Cannabis Regulations (SOR/2018-144)

Marginal note:Dissolution and disintegration

• 95 (1) Each discrete unit of a cannabis product that is intended for ingestion or nasal, rectal or vaginal use must meet, if the form of the unit is similar to a dosage form for which a dissolution or disintegration test is set out in a publication referred to in Schedule B to the Food and Drugs Act, the requirements of the test or, if there is more than one applicable test, the requirements of any such test that is suitable for demonstrating that the cannabis product will perform as intended.

• Marginal note:Exception

  (2) Subsection (1) does not apply to edible cannabis.

Marginal note:Maximum quantity of THC — discrete unit

• 96 (1) Subject to subsection 97(1), each discrete unit of a cannabis product that is intended for ingestion or nasal, rectal or vaginal use must not contain a quantity of THC that exceeds 10 mg, taking into account the potential to convert THCA into THC.

• Marginal note:Exception

  (2) Subsection (1) does not apply to edible cannabis.

Marginal note:Variability limits

• 97 (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, in respect of any quantity or concentration of THC or CBD that is displayed on the label, less than 85% or more than 115% of that quantity or concentration.

• Marginal note:Edible cannabis

  (2) Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain

  • (a) if a quantity of THC or CBD that is displayed on the label exceeds 5 mg, less than 85% or more than 115% of that quantity;

  • (b) if a quantity of THC or CBD that is displayed on the label exceeds 2 mg but does not exceed 5 mg, less than 80% or more than 120% of that quantity; and

  • (c) if a quantity of THC or CBD that is displayed on the label does not exceed 2 mg, less than 75% or more than 125% of that quantity.

Marginal note:Variability limits — divisible cannabis products

• 97.1 (1) If a cannabis product that is not in discrete units is represented as being able to be divided into discrete units, each represented unit must not contain

  • (a) a quantity of THC that is less than 75% or more than 125% of the quantity of THC in each of the other represented units, taking into account the potential to convert THCA into THC; and

  • (b) a quantity of CBD that is less than 75% or more than 125% of the quantity of CBD in each of the other represented units, taking into account the potential to convert CBDA into CBD.

• Marginal note:Divisible units

  (2) If a cannabis product is in discrete units that are represented as being able to be divided into discrete sub-units, each represented subunit must not contain

  • (a) a quantity of THC that is less than 75% or more than 125% of the quantity of THC in each of the other represented subunits, taking into account the potential to convert THCA into THC; and

  • (b) a quantity of CBD that is less than 75% or more than 125% of the quantity of CBD in each of the other represented subunits, taking into account the potential to convert CBDA into CBD.

Marginal note:Products that must not be sold or distributed

98 The following cannabis products must not be sold or distributed:

• (a) a cannabis product that is intended to be used in the area of the human eye bounded by the supraorbital and infraorbital ridges, including the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge; and

• (b) a cannabis product that is intended to be used on damaged or broken skin or to penetrate the skin barrier other than by absorption.

Marginal note:Multiple units

98.1 It is prohibited for a holder of a licence to sell or distribute a cannabis extract, a cannabis topical or edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — if the immediate container contains multiple discrete units, unless the properties of each unit, including size but excluding flavour and colour, as applicable, are consistent.

Dried and Fresh Cannabis

Marginal note:Addition of THC or THCA

99 THC or THCA must not be added to dried or fresh cannabis that will become a cannabis product or that is, or will be, contained in a cannabis accessory that will become a cannabis product.

Marginal note:Consumption by inhalation — net weight of dried cannabis

100 The net weight of dried cannabis that is intended to be consumed by means of inhalation in each discrete unit of a cannabis product must not exceed 1.0 g.

Cannabis Extracts and Cannabis Topicals

Marginal note:Things injurious to health

• 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 anything that may cause injury to the health of the user when the cannabis product is used as intended or in a reasonably foreseeable way.

• Marginal note:Exception

  (2) Subsection (1) does not, in respect of a cannabis extract that is intended to be combusted and inhaled, prohibit anything that may cause injury as a result of the intended combustion and inhalation.

• Marginal note:Things that do not cause injury

  (3) For the purposes of subsection (1), a cannabis extract or a cannabis topical does not contain or have on it anything that may cause injury to the health of the user 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 that 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; or

  • (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 the intended use and any reasonably foreseeable use of the cannabis product.

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 — ingested cannabis extract

  (6) A cannabis extract referred to in subsection (1) must not contain ethyl alcohol unless

  • (a) the cannabis extract is intended to be ingested; and

  • (b) the net weight of the cannabis extract in each immediate container of the cannabis product does not exceed 7.5 g.

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 the subject of a marketing authorization 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 marketing authorization permits the food additive to be in or on the food;

  • (c) the conditions under which the marketing authorization permits the food additive to be in or on the food — including any maximum levels of use — are complied with; and

  • (d) the food additive is not caffeine or caffeine citrate.

• 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]