(fra kommisjonsforordningen)

(1) Commission Implementing Regulation (EU) 2020/617 renewed the approval of the active substance metalaxyl-M. 

(2) The conditions of the approval of the active substance metalaxyl-M, as inserted in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 by Implementing Regulation (EU) 2020/617, include 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 that the use of plant protection products containing metalaxyl-M for seed treatment is to be 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 rapporteur Member State, Belgium, seeking an amendment to 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. The application was found to be admissible by the rapporteur Member State. 

(4) The rapporteur Member State assessed the proposed new use of the active substance metalaxyl-M and the proposed updated level of the impurity CGA226048 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 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. The rapporteur Member State evaluated the additional information and submitted the revised renewal assessment report to the Commission and to the Authority on 13 April 2023. 

(6) On 3 October 2023, the Authority communicated to the Commission its conclusion on whether the proposed new use of the active substance metalaxyl-M and the proposed updated level of the impurity CGA226048 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(7) It was established in the conclusion of the Authority that, with a level of less than 10 g/kg for impurity CGA226048, the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. 

(8) Based on the conclusion of the Authority, 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. 

(9) By Commission Implementing Regulation (EU) 2024/1718, The Commission amended the approval of metalaxyl-M setting a revised maximum level for CGA226048. 

(10) With regard to the restriction concerning to the sowing of treated seeds, the Authority identified a critical area of concern. A high acute and long-term risk was identified for birds and wild mammals. However, in the conclusion and its background documents it was indicated that a safe use for treatment and sowing of treated spinach seeds may be possible, when considering precision drilling of seeds. The Commission, in accordance with Article 31 of Regulation (EC) No 178/2002 of the European Parliament and of the Council, read in conjunction with Regulation (EC) No 1107/2009, requested that the Authority provide an updated risk assessment for birds and mammals. 

(11) On 4 July 2025, the Authority communicated to the Commission its updated conclusion on whether the proposed new use 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. 

(12) The Authority established in its updated conclusion that the sowing of seeds treated with plant protection products containing metalaxyl-M outside greenhouses does not pose a risk to wild birds and mammals with the application of refined good agricultural practices (GAPs), in particular by limiting the seed sowing rate and by using precision drilling equipment. 

(13) The Commission presented a second addendum to the review report for metalaxyl-M and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 10 December 2025. 

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

(15) Based on the outcome of the risk assessment, it is considered appropriate to set a maximum sowing rate that should apply unless the outcome of a risk assessment for sowing of seeds carried out as part of the authorisation for the placing on the market of plant protection products for such use indicates that a higher rate does not lead to any unacceptable effects on birds and mammals. It is also considered appropriate to require the use of precision drilling equipment. It is therefore appropriate to remove the restriction limiting the use of plant protection products containing metalaxyl-M for the treatment of seeds intended to be sown in greenhouses only. 

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

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