Health Canada enforces Canadian-based representative requirement for cosmetics

On 5 March 2025, Health Canada updated its cosmetic notification form to include an entry for the Canadian-based representative.

Brand-owners must have a representative based in Canada if they want to sell cosmetics on the Canadian market.

Amendment to the Canadian Cosmetics Regulations

In April 2024, the Canada Gazette published an amendment to the Canadian Cosmetics Regulations, expanding the definition of “manufacturer” to include a representative with a Canadian address for brand owners based outside of Canada. This amendment officially came into force on 9 October 2024.

While Health Canada initially allowed a transition period before strict enforcement, past challenges with notifiers based outside Canada led to difficulties in obtaining necessary product information and holding a responsible party accountable for product compliance and safety.

Definition of manufacturer in Canada

The definition of “manufacturer” under the Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients (SOR/2024-63) has been updated to include:

• A person in Canada who sells a cosmetic under their own name, trademark, trade name, or other identifying mark they own or control.
• A person in Canada authorised to act on behalf of a foreign entity that sells a cosmetic under its own name or brand.

The revised definition clarifies the hierarchy of responsibility when no Canadian entity meets the criteria. In such cases:

• The importer – defined in Section 2 of the Regulations, as “a person that imports a cosmetic into Canada for the purpose of selling it” – assumes the responsibility.
• If no importer exists, the Canadian fabricator or processor acting on behalf of the foreign brand owner takes on the responsibility.

It is worth noting that Health Canada’s newly published guidance refers to the entity authorised to act on behalf of the manufacturer as a “responsible person” – despite this terminology not being explicitly used in the regulations.

Role of the manufacturer’s representative

The obligations of manufacturers, which their representatives will assume, include:

• Compliance with ingredient restrictions.
• Submission of a Cosmetic Notification Form.
• Proper product classification and marketing claims.
• Labelling compliance.
• Keeping available the evidence of safety of cosmetics – similar the European Cosmetic Product Safety Report.

Comparison with EU Cosmetics Regulation

The expanded definition of “manufacturer” purposefully aligns Canada’s regulatory framework more closely with the European Union’s Cosmetics Regulation (EC No. 1223/2009). The amended definition mirrors the EU’s “responsible person” concept, reinforcing Canada’s commitment to regulatory harmonization.

Do you have questions on compliance of cosmetics in Canada? Contact us here or at coslaw@obelis.net.

References:

Canada Gazette. (2024). SOR/2024-63: Regulations Amending Certain Regulations Concerning Drug and Medical Device Safety. Retrieved on 12 February 2025.

Canada Gazette. (2024). Official Publications of the Government of Canada. Retrieved on 12 February 2025.

Justice Laws Website. (2024). Food and Drugs Act – Cosmetic Regulations (C.R.C., c. 869). Retrieved on 12 February 2025.