeneethanamine)

(3)

Benzphetamine (N-benzyl-N,α-dimethylbenzeneethanamine)

(1)

Ethylphenidate (ethyl 2-phenyl-2-(piperidin-2-yl)acetate)

(2)

Isopropylphenidate (isopropyl 2-phenyl-2-(piperidin-2-yl)acetate)

(3)

Propylphenidate (propyl 2-phenyl-2-(piperidin-2-yl)acetate)

(4)

3,4-Dichloromethylphenidate (methyl 2-(3,4-dichlorophenyl)-2-(piperidin-2-yl)acetate)

(5)

4-Methylmethylphenidate (methyl 2-(4-methylphenyl)-2-(piperidin-2-yl)acetate)

(6)

4-Fluoromethylphenidate (methyl 2-(4-fluorophenyl)-2-(piperidin-2-yl)acetate)

(7)

Methylnaphthidate (methyl 2-(naphthalen-2-yl)-2-(piperidin-2-yl)acetate)

(8)

Ethylnaphthidate (ethyl 2-(naphthalen-2-yl)-2-(piperidin-2-yl)acetate) 6 Pentobarbital (ethyl 1-methyl-5 pentylbarbiturate) 6 Pentobarbital (5-ethyl-5-(1-methylbutyl)barbituric acid) 7 Secobarbital (5-allyl-5-(1-methylbutyl)barbituric acid)

(1)

4-Methylaminorex (4-methyl-5-phenyl-4,5-dihydro-1,3-oxazol-2-amine)

(2)

4,4'-Dimethylaminorex (4-methyl-5-(4-methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine) 10 Fentanyline (d,l-3,7-dihydro-1,3-dimethyl-1-7-(2-(1-methyl-2-phenethyl)amino)ethyl)-1H-purine-2,6-dione) and any salt thereof 11 Glutethimide (2-ethyl-2-phenylglutarimide) 13 Mecloqualone (2-methyl-3-(2-chlorophenyl)-4(3H)-quinazolinone) and any salt thereof 14 Mesocarb (3-(α-methylphenethyl)-N-(phenylcarbamoyl)sydnone imine) and any salt thereof 15 Pemoline (2-amino-5-phenyl-oxazolin-4-one) and any salt thereof 16 Zipeprol (4-(2-methoxy-2-phenylethyl)-α-(methoxyphenylmethyl)-1-piperazineethanol) and any salt thereof 17 Amineptine (7-[[10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid) and any salt thereof PART II

(1)

Allobarbital (5,5-diallylbarbituric acid)

(2)

Alphenal (5-allyl-5-phenylbarbituric acid)

(3)

Amobarbital (5-ethyl-5-(3-methylbutyl)barbituric acid)

(4)

Aprobarbital (5-allyl-5-isopropylbarbituric acid)

(5)

Barbital (5,5-diethylbarbituric acid)

(6)

[Repealed, SOR/2017-12, s. 1]

(7)

Butabarbital (5-sec-butyl-5-ethylbarbituric acid)

(8)

Butalbital (5-allyl-5-isobutylbarbituric acid)

(9)

Butallylonal (5-(2-bromoallyl)-5-sec-butylbarbituric acid)

(10)

Butethal (5-butyl-5-ethylbarbituric acid)

(11)

Cyclobarbital (5-(1-cyclohexen-1-yl)-5-ethylbarbituric acid)

(12)

Cyclopal (5-allyl-5-(2-cyclopenten-1-yl)barbituric acid)

(13)

Heptabarbital (5-(1-cyclohepten-1-yl)-5-ethylbarbituric acid)

(14)

Hexethal (5-ethyl-5-hexylbarbituric acid)

(15)

Hexobarbital (5-(1-cyclohexen-1-yl)-1,5-dimethylbarbituric acid)

(16)

Methoparbital (5-ethyl-1-methyl-5-phenylbarbituric acid)

(17)

Methabarbital (5,5-diethyl-1-methylbarbituric acid)

(18)

Methylphenobarbital (5-ethyl-1-methyl-5-phenylbarbituric acid)

(19)

Propallylonal (5-(2-bromoallyl)-5-isopropylbarbituric acid)

(20)

Phenobarbital (5-ethyl-5-phenylbarbituric acid)

(21)

Probarbital (5-ethyl-5-isopropylbarbituric acid)

(22)

Phenylmethylbarbituric Acid (5-methyl-5-phenylbarbituric acid)

(23)

Sigmodal (5-(2-bromoallyl)-5-(1-methylbutyl)-barbituric acid)

(24)

Talbutal (5-allyl-5-sec-butylbarbituric acid)

(25)

Vinbarbital (5-ethyl-5-(1-methyl-1-butenyl)barbituric acid)

(26)

Vinylbital (5-(1-methylbutyl)-5-vinylbarbituric acid)

(1)

Thiabarbital (5-allyl-5-(2-cyclohexen-1-yl)-2-thiobarbituric acid) SCHEDULE

Section G.07.002

(2)

Thiamylal (5-allyl-5-(1-methylbutyl)-2-thiobarbituric acid)

(3)

Thiobarbituric Acid (2-thiobarbituric acid)

(4)

Thiopental (5-ethyl-5-(1-methylbutyl)-2-thiobarbituric acid) 3 Chlorphentermine (1-(p-chlorophenyl)-2-methyl-2-aminopropane) and any salt thereof 5 Phentermine (α,α-dimethylbenzeneethanamine) and any salt thereof 6 Butorphanol (1-N-cyclobutylmethyl-3,14-dihydroxymorphinan) and its salts 7 Nalbuphine (N-cyclobutylmethyl-4,5-epoxy-morphinan-3,6,14-triol) and any salt thereof PART III

(1)

Androisoxazole (17ß-hydroxy-17α-methylandrostano[3,2-c]isoxazole)

(2)

Androstanolone (17ß-hydroxy-5α-androstan-3-one)

(3)

Androstenediol (androst-5-ene-3ß,17ß-diol)

(4)

Bolandiol (estr-4-ene-3ß,17ß-diol)

(5)

Bolasterone (17ß-hydroxy-7α,17-dimethylandrosta-4-en-3-one)

(6)

Bolazine (17ß-hydroxy-2α-methyl-5α-androstan-3-one azine)

(7)

Boldenone (17ß-hydroxyandrost-1,4-dien-3-one)

(8)

Bolenol (19-nor-17α-pregn-5-en-17-ol)

(9)

Calusterone (17ß-hydroxy-7ß,17-dimethylandrosta-4-en-3-one)

(10)

Clostebol (4-chloro-17ß-hydroxyandrosta-4-en-3-one) --- Règlement sur les aliments et drogues

PARTIE G Drogues contrôlées

ANNEXE

Article G.07.002

(26)

vinylbital (acide (méthyl-1 butyl)-5 vinyl-5 barbiturique) 2 Thiobarbituriques, ainsi que leurs sels et dérivés, notamment :

(1)

thialbital (acide allyl-5 (cyclohexène-2 yl-1)-5 thio-2 barbiturique)

(2)

thiamylal (acide allyl-5 (méthyl-1 butyl)-5 thio-2 barbiturique)

(3)

acide thiobarbiturique (acide thio-2 barbiturique)

(4)

thiopental (acide éthyl-5 (méthyl-1 butyl)-5 thio-2 barbiturique) 3 Chlorphentermine (p-chlorophényl)-1 méthyl-2 amino-2 propane) et ses sels 4 Diéthylpropion (diéthylamino-2 propiophénone) et ses sels 5 Phentermine (α,α-diméthylbenzèneéthanamine) et ses sels 6 Butorphanol (1-N-cyclobutylméthyl dihydroxy-3,14 morphinane) et ses sels 7 Nalbuphine (N-cyclobutylméthyl époxy-4,5 morphinane-3,6,14) et ses sels 8 Pyrovalérone (méthyl-4′(pyrrolidinyl-1)-2 valérophénone) et ses sels

PARTIE III

1 Stéroïdes anabolisants et leurs dérivés, notamment :

(1)

androisoxazole (hydroxy-17ß méthyl-17α androstano[3,2-c]isoxazole)

(2)

androstanolone (hydroxy-17ß 5α-androstano-3)

(3)

androstènediol (androstène-5 diol-3ß,17ß)

(4)

bolandiol (estrène-4 diol-3ß,17ß)

(5)

bolastérone (hydroxy-17ß diméthyl-7α,17 androstène-4 one-3)

(6)

bolazine (hydroxy-17ß méthyl-2α 5α-androstano-3 azine)

(7)

boldénone (hydroxy-17ß androstadiène-1,4 one-3)

(8)

bolénol (nor-19-17α-prégnène-5 ol-17)

(9)

calustérone (hydroxy-17ß diméthyl-7ß,17 androstène-4 one-3)

(10)

clostébol (chloro-4 hydroxy-17ß androstène-4 one-3)

(11)

Drostanolone (17ß-hydroxy-2α-methyl-5α-androstan-3-one)

(12)

Enestebol (4,17ß-dihydroxy-17-methylandrosta-1,4-dien-3-one)

(13)

Epitiostanol (2α,3α-epithio-5α-androstan-17ß-ol)

(14)

Ethylestrenol (19-nor-17α-pregn-4-en-17-ol)

(15)

4-Hydroxy-19-nor testosterone

(16)

Fluoxymesterone (9-fluoro-11ß,17ß-dihydroxy — 17-methylandrosta-4-en-3-one)

(17)

Formebolone (11α,17ß-dihydroxy-17-methyl-3-oxoandrosta-1,4-dien-2-carboxaldehyde)

(18)

Furazabol (17-methyl-5α-androstano[2,3-c]furazan-17ß-ol)

(19)

Mebolazine (17ß-hydroxy-2α,17-dimethyl-5α-androstan-3-one azine)

(20)

Mesabolone (17ß-[(1-methoxycyclohexyl)oxy]-5α-androst-1-en-3-one)

(21)

Mesterolone (17ß-hydroxy-1α-methyl-5α-androstan-3-one)

(22)

Metandienone (17ß-hydroxy-17-methylandrosta-1,4-dien-3-one)

(23)

Metenolone (17ß-hydroxy-1-methyl-5α-androst-1-en-3-one)

(24)

Methandriol (17α-methylandrosta-5-ene-3ß,17ß-diol)

(25)

Methyltestosterone (17ß-hydroxy-17-methyl-androst-4-en-3-one)

(26)

Metribolone (17ß-hydroxy-17-methylestra-4,9,11-trien-3-one)

(27)

Mibolerone (17ß-hydroxy-7α,17-dimethylester-4-en-3-one)

(28)

Nandrolone (17ß-hydroxyestr-4-en-3-one)

(29)

Norboletone (13-ethyl-17ß-hydroxy-18,19-dinorpregn-4-en-3-one)

(30)

Norclostebol (4-chloro-17ß-hydroxyestr-4-en-3-one)

(31)

Norethandrolone (17α-ethyl-17ß-hydroxyestr-4-en-3-one)

(32)

Oxabolone (4,17ß-dihydroxyestr-4-en-3-one)

(33)

Oxandrolone (17ß-hydroxy-17-methyl-2-oxa-5α-androstan-3-one)

(34)

Oxymesterone (4,17ß-dihydroxy-17-methylandrosta-4-en-3-one) DIVISION 6 General

Section J.01.001

(35)

Oxymetholone (17ß-hydroxy-2- (hydroxymethylene)-17-methyl-5α- androstan-3-one)

(36)

Prasterone (3ß-hydroxyandrost-5-en-17- one)

(37)

Quinbolone (17ß-1'-cyclopenten-1- yloxy)androsta-1,4-dien-3-one)

(38)

Stanozolol (17ß-hydroxy-17-methyl-5α- androstano[3,2-c]pyrazole)

(39)

Stenbolone (17ß-hydroxy-2-methyl-5α- androst-1-en-3-one)

(40)

Testosterone (17ß-hydroxyandrost-4-en-3- one)

(41)

Tibolone ((7α,17α)-17-hydroxy-7- methyl-19-norpregn-5(10)-en-20-yn-3-one)

(42)

Timosetrone (1α,7α-bis(acetylthio)-17ß- hydroxy-17α-methylandrosta-4-en-3-one)

(43)

Trenbolone (17ß-hydroxyestra-4,9,11- trien-3-one) 2 Zeranol (3,4,5,6,7,8,9,10,11,12- decahydro-7,14,16-trihydroxy-3-methyl-1H-2- benzoxacyclotetradecin-1-one) PART J Restricted Drugs Definitions Definitions Règlement sur les aliments et drogues

PARTIE G Drogues contrôlées

TITRE 6 Dispositions générales

Article J.01.001

(35)

oxymétholone (hydroxy-17ß (hydroxyméthylène)-2 méthyl-17-5α- androstano-3-one)

(36)

prastérone (hydroxy-3ß androstène-5 one-17)

(37)

quinbolone (cyclopentényl-1 oxy-1)-17ß androstadiène-1,4 one-3)

(38)

stanozolol (hydroxy-17ß méthyl-17 5α- androstano[3,2-c]pyrazole)

(39)

stenbolone (hydroxy-17ß méthyl-2 5α- androstène-1 one-3)

(40)

testostérone (hydroxy-17ß androstène-4 one-3)

(41)

tibolone (hydroxy-17ß méthyl-7α nor-19 17α-prégnène-5(10) yn-20 one-3)

(42)

timosétrone (bis(acétylthio)-1α,7α hydroxy-17ß méthyl androstène-4 one-3)

(43)

trenbolone (hydroxy-17ß estra-4,9,11 one-3) 2 Zéranol (trihydroxy-7,14,16 méthyl-3 décahydro-3,4,5,6, 7,8,9,10,11,12 1H-benzoxa-2 cyclotétradécin-1-one)

