Guide on composition requirements for cannabis products
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- Purpose
- Scope
- General restrictions on cannabis products
- Product requirements by class of cannabis
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Disclaimer: This document does not constitute part of the Cannabis Act or its associated regulations. It should be read in conjunction with the relevant sections of the Act and its regulations. The information in this document is not intended to substitute for, supersede or limit the requirements under the legislation. In the event of discrepancy between the legislation and this document, the legislation shall prevail.
The reader is advised to consult other legislation that may apply to them or their activities, such as provincial or territorial legislation.
This document may be updated periodically so the reader is encouraged to check back regularly.
Purpose
This guide provides guidance and information on the definitions of, and requirements for, cannabis and cannabis products under the Cannabis Act (the Act or CA) and the Cannabis Regulations (the Regulations or CR).
This guide will expand on Part 6 of the Regulations which sets out general requirements pertaining to the formulation, production and composition of cannabis products as well as those specific to all classes of cannabis that are set out in Schedule 4 to the Act.
Scope
The information in this guide is based on the Regulations and applies to cannabis products sold and distributed in Canada.
This guide outlines the key regulatory requirements relating to the formulation, production and composition of cannabis products as set out in Part 6 of the Regulations.
This guide does not cover broader requirements under the Act and Regulations such as those related to licensing, physical security, packaging and labelling, and good production practices, among others.
On its website, Health Canada publishes other guidance documents and information that licence holders may use in conjunction with this guide to support their compliance with the Act and its regulations. For consistency and transparency, this guide and other guidance documents and information are updated as required to reflect changes to policies and/or operations.
General restrictions on cannabis products
Definitions: Cannabis, classes of cannabis, cannabis product
Cannabis
Cannabis means a cannabis plant and anything referred to in Schedule 1 to the Act but does not include anything referred to in Schedule 2 to the Act [subs. 2(1), CA].
Cannabis includes | Cannabis does not include |
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Classes of cannabis
Schedule 4 to the Act refers to the classes of cannabis that an authorized person may sell:
- dried cannabis
- fresh cannabis
- cannabis plants
- cannabis plant seeds
- edible cannabis
- cannabis extracts
- cannabis topicals
The definition of each class of cannabis can be found in the Act or the Regulations.
Cannabis product
A 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:
- cannabis or a cannabis accessory that contains cannabis that is intended for an animal
- a drug containing cannabis [subs. 1(2), CR]
Note: For more information on drugs containing cannabis, refer to the Food and Drugs Act and its regulations as well as the Health products containing cannabis or for use with cannabis: Guidance for the Cannabis Act, the Food and Drugs Act, and related regulations.
Cannabis that has been packaged and labelled for sale to a consumer must consist of only one class of cannabis. For example, a cannabis product cannot be edible cannabis and a cannabis extract at the same time. The requirements set out in the Regulations differ depending on the class of cannabis.
Licence holders are expected to determine the most appropriate class based on the product's intended use and formulation. For example, a cannabis product containing cannabis oil could be edible cannabis, a cannabis extract or cannabis topical depending on factors including its formulation, format, intended use or mode of consumption and how the product is represented. The licence holder needs to determine what cannabis class they intend their product to be and to follow the applicable requirements for that class.
General restrictions (applies to all classes of cannabis)
The Act and Regulations set out the rules and restrictions pertaining to the sale, formulation, production and composition of cannabis products. These requirements aim to reduce the:
- appeal of such products to young persons
- risk of accidental consumption
- risk of overconsumption
- risk of foodborne illness
They are also aimed to minimize the potential for toxicity, addiction, noxious and unintended responses (such as, adverse reactions) to cannabis products.
The following restrictions apply to all cannabis products:
Appealing to young persons
Unless authorized under the Act, it is prohibited to sell cannabis or a cannabis accessory that has an appearance, shape or other sensory attribute or a function that there are reasonable grounds to believe could be appealing to young persons [s. 31, CA]. The Policy statement on Cannabis Act prohibitions referring to appeal to young persons provides more information.
