Children’s Exposure to Methyl Salicylate – SCCS Advice

28/09/2023

On 22^nd September the Final SCCS Advice on the safety of children’s exposure to Methyl Salicylate in cosmetic products was published.

Legal Background

This substance (CAS/EC No. 119-36-8/204-317-7) is an ingredient used in many fragrance mixtures and as flavoring and soothing agent in oral hygiene products. It was classified as ‘Toxic for Reproduction Category 2’ by the Regulation (EU) 2021/849. However, the industry submitted an exception dossier which mandated the SCCS to assess its safety following the provisions of Article 15(1) of the Cosmetics Regulation (EC) No. 1223/2009.

On 27 October 2021, the SCCS issued its final opinion on Methyl Salicylate (SCCS/1633/21), stating the maximum safe concentration of the ingredient for several categories of cosmetics.

In November 2022 cosmetic industry submitted additional data to support the use of Methyl Salicylate in cosmetic products intended for children. Following this SCCS opinion and analysis, the European Commission published the Omnibus Act V on 15th September 2022. The SCCS concluded that this substance in toothpaste is safe for children under 6 years of age when used up to the maximum concentration of 2.52%.

Why has this advice come out?

In light of potential differences in metabolism between newborns/infants/toddlers up to six years old, it is worth giving extra consideration to the ingredients used in any cosmetic product. As a result, SCCS considers the use of Methyl Salicylate as safe in cosmetic products intended for children of age 0.5-3 years when used:

up to a maximum concentration of 0.02% in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products, and hair conditioner.
up to 2.52% of toothpaste is considered safe.

How it will affect?

There are numerous changes and adaptations that the cosmetics industry must face out. Currently, the ingredient Methyl Salicylate can’t be used in cosmetic preparations for children unless the exception of toothpaste. Following the advice issued by the SCCS it is not possible to confirm that in the future, the entry of this ingredient in EU Regulation 1223/2009 will be amended to adapt it to the new findings.

From Cosmeservice we want to keep you up to date with all the changes that affect the sector, in order to anticipate and be prepared for the entry into force of new standards and regulations.

Please contact us at info@cosmeservice.com if you need any advice about this subject.

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