Guide on composition requirements for cannabis products

Requirements under the Cannabis Act and the Cannabis Regulations

On this page

• Purpose and scope
• General restrictions on cannabis products
• Product requirements by class of cannabis
• Contact us

Purpose and scope

The information on this page is based on the Cannabis Regulations (the Regulations or CR) and applies to cannabis products sold and distributed in Canada. It is intended for licence holders authorized to conduct activities under the Cannabis Act and its Regulations.

It expands on Part 6 of the Regulations and sets out general requirements for cannabis products and classes of cannabis in Schedule 4 to the Cannabis Act (the Act or CA) pertaining to their:

• production
• formulation
• composition

General restrictions on cannabis products

Cannabis product

A cannabis product means cannabis of only 1 class 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. It does not include:

• cannabis that is intended for an animal
• a cannabis accessory that contains cannabis that is intended for an animal
• a drug containing cannabis

These requirements aim to reduce the:

• risk of foodborne illness
• risk of overconsumption
• risk of accidental consumption
• appeal of such products to young persons

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 if there are reasonable grounds to believe it could be appealing to a young person. This includes its appearance, shape, other sensory attributes or a function. The Policy statement on Cannabis Act prohibitions referring to appeal to young persons provides more information.

Prohibited substances

Unless authorized under the Act, it is prohibited to sell any mixture of substances that contains both:

• cannabis
• any substance that is referred to in column 1 of Schedule 5 to the Act:
  • nicotine
  • caffeine (with some exceptions; refer to the Caffeine subsection in the Edible cannabis subsection)
  • ethyl alcohol (with some exceptions; refer to the Ethyl alcohol subsections)

Prohibited uses

It is prohibited to sell or distribute any cannabis product that is intended to:

• be used on damaged or broken skin
• be used in the area of the human eye (for example, the eyebrow area, eyelid, eyelash, eyeball)
• penetrate the skin barrier by means other than by absorption (for example, through abrasives or needles)

See the Prohibited uses subsection for additional restrictions specific to cannabis extracts.

[s. 98, CR]

Psychological effects, abuse liability and toxicity

When used as intended or in a reasonably foreseeable way (other than heating or combustion), a component of a cannabis product and a cannabis accessory that is packaged with a cannabis product, must not:

• increase the toxicity of the cannabis product
• increase the potential for abuse of the cannabis product
• change, alter or enhance the psychological effects derived from the cannabis product in a way that may cause injury to the health of the user

Ethyl alcohol (ethanol) may be present in certain cannabis products (such as specific extracts or topicals) provided those products comply with the detailed requirements set out in the referenced sections of the Regulations. In practice, this means alcohol can be used for formulation or processing purposes, but only in product types where it is explicitly permitted and where all applicable conditions are met.

Caffeine is not generally allowed in cannabis products. For example, adding purified caffeine or caffeine citrate to edible cannabis is prohibited. It is only permitted in edible cannabis products when it comes from an ingredient that naturally contains caffeine and the total amount of caffeine in each immediate container is not more than 30 mg.

[s. 104, CR]

THC quantity limits

To lower the risks associated with overconsumption (including accidental), the Regulations have limits on the quantity of THC in cannabis products. Some variability in THC and CBD content is permitted for cannabis extracts, cannabis topicals and cannabis edibles. For cannabis products in discrete units (see Packaging and labelling guide for cannabis products) intended for ingestion or nasal, rectal or vaginal use, the quantity of THC per discrete unit must not exceed 10 mg, taking into account the potential to convert THCA into THC. See the Product requirements by class of cannabis section for a description of specific limits by class of cannabis.

For guidance on cannabis products deliberately made with intoxicating cannabinoids other than delta-9-THC, see Guidance on cannabis products with intoxicating cannabinoids other than delta-9-THC.

Cannabis accessory

A cannabis accessory can be considered a cannabis product or not. The following are examples of cannabis accessories that are not cannabis products:

• a thing that is represented to be used with cannabis
• a thing that is commonly used with cannabis that is sold at the same point of sale as cannabis

Examples include:

• bongs
• holders
• droppers
• vaporizers
• vape cartridges
• mechanical pumps
• pipes or water pipes
• rolling papers or wraps

A cannabis accessory is considered a cannabis product if it contains cannabis from one of the classes listed in Schedule 4 to the Act and is packaged and labelled for sale to a consumer at the retail level.

