Editor's Notes: This article was originally published on June 13, 2023, and underwent updates on November 7, 2023, and December 18, 2023, to reflect the latest developments.
On June 8, 2023, the Scientific Committee on Consumer Safety (SCCS) published preliminary opinions respectively on the use of Butylparaben (CAS No. 94-26-8) and Methylparaben (CAS No. 99-76-3) in cosmetics. Following consideration of received comments, final opinions for Butylparaben and Methylparaben were released on November 6, 2023, and December 15, 2023, respectively.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:
Substance Identification | Restrictions | ||
Name | CAS No. | Function | Maximum Concentration |
Butylparaben | 94-26-8 | Preservative | 0.14% (as acid) |
Methylparaben | 99-76-3 | Preservative | 0.4% (as acid) |