(1)

Commission Directive 2005/58/EC (2) included milbemectin as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance milbemectin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 May 2026.

(4)

An application for the renewal of the approval of the active substance milbemectin was submitted to Germany, the rapporteur Member State, and the Netherlands, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossier required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State.

(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 29 June 2017.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8)

In June 2019, the Authority requested additional information from the applicant on the endocrine disrupting properties of milbemectin pursuant to Article 13(3a), first subparagraph, of Implementing Regulation (EU) No 844/2012. The applicant submitted information to the Authority to assess whether the scientific criteria for the determination of endocrine disrupting properties set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 were met.

(9)

In May 2023, the rapporteur Member State made an updated draft renewal assesment report available to the Authority, the Member States and the Commission. In its updated draft renewal assessment report, the rapporteur Member State considered the additional information regarding the criteria to identify endocrine disrupting properties and concluded that milbemectin does not meet the endocrine disrupting criteria for humans nor for non-target organisms.

(10)

On 5 July 2023, the Authority communicated to the Commission its conclusion (6) indicating that, taking into account the approval criteria set out in Annex II to Regulation (EC) No 1107/2009, plant protection products containing milbemectin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(11)

The Commission presented a renewal report to the Standing Committee on Plants, Animals, Food and Feed on 11 March 2025 and a draft of this Regulation on 9 July 2025.

(12)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into due consideration.

(13)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance milbemectin that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(14)

It is therefore appropriate to renew the approval of milbemectin. In accordance with Article 14(1) of Regulation (EC) No 1107/2009, read in conjunction with Article 6 thereof, and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to provide for certain conditions, in particular, to reduce drift to terrestrial and aquatic areas outside the treated field, where appropriate.

(15)

In addition, in order to increase the confidence in the conclusion that any possible aneugenicity and phototoxicity potential of milbemectin does not pose a concern for human health, the applicant should provide information to confirm the absence of aneugenic potential of milbemectin and an in vitro phototoxicity study with milbemectin as confirmatory information.

(16)

Furthermore, given that new scientific and technical knowledge on comparative metabolism has been developed during the evaluation process which was not available at the time of the submission of the supplementary dossier for milbemectin, notably a Scientific Opinion (7) on testing and interpretation of comparative in vitro metabolism studies published by EFSA in 2021, the applicant should provide an in vitro comparative metabolism study with milbemectin as confirmatory information.

(17)

Finally, to increase the confidence in the conclusion that risk mitigation measures will be protective for all aquatic organisms outside of the field and given that the scientific and technical knowledge on conducting the aquatic risk assessment has evolved since the time the supplementary dossier for milbemectin were submitted, the applicant should provide an updated risk assessment for the aquatic sediment organisms as confirmatory information.

(18)

It is therefore appropriate to renew the approval of milbemectin subject to the conditions set out in the Annex to this Regulation. Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(19)

Commission Implementing Regulation (EU) 2025/99 (8) extended the approval period of milbemectin to 31 May 2026 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.

(20)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,