Examples include:

• a vape cartridge filled with cannabis extract
• a dropper included with a bottle of cannabis-infused olive oil

To be clear, the cannabis accessory and the cannabis together are considered the cannabis product. The cannabis accessory is not considered an immediate container. Besides meeting the general requirements of the Act and Regulations, a cannabis accessory that contains cannabis or that is packaged with a cannabis product must not:

• be contaminated
• impart a characterizing flavour to the cannabis
• dispense a quantity of cannabis extract that contains more than a total amount of 10 mg THC per activation, depending on variability limits if either:
  • the cannabis accessory is a cannabis product intended for ingestion or nasal, rectal or vaginal use
  • the cannabis accessory is packaged with, and is intended to dispense, a cannabis extract product intended for such use

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.

[subs. 2(1), CA]
[s. 103, CR]
[s. 103.1, CR]
[s. 103.2, CR]

Product requirements by class of cannabis

The requirements set out in the Regulations differ depending on the class of cannabis.

You are expected to determine the most appropriate class based on factors including:

• formulation
• intended use
• mode of consumption
• how the product is represented

For example, a cannabis product containing cannabis oil could be an edible cannabis, a cannabis extract or cannabis topical. Note that a cannabis product cannot be classified as more than one class (for example, a cannabis product cannot be dried cannabis and a cannabis extract at the same time).

The class of cannabis will dictate the applicable requirements you need to comply with.

As with any other cannabis product, you must ensure that any novel cannabis products (for example, a cannabis product in a format that has never been sold before) meet all requirements.

You should provide information about new cannabis products, including novel products, in a notice of a new cannabis product.

This section outlines the requirements that apply to the class 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.

Product requirements by class of cannabis

• Cannabis plants or cannabis plant seeds
• Dried or fresh cannabis
• Cannabis extracts
• Cannabis topicals
• Edible cannabis

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.

Novel traits

Plants with novel traits are regulated under the:

• Seeds Act
• Seeds Regulations
• Plant Protection Act
• 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.

[s. 92.2, CR]
[subs. 102(1), CR]
[subs. 102.1(1), CR]

Dried or fresh cannabis

Dried or fresh cannabis must not contain or have on it anything other than a part of a cannabis plant as defined in item 1 of Schedule 1 to the Act. You must not add THC or THCA to dried or fresh cannabis.

Also, 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 both:

• appropriate for the intended use and any reasonably foreseeable use of the cannabis product
• established in Schedule B to the Food and Drugs Act

[subs. 93(1), CR]
[subs. 93(2), CR]
[subs. 93(3), CR]
[s. 99, CR]

Cannabis extracts

Ingredients

Cannabis extracts must only contain ingredients that are:

• flavouring agents
• carrier substances
• substances that are necessary to maintain the quality or stability of the cannabis product (for example, binders, disintegrants, preservatives)

The presence of medicinal ingredients such as those in natural health products could result in the cannabis product being represented or implied as having a health benefit. These representations are prohibited for cannabis products.

Cannabis extracts intended for inhalation may contain flavouring agents. Other ingredients may only be used if a standard for those ingredients exists in a publication referred to in Schedule B of the Food and Drugs Act, and the ingredients comply with that standard (for example, the United States Pharmacopoeia).

[subs. 101.3(1), CR]
[subs. 101.3(5), CR]

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

• Maximum net weight: The net weight of the cannabis extract in each immediate container 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 is packaged in an immediate container that prevents the extract from being easily removed
  • it includes an integrated dispensing mechanism that dispenses no more than 10 mg of ethyl alcohol per activation

[subs. 101.3(5.1), CR]

Ingested cannabis extracts

Ethyl alcohol is permitted if the net weight of the cannabis extract in each immediate container does not exceed 7.5 g. If it does, the concentration of ethyl alcohol cannot exceed a concentration of 0.5% weight-by-weight.

[subs. 101.3(6), CR]

Maximum quantities

For all cannabis extracts, the quantity of THC must not exceed 1,000 mg per immediate container. That includes total THC (for example, taking into account the potential to convert THCA into THC).

The quantity of THC per discrete unit must not exceed 10 mg, taking into account the potential to convert THCA into THC, for cannabis extracts:

• in discrete units
• intended for ingestion or nasal, rectal or vaginal use

The immediate container of a cannabis extract not in discrete units must not be easily poured or drunk from the container. It also must have an integrated dispensing mechanism that does not dispense more than a total of 10 mg of THC per activation, if the cannabis extract:

• is not intended for inhalation
• is in liquid form at a room temperature
• contains at least a total amount of 10 mg THC

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.

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 a total amount of 10 mg THC per activation.

