The Cannabis Act will authorize the legal sale of “edibles containing cannabis” and “cannabis concentrates” one year following the coming into force of the Act. Amendments to the Cannabis Regulations are required to address the public health and public safety risks of these new classes of cannabis and must be brought into force by no later than October 17, 2019. With this said, on December 22, 2018, Health Canada released a proposal to amend Schedule 4 to the Cannabis Act to add three new classes of cannabis that could be legally sold by federal licence holders and provincially and territorially authorized distributors and retailers. The one in focus for this article is the edibles category.
Consistent with the comprehensive public health approach to the regulation of all cannabis products established by the Cannabis Regulations, Health Canada is proposing to amend the Cannabis Regulations to establish new regulatory controls to address the public health and public safety risks associated with edibles. The goal of Health Canada in this instance is to address the appeal of these products to youth and the risks of accidental consumption, over-consumption, and food-borne illness, among other risks. The proposed regulations seek to provide the controls to address these risks through restrictions on product composition and ingredients, tetrahydrocannabinol (THC) limits, and new requirements pertaining to packaging and labelling, good production practices and record keeping. While currently citing a small number of food-related standards, It is expected that more of the established standards in the Safe Food for Canadians Act, that currently only addresses food products, will be brought into the fold for control mechanisms under the Cannabis Regulations.
As of January 15, 2019, all food products that are imported, exported and manufactured in Canada must comply with the Safe Food for Canadians Act and Regulations. Many of the currently suggested GPP requirements cited in the Health Canada Proposed Amendments document cite the Safe Food for Canadians Act/Regulations and have completed copied some of the GMP requirements. As more clarity is established, regulators and the Canadian population will expect that the edible products they consume will:
- Not cause accidental consumption due to misrepresentation
- Not allow for over-consumption
- Not cause illness or worse
Anticipating this, it is quite likely that the question will be asked; “If we are ingesting edibles, why are we not holding them to the same standards as that of food?” With this in mind, it is very possible that as part of the edibles regulations, Health Canada may one day even ask processors to attain a Safe Food for Canadians License – which is required for manufacturers of all food products in Canada. This would require a fully written Preventative Control Plan for all activities constituted as part of the edible process (from Receiving to Storage to Processing to QA Checks to Distribution) and an appropriate Recall/Traceability system. Unique points would constitute the development of a Hazard Analysis and Critical Control Point (HACCP) program and associated prerequisite programs (GMPs) to control all identified hazards.
The proposed regulations are under consultation now and the next coming months will be incredibly telling in how this new, exciting product industry will unfold. dicentra will keep you up to date on all of the unfoldings with edible regulations. If you have questions, feel free to reach out to us today to jump head first into this ever-expanding market.
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dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products.