In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Spain, received an application from Cheminova A/S to set an import tolerance for the active substance flutriafol in strawberries from the USA (United States of America), raising the existing EU MRL of 0.5 mg/kg to the proposed level of 1.5 mg/kg. Spain 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 8 December 2015.
EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) (its additional report and its addendum) prepared under Directive 91/414/EEC, the Commission review report, the conclusion on the peer review of the pesticide risk assessment of the active substance, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) evaluation report as well as the conclusions from previous EFSA opinions.
The toxicological profile of flutriafol 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 0.01 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.05 mg/kg bw.
The metabolism of flutriafol in primary crops was investigated in the fruit, root/tuber, cereal/grass and pulses/oilseeds crop groups following foliar application. Based on these studies, the residue definition for enforcement was proposed as flutriafol only. For risk assessment two separate residue definitions were proposed: 1) flutriafol and provisionally 2) Triazole Derivative Metabolites (TDM), pending on a harmonized approach on how to consider TDMs in the risk assessment.
EFSA concludes that the submitted residue trials are sufficient to derive an import tolerance of 1.5 mg/kg in strawberries. Adequate analytical enforcement methods are available to monitor the residues of flutriafol in strawberries at the validated limit of quantification (LOQ) of 0.01 mg/kg.
Studies investigating the nature of flutriafol residues under standard hydrolysis conditions were assessed during the peer review and previous reasoned opinions. For processed commodities the same residue definition as for raw commodities (RAC) is applicable. Processing studies on strawberries were provided and the data were sufficient to derive a processing factor (PF) of 0.84 for strawberry jam, which is recommended to be included in Annex VI of Regulation (EC) No 396/2005.
As the proposed use of flutriafol is for imported crops and since strawberries are not fed to livestock residues in rotational crops and in commodities of animal origin were not assessed.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA updated the comprehensive consumer risk assessment conducted under the Article 12 MRL review, using the median (STMR) and highest (HR) residue levels observed on strawberries in the residue trials. A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The total chronic intake calculated accounted for up to 34% of the ADI (WHO Cluster B). No acute risk was identified. The highest acute consumer exposure was calculated to be 23% of the ARfD for strawberries.
EFSA emphasises that the above assessment does not take into consideration the triazole derivative metabolites (TDMs). EFSA recommends a separate risk assessment for these metabolites to be conducted once a general methodology on the risk assessment of triazole compounds and their triazole derivative metabolites is available.