Allergens Requiring Labeling in Cosmetics

Last updated: August 2025

In Europe, allergen labeling in cosmetic products is strictly regulated under Regulation (EC) No 1223/2009. Recognized allergenic substances are listed in Annex III of this regulation. When these substances are present above specific thresholds, their disclosure on the product label is mandatory to inform consumers and help prevent allergic reactions.

These allergens are mainly found in fragrances or essential oils and must be listed in the INCI ingredients list when their concentration exceeds:

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

For some allergens, the regulation uses a “grouping name”, meaning a single ingredient name can represent multiple related chemical substances. In such cases, the combined total concentration of all substances in the group is used to determine if the threshold for labeling is exceeded.