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,

• (c.1) supplemental ingredient,

• (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, in respect of information that is shown on a label or a sign, means immediately adjacent to the information and without any intervening printed, written or graphic material; (à proximité)

common name

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

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)

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, in respect of a nutrient, the quantity applicable to the nutrient according to subsection B.01.001.1(2); (valeur quotidienne)

Directory of NFT Formats

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

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

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,

• (b.1) supplemental ingredients;

• (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 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

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 hydrogénée)

functional substitute for a sweetening agent

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)

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 cautionary statements

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)

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)

List of Permitted Supplemental Ingredients

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 Supplemented Food Categories

List of Permitted Supplemented Food Categories means the document entitled List of Permitted Supplemented Food Categories, published by the Government of Canada on its website, as amended from time to time; (Liste des catégories autorisées d’aliments supplémentés)

main dish

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

• (d) breads, breakfast cereals, rice and other grains, and alimentary pastes; (plat principal)

marketing authorization

marketing authorization means a marketing authorization issued by the Minister under subsection 30.3(1) of the Act; (autorisation de mise en marché)

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)

mutiple-serving prepackaged product

mutiple-serving prepackaged product means a prepackaged product other than a single-serving prepackaged product; (produit préemballé à portions multiples)

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. It does not include a human milk fortifier; (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)

nutrition symbol

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)

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 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

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 %)

point

point means the unit of measurement for type size that is known as a PostScript point and is equal to 0.3527777778 mm; (point)

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 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

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,

• (d) if the package is a bag with surfaces of equal dimensions, the total area of one of the surfaces,

• (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

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[Repealed, SOR/2016-305, s. 1]

reference amount

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

reference standard[Repealed, SOR/2016-305, s. 1]

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)

single-serving prepackaged product

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

sugars means all monosaccharides and disaccharides; (sucres)

sugars-based ingredient

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

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

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

  • (ii) prepackaged ice;

• (d) a food that has not been processed or that has been minimally processed; or

• (e) a beverage with an alcohol content of more than 0.5%; (aliment supplémenté)

supplemented food caution identifier

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

supplemented food facts table means the supplemented food facts table required by subsection B.29.002(1) to be carried on the label of a supplemented food; (tableau des renseignements sur les aliments supplémentés)

sweetener

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

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

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

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)

Table of Reference Amounts

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)

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)

(3) The following definitions apply in this Division.

human milk fortifier

human milk fortifier has the same meaning as in section B.25.001. (fortifiant pour lait humain)

human milk substitute

human milk substitute has the same meaning as in section B.25.001. (succédané de lait humain)

(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.