Non – renewal of approval of the active substance oxasulfuron

(1)

Commission Directive 2003/23/EC included oxasulfuron as an active substance in Annex I to Council Directive 91/414/EEC.

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011.

(3)

The approval of the active substance oxasulfuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2019.

(4)

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

(5)

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.

(6)

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 (‘the Authority’) and the Commission on 29 January 2016.

(7)

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.

(8)

On 2 February 2017 the Authority communicated to the Commission its conclusion on whether oxasulfuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9)

The Authority identified a large number of data gaps resulting in the inability to finalise the risk assessment in several areas. In particular, the available information on oxasulfuron and its metabolites did not allow finalising the assessment of the overall consumer exposure, the groundwater exposure, the risk to aquatic organisms, earthworms, soil macro- and microorganisms and non-target terrestrial plants.

(10)

The Commission presented the draft renewal report and a draft Regulation for oxasulfuron to the Standing Committee on Plants, Animals, Food and Feed on 19 July 2017.

(11)

The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

(12)

However, despite the arguments put forward by the applicant, the concerns referred to in recital 9 could not be eliminated.

(13)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. The approval of the active substance oxasulfuron should therefore not be renewed.

(14)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(15)

Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing oxasulfuron.

(16)

For plant protection products containing oxasulfuron, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 8 November 2019.

(17)

Commission Implementing Regulation (EU) 2018/917 extended the expiry date of oxasulfuron to 31 July 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Given that a decision is taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

(18)

This Regulation does not prejudice the submission of a further application for the approval of oxasulfuron in accordance with Article 7 of Regulation (EC) No 1107/2009.

(19)

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