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May 12, 2026 - Cosmetics
Methylparaben – new ECHA Assessment Report
Methylparaben (4-hydroxybenzoic acid methyl ester) is currently an approved preservative in cosmetic products and is regulated in the European Cosmetics Regulation EC No. 1223/2009 in Annex V under entry number 12. Thus, the following maximum concentrations in the ready-to-use preparation must not be exceeded: 0.4% (as acid) when using an ester and 0.8% (as acid) when using an ester mixture.
At the beginning of April this year, the French Agency for Food, Environmental, Occupational Health and Safety (ANSES) submitted a report on the substance evaluation of Methylparaben to the European Chemicals Agency (ECHA).
Accordingly, Methylparaben currently does not have an entry in Annex VI of the CLP Regulation (EC No. 1272/2008). As part of the evaluation, the following hazard profile of Methylparaben was highlighted: Reproductive toxicity and endocrine disruptor, both for humans and the environment. Endocrine disruptors are hormonally active substances that negatively affect the natural hormone balance.
Within the framework of the newly introduced hazard classes of the revised CLP Regulation (Delegated Regulation (EU) No. 2023/707), ANSES requires a classification of Methylparaben as an endocrine disruptor for both humans and environmental organisms.
The SCCS published its last opinion on Methylparaben in February 2024 (SCCS/1652/23). It must now be checked to what extent the data from ANSES is already part of this SCCS Opinion or whether a re-evaluation of the substance is necessary.
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