Regulations Amending the Cannabis Regulations (New Classes of Cannabis): SOR/2019-206

Canada Gazette, Part II, Volume 153, Number 13

Registration

SOR/2019-206 June 13, 2019

CANNABIS ACT

P.C. 2019-780 June 13, 2019

Her Excellency the Governor General in Council, on the recommendation of the Minister of Border Security and Organized Crime Reduction, pursuant to subsection 139(1) of the Cannabis Act , makes the annexed Regulations Amending the Cannabis Regulations (New Classes of Cannabis) .

Regulations Amending the Cannabis Regulations (New Classes of Cannabis)

Amendments

1 (1) The definitions cannabis non-solid concentrates and cannabis solid concentrates in subsection 1(1) of the Cannabis Regulations are repealed.

(2) The definition cannabis oil in subsection 1(1) of the Regulations is repealed.

(3) The definitions non-solids containing cannabis and solids containing cannabis in subsection 1(1) of the Regulations are replaced by the following:

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 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 )

(4) Subsection 1(1) of the Regulations is amended by adding the following definitions in alphabetical order:

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 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

a substance produced by (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 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 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 )

(5) The definition common name in subsection 1(2) of the Regulations is repealed.

(6) The definition cannabis product in subsection 1(2) of the Regulations is replaced by the following:

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;

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

a cannabis accessory that contains cannabis that is intended for an animal; or (c) a drug containing cannabis. ( produit du cannabis )

(7) Subsection 1(2) of the Regulations is amended by adding the following definitions in alphabetical order:

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 )

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 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 )

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

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

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

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 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 )

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 )

ingestion includes absorption in the mouth. ( ingestion )

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

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 )

in the case of edible cannabis,

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

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 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 )

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

(8) Section 1 of the Regulations is amended by adding the following after subsection (3):

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.

2 (1) The heading to Part 1 of the Regulations is replaced by the following:

General Authorizations and Prohibition

(2) Subsection 4(1) of the Regulations is amended by striking out “and” at the end of paragraph (c) and by replacing paragraph (d) with the following:

(d) to distribute cannabis to other individuals who are involved in the testing of cannabis as a requirement of their duties at a laboratory that is operated by the Government of Canada or the government of a province;

to distribute cannabis to other individuals who are involved in the testing of cannabis as a requirement of their duties at a laboratory that is operated by the Government of Canada or the government of a province; (e) to distribute cannabis to the individuals referred to in subsection (4); and

to distribute cannabis to the individuals referred to in subsection (4); and (f) to distribute cannabis to the holder of a licence for analytical testing.

(3) Subsection 4(4) of the Regulations is replaced by the following:

Authorized activities — accredited laboratory

(4) Individuals who are involved in the testing of cannabis as a requirement of their duties at a laboratory that is designated as an accredited laboratory under section 2.1 of the Seeds Act are authorized to conduct the activities referred to in paragraphs (1)(a) and (c) to (f), and to offer to conduct the activity referred to in paragraph (1)(c), to the extent necessary to conduct the testing.

3 The Regulations are amended by adding the following after section 5:

Sale of cannabis containing caffeine

5.1 For the purposes of subsection 34(1) of the Act,

(a) a holder of a licence for processing that authorizes the sale of cannabis may, in accordance with the licence, sell edible cannabis that is not a cannabis product and that contains caffeine if the caffeine has been introduced through the use of ingredients that naturally contain caffeine; and

a holder of a licence for processing that authorizes the sale of cannabis may, in accordance with the licence, sell edible cannabis that is not a cannabis product and that contains caffeine if the caffeine has been introduced through the use of ingredients that naturally contain caffeine; and (b) the following persons may, in accordance with their licence or the provincial authorization, as the case may be, sell edible cannabis that is a cannabis product and that contains caffeine if the caffeine has been introduced through the use of ingredients that naturally contain caffeine and the total amount of caffeine in each immediate container of the cannabis product does not exceed 30 mg: (i) a holder of a licence for processing that authorizes the sale of cannabis, (ii) a holder of a licence for sale that authorizes the sale of cannabis products, and (iii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis.

the following persons may, in accordance with their licence or the provincial authorization, as the case may be, sell edible cannabis that is a cannabis product and that contains caffeine if the caffeine has been introduced through the use of ingredients that naturally contain caffeine and the total amount of caffeine in each immediate container of the cannabis product does not exceed 30 mg:

Sale of cannabis containing ethyl alcohol

5.2 (1) For the purposes of subsection 34(1) of the Act,

(a) a holder of a licence for processing that authorizes the sale of cannabis may, in accordance with the licence, sell a cannabis extract that is not a cannabis product and that contains ethyl alcohol; and

a holder of a licence for processing that authorizes the sale of cannabis may, in accordance with the licence, sell a cannabis extract that is not a cannabis product and that contains ethyl alcohol; and (b) the following persons may, in accordance with their licence or the provincial authorization, as the case may be, sell a cannabis extract that is a cannabis product and that contains ethyl alcohol if the cannabis extract is intended to be ingested and the net weight of the cannabis extract in each immediate container of the cannabis product does not exceed 7.5 g: (i) a holder of a licence for processing that authorizes the sale of cannabis, (ii) a holder of a licence for sale that authorizes the sale of cannabis products, and (iii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis.

the following persons may, in accordance with their licence or the provincial authorization, as the case may be, sell a cannabis extract that is a cannabis product and that contains ethyl alcohol if the cannabis extract is intended to be ingested and the net weight of the cannabis extract in each immediate container of the cannabis product does not exceed 7.5 g:

