In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) the Netherlands received an application from Bayer CropScience to set new maximum residue levels (MRLs) for the active substance flupyradifurone in strawberries, blackberries and raspberries in order to accommodate EU indoor uses on these crops. The Netherlands 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 7 July 2015.
EFSA bases its assessment on the evaluation report submitted by the EMS, the DAR prepared under Regulation (EC) No 1107/2009 and the conclusion on the peer review of the pesticide risk assessment of the active substance flupyradifurone.
The toxicological profile of flupyradifurone was assessed in the framework of the peer review under Regulation (EC) No 1107/2009 and the data were sufficient to derive an acceptable daily intake (ADI) of 0.064 mg/kg bw per day and an acute reference dose (ARfD) of 0.15 mg/kg bw.
The metabolism of flupyradifurone in primary crops has been evaluated in four crop groups either by foliar applications (apple, cotton, rice), by soil granule/drench applications (tomato, potato, rice) and by seed dressing (potato). From these studies the peer review established two separate residue definitions for enforcement as: 1) flupyradifurone and 2) DFA, expressed as DFA. For the risk assessment the residue definition was agreed as the “sum of flupyradifurone and DFA, expressed as flupyradifurone”. For the uses on berries, EFSA concludes that the metabolism of flupyradifurone in primary crops has been sufficiently addressed and that the residue definitions derived are applicable.
EFSA concludes that the submitted residue trials are sufficient to derive MRL proposals of 0.4 and 0.03 mg/kg in strawberries and of 1.5 and 0.07 mg/kg in blackberries and raspberries for flupyradifurone and DFA respectively. Adequate analytical enforcement methods are available to monitor the residues of flupyradifurone and DFA in plant matrices under consideration.
Studies investigating the nature of flupyradifurone residues under standard hydrolysis conditions were assessed during peer review and showed the active substance to be hydrolytically stable. Therefore for processed commodities the same residue definition as for raw commodities is applicable. Specific studies investigating the magnitude of flupyradifurone residues in processed berries have not been submitted and are not required.
The nature and magnitude of flupyradifurone residues in rotational crops and livestock is not relevant for the berries under consideration and therefore was not investigated.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). To calculate the chronic exposure, EFSA used median residue values (STMR) derived from the residue trials conducted on strawberries and raspberries. Additionally, EFSA considered in the exposure assessment those plant and animal commodities for which MRL proposals were derived in the framework of the peer review. The acute exposure assessment was performed only for the crops under consideration.
A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated chronic intake accounted for up to 13 % of the ADI (WHO Cluster diet B). The contribution of residues in berries under consideration to the total consumer exposure accounted for a maximum of 0.15 % of the ADI for strawberries and 0.07 % of the ADI for blackberries and raspberries. An acute consumer risk was not identified in relation to the MRL proposals for the berries under consideration.
EFSA concludes that the intended EU indoor uses of flupyradifurone on strawberries, blackberries and raspberries will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a concern for public health.