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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

PART 5Good Production Practices (continued)

General Requirements (continued)

Marginal note:Sanitizers, agronomic inputs and non-food chemical agents

 Any sanitizer, agronomic input or non-food chemical agent that is present at a site must

  • (a) be properly and clearly identified;

  • (b) be suitable for its intended use and not present a risk of contamination of cannabis or anything that will be used as an ingredient; and

  • (c) be handled and used in a manner that does not present a risk of contamination of cannabis or anything that will be used as an ingredient and that is in accordance with the manufacturer’s instructions.

Marginal note:Storage

 Cannabis and anything that will be used as an ingredient must be stored under conditions that maintain their quality.

Marginal note:Distribution

 Cannabis and anything that will be used as an ingredient must be distributed in a manner that maintains their quality.

Marginal note:Building or part of building

 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 must be designed, constructed and maintained in a manner that permits those activities to be conducted appropriately and under sanitary conditions and, in particular, that

  • (a) permits the building or part of the building to be kept clean and orderly;

  • (b) permits the effective cleaning of all surfaces in the building or part of the building;

  • (c) prevents the contamination of the cannabis or thing that will be used as an ingredient; and

  • (d) prevents the introduction of an extraneous substance to the cannabis or thing that will be used as an ingredient.

Marginal note:System — filtration and ventilation

  •  (1) 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 must be equipped with a system that

    • (a) filters air to prevent the escape of odours associated with cannabis plant material to the outdoors;

    • (b) provides natural or mechanical ventilation with sufficient air exchange to provide clean air and to remove unclean air in order to prevent the contamination of the cannabis or thing that will be used as an ingredient;

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

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

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

  • Marginal note:Exception — cultivation, propagation or harvesting of cannabis

    (2) Paragraph (1)(b) does not apply in respect of any building or part of a building where the only activities being conducted in respect of cannabis are its cultivation, propagation or harvesting.

  • Marginal note:Exception — cultivation, propagation or harvesting of anything used as an ingredient

    (3) Paragraphs (1)(b) to (e) do not apply in respect of any building or part of a building where the only activities being conducted in respect of anything that will be used as an ingredient are its cultivation, propagation or harvesting.

Marginal note:Supply of water

  •  (1) Any system that supplies water to a site must be appropriate for any activity being conducted in respect of cannabis or anything that will be used as an ingredient.

  • Marginal note:Cross-connection

    (2) Any system that supplies potable water to a site must not be cross-connected with any other system, unless measures are taken to eliminate any risk of contamination of cannabis or anything that will be used as an ingredient as a result of the cross-connection.

Marginal note:Lighting

  •  (1) 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 must be equipped with natural or artificial lighting that is appropriate for the activity being conducted.

  • Marginal note:Light fixtures

    (2) Any light fixtures in the building or part of the building where the activities referred to in subsection (1) are conducted must

    • (a) be capable of withstanding repeated cleaning and, if necessary to prevent contamination of the cannabis or thing that will be used as an ingredient, repeated sanitizing; and

    • (b) not present a risk of contamination of the cannabis or thing that will be used as an ingredient in the event of breakage.

Marginal note:Equipment

  •  (1) Cannabis and anything that will be used as an ingredient must be produced, packaged, labelled, stored, sampled and tested using equipment that is designed, constructed, maintained, operated and arranged in a manner that

    • (a) permits the effective cleaning of its surfaces;

    • (b) permits it to function in accordance with its intended use;

    • (b.1) is accessible and, if necessary for its cleaning, maintenance or inspection, is capable of being easily disassembled;

    • (c) prevents the contamination of the cannabis or thing that will be used as an ingredient;

    • (d) prevents the introduction of an extraneous substance to the cannabis or thing that will be used as an ingredient; and

    • (e) protects the cannabis or thing that will be used as an ingredient against allergen cross-contamination.

  • Marginal note:Conveyances

    (1.1) Cannabis and anything that will be used as an ingredient must be distributed using a conveyance that is designed, constructed, maintained and operated in a manner that prevents the contamination of the cannabis or thing that will be used as an ingredient.

  • Marginal note:Non-application

    (2) Paragraphs (1)(d) and (e) do not apply to the outdoor cultivation, propagation or harvesting of cannabis or anything that will be used as an ingredient.

Marginal note:Sanitation program

  •  (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

  •  (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

 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:Competencies and qualifications

 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

  •  (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

  •  (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

 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

 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

  •  (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.

 

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