L 16022 Official Journal of the European Union 21.6.2012 COMMISSION IMPLEMENTING DECISION of 18 June 2012 approving restrictions of authorisations of biocidal products containing difethialone notified by Germany in accordance with Article 4(4) of Directive 98/8/EC of the European Parliament and of the Council (notified under document C(2012) 4026) (Only the German text is authentic) (2012/317[EV) 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 Article 4(4) thereof, Whereas: (1) O] 0] Annex [ to Directive 98/8/EC contains the list of active substances approved at Union level for inclusion in biocidal products. The active substance difethialone was approved for inclusion in products belonging to product- type 14, rodenticides, as defined in Annex V to Directive 98/8/EC, by Commission Directive 2007/69/EC of 29 November 2007 amending Directive 98/8/EC of the European Parliament and of the Council to include dife- thialone as an active substance in Annex I thereto (2). Difethialone is an anticoagulant rodenticide known to pose risks of accidental incidents with children, as well as risks for animals and the environment. It has been identified as potentially persistent, liable to bioac- cumulate and toxic (PBT'), or very persistent and very liable to bioaccumulate (‘vPvB’). For reasons of public health and hygiene, it was never- theless found to be justified to include difethialone and other anticoagulant rodenticides in Annex I to Directive 98/8/EC, thus allowing Member States to authorise dife- thialone-based products. However, Directive 2007/69/EC obliges Member States to ensure, when granting auth- orisation of products containing difethialone, that primary as well as secondary exposure of humans, non-target animals and the environment is minimised, by considering and applying all appropriate and available risk mitigation measures. The scientific evaluation leading to the adoption of Directive 2007/69/EC concluded that the most significant reductions in exposure to and risks posed by difethialone L 123, 24.4.1998, p. 1. L 312, 30.11.2007, p. 23. (6) are achieved by restricting its use to treatment campaigns of limited duration, limiting access of non-target animals to the bait and removing unused bait and dead and moribund rodents during a baiting campaign in order to minimise the opportunity of primary or secondary exposure of non-target animals. The evaluation also concluded that only professional users are expected to follow such instructions. The risk mitigation measures mentioned in Directive 2007/69/EC therefore include restriction to professional use only. The company LiphaTech S.A.S. (the applicant) has, in accordance with Article 8 of Directive 98/8/EC, submitted an application to the United Kingdom for authorisation of six rodenticides containing difethialone (the products). The products’ names and reference numbers in the Register for Biocidal Products (R4BP) are indicated in the Annex to this Decision. The United Kingdom granted the authorisations on 20 April 2011 (Generation Pat), on 26 April 2011 (Gen- eration Block, Generation BBlock and Generation SBlock) and on 27 April 2011 (Generation Grain'Tech and Rodilon Trio) (‘the first authorisations’). The products were authorised with restrictions to ensure the conditions of Article 5 of Directive 98/8/EC were met in the United Kingdom. Those restrictions did not include restriction to trained or licensed professional users. On 6 November 2009, the applicant submitted a complete application to Germany for mutual recognition of the first authorisations in respect of the products. On 22 November 2011, Germany notified the Commission, the other Member States and the applicant of its proposal to restrict the first authori- sations in accordance with Article 4(4) of Directive 98/8/EC. Germany proposed to impose a restriction on the products to use by trained or licensed professionals. The Commission invited the other Member States and the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Only the applicant submitted comments within that deadline. The notifi- cation was also discussed between Commission represen- tatives, representatives of Member States’ Competent Authorities for biocidal products and the applicant in the meeting of the Product Authorisation and Mutual