Normativa UE
Jul. 24, 2013UE: autoridad alimentaria modifica límites máximos de residuo para cyflufenamid en frutas pomáceas
In order to accommodate for the intended uses of cyflufenamid, France proposed to raise the existing MRLs from the limit of quantification of 0.02 mg/kg to 0.05 mg/kg in pome fruit and gherkins and 0.04 mg/kg in cucurbits with inedible peel. 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. According to EFSA the data are sufficient to derive a MRL proposal of 0.06 mg/kg for the intended use on quinces, medlar and loquat in France, 0.05 mg/kg for the intended use on pumpkins and watermelons in France and 0.08 mg/kg for the intended use on gherkins in France. Alternatively, the existing MRLs of 0.05 mg/kg on apples and pears and 0.04 mg/kg on melons, which were derived from the same residue data using the previous valid statistically-based calculation method, could be extrapolated to the whole group of pome fruit and cucurbits with inedible peel, respectively. Adequate analytical enforcement methods are available to control the residues of cyflufenamid in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of cyflufenamid on quinces, medlar, loquat, pumpkins, watermelons and gherkins 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
Summary
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 the company Nisso Chemical Europe GmbH to modify the existing MRLs for the active substance cyflufenamid in pome fruit (quinces, medlar, loquat), cucurbits with inedible peel (pumpkins, watermelons) and gherkins. In order to accommodate for the intended uses of cyflufenamid, France proposed to raise the existing MRLs from the limit of quantification of 0.02 mg/kg to 0.05 mg/kg in pome fruit and gherkins and 0.04 mg/kg in cucurbits with inedible peel. 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 4 December 2012.
EFSA bases its assessment on the evaluation report, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the Commission Review Report on cyflufenamid, the conclusion on the peer review of the pesticide risk assessment of the active substance cyflufenamid as well as the conclusions from previous EFSA opinions on cyflufenamid.
The toxicological profile of cyflufenamid was assessed in the framework of the peer review under Council Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.04 mg/kg bw per day and an ARfD of 0.05 mg/kg bw.
The metabolism of cyflufenamid in primary crops was investigated in wheat (cereals), apples and cucumbers (fruits and fruiting vegetable). For these crop groups the residue definition for enforcement and risk assessment has been established as the sum of cyflufenamid (Z-isomer) and its E-isomer. For the crops under consideration, EFSA concludes that the metabolism of cyflufenamid is sufficiently addressed and that the residue definitions agreed in the peer review 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 quinces, medlar and loquat in France, 0.05 mg/kg for the intended use on pumpkins and watermelons in France and 0.08 mg/kg for the intended use on gherkins in France. Alternatively, the existing MRLs of 0.05 mg/kg on apples and pears and 0.04 mg/kg on melons, which were derived from the same residue data using the previous valid statistically-based calculation method, could be extrapolated to the whole group of pome fruit and cucurbits with inedible peel, respectively. Adequate analytical enforcement methods are available to control the residues of cyflufenamid in the commodities under consideration at the validated LOQ of 0.01 mg/kg.
Specific studies investigating the magnitude of cyflufenamid residues in processed commodities are not required as the residues expected in the raw agricultural commodities (RAC) are low and the total theoretical maximum daily intake (TMDI) is below the trigger value of 10 % of the ADI.
The occurrence of cyflufenamid residues in rotational crops was investigated in the framework of the peer review. Based on the available information, EFSA concludes that significant residue levels are unlikely to occur in rotational crops provided that the compound is used on cucurbits according to the proposed GAP (Good Agricultural Practice).
Residues of cyflufenamid in commodities of animal origin were not assessed in the framework of this application, since quinces, medlar, loquat, pumpkins, watermelons and gherkins 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 median residue values as derived for the intended uses on the crops under consideration and the median residue values for commodities covered by previously issued EFSA reasoned opinions. 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. The estimated exposure was then compared with the toxicological reference values derived for cyflufenamid.
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 4.6 % of the ADI (FR toddler diet). The contribution of cyflufenamid residues in watermelons to the total consumer exposure accounted for a maximum of 0.025 % of the ADI (WHO Cluster diet B), whereas the individual contribution for the remaining crops under consideration accounted from no more than 0.011 % of the ADI. No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration.
EFSA concludes that the proposed use of cyflufenamid on quinces, medlar, loquat, pumpkins, watermelons and gherkins 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.