[subs. 96(1), CR]
[s. 101.2, CR]
[s. 103.2, CR]
[s. 122.3, CR]
[subs. 122.5(1), CR]

Multiple units

You can only sell or distribute a cannabis extract with multiple discrete units within one immediate container if the properties of each unit, including size but excluding flavour and colour, are consistent.

For more information, refer to the Packaging and labelling guide for cannabis products: Co-packing cannabis.

[s. 98.1, CR]

Prohibited ingredients

The following substances are prohibited from being used as ingredients:

• substances listed in column 1 of the table in Schedule 2 to the Tobacco and Vaping Products Act
  • specifically:
    • taurine
    • caffeine
    • probiotics
    • amino acids
    • colouring agents
    • mineral nutrients
    • glucuronolactone
    • essential fatty acids
    • vitamins (with exceptions)
  • you may use a vitamin as an ingredient to maintain the quality or stability, if you use it in an amount that does not exceed what is necessary to do so
• sugars, sweeteners or sweetening agents as defined in subsection B.01.001(1) of the Food and Drug Regulations
  • specifically:
    • sugars: all monosaccharides and disaccharides
    • sweetener: any food additive used to impart a sweet taste to a food
    • sweetening agent: any food for which a standard is in Volume 15 of the Food Compositional Standards Document, but does not include a sweetener

Any of these prohibited substances are permitted in an ingredient so long as:

• it occurs naturally in that ingredient
• it is not present above the naturally occurring level for that ingredient

Note that nicotine is not permitted in cannabis extracts.

[subs. 101.3(2), CR]
[subs. 101.3(3), CR]
[subs. 101.3(4), CR]

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.

This excludes:

• the cannabis (item 1 or 3 of Schedule 1 to the Act)
• residues of a pest control product unless they are within any maximum residue limits
• 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 accepted tolerance limit for human use established in a publication in Schedule B of the Food and Drugs Act
• appropriate for the intended use and any reasonably foreseeable use of the cannabis product

[subs. 101(1), CR]
[s. 101(3), CR]
[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

You can use denatured ethyl alcohol as an ingredient in cannabis topicals with no concentration limit or maximum net weight.

[s. 101.31, CR]

Maximum quantities

The total quantity of THC must not exceed 1,000 mg per immediate container.

[s. 101.2, CR]

Multiple units

You can only sell or distribute a cannabis topical with multiple discrete units within one immediate container if the properties of each unit, including size but excluding flavour and colour, are consistent. For more information, refer to the Packaging and labelling guide for cannabis products: Co-packing cannabis.

[s. 98.1, CR]

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.

This excludes:

• the residues of a pest control product authorized for use on cannabis within any maximum residue limits
• microbial or chemical contaminants (either under the Pest Control Products Act or the Cannabis Act) that meet the exception described in paragraph 101(3)(c) of the Regulations

The Hotlist is not exhaustive and is updated from time to time.

You should make use of the Hotlist to decide whether an ingredient could pose a risk of injury to the health of the consumer when used in a cannabis topical product.

[subs. 101(1), CR]
[subs. 101(3), CR]

Uniform distribution

The cannabinoids and terpenes must be uniformly distributed throughout the cannabis topical.

[s. 101.4, CR]

Edible cannabis

Ingredients

Edible cannabis must only contain ingredients that are food and food additives.

Food has the same meaning as in section 2 of the Food and Drugs Act. It is any article manufactured, sold or represented as:

• chewing gum
• food or drink for human beings
• any ingredient that may be mixed with food for any purpose

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
• Cannabis Regulations

[subs. 102(1), CR]

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)
• the total amount of caffeine in each immediate container does not exceed 30 mg

Note that you cannot use caffeine or caffeine citrate as a food additive.

[s. 5.1 and 102.2, CR]
[para. 102(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 of the edible cannabis.

[s. 102.3, CR]

Food additives

You can use food additives in edible cannabis if you meet all conditions indicated in the Lists of permitted food additives.

[subs. 102(5), CR]

Foods with temporary marketing authorization

You must not use any food as an ingredient or constituent of an ingredient to produce edible cannabis that has received a Temporary Marketing Authorization Letter issued under section B.01.054(1) of the Food and Drug Regulations. You 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.

