BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Directive 2004/62/EC included mepanipyrim 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 mepanipyrim, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 March 2025. 

(4) An application for the renewal of the approval of the active substance mepanipyrim was submitted to Belgium, the rapporteur Member State, and Greece, the corapporteur 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 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 Authority and the Commission on 3 May 2016. In its draft renewal assessment report the rapporteur Member State proposed to renew the approval of mepanipyrim. 

(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the 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 12 May 2017, the Authority communicated to the Commission its conclusion on whether mepanipyrim can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(9) The Commission presented an initial draft renewal report for mepanipyrim to the Standing Committee on Plants, Animals, Food and Feed on 5 October 2017.

 (10) In accordance with Article 14(1a), first subparagraph, of Implementing Regulation (EU) No 844/2012, the Commission requested the Authority to reassess the available information on endocrine disrupting properties of the active substance. 

(11) On 14 July 2023, the Authority communicated to the Commission its updated conclusion on whether mepanipyrim can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 including its finalised assessment of endocrine disrupting properties. 

(12) The Authority identified certain specific concerns. In particular, it concluded that mepanipyrim is considered to meet the criteria for endocrine disruptors for humans and wild mammals as non-target organisms set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, due to its oestrogen, androgen and steroidogenesis (EAS)-modalities. Negligible exposure of humans to mepanipyrim cannot be demonstrated since residues above the default value of 0.01 mg/kg are expected to occur. Therefore, the requirements set out in point 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 are not fulfilled. Additionally, a high longterm risk was identified for wild mammals exposed to mepanipyrim via dietary exposure, for all representative uses. Furthermore, several issues could not be finalised, including the consumer risk assessment. 

(13) Article 4(7) of Regulation (EC) No 1107/2009 provides for the possibility of a restricted approval of substances identified as endocrine disruptors if it can be demonstrated that the active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods. As the applicant did not provide any information to demonstrate such necessity, this derogation cannot be considered. 

(14) The Commission presented an updated draft renewal report for mepanipyrim to the Standing Committee on Plants, Animals, Food and Feed on 12 October 2023. 

(15) 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. 

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

(17) 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 mepanipyrim. 

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

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

(20) For plant protection products containing mepanipyrim, 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. 

(21) Commission Implementing Regulation (EU) 2023/689 of 20 March 2023 extended the period of approval of mepanipyrim until 15 March 2025 in order to allow the renewal process to be completed before the expiry of the approval period of that substance. However, given that a decision on the non-renewal of the approval is taken ahead of the expiry of that extended approval period, this Regulation should apply earlier than that date. 

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

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