Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

Cannabis Regulations (SOR/2018-144)

Full Document:  

Regulations are current to 2021-11-17 and last amended on 2020-10-17. Previous Versions

PART 5Good Production Practices (continued)

Additional Requirements — Holder of Licence for Processing (continued)

Marginal note:Preventive control plan

  •  (1) A holder of a licence for processing that conducts activities in relation to a cannabis extract or edible cannabis must prepare, retain, maintain and implement a written preventive control plan for any activity they conduct in respect of the cannabis or anything that will be used as an ingredient in the production of the cannabis extract or edible cannabis.

  • Marginal note:Content of preventive control plan

    (2) The preventive control plan must include

    • (a) a description of the measures for ensuring that the applicable requirements of sections 101.3, 101.4, 102, 102.2, 102.3, 102.5 and 102.6 are met;

    • (b) in relation to the applicable requirements of these Regulations,

      • (i) a description of the biological, chemical and physical hazards that are identified under subsection 88.93(1) that present a risk of contamination of the cannabis extract, edible cannabis or anything that will be used as an ingredient in the production of the cannabis extract or edible cannabis,

      • (ii) a description of the control measures for preventing, eliminating or reducing to an acceptable level the hazards referred to in subparagraph (i) and the evidence that the control measures are effective,

      • (iii) a description of the critical control points, the related control measures and the evidence that the control measures are effective,

      • (iv) a description of the critical limits for each critical control point,

      • (v) the procedures for monitoring the critical control points in relation to their critical limits,

      • (vi) the corrective action procedures for each critical control point,

      • (vii) the procedures for verifying that the implementation of the preventive control plan results in compliance with these Regulations, and

      • (viii) documents that substantiate that the preventive control plan has been implemented with respect to subparagraphs (i) to (vii); and

    • (c) supporting documents that show evidence of the information recorded under paragraph (a) and subparagraphs (b)(i) to (vii).

  • Marginal note:Retention period

    (3) Each document referred to in subparagraph (2)(b)(viii) must be retained for at least two years after the day on which it is prepared.

Testing

Marginal note:Sale and exportation — cannabis product

 A holder of a licence must not sell or export a cannabis product unless the applicable requirements set out in sections 90 to 92 have been met.

Marginal note:Testing for phytocannabinoids

  •  (1) Testing for the quantity or concentration, as the case may be, of THC, THCA, CBD and CBDA must be conducted on each lot or batch of cannabis, other than cannabis plants or cannabis plant seeds, that

    • (a) is or will become a cannabis product; or

    • (b) is or will be contained in a cannabis accessory that is or will become a cannabis product.

  • Marginal note:Timing of testing

    (2) The testing must be conducted on the final form of the cannabis, either before or after it — or the cannabis accessory that contains it — is packaged and labelled as a cannabis product.

Marginal note:Testing for contaminants

  •  (1) Testing for microbial and chemical contaminants — other than residues of a pest control product or its components or derivatives — must be conducted on

    • (a) each lot or batch of cannabis — other than cannabis plants, cannabis plant seeds or edible cannabis — that

      • (i) is or will become a cannabis product, or

      • (ii) is or will be contained in a cannabis accessory that is or will become a cannabis product; or

    • (b) each lot or batch of cannabis — other than cannabis plant seeds — that

      • (i) is used to produce the cannabis referred to in paragraph (a), or

      • (ii) is used to produce edible cannabis that is or will become a cannabis product, or that is or will be contained in a cannabis accessory that is or will become a cannabis product.

  • Marginal note:Timing of testing

    (2) The testing on a lot or batch of cannabis must be conducted as follows:

    • (a) the testing referred to in paragraph (1)(a) must be conducted on the final form of the cannabis, either before or after it — or the cannabis accessory that contains it — is packaged and labelled as a cannabis product; and

    • (b) the testing referred to in paragraph (1)(b) must be conducted after the final step in the production process during which the contaminants referred to in subsection (1) could have been introduced or could be concentrated, whichever is later.

