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

DIVISION 27Low-Acid Foods Packaged in Hermetically Sealed Containers

B.27.001 In this Division,

commercially sterile

commercially sterile means the condition obtained in a food that has been processed by the application of heat, alone or in combination with other treatments, to render the food free from viable forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage; (stérilité commerciale)

hermetically sealed container

hermetically sealed container means a container designed and intended to be secure against the entry of microorganisms, including spores; (récipient hermétiquement fermé)

low-acid food

low-acid food means a food, other than an alcoholic beverage, where any component of the food has a pH greater than 4.6 and a water activity greater than 0.85; (aliment peu acide)

refrigeration

refrigeration means exposure to a temperature of 4°C or less but does not mean frozen; (réfrigéré)

shipping container

shipping container means a receptacle, package or wrapper in which containers of food are placed for transportation; (contenant d’expédition)

water activity

water activity means the ratio of the water vapour pressure of a food to the vapour pressure of pure water, at the same temperature and pressure. (activité de l’eau)

• B.27.002 (1) No person shall sell a low-acid food packaged in a hermetically sealed container unless the food is commercially sterile.

• (2) Subsection (1) does not apply in respect of a low-acid food packaged in a hermetically sealed container where

  • (a) the low-acid food is kept under refrigeration and the statement “Keep Refrigerated” and “Garder réfrigéré” is carried on the principal display panel of the label of its container, as well as on the label of its shipping container; or

  • (b) the low-acid food is kept frozen and the statement “Keep Frozen” and “Garder congelé” is carried on the principal display panel of the label of its container, as well as on the label of its shipping container.

• (3) Subsection (1) does not apply in respect of tomatoes or tomato products packaged in hermetically sealed containers where the tomatoes or tomato products have a pH of 4.7 or less after heat processing.

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 Minister, the sale of a low-acid food packaged in a hermetically sealed container may contravene section B.27.002 or B.27.003, the Minister 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 Minister is of the opinion that the evidence submitted by a manufacturer or importer pursuant to subsection (1) is not sufficient, the Minister 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 Minister 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.

DIVISION 28Novel Foods

Interpretation

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)

Pre-Market Notification

• B.28.002 (1) No person shall sell or advertise for sale a novel food unless the manufacturer or importer of the novel food

  • (a) has notified the Minister in writing of their intention to sell or advertise for sale the novel food; and

  • (b) has received a written notice from the Minister under paragraph B.28.003(1)(a) or subsection B.28.003(2).

• (2) A notification referred to in paragraph (1)(a) shall be signed by the manufacturer or importer, or a person authorized to sign on behalf of the manufacturer or importer, and shall include the following information:

  • (a) the common name under which the novel food will be sold;

  • (b) the name and address of the principal place of business of the manufacturer and, if the address is outside Canada, the name and address of the principal place of business of the importer;

  • (c) a description of the novel food, together with

    • (i) information respecting its development,

    • (ii) details of the method by which it is manufactured, prepared, preserved, packaged and stored,

    • (iii) details of the major change, if any,

    • (iv) information respecting its intended use and directions for its preparation,

    • (v) information respecting its history of use as a food in a country other than Canada, if applicable, and

    • (vi) information relied on to establish that the novel food is safe for consumption;

  • (d) information respecting the estimated levels of consumption by consumers of the novel food;

  • (e) the text of all labels to be used in connection with the novel food; and

  • (f) the name and title of the person who signed the notification and the date of signing.