7.7.2012 Official Journal of the European Union L 177/25 DIRECTIVES COMMISSION DIRECTIVE 2012/20/EU of 6 July 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include flufenoxuron as an active substance for product-type 8 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: 1 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, IA or IB to Directive 98/8/EC. That list includes flufenoxuron. Pursuant to Regulation (EC) No 1451/2007, flufen- oxuron 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. France was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 17 March 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. 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 22 September 2011, in an assessment report. It appears from the evaluations that biocidal products used as wood preservatives and containing flufenoxuron L 123, 24.4.1998, p. 1. L 325, 11.12.2007, p. 3. may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. Therefore, and notwith- standing the fact that flufenoxuron has not been approved in certain other areas for which the use specific risk assessments gave a different result (%), it is appropriate to include flufenoxuron for use in product- type 8 in Annex I to that Directive. In view of its characteristics, which render it persistent, liable to bioaccumulate and toxic (PBT), as well as very persistent and very liable to bioaccumulate (vPvB), in accordance with the criteria laid down in Annex XIII to 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 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 (*), flufenoxuron should be included in Annex 1 for three years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)() of Directive 98/8/EC before its inclusion in Annex I is renewed. The Union level risk assessment of flufenoxuron used in wood preservatives only addressed treatment of wood intended to be used indoors (use classes 1 and 2 as defined by OECD (°)) or outdoors not covered and not in contact with the ground and continually exposed to the weather, protected from the weather but subject to frequent wetting or in contact with fresh water (use class (}) Commission Implementing Regulation (EU) No 942/2011 of 22 September 2011 concerning the non-approval of the active substance flufenoxuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Decision 2008/934/EC (O] L 246, 23.9.2011, p. 13); Commission Decision 2012/77[EU of 9 February 2012 concerning the non-inclusion of flufenoxuron for product type 18 in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (O] L 38, 11.2.2012, p. 47). () OJ L 396, 30.12.2006, p. 1. (°) OECD series on emission scenario documents, Number 2, Emission Scenario Document for Wood Preservatives, part 2, p. 64.