Food and Drug Regulations (C.R.C., c. 870)

• 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) 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;

  • (d) a list of the ingredients of the food, stated quantitatively;

  • (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;

  • (j) a description of the type of packaging to be used;

  • (k) 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.

• (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.

• (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) 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).

DIVISION 25

Interpretation

B.25.001 In this Division,

expiration date

expiration date means, in respect of a 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 substitute

human milk substitute means any food that is represented

• (a) for use as a partial or total replacement for human milk and intended for consumption by infants, or

• (b) for use as an ingredient in a food referred to in paragraph (a); (succédané de lait humain)

infant

infant means a person who is under the age of one year; (bébé)

infant food

infant food means a food that is represented for consumption by infants; (aliment pour bébés)

junior (naming a food)

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)

major change

major change means, in respect of a human milk substitute, any change of an ingredient, the amount of an ingredient or the processing or packaging of the 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 chemical safety of, the human milk substitute; (changement majeur)

new human milk substitute

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

• (c) manufactured by a person who manufactures it for the first time; (succédané de lait humain nouveau)

strained (naming a food)

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)

Infant Foods

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

  • (a) strained fruit,

  • (b) fruit juice,

  • (c) fruit drink, or

  • (d) cereal,

  if sodium chloride has been added to that food.

• (2) Subsection (1) does not apply to strained desserts containing any of the foods mentioned in paragraphs (1)(a) to (d).

Human Milk Substitutes and Food Containing Human Milk Substitutes

B.25.045 The common name of a human milk substitute or a new human milk substitute shall be infant formula. (préparation pour nourrissons)

• 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.

• (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;

  • (d) a list of all of its ingredients, stated quantitatively;

  • (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;

  • (j) a description of the type of packaging to be used;

  • (k) 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.

• (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.