Lenacil renewed until 30 June 2040 and removed from the list of candidates for substitution; EFSA — DFG S19 with HPLC-MS/MS (LOQ 0.01 mg/kg), air method no longer sensitive enough after the AOEL was lowered, metabolite IN-KF313 in groundwater up to 0.214 µg/L
Commission Implementing Regulation (EU) 2025/833, published on 6 May 2025, renews from 1 July 2025 to 30 June 2040 the approval of the herbicide lenacil (representative uses: sugar and fodder beet). Lenacil was on the list of candidates for substitution as persistent and toxic; the assessment showed that it does not meet the bioaccumulation and toxicity criteria of Annex II, so it was deleted from Regulation (EU) 2015/408. It is based on the EFSA conclusion of 11 June 2024, according to which lenacil has no endocrine-disrupting properties.
- Annex: lenacil, 3-cyclohexyl-6,7-dihydro-1H-cyclopenta[d]pyrimidine-2,4(3H,5H)-dione, CIPAC 163, purity 975 g/kg; EFSA adds that production data would allow a higher minimum purity and that two non-significant impurities need not be included in the specification. Member States must consider the possible need for additional rotational crop field trials and a livestock exposure assessment; the applicant submits these trials (with known and new metabolites) by 25 March 2027.
- Methods (EFSA): food and feed of plant origin — multi-residue method DFG S19 with HPLC-MS/MS, LOQ 0.01 mg/kg; animal products — HPLC-MS/MS after QuEChERS, 0.01 mg/kg (residue definition for them inconclusive); soil 1 µg/kg, surface and drinking water 0.1 µg/L; body fluids 0.05 mg/L, tissues 0.01 mg/kg. The air method has an LOQ of 0.1 mg/m³, but after the new AOEL 0.036 mg/m³ is needed — a data gap; a method for metabolites IN-KD304 and IN-KQ961 in body fluids is also missing.
- Toxicology (EFSA): classification Carc. 2 (H351) for mammary gland tumours in female rats, mode of action unexplained; unlikely to be genotoxic. ADI 0.12 mg/kg bw per day (unchanged), AOEL 0.12 mg/kg bw per day instead of the former 0.4; ARfD and AAOEL not needed. Effects on spleen and thymus — data gap: immunotoxicity study (issue not finalised). For enforcement in plants — lenacil alone; 8 rotational crop field trials (4 NEU, 4 SEU, OECD TG 504) with hydroxylated and oxidised metabolites are missing.
- Environment (EFSA): metabolite IN-KF313 (a ketone) exceeds 0.1 µg/L in groundwater in three of nine FOCUS scenarios, at most 0.214 µg/L (Chateaudun, sugar beet, 4 × 125 g/ha); without a specific assessment it is considered toxicologically relevant because of the classification of the parent — data gap: biological activity study. In a four-year lysimeter study neither lenacil nor IN-KF313 exceeded 0.05 µg/L in the leachate. Lenacil does not meet the criteria for an endocrine disruptor.