BAKGRUNN (fra kommisjonsforordningen)

(1) On 1 April 2019, the Netherlands received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from FMC Agricultural Solutions A/S for the approval of the active substance Bacillus subtilis strain RTI477. 

(2) On 17 May 2019, in accordance with Article 9(3) of Regulation (EC) No 1107/2009, the Netherlands, 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. 

(3) On 3 August 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 in March 2024. 

(5) On 31 July 2024, the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance Bacillus subtilis strain RTI477 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 Bacillus subtilis strain RTI477 to the Standing Committee on Plants, Animals, Food and Feed on 2 October 2024 and on 5 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 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. 

(9) The Commission further considers that Bacillus subtilis strain RTI477 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Bacillus subtilis strain RTI477 fulfils the conditions set in point 5.2.1 of Annex II to Regulation (EC) No 1107/2009 in the version thereof applicable to the procedure for the approval of Bacillus subtilis strain RTI477, because at strain level Bacillus subtilis strain RTI477 has not demonstrated multiple resistance to anti-microbials used in human or veterinary medicine. 

(10) It is therefore appropriate to approve Bacillus subtilis strain RTI477 as a low-risk active substance. 

(11) 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 per se are considered as potential sensitisers. 

(12) 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. 

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