24.11.2012 Official Journal of the European Union L 326/13 DIRECTIVES COMMISSION DIRECTIVE 2012/38/EU of 23 November 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include cis-Tricos-9-ene 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 (%) 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 cis-Tricos-9-ene. Pursuant to Regulation (EC) No 1451/2007, cis-Tricos-9- ene has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 19, repellents and attractants, as defined in Annex V to that Directive. Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 11 November 2009 in accordance with Article 14(4) and (6) of Regu- lation (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 25 May 2012, in an assessment report. L 123, 24.4.1998, p. 1. L 325, 11.12.2007, p. 3. () It appears from the evaluations that biocidal products used as attractants and containing cis-Tricos-9-ene may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include cis-Tricos-9-ene in Annex I to that Directive. Not all potential uses and exposure scenarios have been evaluated at Union level. For example, outdoor use and exposure of food or feeding stuff 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 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 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 according to 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 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. The provisions of this Directive should be applied simul- taneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product-type 19 containing the active substance cis- Tricos-9-ene and also to facilitate the proper operation of the biocidal products market in general. () O] L 152, 16.6.2009, p. 11. ( OJ L 70, 16.3.2005, p. 1.