August 16, 2021
by Tammy J. Murphy, senior regulatory specialist, Supply Chain division
In July 2021, Health Canada posted a pre-consultation notice pertaining to potential amendments to the Cosmetics Regulations.
Cosmetics that are manufactured, imported, advertised and/or sold in Canada are subject to the Food and Drugs Act and various regulations, including the Cosmetic Regulations. These regulations state that “no person can sell any cosmetic that has in it any substance that may cause injury to the health of the user and when the cosmetic is used according to the directions on the label and under normal conditions of use.” Notification is required within 10 days of the first sale of a cosmetic and again if certain changes are made. According to Health Canada, the notification must include information such as “formulation, area of application, form and function.”
Another mandatory requirement is the disclosure of ingredients on the labels. This includes fragrances, which can be a single ingredient or a complex mixture of many ingredients. The Cosmetic Regulations allow parfum to be used at the end of the ingredients list to indicate that fragrances are used in the product instead of listing each ingredient that may be present in the fragrance. A potential amendment to this requirement is one of four main amendments that Health Canada is considering.
The proposed amendments are in the following areas:
- Mandatory disclosure of specific fragrance allergens on labels
- Greater flexibility in the disclosure of ingredients on labels of small packages
- Improved oversight of the cosmetic industry
- Updated administrative items
Interested stakeholders can request a comment package from Health Canada and submit comments prior to Aug. 30, 2021. The information received during this pre-consultation period may be used by Health Canada in the development of the actual proposed amendments. Proposed amendments will be published in the Canada Gazette Part 1 at which time there will be an additional public comment period.
Please see the Food and Drugs Act and the Cosmetic Regulations for details about requirements for cosmetic products. Additional information about cosmetic safety, labeling, ingredients and more can also be found on Health Canada’s Cosmetic Safety website.
Recommended action items:
- Review the Notice to determine if potential amendments to the Cosmetic Regulations may affect your products.
- Request a Notice to Interested Parties comment package from Health Canada.
- Submit comments prior to Aug. 30, 2021.
Reference:
Regulatory Roundup Newsletter
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