Normativa UEOct. 2, 2013
UE: modifican límites máximos de residuos para folpet en uvas de mesa
. Based on the risk assessment results, EFSA concludes that according to the internationally agreed methodology for estimation of the consumer exposure, the expected residues in table grapes do not result in an exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. However, the safety margin for the acute exposure is very narrow.
© European Food Safety Authority, 2013
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 the company Makhteshim Agan Holding B.V. to modify the existing MRLs for the active substance folpet in table grapes. In order to accommodate for the intended uses of folpet on table grapes in Europe, the EMS proposed to raise the existing MRL in grapes to 3 mg/kg for folpet and to 5 mg/kg for folpet and phthalimide, expressed as folpet. The EMS 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 Italy under Council Directive 91/414/EEC, the conclusion on the peer review of the pesticide risk assessment of the active substance folpet as well as the conclusions from previous EFSA reasoned opinions on folpet.
The toxicological profile of folpet was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.1 mg/kg bw per day and an ARfD of 0.2 mg/kg bw. For the metabolite phthalimide which is observed in primary crops and which is extensively formed in processed commodities there is some evidence that the substance is of a lower toxicity compared with folpet. However, as no full toxicological data package was available, it was not possible to derive specific toxicological reference values. Therefore the peer review proposed to apply the toxicological reference values agreed for folpet also for phthalimide.
The metabolism of folpet in primary crops was investigated in grapes, avocado, tomato, potato and wheat. From these studies the peer review concluded to establish the residue definition for enforcement and risk assessment as “sum of folpet and phthalimide, expressed as folpet”. For the use on table grapes, EFSA concludes that the metabolism of folpet in primary crops is sufficiently elucidated and no further metabolism data are necessary. The current residue definition for most plant products, including grapes, established in Regulation (EC) No 396/2005 is parent compound folpet. Pending the revision of the existing residue definition, EFSA derived a MRL proposal according to the existing and the proposed new residue definition. The latter MRL is to be taken into account when the residue definition is amended in the framework of the comprehensive review under Article 12(2) of the above cited Regulation.
EFSA concludes that the submitted supervised residue trials are sufficient to derive for table grapes a MRL proposal of 3 mg/kg or 4 mg/kg for the residue definition “folpet” and 5 mg/kg or 6 mg/kg for the residue definition “folpet and phthalimide, expressed as folpet”. Adequate analytical enforcement methods are available to control the residues of folpet and phthalimide in the grapes.
Studies investigating the nature of folpet residues in processed commodities demonstrated that under processing conditions involving heat treatment the parent compound almost totally converts to phthalimide and to a certain extent to phthalic acid and phthalic anhydride. Therefore for processed commodities derived from grapes the residue definition for enforcement and risk assessment is defined as sum of folpet and phthalimide, expressed as folpet.
In the framework of the current application one study was submitted with grapes being processed to raisins. Another study was available from the peer review but residue data on phthalimide were not provided. Considering the limited number of studies available, the diverging results and the limited validity of the study where phthalimide was not quantified, EFSA is of the opinion that the data are not sufficient to derive reliable processing factor for raisins which can be recommended for inclusion in Annex VI of Regulation (EC) No 396/2005.
Grape is a permanent crop and therefore the investigations of residues in rotational crops are not required.
Since grapes and their by-products are normally not fed to livestock, the nature and magnitude of folpet 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). The chronic exposure calculations performed in the framework of previous MRL applications were now updated to take into account the residues of folpet and phthalimide in table grapes from the new intended use.
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 81% of the ADI (DE child diet). The contribution of residues in table grapes to the total consumer exposure accounted for a maximum of 1.5% of the ADI (DE child diet). No acute consumer risk was identified in relation to the intended use on table grapes as the calculated maximum exposure in percentage of the ARfD was 93%. EFSA notes that the short term exposure related to table grapes exceeds the ARfD if grapes contain residues at the proposed MRL of 3 mg/kg or 4 mg/kg (for folpet), taking into account the variability factor of 3 and the conversion factor of 1.8 for the risk assessment residue definition. The acute exposure accounts for 106% ARfD and 141% ARfD for the respective MRL proposals for folpet.
EFSA concludes that, according to the internationally agreed methodology for estimation of the consumer exposure, the expected residues in table grapes do not result in an exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. However, the safety margin for the acute exposure is very narrow.
Thus EFSA proposes to amend the existing MRLs as reported in the summary table.