SCCS OPINION on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - SCCS/1651/23– 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 (136 pages) Mise en ligne : 8 Juin 2023 https://health.ec.europa.eu/publications/butylparaben-cas-no-94-26-8-ec-no-202-318-7_en https://health.ec.europa.eu/system/files/2023-06/sccs_o_275.pdf Details Publication date : 8 June 2023 Author : Scientific Committee on Consumer Safety (SCCS) Description SCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers (Rapporteur), 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/1651/23 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 Butylparaben, does the SCCS consider Butylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %? On the basis of safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid) is safe. (2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Butylparaben as a preservative in cosmetic products? / (3) Does the SCCS have any further scientific concerns with regard to the use of Butylparaben in cosmetic products? In the absence of solid exposure data for children to Butylparaben in cosmetic products, potential safety concerns have been noted by the SCCS. The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Butylparaben for the environment. Keywords: SCCS, scientific opinion, butylparaben, preservative, Regulation 1223/2009, CAS No. 94-26-8, EC No. 202-318-7 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on butylparaben (CAS No. 94-26-8, EC No. 202-318-7), preliminary version of 6-7 June 2023, SCCS/1651/23.