Food and Drug Regulations

B.01.001 (1) In this Part,

agricultural chemical

agricultural chemical means any substance that is used, or represented for use, in or 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,

• (c) vitamin, mineral nutrient or amino acid,

• (d) essential oil, flavouring preparation, natural extractive, oleoresin, seasoning or spice,

• (e) food packaging material or any substance of which that material is composed, or

• (f) drug recommended for administration to animals that may be consumed as food; (produit chimique agricole)

available display surface

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

• (f) the area occupied by the universal product code; (surface exposée disponible)

close proximity

close proximity means, with reference to the common name, immediately adjacent to the common name without any intervening printed, written or graphic matter; (à proximité)

common name

common name means, with reference to a food,

• (a) the name of the food printed in boldface type in 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; (nom usuel)

component

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)

daily value

daily value means

• (a) in respect of a vitamin or mineral nutrient referred to in the definition recommended daily intake, the recommended daily intake for that vitamin or mineral nutrient, and

• (b) in respect of a nutrient referred to in the definition reference standard, the reference standard for that nutrient; (valeur quotidienne)

durable life

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

durable life date means the date on which the durable life of a prepackaged product ends; (date limite de conservation)

energy value

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

extended meat product means a meat product to which a meat product extender has been added; (produit de viande avec allongeur)

extended poultry product

extended poultry product means a poultry product to which a poultry product extender has been added; (produit de volaille avec allongeur)

fish product

fish product means fish or prepared fish; (produit de poisson)

flavouring preparation

flavouring preparation includes any food for which a standard is provided in Division 10; (préparation aromatisante)

food additive

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;

• (d) agricultural chemicals, other than those listed in the tables to Division 16,

• (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

food colour means those colours permitted for use in or upon food by Division 6; (colorant alimentaire)

gelling agent

gelling agent means gelatin, agar and carrageenan; (agent gélatinisant)

ingredient

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

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)

meal replacement

meal replacement means a formulated food that, by itself, can replace one or more daily meals; (substitut de repas)

meat product

meat product means meat, meat by-product, prepared meat or prepared meat by-product; (produit de viande)

meat product extender

meat product extender means a food that is a source of protein and that is represented as being for the purpose of extending meat products; (allongeur de produit de viande)

mechanically tenderized beef

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

• (b) the beef is injected with a marinade or other tenderizing solution; (boeuf attendri mécaniquement)

monounsaturated fatty acids

monounsaturated fatty acids, monounsaturated fat, monounsaturates or monounsaturated means cis-monounsaturated fatty acids; (acides gras monoinsaturés, graisses monoinsaturées, gras monoinsaturés, lipides monoinsaturés ou monoinsaturés)

nutritional supplement

nutritional supplement means a food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients; (supplément nutritif)

nutrition facts table

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 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, lipides polyinsaturés oméga-3, polyinsaturés oméga-3 ou oméga-3)

omega-6 polyunsaturated fatty acids

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, polyinsaturés oméga-6 ou oméga-6)

ornamental container

ornamental container means a container that, except on the bottom, does not have any promotional or advertising material thereon, other than a trade mark 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

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; (surtitrage)

parts per million

parts per million[Repealed, SOR/2010-94, s. 1]

parts per million

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

per cent or % means per cent by weight, unless otherwise stated; (pour cent ou %)

polyunsaturated fatty acids

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

poultry product means poultry meat, prepared poultry meat, poultry meat by-product or prepared poultry meat by-product; (produit de volaille)

poultry product extender

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

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

• (b) vegetables, fruit or grain products; (repas préemballé)

prepackaged product

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

principal display panel means, despite the meaning assigned to that term in section A.01.010,

• (a) in the case of a label applied to a prepackaged product that is subject to the Consumer Packaging and Labelling Act the principal display panel as defined in the Consumer Packaging and Labelling Regulations,

• (b) in the case of a label applied to a prepackaged product that is not subject to the Consumer Packaging and Labelling Act, that part of the label applied to all or part of the side or surface of the container that is displayed or visible under normal or customary conditions of sale or use, and where the container does not have such a side or surface, that part of the label applied to any part of the container, except the bottom, if any, and

• (c) in the case of a label applied to a food that is not a prepackaged product, that part of the label 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)

reasonable daily intake

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)

recommended daily intake

recommended daily intake, in respect of a vitamin or mineral nutrient set out in column I of Table I to Division 1 of Part D or in column I of Table I to Division 2 of Part D, means

• (a) in the case of a prepackaged product intended solely for children under two years of age, the quantity set out in column III, and

• (b) in any other case, the quantity set out in column II; (apport quotidien recommandé)

reference amount

reference amount, in respect of a food set out in column 1 of Schedule M, means the amount of that food set out in column 2; (quantité de référence)

reference standard

reference standard, in respect of a nutrient set out in column 1 of the table to section B.01.001.1, means the amount set out in column 2; (norme de référence)

saturated fatty acids

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)

simulated meat product

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

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)

sugars

sugars means all monosaccharides and disaccharides; (sucres)

sweetener

sweetener means any food additive listed as a sweetener in Table IX to section B.16.100; (édulcorant)

sweetening agent

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)

trans fatty acids

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

unstandardized food means any food for which a standard is not prescribed in this Part; (aliment non normalisé)

weighted recommended nutrient intake

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)

yolk-replaced egg

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

• (c) meets the requirements of section B.22.032; (oeuf à jaune substitué)

(2) The definitions in this subsection apply for the purposes of the Act.

agricultural chemical

agricultural chemical has the same meaning as in subsection (1). (produit chimique agricole)

food additive

food additive has the same meaning as in subsection (1). (additif alimentaire)