On July 26, 2023, the EU Commission published Regulation (EU) 2023/1545 amending Annex III to the Cosmetics Regulation (EC) 1223/2009 with regards to individual labeling requirements of fragrance allergens in cosmetic products by adding new substances and updating restrictions to certain already listed fragrance allergens.

Fragrance substances are used in various products, including cosmetic products, to provide a characteristic, pleasant odor to a product but they can possibly induce contact allergy and sensitization to a person. Under Article 19(1), point (g) of the Cosmetics Regulation, ingredients used as fragrance compositions are listed on the label as "parfum" or "aroma." However, for substances deemed as fragrance allergens, individual labeling is required when these substances are present at concentrations greater than 0.001% in leave-on products and greater than 0.01% in rinse-off products. Before amendment (EU) 2023/1545 was published, only 24 fragrance allergens requiring individual labeling were listed in Annex III of the Cosmetics Regulation.

The Commission requested from the Scientific Committee on Consumer Safety (SCCS) to research additional fragrance allergens for which the individual labeling requirement would apply. The SCCS adopted opinion SCCS/1459/11 (of 26-27 June 2012), identifying 56 additional substances, which caused allergies to humans but had no individual labeling requirement yet. Based on the SCCS opinion, amendment (EU) 2023/1545 expands the list of fragrance allergens requiring individual labeling and includes them in Annex III to the Cosmetics Regulation.

Additionally, substances such as Prehaptens and Prohaptens which can be oxidized or bio-activated and transform to known allergens should be treated as equivalents to fragrance allergens and have the same labeling requirements. To facilitate the work of economic operators and national authorities, it was also necessary to update certain existing entries for fragrance allergens in Annex III to the Cosmetics Regulat

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