PARTIE J

Drogues d’usage restreint Définitions Définitions J.01.001 Les définitions qui suivent s’appliquent la présente partie. autorité compétente Organisme public d’un pays étranger qui est habilité, au titre des lois du pays, à consentir à l’importation ou à l’exportation de drogues d’usage restreint. (competent authority) chercheur compétent Personne ci-après autorisée par le ministre, en vertu du paragraphe J.01.059(4), à utiliser et à posséder une drogue d’usage restreint : a) celle qui est employée par un établissement ou qui y est associée; (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d). (infraction désignée en matière criminelle) licensed dealer means the holder of a licence issued under section J.01.015. (distributeur autorisé) b) celle qui fait des essais cliniques ou de la recherche en laboratoire à l’égard de cette drogue à un établissement. (qualified investigator) composé Vise notamment les préparations. (compound) destruction S’agissant d’une drogue d’usage restreint, le fait de l’altérer ou de la dénaturer au point d’en rendre la consommation impossible ou improbable. (destroy) Directive en matière de sécurité La Directive sur les exigences en matière de sécurité physique pour les substances désignées et les drogues contenant du cannabis, avec ses modifications successives, publiée par le gouvernement du Canada sur son site Web. (Security Directive) distributeur autorisé Titulaire d’une licence délivrée au titre de l’article J.01.015. (licensed dealer) drogue d’usage restreint S’entend des substances désignées qui sont visées à l’annexe de la présente partie. (restricted drug) emballage Vise notamment toute chose dans laquelle une drogue d’usage restreint est, en tout ou en partie, contenue, placée ou empaquetée. (package) établissement Établissement qui fait de la recherche sur les drogues, y compris l’hôpital, l’université au Canada, le ministère ou l’organisme du gouvernement du Canada ou du gouvernement d’une province ou une partie quelconque de ceux-ci. (institution) étiquette S’entend au sens de l’article 2 de la Loi sur les aliments et drogues. (label) hôpital L’établissement, selon le cas : a) qui peut, au titre d’une licence, d’une autorisation ou d’une désignation délivrée par une province sous le régime de ses lois, fournir des soins ou des traitements aux personnes ou aux animaux atteints d’une maladie ou d’une affection; b) qui fournit des services de santé et qui soit appartenant au gouvernement du Canada ou au gouvernement d’une province, soit est exploité par lui. (hospital) infraction désignée en matière criminelle S’entend des infractions suivantes : a) infraction relative au financement du terrorisme visée à l’un des articles 83.02 à 83.04 du Code criminel; pharmacist [Repealed, SOR/2021-271, s. 1] prescription [Repealed, SOR/2021-271, s. 1] (b) engaged in clinical testing or laboratory research in an institution in respect of that drug. (chercheur compétent) qualified person in charge means the individual designated under subsection J.01.012(1). (responsable qualifié) (b) infraction de fraude visée à l’un des articles 380 à 382 du Code criminel; c) infraction de recyclage des produits de la criminalité visée à l’article 462.31 du Code criminel; d) infraction relative à une organisation criminelle visée à l’un des articles 467.11 à 467.13 du Code criminel; e) tentative ou complot en vue de commettre une infraction visée à l’un des alinéas a) à d), complicité après le fait à son égard ou fait de conseiller de la commettre. (designated criminal offence) Loi La Loi réglementant certaines drogues et autres substances. (Act) nécessaire d’essai Nécessaire qui a les caractéristiques suivantes : a) il contient d’une part une drogue d’usage restreint et d’autre part un réactif ou une substance tampon; b) il est utilisé dans un processus chimique ou analytique de dépistage ou de quantification d’une drogue d’usage restreint à des fins médicales, industrielles, éducatives, pour des travaux de laboratoire ou de recherche ou pour l’application ou l’exécution de la loi; c) son contenu n’est pas destiné à être consommé par une personne ou un animal, ni à leur être administré et il n’est pas susceptible de l’être. (test kit) nom propre S’agissant d’une drogue d’usage restreint, l’un des noms français ou anglais suivants : a) celui figurant à l’article C.01.002; b) celui figurant en caractères gras dans le présent règlement et, si elle est délivrée sous une autre forme que celle visée à la partie C sous laquelle la drogue est désignée; c) s’agissant d’une drogue non visée aux alinéas a) ou b), celui figurant dans l’une des publications mentionnées à l’annexe B de la Loi sur les aliments et drogues. (proper name) obligation internationale Toute obligation relative à une drogue d’usage restreint prévue par une convention, un traité ou un autre instrument multilatéral ou bilatéral que le Canada a ratifié ou auquel il adhère. (international obligation) ordonnance [Abrogée, DORS/2021-271, art. 1] pharmacien [Abrogée, DORS/2021-271, art. 1] (c) the contents of which are not intended or likely to be consumed by, or administered to, a person or an animal. (nécessaire d’essai) SOR/98-282, s. 22; SOR/2004-238, s. 31; SOR/2013-172, s. 1; SOR/2019-171, s. 22; SOR/2021-271, s. 1. SOR/98-282, s. 23; SOR/99-125, s. 7; SOR/2010-222, s. 23; SOR/2015-210, s. 2; SOR/2018-85, s. 1; SOR/2019-171, s. 22. SOR/2004-238, s. 32; SOR/2019-171, s. 22. J.01.003.1 [Repealed, SOR/2019-171, s. 22] J.01.003.2 [Repealed, SOR/2019-171, s. 22] Possession Authorized persons (d) a person exempted under section 56 of the Act with respect to the possession of that drug; and (e) the Minister. Agent or mandatary SOR/2019-171, s. 22; SOR/2021-271, s. 2. J.01.004.1 [Repealed, SOR/2019-171, s. 22] Test Kits (i) the name of the manufacturer, (iii) the registration number; and SOR/2019-171, s. 22. SOR/2019-171, s. 22. Issuance of registration number (i) le nom du fabricant, (ii) le nom commercial ou la marque de commerce, (iii) le numéro d’enregistrement; c) le nécessaire d’essai sera utilisé à des fins médicales, industrielles ou éducatives, pour des travaux de laboratoire ou de recherche ou pour l’application ou l’exécution de la loi. DORS/2019-171, art. 22. Numéro d’enregistrement — demande J.01.006 (1) Le fabricant d’un nécessaire d’essai peut obtenir un numéro d’enregistrement en présentant au ministre une demande qui contient les renseignements suivants : a) une description détaillée de la conception et de la fabrication du nécessaire d’essai; b) une description détaillée de la drogue d’usage restreint et, le cas échéant, des autres substances que contient le nécessaire d’essai, ainsi que la description qualitative et quantitative de chacun des composants; c) une description de l’utilisation à laquelle est destiné le nécessaire d’essai. Signature et attestation

(2)

La demande satisfait aux exigences suivantes : a) elle est signée et datée par la personne autorisée à cette fin par le demandeur; b) elle comprend une attestation de celle-ci portant qu’à sa connaissance, tous les renseignements fournis à l’appui de la demande sont exacts et complets. Renseignements et documents complémentaires

(3)

Le demandeur fournit au ministre, au plus tard à la date précisée dans la demande écrite de celui-ci et à cet effet, tout renseignement ou document que le ministre juge nécessaire pour compléter l’examen de la demande du numéro d’enregistrement. DORS/2019-171, art. 22. Numéro d’enregistrement — attribution J.01.007 Le ministre, au terme de l’examen de la demande de numéro d’enregistrement, attribue un numéro d’enregistrement précédé des lettres « TK » au nécessaire SOR/2004-238, s. 33; SOR/2010-222, s. 25; SOR/2014-260, ss. 9, 16(F); SOR/2019-171, s. 22. J.01.007.1 [Repealed, SOR/2019-171, s. 22] J.01.007.2 [Repealed, SOR/2019-171, s. 22] J.01.007.3 [Repealed, SOR/2019-171, s. 22] J.01.007.4 [Repealed, SOR/2019-171, s. 22] J.01.007.5 [Repealed, SOR/2019-171, s. 22] J.01.007.6 [Repealed, SOR/2019-171, s. 22] J.01.007.7 [Repealed, SOR/2019-171, s. 22] J.01.007.8 [Repealed, SOR/2019-171, s. 22] J.01.007.9 [Repealed, SOR/2019-171, s. 22] J.01.007.91 [Repealed, SOR/2019-171, s. 22] Cancellation of registration number SOR/2019-171, s. 22. Authorized Activities Permit — import and export SOR/2019-171, s. 22. Dealer’s Licences Preliminary Requirements Eligible persons (a) an individual who ordinarily resides in Canada; SOR/2019-171, s. 22. SOR/2004-238, s. 34; SOR/2019-171, s. 22. Qualifications (a) they work at the site specified in the dealer’s licence; Exception SOR/2004-238, s. 34; SOR/2010-222, s. 30; SOR/2019-171, s. 22. J.01.012.1 [Repealed, SOR/2019-171, s. 22] J.01.012.2 [Repealed, SOR/2019-171, s. 22] Ineligibility SOR/2004-238, s. 34; SOR/2019-171, s. 22. Issuance of Licence Application (i) an individual, the individual’s name, désignée au sens du paragraphe 2(1) de la Loi sur le cannabis : (i) soit a été condamné en tant qu’adulte, (ii) soit s’est vu imposer en tant qu’adolescent, au sens du paragraphe 2(1) de la Loi sur le système de justice pénale pour les adolescents, une peine applicable aux adultes, au sens de ce paragraphe; b) à l’égard d’une infraction commise dans un pays étranger qui, si elle avait été commise au Canada, aurait constitué une infraction désignée en matière de substances, une infraction criminelle désignée ou une infraction désignée au sens du paragraphe 2(1) de la Loi sur le cannabis : (i) soit a été condamné en tant qu’adulte, (ii) soit s’est vu imposer, pour une infraction commise alors qu’il avait au moins quatorze ans et au moins de dix-huit ans, une peine plus longue que la peine maximale prévue par la peine spécifique, au sens du paragraphe 2(1) de la Loi sur le système de justice pénale pour les adolescents pour une telle infraction. DORS/2004-238, art. 34; DORS/2019-171, art. 22. Délivrance d’une licence Demande J.01.014 (1) La personne qui prévoit effectuer l’une des opérations visées à l’article J.01.009 doit obtenir une licence de distributeur autorisé pour chaque installation où elle prévoit effectuer celle-ci en présentant au ministre une demande qui contient les renseignements suivants : a) les précisions ci-après à l’égard de la personne qui demande la licence : (i) s’agissant d’un individu, son nom, (ii) s’agissant d’une personne morale, sa dénomination sociale et tout autre nom enregistré dans une province sous lequel elle entend effectuer les opérations précisées dans sa licence de distributeur autorisé ou s’identifier, (iii) s’agissant du titulaire d’un poste visé à l’alinéa J.01.010c), son nom et le titre de son poste; b) l’adresse municipale, le numéro de téléphone et, le cas échéant, l’adresse électronique de l’installation même que, si elle diffère de l’adresse municipale, son adresse postale; (i) the name of the restricted drug, Documents (i) a copy of the person’s diploma, certificate or credential referred to in subparagraph J.01.012(3)(b)(ii) or (iii), or SOR/2019-171, s. 22. de ce pays précisant si elle a fait l’objet d’une condamnation visée au sous-alinéa J.01.013b)(i) ou s’est vu imposer une peine visée au sous-alinéa J.01.013b)(ii) dans ce pays au cours de cette période; e) une déclaration, signée et datée par le responsable principal, attestant que le responsable qualifié et tout responsable qualifié suppléant proposés ont les connaissances et l’expérience exigées aux alinéas J.01.012(3)c) et d); f) dans le cas où le responsable qualifié ou tout responsable qualifié suppléant proposé ne satisfaisait pas à l’exigence visée au sous-alinéa J.01.012(3)b)(i) : (i) une copie du diplôme, du certificat ou de l’attestation visé aux sous-alinéas J.01.012(3)b)(ii) ou (iii), (ii) une description détaillée des études, de la formation et de l’expérience de travail visées à l’alinéa J.01.012(4)c), accompagnée de pièces justificatives telles une copie des relevés de notes ou de l’attestation faite par la personne qui a dispensé la formation. Signature et attestation

(3)

La demande satisfait aux exigences suivantes : a) elle est signée et datée par le responsable principal proposé; b) elle comprend une attestation de celui-ci portant sur les faits suivants : (i) à sa connaissance, tous les renseignements et documents fournis à l’appui de la demande sont exacts et complets, (ii) il est habilité à lier le demandeur. Renseignements et documents complémentaires

(4)

