BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Directive 2008/108/EC included mepiquat chloride as an active substance in Annex I to Council Directive 91/414/EEC, under the name “mepiquat”. 

(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 that active substance, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 15 October 2025. 

(4) An application for the renewal of the approval of the active substance mepiquat chloride was submitted to Finland, the rapporteur Member State, and Estonia, the corapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 and 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. This 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 19 December 2018. In its draft renewal assessment report, the rapporteur Member State could not propose to renew the approval of mepiquat chloride, since further information was needed to exclude the endocrine disrupting properties of that active substance. 

(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 20 April 2020, the Authority requested additional information from the applicant on the endocrine disrupting properties of mepiquat chloride pursuant to Article 13(3a), first subparagraph, of Implementing Regulation (EU) No 844/2012. The applicant submitted information to allow the Authority to conclude the assessment as regards whether the scientific criteria for the determination of endocrine disrupting properties set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as introduced by Commission Regulation (EU) 2018/605 are met. 

(9) In April 2023, the rapporteur Member State made an updated draft renewal assesment report available to the Authority, the Member States and the Commission. In its updated draft renewal assessment report, the rapporteur Member State considered the additional information submitted by the applicant regarding the criteria to identify endocrine disrupting properties and concluded that mepiquat chloride had no such properties with respect to human, mammalian species and other non-target organisms. 

(10) On 4 July 2024, the Authority communicated to the Commission its conclusion, which indicated that mepiquat chloride can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(11) The Commission presented a renewal report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 2 October 2024. 

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

(13) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance mepiquat chloride that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. 

(14) It is therefore appropriate to renew the approval of mepiquat chloride. 

(15) Although the risk assessment for the renewal of the approval of the active substance mepiquat chloride is based on a limited number of representative uses, this does not restrict the uses for which plant protection products containing mepiquat chloride may be authorised. It is therefore appropriate not to maintain the restriction to use mepiquat chloride only as a plant growth regulator. 

(16) In accordance with Article 14(1) of Regulation (EC) No 1107/2009, in conjunction with Article 6 thereof, and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to provide for certain conditions, in particular with respect to the specification of the technical material and the protection of operators. It is no longer necessary to maintain the specific condition that Member States pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers, as the provisional consumer risk assessment showed an acceptable risk even for critical consumer groups. 

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

(18) Commission Implementing Regulation (EU) 2024/3248 extended the approval period of mepiquat to 15 October 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 renewal of the approval of that active substance has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date. 

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