Cannabis Regulations (SOR/2018-144)

Marginal note:Sanitation program

• 87 (1) Cannabis and anything that will be used as an ingredient must be produced, packaged, labelled, distributed, stored, sampled and tested in accordance with a sanitation program that sets out

  • (a) procedures for effectively cleaning the building or part of the building in which those activities are conducted;

  • (b) procedures for effectively cleaning the equipment and conveyances used in those activities;

  • (c) procedures for handling any substance used in those activities; and

  • (d) all requirements, in respect of the health and hygienic behaviour of the personnel who are involved in those activities, that are necessary to ensure that those activities are conducted in sanitary conditions.

• Marginal note:Non-application

  (2) Paragraph (1)(a) does not apply to the outdoor cultivation, propagation or harvesting of cannabis or anything that will be used as an ingredient.

Marginal note:Hand cleaning and hand sanitizing stations and lavatories

• 87.1 (1) If necessary to prevent the contamination of cannabis or anything that will be used as an ingredient, a site must be equipped with hand cleaning and hand sanitizing stations and lavatories that

  • (a) are appropriately equipped and adequate in number and size for the number of individuals using them;

  • (b) are located so that they are readily accessible to the individuals using them; and

  • (c) are capable of withstanding repeated cleaning and, as necessary, repeated sanitizing.

• Marginal note:Hand cleaning and hand sanitizing stations

  (2) The hand cleaning and hand sanitizing stations must permit the effective cleaning and sanitization of hands.

• Marginal note:Lavatories

  (3) The lavatories must be located and maintained so that they do not present any risk of contamination of cannabis or anything that will be used as an ingredient.

Additional Requirements — Holder of Licence for Processing

Marginal note:Quality assurance

• 88 (1) A holder of a licence for processing must ensure that

  • (a) every investigation in respect of the matters referred to in paragraphs 19(2)(b) and (c) is conducted under the responsibility of the quality assurance person referred to in section 19;

  • (b) if necessary following an investigation, the quality assurance person immediately causes measures to be taken to mitigate any risk;

  • (c) cannabis and anything that will be used as an ingredient are produced, packaged, labelled, distributed, stored, sampled and tested using methods and procedures that, prior to their implementation, have been approved by the quality assurance person;

  • (d) in the case of a cannabis extract or edible cannabis, the quality assurance person approves the preventive control plan referred to in section 88.94 prior to its implementation; and

  • (e) every lot or batch of cannabis is approved by the quality assurance person before it is made available for sale.

• Marginal note:Activities under the responsibility of quality assurance person

  (2) The activities assigned to the quality assurance person under paragraphs (1)(b) to (e) can also be conducted under the responsibility of that person.

Marginal note:Competencies and qualifications

88.1 A holder of a licence for processing must ensure that any individual who conducts activities in relation to edible cannabis or anything that will be used as an ingredient in the production of edible cannabis has the competencies and qualifications that are necessary to conduct those activities at the site set out in the licence.

Marginal note:Temperature and humidity

• 88.2 (1) A holder of a licence for processing must ensure that the temperature and humidity of any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored or tested are maintained at levels that are appropriate for the activity being conducted with the cannabis or thing that will be used as an ingredient.

• Marginal note:Heating, cooling or humidity-control system

  (2) If the building or part of the building is equipped with a heating, cooling or humidity-control system, the holder of the licence must ensure that the system

  • (a) if necessary to prevent contamination of the cannabis or thing that will be used as an ingredient, is equipped with instruments to control and indicate the temperature and humidity levels;

  • (b) is accessible and, if necessary for its cleaning, maintenance or inspection, is capable of being disassembled;

  • (c) is capable of withstanding repeated cleaning; and

  • (d) functions in accordance with its intended use.

Marginal note:Incompatible activities

• 88.3 (1) A holder of a licence for processing must ensure that physical or other effective means are used to separate incompatible activities in order to prevent contamination of cannabis or anything that will be used as an ingredient.

• Marginal note:Production of food

  (2) A holder of a licence for processing must not produce, package, label or store cannabis at a site set out in the licence if food that is to be sold is also produced, packaged or labelled at that site.

• Marginal note:Exception

  (3) Despite subsection (2), a holder of a licence for processing may produce, package, label or store cannabis in a building within a site where food that is to be sold is produced, packaged or labelled if the food is not produced, packaged or labelled in the same building.

Marginal note:Separation of cannabis and ingredients from contaminants

88.4 A holder of a licence for processing must ensure that physical or other effective means are used to separate cannabis or anything that will be used as an ingredient from anything that presents a risk of contamination of the cannabis or thing that will be used as an ingredient.

Marginal note:Ingredients — risk of injury to human health

88.5 A holder of a licence for processing must ensure that anything that will be, or was intended to be, used as an ingredient that presents a risk of injury to human health is identified as such and is stored in a designated area within the site.

Marginal note:Potable water

• 88.6 (1) A holder of a licence for processing must ensure that any water that might come into contact with a cannabis extract, a cannabis topical, edible cannabis or anything that will be used as an ingredient is potable and, if the water is not potable, must ensure that it does not present a risk of contamination of the cannabis extract, cannabis topical, edible cannabis or thing that will be used as an ingredient.

• Marginal note:Steam and ice from potable water

  (2) A holder of a licence for processing must ensure that any steam or ice that might come into contact with a cannabis extract, a cannabis topical, edible cannabis or anything that will be used as an ingredient is made from water that meets the requirements of subsection (1) and, if the steam or ice does not meet those requirements, must ensure that it does not present a risk of contamination of the cannabis extract, cannabis topical, edible cannabis or thing that will be used as an ingredient.

Marginal note:No presence of animals

88.7 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

88.8 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

• 88.9 (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

88.91 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

88.92 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

• 88.93 (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

• 88.94 (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

89 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

• 90 (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.