On December 20, 2018, Health Canada launched a public consultation on draft regulations governing the production and sale of cannabis edibles, cannabis extracts and cannabis topicals. The draft regulations will be published in the December 21, 2018 edition of the Canada Gazette I. Canadians and industry will have until February 20, 2018 to share their feedback on the governments proposal.
We have provided a synopsis and analysis of the key points regarding these proposed regulations below. Keep in mind the regulations are draft only. Therefore, providing input during the consultation period will be extremely important. In addition, over the next 60 days there will be a significant amount of discussion about what these regulations mean for industry, stakeholders and citizens so interpretations will continue to evolve.
Summary of Proposed Regulations
The proposed changes to Schedule 4 of the Cannabis Act add the following three new classes of cannabis:
- Edible cannabis – which are defined as products containing cannabis that are intended to be consumed in the same manner as food (eaten or drunk) THC Limit – 10 mg of THC per discrete unit and per package.
- Cannabis extracts – which are defined as products that are produced using extraction processing methods or by synthesizing photocannabinoids THC Limit – 10 mg of THC per discrete unit. 1000 mg of THC in a single package; and
- Cannabis topicals – which are defined as products that include cannabis as an ingredient and which are intended to be used on external body surfaces (i.e., hair, skin and nails) THC Limit – 1000 mg of THC per package.
The proposed regulations also introduce new regulatory controls to address concerns relating to accidental and overconsumption; restrictions on production, composition and ingredients; as well as slightly revised packaging and labelling requirements.
Cannabis Oil – It is proposed that “cannabis oil” be removed from Schedule 4 six months after the amended regulations come into force. Cannabis oils will then be incorporated under the new product classes.
Safe Food for Canadians Regulations – While the Food and Drugs Act would not apply to cannabis edibles, Part 5 of the Cannabis Act which establishes requirements pertaining to the production, distribution and storage of cannabis has been adapted and will be informed by the Safe Food for Canadians Regulations.
Composition and Ingredients – All edible cannabis must be shelf-stable (could not require refrigeration or freezing) Edible cannabis cannot be fortified with vitamins or mineral nutrients. The use of meat products, poultry products and fish as ingredients would be prohibited (unless dried by a person authorized to do so). The use of ingredients containing naturally occurring caffeine (chocolate, tea, coffee) would be permitted as long as the total amount of caffeine in a single package does not exceed 30 mg. Caffeine additives will not be permitted. Cannabis extracts can contain flavouring agents in addition to one or more carrier substance, however, cannabis extracts cannot contain ingredients that are sugars, sweeteners, or sweetening agents.
Packaging and Labelling – The current plain packaging and labelling requirements are being applied to cannabis edibles, extracts and concentrates. The regulations are however being amended to allow for expanded panels, peel-back labels, making it easier for additional product information to be displayed. Tags and package inserts will still be prohibited. Cannabis edibles would have to include a list of all ingredients, indications of any allergens, a “best before” date and a cannabis specific nutrition facts table (calories, fat, fibre, etc.).
Cannabis Beer and Wine – The proposed regulations prohibit the use of alcohol beverage-related terms including beer and wine on cannabis products. Metal beverage cans will however be permitted under the current proposal and a matte finish will not be required on packaging.
Vaping Products – Consistent with the Tobacco and Vaping Products Act, the proposed regulations state that cannabis vaping products cannot include flavours that would appeal to youth (i.e. dessert or candy).
Record Keeping – Requirements that currently extend to cannabis oil would be amended to apply to edible cannabis, cannabis extracts and cannabis topicals. However, a new requirement is being proposed that would call for records to be kept of all ingredients used in the production cannabis edibles, extracts and topicals.
Analysis
To be able to produce a cannabis edible and/or concentrate, a Health Canada processing license (micro or standard) is required. It is not clear yet if Health Canada will dedicate distinct resources to process these specific applications. Depending on industry readiness and the Health Canada regulatory review process it will be interesting to see if any products are prepared to launch when these regulations come into force by the Fall of 2019.
The type of products and what can and can not be included is restrictive as is labelling, packaging and record keeping. This approach is in keeping with the government’s goal of not normalizing cannabis use. It is not clear then how these changes will impact and decrease the current illegal market where edible and concentrate products are easily available on-line.
These regulations also appear to be silent when it comes to R&D and testing. It is not evident nor specified how a company should conduct the testing of products under development for sensory and taste qualities. However, these regulations do define cannabis edibles as a food under the Food and Drugs Act.
Next Steps
At this time, Health Canada is encouraging stakeholders to provide written submissions and answer an on-line questionnaire all before February 20, 2019. While a 60-day consultation is not prefect (in our opinion) given the magnitude of these changes, we would encourage all interested stakeholder to actively contribute to the process.
We also understand that Health Canada will hold a WebEx on January 9, 2019 and a total of 4 roundtable sessions will occur in the following locations:
- January 17, 2019 – Vancouver (English session).
- January 24, 2019 – Ottawa (Bilingual session with simultaneous interpretation available).
- January 25, 2019 – Ottawa (Bilingual session with simultaneous interpretation available).
- January 30, 2019 – Montreal (French session with simultaneous interpretation available).
Officials from the Cannabis Legalization and Regulation Branch (Health Canada) will conduct these sessions.