Prohibited sales
Unless authorized under the Act, it is prohibited for a person that is authorized to sell cannabis to sell cannabis of any class that is not referred to in Schedule 4 to the Act [s. 33, CA].
Prohibited substances
Unless authorized under the Act, it is prohibited to sell any mixture of substances that contains cannabis and any substance that is referred to in column 1 of Schedule 5 to the Act. These are:
- nicotine
- caffeine (with some exceptions provided by the Regulations, refer to the Caffeine subsection)
- ethyl alcohol (with some exceptions provided by the Regulations, refer to the Ethyl alcohol subsections and the Product requirements by class of cannabis section) [s. 34, CA]
The Regulations prohibits foods described in a Temporary Marketing Authorization Letter from being used as an ingredient or a constituent of an ingredient to produce edible cannabis [para. 102(2)(a), CR].
In addition, it is prohibited for supplemented foods (and the foods that would otherwise be exempted due to the transitional provisions of the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods)) to be used as an ingredient or as a constituent of an ingredient to produce edible cannabis [para. 102(2)(b), CR].
Prohibited uses
It is prohibited to sell or distribute any cannabis product that is intended to:
- be used in the area of the human eye (for example, including the eyebrow area, eyelid, eyelash, eyeball)
- be used on damaged or broken skin
- penetrate the skin barrier by means other than by absorption (for example, through abrasives or needles) [s. 98, CR]
See subsection Prohibited uses for restrictions specific to cannabis extracts.
Psychological effects, abuse liability and toxicity
A component of a cannabis product (excluding anything referred to in item 1 or 3 of Schedule 1 to the Act – refer to subsection Cannabis) or a cannabis accessory that is packaged with a cannabis product, when used as intended or in a reasonably foreseeable way (other than heating or combustion), must not:
- alter or enhance the psychological effects derived from the cannabis product in a manner that may cause injury to the health of the user
- increase the potential for abuse of the cannabis product
- increase the toxicity of the cannabis product [subs. 104(1), CR]
Ethyl alcohol and caffeine are excluded when a cannabis product meets the conditions set out in the Regulations [s. 104, CR].
THC quantity limits
To reduce the risks associated with overconsumption (including from accidental consumption), the Regulations define limits on the amount of THC that can be present in cannabis products. See section Product requirements by class of cannabis for a description of specific limits by class of cannabis, which are set for individual servings (or "discrete units") intended for ingestion or nasal, rectal or vaginal use and for single immediate containers (as defined in subsection 1(2) of the Regulations).
Important: The Act and Regulations do not set limits on the amount of other cannabinoids, including CBD. However, there are labelling requirements for displaying CBD content to help consumers make informed choices.
Product requirements by class of cannabis
This section of the guide outlines the requirements that apply to the classes of cannabis. Unless stipulated otherwise, the requirements apply to the cannabis that is a cannabis product or that is, or will be, contained in a cannabis accessory that will become a cannabis product.
Cannabis plants or cannabis plant seeds
A cannabis plant or cannabis plant seed 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 section 10 of that act [s. 92.2, CR].
Dried or fresh cannabis
Dried cannabis or fresh cannabis must not contain or have on it anything other than anything referred to in item 1 of Schedule 1 to the Act [subs. 93(1), CR].
Dried or fresh cannabis 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 section 10 of that act [subs. 93(2), CR].
In addition, dried or fresh cannabis must not contain or have on it microbial or chemical contaminants unless these contaminants are within generally accepted tolerance limits for human use that are established in Schedule B to the Food and Drugs Act and are appropriate for the intended use and any reasonably foreseeable use of the cannabis product [subs. 93(3), CR].
Composition
- Dried or fresh cannabis must not contain or have on it anything other than a part of a cannabis plant (anything referred to in item 1 of Schedule 1 to the Act)
- THC or THCA must not be added to dried or fresh cannabis [s. 99, CR]
Maximum quantities
For dried or fresh cannabis products in discrete units that is intended for ingestion or nasal, rectal or vaginal use, the quantity of THC per discrete unit must not exceed 10 mg, taking into the account of potential to convert delta-9-tetrahydrocannabinolic acid (THCA) into THC (as defined in subsection 1(2) of the Regulations) [subs. 96(1), CR].
