A major regulatory change is approaching for cosmetic products in the European Union. From 31 July 2026, cosmetic products placed on the EU market must include the disclosure of 56 additional fragrance allergens on product labels whenever applicable.
This amendment goes far beyond a simple label update. It also requires manufacturers to review:
- Product Information Files (PIF),
- CPSRs,
- IFRA documentation,
- raw material assessments,
- CPNP notifications.
Regulatory Background
In 1999, the SCCNFP (now SCCS – Scientific Committee on Consumer Safety) identified 26 fragrance substances that should be declared on cosmetic labels to help prevent allergic reactions.
Further scientific and clinical evaluations later demonstrated that many additional fragrance ingredients may also act as sensitizers.
As a result, Commission Regulation (EU) 2023/1545 amended Annex III of Cosmetic Regulation (EC) No 1223/2009 by introducing 56 additional fragrance allergens subject to mandatory labelling requirements.
The total number of declarable fragrance allergens now exceeds 80 substances.
What Are Fragrance Allergens?
Fragrance substances are organic compounds used in perfumes, cosmetics, detergents, and many consumer products due to their pleasant odours. However, repeated skin exposure to certain fragrance ingredients may lead to: contact allergies, sensitization, allergic contact dermatitis (eczema).
The EU Commission aims to provide consumers with transparent allergen information so sensitised individuals can avoid substances to which they are allergic.
Required Documentation:
In addition to standard technical documentation, fragrance ingredients require specific supporting documents:
- IFRA Certificate
- Confirms compliance of the fragrance composition with IFRA standards.
- Allergen Declaration / Allergen List
- Provides a detailed breakdown of regulated fragrance allergens contained in the fragrance composition.
- Assessment must now consider all 82 allergens listed in Annex III.
Analytical testing of the finished product is also strongly recommended.
Disclosure Thresholds
Under EU cosmetics legislation, fragrance allergens must be declared when concentrations exceed:
0.001% in leave-on products
0.01% in rinse-off products
Does This Only Concern Synthetic Fragrances?
No. Many natural ingredients and essential oils naturally contain allergenic compounds. Ingredients such as: essential oils, botanical extracts, plant-derived oils may also fall under the same labelling obligations.
Appropriate allergen documentation and analytical verification should therefore also be considered for natural-origin ingredients.
Key Actions for Beauty Brands
To comply with the July 2026 deadline, brands should:
- Obtain updated supplier documentation,
- Review IFRA certificates and allergen declarations,
- Assess allergen concentrations in finished products,
- Update labels where necessary,
- Revise CPNP notifications,
- Update CPSRs accordingly.
What Does “Placing on the Market” Mean?
The new requirements apply only to products first placed on the EU market after 31 July 2026. According to the EU Blue Guide, “placing on the market” means: The first supply of a product on the EU market.
Crutial Point:
Even if a product type already exists on the market, every new individual unit introduced after the regulatory deadline must comply with the updated requirements. Products already placed on the market before 31 July 2026 may continue to be sold until 31 July 2028.