Non-renewal of approval of the active substance quinoxyfen

(1)

Commission Directive 2004/60/EC  included quinoxyfen 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 quinoxyfen, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2019.

(4)

An application for the renewal of the approval of quinoxyfen 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 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 5 December 2016.

(7)

In accordance with Article 11of Implementing Regulation (EU) No 844/2012, that assessment was limited to a targeted assessment. The assessment did not go beyond the identity, methods of analysis, environmental fate and behavior and ecotoxicology information that related to the potential persistent bioaccumulative and toxic (PBT) properties, very persistent and very bioaccumulative (vPvB) properties and persistent organic pollutant (POP) properties of quinoxyfen, since the approval criteria set out in point 3.7.2 and 3.7.3 of Annex II to Regulation (EC) No 1107/2009 are not satisfied.

(8)

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.

(9)

On 24 November 2017 the Authority communicated to the Commission its conclusion on whether quinoxyfen can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The conclusion is limited to a hazard targeted assessment (focussed on the elements referred to in point 3.7 of Annex II to Regulation (EC) No 1107/2009) and does not cover all the approval criteria. The Authority concluded that quinoxyfen is a PBT substance as well as a vPvB substance.

(10)

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

(11)

However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.

(12)

Based on the concerns identified, it has not been established with respect to one or more representative uses of at least one plant protection product containing quinoxyfen that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of quinoxyfen in accordance with Article 20 of that Regulation.

(13)

Member States should be provided with sufficient time to withdraw authorisations for plant protection products containing quinoxyfen.

(14)

For plant protection products containing quinoxyfen, 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 27 March 2020.

(15)

Commission Implementing Regulation (EU) 2018/524 extended the expiry date of quinoxyfen to 30 April 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Given that a decision has been taken ahead of this extended expiry date, this Regulation should apply as soon as possible.

(16)

This Regulation does not prevent the submission of a further application for the approval of quinoxyfen pursuant to Article 7 of Regulation (EC) No 1107/2009.

(17)

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