Health Canada Proposed Regulations for Cannabis Edibles, Extracts and Topicals

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The moment we’ve all been waiting for – Health Canada releases proposed regulations for additional cannabis products including edibles, extracts and topicals. These products will be permitted for legal sale under the Cannabis Act no later than October 17, 2019. Health Canada has opened a consultation period on the proposed regulations with feedback accepted until February 20, 2019.

Here are some of the key points to take away from the draft regulations:

  • Limits on THC content
  • A maximum of 10 mg of THC per package for cannabis edibles (solid or beverage; resulting in products that are essentially a single serving size)
  • A maximum of 10 mg of THC per unit (e.g. capsule) or dispensed amount and 1000 mg of THC per package for ingestible cannabis extracts
  • A maximum of 1000 mg of THC per package for inhalable cannabis extracts, concentrated cannabis extracts and cannabis topicals
  • A ban or limit on the following additives: vitamins, minerals, alcohol, sugars, colours, sweeteners, nicotine and caffeine
  • Cannabis topicals are for use on skin, hair and nails (excluding eyes and damaged skin) and must only contain cosmetic grade ingredients
  • All edible cannabis products would need to be shelf-stable (i.e. they could not require refrigeration or freezing).
  • Packaging must be plain and child-resistant (with a maximum package size of 90 mL for ingestible and inhalable cannabis extracts and a maximum package size of 7.5 g for concentrated cannabis extracts)
  • Products must not be appealing to children, must not make health, dietary or cosmetic claims and must not contain elements that would associate the product with alcoholic beverages or brands of alcohol
  • Labelling must contain the following: standardized cannabis symbol for products containing THC, a health warning message, THC/CBD content, an ingredient list, allergens, nutrition facts table, the intended use (for extracts and topicals only), the directions for use and a warning statement about not swallowing or using on broken skin (topicals only)

So, what does all of this mean for industry? Consider the following:

  1. It is proposed that a processing license (standard or micro) would be required in order to manufacture cannabis edibles, cannabis extracts and cannabis topicals, and to package and label these types of cannabis products for sale to consumers.
  2. With food safety and public health concerns around manufacturing facilities that produce multiple products, it is proposed that production of edible cannabis at a site where conventional food products are also being manufactured for sale could only be done if the edible cannabis was being produced within another building within the licensed site. This means that food facilities may require a separate site for processing of cannabis edibles.
  3. The Good Production Practices, as required under the Cannabis Regulations, are proposed to be amended to adapt aspects of the Safe Food for Canadians Regulations (SFCR) to address the risk of contamination and foodborne illness associated with edible cannabis.

How we can help you

Cannabis License Experts offers end-to-beyond license solutions for cannabis businesses to meet federal or provincial regulations.  Contact us today to discover how we can license and legalize your cannabis business and provide you with an Edibles Safety Plan to help get you started.

Resources:

https://www.canada.ca/en/health-canada/programs/consultation-strict-regulation-edible-cannabis-extracts-topicals.html

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-medication/cannabis/resources/proposed-regulations-edible-cannabis-extracts-topical-eng.pdf

https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html

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