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Cannabis Regulations (SOR/2018-144)

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Regulations are current to 2024-08-18 and last amended on 2022-12-02. Previous Versions

Cannabis Regulations

SOR/2018-144

CANNABIS ACT

CONTROLLED DRUGS AND SUBSTANCES ACT

FOOD AND DRUGS ACT

Registration 2018-06-27

Cannabis Regulations

P.C. 2018-948 2018-06-26

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1)Footnote a of the Food and Drugs ActFootnote b, subsection 55(1)Footnote c of the Controlled Drugs and Substances ActFootnote d and subsection 139(1) and section 161 of the Cannabis ActFootnote e, makes the annexed Cannabis Regulations.

Interpretation

Marginal note:Definitions — Act and Regulations

  •  (1) The following definitions apply in the Act and in these Regulations.

    cannabis beverage

    cannabis beverage means edible cannabis that is intended to be consumed by drinking and has a concentration of 3% w/w or less of THC, taking into account the potential to convert THCA into THC. (boisson de cannabis) 

    cannabis concentrate

    cannabis concentrate means a substance that has a concentration of greater than 3% w/w of THC, taking into account the potential to convert THCA into THC. (cannabis sous forme de concentré)

    cannabis extract

    cannabis extract means

    • (a) a substance produced by

      • (i) subjecting anything referred to in item 1 of Schedule 1 to the Act to extraction processing, or

      • (ii) synthesizing a substance that is identical to a phytocannabinoid produced by, or found in, a cannabis plant; or

    • (b) a substance or mixture of substances that contains or has on it a substance produced in a manner referred to in paragraph (a).

    It does not include a cannabis topical or edible cannabis. (extrait de cannabis)

    cannabis non-solid concentrates

    cannabis non-solid concentrates[Repealed, SOR/2019-206, s. 1]

    cannabis oil

    cannabis oil[Repealed, SOR/2019-206, s. 1]

    cannabis solid concentrates

    cannabis solid concentrates[Repealed, SOR/2019-206, s. 1]

    cannabis topical

    cannabis topical means a substance or mixture of substances that contains or has on it anything referred to in item 1 or 3 of Schedule 1 to the Act and that is intended for use, directly or indirectly, exclusively on external body surfaces, including hair and nails. (cannabis pour usage topique)

    edible cannabis

    edible cannabis means a substance or mixture of substances that contains or has on it anything referred to in item 1 or 3 of Schedule 1 to the Act and that is intended to be consumed in the same manner as food. It does not include dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds. (cannabis comestible)

    fresh cannabis

    fresh cannabis means freshly harvested cannabis leaves, flowers or buds, but does not include plant material that can be used to propagate cannabis. (cannabis frais)

    non-solids containing cannabis

    non-solids containing cannabis means substances that are in non-solid form at a temperature of 22 ± 2°C and that have a concentration of 3% w/w or less of THC, taking into account the potential to convert THCA into THC. (substances qui ne sont pas solides et qui contiennent du cannabis)

    solids containing cannabis

    solids containing cannabis means substances that are in solid form at a temperature of 22 ± 2°C and that have a concentration of 3% w/w or less of THC, taking into account the potential to convert THCA into THC. (solides qui contiennent du cannabis)

  • Marginal note:Definitions — Regulations

    (2) The following definitions apply in these Regulations.

    Act

    Act means the Cannabis Act. (Loi)

    cannabis drug licence

    cannabis drug licence means a licence for a drug containing cannabis. (Version anglaise seulement)

    cannabis product

    cannabis product means cannabis of only one of the classes set out in Schedule 4 to the Act — or a cannabis accessory that contains such cannabis — after it has been packaged and labelled for sale to a consumer at the retail level. It does not include

    • (a) cannabis that is intended for an animal;

    • (b) a cannabis accessory that contains cannabis that is intended for an animal; or

    • (c) a drug containing cannabis. (produit du cannabis)

    CBD

    CBD means cannabidiol. (CBD)

    CBDA

    CBDA means cannabidiolic acid. (ACBD)

    client

    client means, in respect of a holder of a licence for sale for medical purposes, an individual who is registered with that holder of the licence under subsection 282(1). (client)

    combination product

    combination product means a product, consisting of a device and a prescription drug, for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations. (produit mixte)

    common-law partner

    common-law partner means an individual who is cohabiting with an individual in a conjugal relationship, having done so for a period of at least one year. (conjoint de fait)

    common name

    common name[Repealed, SOR/2019-206, s. 1]

    constituent

    constituent means an individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an ingredient. (constituant)

    contaminated

    contaminated means, in respect of cannabis, a cannabis accessory or an ingredient, containing or having on it anything — including a micro-organism but excluding anything referred to in item 1 or 3 of Schedule 1 to the Act — that may render the cannabis, cannabis accessory or ingredient injurious to human health or unsuitable for human use. (contaminé)

    controlled substance offence

    controlled substance offence means

    • (a) an offence under Part I of the Controlled Drugs and Substances Act, except subsection 4(1) of that Act; or

    • (b) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction relative à une substance désignée)

    device

    device has the same meaning as in section 2 of the Food and Drugs Act. (instrument)

    drug

    drug has the same meaning as in section 2 of the Food and Drugs Act, but excludes cannabis that is

    • (a) a natural health product to which the Natural Health Products Regulations apply; or

    • (b) manufactured or sold — within the meaning of section 2 of the Food and Drugs Act — and is not represented, for use in 

      • (i) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings, or

      • (ii) restoring, correcting or modifying organic functions in human beings.

