L 19546 Official Journal of the European Union 27.7.2011 DIRECTIVES COMMISSION DIRECTIVE 2011/71/EU of 26 July 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include creosote as an active substance in Annex I thereto (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (!), and in particular the second subparagraph of Article 16(2) thereof, Whereas: (") ¢ Commission  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 (2 establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, TA or IB to Directive 98/8/EC. That list includes creosote. Pursuant to Regulation (EC) No 1451/2007, creosote has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to that Directive. Sweden was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 31 October 2007 in accordance with Article 14(4) and (6) of Regu- lation (EC) No 1451/2007. It follows from the report that the evaluation only covers Grade B and Grade C creosote  as  specified in  European  Standard EN 13991:2003. L 123, 24.4.1998, p. 1. L 325, 11.12.2007, p. 3. S ) A stakeholder consultation was launched on 30 April 2008. The outcome of the consultation was made public and discussed in the 30th meeting of represen- tatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market. The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 17 December 2010 in an assessment report. It appears from the assessment report that wood preserv- atives containing creosote may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, when applied on wood in some of the scenarios evaluated. Furthermore, there were strong indications in the abovementioned stakeholder consultation that there are considerable socioeconomic benefits of using creosote in certain applications. Life cycle analyses submitted and published in the context of the consul- tation have suggested that, in certain cases, no appro- priate alternatives to creosote exist, which are less damaging to the environment. It is therefore appropriate to include creosote in Annex I. However, for certain wood use scenarios presented in the assessment  report, unacceptable risks for the environment were identified in the risk assessment. Furthermore, creosote is considered to be a non- threshold carcinogen and is classified as carcinogen category 1B in accordance with 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 (°). () OJ L 353, 31.12.2008, p. 1.