Normativa UEJul. 18, 2014
UE: autoridad alimentaria modifica límites máximos de residuo de fenhexamid en berries
In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing maximum residue levels (MRLs) for the active substance fenhexamid in cranberries, blueberries, gooseberries and azarole (kiwiberry). In order to accommodate for the uses of fenhexamid under greenhouse conditions, Belgium proposed to raise the MRLs proposed during the review of the existing MRLs under Article 12 of the Regulation (EC) No 396/2005, to 15 mg/kg. Belgium drafted an evaluation report, which was submitted to the European Commission and forwarded to EFSA on 27 February 2014.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the Commission Review Report on fenhexamid, the Renewal Assessment Report (RAR) prepared under Regulation (EU) No 1141/2010, the JMPR Evaluation, as well as the EFSA reasoned opinion on the review of the existing MRLs and the EFSA Conclusion on the peer review of the renewal of the approval of the active substance.
The toxicological profile of fenhexamid was assessed in the framework of the renewal of the approval of the active substance. The data were sufficient to confirm the ADI value of 0.2 mg/kg bw per day. No ARfD was deemed necessary.
The metabolism of fenhexamid in primary crops was investigated in fruits and fruiting vegetables, leafy vegetables and oilseeds/pulses. From these studies the peer review established the residue definition for enforcement and risk assessment as fenhexamid. For the use on crops under consideration, EFSA concludes that the metabolism of fenhexamid in primary crops is sufficiently addressed and that the residue definition is applicable.
EFSA concludes that the submitted residue trials conducted on currants under greenhouse conditions are sufficient to extrapolate the MRL of 15 mg/kg set on currants to azarole (kiwiberry). In contrast, the extrapolation to cranberries, blueberries and gooseberries is not recommended, since the maximum application rate of 1000 g/ha proposed on these crops, is not covered by the trials conducted on currants at a dose rate of 750 g/ha. Adequate analytical enforcement methods are available to control the residues of fenhexamid in the commodities under consideration at the validated LOQ of 0.01 mg/kg.
Studies investigating the nature of fenhexamid residues in processed commodities were assessed in the peer review for the renewal of the approval. Fenhexamid is hydrolytically stable under processing conditions representative of pasteurisation, boiling/cooking and sterilisation. Therefore, for processed commodities the same residue definition as for raw agricultural commodities (RAC) is applicable.
Since the proposed use of fenhexamid is on permanent crops, investigation of residues in rotational crops is not required.
Residues of fenhexamid in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration are normally not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005, a comprehensive long term exposure assessment was performed taking into account the existing uses of fenhexamid at EU level. EFSA updated this risk assessment with median residue values derived from the submitted supervised residue trials. For azaroles very limited consumption data were reported in the national food surveys used as basis for the EFSA PRIMo. Thus, the exposure to fenhexamid residues via azaroles is expected to be insignificant.
EFSA concludes that the proposed use of fenhexamid on azarole (kiwiberry) will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.Thus EFSA proposes to amend the existing MRLs as reported in the summary table.