29.1.2011 Official Journal of the European Union L 26/11 DIRECTIVES COMMISSION DIRECTIVE 2011/8/EU of 28 January 2011 amending Directive 2002/72/EC as regards the restriction of use of Bisphenol A in plastic infant feeding bottles (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 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular Article 18(3) thereof, After consulting the European Food Safety Authority, Whereas: (1)  Commission Directive 2002/72[EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (2 authorises the use of 2,2-bis(4-hydroxyphenyl)propane, commonly known as Bisphenol A (hereinafter ‘BPA’), as monomer for the manufacture of plastic materials and articles intended to come into contact with foodstuffs in accordance with the opinions of the Scientific Committee on Food (here- inafter ‘SCF) (}) and the European Food Safety Authority (hereinafter ‘the EFSA’) (). (2)  BPA is used as monomer in the manufacture of poly- carbonate plastics. Polycarbonate plastics are used amongst others in the manufacture of infant feeding bottles. When heated under certain conditions small amounts of BPA can potentially leach out from food containers into foods and beverages and be ingested. () OJ L 338, 13.11.2004, p. 4. () OJ L 220, 15.8.2002, p. 18. (’) Opinion of the Scientific Committee on Food on Bisphenol A, expressed on 17 April 2002. SCF/CS/PM/3936 Final, 3 May 2002. http://ec.europa.eu/food|fs/sc/scflout128_en.pdf Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to 2,2-BIS(4-HYDRO- XYPHENYL)PROPANE (Bisphenol A) Question number EFSA-Q- 2005-100, Adopted on 29 November 2006, The EFSA Journal (2006) 428, p. 1. and Toxicokinetics of Bisphenol A, Scientific Opinion of the Panel on Food additives, Flavourings, Processing aids and Materials in Contact with Food (AFC) (Question No EFSA-Q-2008-382) Adopted on 9 July 2008, The EFSA Journal (2008) 759, p. 1. — = (3)  On 29 March 2010 the Danish Government informed the Commission and the Member States that it has decided to apply the safeguard measures provided for in Article 18 of Regulation (EC) No 1935/2004 and to temporarily ban the use of BPA for the manufacture of plastic materials in contact with food intended for children aged 0-3 (°). (4)  The Danish Government substantiated its safeguard measure with a risk assessment provided on 22 March 2010 by the National Food Institute at the Technical University of Denmark (hereinafter ‘DTU Food’). The risk assessment covers the evaluation of a comprehensive study carried out on animals exposed to BPA in low doses monitoring the development of the nervous system and the behaviour in newborn rats. DTU Food has also evaluated whether the new data changes its previous evaluation of the toxic effects on the devel- opment of the nervous system and behaviour possibly caused by BPA. (5)  In accordance with the procedure provided for in Article 18 of Regulation (EC) No 1935/2004 on 30 March 2010 the Commission asked the EFSA to give its opinion on the grounds adduced by Denmark for concluding that the use of the material endangers human health, although it complies with the relevant specific measures. (6)  On 6 July 2010 the French Government informed the Commission, and on 9 July 2010 the Member States, that it has decided to apply the safeguard measures provided for in Article 18 of Regulation (EC) No 1935/2004 and to temporarily ban the manufacture, import, export and placing on the market of feeding bottles containing BPA (9). (7)  The French Government substantiated its safeguard measure with two opinions issued by the French Food Safety Authority (AFSSA) on 29 January and 7 June 2010 and the report published on 3 June 2010 by the National Institute of Health and Medical Research (INSERM). (°) Bekendtgorelse om @ndring af bekendtgerelse om materialer og genstande bestemt til kontakt med fodevarer, Lovtidende A, Nr. 286, 27.3.2010. (°) LOI n® 2010-729 du 30 juin 2010 tendant a suspendre la commer- cialisation de biberons produits a base de bisphénol A, JORF n° 0150 du 1 juillet 2010, page 11857.