Butylparaben (CAS No. 94-26-8, EC No. 202-318-7)

SCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1651/23
Adopted on: 26 October 2023

Conclusion of the opinion:

(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Butylparaben, does the SCCS consider Butylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %?

On the basis of safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid) is safe.

(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Butylparaben as a preservative in cosmetic products?

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(3) Does the SCCS have any further scientific concerns with regard to the use of Butylparaben in cosmetic products?

In the absence of exposure data specific for children to Butylparaben in cosmetic products, potential safety concerns cannot be excluded.

The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Butylparaben for the environment.

Keywords:

SCCS, scientific opinion, butylparaben, preservative, Regulation 1223/2009, CAS No. 94-26-8, EC No. 202-318-7

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on butylparaben (CAS No. 94-26-8, EC No. 202-318-7), preliminary version of 6-7 June 2023, final version of 26 October 2023, SCCS/1651/23.