Commission Implementing Regulation (EU) 2015/1727 of 28 September 2015 approving 5-Chloro-2-(4-chlorophenoxy)phenol as an existing active substance for use in biocidal products for product-types 1, 2 and 4 (Text with EEA relevance)
Commission Implementing Regulation (EU) 2015/1727of 28 September 2015approving 5-Chloro-2-(4-chlorophenoxy)phenol as an existing active substance for use in biocidal products for product-types 1, 2 and 4(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. That list includes 5-Chloro-2-(4-chlorophenoxy)phenol.(2)5-Chloro-2-(4-chlorophenoxy)phenol 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 1, human hygiene biocidal products, product-type 2, private area and public health area disinfectants and other biocidal products, and product-type 4, food and feed area disinfectants, as defined in Annex V to that Directive, which correspond respectively to product-types 1, 2 and 4, as defined in Annex V to Regulation (EU) No 528/2012.(3)Austria was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, to the Commission on 13 February 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)..(4)In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 4 December 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.(5)According to those opinions, biocidal products used for product-types 1, 2 and 4 and containing 5-Chloro-2-(4-chlorophenoxy)phenol 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.(6)It is therefore appropriate to approve 5-Chloro-2-(4-chlorophenoxy)phenol for use in biocidal products for product-types 1, 2 and 4 subject to compliance with certain specifications and conditions.(7)The opinions conclude that 5-Chloro-2-(4-chlorophenoxy)phenol meets the criteria for being very bioaccumulative (vB) and toxic (T) according to Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilRegulation (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 1488/94 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)..(8)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 10 years in accordance with the practice established under Directive 98/8/EC.(9)For the purposes of Article 23 of Regulation (EU) No 528/2012 however, 5-Chloro-2-(4-chlorophenoxy)phenol meets the conditions of Article 10(1)(d) of that Regulation and should therefore be considered a candidate for substitution.(10)For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing 5-Chloro-2-(4-chlorophenoxy)phenol in materials and articles intended to come into contact directly or indirectly with food within the meaning of Regulation (EC) No 1935/2004 of the European Parliament and of the CouncilRegulation (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 (OJ L 338, 13.11.2004, p. 4).. Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of Regulation (EC) No 1935/2004. The approval should therefore not cover such use unless the Commission has established such limits or it has been established pursuant to that Regulation that such limits are not necessary.(11)Since 5-Chloro-2-(4-chlorophenoxy)phenol meets the criteria for being very bioaccumulative (vB), treated articles treated with or incorporating 5-Chloro-2-(4-chlorophenoxy)phenol should be appropriately labelled when placed on the market.(12)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.(13)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,HAS ADOPTED THIS REGULATION: