The United Kingdom received an application from the Horticultural Development Council to modify the existing MRL for indoxacarb in Brussels sprouts. The United Kingdom as an Evaluating Member State (EMS) drafted an Evaluation Report which was submitted to the European Commission and forwarded to EFSA on 26 September 2008. EFSA derives the following conclusions regarding the application, based on the Evaluation Report, the Draft Assessment Report prepared by The Netherlands in the framework of Directive 91/414/EEC as well as MRL proposals prepared by several Member States under the former MRL legislation: The toxicological profile of indoxacarb was investigated in the peer review and the data were sufficient to conclude on an ADI value of 0.006 mg/kg bw/d and an ARfD value of 0.125 mg/kg bw/d. The metabolism of indoxacarb in primary crops is elucidated in several crop categories and residue definitions have been derived for all plant commodities. The residue definition for risk assessment and enforcement is set as "indoxacarb (sum of R and S isomers)". Consequently, the MRL application for Brussels sprouts does not require additional metabolism studies. Analytical methods are available to enforce an MRL in Brussels sprouts. The possible occurrence of indoxacarb residues in rotational crops was also investigated. It was concluded that the nature of residues in rotational crops and primary crops is expected to be similar but significant residue levels in rotational crops (exceeding 0.01 mg/kg) will not occur provided that the active substance is applied according to the proposed GAP. Residues in commodities of animal origin were not assessed in the framework of this application considering that Brussels sprouts are not usually fed to livestock. Submitted data on supervised field trials reveal that the current MRL does not accommodate the intended GAP in the United Kingdom and a higher MRL of 0.1 mg/kg would be necessary. EFSA performed the consumer intake risk assessment with the EFSA PRIMo-rev. 2, using the MRLs as established in Annex II and Annex IIIB of Regulation (EC) 396/2005 for indoxacarb as well as the HR and STMR values derived for the intended use on Brussels sprouts. In addition, EFSA looked for the relevant information in available evaluation reports submitted to EC for MRL proposals during 2006-2008 and used the available STMR values of various commodities in the chronic consumer intake calculations. The chronic dietary intake calculation did not reveal any consumer intake concerns and no acute intake risk was identified for Brussels sprouts since the IESTI is only 0.3% of the ARfD. Regarding the risk assessment of current MRLs for indoxacarb, they will be subject to a full risk assessment according to Article 12 (2) of Regulation (EC) No 396/2005 by 2 September 2009. [GRAPHICS] EFSA concludes that the proposed MRL of 0.1 mg/kg for indoxacarb in Brussels sprouts can be supported as no risk for consumer safety was identified in relation to the Brussels sprouts.
