"SCCS OPINION ON Octocrylene" SCCS/1627/21- Preliminary Opinion U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von Goetz The SCCS adopted this document by written procedure on 15 January 2021 (47 Pages) Mise en ligne 18 January 2021 https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_249.pdf SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry (Rapporteur), P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven SCCS external expert: A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur) Contact: SANTE-C2-SCCS@ec.europa.eu On request from: European Commission SCCS Number: SCCS/1627/21 Adopted on: 15 January 2021 Conclusion of the opinion: 1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Octocrylene, does the SCCS consider Octocrylene safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10% (as acid)? On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of Octocrylene (CAS No 6197-30-4), the SCCS considers that it is safe at concentrations of up to 10% when used individually or together as a UV-filter in cosmetic products, i.e. in sunscreen cream/lotion, sunscreen pump spray, face cream, hand cream and lipstick. Also, the use of sunscreen propellant spray is considered safe at concentrations of up to 10% when used individually but not safe when used together with face cream, hand cream, and lipstick. 2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Octocrylene as a UV-filter in cosmetic products? The use of Octocrylene in sunscreen propellant spray is considered safe when its concentration does not exceed 9% when used together with face cream, hand cream and lipstick containing 10% Octocrylene. 3. Does the SCCS have any further scientific concerns with regard to the use of Octocrylene in cosmetic products? The SCCS considers that, whilst there are indications from some in vivo studies to suggest that Octocrylene may have endocrine effects, the evidence is not conclusive enough at present to enable deriving a specific endocrine-related toxicological point of departure for use in safety assessment. Contact sensitisation to Octocrylene has been reported, however, taking into consideration the widespread use of Octocrylene in cosmetic products, the number of reported cases of allergic contact dermatitis appears to be negligible. It should be noted that occurrence of photoallergy to Octocrylene is strongly related to a previous photoallergy to topical ketoprofen. Exposure to Octocrylene from other products than those in this Opinion has not been considered. Keywords: SCCS, scientific opinion, Octocrylene, UV-filter, Regulation 1223/2009, CAS No 6197-30-4, EC No 228-250-8 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Octocrylene (CAS No 6197-30-4, EC No 228-250-8), preliminary version of 15 January 2021, SCCS/1627/21.