26.9.2014 Official Journal of the European Union L 282/5 COMMISSION REGULATION (EU) No 1004/2014 of 18 September 2014 amending Annex V to Regulation (EC) No 12232009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (!), and in particular Article 31(1) thereof, 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), established pursuant to Commission Decision 2008/721/EC (3, adopted an opinion on parabens in December 2010 (*). This opinion was followed by a clarifi- cation of October 2011 (%) in response to a unilateral decision by Denmark to ban propylparaben and butylpar- aben, their isoforms and their salts in cosmetic products for children under three years of age based on those substances’ potential endocrine activity, taken in accordance with Article 12 of Council Directive 76/768/EEC (). 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 methyl- paraben 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 to the consumer, as long as the sum of their individual concentrations does not exceed 0,19 % (as esters). (6)  For general cosmetic products containing butylparaben and propylparaben, excluding specific products for the nappy area, the SCCS concluded that there was no safety concern for children of any age group as the margin of safety was based on very conservative assumptions, with regards to both toxicity and exposure. (7)  However, the SCCS maintained that concerning butylparaben and propylparaben present in leave-on cosmetic products designed for application on the nappy area of children below the age of six months, a risk could not be excluded in the light of both immature metabolism of such children and the possibility of damaged skin in the nappy area. Based on a worst case assumption of exposure, safety concerns might be raised. (8)  No concerns were raised on the safety of 4-Hydroxybenzoic acid and its salts (calcium paraben, sodium paraben, potassium paraben). (9)  The Commission considers that the continued use of butylparaben and propylparaben under the current condi- tions may constitute a potential risk for human health. It therefore considers that the conditions for their use should be aligned with the recommendations of the SCCS. () OJL342,22.12.2009, p. 59. (*) Commission Decision 2008/721/EC of 5 September 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC (O] L 241, 10.9.2008, p. 21). (}) SCCS/1348/10 Revision 22 March 2011. () SCCS[1446/11. () Council Directive 76/768EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262,27.9.1976, p. 169). () SCCS[1514/13. () Commission Regulation (EU) No 358/2014 of 9 April 2014 amending Annexes Il and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (O] L 107, 10.4.2014, p. 5).