Following the classification of Methyl Salicylate as a category 2 reprotoxicant under the CLP Regulation, the SCCS initially concluded that it was safe in different concentrations depending on the product category, except in cosmetics intended for children under the age of six. The industry submitted specific data on this point, and a Scientific Opinion was requested. The Scientific Committee has just published the final version.
Background
Methyl Salicylate is used in many fragrance mixtures and as flavouring and soothing agent in oral hygiene products.
Following its classification as “Toxic for reproduction Category 2”, the SCCS was mandated to assess its safety, and defined specific concentration limits for different product types and age groups, which were included in entry 324 of Annex III to Cosmetics Regulation (EC) No.1223/2009.
However, the use of the substance was prohibited in preparations for children under 6 years of age, with the exception of toothpaste.
Considering that the margin of safety was sufficient, the industry provided additional data to support the use of Methyl Salicylate in cosmetic products intended for children (age groups 0-3 years and 3-6 years).
The SCCS published the preliminary version of its Scientific Advice in May 2023.
It has exceptionally been subject to a commenting period of four weeks after its initial publication (from 16 May until 19 June 2023). Comments received during this period were considered by the SCCS and main changes occurred in section 3.2.4, Table 4 (SED calculations) and conclusions.
For an exhaustive background information, see the articles
• Methyl Salicylate: Request for the SCCS Opinion, CosmeticOBS, 22 September 2020
• Publication of …
