Health Canada Publishes Draft Edibles Regulation
Health Canada published Draft Regulations on New Classes of Cannabis including Edibles, Vapes, Oils and Topicals on December 20, outlining products to be permitted for legal sale under the Cannabis Act and Regulations. It is expected these regulations will come into force no later than October 17, 2019. This is phase two of Canada's legalization of recreational cannabis following last October's legalization for dried cannabis products. The online consultation is open for comments until February 20, 2019.
Health Canada’s thoughts on the purpose of the new draft regulation are interesting, as well: it opened its news release with the statement: “The old approach to cannabis did not work. It let criminals and organized crime profit, while failing to keep cannabis out of the hands of Canadian youth. In many cases, it has been easier for our kids to buy cannabis than cigarettes.”
There are, of course, a number of restrictions in the draft regulation. One key restriction that will significantly impact alcohol producers is that alcoholic products will not be cannabis infused, except those with minimal alcohol content (e.g., tinctures). Additionally, cannabis could not be packaged or labeled as beer or wine products, nor could a company producing alcohol put its branding on a cannabis beverage. Nor can caffeine be added to cannabis edibles, but it will be allowed in chocolate and coffee where caffeine is naturally occurring.
Additionally, cannabis products must not be appealing to kids, or carry any health or dietary claims, and each "discrete" package of cannabis edibles cannot contain more than 10 mg THC.
Processors of these products will require a licence, although many companies are already licenced under previous medical cannabis licence structure. Interestingly, the Safe Food for Canadians Act and Regulations will not apply to cannabis edibles even though they are food under these laws, so no CFIA license will be required. Also, cannabis edibles cannot be produced in regular food plants unless there is a separate licenced building for the cannabis production.
Edibles processors will be inspected by Health Canada with some of the food regulatory requirements from SFCA and SFCR included in the new cannabis edible regulation, including mandatory Preventive Control Programs, requirement for a person knowledgeable in food safety, and annual mock recalls. Many standard food Good Manufacturing Practices, such as pest control, potable water, filtered air, sanitation, handwashing and lavatory facilities, etc., will also be brought into these new Cannabis Regulations.
Packaging and labelling requirements are extensive and very prescriptive, with branding requirements for the THC symbol, specific Nutrition Facts tables, and child-proof packaging required. Given the extensive labeling requirements and what will likely be small packages, “accordion” type labeling panels will be allowed.
One area of concern is that with Health Canada Cannabis inspectors delivering the regulatory program for these new regulations, there will be a potential knowledge gap in this inspection workforce. Health Canada will have to quickly develop food safety and quality expertise in order to be able to properly regulate the cannabis edibles industry. It is somewhat surprising that the Government of Canada food inspection expertise currently in the CFIA will not be used in this program.
A full summary of the draft regulation proposals for edible cannabis, Cannabis extracts, and
Cannabis topicals is available in the Health Canada Backgrounder, and Health Canada also published a table of Types of Cannabis Product and Proposed Regulations Associated.
For more information and consultation on how the new draft regulation can impact your company, please contact us at https://www.hashtag.global/contact.
Led by Dr. David Acheson, HashTAG is part of The Acheson Group (TAG), a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With a focus on the Cannabis Edibles Industry, the HashTAG team brings in-depth industry knowledge combined with real-world experience to help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. To learn more about HashTAG services and expertise, please visit: www.HashTAG.global