Edible cannabis

(2) For the purposes of subsection 34(1) of the Act,

(a) a holder of a licence for processing that authorizes the sale of cannabis may, in accordance with the licence, sell edible cannabis that is not a cannabis product and that contains ethyl alcohol; and

a holder of a licence for processing that authorizes the sale of cannabis may, in accordance with the licence, sell edible cannabis that is not a cannabis product and that contains ethyl alcohol; and (b) the following persons may, in accordance with their licence or the provincial authorization, as the case may be, sell edible cannabis that is a cannabis product and that contains ethyl alcohol if the concentration of ethyl alcohol does not exceed 0.5% w/w of the edible cannabis: (i) a holder of a licence for processing that authorizes the sale of cannabis, (ii) a holder of a licence for sale that authorizes the sale of cannabis products, and (iii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis.

the following persons may, in accordance with their licence or the provincial authorization, as the case may be, sell edible cannabis that is a cannabis product and that contains ethyl alcohol if the concentration of ethyl alcohol does not exceed 0.5% w/w of the edible cannabis:

Prohibition to sell — voluntary recall

5.3 A person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis must not sell a cannabis product that they know is the subject of a voluntary recall in Canada that has been commenced for reasons respecting

(a) the quality of the cannabis product; or

the quality of the cannabis product; or (b) the applicable requirements of Part 5 or 6 are otherwise not being met.

4 Subsection 10(1) of the Regulations is replaced by the following:

Obtaining cannabis

10 (1) Subject to the other provisions of these Regulations, a holder of a licence that authorizes the possession of cannabis must only possess cannabis that was obtained in accordance with the former Access to Cannabis for Medical Purposes Regulations , the former Industrial Hemp Regulations or the Industrial Hemp Regulations or that is obtained in accordance with these Regulations or from a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis.

5 (1) Subparagraph 11(5)(c)(ii) of the Regulations is replaced by the following:

(ii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis; and

(2) Subparagraph 11(5)(d)(i) of the Regulations is replaced by the following:

(i) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis, or

6 (1) Subparagraph 14(5)(b)(ii) of the Regulations is replaced by the following:

(ii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis; and

(2) Subparagraph 14(5)(c)(i) of the Regulations is replaced by the following:

(i) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis, or

7 (1) Subparagraph 17(5)(d)(ii) of the Regulations is replaced by the following:

(ii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis; and

(2) Subparagraph 17(5)(e)(i) of the Regulations is replaced by the following:

(i) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis, or

(3) Subsection 17(6) of the English version of the Regulations is replaced by the following:

Client’s shipping address

(6) If a holder of a licence for micro-processing or standard processing sends or delivers cannabis products under subparagraph (5)(e)(ii) further to the sale of such products under section 289, the holder must send or deliver the products to the client’s shipping address as indicated by the holder of a licence for sale for medical purposes.

8 Paragraph 18(1)(a) of the Regulations is replaced by the following:

(a) the sale or distribution of cannabis products to a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis; and

9 (1) Subsection 19(1) of the Regulations is replaced by the following:

Quality assurance person

19 (1) A holder of a licence for processing must retain the services of one individual as a quality assurance person who has the training, experience and technical knowledge related to the requirements of Parts 5 and 6 that are applicable to the class of cannabis in respect of which activities are conducted under the licence.

Exception — edible cannabis

(1.1) Despite subsection (1), if the quality assurance person does not have the training, experience and technical knowledge related to the requirements of Parts 5 and 6 that are applicable to edible cannabis, the holder of a licence for processing that conducts activities in respect of that class of cannabis must retain the services of another individual who has that training, experience and technical knowledge.

(2) Subsection 19(2) of the Regulations is amended by striking out “and” at the end of paragraph (a) and by replacing paragraph (b) with the following:

(b) investigating every complaint received in respect of the quality of the cannabis and, if necessary, immediately taking measures to mitigate any risk; and

investigating every complaint received in respect of the quality of the cannabis and, if necessary, immediately taking measures to mitigate any risk; and (c) if they suspect, on reasonable grounds, that the cannabis or anything that will be used as an ingredient presents a risk of injury to human health or that the applicable requirements of Part 5 or 6 are otherwise not being met, immediately investigating the matter and, if necessary, immediately taking measures to mitigate any risk.

10 Items 5 and 6 of the table to section 21 of the Regulations are replaced by the following:

Item Column 1



Class of cannabis Column 2



Amount that is equivalent to 1 kg of dried cannabis 5 cannabis concentrates 0.25 kg

11 Section 22 of the Regulations is amended by adding the following after subsection (3):

Distribution

(4) A holder of a licence for analytical testing is also authorized, for the purpose of testing, to distribute cannabis to another holder of a licence for analytical testing or the individuals referred to in section 4.

12 Subsection 23(1) of the Regulations is replaced by the following:

Head of laboratory

23 (1) A holder of a licence for analytical testing must retain the services of one individual as the head of laboratory who must work at the site set out in the licence and who is responsible for the testing referred to in sections 90 to 91.1.

13 Section 25 of the Regulations is replaced by the following:

Destruction

25 (1) A holder of a licence for analytical testing must destroy the sample of a lot or batch of cannabis that has been distributed to them, and all cannabis obtained from that sample, within 90 days after completing the testing of the sample of the lot or batch.

Sample not tested

(2) If testing of the sample of a lot or batch of cannabis distributed to the holder of the licence for analytical testing is not initiated within 120 days of its receipt, the holder must, by the end of that period, either destroy the sample or distribute it to another holder of a licence for analytical testing or to the individuals referred to in section 4.

14 Paragraph 28(5)(a) of the Regulations is replaced by the following:

(a) cannabis to any of the following: (i) another holder of a licence for research, (ii) a holder of a licence for analytical testing, (iii) a holder of a cannabis drug licence, (iv) the individuals referred to in section 4, or (v) the Minister; and

cannabis to any of the following:

15 Section 29 of the Regulations is amended by striking out “and” at the end of paragraph (i), by adding “and” at the end of paragraph (j) and by adding the following after paragraph (j):

(k) in respect of a licence for processing, the applicant has, in the past 10 years, been convicted of an offence under the Safe Food for Canadians Act or an Act referred to in subsection 374(2) of the Safe Food for Canadians Regulations .

