12.5.2017   

EN

Official Journal of the European Union

L 121/31

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009 France received on 19 June 2013 an application from Novozymes Biologicals France for the approval of the active substance Bacillus amyloliquefaciens strain FZB24.

(2)

In accordance with Article 9(3) of that Regulation, France, 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 on 4 September 2013.

(3)

On 13 April 2015, 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 complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it 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 format of an updated draft assessment report on 22 February 2016.

(5)

On 10 May 2016, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Bacillus amyloliquefaciens strain FZB24 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)

On 6 October 2016, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for Bacillus amyloliquefaciens strain FZB24 and a draft Regulation providing that Bacillus amyloliquefaciens strain FZB24 is approved.

(7)

The applicant was given the possibility to submit comments on the review report.

(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. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve Bacillus amyloliquefaciens strain FZB24.

(9)

The Commission further considers that Bacillus amyloliquefaciens strain FZB24 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Bacillus amyloliquefaciens strain FZB24 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. Bacillus amyloliquefaciens strain FZB24 is a wild-type strain naturally occurring in the environment. It is not pathogenic to humans or animals. The additional exposure of humans, animals and the environment by the uses approved under Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure expected through realistic natural situations.

(10)

It is therefore appropriate to approve Bacillus amyloliquefaciens strain FZB24 substance for a period of 15 years.

(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, however, necessary to include certain conditions.

(12)

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