Wednesday, October 31, 2012SCCS

Propyl and Butyl parabens: a request for the SCCS opinion

©CosmeticOBS-L'Observatoire des Cosmétiques

Propyl- and butyl- parabens: is their safety for use to be evaluated again? Anyway, the SCCS is resquested today to reconsider its previous evaluations of these ingredients, taking into account the data from a new study on their toxicity for reproduction. Deadline for the next Opinion: March 2013.

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Parabens are currently authorized as preservatives in entry 12 of Annex VI to the Cosmetics Directive at a maximum concentration of 0.4% when used individually or 0.8% when used as a mixture of esters. Different substances are covered by this entry, with the most commonly used being: methyl-, ethyl-, propyl-, butyl-, isopropyl- and isobutyl- parabens.

Since 2005, these substances have been assessed by the subsequent Scientific Committees on a number of occasions. 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%.
• 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 butyl- parabens, the isoforms and salts in cosmetic products for children up to three years of age.

On 10 October 2011, the SCCS adopted a clarification to its previous opinion in light of the Danish clause of safeguard. The Committee (SCCS/1446/11) concluded that:
• For general cosmetic products containing parabens, excluding specific products …

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