Methyl Salicylate (CAS no. 119-36-8) is a substance with different functions in cosmetics formulas, it can be used as fragrance/flavoring ingredient and soothing agent.

In May 2021, ECHA classified Methyl Salicylate as a CMR substance of category 2: suspected to be toxic for reproduction. As the ingredient is widely used, the cosmetic industry asked the European Commission to apply the exemption procedure set by Article 15(1) of the EU Cosmetics Regulation. According to it, the use of a substance classified as CMR 2 can be permitted by way of exemption if the Scientific Committee on Consumer Safety (SCCS) evaluates the substance and finds that is safe.

As a result, on October 26-27, 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.

Following this SCCS opinion and analysis, the European Commission published the Omnibus Act V 15^th September 2022. The new restrictions will apply as of December 17, 2022 — the exact date from which the 17th ATP will be applicable.

Restrictions of use:

• Up to 0.06% in leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant, and hydroalcoholic-based fragrances) and leave-on hair products (except spray/aerosol products);
• Up to 0.05% in face makeup (except lip products, eye makeup, and makeup remover);
• Up to 0.002% in eye makeup and makeup remover;
• Up to 0.009% in leave-on hair products spray/aerosol;
• Up to 0.003% in deodorant spray/aerosol;
• Up to 0.4% in body lotion spray/aerosol;
• Up to 0.06% in rinse-off skin products (except hand wash) and rinse-off hair products;
• Up to 0.6% in hand wash, hydroalcoholic-based fragrances, and mouthwash intended for children above 10 years of age and adults;
• Up to 0.03% in lip products;
• Up to 2.52% in toothpaste;
• Up to 0.1% in mouthwash intended for children aged 6-10 years;
• Up to 0.65% in mouth spray.

Furthermore, cosmetic products for children under six years cannot contain Methyl Salicylate, with the exception of toothpaste.

Deadline

Please, take into account that Omnibus Acts do not differentiate between placing on the market and making available on the market of the substances listed. Hence, as of 17^th December 2022, cosmetic products cannot be placed on the market nor also being available on the shelves if they are not compliant with Omnibus Act V.

Please contact us if you need any advice about your products. The cosmeservice team is at your disposal, if you wish to get more information about this subject feel free to contact us at info@cosmeservice.com.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R1531

 

COSMESERVICE TEAM