Health Canada Amends Cosmetic Regulations

Health Canada Amends Cosmetic Regulations

May 1, 2024 By

On April 24, 2024, Health Canada published amendments to the Cosmetics Regulations in Canada. These amendments, detailed in the Cosmetic Regulations under the Food and Drugs Act, signify important changes in the disclosure of cosmetic ingredients and aim to enhance oversight within the industry.

Background

Health Canada, trusted with protecting Canadians’ health and safety, oversees cosmetics sold in the country, with regulations dating back to 1939 within the Food and Drugs Act. Initially considered under the Act’s definition of “drug,” cosmetics gained separate regulations in 1977. Essential for daily hygiene and grooming, these products must meet stringent safety criteria, prohibiting any harmful substances. Health Canada’s post-market approach involves manufacturers and importers notifying within 10 days of sales, with over 57,000 notifications processed annually. Since 2006, cosmetic labels have been mandated to list ingredients using the INCI naming convention, mirroring global standards and ensuring transparency, including the disclosure of fragrance allergens, aligning with EU practices since 2005.

What Are the Amendments?

  1. Disclosure of Fragrance Allergens: The regulations now mandate the disclosure of certain fragrance allergens on cosmetic labels, subject to specified concentration limits.
  2. Flexibility for Small Package Labeling: Manufacturers can now opt to use a website to disclose complete ingredient lists, accompanied by bilingual statements on product labels directing consumers to the online resource.
  3. Enhanced Oversight: Definitions for “manufacturer” and “importer” have been clarified, along with strengthened notification requirements, including provisions for discontinuation of sale and response timelines to Ministerial requests.
  4. Modernized Labelling Requirements: Updates include the removal of distributor information from cosmetic notifications, identification requirements for rinse-off and leave-on products, and the use of INCI names for ingredient identification.
  5. Safety Evidence Requirement: Importers may now be required to provide evidence of safety, alongside manufacturers, to ensure compliance with regulatory standards.

How Will This Impact Industry?

Most amendments, barring those concerning the disclosure of fragrance allergens on cosmetic labels, are scheduled to take effect 180 days after registration, specifically by October 9, 2024. This timeframe necessitates industry stakeholders to promptly adapt to revised labelling requirements, enhanced oversight mechanisms, and updated notification procedures. However, it’s noteworthy that the provisions related to disclosing fragrance allergens will be implemented with a delay, becoming effective two years after registration, precisely on April 12, 2026. This staggered implementation allows businesses time to adjust their practices and ensure compliance with the new regulations. Industry players must proactively navigate these changes to uphold regulatory compliance, maintain consumer trust, and facilitate seamless operations within the evolving regulatory landscape.

How Can I Be Prepared?

To prepare for the upcoming amendments to the Cosmetic Regulations, it’s essential to familiarize yourself with the full update provided by Health Canada and review your cosmetic product labels to ensure compliance. Our cosmetic label review services offer expert assistance in assessing compliance and mitigating risks. By proactively addressing any non-compliance issues and leveraging specialized support, you can navigate the regulatory changes effectively and maintain your competitive edge in the cosmetics industry.