Following its harmonised classification as a category 2 reprotoxicant, Methyl salicylate was subject to a safety assessment and opinion of the SCCS published in October 2021 which has been transposed into the 5th “CMR” Regulation. As the industry has submitted a new dossier to propose to adjust the maximum safe concentrations, the European Commission has now given a new mandate to the Scientific Committee to evaluate the latest data provided.
Background
Methyl Salicylate (CAS/EC No.119-36-8/204-317-7) is the INCI name of “methyl 2-hydroxybenzoate” an ingredient used in many fragrance mixtures and as flavouring and soothing agent in oral hygiene products.
Following its classification as “Toxic for Reproduction Category 2” by the Commission Delegated Regulation (EU) 2021/849 and the submission of an exception dossier by industry, the Commission services mandated the SCCS to assess its safety following the provisions of Article 15(1) of the Cosmetics Regulation (EC) No.1223/2009. On 27 October 2021, the SCCS concluded on the safety of Methyl Salicylate and Regulation (EU) 2022/1531 restricted its use in cosmetic products. Methyl Salicylate is currently listed in entry 324 of Annex III to the Cosmetic Regulation (EC) No.1223/2009, with specific concentration limits for various product types and age groups.
Currently allowed concentrations of Methyl Salicylate in cosmetic products
a) 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): 0.06%
b) Face makeup (except lip products, eye makeup and makeup remover): 0.05%
c) Eye makeup and makeup remover: 0.002%
d) Leave-on hair products (spray/aerosol): 0.009%
e) Deodorant spray/aerosol: 0.003%
f) Body lotion spray/aerosol: 0.04%
g) Rinse-off skin products (except hand wash) …
