SCCS OPINION on Methylparaben (CAS No. 99-76-3, EC No. 202-785-7) - SCCS/1652/23– Preliminary Opinion U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz The SCCS adopted this document during its plenary meeting on 6-7 June 2023 2023 (95 pages) Mise en ligne : 8 Juin 2023 https://health.ec.europa.eu/publications/methylparaben-cas-no-99-76-3-ec-no-202-785-7_en https://health.ec.europa.eu/system/files/2023-06/sccs_o_276.pdf Details Publication date : 8 June 2023 Author : Scientific Committee on Consumer Safety (SCCS) Description SCCS members: U. Bernauer (Rapporteur), L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven SCCS external experts: E. Benfentati, 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/1652/23 Adopted on: 6-7 June 2023 Conclusion of the opinion: (1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Methylparaben, does the SCCS consider Methylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.4% (as acid) when used on its own and up to 0.8% (as acid) for mixtures of esters as indicated in entry 12 of Annex V to the Cosmetics Regulation? On the basis of the safety assessment of Methylparaben, and considering the concerns related to potential endocrine activity, the SCCS has concluded that Methylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.4% (as acid) when used on its own and up to 0.8% (as acid) for mixtures of esters as indicated in entry 12 of Annex V to the Cosmetics Regulation. (2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Methylparaben as a preservative in cosmetic products? / (3) Does the SCCS have any further scientific concerns with regard to the use of Methylparaben in cosmetic products? The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Methylparaben for the environment. Keywords: SCCS, scientific opinion, methylparaben, preservative, Regulation 1223/2009, CAS No. 99-76-3, EC No. 202-785-7 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Methylparaben (CAS No. 99-76-3, EC No. 202-785-7), preliminary version of 6-7 June 2023, SCCS/1652/23.