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On January 16, 2025, UK notified WTO of a draft regulation titled The Cosmetic Products (Restriction of Chemical Substances) Regulations 2025, proposing restrictions on the use of methyl salicylate (CAS No. 119-36-8) in cosmetics. The proposed restrictions are based on the opinion of the UK's Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS), and partially differ from EU regulations. The draft is open for comments until March 17, 2025, with adoption scheduled for April 30, 2025.1
Methyl salicylate is a flavoring and soothing agent in oral hygiene products, and also commonly found in fragrance mixtures. It has been previously subject to safety evaluation by SAG-CS regarding its reproductive toxicity. In the corresponding opinion, SAG-CS concluded the safe-use concentrations for this substance in various types of products. Following this opinion, UK prepared the draft regulation, newly including methyl salicylate as a restricted ingredient in UK's Regulation (EC) 1223/2009 (Cosmetics Regulation), with restrictions specified in the table below.
Ref. No. | Substance Identification | Restrictions | ||||
Chemical Name / INN | Name of Common Ingredients Glossary | CAS No. | EC No. | Product Type | Maximum Concentration | |
324 | Methyl 2-hydroxybenzoate | Methyl salicylate | 119-36-8 | 204-317-7 | (A) Rinse-off skin & hair products (except hand wash products) | (A) |
(B) Hand wash products | (B) | |||||
(C) Leave on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant, and hydroalcoholic-based fragrances), and hair products (non-aerosol) | (C) | |||||
(D) Lipsticks & lip balm | (D) | |||||
(E) Face makeup products | (E) 0.05% | |||||
(F) Eye makeup products & makeup remover | (F) 0.002% | |||||
(G) Toothpaste | (G) 2.5% | |||||
(H) Mouthwash | (H) | |||||
(I) Mouth spray | (I) 0.65% | |||||
(J) Hydroalcoholic-based fragrances | (J) 0.6% | |||||
(K) Deodorant spray/aerosol products | (K) 0.003% | |||||
(L) Hair products (spray/aerosol) | (L) 0.009% | |||||
(M) Body lotion spray | (M) 0.04% | |||||
Notes: | ||||||
It is important to note that the restrictions outlined above differ from those specified under the EU's cosmetics regulatory framework. Specifically,
UK sets lower concentration limits for toothpaste, as well as mouthwash for children over 10 years and adults;
Taking into account children's exposure, UK applies distinct concentration limits for product types (A), (B), (C), and (D) in the table, differentiating between products intended for children aged 0.5-1 year, and those for children over 1 year and adults. In comparison, EU stipulates that, other than toothpaste, methyl salicylate-contained products shall not be used for children under 6 years of age;
EU now regulates methyl salicylate as a fragrance allergen, requiring it to be individually labelled in the "list of ingredients" when its concentration exceeds 0.001% in leave-on products, and 0.01% in rinse-off products. In contrast, as per the draft regulation, UK has not yet imposed this labelling requirement for methyl salicylate as a fragrance allergen.
Detailed information on methyl salicylate restrictions under the EU cosmetics regulatory framework can be found in the Cosme-list.
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