16 Section 30 of the Regulations is amended by striking out “and” at the end of paragraph (b) and by replacing paragraph (c) with the following:

(c) the holder of a licence does not hold a cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001 , if it is required; and

the holder of a licence does not hold a cannabis licence issued under subsection 14(1.1) of the , if it is required; and (d) the cannabis licence issued to the holder under subsection 14(1.1) of the Excise Act, 2001 is suspended under subsection 23(2) of that Act.

17 Section 31 of the Regulations is amended by striking out “and” at the end of paragraph (c), by adding “and” at the end of paragraph (d) and by adding the following after paragraph (d):

(e) in the case of a licence for processing, the holder has, since its issuance, been convicted of an offence under the Safe Food for Canadians Act or an Act referred to in subsection 374(2) of the Safe Food for Canadians Regulations .

18 Section 42 of the Regulations is renumbered as subsection 42(1) and is amended by adding the following after that subsection:

Irradiation of edible cannabis

(2) For greater certainty, in the case of the irradiation of edible cannabis by a holder of a licence for processing, the requirements set out in subsection (1) apply in addition to the conditions set out in paragraphs 102.6(a) and (b).

19 Section 46 of the Regulations is replaced by the following:

Recall

46 (1) A holder of a licence, other than a licence for analytical testing, must establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of cannabis that has been sold or distributed.

Recall simulation

(2) The holder must

(a) at least once every 12 months, conduct a recall simulation based on the system of control;

at least once every 12 months, conduct a recall simulation based on the system of control; (b) after completing the recall simulation, prepare a document that sets out the details of how it was conducted and the results; and

after completing the recall simulation, prepare a document that sets out the details of how it was conducted and the results; and (c) retain the document for at least two years after the day on which the recall simulation is completed.

20 The heading “General Provisions” before section 79 of the Regulations and sections 79 and 80 are replaced by the following:

Definitions

Definitions

78.1 The following definitions apply in this Part.

acceptable level means a level of a biological, chemical or physical hazard that does not present a risk of contamination of cannabis or anything that will be used as an ingredient. ( niveau acceptable )

control measure means a measure that can be applied to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of cannabis or anything that will be used as an ingredient, or to reduce the hazard to an acceptable level. ( mesure de contrôle )

critical control point means a step at which the application of a control measure is essential to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of cannabis or anything that will be used as an ingredient, or to reduce the hazard to an acceptable level. ( point de contrôle critique )

sanitary condition means a condition that does not present a risk of contamination, allergen cross-contamination or introduction of an extraneous substance to cannabis or anything that will be used as an ingredient. ( conditions hygiéniques )

General Requirements

Sale, distribution and exportation — cannabis

79 A holder of a licence must not sell, distribute or export cannabis unless the applicable requirements set out in sections 80 to 88.94 have been met.

Non-application — person not holding a licence

79.1 The requirements of this Part do not apply to any activity that a person conducts in respect of anything that will be used as an ingredient unless the activity is conducted by a holder of a licence.

Non-application — holder of licence for analytical testing or research

79.2 Sections 80 to 87.1 do not apply to a holder of a licence for analytical testing or a licence for research.

Standard operating procedures

80 Cannabis and anything that will be used as an ingredient must be produced, packaged, labelled, distributed, stored, sampled and tested in accordance with standard operating procedures that are designed to ensure that those activities are conducted in accordance with the applicable requirements of this Part and Part 6.

21 Section 81 of the Regulations is renumbered as subsection 81(1) and is amended by adding the following:

Exception — edible cannabis

(2) Despite subsection (1), edible cannabis may be treated during the course of production with a pest control product referred to in subparagraph 3(1)(b)(ii) of the Pest Control Products Regulations .

22 Sections 82 to 85 of the Regulations are replaced by the following:

Sanitizers, agronomic inputs and non-food chemical agents

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

(a) be properly and clearly identified;

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

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.

Storage

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

Distribution

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

Building or part of building

84 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;

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;

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

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.

System — filtration and ventilation

85 (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;

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;

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;

is accessible and, if necessary for its cleaning, maintenance or inspection, is capable of being disassembled; (d) is capable of withstanding repeated cleaning; and

is capable of withstanding repeated cleaning; and (e) functions in accordance with its intended use.

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.

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.

Supply of water

85.1 (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.

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.

Lighting

85.2 (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.

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

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.

23 (1) The portion of subsection 86(1) of the Regulations before paragraph (a) is replaced by the following:

Equipment

86 (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

(2) Paragraphs 86(1)(c) and (d) of the Regulations are replaced by the following:

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

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;

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

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.

(3) Subsection 86(2) of the Regulations is replaced by the following:

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.

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.

24 (1) The portion of subsection 87(1) of the Regulations before paragraph (a) is replaced by the following:

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

(2) Paragraph 87(1)(b) of the Regulations is replaced by the following:

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

(3) Subsection 87(2) of the Regulations is replaced by the following:

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.

25 Section 88 of the Regulations is replaced by the following:

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;

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

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.

Hand cleaning and hand sanitizing stations

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

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

Quality assurance

88 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;

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;

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;

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

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.

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.

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.

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;

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;

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

is capable of withstanding repeated cleaning; and (d) functions in accordance with its intended use.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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;

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

is identified as being reserved for that purpose; and (c) meets the applicable requirements of section 86.

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.

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.

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.

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.

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;

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

in relation to the applicable requirements of these Regulations, (c) supporting documents that show evidence of the information recorded under paragraph (a) and subparagraphs (b)(i) to (vii).

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.

26 Sections 90 to 92 of the Regulations are replaced by the following:

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

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.

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.

Testing for contaminants

91 (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

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

each lot or batch of cannabis — other than cannabis plant seeds — that

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

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.

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.

Dissolution and disintegration testing

91.1 (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.

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.

Testing method

92 (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.

