Metalaxyl-M: treated seeds may be sown outside greenhouses — with precision drills and up to 2 000 000 seeds/ha; impurity CGA226048 at < 10 g/kg, information on the effect of water treatment on residues by 10 July 2026; EFSA — metabolite NOA409045 above 0.1 µg/L in groundwater in 6–7 of 7 scenarios for spinach, considered non-relevant
Commission Implementing Regulation (EU) 2026/1353, published on 16 June 2026, lifts the 2020 restriction under which products containing metalaxyl-M could be used only to treat seeds sown in greenhouses. The application was submitted by Syngenta Crop Protection AG in 2020, the rapporteur was Belgium. In its first conclusions (3 October 2023) EFSA identified a critical area of concern — a high acute and long-term risk to birds and wild mammals; in the updated conclusions (4 July 2025) it considered sowing outside greenhouses safe for them under refined practice: a lower sowing rate and precision drilling.
- New approval conditions (period unchanged: 1 June 2020 – 31 May 2035): for seed treatment of seeds to be sown outdoors, Member States limit the sowing density and require precision drilling equipment; 2 000 000 seeds/ha is not exceeded unless the risk assessment for a specific use shows no unacceptable effects on birds and mammals at a higher rate. By 10 July 2026 the applicant must submit confirmatory information on the effect of water treatment processes on the nature of residues in drinking water. Particular attention: specification of the technical material; protection of operators and workers (personal protective equipment); protection of groundwater in regions with vulnerable soil or climatic conditions; protection of non-target arthropods, birds and mammals.
- Specification (CAS No 70630-17-0, CIPAC No 580, methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate): purity ≥ 920 g/kg; toxicologically relevant impurities — 2,6-dimethylphenylamine (CGA72649) ≤ 0.5 g/kg, 4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide (CGA363736) ≤ 1 g/kg and 2-[(2,6-dimethylphenyl)-(2-methoxyacetyl)amino]propionic acid 1-methoxycarbonylethyl ester (CGA226048) < 10 g/kg instead of the original 0.18 g/kg (already amended by Regulation 2024/1718). EFSA: CGA226048 is unlikely to be genotoxic and a level below 10 g/kg raises no toxicological concern; the new data do not change the earlier conclusions on analytical methods.
- Groundwater (EFSA, PEARL, PELMO and MACRO models): low potential for metalaxyl-M to exceed 0.1 µg/L in all 8 scenarios; for spinach at 200 mL product/100 kg seed the metabolites NOA409045, SYN546520 and CGA67868 above 0.1 µg/L in 7, 6 and 1 of 7 scenarios respectively, at 100 mL — 6, 2 and 0, at 50 mL — 6, 0 and 0; all three were considered non-relevant. For NOA409045 (the R-isomer of metabolite CGA62826) ADI 0.5 mg/kg bw per day, drinking water exposure below 0.1 % of the ADI. The consumer risk assessment via drinking water was not finalised — data on the effect of water treatment are missing (EFSA points first to ozonation and chlorination).
- Birds and mammals (EFSA 2025): representative uses — seed treatment of sunflower and spinach with APRON XL EC against Plasmopara halstedii, Peronospora spp. and Pythium spp. With standard drilling equipment the risk is high; low for spinach sown with precision drilling at densities below 2 000 000 seeds/ha (lowest rate 16.96 g a.s./100 kg seed). For sunflower the higher-tier assessment was insufficient to exclude the risk to birds and mammals eating seeds and seedlings. Endocrine-disrupting properties are dealt with separately, as confirmatory information from the renewal.