Le demandeur fournit au ministre, au plus tard à la date précisée dans la demande écrite de celui-ci à cet effet, tout renseignement ou document que le ministre juge nécessaire pour compléter l’examen de la demande de licence. DORS/2019-171, art. 22. Issuance (a) the licence number; (d) the municipal address of the site at which the dealer may conduct the authorized activities; (f) the effective date of the licence; SOR/2019-171, s. 22. Validity SOR/2019-171, s. 22. Refusal Délivrance J.01.015 Le ministre, au terme de l’examen de la demande de licence et sous réserve de l’article J.01.017, délivre une licence de distributeur autorisé, avec ou sans conditions, qui contient les renseignements suivants : a) le numéro de la licence; b) le nom du distributeur, sa dénomination sociale ou le titre de son poste; c) les opérations autorisées et le nom des drogues d’usage restreint visées par chacune de celles-ci; d) l’adresse municipale de l’installation où le distributeur peut effectuer les opérations autorisées; e) le niveau de sécurité applicable à l’installation, établi conformément à la Directive en matière de sécurité; f) la date de prise d’effet de la licence; g) la date d’expiration de la licence, qui ne peut être postérieure à la troisième année suivant sa prise d’effet; h) toute condition que le ministre estime nécessaire, sur le fondement de motifs raisonnables, pour atteindre l’une des fins suivantes : (i) le respect d’une obligation internationale, (ii) la conformité aux exigences associées au niveau de sécurité visé à l’alinéa e), (iii) la réduction d’un risque d’atteinte à la sécurité ou à la santé publiques, notamment le risque de détournement d’une drogue d’usage restreint vers un marché ou un usage illicite; i) si le distributeur produit une drogue d’usage restreint, la quantité qu’il peut produire et la période de production autorisée. DORS/2019-171, art. 22. Validité J.01.016 La licence de distributeur autorisé est valide jusqu’à la date d’expiration qui y est indiquée ou, si elle est antérieure, jusqu’à la date de sa suspension ou de sa révocation au titre des articles J.01.035 ou J.01.036. DORS/2019-171, art. 22. Refus J.01.017 (1) Le ministre refuse de délivrer une licence de distributeur autorisé dans les cas suivants : (a) the applicant may not apply for a licence under section J.01.010; a) le demandeur ne peut pas demander une licence en vertu de l’article J.01.010; b) le demandeur a contrevenu, dans les dix années précédant la présentation de la demande de licence : (i) soit à une disposition de la Loi, de la Loi sur le cannabis ou de leurs règlements, (ii) soit à une condition d’une licence ou d’un permis qui lui a été délivré en vertu d’un règlement pris en vertu de la Loi ou qui lui a été délivré en vertu de la Loi sur le cannabis ou de ses règlements; c) dans les dix années précédant la présentation de la demande de licence, le responsable principal, le responsable qualifié ou tout responsable qualifié suppléant proposé a fait l’objet d’une condamnation visée aux sous-alinéas J.01.013a)(i) ou b)(i) ou a subi une peine visée aux sous-alinéas J.01.013a)(ii) ou b)(ii); d) l’une des opérations pour lesquelles la licence est demandée entraînerait la violation d’une obligation internationale; e) le demandeur n’a pas mis en place à l’installation les mesures de sécurité prévues dans la Directive en matière de sécurité à l’égard d’une opération pour laquelle il demande la licence; f) la méthode visée à l’alinéa J.01.014(1)(j) ne permet pas la consignation des renseignements conformément à l’article J.01.075; g) soit le demandeur ne s’est pas conformé aux exigences prévues au paragraphe J.01.014(4), soit il s’est conformé, mais les renseignements ou documents fournis sont insuffisants pour terminer l’examen de la demande de licence; h) le ministre a des motifs raisonnables de croire que le demandeur a fourni, dans sa demande de licence ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; i) le ministre a des motifs raisonnables de croire, sur le fondement de renseignements reçus d’une autorité compétente ou de l’Organisation des Nations Unies, que le demandeur a participé au détournement d’une drogue d’usage restreint vers un marché ou un usage illicites ou qu’il a participé à des opérations qui ont entraîné la violation d’une obligation internationale; j) le ministre a des motifs raisonnables de croire que la délivrance de la licence risquerait vraisemblablement de poser un risque pour la santé ou la sécurité publiques, notamment le risque qu’une drogue d’usage restreint soit détournée vers un marché ou un usage illicites. Exceptions Notice SOR/2019-171, s. 22. Renewal of Licence Application j) le ministre a des motifs raisonnables de croire que la délivrance de la licence risquerait vraisemblablement de porter atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement d’une drogue d’usage restreint vers un marché ou un usage illicites. Exceptions

(2)

Le ministre ne peut, dans les cas visés aux alinéas (1)b) ou h), refuser de délivrer la licence si le demandeur remplit les conditions ci-après, sauf s’il a des motifs raisonnables de croire que le refus est nécessaire pour protéger la sécurité ou la santé publiques, notamment pour prévenir le détournement d’une drogue d’usage restreint vers un marché ou un usage illicites : a) le demandeur n’a pas d’antécédents de contravention à la Loi, à la Loi sur le cannabis ou à leurs règlements; b) il a soit pris les mesures correctives nécessaires pour veiller à respecter la Loi, la Loi sur le cannabis et leurs règlements, soit signé un engagement à cet égard. Préavis

(3)

Le ministre, avant de refuser de délivrer la licence, envoie au demandeur un préavis motivé l’informant qu’il peut présenter ses observations à cet égard. DORS/2019-171, art. 22. Renouvellement de la licence Demande J.01.018 (1) Le distributeur autorisé présente au ministre, pour obtenir le renouvellement de sa licence de distributeur autorisé, une demande qui contient les renseignements et documents visés aux paragraphes J.01.014(1) et (2). Signature et attestation

(2)

La demande satisfait aux exigences suivantes : a) elle est signée et datée par le responsable principal de l’installation précisée dans la demande; b) elle comprend une attestation de celui-ci portant sur les faits suivants : (i) à sa connaissance, tous les renseignements et documents fournis à l’appui de la demande sont exacts et complets, (ii) il est habilité à lier le distributeur autorisé. SOR/2019-171, s. 22. Renewal SOR/2019-171, s. 22. Validity SOR/2019-171, s. 22. Refusal Exceptions Notice SOR/85-550, s. 15; SOR/2019-171, s. 22. Application SOR/2019-171, s. 22. SOR/2004-238, s. 36; SOR/2010-222, s. 31(F); SOR/2019-171, s. 22. Validity SOR/2019-171, s. 22. Refusal (d) the licensed dealer has not complied with the requirements of subsection J.01.022(3) or the à cet effet, tout renseignement ou document que le ministre juge nécessaire pour compléter l’examen de la demande de modification. DORS/2019-171, art. 22. J.01.023 (1) Le ministre, au terme de l’examen de la demande de modification et sous réserve de l’article J.01.025, modifie la licence de distributeur autorisé. Conditions

(2)

Le ministre peut, lorsqu’il modifie la licence du distributeur autorisé, ajouter toute condition à la licence, en modifier les conditions ou supprimer l’une de celles-ci s’il a des motifs raisonnables de croire nécessaire pour atteindre l’une des fins suivantes : a) le respect d’une obligation internationale; b) la conformité aux exigences associées au niveau de sécurité précisé dans la licence ou au tout nouveau niveau qu’impose la suite de la modification; c) la réduction d’un risque à l’atteinte à la sécurité ou à la santé publiques, notamment le risque de détournement de la drogue d’usage restreint vers un marché ou un usage illicites. DORS/2004-238, art. 36; DORS/2010-222, art. 31(F); DORS/2019-171, art. 22. Validité J.01.024 La licence de distributeur autorisé modifiée est valide jusqu’à la date d’expiration qui y est indiquée ou, si elle est antérieure, jusqu’à la date de sa suspension ou de sa révocation au titre des articles J.01.035 ou J.01.036. DORS/2019-171, art. 22. Refus J.01.025 (1) Le ministre refuse de modifier la licence de distributeur autorisé dans les cas suivants : a) l’une des opérations pour lesquelles la modification est demandée contrevient à une obligation internationale; b) le distributeur autorisé n’a pas mis en place à l’installation les mesures de sécurité prévues dans la Directive en matière de sécurité à l’égard d’une opération pour laquelle il demande la modification; c) la méthode visée à l’alinéa J.01.014(1)j) ne permet pas la consignation des renseignements conformément à l’article J.01.075; Exceptions Notice SOR/2004-238, s. 36; SOR/2010-222, s. 32; SOR/2019-171, s. 22. Application (a) a change affecting the security measures in place at the site specified in the dealer’s licence; d) soit le distributeur autorisé ne s’est pas conformé aux exigences prévues au paragraphe J.01.022(3), soit il s’y est conformé, mais les renseignements ou documents fournis sont insuffisants pour terminer l’examen de la demande de modification; e) le ministre a des motifs raisonnables de croire que le distributeur autorisé a fourni, dans sa demande de modification ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; f) le ministre a des motifs raisonnables de croire que la modification de la licence risquerait vraisemblablement de porter atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement d’une drogue d’usage restreint vers un marché ou un usage illicites. Exception

(2)

Le ministre ne peut, dans le cas visé à l’alinéa (1)e), refuser de modifier la licence si le distributeur autorisé remplit les conditions ci-après, sauf s’il a des motifs raisonnables de croire que cela est nécessaire pour protéger la sécurité ou la santé publiques, notamment pour prévenir le détournement d’une drogue d’usage restreint vers un marché ou un usage illicites : a) le distributeur autorisé n’a pas d’antécédents de contravention à la Loi, à la Loi sur le cannabis ou à leurs règlements; b) il a soit pris les mesures correctrices nécessaires pour veiller à respecter la Loi, la Loi sur le cannabis et leurs règlements, soit signé un engagement à cet effet. Préavis

(3)

Le ministre, avant de refuser de modifier la licence, envoie au distributeur autorisé un préavis motivé l’informant qu’il peut présenter ses observations à cet égard. DORS/2004-238, art. 36; DORS/2010-222, art. 32; DORS/2019-171, art. 22. Changements exigeant une approbation préalable du ministre Demande J.01.026 (1) Le distributeur autorisé doit obtenir l’approbation du ministre, en lui présentant une demande écrite, avant de procéder à l’un des changements suivants : a) toute modification ayant une incidence sur les mesures de sécurité mises en place à l’installation précisée dans sa licence; PART J Restricted Drugs Dealer’s Licences Sections J.01.026-J.01.027 (d) the replacement or addition of an alternate qualified person in charge. (i) the information specified in paragraph J.01.014(1)(c), and (ii) the declaration specified in paragraph J.01.014(2)(b) and the documents specified in paragraphs J.01.014(2)(c) and (d); and (i) the information specified in paragraph J.01.014(1)(d), and (ii) the declarations specified in paragraphs J.01.014(2)(b) and (e) and the documents specified in paragraphs J.01.014(2)(c), (d) and (f). SOR/2004-238, s. 37; SOR/2019-171, s. 22. Approval Règlement sur les aliments et drogues

PARTIE J Drogues à usage restreint

Distributeurs autorisés Licences de distributeur autorisé

Articles J.01.026-J.01.027

b) le remplacement du responsable principal; c) le remplacement du responsable qualifié; d) le remplacement ou l’adjonction de tout responsable qualifié suppléant. Renseignements et documents

(2)

Le distributeur autorisé fournit au ministre, pour tout changement visé au paragraphe (1), ce qui suit : a) les précisions concernant la modification ayant une incidence sur les mesures de sécurité mises en place à l’installation précisée dans sa licence; b) s’agissant du responsable principal : (i) les renseignements visés à l’alinéa J.01.014(1)c), (ii) la déclaration visée à l’alinéa J.01.014(2)b) et les documents visés aux alinéas J.01.014(2)c) et d); c) s’agissant du responsable qualifié ou d’un responsable qualifié suppléant : (i) les renseignements visés à l’alinéa J.01.014(1)d), (ii) les déclarations visées aux alinéas J.01.014(2)b) et e) ainsi que les documents visés aux alinéas J.01.014(2)c), d) et f). Renseignements et documents complémentaires

(3)

Le distributeur autorisé fournit au ministre, au plus tard à la date précisée dans la demande écrite de celui-ci à cet effet, tout renseignement ou document que le ministre juge nécessaire pour compléter l’examen de la demande d’approbation de changement. DORS/2004-238, art. 37; DORS/2019-171, art. 22. Approbation J.01.027 (1) Le ministre, au terme de l’examen de la demande d’approbation de changement et sous réserve de l’article J.01.028, approuve le changement. Conditions

(2)

Le ministre peut, lorsqu’il approuve le changement, ajouter une condition à la licence de distributeur autorisé, en modifier les conditions ou supprimer l’une de celles-ci s’il a des motifs raisonnables de le croire nécessaire pour atteindre l’une des fins suivantes : a) le respect d’une obligation internationale; SOR/2004-238, s. 38; SOR/2010-222, s. 33; SOR/2019-171, s. 22. Refusal Exception Notice b) la conformité aux exigences associées au niveau de sécurité précisé dans la licence; c) la réduction d’un risque d’atteinte à la sécurité ou à la santé publiques, notamment le risque de détournement d’une drogue d’usage restreint vers un marché ou un usage illicites. DORS/2004-238, art. 38; DORS/2010-222, art. 33; DORS/2019-171, art. 22. Refus J.01.028 (1) Le ministre refuse d’approuver le changement dans les cas suivants : a) dans les dix années précédant la présentation de la demande d’approbation de changement, le responsable principal, la personne qualifiée ou toute personne qualifiée suppléante proposée a fait l’objet d’une condamnation visée aux sous-alinéas J.01.013a)(i) ou b)(i) ou s’est vu imposer une peine visée aux sous-alinéas J.01.013a)(ii) ou b)(ii); b) soit le distributeur autorisé ne s’est pas conformé aux exigences prévues au paragraphe J.01.026(3), soit il s’y est conformé, mais les renseignements ou documents fournis sont insuffisants pour terminer l’examen de la demande d’approbation de changement; c) le ministre a des motifs raisonnables de croire que le distributeur autorisé a fourni, dans sa demande d’approbation de changement ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; d) le ministre a des motifs raisonnables de croire que le changement risquerait vraisemblablement de porter atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement d’une drogue d’usage restreint vers un marché ou un usage illicites. Exception

(2)

Le ministre ne peut, dans le cas visé à l’alinéa (1)c), refuser d’approuver le changement si le distributeur autorisé a pris les mesures correctives nécessaires pour veiller à respecter la Loi, la Loi sur le cannabis et leurs règlements ou a signé un engagement à cet effet, sauf s’il a des motifs raisonnables de croire que le refus est nécessaire pour protéger la sécurité ou la santé publiques, notamment pour prévenir le détournement d’une drogue d’usage restreint vers un marché ou un usage illicites. Préavis

(3)

Le ministre, avant de refuser d’approuver le changement, envoie au distributeur autorisé un préavis motivé SOR/2015-210, s. 3; SOR/2019-171, s. 22. Prior notice SOR/2019-171, s. 22. Notice — five days SOR/2019-171, s. 22. Notice — 10 days SOR/2019-171, s. 22. L'informant qu'il peut présenter ses observations à cet égard. DORS/2015-210, art. 3; DORS/2019-171, art. 22. Changements exigeant un avis au ministre Avis préalable J.01.029 (1) Le distributeur autorisé avise le ministre par écrit de faire avant l'un des changements suivants : a) la fabrication ou l'assemblage d'un produit ou d'un composé qui ne figure pas sur la plus récente version de la liste visée à l'alinéa J.01.014(1)f) qui a été présentée au ministre; b) la modification d'un produit ou d'un composé qui figure sur cette liste, si la modification a une incidence sur les renseignements déjà fournis à son égard. Renseignements et liste

(2)

L'avis contient les précisions visées à l'alinéa J.01.014(1)f) qui sont nécessaires pour mettre à jour la liste et est accompagné de la version révisée de celle-ci. DORS/2019-171, art. 22. Avis — cinq jours J.01.030 Le distributeur autorisé avise le ministre par écrit du fait que le responsable qualifié ou tout responsable qualifié suppléant cesse d'exercer cette fonction dans les cinq jours suivant la cessation. DORS/2019-171, art. 22. Avis — dix jours J.01.031 (1) Le distributeur autorisé avise le ministre par écrit de l'un des changements ci-après dans les dix jours suivant celui-ci : a) le responsable principal cesse d'exercer cette fonction; b) le distributeur autorisé cesse de fabriquer ou d'assembler un produit ou un composé qui figure sur la plus récente version de la liste visée à l'alinéa J.01.014(1)f) qui a été présentée au ministre. Renseignements et liste

