Fenbuconazole and penconazole — MRLs after confirmatory data, from 24 August 2025: fenbuconazole in grapes from 1.5 to 0.01 mg/kg (no data on triazole derivative metabolites, TDMs), in tea 30 mg/kg from Codex, in milk 0.01 instead of 0.05; penconazole in pome fruits 0.3 instead of 0.15, in raspberries and blackberries 0.4 instead of 0.1
Commission Regulation (EU) 2025/195, published on 4 February 2025, replaces the fenbuconazole and penconazole columns in Annex II to Regulation (EC) No 396/2005. It closes the MRL reviews of 2017–2018: in 2019 the Commission set some levels provisionally, with footnotes on missing data; it now assesses the confirmatory data (EFSA 2023) — where they were not provided, MRLs fall to the limit of determination, and all footnotes on missing data are deleted. The new levels apply from 24 August 2025.
- Fenbuconazole (no longer approved in the EU): the applicant tried to keep the Codex limits (CXLs) by submitting trials analysing triazole derivative metabolites (TDMs: 1,2,4-triazole, triazole alanine, triazole acetic acid and others). The gap was closed for grapefruits and oranges (lowered to the CXL: 0.7 → 0.5 and 0.9 → 0.5 mg/kg according to EFSA), peaches (0.6 → 0.5), and maintained: lemons and limes 1, mandarins 0.5, pome fruits 0.5, cherries 1, blueberries 0.5 mg/kg.
- Without TDM data or residue trials, fenbuconazole falls to the limit of determination of 0.01 mg/kg: table and wine grapes (previously 1.5), cranberries (1), bananas (0.05), sweet peppers (0.6), sunflower seeds, peanuts, rapeseed, barley, rye and wheat, as well as apricots, plums and cucurbits (0.3 according to EFSA). In animal products maintained: liver, kidney and edible offals 0.1 mg/kg; in milk the level of 0.05 was lowered to 0.01 mg/kg after assessment by the EU reference laboratory. A new CXL for green and black tea (Codex Alimentarius Commission, 6 February 2023) — 30 mg/kg.
- Penconazole (applicant Syngenta, data evaluated by Germany): the metabolism study (tomato), storage stability of metabolites CGA127841, CGA132465 and CGA190503 (up to 24 months at −20 °C, up to 30 in acidic matrices) and new residue trials were supplied. Increases: pome fruits 0.15 → 0.3, plums 0.09 → 0.15, blackberries and raspberries 0.1 → 0.4 mg/kg; decreases: apricots 0.08 → 0.07, peaches 0.15 → 0.07, grapes 0.5 → 0.4; maintained: cherries 0.15, gooseberries 0.1, tomatoes and aubergines 0.1, as well as pumpkins and watermelons.
- Where trials analysing simultaneously for the monitoring and risk assessment residue definitions were missing, EFSA used a tentative conversion factor of 6 from metabolism studies; the Commission adopted the levels because no consumer risk was shown. EFSA for penconazole: highest acute exposure — pears, 39.9 % of the ARfD; chronic 16 % of the ADI (Dutch toddler diet); enforcement methods validated at an LOQ of 0.01 mg/kg. The EU reference laboratories indicated that technical developments allow some limits of determination to be lowered.