Cannabis Regulations

Marginal note:Requirements of Part 6

• 28.1 (1) The requirements of Part 6, other than those set out in subsection 102(6), apply to the following cannabis or cannabis accessory that is administered or distributed to a human participant in the conduct of non-therapeutic research on cannabis as if the cannabis or cannabis accessory were a cannabis product or will become one:

  • (a) cannabis that is not a cannabis product or is contained in a cannabis accessory that is not a cannabis product; and

  • (b) a cannabis accessory that contains cannabis and that is not a cannabis product.

• Marginal note:References to section 97

  (2) For the purposes of subsection (1), any reference in Part 6 to subsection 97(1) or (2) should be read as a reference to paragraph (3)(a) or (b), respectively.

• Marginal note:Variability limits

  (3) Cannabis that is not a cannabis product — or that is contained in a cannabis accessory that is not a cannabis product — and that is administered or distributed by the holder of a licence for research to human participants in the conduct of non-therapeutic research on cannabis must not contain

  • (a) in the case of a cannabis extract or a cannabis topical, less than 85% or more than 115% of the quantity or concentration of THC or CBD represented by the holder in the application for the licence, or for its renewal or amendment, related to that research; and

  • (b) in the case of edible cannabis,

    • (i) if the quantity of THC or CBD that is represented by the holder in the application exceeds 5 mg, less than 85% or more than 115% of that quantity,

    • (ii) if the quantity of THC or CBD that is represented by the holder in the application exceeds 2 mg but does not exceed 5 mg, less than 80% or more than 120% of that quantity, and

    • (iii) if the quantity of THC or CBD that is represented by the holder in the application does not exceed 2 mg, less than 75% or more than 125% of that quantity.

• Marginal note:Requirements — edible cannabis

  (4) The holder of a licence for research that administers or distributes edible cannabis to human participants in the conduct of non-therapeutic research on cannabis must ensure that

  • (a) a meat product, poultry product or fish, other than a food additive, was not used as an ingredient to produce the edible cannabis, and was not a constituent of such an ingredient, unless the meat product, poultry product or fish

    • (i) was produced by a person that is authorized to produce it under the laws of a province or the Safe Food for Canadians Act or was imported in accordance with that Act, and

    • (ii) had a water activity that did not exceed 0.85 at a temperature of 22 ± 2°C at the time the meat product, poultry product or fish was obtained by the holder that produced the edible cannabis;

  • (b) food that was produced by a holder of a licence for research and that was used by that holder as an ingredient to produce the edible cannabis, or as a constituent of such an ingredient, was not a meat product, poultry product or fish, and the sale of the food would not have been prohibited under section 4 of the Food and Drugs Act;

  • (c) a food additive was not used as an ingredient to produce the edible cannabis unless

    • (i) the edible cannabis would be a food that is set out in column 3 of the Lists of Permitted Food Additives if the edible cannabis did not contain or have on it anything referred to in item 1 or 3 of Schedule 1 to the Act,

    • (ii) the food additive is set out in column 1 and is not caffeine or caffeine citrate,

    • (iii) the food additive is obtained from any corresponding source set out in column 2,

    • (iv) the food additive is used for any corresponding purpose of use set out in column 4,

    • (v) the amount of the food additive does not exceed

      • (A) any corresponding maximum level of use and any corresponding maximum level of residue set out in column 5, and

      • (B) the amount that is required to accomplish the purpose for which it is added, in the case where the words “Good Manufacturing Practice” appear in column 5 for that food additive in the food, and

    • (vi) any other corresponding condition set out in column 5 is met; and

  • (d) the edible cannabis was not irradiated unless

    • (i) the edible cannabis would be a food that is listed in item 3 or 4, column 1, of the table to Division 26 of Part B of the Food and Drug Regulations if the edible cannabis did not contain or have on it anything that is referred to in item 1 or 3 of Schedule 1 to the Act, and

    • (ii) the licence holder that produced the edible cannabis satisfied the requirements set out in paragraphs B.26.003(2)(a) and (b) and subsection B.26.004(1) of the Food and Drug Regulations in respect of the edible cannabis.

• Marginal note:Vitamins and mineral nutrients

  (5) If the conditions set out in subparagraphs (4)(c)(i) to (vi) are met, the holder of a licence for research whose licence authorizes the production of cannabis may use a vitamin or mineral nutrient as an ingredient to produce edible cannabis that is administered or distributed to a human participant in the conduct of non-therapeutic research on cannabis and that is not a cannabis product or is contained in a cannabis accessory that is not a cannabis product.