UK to Introduce New Restrictions on Methyl Salicylate in Cosmetics

On 16 January 2025, the UK notified the World Trade Organization (WTO) of its draft Cosmetic Products (Restriction of Chemical Substances) Regulations 2025. The regulation, which is expected to be adopted on 31 March 2025 and come into force on 30 September 2025, will restrict the use of methyl salicylate in cosmetic products in Great Britain (England, Scotland and Wales). A transitional period will allow products placed on the market before 30 September 2025 to remain available until 31 March 2026.

Methyl Salicylate: Uses and Regulatory Status

Methyl salicylate (CAS No. 119-36-8), also known as wintergreen oil, is widely used in topical analgesics, cosmetics, and personal care products for its soothing and aromatic properties. It is commonly found in pain relieving creams, mouthwashes, deodorants, and food flavouring agents. However, methyl salicylate is classified as a Category 2 CMR (Carcinogenic, Mutagenic, or Reproductive Toxicant) under the EU’s Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008), leading to regulatory restrictions to ensure consumer safety. Appropriate use and concentration limits are essential to prevent potential health risks associated with overexposure.

Scope and Regulatory Amendments

The Regulation will amend Annex 3 of the Cosmetics Regulation (Regulation (EC) No 1223/2009) by adding new restrictions on methyl salicylate in various cosmetic products, including:

• Rinse-off products (except hand wash products): Maximum concentration of 0.02% for children aged 0.5 to 1 year and 0.06% for older children and adults.

• Hand wash products: 0.02% for children aged 0.5 to 1 year and 0.6% for older children and adults.

• Leave-on skin products: 0.02% for children aged 0.5 to 1 year and 0.06% for older children and adults.

• Lipsticks and lip balms: 0.02% for children aged 0.5 to 1 year and 0.03% for older children and adults.

• Face makeup products: Maximum concentration of 0.05%.

• Eye makeup products and makeup removers: Maximum concentration of 0.002%.

• Toothpaste: Maximum concentration of 2.5%.

• Mouthwash: 0.1% for children aged 6 to 10 years and 0.4% for older children and adults.

• Deodorant spray/aerosol products: Maximum concentration of 0.003%.

• Hair products: Maximum concentration of 0.009%.

Scientific Basis and Justification

The restrictions follow the recommendations of the Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS), which considered methyl salicylate to be safe for use in cosmetics at certain concentration limits, despite its classification as a Category 2 CMR substance under Regulation (EC) No 1272/2008.

Comment Period and Availability of Documents

Stakeholders have 60 days from the date of notification to submit comments. For further details, visit the official WTO notification page here.