On December 21, 2018, the Canadian federal government opened a 60-day consultation period respecting the strict regulation of additional cannabis products (which include edibles, extracts and topical products). According to the background information provided by Health Canada, the draft regulations are “designed to better protect the health and safety of Canadians through strict regulatory controls and to enable the legal industry to displace the illegal market. Stakeholders and Canadians who are interested in participating in the consultation are invited to comment on the proposed regulations before February 20, 2019.
The Consultation Paper covers the proposed amendments to the Cannabis Act and Cannabis Regulations, and will permit new forms of cannabis products to be sold legally in Canada by October 17, 2019.
The category of cannabis edibles includes cannabis- containing products intended for consumption in the form of food or beverages. The term cannabis extracts refers to derivatives and vaping products produced using extraction processing methods or by synthesizing phytocannabinoids. Finally, the category of cannabis topicals includes products intended to be used on external body surfaces (i.e., skin, hair and nails) that include cannabis as an ingredient.
Regulation of new classes of cannabis products
The proposed regulations are aimed to amend Schedule 4 of the Cannabis Act by Order in Council to add edibles, extracts and topicals to the list of cannabis products that could be legally sold by federal licence holders and other authorized distributors and retailers. Companies which manufacturer, package and label edibles, extracts or topicals for sale to consumers, would be required to hold a micro or standard processing license from Health Canada. The new regulations would require these cannabis products to be processed in a separate building from any facility which produces conventional food products.
The Consultation Paper includes proposed regulations for the following:
- Good production practices and quality control
The proposed requirements are consistent with the Safe Food for Canadians Regulations (“SFCR”), specifically when addressing edible products, in order to avoid contamination and sanitation problems.
- THC Limits
The limitations on THC content of each new class of cannabis are based on individual serving size/usage. For edibles, the limit is 10 milligrams of THC per discrete unit and per package. For extracts, the limit is 10 milligrams of THC per discrete unit and 1,000 milligrams (1 gram) of THC in a single package. For topicals, the limit is 1,000 milligrams (1 gram) of THC in a package.
The regulations closely follow the Safe Food For Canadians Act (SFCA) to prevent the risk of food-borne illnesses associated with edible cannabis.
- Product forms
The use of any cannabis product intended to be applied or used in the area of the eye, on broken skin or by a means other than absorption is prohibited.
Extensive amendments to labeling requirements include requirements for all new forms of cannabis products to conform to plain packaging and labelling requirements. Moreover, they must also include a list of ingredients on their labelling.
Regulations outlining packaging requirements include the requirement for containers for extracts to be designed to prevent the extract from being poured or drunk directly from the container and to dispense no more than 10 mg of THC. Co-packaging of an edible cannabis and a food is prohibited.
More details regarding the proposed amendments can be found here. All interested parties are invited to submit comments regarding the proposed regulations to [email protected] no later than February 20, 2019. Following a deliberation period, the proposed regulations will be promulgated into law on or before October 17, 2019.