Fragrance allergens update EU
The European Commission issued a new regulation (EU) 2023/1545 on July 27, 2023, updating the list of fragrance allergens in cosmetic products. Fragrance substances are commonly used in various cosmetic and household products, but they can cause contact allergies in some individuals. To protect consumers, the regulation aims for both primary prevention by restricting fragrance allergens and secondary prevention by providing information on allergens on product labels. The update includes 56 additional allergens, which must be individually labeled on the cosmetic product packaging if their concentration exceeds specific limits.
The update is based on the opinion of the Scientific Committee on Consumer Safety (SCCS), confirming the relevance of existing fragrance allergens and identifying new ones causing allergies in humans. The regulation ensures consistency by aligning names and grouping similar substances in one entry in Annex III of Regulation (EC) No 1223/2009.
Manufacturers are required to list fragrance allergens on product labels if their concentration exceeds:
- 0.001% in leave-on products
- 0.01% in rinse-off products
The new regulation provides transition periods for compliance:
- Products must comply with the new labelling requirements within 3 years of the regulation’s publication (deadline: July 31, 2026) for placing the product on the market.
- Products already on the market must comply within 5 years of the regulation’s publication (deadline: July 31, 2028) for making the product available off the shelf.
The updated regulation also aligns existing allergen names with the latest version of the Common Ingredients Glossary, updates CAS and EC numbers, and groups similar substances into a single entry.
In response to these changes, Cosmetics Europe (CE), the European personal care association, is actively working on comprehensive guidance to assist companies in complying with the new regulations. This guidance is expected to be published before the end of 2023 and will cover various aspects, including the proper use of grouping names.
Cosmereg is a regulatory firm that assists cosmetic producers in their efforts to remain compliant with EU/UK cosmetic regulations.for more information about UK Cosmetic regulations email us.
