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Monday, February 20, 2023SCCS

Hexyl Salicylate: request for Opinion to the SCCS

Hexyl salicylate : demande d'Opinion au CSSC

Following the recommendation of the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) to classify Hexyl Dalicylate as “Toxic for Reproduction Category 2”, which raises the spectre of a ban on the substance in cosmetics, the European Commission, on the basis of a dossier provided by industry, is now asking the Scientific Committee on Consumer Safety (SCCS) to assess its safety within nine months.

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Background

Hexyl Salicylate (CAS/EC No.6259-76-3/228-408-6) is the INCI name of “hexyl 2-hydroxybenzoate”, an ingredient with sweet, floral, and fruity odour used in formulations of fragrances in multiple consumer goods including cosmetic, household cleaning products, detergents, and air care products.
Hexyl Salicylate is not listed in the Annexes to the Cosmetic Regulation (EC) No.1223/2009 and its use is not otherwise restricted in cosmetic products.

The European Risk Assessment Committee (RAC) of ECHA issued in March 2022 an opinion recommending a “Toxic for Reproduction Category 2” (i.e., suspected of damaging the unborn child) and “Skin sensitizer Category 1” classification for Hexyl Salicylate. These classifications were based on the results of an LLNA assay and on “read across” from the structural analogue Methyl Salicylate and the metabolite Salicylic Acid, respectively. Hexyl salicylate is the ester of 1-hexanol and Salicylic Acid, with the latter being the main metabolite. Salicylic Acid has been subject to a safety evaluation by SCCNFP in 2002 and SCCS in 2018 and the SCCS is currently re-evaluating its safety in view of endocrine disrupting concerns. The scientific committee has concluded on the safety of Methyl Salicylate in 2021.

Following the RAC opinion, it is expected that the European Commission …

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