[Updated] EU SCCS Finalizes Addendum to Opinion on Hexyl Salicylate, Addressing Children’s Exposure

Editor's note: This article was originally published on July 30, 2024, and was updated on October 28, 2024, as per the latest developments. The updated contents are marked in red below.

On July 29, 2024, EU Scientific Committee on Consumer Safety (SCCS) initiated a public consultation on an addendum to its previous opinion on hexyl salicylate, which highlights concerns about children's exposure.¹ After a thorough consultation phase, SCCS published the final opinion on October 25, 2024, incorporating modifications to the initial conclusions.²

Hexyl salicylate (CAS No. 6259-76-3), a fragrance ingredient with sweet, floral, and fruity odour, is commonly used in cosmetics. In March 2022, the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) recommended classifying it as "Toxic for Reproduction Category 2" and "Skin Sensitizer Category 1". Considering the existing prohibition of CMR substances (those classified as carcinogenic, mutagenic or toxic for reproduction) in Regulation (EC) No 1223/2009 (Cosmetics Regulation), such classification may potentially lead to a ban on hexyl salicylate in cosmetics.

To support the safe use of hexyl salicylate in cosmetics, the industry submitted a dossier in December 2022. Based on this dossier, SCCS established concentration limits for this substance in various product types in SCCS/1658/23, but noted a lack of data on children's exposure and age-related considerations. In May 2024, the industry responded with additional information to address these concerns, particularly for children under three. The European Commission then mandated SCCS to reassess hexyl salicylate's safety with the new information.

Based on the latest assessment results, considering the classification of “Toxic for Reproduction Category 2” and all relevant toxicological endpoints, including potential endocrine disrupting effects, SCCS considers the use of hexyl salicylate safe for children under three when used up to the specified concentrations:

Further Reading

• EU SCCS Issues Final Opinions on Three Cosmetic Ingredient

• EU to Implement a Union-wide Ban on PFHxA in Cosmetics

• An Overview of Cosmetics Regulations in Nordic Countries