Following the SCCS Opinion, the final version of which was published in February 2024 and which excluded children under the age of three from the safe conditions of use of Hexyl Salicylate, the industry submitted new data on this point. The SCCS has just assessed these and published its preliminary Opinion on the matter. It is open for comments until 23 September 2024.
Background
Hexyl Salicylate (CAS/EC No.6259-76-3/228-408-6) is used in formulations of fragrances in multiple consumer goods including cosmetic.
It is not currently listed in the Annexes to the Cosmetic Regulation (EC) No.1223/2009.
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.
In December 2022, stakeholders submitted a dossier to support the safe use of Hexyl Salicylate with specific concentration limits for various product types.
The SCCS concluded in their Opinion SCCS/1658/23 that Hexyl Salicylate is safe when used up to the maximum concentrations provided but noted that specific scenarios for children had not been provided.
In May 2024, industry submitted additional information to address the SCCS concerns.
For an exhaustive background information, see the articles
• Hexyl Salicylate: final Opinion of the SCCS, CosmeticOBS, 18 March 2024
• Children’s exposure to Hexyl Salicylate: request for an addendum to the SCCS Opinion, CosmeticOBS, 10 June 2024
Opinion
(1) In light of the data provided and taking under consideration the CMR Cat.2 classification (to be introduced in Annex VI to Reg. 1272/2008), does …