(2)

L'avis prévu à l'alinéa (1)b) contient les précisions visées à l'alinéa J.01.014(1)f) qui font l'objet du changement et est accompagné de la version révisée de la liste. DORS/2019-171, art. 22. Content of notice Update SOR/2004-238, s. 39; SOR/2019-171, s. 22. J.01.032.1 [Repealed, SOR/2019-171, s. 22] Notice Urgent circumstances Urgent circumstances — notice SOR/99-125, s. 8; SOR/2004-238, s. 40; SOR/2018-69, ss. 67, 69; SOR/2019-171, s. 22 J.01.033.1 [Repealed, SOR/2019-171, s. 22] J.01.033.2 [Repealed, SOR/2019-171, s. 22] J.01.033.3 [Repealed, SOR/2019-171, s. 22] J.01.033.4 [Repealed, SOR/2019-171, s. 22] Notice SOR/2019-171, s. 22. Suspension Notice Reinstatement of licence SOR/97-228, s. 24; SOR/2019-171, s. 22. (d) the licensed dealer does not take the corrective measures specified in an undertaking or notice; Exceptions Notice SOR/97-228, s. 25; SOR/2019-171, s. 22. Return of licence SOR/2018-85, s. 3; SOR/2019-171, s. 22. Import Permits Application SOR/2019-171, s. 22. Issuance (a) the permit number; (b) the information set out in subsection J.01.038(1); (d) the expiry date of the permit, being the earlier of (ii) the expiry date of the dealer’s licence; and SOR/2019-171, s. 22. Signature et attestation

(2)

La demande satisfait aux exigences suivantes : a) elle est signée et datée par le responsable qualifié ou un responsable qualifié suppléant; b) elle comprend une attestation de celui-ci portant qu’à sa connaissance tous les renseignements fournis à l’appui de la demande sont exacts et complets. Renseignements et documents complémentaires

(3)

Le distributeur autorisé fournit au ministre, au plus tard à la date précisée dans la demande écrite de celui-ci à cet effet, tout renseignement ou document que le ministre juge nécessaire pour compléter l’examen de la demande de permis d’importation. DORS/2019-171, art. 22. Délivrance J.01.039 Le ministre, au terme de l’examen de la demande de permis d’importation et sous réserve de l’article J.01.042, délivre au distributeur autorisé un permis d’importation qui contient les renseignements suivants : a) le numéro du permis; b) les renseignements visés au paragraphe J.01.038(1); c) la date de prise d’effet du permis; d) la date d’expiration du permis, qui correspond à celle des dates ci-après qui est antérieure aux autres : (i) la date précisée par le ministre, qui ne peut être postérieure au cent quatre-vingtième jour suivant sa date de prise d’effet, (ii) la date d’expiration de la licence du distributeur autorisé; e) toute condition que le ministre estime nécessaire, sur le fondement de motifs raisonnables, pour atteindre l’une des fins suivantes : (i) le respect d’une obligation internationale, (ii) la réduction d’un risque d’atteinte à la sécurité ou à la santé publiques, notamment le risque de détournement d’une drogue d’usage restreint vers un marché ou un usage illicites. DORS/2019-171, art. 22. Validity (a) the expiry date set out in the permit, (b) the date of the suspension or revocation of the permit under section J.01.045 or J.01.046, SOR/2019-171, s. 22. Return of permit SOR/2019-171, s. 22. Refusal Notice SOR/2019-171, s. 22. Providing copy of permit SOR/2019-171, s. 22. Declaration SOR/2019-171, s. 22. Suspension Notice Reinstatement of permit SOR/2019-171, s. 22. J.01.046 (1) Subject to subsection (2), the Minister must revoke an import permit if Exceptions Notice SOR/2019-171, s. 22. Return of permit SOR/2019-171, s. 22. b) le distributeur autorisé ne prend pas les mesures correctives précisées par le ministre en vertu de l’alinéa J.01.045(2)c) dans le délai imparti; c) le distributeur autorisé a contrevenu à une condition de son permis; d) le ministre a des motifs raisonnables de croire que le distributeur autorisé a fourni, dans sa demande de permis ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; e) le ministre a des motifs raisonnables de croire, sur le fondement de renseignements reçus d’une autorité compétente ou de l’Organisation des Nations Unies, que le distributeur autorisé a participé au détournement d’une drogue d’usage restreint vers un marché ou un usage illicites; f) la licence du distributeur autorisé a été révoquée. Exceptions

(2)

Le ministre ne peut, dans les cas visés aux alinéas (1)d) ou J.01.036(1)e) ou g), révoquer le permis d’importation si le distributeur autorisé remplit les conditions ci-après, sauf s’il a des motifs raisonnables de croire que la révocation est nécessaire pour protéger la sécurité ou la santé publiques, notamment pour prévenir le détournement d’une drogue d’usage restreint vers un marché ou un usage illicites : a) le distributeur autorisé n’a pas d’antécédents de contravention à la Loi, à la Loi sur le cannabis ou à leurs règlements; b) il a soit pris les mesures correctives nécessaires pour veiller à respecter la Loi, la Loi sur le cannabis et leurs règlements, soit signé un engagement à cet effet. Préavis

(3)

Le ministre, avant de révoquer le permis d’importation, envoie au distributeur autorisé un préavis motivé l’informant qu’il peut présenter ses observations à cet égard. DORS/2019-171, art. 22. Retour de permis J.01.047 Le distributeur autorisé retourne au ministre l’original du permis d’importation dans les quinze jours suivant la date de prise d’effet de la révocation. DORS/2019-171, art. 22. Export Permits Application (d) the name and municipal address of the importer in the country of final destination; Permis d’exportation Demande J.01.048 (1) Le distributeur autorisé présente au ministre, pour chaque exportation prévue de drogues d’usage restreint, une demande de permis d’exportation qui contient les renseignements et documents suivants : a) ses nom, adresse municipale et numéro de licence de distributeur autorisé; b) les précisions ci-après concernant la drogue d’usage restreint qu’il prévoit d’exporter : (i) son nom, tel qu’il figure sur la licence de distributeur autorisé, (ii) s’agissant d’un sel, son nom, (iii) sa quantité, (iv) s’agissant d’une matière première, son degré de pureté et son contenu anhydre; c) si la drogue d’usage restreint est contenue dans un produit qu’il prévoit d’exporter, les précisions suivantes concernant ce produit : (i) sa marque nominative, (ii) l’identification numérique qui lui a été attribuée aux termes de l’article C.01.014.2, s’il y a lieu, (iii) la concentration de la drogue d’usage restreint qu’il contient dans chacune de ses unités, le nombre d’unités par emballage et le nombre d’emballages; d) les nom et adresse municipale, dans le pays de destination finale, de l’importateur; e) le nom du bureau de douane où est prévue l’exportation; f) les modes de transport prévus et chaque pays de transit ou de transbordement prévu; g) une copie du permis d’importation délivré par l’autorité compétente du pays de destination finale précisant le nom de l’importateur et l’adresse municipale de son installation située dans ce pays. Signature et attestation

(2)

La demande satisfait aux exigences suivantes : a) elle est signée et datée par le responsable qualifié ou un responsable qualifié suppléant; SOR/2019-171, s. 22. Issuance (a) the permit number; (b) the information set out in paragraphs J.01.048(1)(a) to (f); (d) the expiry date of the permit, being the earliest of (ii) the expiry date of the dealer’s licence, and SOR/2019-171, s. 22. b) elle comprend une attestation de celui-ci portant sur les faits suivants : (i) à sa connaissance, l’exportation prévue ne contrevient à aucune règle de droit du pays de destination finale, de tout pays de transit ou de tout pays de transbordement, (ii) à sa connaissance, tous les renseignements et documents fournis à l’appui de la demande sont exacts et complets. Renseignements et documents complémentaires

(3)

Le distributeur autorisé fournit au ministre, au plus tard à la date précisée dans la demande écrite de celui-ci à cet effet, tout renseignement ou document que le ministre juge nécessaire pour compléter l’examen de la demande de permis d’exportation. DORS/2019-171, art. 22. Délivrance J.01.049 Le ministre, au terme de l’examen de la demande de permis d’exportation et sous réserve de l’article J.01.052, délivre au distributeur autorisé un permis d’exportation qui contient les renseignements suivants : a) le numéro du permis; b) les renseignements visés aux alinéas J.01.048(1)a) à f); c) la date de prise d’effet du permis; d) la date d’expiration du permis, qui correspond à celle des dates ci-après qui est antérieure aux autres : (i) la date précisée par le ministre, qui ne peut être postérieure au cent quatre-vingtième jour suivant sa date de prise d’effet, (ii) la date d’expiration de la licence du distributeur autorisé, (iii) la date d’expiration du permis d’importation délivré par l’autorité compétente du pays de destination finale; e) toute condition que le ministre estime nécessaire, sur le fondement de motifs raisonnables, pour atteindre l’une des fins suivantes : (i) le respect d’une obligation internationale, Validity (a) the expiry date set out in the permit, (b) the date of the suspension or revocation of the permit under section J.01.055 or J.01.056, SOR/2019-171, s. 22. Return of permit SOR/2019-171, s. 22. Refusal Notice SOR/2019-171, s. 22. Providing copy of permit SOR/2019-171, s. 22. Declaration SOR/2019-171, s. 22. Suspension Notice Reinstatement of permit SOR/2019-171, s. 22. J.01.056 (1) Subject to subsection (2), the Minister must revoke an export permit if c) si la drogue d’usage restreint est contenue dans un produit qu’il a exporté, les précisions ci-après concernant ce produit : (i) sa marque nominative, (ii) l’identification numérique qui lui a été attribuée aux termes de l’article C.01.014.2, s’il y a lieu, (iii) la concentration de la drogue d’usage restreint qu’il contient dans chacune de ses unités, le nombre d’unités par emballage et le nombre d’emballages; d) le nom du bureau de douane où a eu lieu l’exportation et la date de celle-ci. DORS/2019-171, art. 22. Suspension J.01.055 (1) Le ministre suspend sans préavis le permis d’exportation dans les cas suivants : a) la licence du distributeur autorisé est suspendue; b) il a des motifs raisonnables de le croire nécessaire pour protéger la sécurité ou la santé publiques, notamment pour empêcher qu’une drogue d’usage restreint vers un marché ou un usage illicites; c) l’exportation contreviendrait aux règles de droit du pays de destination finale, de tout pays de transit ou de tout pays de transbordement. Avis

(2)

La suspension prend effet dès que le ministre envoie au distributeur autorisé un avis de suspension qui contient les précisions suivantes : a) les motifs de la suspension; b) le fait que le distributeur autorisé a la possibilité de présenter ses observations à cet égard; c) les mesures correctives à prendre et le délai accordé à cette fin, s’il y a lieu. Rétablissement du permis

(3)

Le ministre rétablit le permis d’exportation s’il a des motifs raisonnables de croire que la suspension n’est plus nécessaire. DORS/2019-171, art. 22. Révocation J.01.056 (1) Le ministre, sous réserve du paragraphe (2), révoque le permis d’exportation dans les cas suivants : Exceptions Notice SOR/2019-171, s. 22. a) le distributeur autorisé lui en fait la demande ou l’informe de la perte, du vol ou de toute utilisation non autorisée du permis, que celle-ci soit réelle ou potentielle; b) le distributeur autorisé ne prend pas les mesures correctives précisées par le ministre en vertu de l’alinéa J.01.055(2)c) dans le délai imparti; c) le distributeur autorisé a contrevenu à une condition de son permis; d) le ministre a de motifs raisonnables de croire que le distributeur autorisé a fourni, dans sa demande de permis ou à l’appui de celle-ci, des renseignements faux ou trompeurs ou des documents faux ou falsifiés; e) le ministre a de motifs raisonnables de croire, à la lumière de renseignements reçus d’une autorité compétente ou de l’Organisation des Nations Unies, que le distributeur autorisé a participé au détournement d’une drogue d’usage restreint vers un marché ou un usage illicite; f) la licence du distributeur autorisé a été révoquée. Exceptions

(2)

Le ministre ne peut, dans les cas visés aux alinéas (1)d) ou J.01.036(1)e) ou g), révoquer le permis d’exportation si le distributeur autorisé remplit les conditions ci-après, sauf si le ministre a de motifs raisonnables de croire que la révocation est nécessaire pour protéger la sécurité ou la santé publiques, notamment pour prévenir le détournement d’une drogue d’usage restreint vers un marché ou un usage illicite: a) le distributeur autorisé n’a pas d’antécédents de contravention à la Loi, à la Loi sur le cannabis ou à leurs règlements; b) il a soit pris les mesures correctrices nécessaires pour veiller à respecter la Loi, la Loi sur le cannabis et leurs règlements, soit signé un engagement à cet effet. Préavis

(3)

Le ministre, avant de révoquer le permis d’exportation, envoie au distributeur autorisé un préavis motivé l’informant qu’il peut présenter ses observations à cet égard. DORS/2019-171, art. 22. Return of permit SOR/2019-171, s. 22. Name SOR/2019-171, s. 22. Sale of Restricted Drugs Sale to institution Content of application (a) the name and the municipal address of the institution; (d) details of the proposed use of the drug; and Authorized use only SOR/2019-171, s. 22. SOR/2019-171, s. 22. (a) a practitioner of medicine; or Agent or mandatary of practitioner of medicine (a) the practitioner; or (b) the Minister. Practitioner of medicine (b) to the Minister. SOR/2019-171, s. 22. Exception SOR/2019-171, s. 22. Labelling (b) the net contents of the package; (d) the lot number of the drug; (f) the name and municipal address of the manufacturer or assembler of the drug. Exception

(3)

