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Cannabis Regulations (SOR/2018-144)

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Regulations are current to 2019-11-19 and last amended on 2019-10-17. Previous Versions

PART 6Cannabis Products (continued)

Edible Cannabis (continued)

Marginal note:Prohibited things

  •  (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; 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 a product that is to be ingested.

  • SOR/2019-206, s. 28

Marginal note:Caffeine

 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.

  • SOR/2019-206, s. 28

Marginal note:Ethyl alcohol

 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.

  • SOR/2019-206, s. 28

Marginal note:Cannabis products requiring refrigeration

 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.

  • SOR/2019-206, s. 28

Marginal note:Hermetically sealed containers

  •  (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)

  • SOR/2019-206, s. 28

Marginal note:Irradiation

 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.

  • SOR/2019-206, s. 28

Marginal note:Maximum quantity of THC

 Subject to subsection 97(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 quantity of THC that exceeds 10 mg per immediate container, taking into account the potential to convert THCA into THC.

  • SOR/2019-206, s. 28

Cannabis Accessory or Component

Marginal note:Contamination

 A cannabis accessory that is a cannabis product, or that is packaged with a cannabis product, must not be contaminated.

  • SOR/2019-206, s. 29

Marginal note:Flavour

 A cannabis accessory that is a cannabis product, or that is packaged with a cannabis product, must not impart a characterizing flavour to the cannabis.

  • SOR/2019-206, s. 29

Marginal note:Dispensing limit

 Subject to subsection 97(1), each activation of the following cannabis accessories must not dispense a quantity of cannabis extract that contains greater than 10 mg of THC, taking into account the potential to convert THCA into THC:

  • (a) a cannabis accessory that is a cannabis product and that dispenses a cannabis extract that is intended for ingestion or nasal, rectal or vaginal use; or

  • (b) a cannabis accessory that is packaged with, and that is intended to dispense, a cannabis extract that is a cannabis product and that is intended for ingestion or nasal, rectal or vaginal use.

  • SOR/2019-206, s. 29

Marginal note:Psychological effects, abuse liability and toxicity

  •  (1) A component of a cannabis product — other than a component that is anything referred to in item 1 or 3 of Schedule 1 to the Act — and a cannabis accessory that is packaged with a cannabis product must not, through any means other than heating or combustion, and when used as intended or in a reasonably foreseeable way,

    • (a) alter or enhance the psychological effects derived from the cannabis product in a manner that may cause injury to the health of the user;

    • (b) increase the potential for abuse liability of the cannabis product; or

    • (c) increase the toxicity of the cannabis product.

  • Marginal note:Exceptions

    (2) Subsection (1) does not prohibit the presence of

    • (a) ethyl alcohol in or on a cannabis product referred to in subsection 101.3(6) or section 102.3 if the conditions set out in that subsection or section, as the case may be, are met; and

    • (b) caffeine in or on a cannabis product referred to in section 102.2 if the conditions set out in that section are met.

  • SOR/2019-206, s. 29

PART 6.1Promotion

Marginal note:Non-application — prescription drug and combination product

 Sections 104.11 to 104.16 do not apply to a prescription drug or a combination product.

  • SOR/2019-206, s. 29

Marginal note:Flavours

 It is prohibited to promote a cannabis extract — or a cannabis accessory that contains a cannabis extract — under subsections 17(2) to (6) of the Act in a manner that could cause a person to believe that the cannabis extract or the cannabis accessory has a flavour set out in column 1 of Schedule 3 to the Tobacco and Vaping Products Act, other than the flavour of cannabis.

  • SOR/2019-206, s. 29

Marginal note:Health and cosmetic benefits

  •  (1) It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsections 17(2) to (6) of the Act if there are reasonable grounds to believe that the promotion could create the impression that health or cosmetic benefits may be derived from the service or the use of the cannabis or the cannabis accessory.

  • Marginal note:Non-application — medical devices

    (2) Subsection (1) does not apply with respect to a medical device in respect of which a licence has been issued under subsection 36(1) of the Medical Devices Regulations.

  • SOR/2019-206, s. 29
 
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