Review of the existing maximum residue levels for fenbuconazole according to Article 12 of Regulation (EC) No 396/2005

Abstract

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole

“…The review of existing MRLs for the active substance fenbuconazole according to Article 12 of Regulation (EC) No 396/2005 2 (MRL review) has been performed in 2018 (EFSA, 2018c). European Food Safety Authority (EFSA) identified some information as unavailable (data gaps) and derived tentative MRLs for those uses not fully supported by data but for which no risk to consumers was identified.…”

“…EFSA based its assessment on the evaluation report submitted by the RMS (Slovenia, 2022), the reasoned opinion on the MRL review according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2018c).…”

“…Not stable in rapeseeds.EFSA (2018b)−1826 (soyabeans only)MonthsTriazole alanine. Not stable in rapeseeds.−1853MonthsTriazole acetic acid−1848MonthsTriazole lactic acidHigh protein contentDry peas, navy beans–––1,2,4 – triazoleEFSA (2018b)−1815MonthsTriazole alanine−1825MonthsTriazole acetic acid−1848MonthsTriazole lactic acidBean seed−1848Months1,2,4‐triazoleSlovenia, 2022 (study performed for renewal of approval of paclobutrazol; not peer reviewed)Dry/High starchWheat grain−103YearFenbuconazoleStability equals study duration (EFSA, 2018c)Barley, wheat grain−1812Months1,2,4 – triazoleEFSA (2018b)−1826MonthsTriazole alanine−1826MonthsTriazole acetic acid−1848MonthsTriazole lactic acidHigh acid content…”

“…GAP MRL review in the USA (EFSA, 2018c): 1–5 × 105 g/ha (not to exceed 426 g/ha per year), 8–14 days interval, PHI 28 days…”

“…The EU pesticides peer review and the MRL review concluded that in plant commodities, the relevant residue for enforcement and risk assessment is parent fenbuconazole (sum of constituent enantiomers) (EFSA, 2010; EFSA, 2018c).…”