In accordance with Article 6 of Regulation (EC) No 396/2005, France, herewith referred to as the evaluating Member State (EMS), received an application from Syngenta AGRO S.A.S. to modify the existing MRLs for the active substance difenoconazole in a wide range of crops. In order to accommodate for the intended European uses on quinces, several root crops, bulb vegetables, cucurbits (inedible peel), witloof chicory, globe artichokes, rice and chicory roots and to accommodate the authorized use in Brazil on papaya, the EMS proposed to raise the existing MRLs for difenoconazole in all these crops. The EMS 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 24 July 2012.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared by the rapporteur Member State (RMS) Sweden under Council Directive 91/414/EEC, the EFSA conclusion on the peer review of the pesticide risk assessment of the active substance difenoconazole, the JMPR Evaluation reports as well as previous EFSA reasoned opinions on 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 tomatoes, grapes, oilseed rape, potatoes and wheat following foliar and seed treatment (cereals only). 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 the results of the above mentioned metabolism studies can be extrapolated to the crops under consideration and no additional studies are required.
EFSA considers that the submitted supervised residue trials are sufficient to derive MRL proposals for all the crops considered. The applicant has not submitted data on TDM residues in the crops under consideration. 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. From the submitted residue trials on papaya and melons the following peeling factors were derived which are proposed for the inclusion in Annex VI of Regulation (EC) No 396/2005:
- Melon, peeled: <0.2
- Papaya, peeled: 0.15
The occurrence of difenoconazole residues in rotational/succeeding 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. However, there are still some open points regarding the possible occurrence of triazole derivative metabolites in rotational crops which will be addressed as soon as the confirmatory data are available. EFSA therefore recommends that Member States granting an authorization for plant protection products based on difenoconazole should take the necessary risk mitigation measures to avoid TDM residues in rotational crops.
Residues of difenoconazole in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration and/or their by-products 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 the chronic exposure, EFSA used the median residue values as derived from the residue trials on the crops under consideration. For several other crops risk assessment values were available to refine the exposure calculation. 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.
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 98.5% of the ADI (WHO Cluster diet B). The individual contribution of residues in the crops under consideration to the total consumer exposure (in percentage of the ADI) accounted for a maximum of 6.9% for rice, 2.6% for carrots and was below 1% for other crops under consideration.
No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration. The highest maximum exposure in percentage of the ARfD was calculated for the residues in carrots (11% of the ARfD) and was individually below 10% ARfD for other crops under consideration.
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 for difenoconazole and therefore is unlikely to pose a public health concern. The consumer risk assessment regarding the TDMs was not undertaken in the framework of the current application and 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.
Thus EFSA proposes to amend the existing MRLs as reported in the summary table.