Normativa UEOct. 2, 2013
UE: modifican límites máximos de residuos para isopyrazam en varias hortalizas
Based on the risk assessment results, EFSA concludes that the intended uses of isopyrazam on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern.
© European Food Safety Authority, 2013
In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta Crop Protection to modify the existing MRLs for isopyrazam in various root and tuber vegetables, peppers and cucurbits (edible and inedible peel). In order to accommodate for the intended uses of isopyrazam in Europe, the EMS proposed to raise the existing MRLs for isopyrazam in all crops under consideration. France 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 April 2013.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared by the rapporteur Member State (RMS) United Kingdom, the conclusion on the peer review of the pesticide risk assessment of isopyrazam as well as the conclusions from previous EFSA opinions on isopyrazam.
The toxicological profile of isopyrazam was assessed in the framework of the peer review and the data were sufficient to derive an ADI of 0.03 mg/kg bw per day and an ARfD of 0.2 mg/kg bw.
The metabolism of isopyrazam was investigated in the framework of the peer review in fruits, leafy vegetables and in cereals (grapes, lettuce and wheat). Since a similar metabolic pathway in these three different crop groups was observed, the peer review established for all plant commodities the residue definition for enforcement as “isopyrazam (sum of isomers)” and for the risk assessment as the “sum of isopyrazam (sum of isomers) plus its metabolite CSCD459488 (syn-hydroxyl isopyrazam, free and conjugated), expressed as isopyrazam”. For the uses on the crops under consideration, EFSA concludes that the metabolism of isopyrazam is sufficiently addressed and the residue definitions derived by the peer review are applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal for carrots, which can be extrapolated to other root and tuber vegetables, for peppers (indoor GAP), for cucumbers (indoor GAP), which is extrapolated to gherkins and courgettes and for melons (indoor GAP), which can be applied also for pumpkins and watermelons. The intended outdoor uses on peppers and cucurbits (inedible peel) in SEU and on cucurbits (edible peel) in NEU and SEU are not supported by residue data and therefore the MRL proposals are based on the indoor use. Adequate analytical enforcement methods are available to control the residues of isopyrazam in the crops under consideration at the validated LOQ of 0.01 mg/kg.
The effect of processing on the nature of isopyrazam was investigated under standard hydrolysis studies in the framework of the peer review and EFSA concluded that the parent compound is hydrolytically stable under the representative processing conditions and the same residue definitions as for raw agricultural commodities apply. Specific studies to assess the magnitude of isopyrazam residues during the processing of the crops under consideration have not been submitted. The residue trials data on melons indicate that total isopyrazam residues in melon pulp is below the limit of quantification. The following peeling factor is recommended to be included in Annex VI of Regulation (EC) No 396/2005:
Melon, peeled: <0.6
All crops under consideration can be grown in a rotation with other crops. The occurrence of isopyrazam residues in rotational crops was investigated in the framework of the peer review which concluded that for rotational and primary crops the same residue definitions are applicable. Considering that the intended application rate is lower than the application rate tested in the rotational crop studies, EFSA concludes that total isopyrazam residues are unlikely to occur above 0.01 mg/kg in the edible parts of rotational crops from the new intended uses on the crops under consideration. However, as ispoyrazam and its metabolites are persistent in the soil, a consideration has to be given to a possible accumulation of residues in the soil over the years and the subsequent residue uptake in rotational crops. Therefore Member States granting authorisations for isopyrazam should consider appropriate risk mitigation measures.
Swedes and turnips can be fed to livestock and therefore the potential carry-over of isopyrazam residues into food of animal origin was assessed. The calculated livestock dietary burden exceeded the trigger value of 0.1 mg/kg (dry matter) for all relevant livestock species. The new use on swedes and turnips contributes significantly to the dietary burden of poultry and pigs. The metabolism of isopyrazam was investigated in lactating goats and laying hens and the peer review concluded that for the monitoring the residue definition should be defined as “isopyrazam (sum of isomers)”, while for the risk assessment the residue should be defined as “sum of isopyrazam (sum of isomers) and all metabolites containing the CSAA798670 moiety, expressed as isopyrazam”. The metabolism in ruminants and non-ruminants proceeds in a similar pathways and thus additional metabolism study in pigs is not required. Based on the results of the feeding and metabolism studies carried out with isopyrazam, EFSA concludes that there is no need to modify the existing MRLs for isopyrazam in animal commodities, which are currently established at the LOQ of 0.01 mg/kg.
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, multiplied by the conversion factor for risk assessment as derived from the residue trials on the crops under consideration. For several food commodities of animal origin the median residue values, as derived from the feeding studies were used as input values. 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 commodities under consideration.
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 to12% of the ADI (DE child diet). The contribution of residues in the crops under consideration (in the percentage of the ADI) to the total consumer exposure accounted for a maximum of 0.3% for carrots (FR infant diet), below 0.08% for other root and tuber vegetables, 0.13% for cucumbers (DK child diet) and below 0.05% for other cucurbits with edible peel, 0.05% for peppers (WHO Cluster diet B), 0.04% for melons (IE adult diet), 0.04% for watermelons (WHO Cluster diet B) and 0.01% for pumpkins (WHO Cluster diet D).
No acute consumer risk was identified in relation to the intended uses on the crops under consideration.
EFSA concludes that the intended uses of isopyrazam on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern.
Thus EFSA proposes to amend the existing MRLs as reported in the summary table.