Zoxamide — new MRLs from 19 August 2025: onions, garlic and shallots 0.7 mg/kg (import tolerance, US uses), tomatoes 2 mg/kg instead of 0.5, chives 0.01 mg/kg instead of 30, honey 0.2 mg/kg, aubergines 0.5 mg/kg with a footnote; EFSA — QuEChERS with LC-MS/MS, LOQ 0.01 mg/kg
Commission Regulation (EU) 2025/146, published on 30 January 2025, replaces the zoxamide column in Annex II to Regulation (EC) No 396/2005 and deletes it from Annex III. It is based on the EFSA reasoned opinion on the review of existing MRLs (Article 12), combined with Gowan Crop Protection’s application for an import tolerance for onions, extrapolated to garlic and shallots. The new levels apply from 19 August 2025; products placed on the market earlier remain under the previous rules.
- New MRLs (residue definition: zoxamide, sum of constituent isomers): table and wine grapes 5 mg/kg, potatoes 0.02, garlic, onions and shallots 0.7 (previously 0.02 at the limit of quantification), tomatoes 2, cucumbers, gherkins, courgettes, melons, pumpkins and watermelons 2, aubergines 0.5 with a footnote (EFSA identified some residue trial information as unavailable; the Commission will consider data submitted by 30 January 2027 or their absence), honey 0.2 mg/kg. Other products — limit of quantification: 0.01 mg/kg, and 0.05 mg/kg for hops and spices. The corrigendum of 4 November 2025 corrects point 2 of the Annex: the zoxamide column is deleted in Part B of Annex III, not Part A.
- Changes compared with previous levels (EFSA Table 3): tomatoes 0.5 → 2 mg/kg (from the existing Codex CXL, supported by data), aubergines 0.02 → 0.5 (tentative, extrapolated from tomatoes), honey 0.05 → 0.2 (tentative). For chives EFSA had no residue trials at all (previously 30 mg/kg) — the act covers them in the group of leaf vegetables and herbs at 0.01 mg/kg. The Commission consulted the EU reference laboratories for residues on the limits of quantification, which proposed analytically achievable levels for all products.
- Methods (EFSA): for enforcement — the multiresidue QuEChERS method with LC-MS/MS validated at an LOQ of 0.01 mg/kg in the four main plant matrix groups and in honey; according to the EU reference laboratories an LOQ of 0.01 mg/kg is achievable routinely also in black tea and honey. An independent laboratory validation (ILV) is missing for high acid content matrices (relevant for grapes) and for honey. Residue definition for risk assessment: sum of zoxamide and metabolite RH-141452 expressed as zoxamide; for processed commodities, metabolite RH-150721 separately.
- Risk assessment (EFSA, PRIMo 3.1): ADI of zoxamide 0.5 mg/kg bw per day, no ARfD needed for the parent; highest chronic exposure 0.5 % of the ADI (Portuguese general population), also when CXLs are considered. For metabolite RH-150721 an ADI of 0.04 mg/kg bw per day; assuming full conversion of the parent, the highest acute exposure — boiled pumpkin, 49 % of the ARfD for this metabolite. The livestock dietary burden (potatoes) is below the trigger of 0.004 mg/kg bw per day, so MRLs in animal products remain at the limit of quantification.