TY - JOUR
T1 - Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7)
AU - SCCS Members
AU - SCCS External Experts
AU - Bodin, Laurent
AU - Rogiers, Vera
AU - Bernauer, Ulrike
AU - Chaudhry, Qasim
AU - Coenraads, Pieter Jan
AU - Dusinska, Maria
AU - Ezendam, Janine
AU - Gaffet, Eric
AU - Galli, Corrado Ludovico
AU - Granum, Berit
AU - Panteri, Eirini
AU - Rousselle, Christophe
AU - Stepnik, Maciej
AU - Vanhaecke, Tamara
AU - Wijnhoven, Susan
AU - Koutsodimou, Aglaia
AU - Uter, Wolfgang
AU - von Goetz, Natalie
N1 - Publisher Copyright:
© 2021
PY - 2021/10
Y1 - 2021/10
N2 - In cosmetic products, the ingredient propylparaben (CAS No 94-13-3, EC No 202-307-7) with the chemical names Propyl 4-hydroxybenzoate and 4-Hydroxybenzoic acid propyl ester is currently regulated as a preservative in a concentration up to 0.14% (as acid) (Annex V/12a). In addition, a safe concentration was established for mixtures of parabens, where the sum of the individual concentrations should not exceed 0.8% (as acid). However, in such mixtures the sum of the individual concentrations of butyl- and propylparaben and their salts should not exceed 0.14%. Propylparaben was subject to different safety evaluations in 2005 (SCCP/0874/05), 2006 (SCCP/1017/06), 2008 (SCCP/1183/08), 2010 (SCCS/1348/10), 2011 (SCCS/1446/11), and in 2013 (SCCS/1514/13). On the basis of the safety assessment of propylparaben, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that propylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14%. The available data on propylparaben provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of propylparaben for the environment. Link to the Opinion (SCCS/1623/20): https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_243.pdf
AB - In cosmetic products, the ingredient propylparaben (CAS No 94-13-3, EC No 202-307-7) with the chemical names Propyl 4-hydroxybenzoate and 4-Hydroxybenzoic acid propyl ester is currently regulated as a preservative in a concentration up to 0.14% (as acid) (Annex V/12a). In addition, a safe concentration was established for mixtures of parabens, where the sum of the individual concentrations should not exceed 0.8% (as acid). However, in such mixtures the sum of the individual concentrations of butyl- and propylparaben and their salts should not exceed 0.14%. Propylparaben was subject to different safety evaluations in 2005 (SCCP/0874/05), 2006 (SCCP/1017/06), 2008 (SCCP/1183/08), 2010 (SCCS/1348/10), 2011 (SCCS/1446/11), and in 2013 (SCCS/1514/13). On the basis of the safety assessment of propylparaben, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that propylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14%. The available data on propylparaben provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of propylparaben for the environment. Link to the Opinion (SCCS/1623/20): https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_243.pdf
KW - CAS No 94-13-3
KW - EC No 202-307-7
KW - Preservative
KW - Propylparaben
KW - Regulation 1223/2009
KW - SCCS
KW - SCCS/1623/20
KW - Scientific opinion
U2 - 10.1016/j.yrtph.2021.105005
DO - 10.1016/j.yrtph.2021.105005
M3 - Comment/Letter to the editor
AN - SCOPUS:85111029677
SN - 0273-2300
VL - 125
JO - Regulatory toxicology and pharmacology
JF - Regulatory toxicology and pharmacology
M1 - 105005
ER -