Regulatory amendments concerning the sale of cosmetics in Canada

The Government of Canada recently released the Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients (the Amending Regulations) in Canada Gazette, which is now open for public comment until April 22, 2023. 

The Amending Regulations address notification and labeling requirements for cosmetics under the Food and Drugs Act and the Cosmetic Regulations, and consequentially under the Cannabis Act. Importers will also have greater obligations to ensure products sold in Canada comply with the Cosmetic Regulations, especially when the manufacturer is not based in Canada. 

Changes to notification requirements for cosmetics

Three types of notifications are currently regulated and maintained by Health Canada. First, the Cosmetic Regulations require the manufacturer and importer to submit a cosmetic notification form (CNF) to Health Canada within 10 days of the first Canadian sale of the cosmetic. Second, a revised CNF must be submitted to Health Canada within 10 days of modifying information previously provided. Third, persons who submitted the CNF must promptly provide additional information requested by Health Canada regarding the CNF. 

The Amending Regulations clarify that:

• cosmetics cannot be sold beyond the initial 10-day period unless the CNF has been filed;
• cosmetics that require a revised CNF to be provided cannot be sold beyond the 10-day period after such revised notification was required;
• if the minister has requested additional information from the manufacturer or importer with respect to the CNF, the cosmetic cannot be sold after 10 days from when the minister requested the information; and 
• the discontinuation of sale in Canada is a change requiring the filing of a revised CNF. 

If a manufacturer or importer does not respond to Health Canada’s inquiry related to a CNF, amendment, or request for information, then Health Canada may pursue prosecution or seizure from the market.

The CNF itself must also now include the following information:

• the functionality of the cosmetic (e.g., as a leave-on product or a rinse-off product);
• a list of the cosmetic’s ingredients based on its International Nomenclature Cosmetic Ingredient (INCI) name or its chemical name;
• the exact concentration or range of concentrations for each ingredient; and
• the name and address of the manufacturer or importer in Canada.

“Rinse-off product” and “leave-on product” are now defined terms. The definitions relate to whether the product is “intended to be removed after application to” or “intended to stay in prolonged contact with” the skin, hair, or mucous membranes.

Health Canada states that the rationale for these changes is that the risk profile of an ingredient can be significantly different based on the functionality and concentrations of the ingredients. In addition, since manufacturers and importers may have multiple distributors that can change throughout the product’s lifespan, there is no longer a need to report the names of distributors on the CNF. As such, the change of distributors no longer requires notifying parties to update their cosmetic notification, as this information can be obtained by Health Canada as needed.

Under s. 29 of the Cosmetic Regulations, Health Canada may request a manufacturer or importer to submit, in writing, evidence to establish the safety of a cosmetic under the recommended or normal conditions of use on or before a specified date. The Amending Regulations would impose a similar obligation on the importer of a cosmetic. For the purposes of protecting proprietary information, a foreign manufacturer or a third party would be able to provide the evidence of safety information to Health Canada on an importer’s behalf.

Changes to labelling requirements for cosmetics

The Amending Regulations have increased the labeling requirements for cosmetics. The Amending Regulations do not make clear whether cosmetics currently sold on the Canadian market will be subject to the new labeling requirements when the Amending Regulations come into force.

The following information will now be required on all cosmetic labels for products sold in Canada:

• the inner label must contain an email address, a telephone number, website address, postal address or any other information that enables consumers to ask direct questions about the cosmetic to a contact person; 
• ingredients must continue to be listed by their INCI name unless listed in the Schedule to the Cosmetic Regulations, in which case, the ingredient may be listed by its (a) European Union (EU) technical name; (b) appropriate INCI name and French equivalent; or (c) all three names; and
• fragrance allergens listed on the European Restricted Substances List must be listed in the cosmetic label’s list of ingredients when concentrations are greater than 0.01% in rinse-off products, and 0.001% in leave-on products.

For cosmetic containers or outside packages that are too small for the label to be clear and legible, in compliance with s. 18(b) of the Cosmetic Regulations, the list of ingredients may now appear on a tag, tap or card affixed to the container or package, or on a website, provided that the outer label contains a statement specifying the website and that the list of ingredients appears on the website.

The applicable day on which the fragrance allergen must be listed in the list of ingredients of a cosmetic in order for the cosmetic to be made available on the EU market, as set out or referred to in the entry in the European Restricted Substances List for that fragrance allergen, will similarly apply in Canada.

The author wishes to thank Katie Cheung, articling student, for her help in preparing this legal update.