Client Update: Canada’s Proposed Cannabis Edibles, Extracts and Topicals Regulations Revealed
The first look at regulations for cannabis edibles, extracts and topicals has arrived. The Federal Government has opened a 60-day consultation period respecting the strict regulation of additional cannabis products. Notice of the consultation was accompanied by release of a document titled: Proposed Regulations Amending the Cannabis Regulations (New Classes of Cannabis) And Proposed Order Amending Schedules 3 and 4 to the Cannabis Act (“Consultation Paper”).
The Consultation Paper outlines proposed amendments to the Cannabis Regulations and Cannabis Act which would result in the legalization of several new forms of cannabis by October 17, 2019 or sooner:
- Cannabis edibles: products containing cannabis that are intended to be consumed in the form of food or beverages;
- Cannabis extracts: derivatives and vaping products that are produced using extraction processing methods or by synthesizing phytocannabinoids; and
- Cannabis topicals: products intended to be used on external body surfaces (i.e., skin, hair and nails) that include cannabis as an ingredient.
Interested parties have until February 20, 2019 to complete an online questionnaire, or send a written submission to the Cannabis Legalization and Regulation Branch before the final regulations are published in the Canada Gazette Part II.
How will edibles, extracts and topicals be regulated?
Amending Schedule 4 of the Cannabis Act
Schedule 4 of the Cannabis Act outlines types of cannabis that may be sold by licensed parties. The Consultation Paper proposes to amend Schedule 4 of the Cannabis Act by Order in Council to add edibles, extracts and topicals to the list of cannabis types that could be legally sold by federal licence holders and other authorized distributors and retailers.
Transitional provisions in the Consultation Paper would remove cannabis oil from Schedule 4 six months after the amended Cannabis Regulations come into force. Following the six-month transition period, cannabis oil would be still be permitted but would be governed under the newly introduced classes of cannabis.
Processing licenses required
Instead of creating a new license specifically for edibles, extracts and topicals, the Consultation Paper would require manufacturers, and those who package and label edibles, extracts or topicals for sale to consumers, to hold a micro or standard processing license. There are no changes to current Cannabis Act personnel requirements, application process or physical security requirements for processing of edibles, extracts or topicals.
The proposed regulations would require edibles, extracts and topical products to be processed in a separate building from any facility that produces conventional food products.
Adjustments to good production practices
In general, the Consultation Paper proposes requirements consistent with the Safe Food for Canadians Regulations (“SFCR”) particularly with respect to edible products so as to avoid issues with contamination and sanitation. In keeping with the SFCR, the Consultation Paper introduces a requirement for a written Preventive Control Plan (“PCP”) which each licensed processor must implement. The PCP will identify and address any potential hazards or risks to the production of these new classes of cannabis. The licensed processor’s Quality Assurance Person (“QAP”) would be required to verify and approve the PCP prior to its implementation.
Other ancillary amendments will require solvent testing, variability limits, bans on pets in processing facilities, proactive investigation by the QAP into ingredients which may pose a threat to human health, adjustments to licensed processor’s standard operating procedures to include provisions for handling of ingredients and requirements pertaining to the use of potable water in processing activities.
Quality Assurance Person credentials
The skill and experience required of QAPs will change if the proposed regulations are accepted as written. QAPs will require sufficient qualifications to oversee the production of all classes of cannabis the licensed processor is producing. Should current QAPs not have appropriate knowledge, the licensed processor will be expected to retain the services of another individual with skills sufficient to oversee production of these new classes of cannabis.
All license holders to be subject to recall simulations
Current requirements for seed to sale tracking on all cannabis produced is intended to facilitate product recalls. The Consultation Paper builds on those requirements and would force all licence holders to conduct a recall simulation once every year to evaluate the effectiveness of their recall systems and processes and prepare a report outlining how the simulation was conducted and the results.
THC limits
The Consultation Paper proposes limits on the amount of Tetrahydrocannabinol (“THC”) in edibles, extracts and topicals. Limits are placed both on “discrete units” (individual servings) and on the total THC in a single package of any product:
- Cannabis edibles: limit of 10 milligrams of THC per discrete unit and per package.
- Cannabis extracts: limit of 10 milligrams of THC per discrete unit and limit of 1,000 milligrams (1 gram) of THC in a single package.
- Cannabis topicals: limit of 1,000 milligrams (1 gram) of THC in a package.
Restrictions on edibles
All edible cannabis products must be shelf-stable and cannot contain additives like vitamins or mineral nutrients. Given that edibles cannot require refrigeration or freezing, and that meat, poultry and fish ingredients would be prohibited (other than in dried forms) the proposed regulations raise questions about the viability of cannabis-infused items eventually being served in restaurants by chefs and others pursuing that variety of cannabis cuisine.
0.03 grams (3 milligrams), of caffeine per package will be permitted in edible cannabis products but the presence of caffeine is limited to caffeine present in edible products through the use of ingredients containing naturally occurring caffeine.
Restrictions on extracts
Because 0.025 grams of cannabis extract are deemed the equivalent of 1 gram of dried cannabis, and because no person may possess more than 30 grams of dried cannabis (or equivalent) a maximum package size of 7.5 grams will be imposed for cannabis extracts.
Restrictions on packaging and labels
The Consultation Paper introduces several amendments to packaging and labeling requirements:
- Terms such as “beer” or “wine” and elements associated with alcoholic beverages or brands would not be permitted on cannabis products.
- Representations regarding health benefits such as “a healthy diet low in saturated and trans fat may reduce the risk of heart disease”, or “oat fibre helps lower cholesterol” will be prohibited for cannabis products.
- Representations regarding cosmetic benefits, such as “reduces the appearance of wrinkles” or “softens skin” will be prohibited for cannabis products.
- Packages too small to hold Health Canada warning labels and messaging will be permitted fold out panels on packaging to ensure they display required information.
- A 90 millilitre size limit will be imposed on all liquid cannabis extracts.
This update is intended for general information only. If you have questions about the above, please contact a member of our Cannabis group.