BAKGRUNN (fra kommisjonsforordningen)

(1) On 15 March 2021, Belgium received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from Biovitis S.A. for the approval of the active substance Pythium oligandrum B301. 

(2) On 9 April 2021, Belgium, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application in accordance with Article 9(3) of Regulation (EC) No 1107/2009. 

(3) On 13 June 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. 

(4) 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 19 June 2023. 

(5) On 18 July 2024, the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance Pythium oligandrum B301 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public. 

(6) The Commission presented a review report and a draft Regulation regarding Pythium oligandrum B301 to the Standing Committee on Plants, Animals, Food and Feed on 2 October 2024 and on 4 December 2024, respectively. 

(7) 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. 

(8) It has been established with respect to one or more representative uses of at least one plant protection product containing Pythium oligandrum B301, 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. 

(9) It is therefore appropriate to approve Pythium oligandrum B301. 

(10) 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 microorganisms are per se considered as potential sensitizers. 

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

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