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.

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

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.

27 Sections 93 to 98 of the Regulations are replaced by the following:

Interpretation — residues of pest control products

92.1 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.

Residues of pest control products — cannabis plants and seeds

92.2 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.

Dried and fresh cannabis

93 (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.

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.

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

established in a publication referred to in Schedule B to the ; and (b) appropriate for the intended use and any reasonably foreseeable use of the cannabis product.

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.

Cannabis used in production

94 (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;

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

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.

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

established in a publication referred to in Schedule B to the ; and (b) appropriate for a product that is to be ingested.

Dissolution and disintegration

95 (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.

Exception

(2) Subsection (1) does not apply to edible cannabis.

Maximum quantity of THC — discrete unit

96 (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.

Exception

(2) Subsection (1) does not apply to edible cannabis.

Variability limits

97 (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.

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;

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

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.

Variability limits — divisible cannabis products

97.1 (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

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.

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

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.

Products that must not be sold or distributed

98 The following cannabis products must not be sold or distributed:

(a) a cannabis product that is intended to be used in the area of the human eye bounded by the supraorbital and infraorbital ridges, including the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge; and

a cannabis product that is intended to be used in the area of the human eye bounded by the supraorbital and infraorbital ridges, including the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge; and (b) a cannabis product that is intended to be used on damaged or broken skin or to penetrate the skin barrier other than by absorption.

Multiple units

98.1 It is prohibited for a holder of a licence to sell or distribute a cannabis extract, a cannabis topical or edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — if the immediate container contains multiple discrete units, unless the properties of each unit, including size but excluding flavour and colour, as applicable, are consistent.

28 The heading before section 101 of the Regulations and sections 101 and 102 are replaced by the following:

Cannabis Extracts and Cannabis Topicals

Things injurious to health

101 (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 or have on it anything that may cause injury to the health of the user when the cannabis product is used as intended or in a reasonably foreseeable way.

Exception

(2) Subsection (1) does not, in respect of a cannabis extract that is intended to be combusted and inhaled, prohibit anything that may cause injury as a result of the intended combustion and inhalation.

Things that do not cause injury

(3) For the purposes of subsection (1), a cannabis extract or a cannabis topical does not contain or have on it anything that may cause injury to the health of the user by reason only that it contains or has on it

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

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

residues of a pest control product that is registered for use on cannabis under the , 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; or (c) microbial or chemical contaminants — other than residues of a pest control product referred to in paragraph (b) — if the contaminants are within generally accepted tolerance limits for human use that are (i) established in a publication referred to in Schedule B to the Food and Drugs Act , and (ii) appropriate for the intended use and any reasonably foreseeable use of the cannabis product.

microbial or chemical contaminants — other than residues of a pest control product referred to in paragraph (b) — if the contaminants are within generally accepted tolerance limits for human use that are

Microbial and chemical contaminants

101.1 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 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

established in a publication referred to in Schedule B to the ; and (b) appropriate for the intended use and any reasonably foreseeable use of the cannabis product.

Maximum quantity of THC

101.2 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 a quantity of THC that exceeds 1000 mg per immediate container, taking into account the potential to convert THCA into THC.

Cannabis extract — content

101.3 (1) A cannabis extract that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain any ingredients other than

(a) carrier substances;

carrier substances; (b) flavouring agents; and

flavouring agents; and (c) substances that are necessary to maintain the quality or stability of the cannabis product.

Prohibited ingredients

(2) The following substances must not be used as ingredients to produce a cannabis extract referred to in subsection (1):

(a) substances that are listed in column 1 of the table in Schedule 2 to the Tobacco and Vaping Products Act ; or

substances that are listed in column 1 of the table in Schedule 2 to the ; or (b) sugars or sweeteners or sweetening agents , as those terms are defined in subsection B.01.001(1) of the Food and Drug Regulations .

Exception — vitamins

(3) Despite paragraph 2(a), a vitamin may be used as an ingredient to maintain the quality or stability of the cannabis extract referred to in subsection (1) if it is used in an amount that does not exceed what is necessary to maintain the quality or stability of the cannabis product.

Naturally occurring substances

(4) An ingredient that is used to produce the cannabis extract referred to in subsection (1) may contain a substance referred to in subsection (2) only if that substance is naturally present in the ingredient at a level that is not above the naturally occurring level for that ingredient.

Permitted ingredients — inhaled cannabis extract

(5) An ingredient — other than a flavouring agent — must not be used to produce a cannabis extract referred to in subsection (1) that is intended to be consumed by means of inhalation unless

(a) a standard for the ingredient is set out in a publication referred to in Schedule B to the Food and Drugs Act ; and

a standard for the ingredient is set out in a publication referred to in Schedule B to the ; and (b) the ingredient complies with the standard.

Ethyl alcohol — ingested cannabis extract

(6) A cannabis extract referred to in subsection (1) must not contain ethyl alcohol unless

(a) the cannabis extract is intended to be ingested; and

the cannabis extract is intended to be ingested; and (b) the net weight of the cannabis extract in each immediate container of the cannabis product does not exceed 7.5 g.

Uniform distribution — cannabinoids and terpenes

101.4 The cannabinoids and terpenes in 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 be uniformly distributed throughout the cannabis extract or cannabis topical.

Cannabis extract — external body surfaces

101.5 A cannabis extract that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not be represented for use, directly or indirectly, on external body surfaces, including hair and nails.

Edible Cannabis

Ingredients — edible cannabis

102 (1) Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain any ingredients other than food and food additives.

Temporarily marketed foods

(2) A food that is described in a Temporary Marketing Authorization Letter issued under subsection B.01.054(1) of the Food and Drug Regulations must not be used as an ingredient to produce edible cannabis referred to in subsection (1) and must not be a constituent of such an ingredient.

