Responsible Person in Canada: Amendments to SOR/2024-63

With the implementation of amendment SOR/2024-63, effective April 2024, the definition of “Manufacturer” in the Cosmetics Regulations has been expanded to include the designation of a “Responsible Person.” This figure is a representative established in Canada, authorized to act on behalf of foreign companies and assume legal responsibilities related to regulatory compliance.

Table of contents

1. Responsibilities of the Responsible Person in Canada

2. Benefits and Implications

3. Our conclusion

As of October 9, 2024, new regulatory provisions allow foreign companies to appoint a representative established in Canada as their Responsible Person. This representative, by assuming this role, can operate as if it were the manufacturer itself with regard to compliance with local regulations.

Responsibilities of the Responsible Person in Canada

The Responsible Person acts as the primary link between foreign companies and Health Canada. Their primary responsibilities include:

1. Regulatory Compliance : Ensure products comply with all regulatory requirements, including labeling, safe formulations, and ingredient restrictions.

2. Post-market Claims and Safety Management : Monitor and report adverse events associated with products, following pharmacovigilance requirements.

3. Interaction with Authorities : Facilitate audits, respond to regulatory queries and provide additional documentation to Health Canada when required.

4. Recall Management : Coordinate corrective actions in case of defective or unsafe products.

   
   

Responsible Person in Canada: Benefits and Implications

The introduction of the Responsible Person offers several benefits, including:

• Facilitates access to the Canadian market : Allows foreign brands to operate without the need to establish a local corporate entity.

• Improves oversight and traceability : Provides Health Canada with a clear contact to manage regulatory incidents and inquiries.

• Promotes consumer safety : Strengthens controls to prevent non-compliant products from entering the market.

  
  

However, it also poses challenges, such as the need to adequately train and educate entities designated as Responsible Persons and increased operating costs for foreign companies.

Our conclusion

The Responsible Person model in Canada represents a significant step towards stricter and more effective regulation of consumer products. This model not only strengthens consumer confidence, but also ensures a level of regulatory compliance in line with international best practices.

Contact an Expert in Canadian Cosmetic Regulation

Companies interested in operating in Canada should carefully consider selecting a competent Responsible Person prepared to assume the legal and regulatory obligations in this dynamic market.