Division 28 of the food and drug regulations
Novel Foods
Interpretation
B.28.001. The definitions in this section apply in this Division.
"genetically modify" means to change the heritable traits of a plant, animal or microorganism by
means of intentional manipulation. ( modifier génétiquement)
"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" 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 Director in writing of their intention to sell or advertise for sale the novel
food; and
(b) has received a written notice from the Director 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.
B.28.003. (1) Within 45 days after receiving a notification referred to in
paragraph B.28.002(1)(a), the Director shall review the information included in the
notification and
(a) if the information establishes that the novel food is safe for consumption, notify the
manufacturer or importer in writing that the information is sufficient; or
(b) if additional information of a scientific nature is necessary in order to assess the safety
of the novel food, request in writing that the manufacturer or importer submit that information.
(2) Within 90 days after receiving the additional information requested under paragraph (1)(b)
the Director shall assess it and, if it establishes that the novel food is safe for
consumption, notify the manufacturer or importer in writing that the information is sufficient.
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