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Monday, June 10, 2024SCCS

Children's exposure to Hexyl Salicylate: request for an addendum to the SCCS Opinion

Exposition des enfants à l'Hexyl salicylate : demande d'addendum à l'Opinion du CSSC

Following the SCCS Opinion, the final version of which was published in February 2024 and which excluded children under the age of three from safe conditions of use, the industry submitted new data on this point. The European Commission has now asked the Scientific Committee to assess these data.

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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, while the SCCS has recently re-evaluating its safety in view of endocrine disrupting concerns.
In addition, the Scientific Committee has concluded on the safety of Methyl Salicylate in 2021.

Following the RAC opinion, it is expected that …

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