Meat products, poultry products and fish

(3) A meat product, poultry product or fish, other than a food additive, must not be used as an ingredient to produce edible cannabis referred to in subsection (1) — and must not be a constituent of such an ingredient — unless the meat product, poultry product or fish

(a) has been produced by a person that is authorized to produce it under the laws of a province or the Safe Food for Canadians Act or has been imported in accordance with that Act; and

has been produced by a person that is authorized to produce it under the laws of a province or the or has been imported in accordance with that Act; and (b) has a water activity that does not exceed 0.85 at a temperature of 22 ± 2°C at the time the meat product, poultry product or fish is obtained by the holder of the licence for processing that is producing the edible cannabis.

Self-produced food

(4) A holder of a licence for processing that produces a food may use it as an ingredient to produce edible cannabis referred to in subsection (1) — or as a constituent of such an ingredient — if

(a) the food is not a meat product, poultry product or fish; and

the food is not a meat product, poultry product or fish; and (b) the sale of the food would not be prohibited under section 4 of the Food and Drugs Act .

Food additives

(5) A holder of a licence for processing may use a food additive as an ingredient to produce edible cannabis referred to in subsection (1) only if

(a) the edible cannabis would be a food that is the subject of a marketing authorization if the edible cannabis did not contain or have on it anything referred to in item 1 or 3 of Schedule 1 to the Act;

the edible cannabis would be a food that is the subject of a marketing authorization if the edible cannabis did not contain or have on it anything referred to in item 1 or 3 of Schedule 1 to the Act; (b) the marketing authorization permits the food additive to be in or on the food;

the marketing authorization permits the food additive to be in or on the food; (c) the conditions under which the marketing authorization permits the food additive to be in or on the food — including any maximum levels of use — are complied with; and

the conditions under which the marketing authorization permits the food additive to be in or on the food — including any maximum levels of use — are complied with; and (d) the food additive is not caffeine or caffeine citrate.

Vitamins and mineral nutrients

(6) A vitamin or mineral nutrient must not be used as an ingredient to produce edible cannabis referred to in subsection (1) unless its use is permitted under subsection (5).

Definitions

(7) The following definitions apply in this section.

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

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

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

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 )

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

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

water activity 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 )

Prohibited things

102.1 (1) Edible 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 in a quantity that would cause the sale of the edible cannabis to be prohibited under any of paragraphs 4(1)(a) to (d) of the Food and Drugs Act if the edible cannabis were a food to which that Act applies.

Not poisonous, harmful or adulterated

(2) Edible cannabis does not have a poisonous or harmful substance in or on it, within the meaning of paragraph 4(1)(a) of the Food and Drugs Act , and is not adulterated, within the meaning of paragraph 4(1)(d) of that Act, by reason only that it contains or has on it

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

anything referred to in item 1 or 3 of Schedule 1 to the Act; (b) residues of a pest control product that is registered for use on cannabis under the Pest Control Products Act , or 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; or

residues of a pest control product that is registered for use on cannabis under the , or 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; or (c) microbial or chemical contaminants — other than residues of a pest control product referred to in paragraph (b) — if the contaminants are within generally accepted tolerance limits for human use that are (i) established in a publication referred to in Schedule B to the Food and Drugs Act , and (ii) appropriate for a product that is to be ingested.

microbial or chemical contaminants — other than residues of a pest control product referred to in paragraph (b) — if the contaminants are within generally accepted tolerance limits for human use that are

Caffeine

102.2 Edible 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 caffeine unless

(a) the caffeine has been introduced through the use of ingredients that naturally contain caffeine; and

the caffeine has been introduced through the use of ingredients that naturally contain caffeine; and (b) the total amount of caffeine in each immediate container of the cannabis product does not exceed 30 mg.

Ethyl alcohol

102.3 Edible 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 ethyl alcohol unless the concentration of ethyl alcohol does not exceed 0.5% w/w of the edible cannabis.

Cannabis products requiring refrigeration

102.4 It is prohibited for a holder of a licence to sell or distribute edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — if the unopened immediate container must be stored at or below 4°C to prevent the cannabis product from becoming contaminated before its durable life date.

Hermetically sealed containers

102.5 (1) It is prohibited for a holder of a licence to sell or distribute edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — in a hermetically sealed container if any component of the edible cannabis has a pH that exceeds 4.6 and a water activity that exceeds 0.85 at a temperature of 22 ± 2°C.

Definitions

(2) The following definitions apply in subsection (1).

hermetically sealed container means a container that, due to its design, is secure against the entry of micro-organisms, including spores. ( contenant hermétiquement scellé )

water activity means the ratio of the water vapour pressure of the component to the vapour pressure of pure water, at the same temperature and pressure. ( activité de l’eau )

Irradiation

102.6 A holder of a licence for processing must not irradiate edible cannabis unless

(a) the edible cannabis would be a food that is listed in item 3 or 4, column 1, of the table to Division 26 of Part B of the Food and Drug Regulations if the edible cannabis did not contain or have on it anything that is referred to in item 1 or 3 of Schedule 1 to the Act; and

the edible cannabis would be a food that is listed in item 3 or 4, column 1, of the table to Division 26 of Part B of the if the edible cannabis did not contain or have on it anything that is referred to in item 1 or 3 of Schedule 1 to the Act; and (b) the holder satisfies the requirements set out in paragraphs B.26.003(2)(a) and (b) and subsection B.26.004(1) of those Regulations in respect of the edible cannabis.

Maximum quantity of THC

102.7 Subject to subsection 97(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 quantity of THC that exceeds 10 mg per immediate container, taking into account the potential to convert THCA into THC.

29 Sections 103 and 104 of the Regulations are replaced by the following:

Contamination

103 A cannabis accessory that is a cannabis product, or that is packaged with a cannabis product, must not be contaminated.

Flavour

103.1 A cannabis accessory that is a cannabis product, or that is packaged with a cannabis product, must not impart a characterizing flavour to the cannabis.

