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New Health Canada rules released on cannabis edibles, extracts and topicals

New Health Canada rules released on cannabis edibles, extracts and topicals

The highly-anticipated amendments to the Cannabis Regulations1Cannabis Regulations – SOR/2018-144. (the “Amended Regulations”) were released by Health Canada today, and officially come into force on October 17, 2019.

The Amended Regulations will allow Health Canada licensed processors (“Licensed Businesses”) to manufacture and sell three new classes of cannabis products:

  • Edible/Drinkable Cannabis: products containing cannabis intended to be eaten or drunk (e.g. baked goods and canned beverages).
  • Cannabis Extracts: products made by extracting cannabis or by synthesizing phytocannabinoids (e.g. hash oil, shatter and wax).
  • Topical Cannabis: products containing cannabis intended to be used on skin, hair and nails (e.g. lotions, creams and salves).

Current Cannabis Regulations only allow Licensed Businesses to produce and sell dried cannabis, fresh cannabis, cannabis oil, cannabis plants, and cannabis plant seeds.

Health Canada adopted the Amended Regulations to enable the legal cannabis industry to displace the illegal “blackmarket” by permitting a broader diversity of cannabis products for human use in Canada.

The Amended Regulations address the public health and safety risks associated with these new classes of cannabis, including: restrictions on cannabis product ingredients, tetrahydrocannabinol (THC) limits, and new requirements for promotion, packaging, and good production practices.

A Licensed Business is required to notify Health Canada of its intention to sell edibles, extracts or topical cannabis products at least 60 days before making the product available for sale to consumers. This means that we will not likely see these new cannabis products available for sale to consumers until the first quarter of 2020.


Restrictions on what can be included in the new cannabis products

Under the Amended Regulations, certain ingredients and substances cannot be included in the new cannabis products, including:

  • Added vitamins or mineral nutrients: edibles can only contain food and food additives as ingredients and cannot be fortified with vitamins or mineral nutrients.
  • Added caffeine: edibles cannot contain caffeine unless the caffeine comes from an ingredient that naturally contains caffeine, such as chocolate, tea or coffee, and is in an amount not exceeding 30 mg per immediate container.
  • Fish, meat or poultry: edibles cannot contain fish, meat products or poultry products unless such products are dried and are produced by a person authorized under the Safe Foods for Canadians Act2Safe Food for Canadians Act, S.C. 2012, c.24..
  • Edibles must be “shelf-stable” and not require refrigeration to prevent spoilage.
  • Nicotine and added sugars/sweeteners: a cannabis extract cannot contain nicotine or any added sugars or sweeteners.
  • Topical eye drops, eye cream or eye makeup: a cannabis product cannot be intended to be used in or around a person’s eyes. This excludes eye drops, eye cream and eye makeup that contain cannabis from being sold.

Preventing contamination

The Amended Regulations contain a number of requirements intended to control the quality of and prevent contamination of cannabis products. For example:

  • Cannabis products cannot be produced, packaged, labeled or stored in the same building as food.
  • A ventilation system must be present in any part of a building where cannabis is present.

Limitations on the amount of THC in products

In an effort to prevent overconsumption, THC content will be limited under the Amended Regulations to:

  • Edibles: 10 milligrams (mg) per serving and/or per package (e.g. per immediate container).
  • Extracts: 10 mg per serving that is intended for ingestion and 1,000 mg per package.
  • Topicals: 1,000 mg per package.

Promotion of cannabis products

Under the Amended Regulations, Licensed Businesses may not (among numerous other restrictions):

  • Make health claims related to a cannabis product.
  • Communicate any information about calories in the product (except on a nutrition facts table).
  • Market the product in a way that could associate it with alcohol products, tobacco products, or vaping products.

Packaging of products

Plain packaging requirements for cannabis products are maintained under the Amended Regulations.  For example, packaging must still be one uniform colour, not display an image, and must be child resistant.

Additional restrictions on the packaging of cannabis products pursuant to the Amended Regulations include informational requirements, such as including a list of ingredients, a nutrition facts table, and the name of any food allergen.


An experienced cannabis lawyer is essential to assist businesses in understanding and navigating the complex regulatory and legal framework for cannabis products in Canada. The Carscallen Cannabis Group provides comprehensive and sophisticated legal services to businesses involved at every stage of the cannabis industry, and works with its clients to find the most strategic and practical solutions to their legal needs.

If you have any questions on how the Amended Regulations will affect your business, or any other cannabis-related inquiries, please contact John M. Davidson or any member of the Carscallen Cannabis Group.

  • 1
    Cannabis Regulations – SOR/2018-144.
  • 2
    Safe Food for Canadians Act, S.C. 2012, c.24.
*This update is intended for general information only on the subject matter and is not to be taken as legal advice.

Posted: June 26, 2019

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