Food and Drug Regulations

B.01.056 (1) Notwithstanding sections B.01.042 and B.01.043, where a food does not comply with the requirements of these Regulations, the manufacturer or distributor of the food, or of a food additive, agricultural chemical, veterinary drug, vitamin, mineral nutrient or amino acid present in the food, may make a written request to the Director

• (a) for the exemption of the food from the application, in whole or in part, of the requirements relating to it under these Regulations;

• (b) for a Notice of Interim Marketing Authorization concerning the food that confirms the exemption; and

• (c) that these Regulations be amended.

(2) For the purposes of this section, a food does not comply with the requirements of these Regulations if

• (a) any of the following is present in the food:

  • (i) a food additive that is

    • (A) set out in column I of an item of any of the tables to section B.16.100 in an amount that exceeds the maximum level of use set out in column III or IV of that item in respect of that food, or

    • (B) not included in the standard for that food in these Regulations,

  • (ii) an agricultural chemical, or any of its derivatives, set out in column I of an item of Table II to Division 15 of Part B, in an amount that exceeds the maximum residue limit set out in column III of that item,

  • (iii) a veterinary drug set out in column I of an item of Table III to Division 15 of Part B in an amount that exceeds the maximum residue limit set out in column III of that item,

  • (iv) an ingredient in a form other than the form described in the standard for that food in these Regulations, or

  • (v) a vitamin, mineral nutrient or amino acid

    • (A) that is not set out in the Table to section D.03.002, or

    • (B) the level of use of which is at variance with the level permitted under these Regulations;

• (b) the food

  • (i) is not set out in column IV of Table II to Division 15 of Part B and contains an agricultural chemical or any of its derivatives set out in column I of that Table,

  • (ii) is not set out in column IV of Table III to Division 15 of Part B and contains a veterinary drug set out in column I of that Table, or

  • (iii) is not set out in column II of any of Tables I to IV and VI to XV or in column III of Table V to section B.16.100, and contains a food additive set out in column I of that Table.

(3) The request referred to in subsection (1) shall be accompanied by the following information:

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

• (b) the reasons for which the exemption, the Notice of Interim Marketing Authorization and an amendment to these Regulations are required;

• (c) a description of every proposed variation from the requirements of these Regulations;

• (d) adequate data, including results of tests and scientific analysis, that demonstrate that the use of the food will not be detrimental to the health of the purchaser or user; and

• (e) where the request relates to the addition of a vitamin, mineral nutrient or amino acid to the food, a statement, with supporting documentation, as to the consistency of the request with the General Principles for the Addition of Essential Nutrients to Foods adopted by the Joint Food and Agriculture Organization of the United Nations / World Health Organization Codex Alimentarius Commission and published in the Codex Alimentarius (Rome, 1996), as amended from time to time.

(4) Where the Director determines after examining the request and the information submitted under subsection (3) that use of the food will not be harmful to the health of the purchaser or user, the Director shall exempt the food from the application, in whole or in part, of the requirements relating to it under these Regulations and issue a conditional or unconditional Notice of Interim Marketing Authorization relating to the food. The Director shall also indicate his or her intention to recommend that these Regulations be amended in relation to the food.

(5) The Notice of Interim Marketing Authorization issued under subsection (4) shall set out

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

• (b) the reasons for which the exemption is established and the Notice of Interim Marketing Authorization issued; and

• (c) such of the following as are applicable to the food:

  • (i) the maximum residue limit of any agricultural chemical or any of its derivatives, expressed in parts per million,

  • (ii) the maximum level of use of any food additive that the food is permitted to contain, or have on it, expressed in the applicable units of measurement,

  • (iii) the maximum residue limit of any veterinary drug, expressed in parts per million, and

  • (iv) the minimum and maximum limits for the addition of any vitamin, mineral nutrient or amino acid, expressed in the applicable units of measurement.

(6) The Notice of Interim Marketing Authorization issued under subsection (4) must be published in the Canada Gazette Part I and has effect beginning on the date of publication.

(7) The Director may, by a notice published in the Canada Gazette Part I, revoke an exemption and Notice of Interim Marketing Authorization relating to a food where the Director believes on reasonable grounds, after reviewing any information that comes to the attention of the Director, that use of the food is or may be harmful to the health of the purchaser or user.

(8) A Notice of Interim Marketing Authorization issued under subsection (4) in relation to a food loses its effect on the coming into force of any amendment to these Regulations resulting from the Director’s recommendation referred to in that subsection.