L 4414 Official Journal of the European Union 15.2.2013 COMMISSION DIRECTIVE 2013/5/EU of 14 February 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include pyriproxyfen 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) (") ¢ 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 pyriproxyfen. Pursuant to Regulation (EC) No 1451/2007, pyriproxyfen has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insec- ticides, acaricides and products to control other arth- ropods, as defined in Annex V to that Directive. The Netherlands were designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 2 October 2009 in accordance with Article 10(5) and (7) 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 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 pyriproxyfen may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include pyriproxyfen for use in product type 18 in Annex [ to that Directive. L 123, 24.4.1998, p. 1. L 325, 11.12.2007, p. 3. (6) Not all potential uses and exposure scenarios have been evaluated at Union level, which, in particular, included only professional use. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental 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 (¥). Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded. In view of the assumptions made during the risk assessment, it is appropriate to require that products authorised for professionals are used with appropriate personal protective equipment, unless it can be demon- strated in the application for product authorisation that risks to workers and operators can be reduced to an acceptable level. In view of the risks identified for the environment, it is appropriate to require that products are not authorised for direct use on surface water, unless it can be demon- strated in the application for product authorisation that risks to the aquatic and terrestrial ecosystems and groundwater can be reduced to an acceptable level, and that any authorisation of products intended to be used in waste treatment facilities is subject to appropriate risk mitigation measures to avoid contamination of the area outside the waste treatment site. () O] L 152, 16.6.2009, p. 11. (4 OJ L 70, 16.3.2005, p. 1.