Cannabis extracts
Ethyl alcohol
The use of ethyl alcohol as an ingredient in inhaled or ingested cannabis extracts is permitted under the following conditions:
Inhaled cannabis extracts [subs. 101.3(5.1), CR]
- Maximum net weight: the net weight of the cannabis extract in each immediate container (as defined in subsection 1(2) of the Regulations) must not exceed 7.5 g
- For discrete units: Each unit must not contain more than 10 mg of ethyl alcohol
- For non-discrete units: Each unit must not contain more than 10 mg of ethyl alcohol unless:
- it includes an integrated dispensing mechanism that dispenses no more than 10 mg of ethyl alcohol per activation
- it is packaged in an immediate container that prevents the extract from being easily removed
Ingested cannabis extracts [subs. 101.3(6), CR]
Ethyl alcohol is permitted if the net weight of the cannabis extract in each immediate container does not exceed 7.5 g, or if it does, the concentration of ethyl alcohol does not exceed a maximum concentration of 0.5% weight-by-weight (w/w).
Ingredients
Cannabis extracts must only contain ingredients (as defined in subsection 1(2) of the Regulations) that are:
- carrier substances
- flavouring agents
- substances that are necessary to maintain the quality or stability of the cannabis product (for example, binders, disintegrants, preservatives) [subs. 101.3(1), CR]
It is important to consider that substances that are known medicinal ingredients such as those found in natural health products, when used in cannabis products could result in the product being represented or implied as having a health benefit. These representations are prohibited for cannabis products.
For a cannabis extract that is intended to be inhaled, it may only contain ingredients (as defined in subsection 1(2) of the Regulations), other than flavouring agents, for which there is a standard in a publication referred to in Schedule B of the Food and Drugs Act, and the ingredients have to comply with the standard (for example, the United States Pharmacopoeia) [subs. 101.3(5), CR].
Maximum quantities
For all cannabis extracts, the THC quantity must not exceed 1,000 mg per immediate container (as defined in subsection 1(2) of the Regulations), taking into account the potential to convert THCA into THC (as defined in subsection 1(2) of the Regulations) [s. 101.2, CR].
For cannabis extract products that are in discrete units, and intended for ingestion or nasal, rectal or vaginal use, the quantity of THC per discrete unit must not exceed 10 mg, taking into the account of potential to convert THCA into THC [subs. 96(1), CR].
The immediate container (as defined in subsection 1(2) of the Regulations) for cannabis extracts that contain at least 10mg THC, that are not in discrete units, not intended for inhalation and in liquid form at room temperature are required, among other things, to have an integrated dispensing mechanism (for example, pump or metered spray for a bottle) that does not dispense more than 10 mg of THC per activation, taking into account the potential to convert THCA into THC [subs. 122.5(1), CR].
For cannabis extracts that are in non-solid form at room temperature, the immediate container must not contain more than 90 mL of the extract [s. 122.3, CR].
A cannabis accessory that dispenses a cannabis extract or that is packaged with and intended to dispense a cannabis extract intended for ingestion, nasal, rectal or vaginal use must not dispense more than 10 mg THC per activation, taking into account the potential to convert THCA into THC [s. 103.2, CR].
Multiple units
It is prohibited to sell or distribute a cannabis extract, if the immediate container (as defined in subsection 1(2) of the Regulations) contains multiple discrete units, unless the properties of each unit, including size but excluding flavour and colour, as applicable, are consistent [s. 98.1, CR]. For more information refer to the Packaging and labelling guide for cannabis products.
