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ADDENDUM to the SCIENTIFIC OPINION on Hexyl Salicylate SCCS/1658/23 (CAS/EC No. 6259-76-3/228-408-6) - - Children exposure 0-3 years old - SCCS/1668/24 – Preliminary Opinion

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ADDENDUM to the SCIENTIFIC OPINION on Hexyl Salicylate SCCS/1658/23 (CAS/EC No. 6259-76-3/228-408-6) - - Children exposure 0-3 years old - SCCS/1668/24 – Preliminary Opinion Preliminary Opinion open for comments - Deadline for comments: 23 September 2024 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. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz The SCCS adopted this document by written procedure on 26 July 2024 Mise en ligne : 29 Juillet 2024 https://health.ec.europa.eu/publications/sccs-addendum-scientific-opinion-hexyl-salicylate-sccs165823-casec-no-6259-76-3228-408-6-children_en https://health.ec.europa.eu/document/download/7aa2f176-65af-494f-883e-3cf578b46cee_en?filename=sccs_o_290.pdf Details Publication date 29 July 2024 Author Scientific Committee on Consumer Safety (SCCS) Description SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven SCCS external experts: E. Benfenati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz (Rapporteur) Contact: SANTE-SCCS@ec.europa.eu On request from: European Commission SCCS Number: SCCS/1668/24 Adopted on: 26 July 2024 Conclusion of the opinion: (1) In light of the data provided and taking under consideration the CMR Cat.2 classification (to be introduced in Annex VI to Reg. 1272/2008), does the SCCS consider Hexyl Salicylate safe for children below 3 years of age when used up to the maximum concentrations provided in the dossier? Based on the assessment of data provided and taking into consideration the concerns related to potential endocrine disrupting properties, the SCCS considers Hexyl Salicylate safe for children < 3 years old when used up to the maximum concentrations as provided below. Product typeMaximum concentration (% w/w) Shower gel, hand soap, shampoo, hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm, fragrance products0.1 Toothpaste0.001 (2) Alternatively, what is according to the SCCS the maximum concentration of Hexyl Salicylate that is considered safe for children below 3 years of age? / (3) Does the SCCS have any further scientific concerns with regard to the use of Hexyl Salicylate in cosmetic products and children’s exposure? The results of the infant survey by Cosmetics Europe that have been available as draft to the SCCS show that a significant proportion of babies had “skin issues” and that children with damaged skin could be exposed to cosmetic products containing Salicylates. This raises concern to the SCCS as it is not known whether Salicylic Acid may be present in the products as an impurity or resulting from the breakdown of hexyl salicylate. Furthermore, Salicylic Acid is classified as a skin sensitiser Category 1 and Salicylic Acid is not permitted in cosmetic products used by children under the age of 3 years. The amount of toothpaste ingested by children below 3 years old considered in this opinion for the calculation of the MoS has been adapted based on available data and now is much higher than the one used in previous opinions on Salicylates in cosmetic products used by children (eg. Methyl salicylates, SCCS/1654/23). This may raise concerns about their safety, in particular wwhere the MoS is close to 100. The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Hexyl Salicylate for the environment. Keywords: SCCS, scientific opinion, addendum, Hexyl Salicylate, CAS/EC No. 6259-76-3/228-408-6, children exposure, SCCS/1658/23, SCCS/1668/24, Regulation 1223/2009 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Addendum to the Scientific Opinion on Hexyl Salicylate SCCS/1658/23 (CAS/EC No. 6259-76-3/228-408-6) – children exposure 0-3 y.o., SCCS/1668/24, preliminary version of 26 July 2024.

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hal-04664081 , version 1 (29-07-2024)

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  • HAL Id : hal-04664081 , version 1

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U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, J. Ezendam, et al.. ADDENDUM to the SCIENTIFIC OPINION on Hexyl Salicylate SCCS/1658/23 (CAS/EC No. 6259-76-3/228-408-6) - - Children exposure 0-3 years old - SCCS/1668/24 – Preliminary Opinion. Scientific Committee for Consumer Safety (SCCS, EC). , 2024. ⟨hal-04664081⟩
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