Pyrimethanil renewed until 30 April 2041: limits for cyanamide 0.5, aniline 4 and acetylacetone 0.1 g/kg; EFSA — multi-residue method DFG S19 (LC-MS/MS, LOQ 0.01 mg/kg), ADI lowered from 0.17 to 0.013 mg/kg bw; a corrigendum moved the date of application to 1 May 2026
Commission Implementing Regulation (EU) 2026/355, published on 19 February 2026, renews the approval of the fungicide pyrimethanil from 1 May 2026 to 30 April 2041. A corrigendum of 30 April 2026 changed the date of application in Article 3 from 1 April to 1 May 2026. It is based on the EFSA conclusion of 3 September 2024 (uses in grapevine, pome fruit, strawberry and lettuce); pyrimethanil does not meet the criteria for an endocrine disruptor. Member States must pay particular attention to operators, bystanders and residents, aquatic organisms, bees and other pollinators.
- Annex: pyrimethanil, N-(4,6-dimethylpyrimidin-2-yl)aniline, CAS No 53112-28-0, CIPAC 714, purity ≥ 975 g/kg; in the technical material cyanamide ≤ 0.5 g/kg, aniline ≤ 4 g/kg, acetylacetone ≤ 0.1 g/kg. In the EFSA conclusion the maximum acceptable level of acetylacetone could not be set (issue not finalised), and the batches used in toxicity studies did not match the specification. Methods for acetylacetone and aniline in the formulation are missing.
- Methods (EFSA): residues in food and feed of plant origin — multi-residue method DFG S19 with LC-MS/MS, LOQ 0.01 mg/kg in all groups; in high-oil commodities also QuEChERS with LC-MS/MS (0.01 mg/kg). In animal products pyrimethanil, M605F002 and M605F003 — LC-MS/MS, 0.01 mg/kg each; the efficiency of enzymatic hydrolysis was shown for sulfate but not for sugar conjugates — a data gap. Soil 0.01 mg/kg, water 0.05 µg/L, urine and blood 0.01 mg/L.
- Reference values (EFSA): ADI 0.013 mg/kg bw per day (previously 0.17 — liver effects in rats are now considered relevant), ARfD 1 mg/kg bw (not set before), AOEL 0.3 mg/kg bw per day (previously 0.12), AAOEL 1 mg/kg bw. Residue definition in milk — sum of pyrimethanil and M605F003 including conjugates, in tissues and eggs — sum of pyrimethanil and M605F002 including conjugates, expressed as pyrimethanil. Provisional assessment: 28 % of the ADI (NL toddler), 47 % of the ARfD (lettuce); risk assessment definitions provisional pending toxicity data on M605F004 and M605F007.
- Environment (EFSA): pyrimethanil and soil metabolite M605F007 below 0.1 µg/L in groundwater in all FOCUS scenarios; an unidentified soil metabolite U2 and missing data on the effect of water treatment prevented a full assessment. High long-term risk to mammals (lettuce in greenhouses) and high chronic risk to bees (pome fruit, grapevine, strawberry). By 11 March 2028 the act requires data on the toxicity of M605F004 with conjugates and M605F007, the effect of water treatment and degradation in soil (with an assessment of U2 if it proves relevant).