The labelling requirements set out in section C.01.004 do not apply to a restricted drug. SOR/2019-171, s. 22. (d) in the case of a drug to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported. SOR/2019-171, s. 22. SOR/2019-171, s. 22. (b) an institution; (d) a person exempted under section 56 of the Act with respect to the possession of the restricted drug. SOR/2019-171, s. 22. Theft or loss — licences and permits SOR/2019-171, s. 22. Theft or loss — restricted drugs SOR/2019-171, s. 22. Suspicious transaction Good faith SOR/2019-171, s. 22. SOR/2019-171, s. 22. Destruction of Restricted Drugs SOR/2019-171, s. 22. SOR/2019-171, s. 22. (d) a brief description of the method of destruction; SOR/2019-171, s. 22. Approval SOR/2019-171, s. 22. Documents SOR/2019-171, s. 22. Information — general SOR/2019-171, s. 22. Explainable loss of restricted drug (d) the explanation for the loss. SOR/2019-171, s. 22. Destruction (a) the municipal address of the place of destruction; (d) the date of destruction. SOR/2019-171, s. 22. SOR/2019-171, s. 22. Institutions SOR/2019-171, s. 22. Information (d) the names and qualifications of every person who makes use of a restricted drug in the institution; and SOR/2019-171, s. 22. Non-renouvellement ou révocation après le troisième mois

(3)

Le distributeur autorisé dont la licence expire sans être renouvelée ou est révoquée après le troisième mois d’une année civile fournit au ministre, dans les trois mois suivant l’expiration ou la révocation, un rapport pour la période de l’année civile durant lesquels la licence était valide contenant les renseignements visés au paragraphe (1), la quantité devant être évaluée selon l’inventaire physique établi à la date d’expiration ou de révocation. DORS/2019-171, art. 22. Établissements Méthode de consignation J.01.080 L’établissement qui consigne des renseignements en application de la présente partie le fait selon une méthode qui en permet la vérification à tout moment. DORS/2019-171, art. 22. Renseignements J.01.081 L’établissement consigne les renseignements suivants: a) le nom, la forme et la quantité de toute drogue d’usage restreint qu’il commande, le nom de la personne qui fait la commande pour son compte et la date de la commande; b) le nom, la forme et la quantité de toute drogue d’usage restreint qu’il reçoit ainsi que les nom et adresse municipale du distributeur autorisé qui la lui a vendue ou fournie et la date de réception; c) les précisions concernant l’utilisation de toute drogue d’usage restreint dans l’établissement; d) les nom et qualifications des personnes utilisant toute drogue d’usage restreint dans l’établissement; e) les données cliniques concernant l’utilisation de toute drogue d’usage restreint reçue par l’établissement. DORS/2019-171, art. 22. SOR/2019-171, s. 22. Information SOR/2019-171, s. 22. Record Keeping Retention period SOR/2019-171, s. 22. SOR/2019-171, s. 22. SOR/2019-171, s. 22. Content of notification

(2)

The notification must specify SOR/2019-171, s. 22. SCHEDULE (Sections J.01.001, J.01.002 and J.01.004) PART I

(1)

N-ethylamphetamine (N-ethyl-α-methylbenzeneethanamine) PART J Restricted Drugs SCHEDULE

Section J.01.087

(2)

4-methyl-2,5-dimethoxyamphetamine (STP) (2,5-dimethoxy-4,α-dimethylbenzeneethanamine)

(3)

3,4-methylenedioxyamphetamine (MDA) (α-methyl-1,3-benzodioxole-5-ethanamine)

(4)

2,5-dimethoxyamphetamine (2,5-dimethoxy-α-methylbenzeneethanamine)

(5)

4-methoxyamphetamine (4-methoxy-α-methylbenzeneethanamine)

(6)

2,4,5-trimethoxyamphetamine (2,4,5-trimethoxy-α-methylbenzeneethanamine)

(7)

N-methyl-3,4-methylenedioxyamphetamine (N,α-dimethyl-1,3-benzodioxole-5-ethanamine)

(8)

4-ethoxy-2,5-dimethoxyamphetamine (4-ethoxy-2,5-dimethoxy-α-methylbenzeneethanamine)

(9)

5-methoxy-3,4-methylenedioxyamphetamine (7-methoxy-α-methyl-1,3-benzodioxole-5-ethanamine)

(11)

N-ethyl-3,4-methylenedioxyamphetamine (N-ethyl-α-methyl-1,3-benzodioxole-5-ethanamine)

(12)

4-ethyl-2,5-dimethoxyamphetamine (DOET) (4-ethyl-2,5-dimethoxy-α-methylbenzeneethanamine)

(13)

4-bromo-2,5-dimethoxyamphetamine (4-bromo-2,5-dimethoxy-α-methylbenzeneethanamine)

(14)

4-chloro-2,5-dimethoxyamphetamine (4-chloro-2,5-dimethoxy-α-methylbenzeneethanamine)

(15)

4-ethoxyamphetamine (4-ethoxy-α-methylbenzeneethanamine)

(16)

N-Propyl-3,4-methylenedioxyamphetamine (α-methyl-N-propyl-1,3-benzodioxole-5-ethanamine)

(17)

N-hydroxy-3,4-methylenedioxyamphetamine (N-[α-methyl(methylenedioxy)phenethyl]hydroxyamine)

(18)

3,4,5-trimethoxyamphetamine (3,4,5-trimethoxy-α-methylbenzeneethanamine) 2 Lysergic acid diethylamide (LSD) (N,N-diethyllysergamide) and any salt thereof PART J Restricted Drugs SCHEDULE

Section J.01.087

3 N,N-Diethyltryptamine (DET) (3-[(2-diethylamino)ethyl]indole) and any salt thereof 11 1-[1-(2-Thienyl)cyclohexyl]piperidine (TCP) and any salt thereof 13 Mescaline (3,4,5-trimethoxybenzeneethanamine) and any salt thereof, but not peyote (lophophora) 14 [Repealed, SOR/2017-250, s. 2] 18 Etryptamine (3-(2-aminobutyl)indole) and any salt thereof 19 Rolicyclidine (1-(1-phenylcyclohexyl) pyrrolidine) and any salt thereof 24 Les 2C-phénéthylamines, leurs sels, dérivés et isomères, ainsi que les sels de leurs dérivés et isomères

(1)

4-bromo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25B-NBOMe)

(2)

4-chloro-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25C-NBOMe)

(3)

4-iodo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25I-NBOMe)

(4)

4-bromo-2,5-dimethoxybenzeneethanamine (2C-B)

(1)

Diphenidine (DEP) (1-(1,2-diphenylethyl)piperidine)

(2)

Methoxphenidine (2-MeO-Diphenidine, MXP) (1-(1-(2-methoxyphenyl)-2-phenylethyl)piperidine)

(3)

Ephenidine (NEDPA, EPE) (N-ethyl-1,2-diphenylethylamine)

(4)

Isophenidine (NPDPA) (N-isopropyl-1,2-diphenylethylamine)

(1)

Bromadoline (4-bromo-N-(2-(dimethylamino)cyclohexyl)benzamide)

(2)

U-47109 (3,4-dichloro-N-(2-(dimethylamino)cyclohexyl)benzamide)

(3)

U-48520 (4-chloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide)

(4)

U-50211 (N-(2-(dimethylamino)cyclohexyl)-4-hydroxy-N-methylbenzamide)

(5)

U-77891 (3,4-dibromo-N-methyl-N-(1-methyl-1-azaspiro[4.5]decan-6-yl)benzamide) PART II

(1)

Salvinorin A ((2S,4aR,6aR,7R,9S,10aS,10bR)-9-(acetoxy)-2-(3-furanyl)dodecahydro-6a,10b-dimethyl-4,10-dioxo-2H-naphtho[2,1-c]pyran-7-carboxylic acid methyl ester)

(1)

Cathine (d-threo-2-amino-1-hydroxy-1-phenylpropane)

(2)

Cathinone ((-)-α-aminopropiophenone) and its salts PART J Restricted Drugs SCHEDULE

Section J.01.087

PART III Column 1 Item Column 2 Substance Period SOR/97-228, s. 25; SOR/2003-34, s. 4, 5; SOR/2012-65, s. 1; SOR/2012-177, s. 1; SOR/2015-172, s. 2; SOR/2015-210, ss. 31, 44; SOR/2016-126, s. 2; SOR/2016-239, s. 1; SOR/2017-12, s. 4; SOR/2017-278, s. 2; SOR/2018-69, s. 6; SOR/2018-85, s. 4; SOR/2019-171, s. 23. Règlement sur les aliments et drogues

