Renewal of the approval of the active substance Abamectin

(1)

Commission Directive 2008/107/EC (2) included abamectin 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 abamectin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2023.

(4)

An application for the renewal of the approval of the active substance abamectin was submitted to Austria, the rapporteur Member State, and Malta, 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 dossiers 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 complete 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 17 April 2019. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of abamectin.

(7)

The Authority communicated the draft renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8)

On 15 July 2020, the Authority communicated to the Commission its conclusion (6) on whether abamectin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority identified a number of issues that could not be finalised. In particular it identified risks as regards birds and mammals, aquatic organisms and soil macroorganisms.

(9)

On 1 February 2022, the Commission sent a mandate to the Authority with a request to review the exposure and risk assessments as regards birds and mammals, aquatic organisms and soil macroorganisms. The Authority sent to the Commission an updated conclusion on 27 July 2022 (7). In its updated Conclusion, the Authority confirmed the risks identified in the previous assessment.

(10)

The Commission presented a renewal report and the draft Regulation for abamectin to the Standing Committee on Plants, Animals, Food and Feed, on 25 March 2021 and revised versions of the two documents on 8 December 2022 to take into account the outcomes in the updated Conclusion of the Authority.

(11)

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 on both versions of the renewal report, which have been carefully examined.

(12)

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

(13)

The risk assessment for the renewal of the approval of the active substance abamectin is based on representative uses as insecticide and acaricide in protected crops. While it is not necessary, in the light of this risk assessment, to maintain the restriction to use only as insecticide and acaricide, it is necessary to provide, in accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, for certain conditions and restrictions. It is, in particular, appropriate to restrict the use of plant protection products containing abamectin to uses which allow controlled exchange of material and energy with the surroundings, so as to prevent the release of plant protection products into the environment and mitigate the high risk identified to aquatic organisms and wild terrestrial non-target organisms. Accordingly, uses in permanent greenhouses may be authorised.

(14)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(15)

Commission Implementing Regulation (EU) 2022/378 (8) extended the approval period of abamectin to 30 April 2023 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. Given that a decision on renewal has been taken ahead of that extended expiry date, and taking into account that the current approval of abamectin expires on 30 April 2023, this Regulation should enter into force as soon as possible and apply earlier then that date.

(16)

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