(fra kommisjonsbeslutningen)

(1)    Brodifacoum, bromadiolone, chlorophacinone, coumatetralyl, difenacoum, difethialone and flocoumafen are approved as active substances for use in biocidal products of product-type 14 (rodenticides) under Regulation (EU) No 528/2012 by  Commission Implementing Regulation (EU) 2017/1381 , Commission Implementing Regulation (EU) 2017/1380 , Commission Implementing Regulation (EU) 2017/1377 , Commission Implementing Regulation (EU) 2017/1378 , Commission Implementing Regulation (EU) 2017/1379 , Commission Implementing Regulation (EU) 2017/1382  and Commission Implementing Regulation (EU) 2017/1383  (‘the approvals’). The approvals were to expire on 30 June 2024. 

(2)    In accordance with Article 13(1) of Regulation (EU) No 528/2012, applications were submitted to the European Chemicals Agency for the renewal of the approvals of brodifacoum, bromadiolone, chlorophacinone, coumatetralyl, difenacoum, difethialone and flocoumafen for use in biocidal products of product-type 14 (rodenticides) (‘the applications’). The applications have been evaluated by the competent authorities of Denmark, Finland, France, The Netherlands, Norway and Spain as the evaluating competent authorities.

(3)    The evaluating competent authorities informed the Commission  that they had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that full evaluations of the applications were necessary. 

(4)    Commission Implementing Decision (EU) 2024/734  postponed the expiry date of the approval of brodifacoum, bromadiolone, chlorophacinone, coumatetralyl, difenacoum, difethialone and flocoumafen for use in biocidal products of product-type 14 to 31 December 2026, in order to allow sufficient time for the examination of the applications. 

(5)    In accordance with Article 14(3) of Regulation (EU) No 528/2012, on 14 May 2025, the European Chemicals Agency adopted the opinions,  formulated by its Biocidal Products Committee, having regard to the conclusions of the evaluating competent authorities and submitted them to the Commission.

(6)    According to the opinions of the European Chemicals Agency, brodifacoum, bromadiolone, chlorophacinone, coumatetralyl, difenacoum, difethialone and flocoumafen are classified in Regulation (EC) No 1272/2008 of the European Parliament and of the Council  as toxic for reproduction category 1A or 1B, and thus they meet the exclusion criterion set out in Article 5(1), point (c), of Regulation (EU) No 528/2012. The substances brodifacoum, bromadiolone, difenacoum, difethialone and flocoumafen also meet the criteria in Regulation (EC) No 1907/2006 of the European Parliament and of the Council  for being persistent, bioaccumulative and toxic, and thus they meet the exclusion criterion set out in of Article 5(1), point (e), of Regulation (EU) No 528/2012. The substances difethialone and flocoumafen also meet the criteria in Regulation (EC) No 1907/2006 of the European Parliament and of the Council for being very persistent and very bioaccumulative (‘vPvB’), and thus they meet the exclusion criterion set out in of Article 5(1), point (e), of Regulation (EU) No 528/2012.

(7)    Pursuant to Article 12(1) of Regulation (EU) No 528/2012, the approvals of brodifacoum, bromadiolone, chlorophacinone, coumatetralyl, difenacoum, difethialone and flocoumafen, may only be renewed if the active substances still meet the conditions laid down in Article 4(1) and at least one of the conditions set out in Article 5(2), first subparagraph, of that Regulation.

(8)    Considering the time still needed for the Commission to complete its analysis and submit a proposal for a decision on the renewals of the approvals of the active substances to the Standing Committee on Biocidal Products, including discussions with the Member States representatives, it will not be possible to adopt decisions on the applications before the expiry of the current approvals. 

(9)    Consequently, for reasons beyond the control of the applicants, the approvals are likely to expire before a decision has been taken on their renewal. It is therefore appropriate to further postpone the expiry date of the approvals for a period of time sufficient to complete the examination of the applications. 

(10)    Taking into account the time needed for the Commission to decide whether to renew the approvals of these active substances for use in biocidal products of product-type 14, the expiry dates of those approvals should be postponed to 31 December 2027.

(11)    After the postponement of the expiry date of the approvals, brodifacoum, bromadiolone, chlorophacinone, coumatetralyl, difenacoum, difethialone and flocoumafen remain approved for use in biocidal products of product-type 14 subject to the conditions set out in the Annexes to their approvals,