21.11.2015   

EN

Official Journal of the European Union

L 305/31

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Hungary received on 3 April 2012 an application from Exponent International Ltd on behalf of Syngenta Crop Protection AG for the approval of the active substance flumetralin. In accordance with Article 9(3) of that Regulation, Hungary, as rapporteur Member State, notified the Commission on 28 September 2012 of the admissibility of the application.

(2)

On 30 October 2013 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the European Food Safety Authority (hereinafter ‘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.

(3)

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 in September 2014.

(4)

On 20 November 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance flumetralin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public.

(5)

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

(6)

On 29 May 2015, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for flumetralin and a draft Regulation providing that flumetralin is approved.

(7)

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.

(8)

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 and restrictions. It is, in particular, appropriate to require further confirmatory information.

(9)

The Commission however considers that flumetralin is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Flumetralin is a persistent and toxic substance in accordance with points 3.7.2.1 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in fresh water is greater than 40 days and the long-term no-observed effect concentration for freshwater organisms is less than 0,01 mg/L. Flumetralin therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

(10)

It is therefore appropriate to approve flumetralin as a candidate for substitution.

(11)

In accordance with Article 24(2) of Regulation (EC) No 1107/2009, candidates for substitution are to be listed separately in the Regulation referred to in Article 13(4) of Regulation (EC) No 1107/2009. It is therefore appropriate to add a Part E in the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). That Regulation 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,