BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Implementing Regulation (EU) 2020/617 renewed the approval of the active substance metalaxyl-M and restricted the use of seeds treated with plant protection products containing it. 

(2) The approval of the active substance metalaxyl-M, as set out in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011, included a maximum level of 0,18 g/kg for the impurity CGA226048 (2-[(2,6-dimethyl-phenyl)- (2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester) as well as a restriction as regards the treatment of seeds, i.e. the use of metalaxyl-M is limited to the treatment of seeds intended to be sown in greenhouses. 

(3) In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 17 June 2020, Syngenta Crop Protection AG submitted an application to the designated rapporteur Member State, Belgium, seeking an amendment of the conditions of approval of metalaxyl-M, in order to remove the restriction concerning the sowing of seeds and to update the maximum level of the impurity CGA226048 contained therein. The application was found to be admissible by the designated rapporteur Member State. 

(4) The designated rapporteur Member State assessed the request for an amended use of the active substance metalaxyl-M in relation to the potential effects on human and animal health and the environment in accordance with the provisions of 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 9 March 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. Belgium evaluated the additional information and submitted a revised renewal assessment report to the Commission and to the Authority in April 2023. 

(6) On 14 August 2023, the Authority communicated to the Commission its conclusion on whether the amended conditions of approval of the active substance metalaxyl-M can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(7) The Commission presented an addendum to the review report for metalaxyl-M and a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed on 22 May 2024. 

(8) The applicant was invited to submit comments on the addendum to the review report. 

(9) It has been established that, with a maximum level of less than 10 g/kg for impurity CGA226048 (2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester), the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to update the maximum level of that impurity and to amend the conditions of approval. 

(10) Concerning the restriction concerning the sowing of seeds, following the outcome of the application for amendment of conditions of approval, the Commission has requested the Authority to further review certain issues and to update the risk assessment. Therefore, currently that restriction is maintained. 

(11) Furthermore, it is necessary that the applicant submits to the Commission, the Member States and the Authority further confirmatory information on the assessment of water treatment processes on the nature of residues of the active substance or its metabolites in water abstracted for the production of drinking water. 

(12) Implementing Regulations (EU) 2020/617 and No 540/2011 should therefore be amended accordingly. 

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