UK SAG-CS Publishes Final Opinion on Methyl Salicylate: Setting Safe Limits in Cosmetics

The UK Scientific Advisory Group on the Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) published its final opinion on methyl salicylate in cosmetics on 8 March 2024. The opinion sets specific concentration limits for a range of products and age groups and aims to ensure consumer safety.

SAG-CS

The SAG-CS is the UK equivalent of the EU Scientific Committee on Consumer Safety (SCCS) and is responsible for advising the Office for Products Safey and Standards (OPSS) on risk management measures for cosmetic ingredients.

Methyl Salicylate

Methyl salicylate (methyl 2-hydroxybenzoate; CAS No. 119-36-8) is used in a variety of cosmetic products as a flavouring or soothing agent in oral hygiene products or as a fragrance ingredient. It can be found in hair, bath and oral hygiene products, as well as in perfumes and make-up.

Under the GB Classification, Labelling and Packaging (CLP) Regulation, methyl salicylate has recently been classified as follows:

• Reproductive toxicity – category 2

• Acute toxicity – category 4

• Skin sensitiser – category 1B

As the use of substances classified as CMR (Carcinogenic, Mutagenic and Reprotoxic) Category 1A, 1B and 2 (CMR) in cosmetic products is prohibited under the GB CLP Regulation, the UK cosmetics industry submitted a dossier to OPSS to support the safe use of methyl salicylate at certain concentration levels.

Conclusion of the SAG-CS

In its deliberations, the SAG-CS acknowledged the findings of respected bodies such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the United States Environmental Protection Agency (US-EPA), the Biopesticides and Pollution Prevention Division of the Norwegian Food Safety Authority (NFSA) and the European Food Safety Authority (EFSA). These organisations have established an Acceptable Daily Intake (ADI) for methyl salicylate of 0.5mg/kg bw/day based on extensive research and toxicity studies.

In addition, the opinion reflects extensive discussions by the SAG-CS on critical aspects such as dermal absorption rates, oral absorption values, metabolism and excretion pathways of methyl salicylate. The Committee also discussed concerns about total exposure to salicylates and emphasised the need for rigorous safety assessments taking into account exposure routes and sources of exposure.

In particular, the safety assessment differentiated between age groups, with particular attention to infants, toddlers, children and adolescents. For example, infants aged 0-0.5 years were excluded from the safety assessment due to insufficient data, while concentration limits were adjusted to ensure adequate safety margins for different age groups.

A summary of the acceptable concentrations of methyl salicylate agreed by the members of the SAG-CS is given in the table below.

Conclusion

In conclusion, the final opinion of the SAG-CS provides a comprehensive framework for the safe use of methyl salicylate in cosmetic products, reflecting a balance between consumer protection and industry interests. Stakeholders are urged to adhere to the prescribed concentration limits in order to effectively maintain consumer safety standards.

For more details  please refer to the SAG-CS opinion here.