EU Cosmetic Regulation Adds 56 New Fragrance Allergens

Annex III update will give manufacturers three years to update labelling, reformulate products, and widen testing scope

On July 26, the EU Commission published a regulation update regarding the labelling of fragrance allergens in cosmetic products in the Official Journal of the European Union.

Commission Regulation (EU) 2023/1545 introduces 56 new fragrance allergens requiring labelling in response to a Scientific Committee on Consumer Safety (SCCS) opinion that concluded there was a potential human health risk from these additional allergens when present in cosmetics. They advised that the obligation to label these additional allergens should be introduced to Annex III of Regulation (EC) No 1223/2009 if they are present at over 0.001% in leave-on products and 0.01% in rinse-off products.

Amendments to existing fragrance allergens

This change expands the previous list of 25 labelled allergens to more than 80. The regulation update also amended existing entries for certain fragrance allergens, such as adding isomers and updating CAS and EC numbers, and it details how substances with multiple common names will be grouped together as one entry. For example, geranial and neral will be known as "citral." This reduces confusion for the consumer, as "citral" is the more commonly known name.

Additionally, fragrance substances such as prehaptens and prohaptens, which can be transformed to contact allergens through oxidation or bioactivation, will now be treated as equivalent to fragrance allergens; therefore, they are subject to the same regulatory restrictions and requirements.

Implementation timeline for new fragrance allergens regulation

Manufacturers have less than 3 years to adhere to the new regulation, allowing for time to reformulate, collaborate with their fragrance suppliers, amend product packaging and labelling, and remove non-compliant products from the market. The following timeline has been established:

• July 31, 2026, for placing new products on the market, meaning only compliant products are allowed to be placed on the EU market after this date.
• July 31, 2028, for making available on the market (off-shelf). From this date, only compliant products can be made available in the EU market, meaning that companies should withdraw non-compliant products placed on the market before the regulation update.

For cosmetic manufacturers, brands, and companies placing product on the EU market, this will mean:

• Fragrance suppliers/manufacturers will need to widen their scope of testing for new allergens.
• Any manufacturer/brand/company that is the legal "Responsible Person" (RPs are responsible for ensuring all cosmetic products they place on the EU market comply with the regulation) will be required to update their Cosmetic Product Safety Reports (CPSRs) and Product Information Files (PIFs) to include the updated allergen information before the implementation date.