Opinion of the Scientific Committee on Consumer Safety (SCCS) - Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7).
Regul Toxicol Pharmacol
; 125: 105005, 2021 Oct.
Article
en En
| MEDLINE
| ID: mdl-34274358
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.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Parabenos
/
Conservadores Farmacéuticos
/
Seguridad de Productos para el Consumidor
Tipo de estudio:
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Año:
2021
Tipo del documento:
Article
Pais de publicación:
Países Bajos