Review of the existing MRLs for fenamiphos

Article 12(2) of Regulation (EC) No 396/2005 lays down that EFSA shall provide by 01 September 2009 a reasoned opinion on the review of the existing MRLs for fenamiphos as this active substance was included in Annex I to Directive 91/414/EEC before 02 September 2008. In order to collect the pesticide residues data supporting the existing MRLs for that active substance, EFSA asked The Netherlands, as the designated Rapporteur Member State, to complete the Pesticide Residues Overview File (PROFile). The completed PROFile was submitted to EFSA on 28 August 2008. According to Article 6(1) of the Regulation, The Netherlands also received an application from the company Makhteshim Agan to maintain the existing MRL of 0.05 mg/kg for fenamiphos in melons for which EFSA identified potential intake concerns in the framework of a previous reasoned opinion. The subsequent evaluation report drafted by The Netherlands was forwarded to EFSA on 29 May 2009 according to Article 9 of the Regulation. Based on the information provided in the evaluation report for melons, the PROFile and the EFSA conclusion on fenamiphos prepared in the framework of Directive 91/414/EEC, EFSA derives the following conclusions and recommendations. Metabolism was investigated in four different crop groups using three different types of applications. Metabolic patterns in the different studies were shown to be similar and the relevant residue for enforcement and risk assessment in all plant commodities could be defined as the sum of fenamiphos and its sulfone and sulfoxide, expressed as fenamiphos. A validated analytical method for enforcement of this residue definition with a LOQ of 0.02 mg/kg in all plant commodities is also available. Additionally, a sufficient number of supervised residues trials is available to support the GAPs reported by the RMS, except for bananas, carrots and head cabbage. Conclusions regarding these 3 crops were already derived in the framework of a previous reasoned opinion on MRLs of concern for fenamiphos. For the remaining crops, available trials allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive appropriate MRLs. As residues of fenamiphos are all below 0.1 mg/kg and contribution of these residues to chronic consumer exposure is generally low, investigating the effect of industrial and/or household processing was not considered necessary. Studies investigating the magnitude of residues in some processed products were submitted but were not sufficient to recommend robust processing factors for enforcement purposes. Derived processing factors were only considered as indicative for the risk assessment, in particular with regard to the peeling of melons. Occurrence of fenamiphos residues in rotational crops was investigated during the peer review of fenamiphos and it was concluded that metabolic patterns in primary and succeeding crops are similar. Nevertheless, based on a confined rotational crop study and an additional field trial, it is concluded that residues in succeeding crops cannot be excluded and a plant- back interval of 8 months was recommended for the outdoor use of fenamiphos. For the indoor use in fruiting vegetables, an appropriate plant- back interval could not be proposed as no appropriate study was made available. Occurrence of residues in food of animal origin was not considered in the framework of this review because the crops under consideration are not fed to livestock. Both chronic and acute consumer exposure resulting from the MRLs proposed in the framework of this review were calculated, but exceedances of the ARfD were identified for melons and watermelons, representing 188 and 152% of the ARfD respectively. Excluding these two MRLs from the calculation, the highest chronic exposure represented 13.2% of the ADI (WHO Cluster diet B) and the highest acute exposure amounted to 52.4% of the ARfD (table grapes). Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for fenamiphos. Additional calculations of the consumer exposure, including these CXLs, were therefore performed and exceedances of the ARfD were identified for the existing CXLs in melons and head cabbage, representing 303 and 105% of the ARfD, respectively. Excluding these two CXLs from the calculation, the highest chronic exposure represented 37.6% of the ADI (Dutch child) and the highest acute exposure amounted to 66.9% of the ARfD (bananas). An overview of the MRL recommendations resulting from these calculations is included in the table below. As all the proposed MRLs are fully supported by data, they are recommended for inclusion in Annex II to Regulation (EC) No 396/2005. In conclusion, the above assessment revealed one data gap for a rotational crops study representative for fruiting vegetables in glasshouse. Critical areas of concern were identified with regard to the acute consumer exposure resulting from fenamiphos residues in melons and head cabbage. (GRAPHICS)