lunes, 10 de junio de 2013

REGULATORY 10/06/13 -OC-opinion on propyl and butyl paraben

"Parabens" are currently authorized as preservatives at a maximum concentration of 0.4% when used individually or 0.8%  when used as a mixture of esters.


In March 2011, the Scientific Committee on Consumers Safety  (SCCS/1348/10) considered that: 
- Methylparaben and ethylparaben were safe, when used at the maximum authorized concentrations;
- Butylparaben and propylparaben were safe, if the sum of their individual concentrations did not exceed 0.19% (NOEL 2 mg/kg bw/day, the use percentage was calculated in order to obtain MOS>100).
- For isopropylparaben, isobutylparaben, phenylparaben, benzylparaben and  pentylparaben, the human risk could not be evaluated for lack of data.
On 21 March 2011, Denmark notified the Commission that it had banned propyl- and butylparaben, the isoforms and salts in cosmetic products for children up to three years of  age. On 10 October 2011.

The concerns of the SCCP/SCCS expressed previously and reiterated in recent Opinions remain unchanged and reinforced after the evaluation of both the reproductive  toxicity and the toxicokinetic studies on propylparaben recently submitted to the SCCS.
For these reasons, the  SCCS reiterates its previous conclusions and requests regarding  an improvement of the  data, in particular:
a) on the exposure of humans including children to propyl- and butylparaben in cosmetic products and
b) the toxicokinetics of propyl- and butylparaben in humans.


Dead Line for comments:01/07/2013

Regulatory Survey Archive http://www.biophilgroup.com/elenco_news_corporate_home_tecnica.asp