Prohibited ingredients
The following substances are prohibited to be used as ingredients:
- substances listed in column 1 of the table in Schedule 2 to the Tobacco and Vaping Products Act (specifically, amino acids, caffeine, colouring agents, essential fatty acids, glucuronolactone, probiotics, taurine, vitamins, or mineral nutrients) [subs. 101.3(2), CR)]. A vitamin may be used as an ingredient to maintain the quality or stability, if it is used in an amount that does not exceed what is necessary to do so [subs. 101.3 (3), CR]
- sugars, sweeteners or sweetening agents as defined in subsection B.01.001(1) of the Food and Drug Regulations (FDR). Specifically, sugars, means all monosaccharides and disaccharides; sweetener means any food additive used to impart a sweet taste to a food; and sweetening agent includes any food for which a standard is set out in Volume 15 of the Food Compositional Standards Document, but does not include a sweetener [subs. 101.3(2), CR]
Important: In assessing which sweeteners are prohibited in cannabis extracts, Health Canada considers the List of permitted sweeteners, as well as any other relevant information.
Any of these prohibited substances may be present in an ingredient that is used to produce the cannabis extract so long as it occurs naturally in that ingredient and is not present above the naturally occurring level for that ingredient [subs. 101.3(4), CR]. Note that nicotine and caffeine are not permitted in cannabis extracts.
Prohibited uses
Cannabis extracts must not be represented for use, directly or indirectly, on external body surfaces, including hair and nails [s. 101.5, CR].
Things injurious to health
A cannabis extract 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 [subs. 101(1), CR].
This excludes the cannabis (items 1 or 3 of Schedule 1 to the Act), residues of a pest control product as described at paragraph 101(3)(b), or microbial or chemical contaminants that meet the exception described in paragraph 101(3)(c) of the Regulations.
For example, if a chemical contaminant such as lead is found within a cannabis extract, it must be within the generally accepted tolerance limit for human use established in a publication referred to in Schedule B of the Food and Drugs Act and must be appropriate for the intended use and any reasonably foreseeable use of the cannabis product [s. 101.1, CR].
Uniform distribution
The cannabinoids and terpenes must be uniformly distributed throughout the cannabis extract [s. 101.4, CR].
Cannabis topicals
Ethyl alcohol
The use of denatured ethyl alcohol as an ingredient in cannabis topicals is permitted as an exception to Schedule 4 to the Act with no concentration limit or maximum net weight [s.101.31, CR].
Maximum quantities
For all cannabis topicals, the THC quantity must not exceed 1,000 mg per immediate container (as defined in subsection 1(2) of the Regulations), taking into account the potential to convert THCA into THC (as defined in subsection 1(2) of the Regulations) [s. 101.2, CR].
Multiple units
It is prohibited to sell or distribute a cannabis topical, if the immediate container (as defined in subsection 1(2) of the Regulations) contains multiple discrete units, unless the properties of each unit, including size but excluding flavour and colour, as applicable, are consistent [s. 98.1, CR]. For more information refer to the Packaging and labelling guide for cannabis products.
Things injurious to health
A cannabis topical 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. [subs. 101(1), CR].
This excludes the cannabis (anything referred to in items 1 or 3 of Schedule 1 to the Act), residues of a pest control product or microbial or chemical contaminants so long as they meet the requirements as noted in subsection 101(3) of the Regulations.
Important: For example, with regards to cannabis topicals, the Cosmetic Ingredient Hotlist is used to communicate that certain substances may not be compliant with requirements of the Food and Drugs Act or the Cosmetic Regulations. Some of these ingredients (as defined in subsection 1(2) of the Regulations) listed may also be considered injurious to the health of the user of cannabis topicals under the Regulations, depending on the quantity or concentration of the ingredient as well as the nature and intended or reasonably foreseeable use of the particular product. This list is not exhaustive and is updated from time to time.
Health Canada strongly encourages licensed processors to make use of the Hotlist when looking to determine whether a particular ingredient could pose a risk of injury to the health of the consumer when used in a cannabis topical product.
Uniform distribution
The cannabinoids and terpenes must be uniformly distributed throughout the cannabis topical [s. 101.4, CR].
Edible cannabis
Caffeine
Edible cannabis must not contain or have caffeine on it unless it has been introduced through the use of ingredients that naturally contain caffeine (for example, chocolate, tea) and the total amount of caffeine in each immediate container (as defined in subsection 1(2) of the Regulations) does not exceed 30 mg [s. 5.1 and 102.2, CR].
