Yesterday, after much public anticipation, Health Canada launched its regulatory consultation for proposed amendments to Schedule 4 of the Cannabis Act to add “edible cannabis”, “cannabis extracts”, and “cannabis topicals” as new classes of cannabis to be legally sold by federally licensed producers and provincially/territorially authorized retailers and distributors.
The proposal also contains amendments to the Cannabis Regulations to establish new regulatory controls including restrictions on ingredients and product composition, THC limits, packaging and labelling requirements, good production practices, and record keeping requirements. These additional controls are intended to address public safety risks, especially as they pertain to youth.
The proposal was informed by the same things that the original Cannabis Act was, including: consultations conducted by the Task Force on Cannabis Legalization and Regulation, the experience of US jurisdictions that have legalized and regulated access to cannabis, consultations with stakeholders and regulated parties, as well as a study of Bill C-45 and the development of the current Cannabis Regulations. The proposal focuses on four policy principles: (1) that new classes of cannabis are integrated into the existing control framework; (2) that the proposed new requirements are evidence-informed; (3) that the proposed new requirements are consistent with analogous regulatory frameworks; and (4) that amendments would enable a comprehensive range of product forms.
Schedule 4 of the Cannabis Act sets out classes of cannabis that can be sold by authorized persons. Currently, Schedule 4 contains: dried cannabis, cannabis oil, fresh cannabis, cannabis plants, and cannabis plant seeds.
The new classes of cannabis proposed to be added are:
Six months after the amended Cannabis Regulations come into force, it is proposed that an Order be made removing “cannabis oil” from the current Schedule 4, as it will be subsumed into the “extracts” category as it is proposed above.
Certain products will continue to be prohibited, including products that are intended to be used in the area of the human eye (i.e. eye drops) and products intended to be used on damaged or broken skin or to penetrate the skin barrier by means other than absorption (i.e. through the use of abrasives or needles).
Under the proposal, all edible cannabis products will need to be shelf-stable (i.e. they could not require refrigeration or freezing). Only food and food additives could be used as ingredients in edible cannabis and cannot contain hazardous or poisonous substances. The use of meat products, poultry products, and fish, as ingredients, will be prohibited.
Products that contain naturally occurring caffeine, such as chocolate, tea, or coffee, would be permitted provided the total amount of caffeine per package does not exceed 30 milligrams. Caffeine as a food additive, however, will be prohibited.
The proposal suggests allowing for a small concentration of ethyl alcohol in edible cannabis, given that it is present as a by-product in some fermented ingredients or products.
Extracts, under the proposal, may contain flavouring agents in addition to carrier substances but may not contain any ingredients that are sugars, sweeteners, or sweetening agents. They may also not contain any ingredient prohibited from being contained in vaping products. Any ingredient used in the preparation of extracts that is intended to be inhaled must comply with a standard set out in an official publication which sets out Food and Drug Standards.
The use of ethyl alcohol will be permitted in cannabis extracts that are designed to be ingested, but the proposal suggests maximum package sizes for these types of products, given the increased risk of accidental consumption and overconsumption.
Topicals will not be permitted to contain any ingredient that may cause injury to a consumer. Health Canada will look to its Cosmetic Ingredient Hotlist, as a resource when looking to determine whether an ingredient may pose a risk.
It is proposed that a processing license (either standard or micro) will be required in order to manufacture edible cannabis, cannabis extracts and topicals, and to package these types of cannabis products.
The proposal suggests that Part 6 of the Cannabis Regulations should be amended to establish rules for edibles, extracts, and topicals, including THC limits per serving/per package and rules pertaining to product composition and ingredients.
In a single package, the THC limit proposed is:
Health Canada proposes that the Cannabis Regulations be amended to set out variability limits with respect to the amount of THC and CBD in new classes of cannabis, in that it is possible that the amount contained inside actually differs from the amount contained on the product label. The variability percentage ranges from 15% - 25% depending on the type of product class, the quantity of THC or CBD in milligrams, etc.
It is proposed that the same plain packaging and labelling requirements that apply to all cannabis products currently, including the standardized cannabis symbol, health warning messages, THC and CBD content, and child-resistant packaging, be adopted for the new product classes. Certain additional requirements have been proposed to address the risk of accidental consumption and over consumption.
The maximum package size and public possession limit of 7.5 grams (which is equivalent to 30 grams of dried cannabis) would apply to edibles, extracts, and topicals that contain more than 3% w/w THC (i.e. cannabis “concentrates”).
All labels will need to be plain, not appealing to children, and make no health claims. For edibles, there may be no dietary claims, and for topicals, there may be no cosmetic claims. For all of the new product classes, packaging and labelling must not contain any elements that associate the product with an alcoholic beverage, alcohol, or an alcohol brand.
New product classes will, in addition to current labelling requirements, need to include a list of ingredients and a list of allergens. Edibles will also need to contain a nutrition facts label, where extracts and topicals will need to contain a statement of intended use. Topicals will also need to include a warning statement about not swallowing or using on broken skin.
There will be changes made to labelling requirements to account for smaller packaging, including peel back labels, in order to facilitate the need for all of the information required.
In terms of packaging, all packaging will continue to be required to be child-resistant. There are some proposed changes to the current requirement in place for matte packaging. It is proposed that changes be made so that:
The current proposal is subject to a public comment period ending 60 days following its publication in the Canada Gazette, Part I. Continue to check CCL for more in depth review of the proposal and for continued updates on Health Canada and legislative releases.