13.3.2014 Official Journal of the European Union L 73/5 DECISIONS COMMISSION IMPLEMENTING DECISION of 11 March 2014 rejecting the refusal of authorisations of biocidal products containing bromadiolone notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (notified under document C(2014) 1362) (Text with EEA relevance) (2014/133/EV) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ('), and in particular Article 36(3) thereof, Whereas: Annex [ to Directive 98/8/EC of the European Parliament and of the Council (%) contained the list of active substances approved at Union level for use in biocidal products. Commission Directive 2009/92/EC (*) added the active substance bromadiolone for use in products belonging to product-type 14, Rodenticides, as defined in Annex V to Directive 98/8/EC. In accordance with Article 8 of Directive 98/8/EC, the companies Pelgar International Limited and Unichem d.o.o. (the applicants) submitted applications to the United Kingdom for authorisation of biocidal products containing bromadiolone as a wax block formulation (‘the contested products’). The United Kingdom auth- orised before 1 September 2013 the contested products for a number of uses including professional application in and around buildings and in sewers. A number of () OJ L 167, 27.6.2012, p. 1. (%) 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 (O] L 123, 24.4.1998, p. 1). (}) Commission Directive 2009/92/EC of 31 July 2009 amending 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). Member States have subsequently authorised the contested products through mutual recognition. The German competent authority for biocidal products received applications for mutual recognition of authori- sations according to Article 4(1) of Directive 98/8EC for the contested products. Germany has notified the Commission, the other Member States and the applicants of its proposal to refuse the authorisations in accordance with Article 4(4) of Directive 98/8/EC, as Germany considers that the contested products do not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to effects on human health. According to the notifications, Germany disagrees with the evaluation carried out by the United Kingdom regarding the dermal absorption value used in such evaluation (0,04 %). Germany considers this value as inappropriate according to OEDC standards on in vitro dermal absorption methods (*) and pointed out that based on a more conservative value of 0,36 % as per these standards the assessment results in an unacceptable dermal exposure to bromadiolone for professional users. For each notification, the Commission invited the other Member States and the applicants to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within that deadline by the United Kingdom, Belgium, Germany and one of the applicants. The notification was also discussed between Commission representatives and representatives of Member States’ Competent Authorities for biocidal products in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 14 May 2013. (*) See OECD Guideline for the testing of chemicals 428 on skin absorption: in vitro method, available on the website http://www.oecd-ilibrary. orgfenvironment/test-no-428-skin-absorption-in-vitro-method_ 9789264071087-en