Cannabis Regulations (SOR/2018-144)

Marginal note:Microbial and chemical contaminants

101.1 A cannabis extract, or a cannabis topical, that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain or have on it microbial or chemical contaminants unless the contaminants are within generally accepted tolerance limits for human use that are

• (a) established in a publication referred to in Schedule B to the Food and Drugs Act; and

• (b) appropriate for the intended use and any reasonably foreseeable use of the cannabis product.

Marginal note:Maximum quantity of THC

101.2 A cannabis extract, or a cannabis topical, that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain a quantity of THC that exceeds 1000 mg per immediate container, taking into account the potential to convert THCA into THC.

Marginal note:Cannabis extract — content

• 101.3 (1) A cannabis extract that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain any ingredients other than

  • (a) carrier substances;

  • (b) flavouring agents; and

  • (c) substances that are necessary to maintain the quality or stability of the cannabis product.

• Marginal note:Prohibited ingredients

  (2) The following substances must not be used as ingredients to produce a cannabis extract referred to in subsection (1):

  • (a) substances that are listed in column 1 of the table in Schedule 2 to the Tobacco and Vaping Products Act; or

  • (b) sugars or sweeteners or sweetening agents, as those terms are defined in subsection B.01.001(1) of the Food and Drug Regulations.

• Marginal note:Exception — vitamins

  (3) Despite paragraph 2(a), a vitamin may be used as an ingredient to maintain the quality or stability of the cannabis extract referred to in subsection (1) if it is used in an amount that does not exceed what is necessary to maintain the quality or stability of the cannabis product.

• Marginal note:Naturally occurring substances

  (4) An ingredient that is used to produce the cannabis extract referred to in subsection (1) may contain a substance referred to in subsection (2) only if that substance is naturally present in the ingredient at a level that is not above the naturally occurring level for that ingredient.

• Marginal note:Permitted ingredients — inhaled cannabis extract

  (5) An ingredient — other than a flavouring agent — must not be used to produce a cannabis extract referred to in subsection (1) that is intended to be consumed by means of inhalation unless

  • (a) a standard for the ingredient is set out in a publication referred to in Schedule B to the Food and Drugs Act; and

  • (b) the ingredient complies with the standard.

• Marginal note:Ethyl alcohol — inhaled cannabis extract

  (5.1) A cannabis extract referred to in subsection (1) that is intended to be consumed by means of inhalation may contain the following quantities of ethyl alcohol if the net weight of the cannabis extract in each immediate container of the cannabis product does not exceed 7.5 g:

  • (a) if it is in discrete units, 10 mg or less per unit; or

  • (b) if it is not in discrete units,

    • (i) 10 mg or less, or

    • (ii) more than 10 mg, if the immediate container does not permit the extract to be easily removed from the container and contains an integrated mechanism that dispenses no more than 10 mg of ethyl alcohol per activation.

• Marginal note:Ethyl alcohol — ingested cannabis extract

  (6) A cannabis extract referred to in subsection (1) that is intended to be ingested may contain ethyl alcohol if

  • (a) the net weight of the cannabis extract in each immediate container of the cannabis product does not exceed 7.5 g, or

  • (b) in the case where the net weight of the cannabis extract in each immediate container of the cannabis product exceeds 7.5 g, the concentration of ethyl alcohol does not exceed 0.5% w/w of the cannabis extract.

Marginal note:Cannabis topical — denatured ethyl alcohol

101.31 A cannabis topical that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product may contain denatured ethyl alcohol.

Marginal note:Uniform distribution — cannabinoids and terpenes

101.4 The cannabinoids and terpenes in a cannabis extract, or a cannabis topical, that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must be uniformly distributed throughout the cannabis extract or cannabis topical.

Marginal note:Cannabis extract — external body surfaces

101.5 A cannabis extract that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not be represented for use, directly or indirectly, on external body surfaces, including hair and nails.

Edible Cannabis

Marginal note:Ingredients — edible cannabis

• 102 (1) Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain any ingredients other than food and food additives.

• Marginal note:Temporarily marketed foods and supplemented foods

  (2) The following foods must not be used as an ingredient to produce edible cannabis referred to in subsection (1) and must not be a constituent of such an ingredient:

  • (a) a food that is described in a Temporary Marketing Authorization Letter issued under subsection B.01.054(1) of the Food and Drug Regulations;

  • (b) a supplemented food within the meaning of section B.01.001 of those Regulations; or

  • (c) a food in respect of which the manufacturer, as defined in section A.01.010 of the Food and Drug Regulations, is exempt from the application of those Regulations in accordance with section 32 or 33 of the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods), as the case may be.

