In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Belgium, received an application from ISK Biosciences Europe N.V. to modify the maximum residue levels (MRLs) for the active substance cyazofamid in hops, globe artichokes, leeks and spring/green and Welsh onions. In order to accommodate for the intended uses of cyazofamid, Belgium proposed to set the MRL at 0.4 mg/kg for leeks, spring/green onions and Welsh onions, at 0.15 mg/kg for globe artichokes and at 20 mg/kg for hops. Belgium 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 28 January 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 Commission review report on cyazofamid, as well as the conclusions from previous EFSA reasoned opinions on cyazofamid.
The toxicological profile of cyazofamid 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 0.17 mg/kg body weight (bw) per day. No acute reference dose (ARfD) was deemed necessary.
The metabolism of cyazofamid in primary crops was investigated in the fruit, root and leafy crop groups following foliar applications. From these studies the peer review established the residue definition for enforcement and for risk assessment as cyazofamid for foliar treatments only. For the uses on the crops under consideration, EFSA concludes that the metabolism of cyazofamid in primary crops has been sufficiently addressed and that the residue definitions derived are applicable.
EFSA concludes that residue data are sufficient to derive MRL proposals of 0.4 mg/kg on spring/green and Welsh onions by extrapolation from the residue trials conducted on leeks and of 20 mg/kg on hops. Sufficient trials were submitted to propose an MRL value of 0.1 mg/kg on globe artichokes and of 0.4 mg/kg on leeks. However, since these crop commodities are mostly consumed after cooking and since cyazofamid is almost fully degraded to the CCIM metabolite under processing conditions, EFSA would not recommend the setting of MRLs on globe artichokes and leeks as long as the toxicity of this metabolite is not fully addressed. Adequate analytical enforcement methods are available to monitor the residues of cyazofamid on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg.
Studies investigating the nature of cyazofamid residues under standard hydrolysis conditions were assessed in the framework of this application and showed the active substance to be almost totally degraded to CCIM under standard processing conditions but the toxicological profile of this compound has not been fully addressed. Therefore a different residue definition for monitoring and risk assessment is provisionally proposed as cyazofamid and CCIM for processed commodities, pending the outcome of the outstanding toxicological data on CCIM.
Processing studies on hops were provided and the data were sufficient to derive a processing factor (PF) of 0.0013 for the processing to beer. Pending the conclusions on the residue definition applicable to processed commodities, EFSA would not recommend the inclusion of this PF value in Annex VI of Regulation (EC) No 396/2005.
The occurrence of cyazofamid residues in rotational crops was investigated in the framework of the peer review. Based on the available information, it was concluded that significant residue levels are unlikely to occur in rotational crops, provided that the compound is used according to the proposed good agricultural practice (GAP).
Residues of cyazofamid in commodities of animal origin were not assessed, since the crops under consideration in this MRL application are normally not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo) and considering the MRL proposals on spring/green onions, Welsh onions and hops only. No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated chronic intake accounted for up to 0.3% of the ADI (DE child). The contribution of residues in hops and spring onions/green and Welsh onions to the total consumer exposure was negligible.
EFSA concludes that the proposed use of cyazofamid on spring onions/green onions and Welsh onions and on hops will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a health risk to consumers.
The Evaluation Report is available in the Register of Questions