Commission Implementing Regulation (EU) 2015/1981 of 4 November 2015 approving Formaldehyde released from N,N-Methylenebismorpholine as an existing active substance for use in biocidal products for product-types 6 and 13 (Text with EEA relevance)
Commission Implementing Regulation (EU) 2015/1981of 4 November 2015approving Formaldehyde released from N,N-Methylenebismorpholine as an existing active substance for use in biocidal products for product-types 6 and 13(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to 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 productsOJ L 167, 27.6.2012, p. 1., and in particular the third subparagraph of Article 89(1) thereof,Whereas:(1)Commission Delegated Regulation (EU) No 1062/2014Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1). establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products.(2)That list includes N,N-Methylenebismorpholine, to be renamed formaldehyde released from N,N-Methylenebismorpholine (hereafter referred to as "MBM"), as the result of its evaluation.(3)MBM has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the CouncilDirective 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1). for use in product-type 6, in-can preservatives, and product-type 13, metalworking-fluid preservatives, as defined in Annex V to that Directive, which correspond respectively to product-types 6 and 13 as defined in Annex V to Regulation (EU) No 528/2012.(4)Austria was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, to the Commission on 25 July 2013 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3)..(5)In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 3 October 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.(6)According to those opinions, biocidal products used for product-types 6 and 13 and containing MBM may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain conditions concerning its use are complied with.(7)It is therefore appropriate to approve MBM for use in biocidal products for product-types 6 and 13 subject to compliance with the specific conditions in the Annex.(8)The opinions conclude that MBM meets the criteria for classification as carcinogenic category 1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilRegulation (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 (OJ L 353, 31.12.2008, p. 1)..(9)Since pursuant to Article 90(2) of Regulation (EU) No 528/2012, substances for which the Member States' evaluation has been completed by 1 September 2013 should be approved in accordance with Directive 98/8/EC, the period of approval should be 5 years in accordance with the practice established under that Directive.(10)For the purposes of Article 23 of Regulation (EU) No 528/2012 however, MBM meets the conditions of Article 10(1)(a) of that Regulation and should therefore be considered a candidate for substitution.(11)Furthermore, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the competent authorities should also evaluate whether the conditions of Article 5(2) can be satisfied to decide if a biocidal product containing MBM can be authorised or not.(12)Since MBM meets the criteria for classification as carcinogenic category 1B, and as skin sensitiser category 1 as defined in Annex I to Regulation (EC) No 1272/2008, treated articles treated with or incorporating MBM should be appropriately labelled when placed on the market.(13)A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.(14)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,HAS ADOPTED THIS REGULATION: