In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Greece received an application from Syngenta Switzerland to modify the existing maximum residue levels (MRL) for the active substance azoxystrobin in chervil, rhubarb, linseed, safflower and borage seeds. Greece 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 26 November 2015.
EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) prepared under Directive 91/414/EEC, the conclusions on the peer review of the pesticide risk assessment as well as previous reasoned opinions on the review of existing MRLs according to Article 12 (hereafter Article 12 MRL review) or according to Article 10 of Regulation (EC) No 396/2005.
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 body weight (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 applications and the residue definition for enforcement and risk assessment were established as azoxystrobin. For the crops under consideration, 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 0.4 mg/kg on linseed, safflower and borage. For chervil, the submitted trials indicate no need to modify the existing MRL, while for rhubarb, the submitted residue trials do not support the intended good agricultural practice (GAP). Adequate analytical enforcement methods are available to monitor the residues of azoxystrobin in crops under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg.
Studies investigating the magnitude of azoxystrobin residues in processed commodities were not submitted and are not required, as the contribution of the residues in crops under consideration to the total theoretical maximum daily intake (TMDI) is below 10% of the ADI.
The occurrence of azoxystrobin residues in rotational crops was investigated in the framework of the peer review. On the basis of the available information, it was concluded that significant residue levels are unlikely to occur in rotational crops provided that the compound is used on the crops under consideration according to the proposed GAP.
The contribution of azoxystrobin residues in linseed, safflower and borage to the overall dietary livestock burden is insignificant. Thus, EFSA concludes that an amendment to the MRLs for the products of animal origin is unnecessary.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). No long-term or acute consumer intake concerns were identified. For azoxystrobin, the highest estimated chronic intake accounted for 21% of the ADI (NL child). The contribution of residues in the crops under consideration to the total consumer exposure is insignificant (lower than 0.1% of the ADI).
EFSA concludes that the intended use of azoxystrobin on chervil, linseed, safflower and borage will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a concern for public health. EFSA proposes to amend the existing MRLs as reported in the following summary table.
