In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Italy received an application from Syngenta Italia S.p.a to modify the existing maximum residue levels for the active substance azoxystrobin in table and wine grapes. Italy 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 evaluation report submitted by the EMS, the DAR prepared under Directive 91/414/EEC, the conclusions on the peer review of the pesticide risk assessment as well as the conclusions from the review of azoxystrobin MRLs according to Article 12 of Regulation (EC) No 396/2005 (here after - Article 12 MRL review).
The toxicological profile of azoxystrobin 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 0.2 mg/kg bw per day. No acute reference dose (ARfD) was deemed necessary.
The metabolism of azoxystrobin in primary crops was investigated in the fruit, cereal/grass and pulses/oilseeds crop groups following foliar application and the peer review established the residue definition for enforcement and risk assessment as azoxystrobin. For the uses on grapes, EFSA concludes that the metabolism of azoxystrobin has been sufficiently addressed and that the residue definitions derived are applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 3 mg/kg on table and wine grapes. Adequate analytical enforcement methods are available to monitor the residues of azoxystrobin in grapes at the validated LOQ of 0.01 mg/kg.
Azoxystrobin is hydrolytically stable under standard hydrolysis conditions and the residue definitions proposed for primary crops are also applicable for processed commodities. The magnitude of azoxystrobin residues during the processing of grapes has been assessed in the framework of the Article 12 MRL review and therefore new studies are not required. The assessment of nature and magnitude of azoxystrobin residues in rotational crops and livestock is of no relevance for the current application.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). The comprehensive long-term exposure assessment performed under Article 12 MRL review was now updated with the median residue value (STMR) derived from the trials conducted on grapes and the Codex limits (CXLs) implemented in the EU legislation and not taken into account in the consumer risk assessment performed during the Article 12 MRL review. An acute consumer risk assessment was not performed, since the setting of an ARfD was concluded to be unnecessary.
The total calculated chronic intake accounted for up to 21 % of the ADI (NL child). The contribution of residues in grapes to the total consumer exposure accounted for a maximum of 1.5 % of the ADI for wine grapes (FR all population) and 0.5 % of the ADI for table grapes (DE child).
EFSA concludes that the intended use of azoxystrobin on table and wine grapes will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a concern for public health.