Normativa UEJun. 19, 2014
UE: modifican límites máximos de residuo de spirotetramat en aceitunas para aceite de oliva
In accordance with Article 6 of Regulation (EC) No 396/2005, Austria, hereafter referred to as the evaluating Member State (EMS), received an application from Bayer CropScience to modify the existing Maximum Residue Level (MRL) for the active substance spirotetramat in olives for oil production. In order to accommodate for the intended use of spirotetramat in southern EU, the EMS proposed to raise the existing MRL from the limit of quantification 0.1 mg/kg to 4 mg/kg. Austria 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 EFSA on 8 January 2014.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) (and its addendum/addenda) prepared under Council Directive 91/414/EEC, the Commission Review Report on spirotetramat, the conclusion on the peer review of the pesticide risk assessment of the active substance spirotetramat, the JMPR Evaluation report as well as the conclusions from previous EFSA opinions on spirotetramat.
The toxicological profile of spirotetramat 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 0.05 mg/kg bw per day and an acute reference dose (ARfD) of 1 mg/kg bw.
The metabolism of spirotetramat in primary crops following foliar treatment was investigated in four crop groups. Based on these studies the peer review proposed to set risk assessment residue definition as the ‘sum of spirotetramat, spirotetramat-enol, spirotetramat-enol-Glc, spirotetramat-ketohydroxy and spirotetramat-monohydroxy, expressed as spirotetramat’. For monitoring the residue definition was limited to the “sum of spirotetramat and spirotetramat-enol, expressed as spirotetramat”. EFSA noted that the existing enforcement residue definition according to Regulation (EC) No 396/2005 is wider than the enforcement residue definition proposed by the peer review. Changing the residue definition would affect the existing EU MRLs and therefore EFSA proposed that it is done in the framework of Article 12 of Regulation (EC) No 396/2005.
Submitted supervised residue trials were sufficient to derive an MRL proposal for olives for oil production. Two MRL proposals were derived; according to the existing enforcement residue definition and according to the residue definition proposed in the conclusion of the peer review. It should be noted that the same MRL value of 4 mg/kg is derived, regardless of the proposed residue definition. Adequate analytical enforcement methods were available to control the residues of spirotetramat in olives for oil production.
The peer review concluded that the metabolism of spirotetramat in processed commodities is qualitatively similar to that in raw primary commodity and thus, the same residue definitions are applicable. In the framework of a previous EFSA opinion the applicant submitted processing studies with olives. . A reduction of residues was observed in oil. Based on the existing residue definitions, the inclusion in Annex IV of Regulation (EC) No 396/2005 of a processing factor of 0.18 for refined oil was recommended. Considering the residue definitions proposed in the course of the peer review, this processing factor was calculated to be 0.13 with a conversion factor for risk assessment of 1.24.
Since the proposed use of spirotetramat is on permanent crops investigations of residues in rotational crops are not required.
Residues of spirotetramat in commodities of animal origin were not assessed in the framework of this application, since the olives are normally not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the calculation of chronic exposure, EFSA used the STMR value as derived from the residue trials on table olives extrapolated to olives for oil production and the STMR value for commodities covered by a previous EFSA opinion. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to the commodity under consideration. The estimated exposure was then compared with the toxicological reference values derived for spirotetramat.
No acute and long-term consumer risk was identified in relation to the MRL proposals for olives for oil production. The total consumer chronic exposure accounted for up to 66.2 % of the ADI (WHO Cluster diet B). The contribution of residues in olives for oil production to the total consumer exposure accounted for a maximum of 2.76 % of the ADI (WHO Cluster diet B) and 0.3 % of the ARfD (Spanish children’s diet).
EFSA concludes that the proposed use of spirotetramat on olives for oil production 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 MRL as reported in the summary table.