Reasoned opinion on the modification of the existing MRLs for fenpyroximate in various crops

Abstract 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 the company Nichino Europe Co Ltd. to modify the existing MRLs for fenpyroximate in various crops. In order to accommodate for the authorized uses in European Member States, the EMS Germany proposed to raise the existing MRLs of fenpyroximate in peaches, raspberries, blackberries, peppers and beans (with pods) and to lower MRLs for citrus fruit, loquat, quinces, medlar, plums, apricots, wine grapes and strawberries. No need to modify MRLs was identified for apples, pears, tomatoes and aubergines. 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 4 December 2012. EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) and its addendum prepared by the rapporteur Member State Germany under Council Directive 91/414/EEC, the Commission Review Report on fenpyroximate, the conclusion on the peer review of the pesticide risk assessment of the active substance fenpyroximate and the JMPR evaluation. The toxicological profile of fenpyroximate was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.01 mg/kg bw per day and an ARfD of 0.02 mg/kg bw. The metabolism of fenpyroximate ( E ‐isomer) in citrus fruits, apples, grapes and beans was evaluated in the framework of the peer review. The peer review concluded that the enforcement residue definition for plants can be restricted to the parent compound. It was also noted that information is necessary to confirm that the toxicological reference values of fenpyroximate can be used for its Z‐isomer which was found as a metabolite. Provisionally the expert meeting on residues agreed to consider this metabolite as toxic as the parent and to include it in the residue definition for risk assessment. The enforcement residue definition in Regulation (EC) No 396/2005 is set as parent fenpyroximate ( E ‐isomer). For the uses on the crops under consideration EFSA concludes that the metabolism of fenpyroximate is sufficiently addressed and the residue definitions agreed in the peer review are applicable. EFSA considers that the submitted supervised residue trials data are sufficient to support the lowering of the existing EU MRLs for citrus fruit, pome fruit, plums, wine grapes and strawberries. The submitted residue data on raspberries, blackberries, peppers and beans (with pods) substantiate the proposal to raise the existing EU MRL. The submitted residue data on peaches, tomatoes and aubergines confirm the existing EU MRL. For apricots insufficient data were provided to support the authorized use. Adequate analytical enforcement methods are available to control the residues of fenpyroximate in the crops under consideration at the validated LOQ of 0.01 mg/kg. The effect of processing on the nature of fenpyroximate residues has not been investigated and a data gap was noted by the peer review. In some submitted residue trials the magnitude of fenpyroximate and Z ‐isomer residues was reported also for simply processed products. However, since the nature of fenpyroximate under processing conditions has not been investigated, the processing factors were not derived for enforcement purposes. EFSA concludes that a study investigating the effects of processing on the nature of fenpyroximate residues has to be submitted in the framework of the MRL review according to Article 12 of Regulation (EC) No 396/2005. The nature and magnitude of fenpyroximate residues in rotational crops has not been investigated. The degradation rate of fenpyroximate and its Z‐isomer in soil would not trigger the need for rotational crop studies, but the soil metabolite M‐3 was found to be more persistent in soil. The peer review concluded that the uptake of fenpyroximate residues, in particular residues of metabolite M‐3 and/or its degradation products, in rotational crops cannot be excluded and should be further addressed in studies performed according to EU guidelines. Pending the investigation of possible uptake of fenpyroximate residues in rotational crops, EFSA recommends that Member States when granting fenpyroximate authorisations apply necessary risk mitigation measures to avoid fenpyroximate related residues in rotational/succeeding crops. The data requirement for rotational crop studies will be reconsidered in the framework of the MRL review of fenpyroximate according to Article 12 of Regulation (EC) No 396/2005. The by‐products of citrus and pome fruit (pomace) can be fed to livestock and thus the nature and magnitude of fenpyroximate residues in livestock has to be further assessed. However, since MRL proposals derived for citrus and pome fruits under current MRL application are lower than or identical with the existing EU MRLs, the notified uses will not affect the current livestock dietary burden and thus the potential carry‐over of residues into food of animal origin was not further investigated. The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). EFSA calculated the consumer exposure according two scenarios. For chronic exposure, in both scenarios for raspberries, blackberries, peppers and beans (with pods) the median residue as derived from the submitted residue trials was used as an input value, considering that for these crops the raising of the existing EU MRL is proposed. In scenario 1 the existing EU MRLs or corresponding risk assessment values were used as input values for the remaining crops under consideration. The scenario 2 was calculated to assess the consumer exposure in case the lowering of EU MRLs is supported for citrus fruit, pome fruit, plums, strawberries and wine grapes. For those crops the input value was the median residue as derived from the residue trials submitted under the current application. For apricots, the notified use was not supported by residue data and thus the LOQ was used as an input value. For the remaining commodities the input values were the same as in scenario 1. 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 or at the MRL. The estimated exposure was then compared with the toxicological reference values derived for fenpyroximate. According to scenario 1, 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 40.5% of the ADI (WHO Cluster diet B). The contribution of residues in individual crops (in percentage of the ADI) accounted for 0.12% for blackberries (IE adult diet), 0.12% for raspberries (NL child diet), 0.35% for peppers (WHO Cluster diet B) and 1.27% beans (with pods) (FR toddler diet). No acute consumer risk was identified for fenpyroximate residues in the crops under consideration. The highest calculated short‐term exposure was identified from residues in apples (78.4%), wine grapes (78.3%), strawberries (78%), pears (72.9%) and peaches (62.3%). For other crops the calculated exposure was below 50% of the ARfD. According to scenario 2, 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 29.2% of the ADI (DE child diet). No acute consumer risk was identified for fenpyroximate residues in the crops under consideration. The highest calculated short‐term exposure was identified from residues in apples (63.7%), peaches (62.3%) and pears (59.2%). For other crops the calculated exposure was below 50% of the ARfD. EFSA concludes that the raising of the existing EU MRLs for fenpyroximate in raspberries, blackberries, peppers and beans (with pods) and the maintaining or lowering of the existing EU MRLs for other 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. Data gaps regarding the lack of processing studies and rotational crop studies identified by the peer review are confirmed in the current assessment and have to be further considered in the framework of the MRL review according to Article 12 of Regulation (EC) No 396/2005. Thus EFSA proposes to amend the existing MRLs as reported in the summary table.