What’s new?
On 30 April 2025, the Scientific Committee on Consumer Safety (SCCS) adopted a revised Scientific Advice on children’s exposure to Methyl salicylate (methyl 2-hydroxybenzoate). This revision supersedes the previous Scientific Advice SCCS/1654/23 published in September 2023, incorporating new aggregate exposure considerations based on conclusions from the Hexyl Salicylate assessment (SCCS/1658/23).
The revision was specifically requested by the European Commission to re-assess maximum safe concentrations for Methyl Salicylate in products intended for children aged 0-3 years, taking into account potential cumulative exposure from multiple salicylate sources.
Methyl Salicylate is currently regulated under Entry 324 of Annex III to the EU Cosmetics Regulation following its classification as a CMR Category 2 substance (toxic for reproduction). The ingredient functions as a fragrance component, flavoring agent, and soothing agent in cosmetic products, with particular use in oral hygiene formulations.
Revised concentration limits for children 0-3 years:
- Maximum 0.4% in toothpaste
- Maximum 0.02% in all other cosmetic products
Expected regulatory implementation timeline:
- Scientific Advice published as final version on 30 April 2025
- Amendment to Annex III Entry 324 of Cosmetics Regulation is expected
- Transition periods typically provided for industry compliance (18-24 months)