Food and Drug Regulations

B.01.056 (1) This section applies in respect of interim marketing authorizations that the Minister may issue under subsection 30.2(1) of the Act.

(2) In this section, food for special dietary use has the same meaning as in section B.24.001.

(3) The manufacturer of a food or of an agricultural chemical, veterinary drug, food additive, vitamin, mineral nutrient or amino acid present in or on a food may submit an application in writing to the Minister for the issuance of an interim marketing authorization in respect of the food that provides for any matter referred to in subsection 30.2(2) of the Act.

(4) The application shall be accompanied by the following information:

• (a) the common name and description of the food;

• (b) the reasons for which the interim marketing authorization is requested;

• (c) a description of every exemption requested in respect of the food from the application, in whole or in part, of sections 5 to 6.1 of the Act and the applicable requirements of these Regulations;

• (d) adequate data, including results of tests and scientific analysis, that demonstrate that the food would not be harmful to the health of the purchaser or consumer;

• (e) if the application relates to the addition of vitamins, mineral nutrients or amino acids to the food, a statement, with supporting documentation, indicating that the proposed addition is for one or more of the following purposes:

  • (i) to restore the levels of vitamins or mineral nutrients to the levels that were present in the food before processing or, in the case of amino acids, to provide protein of a nutritional quality that is equivalent to that which was present in the food before processing,

  • (ii) to make the food that is intended to be sold as a substitute for another food nutritionally equivalent to the food that it is intended to replace in the diet in respect of

    • (A) the levels of added vitamins or mineral nutrients, or

    • (B) the quality of protein provided through the addition of amino acids,

  • (iii) to prevent or correct a deficiency of vitamins or mineral nutrients in the population or specific population groups, or

  • (iv) to modify the levels of vitamins, mineral nutrients or amino acids in the food for special dietary use; and

• (f) if the application relates to the use of a food additive in or on the food, the information described in section B.16.002.

(5) In addition to the matters that may be provided for in accordance with subsections 30.2(2) and (4) of the Act, an interim marketing authorization shall set out

• (a) the common name and description of the food;

• (b) the reasons for which the interim marketing authorization is issued; and

• (c) the provisions of the Act and of these Regulations in respect of which the food is exempted.

(6) An interim marketing authorization may be cancelled by the Minister if the Minister determines, after reviewing any additional information that comes to his or her attention, that the food for which the authorization was issued is or may be harmful to the health of the purchaser or consumer.