BAKGRUNN (fra kommisjonsforordningen)

(1) On 30 November 2018, the Netherlands received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from Andermatt Biocontrol Suisse AG for the approval of the active substance Phthorimaea operculella granulovirus. 

(2) The name Phthorimaea operculella granulovirus was changed to Betabaculovirus phoperculellae in 2023 by the International Committee on Taxonomy of Viruses. The European Food Safety Authority (‘the Authority’) confirmed the scientific correctness of this taxonomic reallocation. 

(3) In accordance with Article 9(3) of that Regulation, on 7 June 2019, the Netherlands, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the Authority of the admissibility of the application. 

(4) On 25 March 2022, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(5) The Authority circulated the draft assessment report received from the rapporteur Member State to the applicant and the other Member States. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, the Authority requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated draft assessment report on 10 November 2023.

(6) On 22 July 2024, the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance at issue can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The conclusion still referred to the name Phthorimaea operculella granulovirus. The Authority made its conclusion available to the public. 

(7) The Commission presented a review report and a draft Regulation regarding Betabaculovirus phoperculellae to the Standing Committee on Plants, Animals, Food and Feed on 2 October 2024 and on 4 December 2024, respectively. 

(8) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 13(1) of Regulation (EC) No 1107/2009, on the review report. The applicant submitted its comments, which have been carefully examined. 

(9) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. 

(10) The Commission further considers that Betabaculovirus phoperculellae is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Betabaculovirus phoperculellae is not a substance of concern and fulfils the conditions set in point 5.2.2 of Annex II to Regulation (EC) No 1107/2009, in the version thereof applicable to the procedure for the approval of that active substance, as it belongs to the Baculoviridae family and has not demonstrated adverse effects on any non-target insects. 

(11) It is therefore appropriate to approve Betabaculovirus phoperculellae as a low-risk active substance. 

(12) In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions in order to ensure the fulfilment of the limits on relevant microbiological contamination and the protection of operators and workers, taking into account that all microorganisms are considered as potential sensitizers. 

(13) In accordance with Article 13(4) of Regulation (EC) No 1107/2009 in conjunction with Article 22(2) thereof, Implementing Regulation (EU) No 540/20113 should be amended accordingly. 

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