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Cannabis Regulations (SOR/2018-144)

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Regulations are current to 2023-01-25 and last amended on 2022-12-02. Previous Versions

PART 5Good Production Practices (continued)

Additional Requirements — Holder of Licence for Processing (continued)

Marginal note:No presence of animals

 A holder of a licence for processing must ensure that no animal is present in any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled or stored.

Marginal note:Land — risk of contamination

 If any land that forms part of a site set out in a licence for processing, or any land that is located near such a site, presents a risk of contamination of cannabis or anything that will be used as an ingredient, the holder of the licence must take measures to eliminate the risk.

Marginal note:Removal and disposal of contaminated materials and waste

  •  (1) A holder of a licence for processing must ensure that any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled or stored has means for the removal and disposal of contaminated materials and waste and, if necessary to prevent contamination of the cannabis or thing that will be used as an ingredient, that the building or part of the building is equipped with a drainage, sewage and plumbing system that functions in accordance with its intended use.

  • Marginal note:Frequency and manner

    (2) The holder of the licence must ensure that contaminated materials and waste are removed and disposed of at a frequency that is sufficient to prevent contamination of the cannabis or thing that will be used as an ingredient and in a manner that does not present a risk of contamination of the cannabis or thing that will be used as an ingredient.

Marginal note:Conveyances and equipment

 A holder of a licence for processing must ensure that any conveyance or equipment that is used at the site set out in the licence to handle any contaminated materials or any waste, unless that conveyance or equipment does not come into contact with those materials or waste,

  • (a) is used only for that purpose;

  • (b) is identified as being reserved for that purpose; and

  • (c) meets the applicable requirements of section 86.

Marginal note:Clothing, footwear and protective coverings

 A holder of a licence for processing must ensure that any individual who enters or is in any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored, sampled or tested wears clothing, footwear and protective coverings, including gloves, a hairnet, a beard net and a smock, that are in good condition, clean and in sanitary condition and that are appropriate for the activity being conducted with the cannabis or thing that will be used as an ingredient.

Marginal note:Identification and analysis of hazards

  •  (1) A holder of a licence for processing that produces a cannabis extract or edible cannabis must identify and analyze the biological, chemical and physical hazards that present a risk of contamination of the cannabis or anything that will be used as an ingredient in the production of the cannabis extract or edible cannabis.

  • Marginal note:Prevention, elimination and reduction of hazards

    (2) The holder of the licence must prevent, eliminate or reduce to an acceptable level the hazards referred to in subsection (1) by using control measures that are shown by evidence to be effective, including any treatment or process.

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.

 
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