Commission Implementing Regulation (EU) 2026/1353 of 15 June 2026 amending Implementing Regulations (EU) 2020/617 and (EU) No 540/2011 as regards the conditions of approval of the active substance metalaxyl-M

Amendment to Implementing Regulation (EU) 2020/617

Article 1

Annex I to Implementing Regulation (EU) 2020/617 is amended in accordance with Annex I to this Regulation.

Amendment to Implementing Regulation (EU) No 540/2011

Article 2

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEX ISupplementary provisions

ANNEX I Annex I to Implementing Regulation (EU) 2020/617 is replaced by the following: Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions ‘Metalaxyl-M CAS No 70630-17-0 (R) CIPAC No 580 methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate ≥ 920 g/kg The following impurities are of toxicological concern and must not exceed the following levels in the technical material: 2,6-dimethylphenylamine: max. content ≤ 0,5 g/kg 4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide: max. content ≤ 1 g/kg 2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester: max. content < 10 g/kg 1 June 2020 31 May 2035 When used for seed treatment where treated seeds are to be sown outdoors, Member States shall, impose appropriate restrictions concerning the sowing density and require the use of precision drilling equipment. A sowing density above 2 000 000 seeds/ha shall not be exceeded unless the outcome of the risk assessment undertaken for the specific uses for which authorisation is applied for demonstrates that a higher rate does not lead to any unacceptable effects on birds and mammals. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl-M, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured; — the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of non-target arthropods, birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water, by 10 July 2026. ( 1 )   Further details on the identity and the specification of the active substance are provided in the review report.’

ANNEX IISupplementary provisions

ANNEX II Row 140, metalaxyl-M, in Part B of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following: No. Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions ‘140 Metalaxyl-M CAS No 70630-17-0 (R) CIPAC No 580 methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate 920 g/kg The following relevant impurities shall not exceed a certain threshold: 2,6-dimethylphenylamine: max. content 0,5 g/kg 4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide: max. content 1 g/kg 2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester): max. content 10 g/kg 1 June 2020 31 May 2035 When used for seed treatment where treated seeds are to be sown outdoors, Member States shall, impose appropriate restrictions concerning the sowing density and require the use of precision drilling equipment. A sowing density above 2 000 000 seeds/ha shall not be exceeded unless the outcome of the risk assessment undertaken for the specific uses for which authorisation is applied for demonstrates that a higher rate does not lead to any unacceptable effects on birds and mammals. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl-M, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured, — the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate, — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of non-target arthropods, birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water, by 10 July 2026.’