On June 14, 2019 the Government of Canada announced its final amendments to the Cannabis Regulations (the “Regulations”), which set the rules for the production and sale of cannabis edibles, extracts and topicals – the three new classes of cannabis products that will be legal for recreational use in Canada later this year.
The Regulations will come into force on October 17, 2019. Health Canada advises that it will begin to accept applications for new product licences in mid-September 2019. However, consistent with the regulations in force now, licence holders will be required to give Health Canada 60-days’ written notice before making a new cannabis product available for sale. This means the earliest date that cannabis edibles, extracts, and topicals can be put on shelves or in online stores will be December 16, 2019.
Changes from draft Regulations proposed last year
After Health Canada proposed its draft regulations for the new products in December 2018, we highlighted what you needed to know about the key product requirements (e.g. THC limits, ingredients and additives, packaging and labelling, etc.) associated with each. The final Regulations are mostly unchanged, with some notable differences and additions relating to:
- packaging and labelling requirements;
- prohibitions on manufacturing cannabis in the same building as food;
- prohibitions on brand promotion; and
- extending the transition period for cannabis oil.
This post seeks to highlight the main differences between the proposed and final Regulations, as well as summarize key components of the final Regulations.
1. Product Rules
- Packaging and Labelling
Cross branding: The proposed prohibition on cross-branding with alcohol products is extended to also prohibit cross-branding with tobacco and vaping products.
Health warning messages: All cannabis products must be labelled with new warning messages listed in the amended Cannabis Health Warning Messages document that will take effect with the Regulations.
Standardized quantity: All cannabis products will be required to display the THC and CBD quantity in a standardized way – either milligrams per gram (mg/g) or milligrams. All products will also be required to display the product’s equivalency to 30 grams of dried cannabis.
Guidance to be provided on packaging that is “appealing to young persons”: In addition, the government received feedback from industry groups that further guidance was needed on how to assess whether a product or package can reasonably be considered “appealing to young persons”. Health Canada plans to publish guidance on the factors to consider when making this assessment (e.g., a product’s shape, colour, ingredients, flavour, packaging).
Transition period: For the new product classes, the new labelling requirements come into effect with the Regulations; however, for existing product classes, processors will have a 12-month transition period to update their packaging to comply.
- Limits on tetrahydrocannabinol (THC) content
The proposed per-unit and per-package THC limits will remain the same for all three product classes: edible cannabis (10 mg/package); cannabis extracts (10 mg/unit; 1,000 mg/package); cannabis topicals (1,000 mg/package). In relation to cannabis extracts intended to be inhaled, such as vaporizer cartridges, there is a limit of 1,000 milligrams of THC per cartridge.
- Composition and Ingredients
The proposed and final restrictions on product additives and ingredients are nearly identical, with the minor clarification that, while products intended to penetrate the skin or eyes will be prohibited, transdermal patches will be allowed as part of the cannabis topicals class.
In addition to the packaging and labelling requirements, the final Regulations will extend the existing Cannabis Act restrictions on promotion so that anything prohibited on a product’s package or label will equally not be allowed in promotions. There are also new specifications on promotional branding which place limits on the size of logos and text on t-shirts, hats, etc.
3. Production Practices – Prohibition on Same-Site Production
The list of “good production practices” required by the proposed Regulations has been maintained, with some changes. Significantly, the prohibition on same-site production of edible cannabis and food has been extended to prohibit the production, packaging, labelling and storage of any class of cannabis product and the production, packaging, labelling and storage of food in the same building on a site.
4. Cannabis Oil
The final Regulations will allow for a 12-month transition period for activities related to cannabis oil, extended from the 6-month period initially proposed. During this 12-month period, cannabis oil can continue to be sold under the current rules, after which it will be subsumed under the new cannabis extracts class.
5. Contaminant Testing
Under the final Regulations, licenced processors will have the option to perform contaminant testing on either the final product or the “input” cannabis. However, for edible cannabis, all testing must be performed on the “input” cannabis only. The Regulations also create new testing requirements which will apply to all classes of cannabis products, including dried and fresh cannabis. The Regulations allow for a 12-month transition period during which dried or fresh cannabis can be sold without compliance with the new contaminant testing requirements.
Additional Health Canada guidance documents
Health Canada will be publishing amended guidance documents that may be of interest if you or your organization intend to engage with the new cannabis products. The following documents will take effect with the Regulations on October 17, 2019:
Provincial rules may continue to vary
It is important to keep in mind that each provincial government continues to be responsible for regulating the possession, consumption, sale and home cultivation of all cannabis products in their respective province. Since recreational cannabis was legalized in Canada last year, we have seen the provinces’ approaches and attitudes toward their respective frameworks continue to evolve and change. This means that, while the above requirements will serve as baseline rules, the province where you or your organization is located may or may not decide to enact stricter requirements.