31.10.2013 Official Journal of the European Union L 289/65 DECISIONS COMMISSION IMPLEMENTING DECISION of 29 October 2013 approving restrictions of the authorisation of one biocidal product containing bromadiolone notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (notified under document C(2013) 7034) (Only the German text is authentic) (2013/630/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, humans, non-target animals and the environment is minimised, by considering and applying all appropriate and available risk mitigation measures. The risk miti- gation measures mentioned in Directive 2009/92/EC therefore include, amongst others, restriction to profes- sional use only. Having regard to Directive 98/8/EC of the European Parliamfent (4 The company Lipha Tech S.A.S. (the applicant) has, in and qf the Council of 16 February 1998 concerning the plgang accordance with Article 8 of Directive 98/8/EC, of .b10c1dal products on the market ('), and in particular submitted an application to the Netherlands for authori- Article 4(4) thereof, sation of one rodenticide containing bromadiolone (‘the product)). The product’s name and reference numbers in the Register for Biocidal Products (R4BP) are indicated in Whereas: the Annex to this Decision. (1) Annex I to Directive 98/8/EC contains the list of active () The =~ Netherlands ~ granted the authorlsaFwn on substances approved at Union level for inclusion in 2 Nf)VF:mber 2012. The product was authorlsed. with biocidal products. Commission Directive 2009/92/EC () restr1§t1on§ to ensure that the conFlltlons of Article 5 added the active substance bromadiolone for use in of D1rect1v? .98/ S/EC were met n t‘he. Netherlapds. products belonging to product-type 14, Rodenticides, as Th0§e restrictions .d1d not include restriction to trained defined in Annex V to Directive 98/8/EC. or licensed professional users. . . . . (6)  On 20 December 2012, the applicant submitted a (2)  Bromadiolone is an anticoagulant rodenticide known to complete application to Germany for mutual recoenition pose risks of accidental incidents with children, as well as ; piere app o Y S . ) ) of the first authorisation in respect of the product. risks for non-target 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). (7)  On 10 April 2013, Germany notified the Commission, the other Member States and the applicant of its proposal to restrict the first authorisation in accordance with ) ) ) Article 4(4) of Directive 98/8/EC. Germany proposed to (3)  For reasons of public health and hygiene, it was never- impose a restriction on the product to use by trained or theless found to be justified to include bromadiolone and licensed professionals. other anticoagulant rodenticides in Annex I to Directive 98/8/EC, thus allowing Member States to authorise bromadiolone-based = products. However, Directive (8) The Commission invited the other Member States and 2009/92[EC obliges Member States to ensure, when granting authorisation of products containing bromad- iolone, that primary as well as secondary exposure of () OJ L 123, 24.4.1998, p. 1. (%) Commission Directive 2009/92/EC of 31 July 2009 amending the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. No comments were submitted within that deadline. The notification was also discussed between the Commission and Member States’ Competent Authorities for biocidal products in the meeting of the Product Authorisation and Mutual Recog- nition Facilitation Group of 14 May 2013. Directive 98/8/EC of the European Parliament and of the Council to include bromadiolone as an active substance in Annex I thereto (O] L 201, 1.8.2009, p. 43).