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Food and Drug Regulations

Version of section B.28.001 from 2006-03-22 to 2022-07-20:


 The definitions in this section apply in this Division.

genetically modify

genetically modify means to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation. (modifier génétiquement)

major change

major change means, in respect of a food, a change in the food that, based on the manufacturer’s experience or generally accepted nutritional or food science theory, places the modified food outside the accepted limits of natural variations for that food with regard to

  • (a) the composition, structure or nutritional quality of the food or its generally recognized physiological effects;

  • (b) the manner in which the food is metabolized in the body; or

  • (c) the microbiological safety, the chemical safety or the safe use of the food. (changement majeur)

novel food

novel food means

  • (a) a substance, including a microorganism, that does not have a history of safe use as a food;

  • (b) a food that has been manufactured, prepared, preserved or packaged by a process that

    • (i) has not been previously applied to that food, and

    • (ii) causes the food to undergo a major change; and

  • (c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

    • (i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism,

    • (ii) the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or

    • (iii) one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism. (aliment nouveau)

  • SOR/99-392, s. 1

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