Ouvrages Année : 2025

SCCS Opinion on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - Children exposure - SCCS/1674/25 - Preliminary Opinion

U. Bernauer
  • Fonction : Auteur
Q. Chaudhry
  • Fonction : Auteur
P.J. Coenraads
  • Fonction : Auteur
J. Ezendam
  • Fonction : Auteur
C. L. Galli
  • Fonction : Auteur
E. Panteri
V. Rogiers
  • Fonction : Auteur
M. Stepnik
  • Fonction : Auteur
T. Vanhaecke
  • Fonction : Auteur
S. Wijnhoven
  • Fonction : Auteur
E. Benfentati
  • Fonction : Auteur
E. Corsini
  • Fonction : Auteur
A. Koutsodimou
  • Fonction : Auteur
H. Louro
  • Fonction : Auteur
W. Uter
  • Fonction : Auteur
N. von Goetz
  • Fonction : Auteur

Résumé

SCCS Opinion on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - Children exposure - SCCS/1674/25 - Preliminary Opinion Preliminary Opinion open for comments - Deadline for comments: 10 March 2025 U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz The SCCS adopted this document by written procedure on 10 January 2025 Publication date : 13 January 2025 https://health.ec.europa.eu/publications/sccs-opinion-butylparaben-cas-no-94-26-8-ec-no-202-318-7-children-exposure_en https://health.ec.europa.eu/document/download/453366da-0b79-48f6-963e-648f8c176000_en?filename=sccs_o_296.pdf Details Publication date : 13 January 2025 Author : Scientific Committee on Consumer Safety (SCCS) Description 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.

Fichier non déposé

Dates et versions

hal-04883766 , version 1 (13-01-2025)

Identifiants

  • HAL Id : hal-04883766 , version 1

Citer

U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, J. Ezendam, et al.. SCCS Opinion on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - Children exposure - SCCS/1674/25 - Preliminary Opinion. Scientific Committee for Consumer Safety (SCCS, EC). , 2025, Scientific Committee for Consumer Safety (SCCS, EC). ⟨hal-04883766⟩
131 Consultations
0 Téléchargements

Partager

  • More