SCIENTIFIC ADVICE – children exposure on Methyl salicylate,(methyl 2-hydroxybenzoate) - SCCS/1654/23 - Preliminary version U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, 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 by written procedure on 15 May 2023 (22 Pages) Mise en ligne : 16 May 2023 https://health.ec.europa.eu/publications/sccs-scientific-advice-children-exposure-methyl-salicylate-methyl-2-hydroxybenzoate_en https://health.ec.europa.eu/system/files/2023-05/sccs_o_274.pdf Details Publication date : 16 May 2023 Author : Scientific Committee on Consumer Safety (SCCS) Description SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle (Rapporteur), M. Stepnik, T. Vanhaecke, S. Wijnhoven SCCS external experts: E. Benfenati, 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/1654/23 Adopted on: 16 May 2023 Conclusion of the opinion: In the SCCS/1633/21 Opinion, the Committee concluded that Methyl Salicylate in toothpaste is safe for children under 6 years of age when used up to the maximum concentration of 2.52%. (1) In light of the data provided and taking under consideration the conclusions of SCCS/1633/21 and the aggregate exposure, does the SCCS consider Methyl Salicylate safe for children of age 0-3, when used up to a maximum concentration of 0.02% in all of the currently regulated cosmetic products included in Table 1 (except toothpaste in which up to 2.52% can be used)? In view of the conclusions of SCCS/1633/21 and the aggregate exposure, the SCCS considers the use of Methyl Salicylate as safe in cosmetic products intended for children of age 0.5-3 years when used up to a maximum concentration of 0.02% in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products. For toothpaste up to a maximum concentration of 2.52% methyl salicylate is considered safe. As no specific data were provided by the applicant for children below 6 months, the SCCS has not considered this age category in this safety assessment. (2) In light of the data provided and taking under consideration the conclusions of SCCS/1633/21 and the aggregate exposure, does the SCCS consider Methyl Salicylate safe for children of age 3-6, when used up to the allowed maximum concentrations for each of the currently regulated cosmetic products included in Table 1 (except toothpaste in which up to 2.52% can be used)? In Annex-1 of this Opinion, the SCCS has noted the basis for concerns over risks that the use of fullerenes, hydroxylated fullerenes and hydrated forms of hydroxylated fullerenes in cosmetic products may pose to the consumer. In brief, the SCCS has a concern in regard to: In view of the conclusions of SCCS/1633/21 and the aggregate exposure, the SCCS considers the use of Methyl Salicylate as safe in cosmetic products intended for children of age 3-6 years, when used up to a maximum concentration of 0.02% in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products, hair conditioner up to the allowed maximum concentrations indicated in Table 1. For toothpaste up to a maximum concentration of 2.52% methyl salicylate is considered safe. Keywords: SCCS, scientific advice, methyl salicylate, methyl 2-hydroxybenzoate, children exposure, Regulation 1223/2009 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Scientific Advice on methyl salicylate (methyl 2-hydroxybenzoate) – children exposure, preliminary version of 16 May 2023, SCCS/1654/23.