L 48/10 Official Journal of the European Union 21.2.2013 DIRECTIVES COMMISSION DIRECTIVE 2013/6/EU of 20 February 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include diflubenzuron 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: (1) O] O] 0] 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 (3) 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  N-[[(4-chlorophenyl)amino]carbonyl]-2,6-diflu- orobenzamide, which is a synonym for diflubenzuron. Pursuant to Regulation (EC) No 1451/2007, diflu- benzuron has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product- type 18, insecticides, acaricides and products to control other arthropods, 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 19 November 2007 in accordance with Article 10(5) and (7) of Commission Regulation (EC) No 2032/2003 of 4 November 2003 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, and amending Regulation (EC) No 1896/2000 (). 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 L 123, 24.4.1998, p. 1. L 325, 11.12.2007, p. 3. L 307, 24.11.2003, p. 1. the Standing Committee on Biocidal Products on 21 September 2012, in an assessment report. It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing diflubenzuron may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include diflubenzuron for use in product-type 18 in Annex [ to that Directive. Not all potential uses and exposure scenarios have been evaluated at Union level. For example, outdoor use, use by non-professionals, and exposure of livestock were not assessed. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environ- mental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels. In the light of the findings in the assessment report that there is a possible indirect human exposure via consumption of food as a result of those uses repre- sented in the assessment, it is appropriate to require, where relevant, verification of the need to set new or to amend existing maximum residue levels in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regu- lation (EC) No 726/2004 of the European Parliament and of the Council (¥) or with Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (). Special consideration should be given to the in vivo genotoxic metabolite PCA. Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded. (% O] L 152, 16.6.2009, p. 11. () O] L 70, 16.3.2005, p. 1.