Details
- Publication date
- 15 December 2023
- Author
- Scientific Committee on Consumer Safety (SCCS)
Description
SCCS members: U. Bernauer (Rapporteur), L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, 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-SCCS
ec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1652/23
Adopted on: 14 December 2023
A corrigendum clarifying SCCS conclusion under question 1 was adopted by written procedure on 28 February 2024
Conclusion of the opinion:
(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Methylparaben, does the SCCS consider Methylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.4% (as acid) when used on its own and up to 0.8% (as acid) for mixtures of esters as indicated in entry 12 of Annex V to the Cosmetics Regulation?
On the basis of the safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Methylparaben as a preservative in cosmetic products at concentrations of up to 0.4% (expressed as acid) is safe. It is also safe when used up to 0.4% in a mixture of esters for which the total concentration of all esters does not exceed 0.8% (as acid), as indicated in entry 12 of Annex V to the Cosmetics Regulation.
(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Methylparaben as a preservative in cosmetic products?
/
(3) Does the SCCS have any further scientific concerns with regard to the use of Methylparaben in cosmetic products?
The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Methylparaben for the environment.
Keywords:
SCCS, scientific opinion, methylparaben, preservative, Regulation 1223/2009, CAS No. 99-76-3, EC No. 202-785-7
Opinion to be cited as:
SCCS (Scientific Committee on Consumer Safety), Opinion on methylparaben (CAS No. 99-76-3, EC No. 202-785-7), preliminary version of 6-7 June 2023, final version of 14 December 2023, SCCS/1652/23.