EU Amends Cosmetics Regulation Regarding Fragrance Allergens

By Percefoni Doufou-Shafiq, Ph.D., senior regulatory specialist, Supply Chain team, UL Solutions

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 labelling 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 labelling 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 labelling 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 labelling 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 labelling requirement yet. Based on the SCCS opinion, amendment (EU) 2023/1545 expands the list of fragrance allergens requiring individual labelling and includes them in Annex III to the Cosmetics Regulation.

Additionally, substances such as Prehaptens and Prohaptens which can be oxidized or bioactivated and transform to known allergens should be treated as equivalents to fragrance allergens and have the same labelling 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 Regulation by adding individual isomers and to align common names of the substances to those of the latest version of the Common Ingredients Glossary (names of ingredients as listed on product labels - Decision (EU) 2022/677). When multiple common ingredient names exist, it is set out in the individual labelling requirement which name should be used so that the label is more consumer friendly and streamlined.

Regulation (EU) 2023/1545 enters into force on Aug. 16, 2023, and is directly applicable to all Member States. Due to the possibly significant changes arising, such as adjusting product formulations, containers, withdrawing non-compliant products, and issuing new labels, the transition period for compliance is until July 31, 2026, for new products and July 31, 2028, for existing products.

UL’s ChemADVISOR™ Regulatory Database is being updated to reflect the changes.

References

• Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
• Regulation (EU) 2023/1545