    It includes cannabis that is an active pharmaceutical ingredient as defined in subsection C.01A.001(1) of the Food and Drug Regulations. It also includes cannabis that is manufactured or sold for use in a clinical trial as defined in section C.05.001 of those Regulations that is not non-therapeutic research on cannabis. (drogue)

    durable life

    durable life means the period, commencing on the day on which a cannabis product is packaged for sale to a consumer at the retail level, during which the product, when it is stored under conditions appropriate to that product, will retain, without any appreciable deterioration, normal palatability and any other qualities claimed for it by the holder of a licence for processing that manufactured the product. (durée de conservation)

    durable life date

    durable life date means the date on which the durable life of a cannabis product ends. (date limite de conservation)

    export permit

    export permit means a permit issued under subsection 62(1) of the Act that authorizes the exportation of cannabis for medical or scientific purposes. (permis d’exportation)

    fish

    fish has the same meaning as in section 1 of the Safe Food for Canadians Regulations. (poisson)

    food

    food has the same meaning as in section 2 of the Food and Drugs Act. (aliment)

    food additive

    food additive means any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of, or affecting the characteristics of, a food or edible cannabis, but does not include

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

    • (b) anything that is excluded from the definition food additive in subsection B.01.001(1) of the Food and Drug Regulations. (additif alimentaire)

    former Access to Cannabis for Medical Purposes Regulations

    former Access to Cannabis for Medical Purposes Regulations means the regulations made by Order in Council P.C. 2016-743 of August 5, 2016 and registered as SOR/2016-230. (ancien Règlement sur l’accès au cannabis à des fins médicales)

    former Industrial Hemp Regulations

    former Industrial Hemp Regulations means the regulations made by Order in Council P.C. 1998-352 of March 12, 1998 and registered as SOR/98-156. (ancien Règlement sur le chanvre industriel)

    grow area

    grow area means, in respect of a site set out in a licence, an area of the site where cannabis plants are cultivated, harvested or propagated. (zone de culture)

    hospital

    hospital means, except in Part 8, a facility 

    • (a) that is licensed, approved or designated by a province under the laws of the province to provide care or treatment to individuals suffering from any form of disease or illness; or

    • (b) that is owned or operated by the Government of Canada or the government of a province and that provides health services. (hôpital)

    immediate container

    immediate container means a container that is in direct contact with cannabis or a cannabis accessory that is a cannabis product or, if a wrapper is in direct contact with the cannabis or the cannabis accessory, with the wrapper. (contenant immédiat)

    import permit

    import permit means a permit issued under subsection 62(1) of the Act that authorizes the importation of cannabis for medical or scientific purposes. (permis d’importation)

    ingestion

    ingestion includes absorption in the mouth. (ingestion)

    ingredient

    ingredient means

    • (a) in the case of a cannabis extract or a cannabis topical, a substance, other than anything referred to in item 1 or 3 of Schedule 1 to the Act, that is used to produce the cannabis extract or cannabis topical, including any substance used in the manufacture of that substance, and that is present in the final form of the cannabis extract or cannabis topical; and

    • (b) in the case of edible cannabis,

      • (i) a substance, other than anything referred to in item 1 or 3 of Schedule 1 to the Act,

        • (A) that is used to produce the edible cannabis if the use of the substance results, or may reasonably be expected to result, in the substance or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or

        • (B) that is part of a mixture of substances referred to in item 2 of that Schedule that is used to produce the edible cannabis if the use of the mixture results, or may reasonably be expected to result, in the substance or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or

      • (ii) a mixture of substances, other than anything referred to in item 1 or 3 of Schedule 1 to the Act,

        • (A) that is used to produce the edible cannabis if the use of the mixture results, or may reasonably be expected to result, in the mixture or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or

        • (B) that is part of a mixture of substances referred to in item 2 of that Schedule that is used to produce the edible cannabis if the use of the latter mixture results, or may reasonably be expected to result, in the former mixture or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis. (ingrédient)

    licence

    licence means a licence issued under subsection 62(1) of the Act in relation to cannabis. (licence)

    marketing authorization

    marketing authorization, except in paragraph 102(2)(a), has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (autorisation de mise en marché)

    meat product

    meat product has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (produit de viande)

    mineral nutrient

    mineral nutrient has the same meaning as in subsection D.02.001(1) of the Food and Drug Regulations except that it does not include sodium, potassium or chloride or compounds that include those elements. (minéral nutritif)

    non-therapeutic research on cannabis

    non-therapeutic research on cannabis means research that involves the distribution of cannabis to human participants by the holder of a licence for research and that is not a clinical trial as defined in section C.05.001 of the Food and Drug Regulations for which the sale of cannabis is authorized in accordance with section C.05.006 of those Regulations. This definition does not include research

