SCCS Opinion on Benzophenone - 1 (CAS No. 131-56-6, EC No. 205-029-4) - SCCS/1672/24 - Preliminary Opinion
Résumé
SCCS Opinion on Benzophenone - 1 (CAS No. 131-56-6, EC No. 205-029-4) - SCCS/1672/24 - Preliminary Opinion Preliminary Opinion open for comments - Deadline: 13 January 2025 U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfenati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz The SCCS adopted this Opinion during the plenary meeting on 25 October 2024 (91 pages) Mise en ligne : 6 Novembre 2024 https://health.ec.europa.eu/publications/sccs-opinion-benzophenone-1-cas-no-131-56-6-ec-no-205-029-4_en https://health.ec.europa.eu/document/download/1161e3b7-8e52-47d8-9153-54433fa0d7fe_en?filename=sccs_o_293.pdf Publication date : 6 November 2024 Author : Scientific Committee on Consumer Safety (SCCS) Description SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry (Rapporteur), P.J. Coenraads (Chairperson), J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven SCCS external experts: E. Benfentati (Rapporteur), N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro , W. Uter, N. von Goetz Contact: SANTE-SCCS@ec.europa.eu On request from: European Commission SCCS Number: SCCS/1672/24 Adopted on: 25 October 2024 Conclusion of the opinion: (1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Benzophenone-1, does the SCCS consider Benzophenone-1 safe when used as a light stabilizer in cosmetic products up to a maximum concentration of 2%? Having considered the data provided, and the concerns relating to potential endocrine disrupting properties of Benzophenone-1, the SCCS cannot conclude on the safety of BP-1, because the information provided is insufficient to exclude genotoxicity. The available evidence also shows that BP-1 is an endocrine-active substance due to clear demonstration of estrogenic activity and weak anti-androgenic activity both in vitro and in vivo, and potential activity against thyroid modality in vitro. (2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Benzophenone-1 in cosmetic products? / (3) Does the SCCS have any further scientific concerns with regard to the use of Benzophenone-1 in cosmetic products? The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of BP-1 for the environment. Keywords: SCCS, scientific opinion, benzophenone – 1, Regulation 1223/2009, CAS No. 131-56-6, EC No. 205-029-4 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Benzophenone-1 (CAS No. 131-56-6, EC No. 205-029-4), preliminary version of 25 October 2024, SCCS/1672/24.