(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 (2), Commission Implementing Regulation (EU) 2017/1380 (3), Commission Implementing Regulation (EU) 2017/1377 (4), Commission Implementing Regulation (EU) 2017/1378 (5), Commission Implementing Regulation (EU) 2017/1379 (6), Commission Implementing Regulation (EU) 2017/1382 (7) and Commission Implementing Regulation (EU) 2017/1383 (8) (‘the approvals’).

(2)

The approvals are to expire on 30 June 2024. In accordance with Article 13(1) of Regulation (EU) No 528/2012, applications were submitted to the European Chemicals Agency (‘the Agency’) for the renewal of the approvals (‘the applications’). The applications are 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 (9) that they had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that full evaluations of the applications were necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.

(4)

The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.

(5)

Within 270 days of receipt of a recommendation from the evaluating competent authorities, the Agency is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.

(6)

On 25 October 2023, the Agency informed the Commission that the evaluating competent authorities intend to submit their assessment reports and the conclusions of their evaluations to the Agency in the third quarter of 2024.

(7)

Brodifacoum, bromadiolone, chlorophacinone, coumatetralyl, difenacoum, difethialone and flocoumafen are classified in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (10) 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 (11) 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, and thus they meet the exclusion criterion set out in of Article 5(1), point (e), of Regulation (EU) No 528/2012.

(8)

Pursuant to Article 12(1) of Regulation (EU) No 528/2012, the approval 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 the conditions for derogation set out in Article 5(2) of that Regulation.

(9)

Discussions need to take place with Member States representatives to decide whether the condition set out in Article 5(2), first subparagraph, of Regulation (EU) No 528/2012 is still met, and whether the approval of brodifacoum, bromadiolone, chlorophacinone, coumatetralyl, difenacoum, difethialone and flocoumafen may therefore be renewed.

(10)

Consequently, for reasons beyond the control of the applicants, the approvals are likely to expire before decisions have been taken on their renewals. It is therefore appropriate to postpone the expiry date of the approvals for a period of time sufficient to enable the examination of the applications. Taking into account the time-limits for evaluations by the evaluating competent authorities, the preparation and submission by the Agency of its opinions and the time needed for the Commission to decide whether to renew the approval of these active substances for use in biocidal products of product-type 14, the expiry dates should be postponed to 31 December 2026.

(11)

After the postponement of the expiry dates 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,