Dispensing limit

103.2 Subject to subsection 97(1), each activation of the following cannabis accessories must not dispense a quantity of cannabis extract that contains greater than 10 mg of THC, taking into account the potential to convert THCA into THC:

(a) a cannabis accessory that is a cannabis product and that dispenses a cannabis extract that is intended for ingestion or nasal, rectal or vaginal use; or

a cannabis accessory that is a cannabis product and that dispenses a cannabis extract that is intended for ingestion or nasal, rectal or vaginal use; or (b) a cannabis accessory that is packaged with, and that is intended to dispense, a cannabis extract that is a cannabis product and that is intended for ingestion or nasal, rectal or vaginal use.

Psychological effects, abuse liability and toxicity

104 (1) A component of a cannabis product — other than a component that is anything referred to in item 1 or 3 of Schedule 1 to the Act — and a cannabis accessory that is packaged with a cannabis product must not, through any means other than heating or combustion, and when used as intended or in a reasonably foreseeable way,

(a) alter or enhance the psychological effects derived from the cannabis product in a manner that may cause injury to the health of the user;

alter or enhance the psychological effects derived from the cannabis product in a manner that may cause injury to the health of the user; (b) increase the potential for abuse liability of the cannabis product; or

increase the potential for abuse liability of the cannabis product; or (c) increase the toxicity of the cannabis product.

Exceptions

(2) Subsection (1) does not prohibit the presence of

(a) ethyl alcohol in or on a cannabis product referred to in subsection 101.3(6) or section 102.3 if the conditions set out in that subsection or section, as the case may be, are met; and

ethyl alcohol in or on a cannabis product referred to in subsection 101.3(6) or section 102.3 if the conditions set out in that subsection or section, as the case may be, are met; and (b) caffeine in or on a cannabis product referred to in section 102.2 if the conditions set out in that section are met.

PART 6.1

Promotion

Non-application — prescription drug and combination product

104.1 Sections 104.11 to 104.16 do not apply to a prescription drug or a combination product.

Flavours

104.11 It is prohibited to promote a cannabis extract — or a cannabis accessory that contains a cannabis extract — under subsections 17(2) to (6) of the Act in a manner that could cause a person to believe that the cannabis extract or the cannabis accessory has a flavour set out in column 1 of Schedule 3 to the Tobacco and Vaping Products Act , other than the flavour of cannabis.

Health and cosmetic benefits

104.12 (1) It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsections 17(2) to (6) of the Act if there are reasonable grounds to believe that the promotion could create the impression that health or cosmetic benefits may be derived from the service or the use of the cannabis or the cannabis accessory.

Non-application — medical devices

(2) Subsection (1) does not apply with respect to a medical device in respect of which a licence has been issued under subsection 36(1) of the Medical Devices Regulations .

Energy value and amount of nutrient

104.13 (1) It is prohibited to promote edible cannabis — or a cannabis accessory that contains edible cannabis — under subsections 17(2) to (6) of the Act by communicating information about the energy value referred to in item 2 of the table to section 132.22 or the amount of any nutrient referred to in items 3 to 15 of that table or in items 5 to 37 of the table to section B.01.402 of the Food and Drug Regulations .

Exception — nutrition facts table

(2) Despite subsection (1), edible cannabis or a cannabis accessory that contains edible cannabis may be promoted by reproducing the nutrition facts table that is required to be included on the label of any container in which the edible cannabis or the cannabis accessory is packaged in accordance with these Regulations using smaller, larger or identical dimensions and spacing.

Dietary requirements

104.14 It is prohibited to promote edible cannabis — or a cannabis accessory that contains edible cannabis — under subsections 17(2) to (6) of the Act if there are reasonable grounds to believe that the promotion could create the impression that the edible cannabis or accessory is intended

(a) to meet the particular dietary requirements of an individual (i) who has a physical or physiological condition as a result of a disease, disorder or injury, or (ii) for whom a particular effect, including weight loss, is to be obtained by a controlled intake of food; or

to meet the particular dietary requirements of an individual (b) to meet the dietary requirements of young persons.

Alcoholic beverages

104.15 It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsections 17(2) to (6) of the Act if there are reasonable grounds to believe that the promotion could associate the cannabis, the cannabis accessory or the service with an alcoholic beverage.

Tobacco products and vaping products

104.16 It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsections 17(2) to (6) of the Act if there are reasonable grounds to believe that the promotion could associate the cannabis, the cannabis accessory or the service with a tobacco product , as defined in section 2 of the Tobacco and Vaping Products Act , or a vaping product to which that Act applies.

Place where young persons are not permitted

104.17 It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under paragraphs 17(2)(b) and (3)(b) of the Act in such a manner that the promotion may be audible or visible from outside a place where young persons are not permitted by law.

Number of brand elements

104.18 It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsection 17(6) of the Act in a manner that results in the same brand element being displayed more than once on a thing referred to in that subsection or in more than one brand element being displayed on the thing.

Public place frequented mainly by young persons

104.19 It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsection 17(6) of the Act by displaying a brand element of cannabis, of a cannabis accessory or of a service related to cannabis on any thing that is in a school, a public playground, a daycare facility or any other public place frequented mainly by young persons or that is visible from such a place.

Dimensions of brand element

104.2 A brand element referred to in subsection 17(6) of the Act must meet the following requirements:

(a) the surface area must be smaller than or equal to 300 cm 2 ; and

the surface area must be smaller than or equal to 300 cm ; and (b) the height of any letter, character or number must be smaller than or equal to 4 cm.

30 (1) The definition immediate container in section 105 of the Regulations is repealed.

