Food and Drug Regulations

B.25.001 In this Division,

expiration date

expiration date means, in respect of a human milk fortifier or 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 fortifier

human milk fortifier means a food that

• (a) includes at least one added vitamin, mineral nutrient or amino acid, and

• (b) is labelled or advertised as intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state; (fortifiant pour lait humain)

human milk substitute

human milk substitute means any food that is labelled or advertised

• (a) for use as a partial or total replacement for human milk and as 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 an individual who is under the age of one year; (bébé)

infant food

infant food means a food that is labelled or advertised 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 fortifier or human milk substitute, any change of an ingredient, the amount of an ingredient or the processing or packaging of the human milk fortifier or 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 fortifier or 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)