SCCS publishes final Scientific Advice on children’s exposure to Methyl Salicylate (SCCS/1676/25)
Ingredient: Methyl Salicylate

Date of publication: 2 May 2025

The SCCS has revised its scientific advice on children's exposure to Methyl Salicylate, establishing more restrictive concentration limits of 0.4% in toothpaste and 0.02% in other products for children aged 0-3 years, following aggregate exposure considerations from related salicylate assessments.

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.

Main conclusions

Revised concentration limits for children 0-3 years:

  • Maximum 0.4% in toothpaste
  • Maximum 0.02% in all other cosmetic products

What now?

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)

References

SCCS (Scientific Committee on Consumer Safety), Scientific Advice on Methyl Salicylate (methyl 2-hydroxybenzoate) – children exposure, version of 17 January 2025, final version of 30 April 2025, SCCS/1676/25

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