(Utkast) Kommisjonens gjennomføringsforordning (EU) …/… om endring av gjennomføringsforordningene (EU) 2019/1085 og (EU) nr. 540/2011 med hensyn til vilkårene for godkjenning at det aktive stoffet 1-metylcyklopropen
Plantevernmidler: vilkår for godkjenning at det aktive stoffet 1-metylcyklopropen
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 19.3.2025
Bakgrunn
(fra kommisjonsforordninen)
(1) Commission Implementing Regulation (EU) 2019/1085 renewed the approval of the active substance 1-methylcyclopropene.
(2) Following that renewal, the approval of the active substance 1-methylcyclopropene, as set out in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011, includes a restriction to uses as plant growth regulator in post-harvest storage in sealable warehouses only.
(3) In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 4 March 2019, AgroFresh Holding France SAS submitted an application to the designated rapporteur Member State, the Netherlands, seeking an amendment to the conditions of approval of 1-methylcyclopropene in order to remove the restriction to uses as plant growth regulator in post-harvest storage in sealable warehouses only and to allow pre-harvest in field uses via orchard spray fed by direct injection system. The application was found to be admissible by the rapporteur Member State.
(4) The rapporteur Member State assessed the proposed new uses of the active substance 1-methylcyclopropene in relation to the potential effects on human and animal health and the environment in accordance with Article 4 of Regulation (EC) No 1107/2009 and prepared a revised renewal assessment report which was submitted to the European Food Safety Authority (‘the Authority’) and the Commission on 12 October 2021.
(5) In accordance with Article 12(1) of Regulation (EC) No 1107/2009, the Authority circulated the revised renewal assessment report to the applicant and to the Member States for comments and made it available to the public. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, additional information was requested from the applicant. The rapporteur Member State evaluated the additional information and submitted the revised renewal assessment report to the Commission and to the Authority in October 2023.
(6) On 19 July 2024, the Authority communicated to the Commission its conclusion on whether the proposed new uses of the active substance 1-methylcyclopropene can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
(7) The Commission presented to the Standing Committee on Plants, Animals, Food and Feed an addendum to the renewal report for 1-methylcyclopropene on 4 December 2024 and a draft of this Regulation on 12 March 2025, respectively.
(8) The Commission invited the applicant to submit comments on the addendum to the renewal report. The applicant submitted comments, which have been carefully examined.
(9) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance 1-methylcyclopropene that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied for the new uses. It is therefore appropriate to remove the restriction and to allow pre-harvest in field uses.
(10) In addition, to increase the confidence in the decision, the applicant should submit to the Commission, the Member States and the Authority confirmatory information as regards the presence of methallyl alcohol in soil and aquatic compartments and, if it is formed in relevant amounts, information on its toxicological properties and potential risk to aquatic and soil organisms. Moreover, the applicant should submit information as regards the effect of water treatment processes on the nature of residues present in drinking water. That confirmatory information should be submitted within 2 years from the date of entry into force of this Regulation.
(11) Implementing Regulations (EU) 2019/1085 and (EU) No 540/2011 should therefore be amended accordingly.
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,