On July 27, 2023, the EU Commission published Regulation (EU) 2023/1545, which updates labelling requirements for fragrance allergens in cosmetic products. It provides an expanded list of allergens that must be disclosed on cosmetic product labels. The fragrance allergens listed in entries 45 and 67—92 of Annex III to Regulation (EC) No 1223/2009 remain relevant, but an additional 56 allergens have been identified to cause allergies in humans and have therefore been added to Annex III.
Fragrance allergens have to be listed on the labels if they are present in a concentration that exceeds:
• 0.001% in leave-on products, and
• 0.01% in rinse-off products.
The transition periods for this new regulation are:
• 3 years for placing the product on the market (deadline: July 31, 2026)
• 5 years for making the product available on the market – off the shelf (deadline: July 31, 2028)
In addition to expanding the list of allergens, the regulation aligns existing allergen names with the latest version of the Common Ingredients Glossary. It also updates CAS and EC numbers and groups similar substances into one entry.
In response to the updated labelling requirements, Cosmetics Europe (CE), the European personal care association, is working on comprehensive guidance to help companies comply with the new regulations. This guidance, expected to be published before the end of 2023, will offer insights on various aspects, including the proper use of grouping names.