Note that caffeine cannot be used as a food additive (as defined in subsection 1(2) of the Regulations) [para. 101(5)(b), CR].
Ethyl alcohol
Edible cannabis must not contain or have on it ethyl alcohol unless the concentration of it does not exceed 0.5% weight-by-weight (w/w) of the edible cannabis [s. 102.3, CR].
Food additives
You can use food additives (as defined in subsection 1(2) of the Regulations) in edible cannabis if all of these conditions are met [subs. 102(5), CR].
- The edible cannabis would be a food listed in column 3: The edible cannabis, if it didn't contain cannabis or have cannabis on it, would be a food listed in column 3 of the relevant Lists of permitted food additives
- The food additive is on a list: The food additive is set out in column 1 of the relevant Lists of permitted food additives
- Caffeine or caffeine citrate cannot be used as food additives in edible cannabis
- Source of the food additive: The food additive is obtained from any corresponding source listed in column 2 of the relevant Lists of permitted food additives
- Purpose of use: The food additive is used for any corresponding purpose of use described in column 4 of the relevant Lists of permitted food additives
- Amount of the food additive: The amount of the food additive does not go over any corresponding maximum levels set out in column 5 of the relevant Lists of permitted food additives
- If "Good Manufacturing Practice" appears in column 5, the amount of the food additive in the food does not exceed the amount that is required to achieve the purpose for which it is added
- Other conditions: Any other corresponding condition in column 5 is met
Note: For more information on food and food additives, see the Food and Drugs Act and its regulations, and Food and nutrition.
Foods with temporary marketing authorization
Any foods that have received a Temporary Marketing Authorization Letter issued under the section B.01.054(1) of the Food and Drug Regulations must not be used as an ingredient or constituent of an ingredient to produce edible cannabis [subs. 102(2), CR].
Foods described in a Temporary Marketing Authorization Letter that would otherwise be exempted due to the transitional provisions in the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) ending on December 31, 2025 must not be used as an ingredient or as a constituent of such an ingredient to produce edible cannabis
Licence holders should review the Lists of foods that have received Temporary Marketing Authorization Letters on a regular basis as these lists are updated as letters are issued.
Hermetically sealed containers
Edible cannabis may not be sold or distributed 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 [subs. 102.5(1) CR].
Ingredients
Edible cannabis must not contain any ingredients other than food and food additives (as defined in subsection 1(2) of the Regulations) [subs. 102(1), CR].
Food has the same meaning as in section 2 of the Food and Drugs Act which is any article manufactured, sold or represented as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatsoever.
A pre-mix of food additive and non-additive ingredients referred to in section B.16.004 of the Food and Drug Regulations is permitted for use in edible cannabis if it meets all requirements of the Food and Drugs Act, Food and Drug Regulations and Cannabis Regulations.
Irradiation
Edible cannabis must not be irradiated unless 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 (such as, wheat, flour, whole wheat flour, whole or ground spices and dehydrated seasoning preparations) 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 relevant Food and Drug Regulations requirements must also be met (paragraphs B.26.003(2)(a) and (b) and subsection B.26.004(1) of the Food and Drug Regulations) [s. 102.6, CR].
For more information about food irradiation, refer to Food irradiation.
Maximum quantities
Subject to the variability limits, the THC quantity for edible cannabis must not exceed 10 mg per immediate container (as defined in subsection 1(2) of the Regulations) taking into account the potential to convert THCA into THC (as defined in subsection 1(2) of the Regulations) [subs. 97(2) and s. 102.7, CR].
This means, for example, that an immediate container could contain edible cannabis with two discrete units that each contains 5 mg of total THC or other combinations so long as the overall THC content does not exceed 10 mg of total THC. Each unit must contain the same amount of total THC as every other unit.