PARTIE J Drogues d’usage restreint

ANNEXE

Article J.01.087

PARTIE III

Colonne 1

Article

Colonne 2 Substance Période DORS/97-228, art. 25; DORS/2003-34, art. 4 et 5; DORS/2012-65, art. 1; DORS/2012-177, art. 1; DORS/2015-172, art. 2; DORS/2015-210, art. 31 et 44; DORS/2016-126, art. 2; DORS/2016-239, art. 1; DORS/2017-12, art. 4; DORS/2017-278, art. 2; DORS/2018-69, art. 6; DORS/2018-85, art. 4; DORS/2019-171, art. 23. SCHEDULE F [Repealed, SOR/2013-122, s. 18] ANNEXE F [Abrogée, DORS/2013-122, art. 18] SCHEDULE K Column I Name and Description Column II R.D.I. 1 Alimentary Pastes, dry ................................................................. 3.0 oz. 85 g 2 3 4 Bread, 5 slices .............................................................................. 5.3 oz. 150 g 5 Butter ............................................................................................ 2.0 oz. 57 g 6 Buttermilk ...................................................................................... 30.0 fl.oz. 852 ml 7 Cereals, Breakfast or Infant ......................................................... 1.0 oz. 28 g 8 Cereals, puffed ............................................................................. 0.5 oz. 14 g 9 10 Cheese, Cottage .......................................................................... 3.5 oz. 100 g 11 12 Cream, whipping .......................................................................... 2.0 oz. 57 g 13 Egg, yolk-replaced egg ................................................................. 3.5 oz. 100 g 14 Evaporated Milk, Evaporated Skim Milk, Evaporated Partly Skimmed Milk ................................................................................ 15.0 fl.oz. 852 ml (reconstituted to original volume) ................................................. 30.0 fl.oz. 15 Fish, Shell Fish ............................................................................. 3.5 oz. 100 g 16 Fruits, dried .................................................................................. 2.0 oz. 57 g 17 Fruits, (other than banana, lemon, lime, watermelon) .................. 3.5 oz. 100 g 18 Fruits, Banana .............................................................................. 5.3 oz. 150 g 19 Fruits, Lemon ............................................................................... 1.8 oz. 50 g 20 Fruits, Lime .................................................................................. 1.8 oz. 50 g 21 Fruits, Watermelon ....................................................................... 7.0 oz. 200 g 22 Fruit Drinks, Fruit Nectars (ready to serve) ................................... 4.0 fl.oz. 114 ml 23 Fruit Drink Bases, Mixes and Concentrates (ready to serve) ....... 4.0 fl.oz. 114 ml 24 Fruit Juices (other than lemon juice and lime juice) ..................... 4.0 fl.oz. 114 ml 25 Fruit Juices, Lemon ..................................................................... 1.0 fl.oz. 28 ml 26 Fruit Juices, Lime ........................................................................ 1.0 fl.oz. 28 ml 27 Ice Cream, Ice Milk ....................................................................... 3.5 oz. 100 g 28 29 30 Margarine ..................................................................................... 2.0 oz. 57 g 31 Meat Products .............................................................................. 3.5 oz. 100 g 32 Meat Product Extenders .............................................................. 3.5 oz. 100 g 33 Extended Meat Products ............................................................. 3.5 oz. 100 g 34 Milk, whole ................................................................................... 30.0 fl.oz. 852 ml 35 Milk Powder (reconstituted and ready to serve) ........................... 30.0 fl.oz. 852 ml 36 (naming the flavour) Milk ............................................................. 30.0 fl.oz. 852 ml 37 Molasses ...................................................................................... 1.5 oz. 43 g Column I 38 Nuts ................................................................................................................. 1.0 oz. 28 g 39 Peanut Butter ................................................................................................... 1.0 oz. 28 g 40 Poultry Products .............................................................................................. 3.5 oz. 100 g 41 Extended Poultry Products ............................................................................. 3.5 oz. 100 g 42 Poultry Product Extenders .............................................................................. 3.5 oz. 100 g 44 Simulated Poultry Products ............................................................................ 3.5 oz. 100 g 45 Skim Milk, Partly Skimmed Milk ..................................................................... 30.0 fl.oz. 852 ml 46 (naming the flavour) Skim Milk, (naming the flavour) Partly Skimmed Milk ............................................................................................. 30.0 fl.oz. 852 ml 47 Skim Milk Powder, Partly Skimmed Milk Powder (reconstituted and ready to serve) .............................................................................. 30.0 fl.oz. 852 ml 49 (naming the flavour) Skim Milk with Added Milk Solids, (naming the flavour) Partly Skimmed Milk with Added Milk Solids ................. 30.0 fl.oz. 852 ml 50 Soup (ready to serve) ..................................................................................... 7.0 fl.oz. 200 ml 51 Sterilized Milk .................................................................................................. 30.0 fl.oz. 852 ml 52 Vegetable Juices ............................................................................................. 4.0 fl.oz. 114 ml 53 Vegetable Drinks ............................................................................................. 4.0 fl.oz. 114 ml 54 Vegetable Drink Concentrates, Mixes and Bases (ready to serve) .............. 4.0 fl.oz. 114 ml 56 Vegetables, baked beans .............................................................................. 8.5 oz. 250 g 57 Vegetables, cooked potatoes ........................................................................ 7.0 oz. 200 g 58 Yeast ............................................................................................................... 0.5 oz. 14 g 59 Yogurt, plain .................................................................................................... 5.0 oz. 150 g Column II R.D.I. SOR/78-64, s. 10; SOR/84-300, s. 63(E). APPENDICES I AND II [Repealed, SOR/81-935, s. 2] APPENDIX III Export Certificate To Wit : I, __________________________ of __________________________ of __________________________ do solemnly declare: or tion relevant thereto has knowingly been withheld. day of __________________________ 20 __ . __________________________ SOR/80-318, s. 2; SOR/2022-100, s. 6; SOR/2022-100, s. 7; SOR/2022-100, s. 8; SOR/2022-100, s. 9. ANNEXE K Ration quotidienne normale de diverses substances alimentaires Colonne I Poste n° | Nom et description 1 | Pâtes alimentaires, sèches 2 | Bacon (de flanc), simili-produit de viande qui rappelle le bacon de flanc (cuit) 3 | Base et mélanges aromatisés, pour boissons, pour ajouter au lait (prêts à servir) 4 | Pain, 5 tranches 5 | Beurre 6 | Lait de beurre 7 | Céréales, à déjeuner ou pour nourrissons 8 | Céréales, soufflées 9 | Fromage (autre que le fromage cottage) 10 | Fromage cottage 11 | Lait condensé 12 | Crème à fouetter 13 | Œuf, jaune d’œuf substitué 14 | Lait évaporé, lait écrémé évaporé, lait partiellement écrémé évaporé Colonne II R.Q.N. 16,0 oz liq | 454 ml 5,3 oz | 150 g 30,0 oz liq | 852 ml 0,5 oz | 14 g 3,5 oz | 100 g 3,5 oz | 100 g 30,0 oz liq | 852 ml (reconstitué à son volume original) 15 | Poisson, coquillages 16 | Fruits secs 17 | Fruits (sauf bananes, citrons, limes, melons d’eau) 18 | Fruits, bananes 19 | Fruits, citrons 20 | Fruits, limes 21 | Fruits, melons d’eau 22 | Boissons aux fruits, nectars de fruits (prêts à servir) 23 | Bases, mélanges et concentrés pour boissons aux fruits (prêts à servir) 24 | Jus de fruit (sauf jus de citron et jus de lime) 25 | Jus de fruit, citron 26 | Jus de fruit, lime 27 | Crème glacée, lait glacé 28 | Préparations pour nourrissons (prêtes à servir) 3,5 oz | 100 g 3,5 oz | 100 g 5,3 oz | 150 g 1,8 oz | 50 g 1,8 oz | 50 g 3,5 oz | 100 g Selon le mode d’emploi inscrit sur l’étiquette 29 | Déjeuner instantané, déjeuner prêt à servir 30 | Margarine 31 | Produits de viande 32 | Allongeurs de produits de viande 33 | Produits de viande avec allongeur 34 | Lait entier 35 | Lait en poudre (reconstitué et prêt à servir) Selon le mode d’emploi inscrit sur l’étiquette 3,5 oz | 100 g 3,5 oz | 100 g 3,5 oz | 100 g 30,0 oz liq | 852 ml 30,0 oz liq | 852 ml Règlement sur les aliments et drogues ANNEXE K Ration quotidienne normale de diverses substances alimentaires Colonne I Poste n° Nom et description 36 Lait (nom de l’arôme) ................................................................. 30,0 oz liq 852 ml 37 Mélasse ...................................................................................... 1,5 oz 43 g 38 Noix ............................................................................................ 1,0 oz 28 g 39 Beurre d’arachide ....................................................................... 1,0 oz 28 g 40 Produits de volaille ..................................................................... 3,5 oz 100 g 41 Produits de volaille avec allongeur ............................................. 3,5 oz 100 g 42 Allongeurs de produits de volaille ............................................... 3,5 oz 100 g 43 Simili-produits de viande, sauf les simili-produits de viande qui rappellent le bacon de flanc ........................................................................ 3,5 oz 100 g 44 Simili-produits de volaille ............................................................ 3,5 oz 100 g 45 Lait écrémé, lait partiellement écrémé ........................................ 30,0 oz liq 852 ml 46 Lait écrémé (nom de l’arôme), lait partiellement écrémé (nom de l’arôme) ...................................................................................... 30,0 oz liq 852 ml 47 Lait écrémé en poudre, lait partiellement écrémé en poudre (reconstitués et prêts à servir) ................................................................ 30,0 oz liq 852 ml 48 Lait écrémé additionné d’extrait sec du lait, lait partiellement écrémé additionné d’extrait sec du lait ............................................. 30,0 oz liq 852 ml 49 Lait écrémé additionné d’extrait sec du lait (nom de l’arôme), lait partiellement écrémé additionné d’extrait sec du lait (nom de l’arôme) ...................................................................................... 30,0 oz liq 852 ml 50 Soupe (prête à servir) .................................................................. 7,0 oz liq 200 ml 51 Jus de légumes .......................................................................... 4,0 oz liq 114 ml 52 Boissons aux légumes ............................................................... 4,0 oz liq 114 ml 53 Concentrés, mélanges et bases pour boissons aux légumes (prêts à servir) ................................................................................. 4,0 oz liq 114 ml 54 Légumes (autres que fèves au four et pommes de terre cuites) ...................................................................................... 3,5 oz 100 g 55 Légumes, fèves au four ............................................................. 8,5 oz 250 g 56 Légumes, pommes de terre cuites ............................................ 7,0 oz 200 g 57 Levure ......................................................................................... 0,5 oz 14 g DORS/58-64, art. 10; DORS/84-390, art. 63(A). APPENDICES I ET II [Abrogés, DORS/81-935, art. 2] APPENDICE III Formules Certificat d’exportation (En vertu de l’article 37 de la Loi sur les aliments et drogues) L’exportateur soussigné certifie par les présentes que (description de l’article) emballé et étiqueté comme suit : et portant distinctement imprimé le mot « Exportation », 1 est fabriqué ou préparé au Canada, 2 n’est pas fabriqué ou vendu pour la consommation ou l’usage au Canada, et 3 que l’emballage et son contenu n’enfreignent aucune règle de droit connue de ___________________________ au(x)quel(s) ils (nom du ou des pays) sont destinés. Fait à ___________________________ le ___________________________ 20 ______ . Canada : ___________________________ En ce qui a trait à un certificat d’exportation délivré en vertu de la Loi des aliments et drogues, EN FOI DE QUOI : Je, ___________________________ de ___________________________ dans ___________________________ de ___________________________ déclare solennellement : 1 que je suis l’« exportateur » délivrant le présent certificat et que je suis au courant des renseignements que j’ai ai [sic] déclarés ___________________________ ou ___________________________ que je suis ___________________________ l’« exportateur » délivrant le présent certificat et que je suis au courant des renseignements que j’ai déclarés (si l’exportateur est une société commerciale, indiquer que le déclarant est l’agent de l’« exportateur »), 2 que tous les renseignements donnés dans ledit certificat sont véridiques, 3 que tous les renseignements pertinents y sont consignés et qu’aucun renseignement utile n’a été omis. Et je fais la présente déclaration solennelle la croyant vraie et sachant qu’elle a la même valeur que si elle était faite sous serment en vertu de la Loi sur la preuve au Canada. Déclaration faite en ma présence à ___________________________ le ___________________________ 20 ______ . ___________________________ Commissaire à l’assermentation DORS/80-318, art. 2; DORS/2022-100, art. 6; DORS/2022-100, art. 7; DORS/2022-100, art. 8; DORS/2022-100, art. 9. SCHEDULE K.1 (Subsections B.01.350(1) and B.01.351(1) and (5)) Unilingual Horizontal Format 1(EH) Sat fat Sugars Sodium Health Canada 2(EH) Sat fat Sugars Health Canada 3(EH) Sat fat Sodium Health Canada 4(EH) Sugars Sodium Health Canada 5(EH) Sat fat Health Canada 6(EH) Sugars Health Canada 7(EH) Sodium Health Canada ANNEXE K.1 (paragraphes B.01.350(1), B.01.351(1) et (5)) Symboles nutritionnels et modèles Modèle horizontal unilingue 1(FH) Élevé en Gras sat Sucres Sodium Santé Canada 2(FH) Élevé en Gras sat Sucres Santé Canada 3(FH) Élevé en Gras sat Sodium Santé Canada 4(FH) Élevé en Sucres Sodium Santé Canada 5(FH) Élevé en Gras sat Santé Canada 6(FH) Élevé en Sucres Santé Canada 7(FH) Élevé en Sodium Santé Canada 1(AH) Sat fat Sugars Sodium Health Canada 2(AH) Sat fat Sugars Health Canada 3(AH) Sat fat Sodium Health Canada 4(AH) Sugars Sodium Health Canada 5(AH) Sat fat Health Canada 6(AH) Sugars Health Canada 7(AH) Sodium Health Canada --- SCHEDULE K.1 8(EH) Sat fat Sugars Health Canada 8(FH) Élevé en Gras sat. Sucres Santé Canada 8(AH) Sat fat Sugars Health Canada 9(EH) Sugars Sodium Health Canada 9(FH) Élevé en Sucres Sodium Santé Canada 9(AH) Sugars Sodium Health Canada 10(EH) Sat fat Sodium Health Canada 10(FH) Élevé en Gras sat. Sodium Santé Canada 10(AH) Sat fat Sodium Health Canada 11(EH) Sat fat Health Canada 11(FH) Élevé en Gras sat. Santé Canada 11(AH) Sat fat Health Canada 12(EH) Sugars Health Canada 12(FH) Élevé en Sucres Santé Canada 12(AH) Sugars Health Canada 13(EH) Sodium Health Canada 13(FH) Élevé en Sodium Santé Canada 13(AH) Sodium Health Canada Unilingual Vertical Format 1(EV) Sat fat Sugars Sodium Health Canada 1(FV) Élevé en Gras sat. Sucres Sodium Santé Canada 1(AV) Sat fat Sugars Sodium Health Canada 2(EV) Sat fat Sugars Health Canada 2(FV) Élevé en Gras sat. Sucres Santé Canada 2(AV) Sat fat Sugars Health Canada 3(EV) Sugars Sodium Health Canada 3(FV) Élevé en Sucres Sodium Santé Canada 3(AV) Sugars Sodium Health Canada Règlement sur les aliments et drogues ANNEXE K.1 4(EV) Sat fat Sodium Health Canada 4(FV) Élevé en Gras sat. Sodium Santé Canada 4(FV) Élevé en Gras sat. Sodium Santé Canada 4(AV) Sat fat Sodium Health Canada 5(EV) Sat fat Sodium Health Canada 5(FV) Élevé en Gras sat. Sodium Santé Canada 5(FV) Élevé en Gras sat. Sodium Santé Canada 5(AV) Sat fat Sodium Health Canada 6(EV) Sugars Health Canada 6(FV) Élevé en Sucres Santé Canada 6(FV) Élevé en Sucres Santé Canada 6(AV) Sugars Health Canada 7(EV) Sodium Health Canada 7(FV) Élevé en Sodium Santé Canada 7(FV) Élevé en Sodium Santé Canada 7(AV) Sodium Health Canada 8(EV) Sat fat Sugars Health Canada 8(FV) Élevé en Gras sat. Sucres Santé Canada 8(FV) Élevé en Gras sat. Sucres Santé Canada 8(AV) Sat fat Sugars Health Canada 9(EV) Sugars Sodium Health Canada 9(FV) Élevé en Sucres Sodium Santé Canada 9(FV) Élevé en Sucres Sodium Santé Canada 9(AV) Sugars Sodium Health Canada 10(EV) Sat fat Sodium Health Canada 10(FV) Élevé en Gras sat. Sodium Santé Canada 10(FV) Élevé en Gras sat. Sodium Santé Canada 10(AV) Sat fat Sodium Health Canada 11(EV) Sat fat Health Canada 11(FV) Élevé en Gras sat. Santé Canada 11(FV) Élevé en Gras sat. Santé Canada 11(AV) Sat fat Health Canada 12(EV) Health Canada 12(FV) Élevé en Sucres Santé Canada 13(EV) Health Canada 13(FV) Élevé en Sodium Santé Canada 12(AV) Health Canada 12(FV) Élevé en Sucres Santé Canada 13(AV) Health Canada 13(FV) Élevé en Sodium Santé Canada Bilingual Horizontal Format 1(BH) Sugars / Sucres Sodium Health Canada / Santé Canada 2(BH) Sugars / Sucres Health Canada / Santé Canada 3(BH) Sodium Health Canada / Santé Canada 4(BH) Sodium Health Canada / Santé Canada 5(BH) Health Canada / Santé Canada 6(BH) Health Canada / Santé Canada 7(BH) Health Canada / Santé Canada Modèle horizontal bilingue 1(HB) Élevé en / High in Gras sat / Sat fat Sucres / Sugars Sodium Santé Canada / Health Canada 2(HB) Élevé en / High in Gras sat / Sat fat Sucres / Sugars Santé Canada / Health Canada 3(HB) Élevé en / High in Sucres / Sugars Sodium Santé Canada / Health Canada 4(HB) Élevé en / High in Gras sat / Sat fat Sodium Santé Canada / Health Canada 5(HB) Élevé en / High in Gras sat / Sat fat Santé Canada / Health Canada 6(HB) Élevé en / High in Sucres / Sugars Santé Canada / Health Canada 7(HB) Élevé en / High in Sodium Santé Canada / Health Canada 8(BH) High in / Élevé en Sat fat / Gras sat. Sugars / Sucres Health Canada / Santé Canada 9(BH) High in / Élevé en Sugars / Sucres Sodium Health Canada / Santé Canada 10(BH) High in / Élevé en Sat fat / Gras sat. Sodium Health Canada / Santé Canada 11(BH) High in / Élevé en Sat fat / Gras sat. Sugars / Sucres Sodium Health Canada / Santé Canada 12(BH) High in / Élevé en Sodium Health Canada / Santé Canada 13(BH) High in / Élevé en Sodium Health Canada / Santé Canada 8(HB) Élevé en / High in Gras sat. / Sat fat Sucres / Sugars Santé Canada / Health Canada 9(HB) Élevé en / High in Sucres / Sugars Sodium Santé Canada / Health Canada 10(HB) Élevé en / High in Gras sat. / Sat fat Sodium Santé Canada / Health Canada 11(HB) Élevé en / High in Gras sat. / Sat fat Sucres / Sugars Sodium Santé Canada / Health Canada 12(HB) Élevé en / High in Sodium Santé Canada / Health Canada 13(HB) Élevé en / High in Sodium Santé Canada / Health Canada Bilingual Vertical Format 1(BV) Élevé en Sat fat Gras sat. Sugars Sucres Sodium Health Canada Santé Canada 2(BV) Élevé en Sat fat Gras sat. Sugars Sucres Sodium Health Canada Santé Canada Modèle vertical bilingue 1(VB) Élevé en Gras sat. Sat fat Sucres Sugars Sodium Santé Canada Health Canada 2(VB) Élevé en Gras sat. Sat fat Sucres Sugars Sodium Santé Canada Health Canada 3(BV) Sugars Sodium Health Canada 4(BV) Sat fat Sodium Health Canada 5(BV) Sat fat Sugars Health Canada 6(BV) Sugars Health Canada 7(BV) Sodium Health Canada 8(BV) Sat fat Sugars Health Canada 3(VB) Élevé en Sucres Sodium Santé Canada 4(VB) Élevé en Gras sat. Sodium Santé Canada 5(VB) Élevé en Gras sat. Sucres Santé Canada 6(VB) Élevé en Sucres Santé Canada 7(VB) Élevé en Sodium Santé Canada 8(VB) Élevé en Gras sat. Sucres Santé Canada 9(BV) Sugars Health Canada Santé Canada 10(BV) Health Canada Santé Canada 11(BV) Sodium Health Canada Santé Canada 12(BV) Sugars Sodium Health Canada Santé Canada 13(BV) Sodium Health Canada Santé Canada SOR/2022-168, s. 51. DORS/2022-168, art. 51. SCHEDULE K.2 (Subsections B.29.021(1), (2) and (8)) Unilingual Standard Format ES Health Canada FS ! Supplémenté Santé Canada Bilingual Standard Format BS ! Supplemented / Supplémenté Health Canada / Santé Canada Bilingual Compact Format BC ! Supplémenté Health Canada Santé Canada SOR/2022-169, s. 29. ANNEXE K.2 (paragraphes B.29.021(1), (2) et (8)) Modèles — identifiant des aliments supplémentés avec mise en garde Modèle standard unilingue FS ! Supplémenté Santé Canada AS Health Canada Modèle standard bilingue SB ! Supplémenté / Supplemented Santé Canada / Health Canada Modèle compact bilingue CB ! Supplémenté Santé Canada Health Canada DORS/2022-169, art. 29. SCHEDULE L [Repealed, SOR/2016-305, s. 71] ANNEXE L [Abrogée, DORS/2016-305, art. 71] SCHEDULE M [Repealed, SOR/2016-305, s. 71] ANNEXE M [Abrogée, DORS/2016-305, art. 71] RELATED PROVISIONS — SOR/97-12, s. 66 — SOR/98-423, s. 10 — SOR/98-423, s. 11 — SOR/98-423, s. 12 (ii) the information referred to in subsection C.01.014.1(2) of the Food and Drug Regulations. — SOR/98-423, s. 13 — SOR/98-423, s. 14 11 38 (1)

