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Monday, May 22, 2023Regulation

Children's exposure to Methyl Salicylate: the SCCS Scientific Advice

Exposition des enfants au Methyl salicylate : l'avis scientifique du CSSC

In November 2021, the SCCS had concluded that Methyl Salicylate, recently classified as a category 2 reprotoxicant under the CLP Regulation, was safe except in cosmetics intended for children under six years of age (except toothpaste). The industry submitted new data to defend the use of the substance in children’s products and the Commission mandated the Scientific Committee to evaluate them. The SCCS has now published its Scientific Advice, following its adoption by written procedure on 16 May 2023.

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Background

Methyl Salicylate is used in many fragrance mixtures and as flavouring and soothing agent in oral hygiene products.
Following its classification as “Toxic for reproduction Category 2”, the SCCS was mandated to assess its safety, and defined specific concentration limits for different product types and age groups, which were included in entry 324 of Annex III to Cosmetics Regulation (EC) No.1223/2009.
However, the use of the substance was prohibited in preparations for children under 6 years of age, with the exception of toothpaste.
Considering that the margin of safety was sufficient, the industry provided additional data to support the use of Methyl Salicylate in cosmetic products intended for children (age groups 0-3 years and 3-6 years).
The SCCS was therefore mandated to evaluate these data.

For an exhaustive background information, see the articles
Methyl Salicylate: Request for the SCCS Opinion, CosmeticOBS, 22 September 2020
Publication of the 17th ATP of the CLP, CosmeticOBS, 7 June 2021
Methyl Salicylate: Final Opinion of the SCCS, CosmeticOBS, 8 November 2021
Methyl Salicylate: new request for Opinion to the SCCS, CosmeticOBS, 2 January 2023

The Scientific advice

In the SCCS/1633/21 Opinion, the Committee concluded that …

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