The final regulations on new cannabis products were promulgated in the Canada Gazette, Part II, on June 26 and will come into force on October 17. The regulations expand the permitted formats for products that contain or are derived from cannabis, including edible cannabis, cannabis extracts and cannabis topicals (new classes of cannabis products). New classes of cannabis products will be available for sale on December 16.
What you need to know
- The regulations are now in final form and amend the Cannabis Act and Cannabis Regulations, allowing for the medical or recreational production and sale of three new classes of cannabis: edible cannabis, cannabis extracts and cannabis topicals.
- Edible cannabis includes food and beverages and must be shelf-stable (i.e., not require refrigeration or freezing).
- Cannabis extracts include products produced from cannabis using extraction processing methods or by synthesizing phytocannabinoids.
- Cannabis topicals include products containing cannabis and used as topicals exclusively on external body surfaces (e.g., on hair, skin or nails, but not in the area of the eyes). Transdermal patches will be considered to be cannabis topicals.
- The regulations address the government’s objective to ensure public health and safety, containing various restrictions on the production, packaging, labelling, storage and promotion of the new classes of cannabis products.
- Federal licence holders wishing to sell new classes of cannabis products should be aware of these key dates:
- July 15, 2019: Existing federal licence holders can submit licence amendment applications to process, package and label the new classes of cannabis products.
- October 17, 2019: Regulations come into force and federal licence holders who have submitted license amendment applications to process, package and label the new classes of cannabis products can submit their notice of intent to sell any new classes of cannabis products. Federal licence holders are required to notify Health Canada of impending sales for any new products at least 60 days before the intended sale date.
- October 17, 2019: For new classes of cannabis products, new packaging and labelling requirements take effect immediately.
- December 16, 2019: This is the earliest date that new classes of cannabis products may be sold.
- October 17, 2020: For existing classes of cannabis, new packaging and labelling requirements take effect (i.e., 12-month transition period expires).
The final regulations
The regulations are now in final form, amending the Cannabis Act and Cannabis Regulations to allow for the medical or recreational production and sale of three new classes of cannabis products: edible cannabis, cannabis extracts and cannabis topicals.
Consistent with the government’s objective to address public health and safety risks, the regulations contain various restrictions on the new classes of cannabis products with respect to ingredient composition, labelling and packaging and products that may appeal to youths. While many aspects of the proposed regulations remain,1 some key changes have been introduced to the final regulations.
The regulations prohibit the production, packaging, labelling and storage of any cannabis products in the same building used to produce, package and label food products. Draft regulations had originally imposed this prohibition on edible cannabis products only and this prohibition has now been expanded to all cannabis products.
Good production practice requirements will apply only to activities conducted by a license holder (rather than activities of its suppliers whose activities are already regulated by other laws). Furthermore, holders of an analytical testing or research license will not automatically be subject to good production practice requirements as the cannabis handled by such license holders is not consumed. Containment testing for edible cannabis is to be conducted on the “input” cannabis.
Storage, packaging and labelling
Multiple containers of edible cannabis (e.g., beverages) packaged together (i.e., multi-pack) will be permitted provided the total amount of THC in the multi-pack does not exceed 10 milligrams, and the total amount of cannabis in the multi-pack does not exceed the public possession limit of 30 grams of dried cannabis or equivalent. In addition, the use of pressurized containers for carbonated beverages and cannabis accessories such as metered-dose inhalers will be permitted.
There are now standardized requirements for the display of THC and CBD concentration on product labels of all classes of cannabis. For example, the amount of THC and CBD must be expressed in milligrams per gram (concentration) or milligram (quantity) for different cannabis products. Labels for all cannabis products (except dried cannabis and cannabis plants) must also indicate the product’s equivalency to grams of dried cannabis.
Promotion and selling
All representations that are prohibited on a cannabis product’s packaging and labelling will also be prohibited in any promotional activity. For example, representations in promotional activities pertaining to certain flavours in cannabis extracts; health or cosmetic benefits; energy value and amount of certain nutrients; special dietary requirements; and alcoholic beverages and tobacco and vaping products, are prohibited. Specifically, all representations that associate a cannabis product (including its brand element) with an alcoholic beverage, a tobacco product, or a vaping product will be prohibited. These prohibitions will not apply with respect to prescription drugs containing cannabis or combination products.
There will be limited promotion of cannabis, cannabis accessories, and services related to cannabis. For example, brand elements on “things” such as t-shirts and hats will be permitted provided that only one branded element appears on the “thing” and the “thing” is not promoted in a public place frequented mainly by young persons (e.g., school, public playground, daycare facility) or that is visible from such a place. There will also be a maximum size restriction for the brand element and for text within the brand element, to reduce the impact of the promotion. Additionally, promotions permitted in a place where young persons are not permitted must also not be audible or visible from outside the place.
Provincially and territorially authorized sellers will be prohibited from selling cannabis products that are subject to a voluntary recall in Canada, if the recall is due to non-compliance with certain aspects of the Cannabis Regulations.
While no sales, distribution or export of new classes of cannabis products can take place before October 17, licensed processors may produce such products in advance of the coming into force. However, such licensed processors must produce, package, label, store, sample and test such products in accordance with the amended regulations. Further, licensed processors must retain the services of a quality assurance person who has the training, experience and technical knowledge related to the new classes of cannabis products being produced.
A 12-month transition period following the coming into force of the regulations apply to all activities pertaining to cannabis oil as cannabis oil will be removed from Schedule 4 of the Cannabis Act on October 17, 2020. While cannabis oil will cease to exist as a standalone class of cannabis starting October 17, 2020, cannabis oil products will continue to exist under the new product classes.
Federal licence holders wishing to sell new classes of cannabis products will need to strategize on how best to bring these products to the market in view of the prescribed timelines by Health Canada.
1 See “Let them eat cannabis – with restrictions!”. In particular, rules surrounding THC limit per individual serving/usage and variability limits for THC and CBD remain unchanged.
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