Following the mandate given by the European Commission to the SCCS in the context of the safety assessment of substances with potential endocrine disrupting properties, the Scientific Committee has just published its final Opinion on Methylparaben (preservative). It had been adopted by written procedure on 14 December 2024.
Background
Methylparaben (CAS No.99-76-3, EC No.202-785-7) is currently regulated as a preservative (Annex V/12 to the European Cosmetics Regulation 1223/2009) in a concentration up to 0.4% (as acid) when used on its own or up to 0.8% for mixtures of esters (Annex V, entry 12, column g) During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of Methylparaben as a preservative in cosmetic products.
The SCCS published its preliminary Opinion in June 2023.
For an exhaustive background information, see the articles
• Endocrine disruptors: 2nd call for data from the European Commission, CosmeticOBS, 22 February 2021
• Methylparaben, Benzyl Salicylate, Salicylic Acid: requests for SCCS Opinions, CosmeticOBS, 14 February 2022
• Methylparaben, Butylparaben : preliminary Opinions of the SCCS, CosmeticOBS, 12 June 2023
This Opinion has been subject to a commenting period of min eight weeks after its initial publication (from 8 June to 21 August 2023). Comments received during this period were considered by the SCCS.
For this Opinion, main changes occurred in the following sections: 3.4.5. Reproductive Toxicity, 3.4.10.1.3. In vivo assays providing data on adverse effects on endocrine relevant endpoints (level 4), 3.5. Safety evaluation and 3.6. Discussion.
