SCCS Opinion on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - Children's exposure

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke (Rapporteur), S. Wijnhoven
SCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro , W. Uter, N. von Goetz
Contact: SANTE-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1674/25
Adopted on: 10 January 2025

Conclusion of the opinion:

(1) In light of the data provided and taking under consideration the conclusions of the SCCS/1651/23 Opinion on children exposure, does the SCCS consider Butylparaben safe for children, when used as a preservative up to a maximum concentration of 0.14 %?

Based on the safety assessment carried out in consideration of all available information, including the potential endocrine effects, the SCCS is of the opinion that the use of Butylparaben as preservative at a maximum concentration of 0.14 % (as acid) in all cosmetic products included in this exposure assessment is not safe for children between 0.5-1 years, 1-3 years, 3-6 years and 6-10 years when used in combination. With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category.

(2) Alternatively, what is, according to the SCCS, the maximum concentration of Butylparaben that is considered safe for the age groups of children considered in this opinion”?

In the SCCS’s opinion, to be safe for all the childrens’ age groups that were considered, the maximum concentration of Butylparaben in final products should not exceed 0.028% (as acid). However, the necessity of a reduction in Butylparaben concentration could be reassessed when a well-carried out dermal absorption study and better exposure studies specifically tailored to EU children become available.

(3) Does the SCCS have any further scientific concerns regarding the use of Butylparaben in cosmetic products and children’s exposure?

This Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.
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, children exposure

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) – children exposure, preliminary version of 10 January 2025, SCCS/1674/25.