  • Marginal note:Tolerance limits

    (3) The results of the testing referred to in subsection (1) must enable a determination of whether the contaminants, if any, are or will be within the tolerance limits referred to in subsection 93(3) or 94(2) or section 101.1, as the case may be.

Marginal note:Dissolution and disintegration testing

  •  (1) If cannabis — or a cannabis accessory that contains cannabis — is or will become a cannabis product to which subsection 95(1) applies, testing must be conducted on each lot or batch of the cannabis or cannabis accessory to determine whether the requirements referred to in that subsection are, or will be, met.

  • Marginal note:Timing of testing

    (2) The testing must be conducted on the final form of the cannabis, either before or after it — or the cannabis accessory that contains it — is packaged and labelled as a cannabis product.

Marginal note:Testing method

  •  (1) Testing that is conducted under sections 90 to 91.1 — or to determine whether the applicable requirements in Part 6 are, or will be, met — must be conducted using validated methods on a representative sample of each lot or batch of cannabis or cannabis accessory that contains cannabis.

  • Marginal note:Retention period

    (2) A portion of the sample referred to in subsection (1) must be retained for at least one year after the date of the last sale of any portion of the lot or batch.

  • Marginal note:Sufficient quantity

    (3) The portion of the sample retained under subsection (2) must be of sufficient quantity to enable a determination of

    • (a) whether the lot or batch meets the requirements of section 81, subsection 93(3), 94(2) or 95(1) or section 101.1, as applicable; and

    • (b) the quantity or concentration of THC, THCA, CBD and CBDA.

PART 6Cannabis Products

General Provisions

Marginal note:Interpretation — residues of pest control products

 In this Part, a reference to residues of a pest control product includes the residues of any component or derivative of the pest control product.

Marginal note:Residues of pest control products — cannabis plants and seeds

 Cannabis plants or cannabis plant seeds that are cannabis products — or that are contained in a cannabis accessory that is a cannabis product — must not contain or have on them 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, unless the residues are within any maximum residue limits that are specified in relation to cannabis under section 9 or 10 of that Act.

Marginal note:Dried and fresh cannabis

  •  (1) Dried cannabis or fresh 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 other than anything referred to in item 1 of Schedule 1 to the Act.

  • Marginal note:Residues of pest control products

    (2) Despite subsection (1), cannabis that is referred to in that subsection may contain or have on it 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.

  • Marginal note:Microbial and chemical contaminants

    (3) Despite subsection (1), cannabis that is referred to in that subsection may contain or have on it microbial or chemical contaminants if 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:More stringent limit applies

    (4) If there are generally accepted tolerance limits referred to in subsection (3) that apply in respect of the residues of a pest control product referred to in subsection (2) for which a maximum residue limit has been specified in relation to cannabis under the Pest Control Products Act, the more stringent limit applies.

Marginal note:Cannabis used in production

  •  (1) Cannabis that is referred to in item 1 or 3 of Schedule 1 to the Act and that is used in the production of the following cannabis must not contain or have on it 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, unless the residues are within any maximum residue limits that are specified in relation to cannabis under section 9 or 10 of that Act:

    • (a) a cannabis extract that will become a cannabis product or that will be contained in a cannabis accessory that will become a cannabis product;

    • (b) a cannabis topical that will become a cannabis product or that will be contained in a cannabis accessory that will become a cannabis product; and

    • (c) edible cannabis that will become a cannabis product or that will be contained in a cannabis accessory that will become a cannabis product.

  • Marginal note:Edible cannabis — microbial and chemical contaminants

    (2) Cannabis that is referred to in item 1 or 3 of Schedule 1 to the Act and that is used in the production of edible cannabis must not, if the edible cannabis will become a cannabis product or will be contained in a cannabis accessory that will become a cannabis product, 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 a product that is to be ingested.

Marginal note:Dissolution and disintegration

  •  (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

  •  (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

  •  (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

  •  (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.

 
Date modified: