(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Danstar Ferment AG and Comercial Quimica Masso submitted to France, on 26 June 2017, an application for the approval of the active substance Bacillus amyloliquefaciens strain IT-45.

(2)

In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicants, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 1 December 2017 of the admissibility of the application.

(3)

On 15 May 2019, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, concluding that the active substance Bacillus amyloliquefaciens strain IT-45 could be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(4)

In accordance with Article 12(3) of Regulation (EC) No 1107/2009, the Authority also set a time limit for the applicants to supply additional information to the Member States, the Commission and the Authority

(5)

In its Conclusion, communicated to the applicants, the Member States and the Commission, following a peer review of the pesticide risk assessment pursuant to Article 12 (2) of Regulation (EC) No 1107/2009, the Authority held that the active substance Bacillus amyloliquefaciens strain IT-45 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 (2).

(6)

On 21-22 October 2021, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed its review report on the active substance Bacillus amyloliquefaciens strain IT-45 and a draft of this Regulation regarding Bacillus amyloliquefaciens strain IT-45.

(7)

The applicants were given the possibility to submit comments on the review report.

(8)

It has been established with respect to one representative use of at least one plant protection product containing the active substance, as 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)

Since the Commission considers that Bacillus amyloliquefaciens strain IT-45 is a low-risk active substance, pursuant to Article 22 of Regulation (EC) No 1107/2009, and since plant protection products containing that substance may be expected to pose only a low risk to human and animal health and the environment, it may be approved for up to 15 years. No critical area of concerns were identified for humans, animals and the environment.

(10)

Bacillus amyloliquefaciens strain IT-45 is a microorganism, which also fulfils the conditions established by Article 22 (2) of Regulation (EC) No 1107/2009, in conjunction with point 5.2. of Annex II to that Regulation. It is therefore appropriate to approve Bacillus amyloliquefaciens strain IT-45 as a low-risk substance.

(11)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, Commission Implementing Regulation (EU) No 540/2011 (3) should therefore 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,