Normativa UEJul. 18, 2013
UE: modifican límites máximos de residuo para metaflumizone en varios productos
In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, herewith referred to as the evaluating Member State (EMS), received an application from BASF Italia Srl. to modify the existing MRLs for metaflumizone in various crops. In order to accommodate for the intended uses of metaflumizone in Europe, Italy proposed to raise the existing MRLs for all the crops under consideration, except for pepper, head cabbage, Brussels sprouts, lettuce, scarole, melon and watermelon as well as to raise MRLs for several animal commodities. Italy drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 29 February 2012.
n 11 January 2013 some data requirements were identified, which prevented EFSA to conclude on the consumer risk assessment. An updated evaluation report, addressing those data requirements, was submitted by the EMS on 4 June 2013 and taken into consideration by EFSA for finalization of this reasoned opinion.
EFSA bases its assessment on the evaluation report submitted by the EMS Italy and the Draft Assessment Report (DAR) and its addenda prepared by the rapporteur Member State (RMS) United Kingdom under Council Directive 91/414/EEC.
The toxicological profile of metaflumizone was assessed in the DAR by the RMS and in the EFSA expert meeting. Data were sufficient to propose an ADI of 0.01 mg/kg bw per day and an ARfD of 0.13 mg/kg bw.
The metabolism of metaflumizone in primary crops was investigated in tomato, cabbage and cotton, representing three crop categories. From these studies the RMS proposed to establish the residue definition for enforcement and risk assessment as the “sum of metaflumizone E- and Z- isomers”. The existing residue definition in Regulation (EC) No 396/2005 is identical. EFSA provisionally agrees with the residue definitions proposed by the RMS. For the use on the crops under consideration the metabolism of metaflumizone is addressed and the derived residue definitions are applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals for all crops under consideration, except for melons, watermelons, herbs and salad plants (except lettuce). For peppers, Brussels sprouts and head cabbage no need to modify the existing MRL was identified. Adequate analytical enforcement methods are available to control the residues of metaflumizone in the crops under consideration at the validated LOQ of 0.01 mg/kg for each isomer.
Studies investigating the nature of metaflumizone residues in processed commodities were assessed in the DAR. The only relevant degradation product was metabolite M320I04, which was formed under pasteurization and boiling conditions. However, as under practical conditions only low levels of this metabolite were present in raw and processed commodities, the RMS proposed to limit the residue definition in processed commodities to metaflumizone E- and Z- isomers. EFSA agrees with the proposal which should be considered provisional pending the outcome of the peer review. The submitted studies on the magnitude of metaflumizone residues in processed cabbage and cotton seed indicated a significant reduction of residues in all processed products, except in cotton seed hulls. Also washing of lettuce reduces residues. The derived processing factors for cotton seed oil and meal are not proposed for enforcement due to insufficient number of studies. The following provisional processing factors are proposed for the inclusion in Annex VI of Regulation (EC) No 396/2005:
Cabbage, cooked: 0.02
Cabbage, sauerkraut (fermented cabbage): 0.02
Crops under consideration can be grown in a crop rotation. The degradation rate of metaflumizone in soil is slow and thus possible occurrence of metaflumizone residues in rotational crops was further investigated. The metabolism studies indicate that, in spite of exaggerated treatment rates, low levels of residues were observed in plant extracts. However, a large part of the radioactivity was not identified or characterized. The RMS concluded that the same residue definition as in primary plants should be applicable. EFSA is of the opinion that, in order to reduce the uncertainties, further attempts should be made to characterise the unidentified metabolites in the rotational crop metabolism studies. Thus the residue definition proposed by the RMS is supported on a provisional basis only. Rotational crop field studies are not available. Since metabolism study did not provide full information on the nature of residues in rotational crops, a final conclusion on the occurrence of residues in rotational crops cannot be drawn.
Head cabbage and cotton seed can be fed to livestock and therefore the nature and magnitude of metaflumizone residues in livestock has to be assessed. However, since the new intended use on head cabbage is less critical than the existing one, EFSA only assessed the impact of the new use on cotton seed to the total dietary burden of livestock. The calculated dietary burdens indicate that the trigger value of 0.1 mg/kg dry matter (DM) is exceeded for all livestock species and is driven by the intake of residues from the existing uses on head cabbage. Thus, the new use on cotton seed does not require the need to modify of the existing MRLs for livestock. EFSA proposes that the magnitude of metaflumizone residues in food of animal origin is further assessed in the framework of the comprehensive MRL review under Article 12 of Regulation (EC) No 396/2005 when the peer review is finalized and when a complete data package on all uses on feed commodities is available.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). For the calculation of the chronic exposure the median residue values as derived from the residue trials were used as input values in cases where the raising of the existing MRL was proposed. 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 assuming the consumption of a large portion of the food items as reported in the national food surveys containing residues at the highest level as observed in supervised field trials. For those plant commodities which were assessed in the framework of the current application but for which no modification of MRL was proposed, the existing MRL was used as an input value.
The estimated exposure was then compared with the toxicological reference values derived for metaflumizone.
No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 66% of the ADI (WHO Cluster diet B). Acute consumer intake concerns could not be excluded for residues in scarole (430% of the ARfD), broccoli (171% of the ARfD) and lettuce (132% of the ARfD). For all other commodities under consideration the acute exposure was below 50% of the ARfD, except for Chinese cabbage, where the acute exposure resulting from the highest residue observed in the residue trials accounted for 83% of the ARfD. Since lower MRL proposals supporting less critical uses have been also derived for lettuce and broccoli, EFSA calculated consumer exposure to metaflumizone residues from these less critical uses. For these alternative scenarios, the chronic consumer exposure decreased to 56% of the ADI (WHO Cluster diet B) and no acute consumer intake concerns were identified for lettuce (42% of the ARfD) and broccoli (53% of the ARfD). For scarole no alternative less critical uses have been reported in the framework of this application.
EFSA notes that, although according to the internationally agreed methodology for acute risk assessment which is based on the highest residue found in the supervised field trials no acute consumer intake concerns were identified for the less critical use on lettuce and broccoli and for the proposed use on Chinese cabbage, the safety margin for acute exposure is very narrow. In case Chinese cabbage contains residues at the existing (6 mg/kg) or the derived new MRL (7 mg/kg), an acute consumer intake concern cannot be excluded as the calculated acute exposure accounts for 200% and 171% of the ARfD, respectively. In case lettuce and broccoli contain residues at the MRL levels derived according to the statistical methodology used at EU level (5 mg/kg and 3 mg/kg), the acute consumer exposure accounts for 103% and 134% ARfD, respectively.
EFSA concludes that acute consumer intake concerns cannot be excluded for residues in scarole and lettuce from indoor use and in broccoli from SEU use. The less critical NEU use on broccoli and lettuce and intended uses of metaflumizone on other crops under consideration will not result in consumer intake concerns. However, in case residues of metaflumizone occur in lettuce, broccoli and Chinese cabbage at the derived MRL value, acute consumer intake concerns cannot be excluded. Risk managers should decide whether the safety margin of the exposure assessment based on the highest residue is sufficient, considering that in reality residues at the proposed MRL might occur.
Thus EFSA proposes to amend the existing MRLs as reported in the summary table.