(2)

(c) the expression “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.

(3)

SOR/2006-241, s. 2 — SOR/2007-302, s. 12 — SOR/2013-74, s. 17 — SOR/2013-74, s. 18, as amended by SOR/2013-178, s. 125 — SOR/2013-172, s. 12 — SOR/2013-172, s. 13 (d) an abbreviated extraordinary use new drug submission that is filed under section C.08.002.1 of those Regulations. (présentation) (a) prescription drugs; or SOR/2014-158, s. 23 SOR/2014-158, s. 24 SOR/2014-158, s. 25 SOR/2014-158, s. 26 SOR/2014-158, s. 27 SOR/2014-158, s. 28 — SOR/2014-158, s. 29 — SOR/2014-158, s. 30 — SOR/2014-158, s. 31 — SOR/2014-158, s. 32 — SOR/2016-74, s. 17 17 (1) In this section, saccharin sweetener means a saccharin sweetener as defined in subsection E.01.001(1) of the former Regulations. (édulcorant à la saccharine) — SOR/2016-305, s. 76 prepackaged product has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (produit préemballé) — SOR/2017-76, s. 11 — SOR/2017-259, s. 24 (a) subsection C.03.202(1); (b) subsection C.03.203(1); or (c) section C.03.208.

(2)

Subsection (1) ceases to apply in respect of a drug

(2)

Subsection (1) ceases to apply in respect of a drug — SOR/2019-62, s. 4 — SOR/2019-62, s. 5 — SOR/2019-62, s. 6 (b) any longer period specified by the Minister. a) le ministre a délivré un avis de conformité en application des articles C.08.004 ou C.08.004.01 du Règlement sur les aliments et drogues; b) le ministre, ayant informé le fabricant, en application des alinéas C.08.004(1)(b) ou C.08.004.01(1)(b) du Règlement sur les aliments et drogues, que la présentation ou le supplément n’était pas conforme aux articles C.08.002, C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1 de ce règlement, a délivré un avis au fabricant informant ce dernier que la présentation ou le supplément était considéré comme ayant été retiré vu l’omission du fabricant de modifier la présentation ou le supplément; c) le ministre a informé le fabricant, en application des alinéas C.08.004(3)(b) ou C.08.004.01(3)(b) du Règlement sur les aliments et drogues, que la présentation ou le supplément n’était pas conforme aux articles C.08.002, C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1 de ce règlement. — DORS/2019-62, art. 6 6 (1) Le présent article s’applique aux renseignements relatifs à un essai clinique qui sont des renseignements commerciaux confidentiels et qui sont contenus dans une présentation ou un supplément : a) déposés par le fabricant dans les quatre-vingt-dix jours précédant l’entrée en vigueur du présent règlement; b) relativement auxquels le ministre a informé le fabricant, en application des alinéas C.08.004(1)(b) ou C.08.004.01(1)(b) du Règlement sur les aliments et drogues, avant la date d’entrée en vigueur du présent règlement, que la présentation ou le supplément n’était pas conforme aux articles C.08.002, C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1 du Règlement sur les aliments et drogues.

(2)

Malgré le paragraphe C.08.009.2(1) du Règlement sur les aliments et drogues, les renseignements relatifs à un essai clinique qui sont contenus dans une présentation ou un supplément cessent d’être des renseignements commerciaux confidentiels à l’expiration du délai ci-après qui s’applique si le fabricant ne modifie pas la présentation ou le supplément dans ce délai : a) quatre-vingt-dix jours suivant la date à laquelle le présent règlement entre en vigueur; b) tout délai plus long imparti par le ministre. SOR/2019-62, s. 7 7 Sections 5 and 6 do not apply to information referred to in subsection C.08.009.2(2) of the Food and Drug Regulations. SOR/2019-98, s. 6 SOR/2019-217, s. 2 SOR/2021-45, s. 18 (b) an application submitted under section 4 of the ISAD Interim Order. (autorisation) SOR/2021-45, s. 19 — SOR/2021-45, s. 20 (a) sections A.01.014, A.01.015, A.01.022 to A.01.043, A.01.050, A.01.051 and A.01.060 to A.01.068; (b) sections C.01.004 to C.01.011, C.01.014.9, C.01.014.10, C.01.017 and C.01.019, subsection

titre 8 de la partie C du même règlement s’appliquent à l’égard de la présentation ou du supplément.

(2)

L’autorisation est révoquée si le fabricant ne dépose pas, à l’égard de la drogue nouvelle, une présentation de drogue nouvelle en application de l’article C.08.002 du Règlement sur les aliments et drogues ou un supplément, selon le cas, dans les délais suivants qui s’applique : a) s’agissant d’une autorisation délivrée avant l’entrée en vigueur du présent article, au plus tard quatre-vingt-dix jours après la date d’entrée en vigueur du présent article; b) s’agissant d’une autorisation délivrée à la date d’entrée en vigueur du présent article ou après cette date, au plus tard quatre-vingt-dix jours après la date de délivrance de l’autorisation.

(3)

Si le fabricant dépose à l’égard de la drogue nouvelle, une présentation de drogue nouvelle en application de l’article C.08.002 du Règlement sur les aliments et drogues ou un supplément dans l’un des délais visés aux alinéas (2)a) et b), l’autorisation est révoquée au moment où, selon le cas : a) le ministre délivre, relativement à la présentation ou au supplément, un avis de conformité en vertu de l’article C.08.004 de ce règlement; b) dans le cas où le ministre délivre, relativement à la présentation ou au supplément, un avis au fabricant en application de l’alinéa C.08.004(1)b) de ce règlement, et le fabricant ne modifie pas la présentation ou le supplément conformément au paragraphe C.08.002(4) de ce règlement, le délai visé à ce paragraphe expire; c) le ministre délivre, relativement à la présentation ou au supplément, un avis au fabricant en vertu de l’alinéa C.08.004(3)b) de ce règlement. — DORS/2021-45, art. 20 20 Le Règlement sur les aliments et drogues — à l’exception des dispositions ci-après — ne s’applique pas à une drogue nouvelle à l’égard de laquelle une autorisation a été délivrée au fabricant de la drogue nouvelle si l’autorisation n’était pas suspendue ou révoquée à la date d’entrée en vigueur du présent article : a) les articles A.01.014, A.01.015, A.01.022 à A.01.043, A.01.050, A.01.051 et A.01.060 à A.01.068; b) les articles C.01.004 à C.01.011, C.01.014.9, C.01.014.10, C.01.017 et C.01.019, le paragraphe

C

01.020(1) and sections C.01.020.1, C.01.040.3 to C.01.053, C.01.064 to C.01.069 and C.01.401; (d) sections C.03.202, C.03.203 and C.03.206 to C.03.209; and (e) sections C.04.013 to C.04.016, C.04.019 and C.04.020. — SOR/2021-45, s. 21 — SOR/2021-45, s. 22 — SOR/2021-45, s. 23 — SOR/2021-45, s. 24 — SOR/2021-45, s. 25 — SOR/2021-45, s. 26 — SOR/2021-45, s. 27 — SOR/2021-45, s. 28 — SOR/2021-45, s. 29 — SOR/2021-45, s. 30 — SOR/2021-57, s. 25 — SOR/2021-199, s. 9 licence d’établissement notifie par écrit au ministre son intention de poursuivre les activités en lien avec la drogue contre la COVID-19 en vertu de la licence d’établissement.

(2)

Malgré le paragraphe 26(2) de l’arrêté d’urgence IVPD, toute modification visée à ce paragraphe qui est apportée à une licence d’établissement continue d’avoir effet après que l’arrêté d’urgence IVPD cesse d’avoir effet si, avant la date à laquelle l’arrêté d’urgence cesse d’avoir effet, le titulaire de la licence d’établissement notifie par écrit au ministre son intention de poursuivre les activités en lien avec la drogue contre la COVID-19 en vertu de la licence d’établissement modifiée. — DORS/2021-45, art. 29 29 Les renseignements et le matériel qui ont été fournis à l’égard d’une drogue désignée contre la COVID-19 aux termes des alinéas 28(1)a) et b) ou 30a) de l’arrêté d’urgence IVPD sont réputés avoir été fournis, selon le cas, aux termes des alinéas C.08.009.03(1)a) et b) ou C.08.009.05a) du Règlement sur les aliments et drogues. — DORS/2021-45, art. 30 30 L’article C.08.009.05 du Règlement sur les aliments et drogues s’applique, avec les adaptations nécessaires, à la drogue désignée contre la COVID-19 importée en vertu de l’article 28 de l’arrêté d’urgence IVPD. — DORS/2021-57, art. 25 25 (1) Au présent article, nouveau règlement s’entend du Règlement sur les aliments et drogues dans sa version à l’entrée en vigueur du présent règlement.

(2)

Un fortifiant pour lait humain, au sens de l’article B.25.001 du nouveau règlement, figurant sur la Liste des fortifiants pour lait humain vendus au Canada au 25 mars 2021 qui est publiée sur un site Web du gouvernement du Canada n’a pas à être étiqueté conformément au nouveau règlement s’il est étiqueté de la même manière qu’il l’était immédiatement avant la date d’entrée en vigueur du nouveau règlement.

(3)

Les paragraphes (1) et (2) cessent d’avoir effet au deuxième anniversaire de la date d’entrée en vigueur du présent règlement. — DORS/2021-199, art. 9 9 Le titulaire d’une licence d’établissement qui a consigné dans un dossier des renseignements en application de l’Arrêté d’urgence sur les pénuries de drogues (protection de l’approvisionnement en drogues), pris par la — SOR/2021-199, s. 10 — SOR/2021-199, s. 11 — SOR/2021-199, s. 12 (a) sections A.01.015 and A.01.017 in paragraph C.10.008(1)(a); (b) sections C.01.040.3 to C.01.049.1 in subparagraph C.10.008(1)(b)(i); (c) subparagraph C.10.008(1)(b)(ii); and (d) sections C.10.009 to C.10.011 in subparagraph C.10.008(1)(b)(iii). — SOR/2021-199, s. 14 — SOR/2021-199, s. 15 — SOR/2022-100, s. 10 d’utilisation la plus tardive attribuée à l’aliment pour des fins diététiques spéciales désigné qu’il a importé.

(6)

Au présent article, date limite d’utilisation s’entend au sens de l’article B.25.001 du Règlement sur les aliments et drogues. — DORS/2021-199, art. 15 15 La personne qui, immédiatement avant que l’Arrêté d’urgence no 2 sur les importations exceptionnelles et les pénuries ne cesse d’avoir effet, était autorisée par le paragraphe 30(2) de cet arrêté d’urgence à poursuivre l’exercice d’une activité à l’égard d’un désinfectant pour les mains désigné peut continuer à exercer l’activité sans être titulaire d’une licence d’établissement l’y autorisant jusqu’au premier des moments suivants : a) le moment où survient l’un des événements visés aux alinéas 30(2)a) à c) de cet arrêté d’urgence; b) le 1er septembre 2023. — DORS/2022-100, art. 10 10 (1) Sauf indication contraire, les termes utilisés au présent article s’entendent au sens du paragraphe C.01A.001(1) du Règlement sur les aliments et drogues.

(2)

Sous réserve du paragraphe (3), durant la période de trois mois commençant à la date d’entrée en vigueur du présent règlement, la drogue qui, jusqu’à cette date, était exemptée de l’application des dispositions prévues à l’article A.01.048 du Règlement sur les aliments et drogues, en vertu du paragraphe 37(1) de la Loi, et qui continue de satisfaire aux exigences de ce paragraphe, à la fois : a) peut continuer, malgré l’article C.01A.004 de ce même règlement, à être manufacturée, emballée-étiquetée, analysée, distribuée ou vendue en gros par la personne qui exerçait cette activité avant cette date et qui ne détient pas une licence d’établissement l’y autorisant; b) est exemptée de l’application des dispositions des titres 2 à 4 de la Partie C de ce même règlement qui sont prévues à l’article A.01.048.

