Normativa UEOct. 2, 2013
UE: modifican límites máximos de residuos para thiacloprid en espinacas y similares
Based on the risk assessment results EFSA concludes that the intended use of thiacloprid on spinach and beet leaves will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.
© European Food Safety Authority, 2013
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 MRLs for the active substance thiacloprid in spinach and similar leaves crop group. In order to accommodate the intended indoor and outdoor uses of thiacloprid in Belgium, the EMS proposed to raise the existing MRLs for thiacloprid in spinach and similar leaves group or only in spinach and beet leaves to 0.15 mg/kg. 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 EFSA on 2 July 2013.
The toxicological profile of thiacloprid was assessed under the peer review and the data were sufficient to conclude on an ADI value of 0.01 mg/kg bw per day and an ARfD of 0.03 mg/kg bw.
The metabolism of thiacloprid in plants was investigated in three crop groups and the residue definition for risk assessment and enforcement was established as parent thiacloprid. These residue definitions are applicable also to the crops under consideration.
EFSA concludes that the submitted supervised residue trials data on lettuce are not sufficient to support the residue data extrapolation to the whole group of spinach and similar leaves. Alternatively, the EMS proposed to extrapolate four outdoor residue trials data on open leaf lettuce to spinach and beet leaves only. Although this extrapolation is not explicitly mentioned in the European guidance document, EFSA is of the opinion that the proposal is acceptable, considering the morphological similarities between spinach/beet leaves and open leave varieties of lettuce and taking into account that spinach and beet leaves are minor crops. Thus, a MRL proposal of 0.15 mg/kg is derived. Adequate analytical enforcement methods are available to control the residues of thiacloprid in spinach and beet leaves.
The effect of processing on the nature of thiacloprid was investigated in the framework of the peer review. Thiacloprid was stable under typical processing conditions. Thus, for processed commodities the same residue definition as for raw agricultural commodities is applicable. Specific processing studies with spinach or beet leaves have not been submitted in the framework of the current application. Given the low individual contribution of residues in these crops to the total consumer exposure, such studies are not explicitly required.
The metabolism of thiacloprid in rotational crops proceeds in a similar pathway as in primary crops and thus the same residue definitions are applicable. The results of the rotational crop metabolism study indicate that significant thiacloprid residues are unlikely to occur in rotational/succeeding crops, provided that thiacloprid on spinach and beet leaves is used according to the intended GAP.
Spinach and beet leaves are not fed to livestock and therefore the nature and magnitude of thiacloprid residues in livestock was not assessed in the framework of this application.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). To calculate the chronic exposure from residues in spinach and beet leaves, EFSA used the median residue value as derived from the residue trials on lettuce. For several other crops the risk assessment values were available to refine the exposure calculation. For the remaining commodities of plant and animal origin, the existing MRLs as established in Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to spinach and beet leaves.
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 77% of the ADI (DE child diet). The contribution of residues in spinach and beet leaves to the total consumer exposure accounted for a maximum of 0.25% (FR toddler diet) and 0.03% (ES child diet) of the ADI, respectively.
No acute consumer risk was identified in relation to the intended use of thiacloprid on spinach and beet leaves. The calculated maximum exposure was 4.5% ARfD for spinach and 3.5% ARfD for beet leaves.
EFSA concludes that the intended use of thiacloprid on spinach and beet leaves will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.
Thus EFSA proposes to amend the existing MRLs as reported in the summary table.