L 103/22 Official Journal of the European Union 5.4.2014 REGULATION (EU) No 334/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Article 2 of Regulation (EU) No 528/2012 of the European Parliament and of the Council (%) sets out the scope of that Regulation, and, among other things, excludes from its application biocidal products when used as processing aids. Article 2(5) should be amended to clarify beyond doubt that ‘processing aids’ means those defined in Regulations (EC) No 1831/2003 (%) and (EC) No 1333/2008 (°) of the European Parliament and of the Council. (2)  Point (s) of Article 3(1) and Article 19(6) of Regulation (EU) No 528/2012 should be amended to allow similar biocidal products to be part of a biocidal product family if they can be satisfactorily assessed based on identifiable maximum risks and minimum level of efficacy. (3)  In point () of Article 19(1) and in Article 19(7) of Regulation (EU) No 528/2012, it should be clarified that the limits required to be established in accordance with Regulation (EC) No 1935/2004 of the European Parliament and of the Council (°) are specific migration limits or limits for the residual content in food contact materials. (4)  To ensure consistency between Regulation (EU) No 528/2012 and Regulation (EC) No 12722008 of the European Parliament and of the Council (’), point (b) of Article 19(4) of Regulation (EU) No 528/2012 should be amended to include specific target organ toxicity by single or repeated exposure category 1 as a classification criterion, in order to preclude authorisation for the making available on the market for use by the general public of a biocidal product meeting the criteria for this classification. Point (c) of Article 19(4) of Regulation (EU) No 528/2012 prohibits authorisation for making available on the market for use by the general public of biocidal products meeting the criteria for being persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumu- lative (‘vPvB’) in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (%). However, whereas biocidal products are often mixtures and sometimes articles, those criteria apply only to substances. Point (c) of Article 19(4) of Regulation (EU) No 528/2012 should therefore refer to biocidal products consisting of, containing or generating, substances meeting those criteria. () OJ C 347, 18.12.2010, p. 62. (%) Position of the European Parliament of 25 February 2014 (not yet published in the Official Journal) and Decision of the Council of 10 March 2014. (’) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (O] L 167, 27.6.2012, p. 1). (% Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (O] L 268, 18.10.2003, p. 29). (°) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (O] L 354, 31.12.2008, p. 16). (°) 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 (O] L 338, 13.11.2004, p. 4). (7) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (O] L 353, 31.12.2008, p. 1). (%) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 148894 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p.- 1).