Modification of the existing MRLs for boscalid in gherkins and courgettes

According to Article 6 of the Regulation (EC) No 396/2005, Belgium, hereafter referred to as the Evaluating Member State (EMS), compiled an application to modify the existing MRLs for boscalid in courgettes and gherkins. In order to accommodate for a new uses of boscalid in Belgium, it is proposed to raise the existing MRL of 0.2 mg/kg for gherkins and courgettes to 2.0 mg/kg. Belgium also intends to authorize the use on kohlrabi, but no MRL proposal was made since the intended use does not require raising of the existing MRL of 0.5 mg/kg. Belgium 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 29 May 2009. EFSA derives the following conclusions regarding the application, based on the above mentioned evaluation report as well as the Draft Assessment Report prepared by Germany. The toxicological profile of boscalid was investigated in the peer review and the data were sufficient to conclude in an ADI value of 0.04 mg/kg bw/d. ARfD value was not established as boscalid does not possess acute toxicological properties. The metabolism of boscalid in primary crops is elucidated in fruits and fruiting vegetables, leafy vegetables, pulses and oilseeds and the risk assessment and enforcement residue definition is established as parent boscalid. Consequently, the MRL application does not require additional metabolism studies. Adequate analytical methods are available to enforce the proposed MRLs. Boscalid is known to be persistent in the soil and therefore boscalid residues might occur in succeeding crops in amounts exceeding 0.01 mg/kg. Taking that into account, the MRL setting for boscalid in annual crops requires consideration of possible boscalid residues in crop when it is grown as a primary crop and when it is grown as a rotational crop. Submitted supervised residue trials data on gherkins and courgettes indicate that a higher MRL of 3.0 mg/kg than requested by the EMS (2.0 mg/kg) would be necessary to accommodate the intended GAP in Belgium. The MRL proposal is expected to cover also the residues originating in these crops when they are grown as rotational crops. Supervised residue trials data on kohlrabi would not require amendment of the existing MRL 0.5 mg/kg which was set in the peer review as a default value to cover possible occurrence of boscalid residues in rotational crops in cases where no specific residue trials or rotational crop study data are available. Submitted residue trials on kohlrabi indicate that an MRL of 0.1 mg/kg would be sufficient when kohlrabi is grown as a primary crop. However, no information is available to EFSA concerning the most critical GAPs in primary crops to make a realistic estimation of boscalid residues occurring in kohlrabi when it is grown as a rotational crop. EFSA will assess this aspect in detail in the framework of the review of the existing MRLs for boscalid according to Article 12 (2) of Regulation 396/2005. Residues in commodities of animal origin were not assessed in the framework of this application considering that the crops under consideration are not used as livestock feed. Consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the chronic intake assessment EFSA used the existing MRLs as established in Annexes III of Regulation (EC) No 396/2005 as well as the STMR values derived for the intended use of boscalid on courgettes and gherkins. For kohlrabi the existing MRL was used as an input value. In addition, for several crops the STMR values were used as reported in the framework of setting the temporary EC MRL for boscalid. No acute risk assessment was undertaken since no ARfD value has been established. No long term intake concerns were identified for any of European diets. The total calculated intake values ranged from 14.5-77.5% of the ADI. The contribution of gherkins and courgettes to the total dietary intake is insignificant being 0.4 % of the ADI for gherkins (WHO Cluster diet B) and 1.24% of the ADI for courgettes (French infant diet). EFSA concludes that the intended use of boscalid on courgettes, gherkins and kohlrabi is sufficiently supported by data and no risk for consumer health was identified. EFSA notes that inconsistencies with regard to MRLs for animal commodities (incompatibility of general MRL set under code 1010000 with specific commodity MRLs) have been identified in Regulation (EC) No 839/2008 as well as in the online EU Pesticides database which should be corrected when amendments to boscalid MRLs are made.(GRAPHICS)