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Monday, November 13, 2023SCCS

Hexyl Salicylate: preliminary Opinion of the SCCS

Hexyl salicylate : Opinion préliminaire du CSSC

Following the recommendation of the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) to classify Hexyl Salicylate as “Toxic for Reproduction Category 2”, the European Commission, on the basis of a dossier provided by industry, asked the Scientific Committee on Consumer Safety to assess its safety. The SCCS has just published its preliminary Opinion, adopted at its plenary meeting on 26 October 2023 and open for comments until 12 January 2024.

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Background

Hexyl Salicylate is a fragrance ingredient currently not subject to restriction under European Cosmetics Regulation 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.
Stakeholders submitted a dossier to support the safe use of Hexyl Salicylate according to Art. 15(1) Reg. 1223/2009 with specific concentration limits for various product type.

Product type, Body parts Maximum concentration (%)
Hydroalcoholic-based fragrances 2
All rinse-off products 0.5
All leave-on products 0.3
Oral care (toothpaste and mouthwash) 0.001

For an exhaustive background information, see the article
Hexyl Salicylate: request for Opinion to the SCCS, CosmeticOBS, 20 February 2023

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 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 …

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