Food and Drug Regulations

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.