On October 17, 2018, the Cannabis Act and its Regulations came into force in Canada. This was a momentous day not only for Canada but for the history of cannabis. Canada became the first G7 Nation to fully legalize cannabis for recreational use. The only other country in the world that can boast about the same accomplishment is Uruguay, which fully legalized cannabis in December of 2013.
Although cannabis is now legal in Canada, it is important to understand that not all classes of cannabis products are actually legal. When the Cannabis Regulations were initially released for consultation, not all classes of cannabis products were included. The classes of cannabis that had been proposed and are now currently legal for purchase by consumers are as follows:
At first glance, nothing seems wrong with this list. Consumers could now legally purchase dried cannabis and cannabis oils. For the more adventurous consumer, cannabis plants and cannabis plant seeds could now be purchased legally and cultivation for personal use could occur in the comfort of your own home (provided that you are of legal age to do so and it is permitted by the province or territory in which you reside). However, “seasoned” consumers and those already heavily invested in cannabis culture and the industry were shocked when certain very desirable classes of cannabis products were omitted from this list. These classes of cannabis products are as follows:
Although these classes of products were not included, the consultation document released by Health Canada indicated that “Edibles and concentrates would automatically be added to Schedule 4 one year following the coming into force of the Act, which would provide time for the Government to develop and consult on appropriate regulatory controls.”2 In layman’s terms: the current regulations would be revised on October 17th, 2019 in order to include the new proposed classes of cannabis products (Please refer to section 193.1 and subsection 226(2) of the Act regarding the inclusion of the new classes of cannabis products by no later than October 17th, 2019).
Fast forward to December 20, 2018. On this date, Health Canada released the proposed regulations for additional cannabis products. These proposed regulations included the different types of cannabis products and the proposed regulations associated with them. The types of cannabis products included by Health Canada were as follows:
Proposed regulations associated with these products were based on the following types of regulations:
It is important to note that along with the release of the proposed regulations for additional cannabis products, Health Canada released a disclaimer stating the following: This is not a complete list of proposed regulatory rules for each class of cannabis. It is also not a complete list of product examples. For more information on the proposed amendments to the Cannabis Regulations, please visit Canada.ca/Cannabis7.
The release of this document was followed up with the publishing of the regulations amending the cannabis regulations (to include the new classes of cannabis) in Part 1 of the Canada Gazette on December 22nd, 2018. Having gone through this document extensively, here are six things you may not have realized about the proposed regulations and:
2. So what’s the deal with “cannabis concentrates”?
In Part 1 of the Canada Gazette, Health Canada has indicated that the term “cannabis concentrates” would not be one of the names used to describe the new classes of cannabis that will be added to Schedule 4 of the Act. Although this is the case, the current proposal would still allow for the legal production and sale of cannabis with higher concentrations of THC. What this means is that even though “cannabis concentrates” won’t be included in Schedule 4 of the Act, licence holders will still be able to produce cannabis products that contain higher concentrations of THC.
3. Edibles and the Safe Food for Canadians Regulations
It has been proposed that Part 5 (Good Production Practices) of the Cannabis Regulations would also be amended to incorporate additional good production practices. The inclusion of these additional GPP’s revolves primarily around edible cannabis. Many of these new requirements, those pertaining to edible cannabis, in particular, have been adapted from the Safe Food for Canadians Regulations (SFCR). Licensed processors looking to produce edible cannabis need to be even more diligent when considering the regulations that will apply to them.
Licensed processors who intend to produce edible cannabis or cannabis extracts will now be required to prepare, retain, maintain and implement a written preventative control plan (PCP). This plan is required in order to identify and address any potential hazards and risks that may arise during the production of these product classes.
5. To edible or not to edible, that is the question
Those currently involved in the production of confectionery items that were looking to cash in on the edible cannabis market may want to think twice before getting involved. Health Canada has proposed that the production of edible cannabis cannot take place at a site where conventional food products are also being manufactured. What this means is that production of edible cannabis would need to happen in a separate building within the licensed site which would require a substantial investiture in the construction of a building dedicated to the production of goods containing edible cannabis.
6. Know your limit, produce within it
Health Canada has proposed various THC limits for the new classes of cannabis. If you intend to produce any of these new classes of cannabis products, it is important for you to pay attention to the proposed limits. For instance, for edible cannabis, there would be a limit of 10 milligrams of THC per discrete unit and per package. What this means, for example, is that if a consumer were to purchase an edible, that product would not have more than 10 milligrams of THC if it were a single item. If there were two items in the package, each of the items in that package would have to contain a maximum of 5 milligrams of THC each.
In addition to the items mentioned above, there are a number of other proposed regulations that may apply to you as a licence holder. Although this may seem overwhelming, the experts on staff at dicentra are readily available to assist you with all of your cannabis product and licensing needs. Be sure to contact us today if you have any questions or concerns regarding your cannabis product(s).
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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.