• Marginal note:Meat products, poultry products and fish

  (3) A meat product, poultry product or fish, other than a food additive, must not be used as an ingredient to produce edible cannabis referred to in subsection (1) — and must not be a constituent of such an ingredient — unless the meat product, poultry product or fish

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

  • (b) has a water activity that does not exceed 0.85 at a temperature of 22 ± 2°C at the time the meat product, poultry product or fish is obtained by the holder of the licence for processing that is producing the edible cannabis.

• Marginal note:Self-produced food

  (4) A holder of a licence for processing that produces a food may use it as an ingredient to produce edible cannabis referred to in subsection (1) — or as a constituent of such an ingredient — if

  • (a) the food is not a meat product, poultry product or fish; and

  • (b) the sale of the food would not be prohibited under section 4 of the Food and Drugs Act.

• Marginal note:Food additives

  (5) A holder of a licence for processing may use a food additive as an ingredient to produce edible cannabis referred to in subsection (1) only if

  • (a) 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;

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

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

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

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

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

    • (ii) 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

  • (f) any other corresponding condition set out in column 5 is met.

• Marginal note:Vitamins and mineral nutrients

  (6) A vitamin or mineral nutrient must not be used as an ingredient to produce edible cannabis referred to in subsection (1) unless its use is permitted under subsection (5).

• (7) [Repealed, SOR/2022-251, s. 15]

Marginal note:Prohibited things

• 102.1 (1) Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain or have on it anything in a quantity that would cause the sale of the edible cannabis to be prohibited under any of paragraphs 4(1)(a) to (d) of the Food and Drugs Act if the edible cannabis were a food to which that Act applies.

• Marginal note:Not poisonous, harmful or adulterated

  (2) Edible cannabis does not have a poisonous or harmful substance in or on it, within the meaning of paragraph 4(1)(a) of the Food and Drugs Act, and is not adulterated, within the meaning of paragraph 4(1)(d) of that Act, by reason only that it contains or has on it

  • (a) anything referred to in item 1 or 3 of Schedule 1 to the Act;

  • (b) residues of a pest control product that is registered for use on cannabis under the Pest Control Products Act, or is otherwise authorized for use under that Act, if the residues are within any maximum residue limits that are specified in relation to cannabis under section 9 or 10 of that Act;

  • (c) microbial or chemical contaminants — other than residues of a pest control product referred to in paragraph (b) — if the contaminants are within generally accepted tolerance limits for human use that are

    • (i) established in a publication referred to in Schedule B to the Food and Drugs Act, and

    • (ii) appropriate for a product that is to be ingested; or

  • (d) a food additive, if the conditions set out in subparagraphs 28.1(4)(c)(i) to (vi) or the requirements set out in paragraphs 102(5)(a) to (f), as the case may be, are met in respect of the use of the food additive as an ingredient to produce the edible cannabis.

Marginal note:Caffeine

102.2 Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain or have on it caffeine unless

• (a) the caffeine has been introduced through the use of ingredients that naturally contain caffeine; and

• (b) the total amount of caffeine in each immediate container of the cannabis product does not exceed 30 mg.

Marginal note:Ethyl alcohol

102.3 Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain or have on it ethyl alcohol unless the concentration of ethyl alcohol does not exceed 0.5% w/w of the edible cannabis.

Marginal note:Cannabis products requiring refrigeration

102.4 It is prohibited for a holder of a licence to sell or distribute edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — if the unopened immediate container must be stored at or below 4°C to prevent the cannabis product from becoming contaminated before its durable life date.

Marginal note:Hermetically sealed containers

• 102.5 (1) It is prohibited for a holder of a licence to sell or distribute edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — in a hermetically sealed container if any component of the edible cannabis has a pH that exceeds 4.6 and a water activity that exceeds 0.85 at a temperature of 22 ± 2°C.

• Marginal note:Definitions

  (2) The following definitions apply in subsection (1).

  hermetically sealed container

  hermetically sealed container means a container that, due to its design, is secure against the entry of micro-organisms, including spores. (contenant hermétiquement scellé)

  water activity

  water activity means the ratio of the water vapour pressure of the component to the vapour pressure of pure water, at the same temperature and pressure. (activité de l’eau)

Marginal note:Irradiation

102.6 A holder of a licence for processing must not irradiate edible cannabis unless

• (a) 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

• (b) the holder satisfies the requirements set out in paragraphs B.26.003(2)(a) and (b) and subsection B.26.004(1) of those Regulations in respect of the edible cannabis.