Meat products, poultry products and fish
A meat product, poultry product or fish must not be used in edible cannabis unless:
- it is a food additive (as defined in subsection 1(2) of the Regulations) (for example, gelatin, when meeting the additive requirements)
- it has a water activity of 0.85 or less at a temperature of 22 ± 2°C at the time it is obtained by a licence holder for processing and it has been produced by a person who is authorized to produce it under provincial legislation or the Safe Food for Canadians Act or is imported in accordance with that Act (for example, jerky) [subs. 102(3), CR]
Multiple units
It is prohibited to sell or distribute edible cannabis, if the immediate container (as defined in subsection 1(2) of the Regulations) contains multiple discrete units, unless the properties of each unit, including size but excluding flavour and colour, as applicable, are consistent [s. 98.1, CR]. For more information, refer to the Packaging and labelling guide for cannabis products: Co-packing cannabis.
Prohibited things
Edible cannabis 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 the Act applies [subs. 102.1 (1), CR].
It must not:
- have in or on it any poisonous or harmful substance
- be unfit for human consumption
- consist in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance
- be adulterated [s. 102.1, CR]
This excludes the cannabis (anything referred to in item 1 or 3 of Schedule 1 to the Act), residues of a pest control product, or microbial or chemical contaminants, or a food additive (as defined in subsection 1(2) of the Regulations) so long as they meet the requirements as noted in subsection 102.1(2) of the Regulations.
Self-produced food
Licence holders may produce their own food to be used as an ingredient in edible cannabis if the food is not a meat product, poultry product or fish and the sale of the food would not be prohibited under section 4 of the Food and Drugs Act [subs. 102(4), CR].
Shelf-stable
Edible cannabis may not be sold or distributed if the unopened (as defined in subsection 1(2) of the Regulations) immediate container requires refrigeration at or below 4°C to prevent the cannabis product from becoming contaminated before its durable life date [s. 102.4, CR].
Supplemented foods
Supplemented foods are prepackaged foods containing one or more added supplemental ingredients, such as vitamins, minerals, amino acids, caffeine, and herbal ingredients, which have been historically marketed as providing specific physiological or health effects. This includes products such as beverages with added vitamins and minerals marketed for hydration, caffeinated energy drinks marketed for temporarily restoring mental alertness, and snack bars with added vitamins marketed for the maintenance of good health.
Supplemented foods cannot be used as an ingredient or constituent of an ingredient to produce edible cannabis, [para.102(2)(b), CR]
Under the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods), Temporary Marketing Authorization Letters for existing supplemented foods will expire. Many of these foods will become supplemented foods as long as they are in compliance with the new regulations. Other supplemented foods will have until the end of the transition period (December 31, 2025) to come into compliance.
Foods described in a Temporary Marketing Authorization Letter will continue to be prohibited in edible cannabis [para. 102(2)(a), CR]
Vitamins and mineral nutrients
Vitamins and mineral nutrients may not be used as ingredients in edible cannabis unless they are permitted to be used as food additives (as defined in subsection 1(2) of the Regulations) and are used according to the relevant rules and limitations for those food additives [subs. 102(6), CR].
It should be noted that vitamins or mineral nutrients are permitted in edible cannabis under the following circumstances:
- there are naturally occurring vitamins or minerals in the food used as ingredients in edible cannabis
- a food used as an ingredient in edible cannabis is required or permitted to be fortified with mineral nutrients and vitamins under the Food and Drugs Act and its regulations (for example, thiamine must be added to flour)
Cannabis accessory
A cannabis accessory means either:
- a thing, including rolling papers or wraps, holders, pipes, water pipes, bongs and vaporizers, that is represented to be used in the consumption of cannabis
- a thing that deemed under subsection 2(3) of the Act to be represented to be used in the consumption of cannabis [subs. 2(1), CA]
Other examples of cannabis accessories include a wide variety of things, such as vaping cartridges, droppers, and mechanical pumps.
A cannabis accessory that contains cannabis (within one of the classes set out in Schedule 4 to the Act) that is packaged and labelled for sale to a consumer at the retail level is a cannabis product for the purposes of the Regulations. For greater clarity: the cannabis accessory and the cannabis together are considered the cannabis product and the cannabis accessory is not considered an immediate container (as defined in subsection 1(2) of the Regulations).