    • (a) related to the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, or the restoration or correction of organic functions, in human beings or animals;

    • (b) involving the distribution of cannabis that is

      • (i) represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, or the restoration or correction of organic functions, in human beings or animals,

      • (ii) manufactured or sold by any person other than a licence holder referred to in paragraph 2(a) of the Cannabis Exemption (Food and Drugs Act) Regulations for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, or in the restoration or correction of organic functions, in human beings or animals,

      • (iii) referred to in any of paragraphs 1(b) to (d) of the Cannabis Exemption (Food and Drugs Act) Regulations, or

      • (iv) referred to in paragraph 1(f) of the Cannabis Exemption (Food and Drugs Act) Regulations in respect of an experimental study as defined in subsection C.08.013(2) of the Food and Drug Regulations;

    • (c) involving the distribution of cannabis that contains any substance that is referred to in column 1 of Schedule 5 to the Act and that

      • (i) in the case of cannabis that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product, does not meet the requirements set out in subsection 101.3(6) or section 102.2 or 102.3, and

      • (ii) in the case of any other cannabis, would not meet the requirements set out in subsection 101.3(6) or section 102.2 or 102.3 if it were a cannabis product or if it were contained in a cannabis accessory that is a cannabis product; or

    • (d) involving the participation of, or relating to, a young person. (recherche non thérapeutique sur le cannabis)

    operations area

    operations area means, in respect of a site set out in a licence, an area of the site — other than a storage area — where cannabis is present as a result of any activities conducted under a licence. It includes a grow area. (zone d’exploitation)

    pest control product

    pest control product has the same meaning as in subsection 2(1) of the Pest Control Products Act. (produit antiparasitaire)

    pharmacist

    pharmacist means an individual who is entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province. (pharmacien)

    point

    point means the unit of measurement for type size that is known as a PostScript point and is equal to 0.3527777778 mm. (point)

    potential to convert CBDA into CBD

    potential to convert CBDA into CBD means the maximum amount of CBD that would be obtained if CBDA was converted into CBD with no further degradation of CBD. (potentiel de transformation de l’ACBD en CBD)

    potential to convert THCA into THC

    potential to convert THCA into THC means the maximum amount of THC that would be obtained if THCA was converted into THC with no further degradation of THC. (potentiel de transformation de l’ATHC en THC)

    poultry product

    poultry product has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (produit de volaille)

    prescription

    prescription has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (ordonnance)

    prescription drug

    prescription drug means a drug

    • (a) that contains cannabis;

    • (b) that is a prescription drug, as defined in section A.01.010 of the Food and Drug Regulations; and

    • (c) for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations. (drogue sur ordonnance)

    proper name

    proper name has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom propre)

    reference standard

    reference standard means a standardized form of cannabis that is intended to be used as a measurement base when testing a substance to confirm its identity, concentration, quality or purity for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose. (étalon de référence)

    security clearance

    security clearance means, except in paragraph 53(2)(g), a security clearance granted by the Minister under section 67 of the Act and includes, for the purpose of paragraph 53(2)(e), a security clearance granted under section 112 of the former Access to Cannabis for Medical Purposes Regulations. (habilitation de sécurité)

    site

    site means, in respect of a holder of a licence, an area that is used exclusively by the holder and that consists of at least one building or one part of a building. (lieu)

    storage area

    storage area means, in respect of a site set out in a licence, an area of the site where cannabis is stored. (zone d’entreposage)

    sugars

    sugars has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (sucres)

    test kit

    test kit means a kit

    • (a) that contains

      • (i) cannabis, and

      • (ii) a reagent system or buffering agent, or both;

    • (b) that is designed to be used during the course of a chemical or analytical procedure to test for the presence or quantity of cannabis for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and

    • (c) the contents of which are not intended or likely to be consumed or administered. (nécessaire d’essai)

    THC

    THC means delta-9-tetrahydrocannabinol. (THC)

    THCA

    THCA means delta-9-tetrahydrocannabinolic acid. (ATHC )

    vitamin

    vitamin, except in subsection 101.3(3), has the same meaning as in subsection D.01.002(1) of the Food and Drug Regulations. (vitamine)

    water activity

    water activity, except in section 102.5, means the ratio of the water vapour pressure of a meat product, poultry product or fish to the vapour pressure of pure water, at the same temperature and pressure. (activité de l’eau)

  • Marginal note:Incorporation by reference

    (3) For the purpose of the incorporation by reference into these Regulations of any documents published by the Government of Canada, terms that are used but not defined in those documents have the same meaning as in these Regulations.

  • Marginal note:Deeming — immediate container

    (4) For the purposes of these Regulations, a cannabis accessory that contains edible cannabis in liquid form at a temperature of 22 ± 2°C and that is a cannabis product is deemed to be an immediate container.

 

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