Update on hexyl salicylate in EU cosmetics regulation

The Scientific Committee on Consumer Safety (SCCS) recently updated guidelines regarding using hexyl salicylate, a commonly used fragrance ingredient, in the European Union’s cosmetic industry. This update follows the European Chemicals Agency’s (ECHA) 2022 recommendation, which identified hexyl salicylate as a potential reproductive toxicant and skin sensitizer.

Key Points:

  • Safety Assurance: The SCCS has officially declared hexyl salicylate safe for cosmetic use if product formulations adhere to specified concentration limits. This determination is based on a comprehensive analysis of the submitted evidence.
  • Defined Concentration Limits: To ensure consumer safety, the SCCS has set the following maximum allowable concentrations for hexyl salicylate in cosmetic products:
  • Hydroalcoholic-based fragrances: 2%
  • Rinse-off products: 0.5%
  • Leave-on products: 0.3%
  • Oral care products (including toothpaste and mouthwash): 0.001%
  • Child Safety Considerations: Despite the absence of direct exposure data for children, the SCCS’s evaluation indicates that children aged 3 to 10 can safely use products containing hexyl salicylate within these concentration limits, based on adult safety margins.

Industry Impact:

This guidance requires cosmetic manufacturers to re-evaluate formulations to ensure compliance with these concentration limits. It highlights the industry’s ongoing commitment to assessing the health impacts of cosmetic ingredients and the importance of conducting comprehensive safety assessments.