With the publication of an official notice on March 6th, Health Canada has backed down on its initial position that the concentration of fragrance allergens be reported in cosmetic notifications and is making such reporting “optional”. This formal notice follows Health Canada’s announcement at CA’s Fall Regulatory Workshop last November that they had heard the arguments of CA on behalf of industry and would take the necessary steps to reverse their initial position.
As you may recall following the adoption of fragrance allergen labelling in Canada for cosmetics, certain Health Canada officials interpreted the regulations to require that the concentrations of these substances be specifically reported in the notification rather than be included under the category of “fragrance/parfum” as had been the case. As these minute levels are difficult to determine within a fragrance ingredient and are not easily provided by suppliers, the presence of the substance is already included in the ingredient listing (and so inform consumers of their presence), and as the concentration level offered no appreciable benefit to regulators that they could have obtained through established means, CA undertook a significant advocacy effort to overturn this view. We also took issue with the proposed interpretation of the regulation. Thankfully, our arguments prevailed saving significant effort by member companies for no appreciable benefit to consumers or consumer safety.
Additional details which member companies should note include:
Reporting the concentration of fragrance allergens on CNF is now optional. While Health Canada is not formally amending the Cosmetic Regulations, they are introducing policy flexibility regarding these disclosures.
The “Wins” at a Glance
- Concentration Reporting is Now Optional: reporting the specific concentration or range code on the CNF will now be optional rather than mandatory for fragrance allergens.
- The Hotlist Exception: If a fragrance allergen is also restricted on the Cosmetic Ingredient Hotlist (e.g., Eucalyptus, Camphor, or Methyl Salicylate), providing the concentration or range code remains mandatory.
Operational Updates
- CNF Updates
The current CNF still requires a concentration entry. However, Health Canada is revising the form to allow allergens to be entered without this data. This update is expected for Summer 2026.
- Interim Strategy: If you do not have the concentration data, you can wait to file your amended CNF until the new form is released.
- Known Concentrations: If you do have the data, Health Canada encourages its inclusion however this is not mandatory. Ensure you check the “Fragrance Allergen” box so the concentration does not count toward the total formula concentration.
- Revised Guidance
An updated Cosmetic Notification Guide will be released concurrently with the new form.
If you have any questions or concerns please reach out to regulatory@cosmeticsalliance.ca.
