Methyl Salicylate-Final Opinion

Methyl salicylate (methyl 2-hydroxybenzoate) is the ester of methyl alcohol and salicylic acid, which has different functions in cosmetic formulations. In the body, the main product of methyl salicylate metabolism is salicylic acid. Methyl salicylate is often used in cosmetics and personal care products as a denaturant, flavoring, perfuming, and soothing agent in oral hygiene products. Methyl salicylate is not included in the annexes of the European Cosmetics Regulation (No. 1223/2009), which means that its use in cosmetic products is not restricted.

The European Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) issued a recommendation in 2009 to classify methyl salicylate as " Toxic for Reproduction Category 2" and " Skin sensitizer Category 1B". In May 2021, ECHA classified methyl salicylate as a CMR substance of category 2: suspected to be toxic to reproduction. The EU Cosmetics Regulation prohibits the use of substances classified as CMR (carcinogenic, mutagenic or toxic for reproduction) in cosmetic products unless certain conditions are fulfilled. CMRs classified as category 2 may be used in cosmetic products, provided the substance has been fully evaluated by the European Commission's Scientific Committee on Consumer Safety (SCCS).

Taking into account the classification of methyl salicylate as "toxic for reproduction category 2" and the opinion of the RAC, a dossier was submitted by Cosmetics Europe to support the safety of Methyl Salicylate. The committee asked SCCS to conduct a safety assessment of methyl salicylate and to stipulate the maximum safe concentration of this ingredient for several categories of cosmetics.

Details:

• Up to 0.06% in leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant, and hydroalcoholic-based fragrances) and leave-on hair products (except spray/aerosol products);
• Up to 0.05% in face makeup (except lip products, eye makeup, and makeup remover);
• Up to 0.002% in eye makeup and makeup remover;
• Up to 0.009% in leave-on hair products spray/aerosol;
• Up to 0.003% in deo spray/aerosol;
• Up to 0.4% in body lotion spray/aerosol;
• Up to 0.06% in rinse-off skin products and rinse-off hair products;
• Up to 0.6% in hand wash, hydroalcoholic-based fragrances, and mouthwash intended for children above 10 years of age and adults;
• Up to 0.03% in lipsticks & lip balm;
• Up to 2.52% in toothpaste;
• Up to 0.65% in mouth spray;
• Up to 0.1% in mouthwash intended for children aged 6-10 years.

Cosmetics for children under 6 cannot contain methyl salicylate, with the exception of toothpaste.

SCCS expressed additional concern regarding the use of methyl salicylate, as this ingredient is used in consumer products other than cosmetics, such as air care products, polishes, biocides, polishes, etc. Such a situation would increase systemic exposure and potentially exceed safe level. And in the body methyl salicylate is metabolized to salicylic acid, which is classified as a reprotoxicant. Based on the above, the combined exposure to products containing various salicylates will increase systemic exposure and may exceed safe level.

Lastly, wintergreen oil used in products may contain up to 99% methyl salicylate, so it should be considered when calculating the amount of methyl salicylate in cosmetics.

Today, when the market and regulations are constantly updated, manufacturers can speed up the process of product development by cooperating with third-party institutions. As an experienced cosmetic testing expert, Creative BioMart makes the optimal decisions for clients on cosmetic regulatory matters with the support of an excellent regulatory affairs team and toxicology department. In addition, we also provide comprehensive cosmetic products prohibited and controlled ingredients testing for efficient product analysis. We help clients simplify the regulatory compliance process and allow their products access to market in the fastest and most cost-effective way.
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