The regulation No 1004/2014 of 18 September 2014 has been published in the Official Journal of the European Union on 26 September 2014. It amends Annex V to Cosmetics Regulation 1223/2009 (allowed preservatives) and places new restrictions for Butylparaben and Propylparaben.
Whereas
1. 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.
2. The Scientific Committee on Consumer Safety (SCCS) adopted an opinion on parabens in December 2010. This opinion was followed by a clarification of October 2011 in response to a unilateral decision by Denmark to ban propylparaben and butylparaben, their isoforms and their salts in cosmetic products for children under three years of age based on those substances' potential endocrine activity. The conclusions of 2010 and 2011 were confirmed by the SCCS in an additional opinion of May 2013, which the Commission had requested in light of a new study on the reprotoxicity of propylparaben.
3. In the above-mentioned opinions, which concerned all the long-chain parabens, the SCCS confirmed that methylparaben and ethylparaben are safe at the maximum authorized concentrations.
4. Isopropylparaben, Isobutylparaben, Phenylparaben, Benzylparaben and Pentylparaben were banned by Commission Regulation (EU) No 358/2014.
5. The SCCS concluded that the use of butylparaben and propylparaben as preservatives in finished cosmetic products is safe …