[subs. 102(2), CR]

Hermetically sealed containers

You can only sell or distribute edible cannabis in a hermetically sealed container if all components of the edible cannabis have at least one of the following characteristics at the temperature of 22 ± 2 °C:

• a pH at or below 4.6
• a water activity at or below 0.85

[s. 102.5, CR]

Irradiation

Edible cannabis can only be irradiated if the non-cannabis components of the product would be a food that is listed in column 1, item 3 or 4, of the table to Part B, Division 26 of the Food and Drug Regulations (such as wheat, flour, whole wheat flour, whole or ground spices and dehydrated seasoning preparations).

You must also meet the relevant:

• paragraphs B.26.003(2)(a) and (b) of the Food and Drug Regulations requirements
• subsection B.26.004(1) of the Food and Drug Regulations requirements

For more information about food irradiation, refer to Food irradiation.

[s. 102.6, CR]

Maximum quantities

The quantity of THC in edible cannabis must not exceed a total of 10 mg per immediate container subject to variability limits. For example, an immediate container of edible cannabis could contain 2 discrete units of 5 mg of total THC each. It could also contain other combinations so long as:

• each unit contains the same amount of total THC
• the total THC content does not exceed 10 mg of total THC

[subs. 97(2) and s. 102.7, CR]

Multiple units

You can only sell or distribute edible cannabis with multiple discrete units within one immediate container if the properties of each unit, including size but excluding flavour and colour, are consistent. An immediate container must not exceed 10 mg total THC. For more information, refer to the Packaging and labelling guide for cannabis products: Co-packing cannabis.

[s. 98.1, CR]

Meat products, poultry products and fish

You must not use a meat product, poultry product or fish as an ingredient in edible cannabis unless both of the following conditions are met:

• the ingredient has a water activity of 0.85 or less at a temperature of 22 ± 2 °C at the time you obtain it for processing
• the ingredient:
  • was produced by a person who is authorized to produce it under provincial legislation or the Safe Food for Canadians Act
  • was imported in compliance with that Act

This restriction does not apply to substances derived from those sources that are permitted for use as food additives.

Examples of meat products, poultry products or fish (that may meet all requirements):

• jerky
• gelatin

[subs. 102(3), CR]

Things injurious to health

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.

It must not:

• be adulterated
• be unfit for human consumption
• have in or on it any poisonous or harmful substance
• be manufactured, prepared, preserved, packaged or stored under unsanitary conditions
• consist in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance

This excludes:

• the cannabis (item 1 or 3 of Schedule 1 to the Act)
• residues of a pest control product as described in paragraph 101(3)(b) of the Regulations unless they are within any maximum residue limits as described in section 94 of the Regulations
• microbial or chemical contaminants that meet the exception described in paragraph 101(3)(c) of the Regulations unless they are:
  • within the accepted tolerance limit for human use established in a publication in Schedule B of the Food and Drugs Act
  • appropriate for a product that is to be ingested
• a food additive so long as it meets the requirements as noted in subsection 102.1(2) of the Regulations

[s. 102.1, CR]

Novel food ingredients in edible cannabis

The Food and Drug Regulations defines a novel food under Division 28 of Part B. In summary, novel foods are those that:

• do not have a history of safe use as a food
• result from a process not previously used in food
• have been modified by genetic manipulation, also known as:
  • genetically modified foods
  • biotechnology derived foods
  • genetically engineered foods

Refer to Genetically modified foods and other novel foods for more information on novel foods.

[s. 34, CA]
[para. 102(2)(a), CR]
[para. 102(2)(b), CR]

Self-produced food

You may produce your own food to be used as an ingredient in edible cannabis if:

• the food is not a meat product, poultry product or fish
• the sale of the food would not be prohibited under section 4 of the Food and Drugs Act

[subs. 102(4), CR]

Shelf-stable

You may not sell or distribute edible cannabis if the unopened immediate container requires refrigeration at or below 4 °C to prevent it from becoming contaminated before its durable life date.

[s. 102.4, CR]

Supplemented foods

You cannot use supplemented foods as an ingredient or constituent of an ingredient to produce edible cannabis.

Supplemented foods are prepackaged foods containing 1 or more added supplemental 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
• snack bars with added vitamins marketed for the maintenance of good health

[subs. 102(2), CR]

Vitamins and mineral nutrients

You may only use vitamins and mineral nutrients as ingredients in edible cannabis if either:

• they are permitted to be used as food additives
• they are naturally occurring in the food used as ingredients in edible cannabis
• they are used according to the relevant rules and limitations for those food additives
• they are required or permitted to fortify a food used as an ingredient under the Food and Drugs Act and its regulations (for example, thiamine in flour)

[subs. 102(5), CR]
[subs. 102(6), CR]

Contact us

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.