In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Denmark, received an application from Syngenta to set an import tolerance at 6 mg/kg for the active substance fludioxonil in pineapples imported from the United States of America (US). In order to accommodate for the use on imported pineapples, Denmark proposed to raise the existing maximum residue level (MRL) from the limit of quantification (LOQ) to 7 mg/kg. Denmark drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 2 September 2015.
EFSA bases its assessment on the updated evaluation report, the draft assessment report (DAR) and its addendum prepared under Directive 91/414/EEC, the Commission review report on fludioxonil, the conclusion on the peer review of the pesticide risk assessment of the active substance fludioxonil, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) evaluation reports as well as the conclusions from previous EFSA opinions, including the review of the existing MRLs for fludioxonil under Article 12 of Regulation (EC) No 396/2005.
The toxicological profile of fludioxonil was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.37 mg/kg body weight (bw) per day. No acute reference dose (ARfD) was deemed necessary.
The metabolism of fludioxonil in primary crops was investigated in fruit, root and leafy crop groups following foliar applications and in root, pulses/oilseeds and cereals crop groups following seed treatment. The residue definitions were proposed as ‘fludioxonil’ for enforcement and as ‘sum of fludioxonil and its metabolites oxidised to metabolite 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155), expressed as fludioxonil’ for risk assessment and confirmed during the Article 12 MRL review. The residue definitions are applicable to the use on the crop under consideration.
The submitted trials conducted in the US support the setting of an import tolerance of 7 mg/kg for pineapples. An adequate analytical enforcement method is available to monitor the residues of fludioxonil in the commodity under consideration at the validated LOQ of 0.01 mg/kg.
Studies investigating the nature of fludioxonil residues in processed commodities showed that the compound is hydrolytically stable under standard hydrolysis conditions. The processing factor (PF) for pineapple juice of 0.96 is to be considered as indicative since based on a single study only.
Since the use of fludioxonil is on an imported crop and since pineapples are normally not fed to livestock, investigations of residues in rotational crops and in animal commodities are not required.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). To calculate the chronic consumer exposure, EFSA updated the assessment conducted in the framework of the Article 12 MRL review, using the supervised trials median residue (STMR) for the whole fruit derived from the residue trials on pineapples. In addition, the STMR values reported in reasoned opinions issued after the Article 12 MRL review and the STMRs related to Codex limits (CXLs) implemented in the EU legislation after the Article 12 MRL were also considered. The highest chronic intake accounted for 18% of the ADI (German child). An acute consumer exposure assessment was not performed, since the setting of an ARfD was concluded to be unnecessary.