EU Expands the List of Fragrance Allergens in Cosmetic Products

On 26th July 2023, the European Union (EU) adopted Regulation (EU) 2023/1545 to update labelling of fragrance allergens under Annex III to Regulation (EC) 1223/2009 on cosmetic products.

This regulation came into force on 16th August 2023. A long transition period of 3 or 5 years is given to the industry to adapt the new requirements in response to Regulation (EU) 2023/1545. 

Expansion of Allergen List

This amendment contains several important changes:

1. Replaces 17 entries
2. Deletes 10 entries
3. Adds 45 entries

Transition Timeline

For new cosmetic products to be placed onto the EU market, they shall comply with the new requirement by 31st Jul 2026 (within 3 years). 

For existing cosmetic products already on the EU market, they shall comply with the new requirement by 31st July 2028 (within 5 years).

Allergens must be declared on the label when it is present in a concentration that exceeds:

• 0,001% in leave-on products
• 0,01% in rinse-off products

The below table shows the expanded list of fragrance allergens:

Grouping of Similar Substances

The regulation grouped similar substances into one entry. It also sets individual labelling requirement which name is to be used in the list of ingredients when there are multiple common ingredient names for a substance. 

Allergen will be either labelled individually for one specific substance (e.g. Benzyl Alcohol as ‘BENZYL ALCOHOL’) or by grouping for similar substances (e.g. Citral, Geranial and Neral as ‘CITRAL’)

What to Do?

Manufacturers and fragrance suppliers are suggested to expand the scope of document to cover new allergens. All industry players, including brands and responsible person, shall make sure the product label, cosmetic product safety report (CPSR) and product information file (PIF) up-to-dated and in compliance with the new requirement by the end of transition timeline.