EU and Canada Allergens

In a significant move toward improving consumer safety and transparency, Europe followed by Canada have amended their Cosmetic Regulations to mandate the disclosure of allergens as well as additional allergens on cosmetic labels. These new ingredient disclosure requirements provide consumers with the information needed to make informed choices about the products they use, particularly for those who may have sensitivities to allergens that could be found in cosmetics.

Key Takeaways

  • Europe and Canada have amended cosmetic regulations related to allergens
  • Mandates now exist for disclosure of allergens on labels
  • Regulations provide transparency to the consumer, particularly those with allergy sensitivity

What you need to know

Following the EU’s decision to increase the number of allergens to be disclosed on cosmetic labeling, Canada has also updated its cosmetic regulations to enhance transparency and protect consumers from potential allergic reactions to ingredients.

  • Effective April 12, 2026, all new and existing cosmetic products in Canada will be required to disclose the EU 24 fragrance allergens on their labels when present above certain concentrations
  • Rinse-off products: Allergens present at concentrations greater than 0.01% must be listed
  • Leave-on products: Allergens present at concentrations greater than 0.001% must be listed
  • These requirements align with the European Union’s Cosmetic Products Regulation, facilitating international consistency
  • Update from Health Canada on 2/21/2025: The following approach will be applied to the disclosure requirements for the first set of 24 fragrance allergens
  • From April 12, 2026 to April 11, 2027, Health Canada will focus on compliance promotion with regulated parties; and
  • From April 12, 2027 onwards, compliance and enforcement will follow a risk-based approach as per standard Departmental and program guidance

The Details

  • Allergen Disclosure Guidelines: Brands must list allergens for a given product type in the ingredient list when their concentration exceeds the specified thresholds.
  • Ingredient Listing Considerations: New allergens and the extended list of allergens mean a longer IL and less free space on cosmetic labels.  To help with this space issue, the same allergen grouping options for the EU also apply in Canada.  These groupings allow for one Group Name to be used in the IL to cover all allergens present in that Group.  However, it should be noted that not all allergens fall into a group and may still be named in the ingredient listing as a single allergen.
  • Small Package Labeling in Canada and Europe: For cosmetics sold in small packages with limited space, ingredient lists, including allergens, can be provided on a tag, tape, or card affixed to the container or package. In Canada, the ingredient list can also be provided on a website, if the outer label of the product includes a statement indicating that the full list of ingredients is available on a website and provides the website location.  In Europe, the Hand-in-Book symbol or an abbreviated indication can be used to to reference the ingredient list found elsewhere.
  • Many of the new allergens on the extended list are more likely to be found not just in fragrances and flavors but the overall formulation itself.  Be aware of this point when reviewing for the potential of grouping of ingredients in the fragrance and the formula.  Unique situations and examples are explained in the Cosmetics Europe Guide found in the Reference section of this article.
  • These changes aim to provide consumers with clearer information about cosmetic ingredients, enabling informed choices and reducing the risk of allergic reactions.

Timeline

All new and existing products sold in Canada must disclose the original EU 24 allergens.

Update from Health Canada on 2/21/2025
April 12, 2026 to April 11, 2027, Health Canada will focus on compliance promotion with regulated parties
All new and existing products for placing on the market in the EU must comply with the new, extended list of allergens.
All new products sold in Canada must disclose the EU expanded list of 81 allergens.
Update from Health Canada on 2/21/2025

April 12, 2027 onwards, compliance and enforcement will follow a risk-based approach as per standard Departmental and program guidance
European withdrawal of products from the market not labeled with the extended list of allergens.
All existing products marketed before August 1, 2026 must disclose the EU expanded list of 81 allergens.

Our expert advice

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Here are some important steps to consider:

  • Educate your business as to the regulatory changes, timelines, and action items to be taken.  Compliance may mean that many departments in the product development process and supply chain will need to work together.
  • Start requesting and tracking receipt of an updated extended allergen list document from your contract manufacturer or fragrance supplier for all fragrance raw materials.
  • Upload your documentation in the Ithos platform identifying the new allergen information, and run your new ILs to be used for Canada and Europe.
  • Generate new labeling which include and are reformatted to fit the new ILs.
  • Review current Canadian and EU artwork label and product production timelines to ensure compliance with effective dates.
  • If applicable, work with distributors and importers in these markets and review how they will address the compliance timelines as well.
Reference links

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