(2) Section 105 of the Regulations is amended by adding the following in alphabetical order:

common name , in respect of edible cannabis, has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations . ( nom usuel )

daily value means

(a) in the case of a nutrient set out in column 1 of Part 1 of the Table of Daily Values , as defined in subsection B.01.001(1) of the Food and Drug Regulations , the quantity set out in column 3; and

in the case of a nutrient set out in column 1 of Part 1 of the , as defined in subsection B.01.001(1) of the , the quantity set out in column 3; and (b) in the case of a nutrient set out in column 1 of Part 2 of the table referred to in paragraph (a), the quantity set out in column 4. ( valeur quotidienne )

energy value means, in respect of a cannabis product, the amount of energy made available to a person’s body when the chemical components of the cannabis product, including protein, fat, carbohydrate and alcohol, are metabolized following ingestion of the cannabis product by the person. ( valeur énergétique )

exterior display surface means the area on the exterior surface of an immediate container to which a label is applied and that is visible under customary conditions of purchase or use. ( espace extérieur d’affichage )

fat has the same meaning as in subsection B.01.400(1) of the Food and Drug Regulations . ( lipides )

food allergen has the same meaning as in subsection B.01.010.1(1) of the Food and Drug Regulations . ( allergène alimentaire )

food allergen source, gluten source and added sulphites statement means a statement appearing on the label of any container in which edible cannabis — or a cannabis accessory that contains edible cannabis — that is a cannabis product is packaged that indicates the source of a food allergen or gluten that is present in the cannabis product or the presence in the cannabis product of added sulphites in an amount of 10 p.p.m. or more. ( mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés )

gluten has the same meaning as in subsection B.01.010.1(1) of the Food and Drug Regulations . ( gluten )

INCI name has the same meaning as in subsection 2(1) of the Cosmetic Regulations . ( appellation INCI )

label does not include a panel referred to in paragraph 132.27(1)(b). ( étiquette )

p.p.m . means parts per million by weight. ( p.p.m .)

saturated fatty acids , saturated fat , saturates or saturated has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations . ( acides gras saturés, graisses saturées, gras saturés, lipides saturés ou saturés )

sugars-based ingredient has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations . ( ingrédient à base de sucres )

sulphites means one or more of the following food additives:

(a) potassium bisulphite;

potassium bisulphite; (b) potassium metabisulphite;

potassium metabisulphite; (c) sodium bisulphite;

sodium bisulphite; (d) sodium dithionite;

sodium dithionite; (e) sodium metabisulphite;

sodium metabisulphite; (f) sodium sulphite;

sodium sulphite; (g) sulphur dioxide; and

sulphur dioxide; and (h) sulphurous acid. ( sulfites )

trans fatty acids , trans fat or trans has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations . ( acides gras trans , graisses trans , gras trans , lipides trans ou trans )

(3) Section 105 of the Regulations is renumbered as subsection 105(1) and is amended by adding the following after subsection (1):

Definition of panel

(2) For the purposes of sections 112 to 117, 121 and 132.13, subsections 132.27(2) to (7) and (9) and sections 132.28 to 132.32, panel means a panel referred to in paragraph 132.27(1)(b).

31 Section 112 of the Regulations is replaced by the following:

Image

112 Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the interior surface, exterior surface and panel of any container in which a cannabis product is packaged must not display any image.

32 (1) Subsection 113(1) of the Regulations is replaced by the following:

Uniform colour

113 (1) Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the colour of the interior surface, exterior surface and panel of any container in which a cannabis product is packaged must be one uniform colour. However, the colour of each surface and the panel may be different.

(2) The portion of subsection 113(2) of the Regulations before paragraph (a) is replaced by the following:

Colour — other requirements

(2) The colour of the interior surface, exterior surface and panel must meet the following requirements:

(3) Subsection 113(3) of the Regulations is replaced by the following:

Exception

(3) Despite subsection (2),

(a) an interior surface that is made of metal may be the colour of the metal; and

an interior surface that is made of metal may be the colour of the metal; and (b) an exterior surface of an immediate container that is made of metal, excluding the label or any image, may be the colour of the metal.

33 Section 114 of the Regulations is repealed.

34 Subsection 115(1) of the Regulations is replaced by the following:

Texture

115 (1) Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the interior surface, exterior surface and panel of any container in which a cannabis product is packaged and any covering of such a container must have a smooth texture without any raised features, embossing, decorative ridges, bulges or other irregularities.

35 Sections 116 and 117 of the Regulations are replaced by the following:

Hidden features

116 (1) The interior surface, exterior surface and panel of any container in which a cannabis product is packaged and any covering of such a container must not include any hidden feature that is designed to change the appearance of the container, covering or panel, such as heat-activated ink or a feature that is visible only through technological means, except a feature that is used to prevent counterfeiting.

Feature designed to change surface area

(2) Subject to section 132.27, the interior surface and exterior surface of any container in which a cannabis product is packaged and any covering of such a container must not include any feature that is designed to change the surface area of the container or covering, such as a fold-out panel.

Scent and sound

117 The interior surface, exterior surface and panel of any container in which a cannabis product is packaged and any covering of such a container must not be capable of emitting a scent or sound.

36 Section 121 of the Regulations is replaced by the following:

Cut-out window

121 The interior surface, exterior surface and panel of any container in which a cannabis product is packaged must not include any cut-out window.

37 The Regulations are amended by adding the following after section 122:

Wrapper

122.1 A wrapper may be used with respect to a cannabis product only if

(a) it is in direct contact with the cannabis or the cannabis accessory and with one or both of the following: (i) the immediate container of the cannabis product, (ii) a wrapper that is in direct contact with the cannabis or the cannabis accessory; and

it is in direct contact with the cannabis or the cannabis accessory and with one or both of the following: (b) it is required to maintain the quality or stability of the cannabis product.

