BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Directive 2007/25/EC2 included metribuzin 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 metribuzin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 February 2025. 

(4) An application for the renewal of the approval of the active substance metribuzin was submitted to Estonia, the rapporteur Member State, and Germany, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/20125 within the time period provided for in that Article.

(5) The applicant submitted the supplementary dossiers required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State. 

(6) The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 30 September 2019. In its draft renewal assessment report, the rapporteur Member State proposed to not renew the approval of metribuzin. 

(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission. 

(8) On 25 July 2023, the Authority communicated to the Commission its conclusion6 on whether metribuzin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(9) The Authority identified concerns. In particular, it concluded that metribuzin meets the criteria to be identified as an endocrine disruptor for the thyroid (T)-modality for humans and that it has not been demonstrated that the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible. Furthermore, the Authority concluded that the bystander and resident exposure estimates exceed the established limit value for all representative uses evaluated, and that the available studies were not sufficient to exclude a high risk to bees. 

(10) The Authority evaluated whether metribuzin is necessary to control a serious danger to plant health which cannot be contained by other available means including nonchemical methods. This evaluation included only cases where metribuzin is used to control weeds for pre-emergence and post-emergence herbicide applications. The Authority concluded that an insufficient number of chemical alternatives were available at the time of assessment for all crops evaluated and therefore that in that regard the derogation is scientifically supported in all crops evaluated. The assessment of non-chemical alternatives for the presented uses concluded that a wide range of non-chemical methods are available, despite of the fact that these methods might not have the same efficacy as chemical methods or might have economic limitations. Therefore, the Commission considers that the conditions for the application of the derogation in Article 4(7) of Regulation (EC) No 1107/2009 are not fulfilled.

(11) The Commission presented a renewal report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 22 May 2024 and on 10 July 2024, respectively. 

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

(13) Despite the arguments put forward by the applicant, the concerns regarding the active substance metribuzin could not be eliminated. 

(14) Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product containing metribuzin 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 the active substance metribuzin in accordance with Article 20(1), point (b), of that Regulation. 

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

(16) Commission Implementing Regulation (EU) 2015/4087 listed metribuzin as a candidate for substitution. In the light of the non-renewal of the approval of metribuzin that listing is no longer relevant. Accordingly, metribuzin should be removed from the Annex to Implementing Regulation (EU) 2015/408. 

(17) Member States should be given sufficient time to withdraw authorisations for plant protection products containing metribuzin. 

(18) For plant protection products containing metribuzin, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 12 months from the date of entry into force of this Regulation. 

(19) Commission Implementing Regulation (EU) 2023/9188 extended the approval period of metribuzin to 15 February 2025 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on the non-renewal of the approval is taken ahead of the expiry date of that extended approval period, this Regulation should apply earlier than that date.

(20) This Regulation does not prevent the submission of another application for the approval of metribuzin pursuant to Article 7 of Regulation (EC) No 1107/2009. 

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