Germany also received an application from Landwirtschaftskammer NRW Pflanzenschutzdienst to modify the existing MRLs for difenoconazole in cucurbits with (edible peel). In order to accommodate the intended NEU outdoor use on raspberries and blackberries and the intended indoor use on cucurbits (edible peel), the EMS proposed to raise the existing MRLs in these berries from 0.3 mg/kg to 1.5 mg/kg and in cucurbits (edible peel) from 0.1 mg/kg to 0.3 mg/kg. The EMS drafted two evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA. According to EFSA, the applications are sufficiently supported by data and EFSA confirmed the MRL proposals made by the EMS. Adequate analytical enforcement methods are available to control the residues of difenoconazole in the crops under consideration. The risk assessment demonstrated that the intended use of difenoconazole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.
Summary
In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from TSGE Deutschland GmbH to modify the existing MRLs for difenoconazole in raspberries and blackberries. The EMS Germany also received an application from Landwirtschaftskammer NRW Pflanzenschutzdienst to modify the existing MRLs for difenoconazole in cucurbits with (edible peel). In order to accommodate the intended NEU outdoor use on raspberries and blackberries and the intended indoor use on cucurbits (edible peel), the EMS proposed to raise the existing MRLs in these berries from 0.3 mg/kg to 1.5 mg/kg and in cucurbits (edible peel) from 0.1 mg/kg to 0.3 mg/kg. The EMS drafted two evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA on 29 February 2012 and on 3 April 2012. Considering that both applications refer to the modification of the existing MRLs for difenoconazole, for reasons of efficiency EFSA addressed both MRL applications in one reasoned opinion.
EFSA bases its assessment on the evaluation reports submitted by the EMS Germany, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the conclusion on the peer review of the pesticide risk assessment of the active substance difenoconazole as well as the conclusions from previous EFSA reasoned opinions on the modification of existing MRLs for difenoconazole.
The toxicological profile of difenoconazole was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to propose an ADI of 0.01 mg/kg bw per day and an ARfD of 0.16 mg/kg bw. EFSA defined toxicological reference values also for the triazole derivative metabolites (TDMs).
The metabolism of difenoconazole in primary crops was investigated in tomato, grape, oilseed rape, potato and wheat. From these studies the peer review concluded to establish the residue definition for enforcement as difenoconazole. The current residue definition set in Regulation (EC) No 396/2005 is identical to that derived in the peer review. For risk assessment, considering that TDMs are toxicologically relevant metabolites, two separate plant residue definitions were proposed: 1) difenoconazole and 2) provisionally, triazole derivative metabolites. TDMs are common metabolites of active substances belonging to the chemical class of triazoles. EFSA concludes that metabolism of difenoconazole in the crops under consideration is sufficiently elucidated and that the derived residue definitions are appropriate.
EFSA considers that the submitted supervised residue trials data are sufficient to derive a MRL proposal of 1.5 mg/kg in raspberries and blackberries and 0.3 mg/kg in cucurbits (edible peel). Adequate analytical enforcement methods are available to control the residues of difenoconazole in the crops under consideration.
Studies investigating the nature of difenoconazole residues in processed commodities were assessed in the peer review and showed that the compound is hydrolytically stable. Studies investigating the effects of processing on the magnitude of difenoconazole residues in the crops under consideration have not been submitted. Considering the low individual contribution of these crops to the total consumer exposure, such studies are not necessary. However, taking into account the high total calculated consumer exposure to difenoconazole residues, processing studies would be desirable for the crops with the highest contribution to the total daily intake.
The occurrence of difenoconazole residues in rotational crops was investigated in the framework of the peer review. The metabolism of difenoconazole in rotational/succeeding crops is to a large extent similar to the metabolic pathway observed in primary crops. Considering the application rates proposed in the framework of this application, it is not likely that significant levels of parent difenoconazole will be found in rotational crops provided that difenoconazole is applied according to the proposed GAP. The data gaps regarding the presence of TDMs in rotational crops will be addressed by the manufacturer by providing confirmatory data.
Residues of difenoconazole in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration are normally not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). For the calculation of chronic exposure, EFSA used the median residue values as derived from the residue trials on raspberries and cucumbers. The median residue value for raspberries was also used as an input value for blackberries and the median residue value for cucumbers was used also as an input value for gherkins and courgettes. For several other crops the median residue values were available to refine exposure calculations. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex III 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 and that these items contained residues at the highest level as observed in supervised field trials.
The estimated exposure was then compared with the toxicological reference values derived for difenoconazole.
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 97.3% of the ADI (related WHO Cluster diet B). The contribution of residues in the crops under consideration to the total consumer exposure (in percentage of the ADI) accounted for a maximum of 0.047 % for blackberries (IE adult diet), 0.048% for raspberries (NL child diet), 0.16% for cucumbers (DK child diet), 0.02% for gherkins (WHO Cluster diet B) and 0.067% for courgettes (FR infant diet).
No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 6.6% for cucumbers, 5.3% for blackberries, 5.2% for courgettes, 2.8% for raspberries and 1.8% for gherkins.
EFSA concludes that the intended use of difenoconazole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.
The consumer risk assessment regarding the TDMs has to be performed as soon as the confirmatory data for triazole pesticides are available and a suitable risk assessment methodology has been developed, taking into account the contribution of the TDMs present in primary crops, rotational crops, processed commodities and products of animal origin resulting from different triazole pesticides.
