SCCS Opinion on Homosalate - SCCS/1622/20 - Final Opinion

SCCS/1622/20 - Preliminary Opinion U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von Goetz The SCCS adopted this document at its plenary meeting on 27-28 October 2020 (50 pages) Mise en ligne le 6 Novembre 2020 https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_244.pdf Conclusion of the opinion: 1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of homosalate, does the SCCS consider homosalate safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10 %? On the basis of safety assessment of homosalate, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that homosalate is not safe when used as a UV-filter in cosmetic products at concentrations of up to 10%. 2. Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of homosalate as a UV-filter in cosmetic products? In the SCCS’s opinion, the use of homosalate as a UV filter in cosmetic products is safe for the consumer up to a maximum concentration of 1.4% homosalate in the final product. 3. Does the SCCS have any further scientific concerns with regard to the use of homosalate in cosmetic products? It needs to be noted that the SCCS has regarded the currently available evidence for endocrine disrupting properties of homosalate as inconclusive, and at best equivocal. This applies to all of the available data derived from in silico modelling, in vitro tests and in vivo studies, when considered individually or taken together. The SCCS considers that, whilst there are indications from some studies to suggest that homosalate may have endocrine effects, the evidence is not conclusive enough at present to enable deriving a specific endocrine-related toxicological point of departure for use in safety assessment. Exposure to homosalate from other products than those in this Opinion has not been considered. Inhalation toxicity of homosalate was not assessed in this Opinion because no data were provided. ________________________________________ Keywords: SCCS, scientific opinion, homosalate, UV-filter, Regulation 1223/2009, CAS No 118-56-9, EC No 204-260-8 ________________________________________ Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on homosalate (CAS No 118-56-9, EC No 204-260-8), preliminary version of 27-28 October 2020, SCCS/1622/20.