Normativa UE
Jul. 11, 2013UE: modifican límites máximos de residuo para clorantraniliprole en tubérculos y oleaginosas
In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from DuPont (UK) Ltd to modify the existing MRLs in several root and tuber vegetables and to set import tolerances in several oilseeds for the active substance chlorantraniliprole. In order to accommodate for the intended uses of chlorantraniliprole, the United Kingdom proposed to raise the existing MRLs in carrots, beetroot, celeriac, horseradish, Jerusalem artichokes, parsnips, parsley root, salsify, swedes, turnips and other root and tuber vegetables, except sugar beet and radish, from the values of 0.02 mg/kg or 0.04 mg/kg (depending on the crop) to 0.06 mg/kg and in oilseeds, except peanuts, soya bean and cotton seed, from the limit of quantification of 0.01 mg/kg to 2 mg/kg. The United Kingdom 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. According to EFSA the data are sufficient to derive a MRL proposal of 0.06 mg/kg for the intended use on carrots, beetroot, celeriac, horseradish, Jerusalem artichokes, parsnips, parsley root, salsify, swedes, turnips, other root and tuber vegetables. For the import tolerance on rape seed, sunflower seed and the minor oilseeds a MRL of 2 mg/kg is derived. The MRLs proposed for rape seed and sunflower seed are tentative, because the submitted dataset was incomplete (six instead of the eight residue trials). Adequate analytical enforcement methods are available to control the residues of chlorantraniliprole in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of chlorantraniliprole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference value and therefore are unlikely to pose a consumer health risk.
© European Food Safety Authority, 2013
Summary
In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from DuPont (UK) Ltd to modify the existing MRLs in several root and tuber vegetables and to set import tolerances in several oilseeds for the active substance chlorantraniliprole. In order to accommodate for the intended uses of chlorantraniliprole, the United Kingdom proposed to raise the existing MRLs in carrots, beetroot, celeriac, horseradish, Jerusalem artichokes, parsnips, parsley root, salsify, swedes, turnips and other root and tuber vegetables, except sugar beet and radish, from the values of 0.02 mg/kg or 0.04 mg/kg (depending on the crop) to 0.06 mg/kg and in oilseeds, except peanuts, soya bean and cotton seed, from the limit of quantification of 0.01 mg/kg to 2 mg/kg. The United Kingdom 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 May 2013.
EFSA bases its assessment on the evaluation report, the Draft Assessment Report (DAR) and its addendum prepared under Council Directive 91/414/EEC, the conclusion on the peer review of the pesticide risk assessment of the active substance chlorantraniliprole, the JMPR evaluation reports and the conclusion from previous EFSA opinions on chlorantraniliprole.
The toxicological profile of chlorantraniliprole was assessed in the framework of the peer review and the data were sufficient to derive an acceptable daily intake (ADI) of 1.56 mg/kg bw per day. No acute reference dose (ARfD) was allocated because of the low acute toxicity of the active substance.
The metabolism of chlorantraniliprole in primary crops was investigated in apples and tomatoes, (fruiting vegetables), lettuce (leafy vegetables) and cotton (pulses and oilseeds) after foliar applications and in rice (cereals) after soil application. From these studies the peer review established a general residue definition for enforcement and for risk assessment as chlorantraniliprole. For the intended EU uses and the import tolerance request, EFSA concludes that the metabolism of chlorantraniliprole in primary crops is sufficiently addressed and that the residue definitions derived are applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.06 mg/kg for the intended use on carrots, beetroot, celeriac, horseradish, Jerusalem artichokes, parsnips, parsley root, salsify, swedes, turnips, other root and tuber vegetables. For the import tolerance on rape seed, sunflower seed and the minor oilseeds a MRL of 2 mg/kg is derived. The MRLs proposed for rape seed and sunflower seed are tentative, because the submitted dataset was incomplete (six instead of the eight residue trials). Adequate analytical enforcement methods are available to control the residues of chlorantraniliprole in the commodities under consideration at the validated LOQ of 0.01 mg/kg.
Specific studies investigating the magnitude of chlorantraniliprole residues in processed commodities are not required as the total theoretical maximum daily intake (TMDI) is below the trigger value of 10 % of the ADI.
The occurrence of chlorantraniliprole and its metabolites in rotational crops was evaluated in the framework of the peer review. Based on the available information on the nature and magnitude of residues in succeeding crops, EFSA concludes that significant residue levels are unlikely to occur in rotational crops provided that the compound is used on the root and tuber crops under consideration according to the proposed GAP (Good Agricultural Practice).
Since swedes and turnips, rape seed and sunflower seed by-products may be used as feed products, a potential carry-over into food of animal origin was assessed. The calculated dietary burdens were mainly driven by the existing uses of chlorantraniliprole and a modification of the existing MRLs for commodities of animal origin was not considered necessary in the framework of the current application. The nature of chlorantraniliprole residues in livestock has been investigated in dairy cattle and hens. From these studies the peer review concluded to establish the residue definition for enforcement as chlorantraniliprole. For risk assessment the residue definition for products of animal origin is the sum of chlorantraniliprole and the metabolites IN-HXH44 and IN-K9T00, expressed as chlorantraniliprole.
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 median residue values as derived from the residue trials on carrots, rape seed and sunflower seed. The median residue values for several other crops were available to refine the exposure calculation. 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. For milk of ruminants and tissues of ruminants and pigs the conversion factors (CF) from enforcement to risk assessment established during the peer review were used to reflect the risk assessment residue definition. No acute consumer exposure assessment was performed, due to the low acute toxicity of the active substance.
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 2 % of the ADI (NL child diet). The contribution of residues in the crops under consideration to the total consumer exposure accounted for a maximum of 0.011 % and 0.009 % of the ADI for sunflower seed (WHO Cluster diet B) and rape seed (WHO Cluster diet E), respectively. The contribution of the remaining crops was insignificant.
EFSA concludes that the proposed uses of chlorantraniliprole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference value and therefore are unlikely to pose a consumer health risk.
Thus EFSA proposes to amend the existing MRLs as reported in the summary table.