Besides meeting the general requirements of the Act and Regulations, a cannabis accessory that is a cannabis product (such as, that contains cannabis) or that is packaged with a cannabis product must:
- not be contaminated [s. 103, CR]
- not impart a characterizing flavour to the cannabis [s. 103.1, CR]
- not dispense a quantity of cannabis extract that contains more than 10 mg of THC per activation, subject to variability limits and taking into account the potential to convert THCA into THC (as defined in subsection 1(2) of the Regulations) if (a) the cannabis accessory is a cannabis product intended for ingestion or nasal, rectal or vaginal use; or (b) if the cannabis accessory is packaged with, and is intended to dispense, a cannabis extract product intended for such use [subs. 97(1) and s. 103.2, CR]
Cannabis accessories may be subject to other Acts and regulations that aim to protect the public, such as the Canada Consumer Product Safety Act and its regulations.
Novel products
As with any other cannabis product, licence holders must ensure that any novel cannabis products (for example, a cannabis product in a format that has never been sold before) meet all requirements. Cannabis extracts or cannabis topical products must not contain anything that may be injurious to health, and edible cannabis must not be adulterated or contain any poisonous or harmful substances and must otherwise meet all applicable requirements [subs. 101(1) and subs. 102.1(2), CR].
Information about new cannabis products, including novel products, should be provided to Health Canada in a notice of a new cannabis product, as outlined in subsection Notice of a new cannabis product.
There are a number of other acts and regulations that apply to novel products that licence holders should be aware of, including those mentioned below.
Cannabis plants and cannabis plant seeds
Plants with novel traits are regulated under the Seeds Act and Seeds Regulations as well as the Plant Protection Act and Plant Protection Regulations. Plants with novel traits include plants into which one or more traits have been intentionally introduced, regardless of method, where:
- the trait is new to cultivated populations of the species in Canada
- the plant has a potential to have a significant negative environmental effect
These traits can be introduced using biotechnology, mutagenesis or conventional breeding techniques.
Note: For more information on cannabis with novel traits, including environmental release and import requirements, refer to the Cannabis with novel traits fact sheet.
Novel food ingredients in edible cannabis
Edible cannabis must not contain any ingredients other than food and food additives (as defined in subsection 1(2) of the Regulations) [subs. 102(1), CR]. In addition, edible cannabis products 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 (refer to the Prohibited things subsection).
The Food and Drug Regulations defines a novel food under Division 28 of Part B. In summary, novel foods are those that:
- result from a process not previously used in food
- do not have a history of safe use as a food
- have been modified by genetic manipulation (also known as genetically modified foods, genetically-modified foods, genetically engineered foods or biotechnology derived foods)
All novel foods must be assessed by Health Canada before they can be sold in Canada.
In that regard, any novel food ingredients should be approved by Health Canada before being used in an edible cannabis product. Failure to secure approval of novel food ingredients could 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 (for example, to be harmful or unfit for human consumption depending on their nature) [subs. 102.1(1), CR].
Refer to Genetically modified foods and other novel foods for more information on novel foods.
Nanotechnology and nanomaterials
To support their regulation, Health Canada has adopted the Policy statement on Health Canada's working definition for nanomaterial. Additionally, more information can be found on Nanotechnology-based health product and food. All nanotechnologies and nanomaterials must comply with all of the relevant provisions in the Act and Regulations.
Notice of a new cannabis product
Holders of a processing licence must notify Health Canada of their intent to sell a cannabis product which have not been previously sold in Canada, other than a product belonging to the cannabis plants, cannabis plant seeds, dried cannabis, or fresh cannabis classes [s. 244, CR].
New product notifications must be provided to Health Canada in a written notice that contains the information set out in section 244, at least 60 calendar days before the cannabis product is made available for sale. This notification to Health Canada does not constitute approval for sale.
Refer to the Notice of new cannabis product guide for more information on notices of new cannabis products.
Contact us
To receive copies of any guidance documents mentioned above, email cannabis@hc-sc.gc.ca. If you have questions about cannabis products or the Cannabis Act and its regulations, email cannabis@hc-sc.gc.ca.
For a more complete list of Government of Canada contact information, refer to Cannabis and industrial hemp contact information for licence holders, applicants and industry.
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