• Opinion of the Scientific Committee on Consumer safety (SCCS) – Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7)

      Bodin, Laurent; Rogiers, Vera; Bernauer, Ulrike; Chaudhry, Qasim; Coenraads, Pieter Jan; orcid: 0000-0001-9458-7129; Dusinska, Maria; Ezendam, Janine; Gaffet, Eric; Galli, Corrado Ludovico; Granum, Berit; et al.
      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), 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 mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of propylparaben for the environment.
    • The SCCS Scientific Advice on the Safety of Nanomaterials in Cosmetics

      Bernauer, Ulrike; Bodin, Laurent; Chaudhry, Qasim; Coenraads, Pieter Jan; Dusinska, Maria; Gaffet, Eric; Panteri, Eirini; Rogiers, Vera; Rousselle, Christophe; Stepnik, Maciej; et al.
      The Cosmetic Regulation (EC) No 1223/2009 specifically covers the risk of nanomaterials used in cosmetic products. If there are concerns regarding the safety of a nanomaterial, the European Commission refers it to the SCCS for a scientific opinion. The Commission mandated the SCCS to identify the scientific basis for safety concerns that could be used as a basis for identifying and prioritising nanomaterials for safety assessment, and to revisit previous inconclusive SCCS opinions on nanomaterials to identify any concerns for potential risks to the consumer health. The SCCS Scientific Advice identified the key general aspects of nanomaterials that should raise a safety concern for a safety assessor/manager, so that the nanomaterial(s) in question could be subjected to safety assessment to establish safety to the consumer. The Advice also developed a list of the nanomaterials notified to the Commission for use in cosmetics in an order of priority for safety assessment, and revisited three previous inconclusive opinions on nanomaterials to highlight concerns over consumer safety that merited further safety assessment.
    • The SCCS scientific advice on the safety of nanomaterials in cosmetics.

      SCCS members. Electronic address: SANTE-C2-SCCS@ec.europa.eu; Bernauer, Ulrike; Bodin, Laurent; Chaudhry, Qasim; Coenraads, Pieter Jan; Dusinska, Maria; Gaffet, Eric; Panteri, Eirini; Rogiers, Vera; Rousselle, Christophe; et al. (2021-09-22)
      The Cosmetic Regulation (EC) No 1223/2009 specifically covers the risk of nanomaterials used in cosmetic products. If there are concerns regarding the safety of a nanomaterial, the European Commission refers it to the SCCS for a scientific opinion. The Commission mandated the SCCS to identify the scientific basis for safety concerns that could be used as a basis for identifying and prioritising nanomaterials for safety assessment, and to revisit previous inconclusive SCCS opinions on nanomaterials to identify any concerns for potential risks to the consumer health. The SCCS Scientific Advice identified the key general aspects of nanomaterials that should raise a safety concern for a safety assessor/manager, so that the nanomaterial(s) in question could be subjected to safety assessment to establish safety to the consumer. The Advice also developed a list of the nanomaterials notified to the Commission for use in cosmetics in an order of priority for safety assessment, and revisited three previous inconclusive opinions on nanomaterials to highlight concerns over consumer safety that merited further safety assessment. [Abstract copyright: Copyright © 2021 Elsevier Inc. All rights reserved.]