Canada amends cosmetic regulations for cosmetic fragrance allergens

On 24 April 2024, Health Canada published an amendment to the labeling and notification requirements for cosmetic ingredients. The amendment was published in the Canada Gazette, part II, Volume 158, No.9. The amendment was adopted on 12 April 2024 and comes into force 180 days after the publication in the Gazette. The requirement for the disclosure of fragrance allergens comes into force on the second anniversary of the day on which these Regulations were registered.

Background Information

Health Canada is amending the Regulations to require the disclosure of certain fragrance allergens on cosmetic labels if they are present above a specified threshold. The amendments require fragrance allergens to be listed in the ingredient list on cosmetic labels and to be included in the cosmetic notification.

In July 2023 the EU adopted amendments to the Cosmetic Regulation (EC 1223/2009), so that Annex III now contains 81 entries that identify fragrance allergens for disclosure on cosmetic labels when present above a defined concentration level. The transition time for implementing the modifications is three years (July 31, 2026) for new products that enter the market, and five years (July 31, 2028) for current products to sell through.

The amended Canadian Regulations incorporate these allergens via an ambulatory incorporation by reference, ensuring compliance with EU regulations. This ensures that the rollout of new fragrance allergen disclosures on cosmetic labels in the Canadian market coincides with similar implementations in the European Union (EU) market, maintaining alignment between the two regions' timelines.

Other amendments to the cosmetic regulations are as follows:

• Health Canada is amending the Regulations to allow cosmetics sold in small packages to disclose their ingredients, including fragrance allergens, on a website. A bilingual statement is required on the label and a digital mechanism, such as a QR code, is also proposed.

• Improving the control of cosmetics.

• Updating the definition of manufacturer and adding the definition of importer.

• Strengthen the cosmetic notification requirement.

• Remove distributor information from the cosmetic notification.

• Add a requirement to identify rinse-off or leave-on in the cosmetic notification.

• Add a requirement to identify ingredients by their INCI name on the cosmetic notification.

• Amend the table of concentration ranges for the cosmetic notification.

• Add the possibility to request evidence of safety from the importer.

• Modernization of the contact information on the label.

• Administrative changes.