Cannabis Regulations 2.0 – edibles, extracts and topicals in the spotlight

On December 20, Health Canada announced the opening of its consultation period on the regulations that will allow cannabis edibles, extracts and topicals to be sold in Canada. This consultation represents the next significant step in Canada’s cannabis legalization effort. Along with the consultation comes draft regulations that will give industry an opportunity to get an idea of the requirements they will need to meet. The draft regulations along with the Regulatory Impact Analysis Statement weigh in at a hefty 195 pages. Here are some of the key details.

THC limits

Edibles

• Caffeine: The total amount of caffeine allowed in edibles will be 30 mg. Additionally, caffeine is only allowed if it “occurs naturally” in the ingredients. This means no added caffeine is allowed.
• Beverages: Cannabis beverages will be regulated as “edible cannabis.”
• Alcohol: Alcohol will be largely prohibited in edible cannabis products. The proposed regulations allow a concentration of only 0.5% alcohol, and any association with alcoholic beverages is prohibited.
• Shelf stability: The proposed regulations require that cannabis edibles are shelf stable. Any cannabis edibles that require refrigeration to prevent spoilage are not permitted.
• Meat products: Meat products would be largely prohibited in cannabis edibles. There is one narrow exception for the use of certain dried meats, poultry or fish.
• Processing facilities: Cannabis edibles may not be made in the same facility where standard food processing occurs.

Extracts

• Carrier Agents: The proposed regulations allow for the addition of “carrier substances.” Substances that “are necessary to maintain the quality or stability of the cannabis product” will also be permitted. However, any substance that is added to an inhaled extract (e.g. vape cartridges) must have standard limits established in a pharmacopeia listed in the Food and Drug Regulations. Certain substances that are prohibited by the Tobacco and Vaping Products Act will also be prohibited in cannabis extracts.
• Flavouring: Cannabis extracts will be permitted to contain flavouring agents. However, sugars, sweeteners and sweetening agents, as defined in the Food and Drug Regulations are prohibited.

Topicals

• Safety: Any ingredient that “may cause injury” to the health of the user when used as intended is prohibited. Health Canada has compiled a list of ingredients called the Cosmetic Ingredient Hotlist, which is a list of substances that are prohibited in cosmetics. However, that list is not exhaustive.
• Therapeutic claims: The proposed regulations prohibit any express or implied representation on the packaging of a cannabis product that the cannabis product has health or cosmetic benefits.

Additional requirements

• Small packages: Under the previous regulations, some producers were unable to fit all of the required information on smaller packaging. The proposed regulations would allow fold-out panels to accommodate smaller packaging formats.
• Microbial and chemical contaminants: Limits for microbial and chemical contaminants will become more flexible. Rather than set a hard limit as the current regulations do, the proposed regulations will limit microbial and chemical contaminants to a limit that is appropriate for the product’s intended use.
• Possession limits: For any edible cannabis, cannabis extract or cannabis topicals with a THC concentration over 3%, the maximum amount that a person will be permitted to possess will be 7.5 grams.
• Recall readiness: At least once every 12 months, licensees would be required to conduct a recall simulation and evaluate the effectiveness of their recall systems and procedures.

Health Canada will be accepting comments on the proposed regulations until February 20, 2019. The federal government is targeting October 17, 2019, as the date on which the new regulations will go into effect.

The author wishes to thank articling student Daniel Weiss for his help in preparing this legal update.