Following the mandate given by the European Commission to the SCCS in September 2020, the Scientific Committee has just published its Preliminary Opinion on the safety of Methyl Salicylate, which has recently undergone a harmonized classification as a reprotoxic of category 2 under the CLP Regulation. It was adopted at the SCCS plenary meeting on June 24-25, 2021 and is open for comments until September 8, 2021.
Background
Methyl Salicylate (CAS: 119-36-8; EC number: 204-317-7) is an ingredient used in many fragrance mixtures and as flavouring and soothing agent in oral hygiene products.
The substance is currently not listed in the Annexes to the EU Cosmetic Products Regulation No.1223/2009 but has been classified as a “Toxic for Reproduction Category 2” and “Skin sensitizer Category 1B” by the Delegated Regulation (EU) 2021/849 (17th adaptation to technical and scientific progress of CLP Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures).
Article 15 of the Cosmetics Regulation lays down that substances which have been classified as carcinogenic, mutagenic or toxic for the reproduction (CMR) under Annex VI to the CLP Regulation shall be prohibited for use in cosmetic products, unless an exemption has been granted.
Cosmetics Europe submitted a dossier to support the safety of Methyl Salicylate and the granting of an exception under Article 15.1 of the Cosmetics Regulation, specifying maximum concentrations in the different product categories.
| Type of cosmetic product exposure | Maximum % concentration |
|---|---|
| Hydroalcoholic-based fragrances | 0.600% |
| Rinse-off skin & hair products (except hand wash products) | 0.060% … |
