Natural Health Products Regulations — 1
1 (1) The following definitions apply in these Regulations. Act means the Food and Drugs Act . ( Loi ) added sulphites means one or more of the food additives that are set out item 21, column 1, of table 2 of the Common Names for Ingredients and Components Document and are present in a natural health product as a result of being added to the product. ( sulfites ajoutés ) adverse reaction means a noxious and unintended response to a natural health product that occurs at any dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying an organic function. ( réaction indésirable ) brand name means a name in English or French, whether or not it includes the name of a manufacturer, corporation, partnership or individual (a) that is used to distinguish the natural health product; and (b) under which a natural health product is sold or advertised. ( marque nominative ) case report means a detailed record of all relevant data associated with the use of a natural health product in a subject. ( fiche d’observation ) Common Names for Ingredients and Components Document means the document entitled Common 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 ) Compendium means the Compendium of Monographs published by the Department of Health and as amended from time to time. ( Compendium ) distributor means a person who sells a natural health product to another person for the purpose of further sale by that other person. ( distributeur ) expiry date means the earlier of (a) the date, expressed at minimum as a year and month, that is the end of the stability period determined under section 52; and (b) the date, expressed at minimum as a year and month, after which the manufacturer recommends that the natural health product should not be used. ( date limite d’utilisation ) 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: (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. ( allergène alimentaire ) food allergen source, gluten source and added sulphites statement means a statement appearing on the label of a natural health 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 ) 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: (i) barley, (ii) oats, (iii) rye, (iv) triticale, (v) wheat; or (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 ) immediate container means the container that is in direct contact with a natural health product. ( contenant immédiat ) importer means a person who imports a natural health product into Canada for the purpose of sale. ( importateur ) inner label means the label on or affixed to an immediate container of a natural health product. ( étiquette intérieure ) List A means the document entitled List of Certain Natural Health Products for Distribution as Samples , dated March 2020 and published by the Government of Canada on its website. ( Liste A ) lot number means any combination of letters, figures, or both, by which a natural health product can be traced in manufacture and identif