SCCS Issued the Final Opinion on the Safety of Hexyl Salicylate

On March 11, 2024, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued a final opinion on Hexyl Salicylate (SCCS/1658/23). The preliminary opinion was released on November 9, 2023.

The SCCS concludes the following:

(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 the SCCS consider Hexyl Salicylate safe when used up to the maximum concentrations provided in the dossier?

Based on the assessment of data provided and taking into consideration the concerns related to potential endocrine disrupting properties, the SCCS considers Hexyl Salicylate safe when used up to the maximum concentrations as provided in Table 1 of this Opinion.

(2) Does the SCCS have any further scientific concerns with regard to the use of Hexyl Salicylate in cosmetic products?

The Applicant did not provide any specific scenarios for children applying cosmetic products on their skin (dermal exposure), nor were the differences between age categories in some exposure parameters (body weight, amount of the products applied, body surface, etc) taken into consideration. However, the SCCS notices that in view of the high MoS for adults, far above 100, the MoS will also be above 100 for children between 3 to 10, considering also the products categories used by children of these ages.

The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Hexyl Salicylate for the environment.

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Further Information

SCCS/1658/23