According to Article 6 of the Regulation (EC) No 396/2005, France, herewith referred to as the Evaluating Member State (EMS), received an application from the company BASF AGRO S.A.S. to modify the existing MRLs for dimoxystrobin in rye, mustard seed and sunflower seed. In order to accommodate for the intended uses of dimoxystrobin on these crops in various northern and southern European countries, the EMS proposes raising the existing MRLs. 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 13 September 2012. EFSA derives the following conclusions based on the submitted evaluation report prepared by the EMS France, the Draft Assessment Report (DAR) prepared by the rapporteur member State (RMS) United Kingdom under Directive 91/414/EEC and the EFSA conclusion on the peer review of dimoxystrobin. The toxicological profile of dimoxystrobin was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI value of 0.004 mg/kg bw/day and an ARfD value of 0.004 mg/kg bw. In the framework of the peer review the metabolism of dimoxystrobin was investigated in cereals. An additional metabolism study on rape seed was submitted in support of the current MRL request. The peer review established the residue definition for risk assessment and enforcement in cereals as parent dimoxystrobin. Following the assessment of the metabolism study submitted on oilseeds, EFSA is of the opinion that the residue definition proposed by the peer review can be extended also to the group of oilseeds. Thus, for the use on the crops under consideration the metabolism of dimoxystrobin is sufficiently elucidated and additional studies are not required. The residue definition according to Regulation (EC) No 396/2005 is established as parent dimoxystrobin. The EMS proposed to extrapolate residue data from wheat to rye and from rape seed to mustard seed, which is in line with the EU guidance document and is supported by a sufficient number of residue trials. An MRL proposal of 0.08 mg/kg in rye, 0.05 mg/kg in mustard seed and 0.3 mg/kg in sunflower seed would be required to support the intended use on these crops in northern Europe. The intended use of dimoxystrobin on sunflower in the southern Europe is not sufficiently supported by residue data and is therefore not recommended by EFSA. Adequate analytical enforcement methods are available to enforce the proposed MRLs in the commodities under consideration. The effects of processing on the nature of dimoxystrobin residues have been investigated in the peer review in a hydrolysis study simulating pasteurization and baking/brewing/boiling. Under these conditions dimoxystrobin remains unchanged and therefore the peer review concluded that for processed commodities the same residue definition as for raw commodities is applicable. In the framework of the current application the applicant submitted studies investigating the effect of processing on dimoxystrobin residues in rape seed and sunflower seed oil. A reduction of residues was observed in refined oil. The following processing factors are proposed for the inclusion in Annex VI of Regulation (EC) No 396/2005: rape seed, refined oil: 0.9 sunflower seed, refined oil: 0.48 The possible occurrence of dimoxystrobin residues in rotational/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 significant residue levels in rotational crops will not occur provided that the active substance is applied according to the proposed GAP. Since all crops under consideration (except mustard seed) and/or their by-products can be fed to livestock, the nature and magnitude of dimoxystrobin residues in livestock was investigated. The calculated livestock dietary burdens exceed the trigger value of 0.1 mg/kg dry matter (DM) for all livestock species, except for poultry. The intake is mainly driven by the existing uses on barley and wheat and the contribution of the feed crops under consideration to the total livestock exposure is insignificant. Therefore the modification of the MRLs for commodities of animal origin was not further investigated in the framework of the current 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 residue trials on wheat, oilseed rape and sunflower. The median residue value for wheat was used as an input value for rye and the median residue value for rape seed was used as the input value for mustard seed. 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 median level as observed in supervised field trials. The calculated exposure was then compared with the toxicological reference values as derived for dimoxystrobin. 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 2.4 to 26.4% of the ADI (maximum for WHO Cluster diet B). The contribution of residues in the crops under consideration to the total consumer exposure (in the percentage of the ADI) accounted for a maximum of 5.5% for rye (DK child diet), 1.9% for sunflower seed (WHO Cluster diet B) and was below 0.1% for mustard seed. No short-term consumer risk was identified in relation to the residues of dimoxystrobin in the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 7.9% for rye, 7.7% for sunflower seed and 0.2% for mustard seed. EFSA concludes that the intended use of dimoxystrobin 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 [GRAPHIC]
