Modification of the existing MRLs for difenoconazole in various leafy vegetables

According to Article 6 of the Regulation (EC) No 396/2005, Belgium hereafter referred to as the Evaluating Member State (EMS), compiled two applications to modify the existing MRLs for difenoconazole in parsley, celery leaves, chervil and fennel. In order to accommodate for a new uses of difenoconazole in Belgium, it is proposed to raise the existing MRLs for fennel from 0.3 mg/kg to 5 mg/kg, for parsley, celery leaves from 3 mg/kg to 10 mg/kg and for chervil from 2 mg/kg to 10 mg/kg. Belgium drafted evaluation reports according to Article 8 of Regulation (EC) No 396/2005 which were submitted to the European Commission and forwarded to EFSA on 29 may 2009. EFSA considered both applications in one reasoned opinion. EFSA derives the following conclusions regarding the applications, based on the above mentioned evaluation reports as well as the Draft Assessment Report prepared by Sweden. The toxicological reference values for difenoconazole are reported in the DAR and currently the ADI is set at 0.01 mg/kg bw/d and the ARfD is set at 0.2 mg/kg bw. According to the DAR metabolism of difenoconazole in primary crops is elucidated in four crop categories and residue definition for risk assessment and enforcement is proposed as parent difenoconazole. Nevertheless, apart from difenoconazole, in several parts of crops triazole derivative metabolites (TDMs), which are known as common metabolites of several substances belonging to the triazole chemical class, were identified as a major part of the TRR. Even though TDMs would not occur in amounts of concern following the proposed use, consideration should be given to the fact that TDMs can occur in plant commodities from other sources than difenoconazole therefore resulting in levels that might require consumer exposure assessment. For addressing this issue, a common EU approach on risk assessment of TDMs is under development. It would involve setting of toxicological reference values for TDMs and performing separate risk assessments for the parent compounds and TDMs. Since in leafy parts of the plants (foliage, leaves) parent difenoconazole was the major residue of concern according to metabolism studies, EFSA concludes that metabolic pathway in crops under consideration (leafy vegetables) is sufficiently addressed and no additional metabolism studies are currently required. This conclusion, however, might be reconsidered in a light of the outcome of the peer review and in accordance with the EU approach regarding risk assessment of TDMs. Adequate analytical methods are available to enforce the proposed MRLs. Submitted supervised residue trials data on fennel, parsley, celery leaves and chervil indicate that higher MRLs than proposed by the EMS would be required in order to accommodate for the intended use of difenoconazole in Belgium. Processing studies have not been submitted with regard to the crops under consideration and are not necessary, since the contribution of them to the total dietary intake is very low. All crops under consideration can be grown as rotational crops therefore occurrence of difenoconazole residues in rotational crops was also investigated. In the DAR it was concluded that the identified metabolites in rotational crops are in accordance with the metabolic pathway observed in primary crops. However, the situation in rotational crops regarding TDMs should be reconsidered taking into account all active substances which produce these common metabolites as soon as the methodology for this type of assessment is available. With regard to the current application, EFSA concludes that significant residue levels of difenoconazole are not expected in rotational crops provided that difenoconazole is applied according to the proposed GAP. Residues in commodities of animal origin were not assessed in the framework of submitted applications since crops under consideration are not used as a livestock feed. The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the chronic intake assessment EFSA used the existing MRLs for difenoconazole as established in Annex III of Regulation (EC) No 396/ 2005 as well as the STMR values derived for the intended use of difenoconazole on crops under consideration. For various plant commodities STMR values were available to refine intake calculations. Acute intake assessment was performed only with regard to crops under consideration, using HR values as derived for the intended use of difenoconazole on these crops. No consumer intake concerns were identified for any of the European diets. Total calculated intake values ranged from 16.6 -98.7 % of the ADI. Contribution of celery leaves, parsley and chervil to the dietary intake is insignificant. The contribution of fennel to the total dietary intake amounts for a maximum of 1.62% of the ADI (IT Adult diet). No acute intake concerns were identified for the crops under consideration. Contribution to the ARfD amounts for a maximum of 33.7% for fennel, 16.3% for celery leaves, 3.7% for chervil and 2.2% for parsley. Consequently, EFSA concludes that the intended use on fennel, parsley, celery leaves and chervil is sufficiently supported by data and no risk for consumers was identified. It should be noted that the contribution of TDM residues in primary crops and rotational crops resulting from the use of difenoconazole has not been taken into account in the consumer risk assessment since at the moment the EU approach for the risk assessment of triazole metabolites is still under development. As the DAR has not yet been peer reviewed by EFSA, the conclusions reached in this reasoned opinion have to be taken as provisional and might be reconsidered in the light of the conclusions reached in the peer review process for difenoconazole.(GRAPHICS)