26.8.2016   

EN

Official Journal of the European Union

L 231/34

(1)

The approval of the active substance ethofumesate, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 31 July 2017.

(2)

An application for the renewal of the approval of ethofumesate was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (3) within the time period provided for in that Article.

(3)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(4)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 28 January 2015.

(5)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(6)

On 18 December 2015 the Authority communicated to the Commission its conclusion (4) on whether ethofumesate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for ethofumesate to the Standing Committee on Plants, Animals, Food and Feed on 8 March 2016.

(7)

The applicant was given the possibility to submit comments on the renewal 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 that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(9)

It is therefore appropriate to renew the approval of ethofumesate.

(10)

The risk assessment for the renewal of the approval of ethofumesate is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing ethofumesate may be authorised. It is therefore appropriate not to maintain the restriction to uses as a herbicide.

(11)

In accordance with Article 14(1) 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 set maximum limits for two toxicologically relevant impurities in the active substance as manufactured.

(12)

In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(13)

Commission Implementing Regulation (EU) 2016/950 (5) extended the expiry date of ethofumesate in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has been taken ahead of the extended expiry date, this Regulation should apply from 1 November 2016.

(14)

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