(3)

Si, avant l’expiration de la période de trois mois, la personne visée à l’alinéa (2)a) présente au ministre de la Santé une demande de licence d’établissement ou une demande de modification d’une licence d’établissement conformément à l’article C.01A.005 ou C.01A.006 du Règlement sur les aliments et drogues afin d’être autorisée à exercer l’activité, cette personne, en ce qui a trait à cette (a) issues the licence or amends it to authorize the activity; or — SOR/2022-168, s. 53 prepackaged product has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (produit préemballé) (a) sections B.01.350 to B.01.358; (b) subsection B.01.503(1.1); (c) subsection B.01.508(2); (d) subsection B.01.509(2); and (e) section D.01.001.2. (a) subsections B.01.008.1(1), (3) and (4); (b) paragraph B.01.008.2(2)(b); (c) subsection B.01.010.3(1); (d) section B.01.010.4; (e) section B.01.014; (f) section B.01.023; (g) paragraph B.01.305(3)(g); and (h) section B.01.467. (a) subsection B.01.305(1) and paragraphs B.01.305(2)(a) and (3)(h); (b) subparagraph B.01.401(3)(e)(ii) and items 2 to 5, 7, 8 and 16 of the table to section B.01.401; (c) section B.01.500; (d) sections B.01.502 to B.01.507; (e) subsection B.01.508(1); (f) subsection B.01.509(1); (g) sections B.01.510 to B.01.512; (h) subparagraph B.01.601(1)(c)(i); (i) items 1 to 3 of the table following section B.01.603; (j) paragraphs B.08.033(1.1)(a) and (1.2)(a); (k) paragraphs B.08.034(1.1)(a) and (1.2)(a); and (l) subsections B.24.003(1.1) and (4). (a) paragraph B.08.003(b); (b) paragraph B.08.004(c); (c) paragraph B.08.005(c); (d) paragraph B.08.007(d); d) l’article B.01.010.4; e) l’article B.01.014; f) l’article B.01.023; g) l’alinéa B.01.305(3)(g); h) l’article B.01.467.

(4)

Il n’est pas nécessaire que les produits préemballés soient étiquetés conformément aux dispositions ci-après du Règlement sur les aliments et drogues s’ils sont étiquetés conformément à l’ancien règlement et si aucun changement n’a été apporté à leur étiquette afin de les rendre conformes à l’une de ces dispositions : a) le paragraphe B.01.305(1) et les alinéas B.01.305(2)(a) et (3)(h); b) le sous-alinéa B.01.401(3)(e)(ii) et les articles 2 à 5, 7, 8 et 16 du tableau de l’article B.01.401; c) l’article B.01.500; d) les articles B.01.502 à B.01.507; e) le paragraphe B.01.508(1); f) le paragraphe B.01.509(1); g) les articles B.01.510 à B.01.512; h) le sous-alinéa B.01.601(1)(c)(i); i) les articles 1 à 3 du tableau suivant l’article B.01.603; j) les alinéas B.08.033(1.1)(a) et (1.2)(a); k) les alinéas B.08.034(1.1)(a) et (1.2)(a); l) les paragraphes B.24.003(1.1) et (4).

(5)

Il n’est pas nécessaire que les aliments visés par l’une des dispositions ci-après du Règlement sur les aliments et drogues contiennent la quantité de vitamine D nécessaire pour satisfaire aux exigences prévues à cette disposition si la quantité qu’ils contiennent satisfait aux exigences prévues à cette disposition de l’ancien règlement : a) l’alinéa B.08.003b); b) l’alinéa B.08.004c); c) l’alinéa B.08.005c); d) l’alinéa B.08.007d); (e) paragraph B.08.010(d); (f) paragraph B.08.011(e); (g) paragraph B.08.012(f); (h) paragraph B.08.013(c); (i) paragraph B.08.014(d); (j) paragraph B.08.016(c); (k) paragraph B.08.017(d); (l) paragraph B.08.018(d); (m) paragraph B.08.019(e); (n) paragraph B.08.020(d); (o) paragraph B.08.023(c); (p) paragraph B.08.026(e); and — SOR/2022-169, s. 31 (a) the List of beverages, beverage mixes and concentrates; — SOR/2022-169, s. 32 conditions d’utilisation, publié par le gouvernement du Canada sur son site Web, dans sa version en vigueur à la date d’entrée en vigueur du présent règlement. (Threshold Levels for Cautionary Statements and Other Conditions of Use)

(2)

Sauf indication contraire du contexte, les termes utilisés au présent article et aux articles 32 à 36 s’entendent au sens de la Loi sur les aliments et drogues et du Règlement sur les aliments et drogues. — DORS/2022-169, art. 32 32 (1) Sous réserve de l’article 35, le fabricant d’un aliment à qui a été délivrée une lettre d’autorisation de mise en marché temporaire en vertu du paragraphe B.01.054(1) du Règlement sur les aliments et drogues, dans le numéro d’autorisation de mise en marché temporaire figure dans les Listes LAMT est exempté de l’application du Règlement sur les aliments et drogues à l’égard de cet aliment si les conditions ci-après sont réunies : a) à l’expiration de la lettre, l’aliment ne faisait pas l’objet d’une demande visant à le retirer du marché; b) depuis l’expiration de la lettre : (i) sous réserve du paragraphe (2), le fabricant s’est conformé au Règlement sur les aliments et drogues, dans sa version antérieure à la date d’entrée en vigueur du présent règlement, à l’exception de toute disposition qui figure à l’annexe 1 de la lettre à laquelle l’aliment n’a pas à se conformer, (ii) le fabricant a respecté les conditions ci-après qui figurent à l’annexe 1 de la lettre, le cas échéant : (A) aucun signe ni aucune déclaration, étiquette ou annonce, y compris aucune distribution d’échantillons de produits, ne fait la promotion de l’aliment aux fins de la consommation par les enfants ou par les femmes qui sont enceintes ou qui allaitent, (B) l’aliment contient les substances précisées à l’annexe 2 de la lettre, et ce, en les teneurs qui y figurent, (C) les énoncés qui figurent à l’annexe 1 de la lettre — ou les énoncés de signification équivalente — figurent sur l’étiquette de l’aliment, (D) il n’y a d’allégations sur l’étiquette de l’aliment faisant référence à sa performance physique ou à ses bienfaits pour la santé, — SOR/2022-169, s. 33 (E) les conditions qui figurent à l’annexe 3 de la lettre sont respectées, (iii) aucune des substances qui figurent à la colonne 1 de la Liste des ingrédients supplémentaires autorisés n’a été ajoutée à l’aliment, à l’exception des substances suivantes : (A) une substance qui figure à l’annexe 2 de la lettre, (B) une substance qui est utilisée comme un additif alimentaire visé par une autorisation de mise en marché.

(2)

Le fabricant peut se conformer aux dispositions du Règlement sur les aliments et drogues qui ont été modifiées par les articles 1 à 11, 13 à 48 et 57 à 75 du Règlement modifiant le Règlement sur les aliments et drogues (étiquetage nutritionnel, autres dispositions d’étiquetage et colorants alimentaires), dans leur version au 13 décembre 2016, relativement à l’aliment visé au paragraphe (1). — DORS/2022-169, art. 33 33 (1) Sous réserve de l’article 35, le fabricant d’un aliment qui a présenté une demande de lettre d’autorisation de mise en marché temporaire à l’égard de l’aliment avant la date d’entrée en vigueur du présent règlement, mais à qui n’a pas été délivrée, avant cette date, une lettre en vertu du paragraphe B.01.054(1) du Règlement sur les aliments et drogues, est exempté de l’application du Règlement sur les aliments et drogues à l’égard de cet aliment si les conditions ci-après sont réunies : a) le ministre l’informe, en application du paragraphe (2), que la vente de l’aliment est autorisée; b) sous réserve des paragraphes (3) et (4), il se conforme au Règlement sur les aliments et drogues, dans sa version antérieure à la date d’entrée en vigueur du présent règlement; c) aucune des substances qui figurent à la colonne 1 de la Liste des ingrédients supplémentaires autorisés n’a été ajoutée à l’aliment, à l’exception des substances suivantes : (i) une substance contenue dans l’aliment en la teneur précisée dans la demande à l’égard de laquelle le ministre a délivré la notification visée à l’alinéa a), (ii) une substance utilisée comme un additif alimentaire visé par une autorisation de mise en marché; (i) les mises en garde applicables qui figurent dans les titres des colonnes 2 à 6 du tableau de la partie I des Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation — ou les énoncés de signification équivalente —, si une substance — utilisée autrement que comme un additif alimentaire visé par une autorisation de mise en marché — qui figure à la colonne 1 de ce tableau a été ajoutée à l’aliment et que la teneur totale de l’aliment en cette substance égale ou excède les seuils maximaux figurant aux colonnes 2 à 6 de ce tableau, (ii) les mises en garde applicables qui figurent dans les titres des colonnes 2 à 4 du tableau de la partie II des Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation — ou les énoncés de signification équivalente —, si la teneur totale de l’aliment en caféine égale ou excède les seuils maximaux figurant aux colonnes 2 à 4 de ce tableau à l’égard de la catégorie d’aliments qui figure à la colonne 1 de ce tableau à laquelle l’aliment appartient; h) s’agissant d’un aliment visé aux alinéas (f) ou (g), le fabricant se conforme aux conditions d’utilisation qui figurent à la colonne 6 du tableau de la partie II des Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation à l’égard de la catégorie d’aliments qui figure à la colonne 1 de ce tableau à laquelle l’aliment appartient; i) si la mise en garde « Non recommandé pour les enfants, les femmes qui sont enceintes ou qui allaitent et les personnes sensibles à la caféine » — ou les énoncés de signification équivalente — figurent sur l’étiquette de l’aliment, aucune marque, déclaration, étiquette ou annonce, y compris aucune distribution d’échantillons, ne fait la promotion de l’aliment aux fins de la consommation par les enfants ou par les femmes qui sont enceintes ou qui allaitent.

(2)

Le ministre informe le fabricant, par écrit, que la vente de l’aliment est autorisée si : a) le fabricant fournit au ministre les renseignements suivants : (i) les renseignements visés aux sous-alinéas B.01.054(1)(a)(i) à (vii) du Règlement sur les aliments et drogues, dans sa version antérieure à la date d’entrée en vigueur du présent règlement, (ii) tout renseignement supplémentaire que le ministre lui demande pour pouvoir évaluer les renseignements visés au sous-alinéa (i); (a) section B.01.043, (c) section D.01.009; (d) section D.01.011; (e) section D.02.009; or (f) section D.03.002. b) l’aliment appartient à une catégorie d’aliments figurant à la colonne 1 de la Liste des catégories autorisées d’aliments supplémentés; c) dans le cas où une substance qui figure à la colonne 1 du tableau de la partie I des Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation a été ajoutée à l’aliment, la teneur totale de l’aliment en cette substance n’excède pas la teneur maximale par jour qui figure aux colonnes 7 ou 9 de la partie I du tableau la concernant; d) dans le cas où de la caféine a été ajoutée à l’aliment, la teneur totale de l’aliment en caféine n’excède pas le teneur maximale par portion qui figure à la colonne 5 du tableau de la partie II des Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation à l’égard de la catégorie d’aliments à laquelle l’aliment appartient.

(3)

Le fabricant n’est pas tenu de se conformer aux dispositions ci-après du Règlement sur les aliments et drogues, dans sa version antérieure à la date d’entrée en vigueur du présent règlement relativement à l’aliment visé au paragraphe (1) : a) l’article B.01.043, selon le cas : (i) à l’égard de la caféine qui a été ajoutée à l’aliment pour une utilisation autre qu’une utilisation qui figure à l’article C.1 des colonnes 2 à 4 de la Liste des additifs alimentaires autorisés ayant d’autres utilisations acceptées, publiée par le gouvernement du Canada sur son site Web, avec ses modifications successives, (ii) à l’égard d’un solvant d’extraction qui a été utilisé dans la fabrication d’un extrait qui a été ajouté à l’aliment autrement qu’à titre de substance aromatique; b) l’article B.01.045, à l’égard de la caféine qui a été ajoutée à l’aliment et qui ne satisfait pas aux spécifications qui figurent dans la publication de la United States Pharmacopeial Convention, Rockville, MD, États-Unis, intitulée Food Chemicals Codex, dixième édition, publiée en 2016, ou dans toute édition subséquente — y compris leurs suppléments —, avec leurs modifications successives; c) l’article D.01.009; d) l’article D.01.011; e) l’article D.02.009; f) l’article D.03.002. — SOR/2022-169, s. 34 — SOR/2022-169, s. 35 — SOR/2022-169, s. 36 AMENDMENTS NOT IN FORCE — SOR/2024-110, s. 76 — SOR/2024-110, s. 77 — SOR/2024-110, s. 78 — SOR/2024-110, s. 79 — SOR/2024-110, s. 80 — SOR/2024-110, s. 81 — SOR/2024-110, s. 82 SOR/2024-136, s. 1 (i) the brand name, (ii) the drug identification number assigned under subsection C.01.014.2(1), (iii) the dosage form, (iv) the strength, (d) the lot numbers of the drug; (e) the dates of fabrication of the drug; (f) the expiration dates of the drug;

(2)

The manufacturer or importer shall (d) the quantity of the drug in Canada that is in the possession or control of the person;

(3)

The person shall — SOR/2024-136, s. 3 a) un système de contrôle qui permet le rappel rapide et complet de tout lot ou tout lot de fabrication de la drogue se trouvant sur le marché; — SOR/2024-136, s. 5

C

02.022 (1) Le grossiste, le distributeur visé à l’article C.01A.003 et l’importateur d’une drogue sous forme posologique conservent les dossiers sur la vente de chaque lot ou lot de fabrication de la drogue pendant un an après sa date limite d’utilisation afin de pouvoir en faire le rappel, à moins que la licence d’établissement de l’intéressé ne prévoie une autre période.

(2)

Le distributeur d’un ingrédient actif visé à l’alinéa C.01A.003a) et le grossiste et l’importateur d’un ingrédient actif conservent les dossiers sur la vente de chaque lot ou lot de fabrication de l’ingrédient actif pendant celle des périodes ci-après qui s’applique afin de pouvoir en faire le rappel, à moins que l’intéressé ne détienne une licence d’établissement qui prévoit une autre période :