Kommisjonens gjennomføringsforordning (EU) 2023/2513 av 16. november 2023 om ikke å fornye godkjenningen av det aktive stoffet triflusulfuron-metyl i samsvar med europaparlaments- og rådsforordning (EF) nr. 1107/2009, og om endring av Kommisjonens gjennomføringsforordning (EU) nr. 540/2011
Avslag på forlenget godkjenning av triflusulfuron-metyl som aktivt stoff i plantevernmidler
- Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 18.10.2023
BAKGRUNN (fra kommisjonsforordningen)
(1) Commission Directive 2009/77/EC included triflusulfuron-methyl 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 triflusulfuron-methyl, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 December 2023.
(4) An application for the renewal of the approval of the active substance triflusulfuron-methyl was submitted to France, the rapporteur Member State, and Denmark, the co-rapporteur Member State, 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 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 26 July 2019. In its draft renewal assessment report France proposed to not renew the approval of triflusulfuron-methyl.
(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 1 April 2022, the Authority communicated to the Commission its conclusion on whether triflusulfuron-methyl can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
(9) The Authority identified a critical concern in relation to the contamination of groundwater by one toxicologically relevant metabolite of triflusulfuron-methyl, IN JU122, which is predicted to occur above the parametric value of 0,1 μg/L in all geoclimatic conditions represented by the groundwater assessment scenarios for all proposed uses of triflusulfuron-methyl. Therefore, it cannot currently be established that the presence of metabolites of triflusulfuron-methyl in groundwater will have no unacceptable effects on groundwater and no harmful effects on human health, as required by Article 4(3), point (b), of Regulation (EC) No 1107/2009.
(10) Furthermore, the Authority concluded that triflusulfuron-methyl has endocrine disrupting properties that may cause adverse effects in humans, as set out in point 3.6.5 of Annex II to Regulation (EC) No 1107/2009 . According to the Authority, negligible exposure cannot be demonstrated for triflusulfuron-methyl since residues above the default value set out in Article 18(1), point (b), of Regulation (EC) No 396/2005 of the European Parliament and of the Council may be expected to occur in rotational crops. Therefore, the requirement set out in point 3.6.5 of Annex II to Regulation (EC) No 1107/2009 is not fulfilled. The Authority also concluded that the consumer dietary risk assessment could not be finalised.
(11) In its evaluation of whether triflusulfuron-methyl is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods in accordance with Article 4(7) of Regulation (EC) No 1107/2009, the Authority concluded that for some uses and in some Member States, there may be an insufficient number of chemical alternatives available at the time of assessment. However, some non-chemical methods are available (for instance, mechanical weeding), although they may not have the same efficacy as chemical methods and/or they may present economic or other feasibility limitations. In addition, further chemical alternatives could be made available in the Member States concerned via mutual recognition of alternative products that are available in other Member States, as provided for in Article 40 of Regulation (EC) No 1107/2009. In addition, the Commission considers that no serious danger to plant health has been identified. 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.
(12) The Commission presented a renewal report on 14 October 2022 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 11 July 2023.
(13) 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.
(14) Despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.
(15) 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. It is therefore appropriate not to renew the approval of the active substance triflusulfuron-methyl in accordance with Article 20(1), point (b), of that Regulation.
(16) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(17) Member States should be given sufficient time to withdraw authorisations for plant protection products containing triflusulfuron-methyl.
(18) For plant protection products containing triflusulfuron-methyl, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 9 months from the date of entry into force of this Regulation.
(19) Commission Implementing Regulation (EU) 2022/1480 extended the approval period of triflusulfuron-methyl to 31 December 2023 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance.
(20) Taking into account that the current approval of triflusulfuron-methyl expires on 31 December 2023, this Regulation should enter into force as soon as possible.
(21) This Regulation does not prevent the submission of another application for the approval of triflusulfuron-methyl pursuant to Article 7 of Regulation (EC) No 1107/2009.
(22) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,