According to Article 6 of the Regulation (EC) No 396/2005, the United Kingdom herewith referred to as the Evaluating Member State United Kingdom (EMS UK), received an application from the Horticultural Development Company to modify the existing MRLs for bentazone in herbs. In order to accommodate for the intended use of bentazone on fresh herbs in the United Kingdom, it is proposed to raise the existing MRL from 0.1 mg/kg (set at the limit of quantification (LOQ)) to 15 mg/kg. The EMS United Kingdom 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 20 December 2010. According to Article 6 of the Regulation (EC) No 396/2005, France, herewith referred to as the Evaluating Member State France (EMS FR), received an application from the company BASF AGRO SAS to modify the existing MRL for bentazone in legume vegetables. In order to accommodate for the intended use of bentazone on these crops in France, it is proposed to raise the existing MRL to 0.5 mg/kg. The EMS France 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 20 January 2011. Considering that both applications refer to the modification of the existing MRLs for bentazone, for reasons of efficiency EFSA addressed both MRL applications in one reasoned opinion. EFSA derived the following conclusions based on the submitted evaluation reports prepared by the United Kingdom and France as well as the draft assessment report (DAR) prepared by the Rapporteur Member state Germany under Directive 91/414/EEC. The toxicological profile of bentazone was investigated under the peer review of Directive 91/414/EEC and an ADI of 0.1 mg/kg bw/d and an ARfD of 0.25 mg/kg bw were derived. The nature of bentazone residues in primary plants is elucidated in three crop categories: cereals, root and tuber vegetables and pulses and oilseeds. The peer review concluded that metabolism data are sufficient to propose a general risk assessment and enforcement residue definition in plant commodities as "the sum of bentazone and the conjugates of 6-hydroxy and 8-hydroxy bentazone expressed as bentazone". This residue definition is in line with that in Regulation (EC) No 396/2005. EFSA concludes that the metabolic pattern of bentazone in the crops under consideration is sufficiently addressed and no further studies are required. Adequate analytical enforcement methods are available to monitor all compounds included in the enforcement residue definition. In support of the intended GAP on herbs a sufficient number of GAP compliant residue data were submitted on basil. The proposed residue data extrapolation from basil to the whole group of herbs is supported and a MRL of 10 mg/kg is derived for the whole group of herbs. In support of the intended GAPs on legume vegetables a sufficient number of GAP compliant residue trials were submitted on beans (with pods) and beans (without pods). EFSA did not support the applicant's proposal to extrapolate the residue data from beans (with pods) to all other crops in the legume vegetable group because there are individual residue data available on beans (without pods) with significantly lower residues observed. Consequently, the available residue data on beans (with pods) were used to extrapolate the residue data to peas (with pods) and the residue data on beans (without pods) were used to extrapolate the residue data to peas (without pods) and lentils. EFSA concludes that the MRL of 0.3 mg/kg would be required to support the intended use of bentazone on beans (with pods) and peas (with pods). The MRL of 0.05 mg/kg would be sufficient to support the intended use on beans (without pods), peas (without pods) and lentils. The nature of bentazone residues during processing has not been investigated. The applicants did not submit specific studies investigating the effect of processing on the magnitude of bentazone residues in processed legumes or herbs. Such studies, however, are not considered necessary taking into account the low contribution of these crops to the total dietary intake. The possible occurrence of bentazone residues in rotational and/or succeeding crops was also investigated. It was concluded that the nature of residues in rotational crops and primary crops is expected to be similar and therefore the same residue definitions are applicable. Considering that the intended seasonal application rates of bentazone on legumes and herbs are lower and that a part of the applied substance is intercepted by a treated crop, it is concluded that significant bentazone residues will not occur in rotational and/or succeeding crops provided that bentazone is applied according to the intended GAP. Since the crops under consideration are not fed to livestock, the nature and magnitude of bentazone residues in livestock was not assessed in the framework of this application. The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the calculation of the chronic exposure, EFSA used the median residue values as derived from the supervised residue field trials on beans (with pods), on beans (without pods) (as an input value also for lentils) and on basil (as an input value also for the whole group of herbs). In addition, for sweet corn, the median residue value was available as reported in a previously issued EFSA reasoned opinion. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes II and IIIB 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 bentazone. No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values ranged from 0.9-4.6% of the ADI (UK toddler diet). The individual contribution of residues in the crops under consideration to the total consumer exposure was insignificant (below 0.1% of the ADI). No short-term consumer intake concerns were identified in relation to the MRL proposals for the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 17.7% for celery leaves, 4.0% for chervil, 3.7% for parsley and below 3% for all the other crops under consideration. EFSA concludes that the intended use of bentazone on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern. The recommendations of EFSA are compiled in the table below: [GRAPHIC]
