Santé Canada : propositions réglementaires visant la divulgation des ingrédients des cosmétiques sur les étiquettes, dont les allergènes de parfum (en anglais)

The Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients ("the draft Regulations") was published in the Canada Gazette, Part I, on Feb. 11, 2023. The draft Regulations are open for consultation until April 22, 2023.

The stated objectives of the proposed regulatory changes are to increase the chemical transparency, improve the regulatory oversight, and address administrative updates for cosmetics, while continuing to facilitate alignment with the European Union ("EU") regulatory environment for cosmetic product labels.

Since 2006, cosmetic product labels have been required to list all ingredients present in the formulation for the product, primarily using internationally recognized nomenclature for cosmetics called INCI. This practice has been in alignment with the same naming conventions used in the EU, and similar requirements in the United States and other jurisdictions. However, one notable exception has been with respect to the declaration of fragrance ingredients and associated allergens.

To that end, the draft Regulations would:

• Introduce a requirement to disclose particular fragrance allergens on cosmetic labels when present in a quantity exceeding a specified threshold.
  • Fragrance allergens to be disclosed when present at a concentration >0.01% in rinse-off products and >0.001% in leave-on products.
  • Fragrance allergens to be disclosed within the list of ingredients on cosmetic labels.
  • Fragrance allergens would be those set out in the European Restricted Substances List (i.e. Annex III, titled List of Substances Which Cosmetic Products Must Not Contain Except Subject To The Restrictions Laid Down, of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products), which would be incorporated by reference into the Cosmetic Regulations. This list currently includes 24 fragrance allergens, but the list is subject to change by the EU.
• Introduce flexibility for cosmetics in small packages to disclose ingredients on a website, if certain conditions are met.
• Introduce a prohibition against selling a cosmetic if an initial notification, an amended notification or requested safety information has not been submitted as required.
• Modify certain other definitions and requirements related to cosmetic notifications, including revising the Concentration Ranges that may be used to indicate the amount of each ingredient within a product.

Gowling WLG has professionals with experience in the regulation of cosmetic products. Please contact us with any questions or concerns with respect to how these proposed changes may impact your business or how to get involved with the consultation.