In accordance with Article 8 of Regulation (EC) No 396/2005, France submitted to the European Commission an evaluation report summarising the background information, without reporting details on the residue trials supporting the MRL request. France also performed a consumer risk assessment demonstrating that these proposed temporary MRLs are safe. On 14 May 2012 the evaluation report was forwarded to EFSA. The EFSA concludes that the emergency use of spinetoram on cherries, raspberries and blueberries is not likely to result in a consumer exposure exceeding the toxicological reference value and therefore is not expected to pose a public health concern. In order to verify assumptions on which the EFSA statement is based, France should update the evaluation report as soon as possible providing detailed information on the supervised field trials on the crops under consideration.
In accordance with Article 53 of Regulation (EC) No 1107/2009, France has granted an authorisation for the use of spinetoram on cherries, raspberries and blueberries for the period from 4 May 2012 to 4 September 2012 to control Drosophila suzukii on these crops. In order to accommodate for the emergency use of spinetoram, France proposed to raise the existing MRLs for these crops from the limit of quantification (0.05 mg/kg) to 0.2 mg/kg for cherries and blueberries and 0.8 mg/kg for raspberries. In accordance with Article 8 of Regulation (EC) No 396/2005, France submitted to the European Commission an evaluation report and performed a consumer risk assessment demonstrating that these proposed temporary MRLs are safe. On 14 May 2012 the evaluation report was forwarded to EFSA requesting a statement on the safety of spinetoram MRLs in cherries, raspberries and blueberries proposed by France, with a view of setting temporary MRLs in line with Article 16(1)(a) and 18(4) of Regulation (EC) No 396/2005.
EFSA bases its assessment on the evaluation report submitted by France, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the JMPR Evaluation report as well as the conclusions from a previous EFSA opinions on spinetoram.
The toxicological profile of spinetoram was assessed in the DAR prepared by the rapporteur Member State (RMS) United Kingdom and the data were sufficient to propose an ADI of 0.021 mg/kg bw per day; due to the low acute toxicity no ARfD was deemed necessary.
The metabolism of spinetoram in primary crops was investigated in apples, lettuce and turnips after foliar application. EFSA agrees with the RMS who derived the residue definition for enforcement as spinetoram (sum of XDE-175-J and XDE-175-L) and for risk assessment as spinetoram (sum of XDE-175-J and XDE-175-L) and the N-demethyl-175-J and N-formyl-175-J metabolites, expressed as spinetoram.
According to the French evaluation sufficient residue data in cherries, raspberries and blueberries are available to propose temporary MRLs for the enforcement residue definition spinetoram (sum of XDE-175-J and XDE-175-L) for cherries, raspberries and blueberries. Since these studies have not been reported in detail in the French Evaluation Report, EFSA is not in a position to check the validity of the supervised field trials and to derive risk assessment values or to verify the MRL proposals derived by France.
The compound was demonstrated to be hydrolytically stable under the representative processing conditions and the residue pattern in processed commodities is similar to the residue pattern in raw commodities. Specific studies to assess the magnitude of spinetoram residues during the processing of cherries, raspberries and blueberries are not available.
Since the emergency use of spinetoram is on permanent/semi-permanent crops only for a limited time period, investigations of residues in rotational crops are not required at the moment.
Nature and magnitude of spinetoram residues in livestock was not assessed since the crops under consideration are not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the proposed MRLs for cherries, raspberries and blueberries multiplied by a surrogate conversion factor taking into account the possible presence of the additional metabolites included in the residue definition for risk assessment. For other crops, EFSA used the existing MRLs established in Annexes III of Regulation (EC) No 396/2005 or, where available, the median residue values derived from residue trials.
No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for up to 42.3 % of the ADI (WHO cluster diet). The contributions of residues in cherries, raspberries and blueberries to the total consumer exposure were found to be insignificant, accounting for a maximum of 0.47 %, 0.62 % and 0.037 % of the ADI, respectively.
No acute consumer risk assessment was performed because of the low acute toxicity of spinetoram.
The consumer risk assessment demonstrates that the safety margin in the chronic exposure calculation is wide enough to conclude that the emergency use of spinetoram on cherries, raspberries and blueberries is not likely to result in a consumer exposure exceeding the toxicological reference value and therefore is not expected to pose a public health concern.
Considering that France has not yet completed the quality assessment of the supervised field trials and that these studies have not been reported in detail in the French Evaluation Report, France is requested to update the evaluation report as soon as possible in order to verify the correctness of the assumptions on which this EFSA statement is based.
EFSA also notes that the conclusions reached in this statement might need to be reconsidered in the light of the outcome of the peer review according to Commission Regulation (EU) No 188/2011 and should therefore be considered as provisional.
