4.3.2017   

EN

Official Journal of the European Union

L 58/3

(1)

The approval of the active substance prosulfuron, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 30 June 2017.

(2)

An application for the renewal of the inclusion of prosulfuron in Annex I to Council Directive 91/414/EEC (3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (4) within the time period provided for in that Article.

(3)

The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. 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 15 July 2013.

(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 25 August 2014 the Authority communicated to the Commission its conclusion (5) on whether prosulfuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for prosulfuron to the Standing Committee on Plants, Animals, Food and Feed on 29 May 2015.

(7)

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 are satisfied. Those approval criteria are therefore deemed to be satisfied.

(8)

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 restrict the use of plant protection products containing prosulfuron in order to minimise the exposure for groundwater by setting a maximum dose of 20 g of active substance per hectare, every third year on the same field and to require further confirmatory information.

(9)

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

(10)

The Commission however considers that prosulfuron is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Prosulfuron 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. Prosulfuron therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

(11)

It is therefore appropriate to renew the approval of prosulfuron as a candidate for substitution.

(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) 2016/549 (6) extended the expiry date of prosulfuron 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 May 2017.

(14)

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