Editor's Notes: This article was originally published on June 13, 2023, and was updated on November 7, 2023, as per the latest developments.
On November 6, 2023, the Scientific Committee on Consumer Safety (SCCS) released the final opinion on Butylparaben (CAS No. 94-26-8). This final opinion includes additional information regarding the benchmark dose (BMD) modelling performed in the safety assessment, and reaffirms the same conclusion as the preliminary one.3
On June 8, 2023, EU SCCS published preliminary opinions respectively on the use of Butylparaben and Methylparaben (CAS No. 99-76-3) in cosmetics. The opinions are open for comments until August 21, 2023.1-2
Endocrine disruptors (EDs) are chemical substances that can alter the functioning of the endocrine system, and consequently produce adverse effects upon human health. In terms of the management of EDs, the Regulation (EC) No 1223/2009 (Cosmetics Regulation) does not contain specific provisions. Instead, substances identified as EDs, including Butylparaben and Methylparaben, are currently subject to the general safety assessment of SCCS. To ensure their safe use in cosmetics, the European Commission requested SCCS to conduct safety assessments on Butylparaben and Methylparaben.
Based on the assessments of all available information, including the potential endocrine effects, SCCS considers the use of Butylparaben and Methylparaben in cosmetics is safe as shown below: