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

• 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 Director 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 Director, 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”

“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)