Recently, The European Commission has tasked the Scientific Committee on Consumer Safety (SCCS) with preparing an addendum to the existing opinion SCCS/1658/23 to evaluate children’s exposure to Hexyl Salicylate (hexyl 2-hydroxybenzoate; CAS/EC No. 6259-76-3/228-408-6) from cosmetic products. This request comes from the Directorate-General for Internal Market, Industry, Entrepreneurship, and SMEs. Hexyl Salicylate, known for its sweet, floral, and fruity odor, is widely used in fragrances across various consumer products, including cosmetics, household cleaners, detergents, and air care products.
Despite its widespread use, Hexyl Salicylate is not currently restricted under the Cosmetic Regulation (EC) No. 1223/2009. However, concerns about its safety have arisen following the European Risk Assessment Committee (RAC) of ECHA’s recommendation in March 2022 to classify it as ‘Toxic for Reproduction Category 2’ and ‘Skin sensitizer Category 1’. This recommendation was based on an LLNA assay and comparative analysis with Methyl Salicylate and Salicylic Acid, both structurally related compounds.
The SCCS’s opinion, SCCS/1658/236, affirmed the safety of Hexyl Salicylate within these limits for adults but highlighted the lack of data on children’s dermal exposure and the need to consider varying exposure parameters across age groups.
In response to these concerns, additional information addressing children’s exposure, particularly for those under three years of age, was submitted by the industry in May 2024. Consequently, the European Commission has requested the SCCS to conduct a thorough safety assessment of Hexyl Salicylate considering this new data. This assessment aims to ensure that the use of Hexyl Salicylate in cosmetic products is safe for children, encompassing different age categories and exposure scenarios.
