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Monday, September 16, 2013European Commission

European consultation on parabens

© CosmeticOBS-L'Observatoire des Cosmétiques

As you know, parabens use in cosmetics has been questioned for several years. The most questioned are Butylparaben and Propylparaben, for which the European Commission plans to restrict usage, by lowering the allowed content in finished products, and by banning them in products for babies’ nappy area. Five more parabens should be completely banned. A public consultation is open up to 1 November 2013.

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Text of the public consultation on Butyl- and Propyl-parabens in the frame of the Regulation (EC) No. 1223/2009

Background

Parabens are regulated as preservatives in entry 12 of Annex V to Regulation (EC) No 1223/2009 on cosmetic products under the denomination 4-hydroxybenzoic acid and its salts and esters, with a maximum concentration of 0.4 % for single ester and 0.8% for mixtures of esters.
The SCCS adopted an opinion on parabens in December 2010, followed by a clarification of October 2011 in response to the Danish unilateral decision to ban Propylparaben and Butylparaben, the isoforms and their salts in cosmetic products for children under three years of age, taken in accordance with article 12 of Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. The conclusions of 2010 and 2011 were confirmed by the SCCS in an additional opinion of May 2013.

The SCCS confirmed that Methylparaben and Ethylparaben are safe at the maximum authorized concentrations. In addition, the SCCS noted that limited to no information was submitted for the safety evaluation of Isopropylparaben, Isobutylparaben, and Phenylparaben. Therefore, for these compounds, the human risk cannot be evaluated. The same is true for …

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