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Methyl Salicylate (CAS no. 119-36-8) is a versatile ingredient commonly incorporated in cosmetics for its multiple functions. It is often used as a fragrance and flavoring component, providing distinctive aromatic notes, and also as a soothing agent valued for its sensory and skin-relief properties. Its broad application across categories makes it especially relevant in regulatory discussions.
Regulatory Background and Safety Assessment
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 15th 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 Methyl salicylate
Following its classification as a CMR substance and the subsequent SCCS safety opinion, the use of Methyl Salicylate in cosmetics has been restricted to specific concentration limits depending on the product category.
These limits are intended to ensure consumer safety while allowing the continued use of the ingredient in formulations where it can be considered safe. The main restrictions are as follows:
- 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.
Methyl Salicylate Compliance Deadline
Please note that the Omnibus laws do not distinguish between the placing on the market and making available on the market of listed substances.
Therefore, as of December 17, 2022, cosmetic products may not be marketed or available on the shelves if they do not comply with Omnibus Law V.
How Cosmeservice Can Support your Compliance
The Cosmeservice team is at your disposal, if you would like more information on this subject please do not hesitate to contact us at info@cosmeservice.com.
