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

B.27.003. No person shall sell a low-acid food packaged in a hermetically sealed container where the container

• (a) is swollen;

• (b) is not properly sealed; or

• (c) has any defect that may adversely affect its hermetic seal.

• B.27.004. (1) Where, in the opinion of the Director, the sale of a low-acid food packaged in a hermetically sealed container may contravene section B.27.002 or B.27.003, the Director may, by notice in writing, request that the manufacturer or importer of the food submit, on or before the date specified in the notice, evidence that establishes that the processes used to manufacture, process and package the food rendered and maintained the food commercially sterile.

• (2) Where a manufacturer or an importer receives a notice issued pursuant to subsection (1), the manufacturer or importer shall make no further sales of the food on or after the day specified in the notice until he has submitted the evidence requested in that notice.

• (3) Where the Director is of the opinion that the evidence submitted by a manufacturer or importer pursuant to subsection (1) is not sufficient, the Director shall notify the manufacturer or importer in writing that the evidence is not sufficient.

• (4) Where, pursuant to subsection (3), a manufacturer or importer is notified that the evidence he has submitted is not sufficient, the manufacturer or importer shall make no further sales of the food until he submits further evidence and is notified in writing by the Director that the further evidence is sufficient.

B.27.005. No person shall sell a commercially sterile low-acid food packaged in a hermetically sealed container unless

• (a) the label or container of the food bears a code or lot number that identifies, in a legible and permanent manner,

  • (i) the establishment in which the product was rendered commercially sterile, and

  • (ii) the day, month and year on which the food was rendered commercially sterile; and

• (b) the exact meaning of each item in any code or lot number referred to in paragraph (a) is available to an inspector at the establishment or, where the food is imported, from the importer.

B.28.001. 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)