Backgrounder: Final regulations on new cannabis products
June 14, 2019
Health Canada has released the amendments to the Cannabis Regulations to control the legal production and sale of edible cannabis, cannabis extracts, and cannabis topicals.
With respect to edible cannabis, the amended Cannabis Regulations include:
- Restricting the use of ingredients that could increase the appeal of edible cannabis, increase the risk of food-borne illness, and encourage over-consumption.
- Placing a limit of 10 mg on the amount of THC that can be in a package of edible cannabis.
- Requiring child-resistant and plain packaging for edible cannabis to lower the risk of accidental consumption and make packages less appealing to young persons.
- The label will need to display the standardized cannabis symbol and a health warning message.
- It will be prohibited to make any claims respecting health benefits or nutrition on the label.
- Putting in place strict new manufacturing controls for the production of edible cannabis to reduce the risk of food-borne illness and to control the quality of products.
- Prohibiting the production of food and cannabis in the same facility to ensure the safety and integrity of Canada’s food system.
With respect to cannabis extracts, the amended Cannabis Regulations include:
- Prohibiting the use of certain ingredients that could appeal to young persons, such as sweeteners and colourants, or ingredients that could increase the appeal of cannabis extracts.
- Prohibiting certain flavours that are appealing to young persons from being displayed on a product label, consistent with rules for vaping products.
- Placing a limit on the amount of THC that could be in a unit of a cannabis extract—such as a capsule—of 10 mg. The total amount of THC in a package of a cannabis extract is capped at 1,000 mg (e.g., 100 10‑mg capsules).
- Requiring child-resistant and plain packaging for cannabis extracts. All packages, as well as certain pre-filled accessories, such as vape pens, are required to display the standardized cannabis symbol. Packages are also required to display a health warning message.
- Prohibiting any claims respecting health benefits on the label.
- Putting in place strict new manufacturing controls for the production of cannabis extracts to control the quality of the products.
With respect to cannabis topicals, the amended Cannabis Regulations include:
- Restricting the use of certain types of ingredients.
- Placing a limit of 1,000 mg of THC in each package of a cannabis topical.
- Requiring child-resistant and plain packaging for cannabis topicals. All packaging is required to display the standardized cannabis symbol and a health warning message.
- Prohibiting any claims respecting health or cosmetic benefits on the label.
- Putting in place strict new manufacturing controls for the production of cannabis topicals to control the quality of the products.
Availability of new products
The amended regulations will take effect on October 17, 2019. However, it will take time before new cannabis products become available for purchase. As with any new regulatory framework, federally licensed processors will need time to become familiar with and prepare to comply with the new rules and to produce new products. Provincially or territorially authorized distributors and retailers will need time to purchase and obtain the new products and make them available for sale. As such, adult consumers should expect to see a limited selection of new products appear gradually in physical or online stores, and no earlier than mid-December 2019.
In order to sell new products, federally licensed processors will need to seek an amendment to their licence and attest that all the regulatory requirements specific to the new cannabis products have been met before being authorized to sell them. Consistent with the Cannabis Regulations in force now, licensed processors will also need to provide Health Canada with a written notice at least 60 days before making a new cannabis product available for sale. The notice must state the product class to which the new product belongs, describe the product (including the brand name), and indicate the date on which the product is expected to be made available for sale. As has always been the case, Health Canada does not approve cannabis products before they are made available for sale, but it may verify compliance of the proposed products with the regulations following these notifications. Licensed processors continue to be responsible for making sure that any new product meets all the requirements set out in the Cannabis Act and the Cannabis Regulations.
Health Canada will begin approving amendments to federal licences to authorize the production and sale of the new products and reviewing notifications for the new products when the amended regulations come into force on October 17, 2019.
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