Packaging requirements — other Regulations

122.2 The following immediate container and wrappers must meet the requirements set out in Division 23 of Part B of the Food and Drug Regulations and subparagraphs 186(a)(i), (ii) and (v) to (vii) of the Safe Food for Canadians Regulations as if the cannabis that the immediate container contains or with which the wrappers are in direct contact were a food for the purposes of that Division and those subparagraphs:

(a) the immediate container in which edible cannabis — or a cannabis accessory that contains edible cannabis — that is a cannabis product is packaged;

the immediate container in which edible cannabis — or a cannabis accessory that contains edible cannabis — that is a cannabis product is packaged; (b) any wrapper that is in direct contact with edible cannabis — or a cannabis accessory that contains edible cannabis — that is a cannabis product; and

any wrapper that is in direct contact with edible cannabis — or a cannabis accessory that contains edible cannabis — that is a cannabis product; and (c) any wrapper that is in direct contact with a cannabis extract that is intended for ingestion — or a cannabis accessory that contains cannabis extract intended for ingestion — that is a cannabis product.

Maximum quantity — cannabis extract

122.3 The immediate container of a cannabis extract that is a cannabis product must not contain more than 90 mL of extract that is in non-solid form at a temperature of 22 ± 2°C.

Outermost container

122.4 (1) The outermost container in which a cannabis product is packaged must not contain

(a) food;

food; (b) more than one class of cannabis set out in Schedule 4 to the Act; or

more than one class of cannabis set out in Schedule 4 to the Act; or (c) more than one immediate container.

Exception — multiple immediate containers

(2) Despite paragraph (1)(c), the outermost container may contain more than one immediate container of edible cannabis if the following requirements are met:

(a) the outermost container meets the requirements of section 132.18;

the outermost container meets the requirements of section 132.18; (b) the immediate containers meet the requirements of section 132.18, if they contain edible cannabis that is in discrete units, or section 132.19, if they contain edible cannabis that is not in discrete units;

the immediate containers meet the requirements of section 132.18, if they contain edible cannabis that is in discrete units, or section 132.19, if they contain edible cannabis that is not in discrete units; (c) the total quantity of THC in the immediate containers does not exceed 10 mg of THC, taking into account the potential to convert THCA into THC;

the total quantity of THC in the immediate containers does not exceed 10 mg of THC, taking into account the potential to convert THCA into THC; (d) the total quantity of cannabis in the immediate containers does not exceed the equivalent of 30 g of dried cannabis, as determined in accordance with subsection 2(4) of the Act;

the total quantity of cannabis in the immediate containers does not exceed the equivalent of 30 g of dried cannabis, as determined in accordance with subsection 2(4) of the Act; (e) the statement “Contains the equivalent of (the quantity of dried cannabis, in grams, that is equivalent to the total quantity of cannabis, in grams, as determined in accordance with subsection 2(4) of the Act, in the immediate containers)g of dried cannabis” is displayed on the label of the outermost container; and

the statement “Contains the equivalent of (the quantity of dried cannabis, in grams, that is equivalent to the total quantity of cannabis, in grams, as determined in accordance with subsection 2(4) of the Act, in the immediate containers)g of dried cannabis” is displayed on the label of the outermost container; and (f) the properties of the edible cannabis in all the immediate containers are consistent.

Interpretation — “unit”

(3) For the purposes of paragraph (2)(a), the word “unit” referred to in subsection 132.18(1) is to be read as “immediate container”.

Control measures for dispensing cannabis extract

122.5 (1) The immediate container of a cannabis extract that is a cannabis product and that is not in discrete units must

(a) not permit the extract to be easily poured or drunk directly from the container; and

not permit the extract to be easily poured or drunk directly from the container; and (b) contain an integrated dispensing mechanism that dispenses no more than 10 mg of THC per activation, taking into account the potential to convert THCA into THC, if the cannabis extract (i) is in liquid form at a temperature of 22 ± 2°C, (ii) is not intended to be consumed only by means of inhalation, and (iii) contains at least 10 mg of THC, taking into account the potential to convert THCA into THC.

contain an integrated dispensing mechanism that dispenses no more than 10 mg of THC per activation, taking into account the potential to convert THCA into THC, if the cannabis extract

Non-application — integrated dispensing mechanism

(2) Paragraph (1)(b) does not apply to an immediate container in which a cannabis accessory referred to in paragraph 103.2(a) is packaged.

38 (1) The portion of subparagraph 123(1)(c)(v) of the Regulations before clause (A) is replaced by the following:

(v) except in the case of a cannabis plant, cannabis plant seeds or edible cannabis, either

(2) Paragraphs 123(1)(e) and (f) of the Regulations are replaced by the following:

(e) one of the health warning messages set out in the document entitled Cannabis Health Warning Messages , as amended from time to time and published by the Government of Canada on its website, that applies to the cannabis product;

one of the health warning messages set out in the document entitled , as amended from time to time and published by the Government of Canada on its website, that applies to the cannabis product; (f) in the case of a cannabis product that contains THC in a concentration greater than 10 μg/g, taking into account the potential to convert THCA into THC, the standardized cannabis symbol that must be obtained from the Minister in the form of an electronic file; and

in the case of a cannabis product that contains THC in a concentration greater than 10 μg/g, taking into account the potential to convert THCA into THC, the standardized cannabis symbol that must be obtained from the Minister in the form of an electronic file; and (g) except in the case of dried cannabis or a cannabis plant, the statement “Contains the equivalent of (the quantity of dried cannabis, in grams, that is equivalent to the quantity of cannabis, in grams or seeds, as the case may be, as determined in accordance with subsection 2(4) of the Act, in the container)g of dried cannabis”.

(3) Subsection 123(2) of the Regulations is replaced by the following:

Expiry date

(2) The label of a container in which cannabis other than edible cannabis is packaged must not include an expiry date unless the holder of the licence for processing that manufactured the cannabis product has data that establishes the stability period during which, after the cannabis is packaged in accordance with these Regulations and stored under its recommended storage conditions,

(a) in the case of dried cannabis or fresh cannabis, (i) it maintains not less than 80% and not more than 120% of its THC content and CBD content, and (ii) the microbial and chemical contaminants it contains or has on it remain within the limits referred to subsection 93(3); and

