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Parliamentary questions
23 January 2014
E-013066/2013
Answer given by Mr Mimica on behalf of the Commission

The Scientific Committee on Consumer Safety provided seven scientific opinions on parabens(1). In the most recent opinions, the Committee confirmed that the methyl‐ and ethyl paraben are considered safe at the current limit of 0.8% (as acids), with no single paraben having a higher concentration than 0.4% (as acids). For propyl‐ and butyl paraben, the Committee recommended to lower the limit to a maximum total concentration of parabens to 0.19% (as ester). However it concluded that a risk could not be excluded for the application of leave-on cosmetic products designed for the nappy area on children below the age of six months. For other parabens (isopropyl-, isobutyl-, phenyl-, benzyl‐ and pentylparaben), only limited or no information was available, and the potential risk could not be assessed.

In its latest opinions, the Committee highlighted that toxicokinetics of parabens in rats and humans differ considerably and asked for an improvement of the data, in particular on the exposure of humans including children to propyl‐ and butylparaben in cosmetic products and the toxicokinetics of propyl‐ and butylparaben in humans.

The Commission agrees that these data would allow a more refined risk assessment. However, the Commission considers that it does not need further studies before implementing the recommendations described above, given that the Committee took into account all the remaining uncertainty factors while calculating the margin of safety and took a very conservative approach(2). At present, the Commission is preparing measures to implement the latest Committee opinions.

(1)SCCP/0874/05, SCCP/0873/05, SCCP/1017/06, SCCP/1183/08, SCCS/1348/10, SCCS/1446/11 and SCCS/1514/13.
(2)SCCS/1446/11.

OJ C 231, 17/07/2014
Last updated: 17 February 2014Legal notice