In accordance with Article 6 of Regulation (EC) No 396/2005, The Netherlands received an application from DuPont Danmark to modify the existing MRLs for the active substance indoxacarb in several crops. Spain and The Netherlands drafted the evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA. For reasons of efficiency EFSA combined both applications in one reasoned opinion. According to EFSA the data are sufficient to derive MRL proposals for the crops under consideration, except for strawberries, raspberries and witloof. The submitted residue data indicate no need to modify the existing EU MRLs for scarole and soya beans. Adequate analytical enforcement methods are available to control the residues of indoxacarb and its R-isomer on the commodities for which a MRL is proposed at the validated LOQ of 0.02 mg/kg. Based on the risk assessment results, EFSA concludes thatthe proposed uses of indoxacarb on Chinese cabbage, lamb’s lettuce, scarole, beans with pods, cardoons, fennel, rhubarb and soya beans will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.
In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, hereafter referred to as the evaluating Member State (EMS-ES), received an application from the Spanish Federation of Associations of Producers and Exporters of Fruits, Vegetables, Flowers and Live Plants (FEPEX) to modify the existing MRLs for the active substance indoxacarb in raspberries and strawberries. In order to accommodate for the intended uses, Spain proposed to raise the existing MRLs from 0.5 mg/kg in raspberries and from the limit of quantification (0.02 mg/kg) in strawberries to 0.6 mg/kg. Spain drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 29 November 2011.
In accordance with Article 6 of Regulation (EC) No 396/2005, The Netherlands, hereafter referred to as the evaluating Member State (EMS-NL), received an application from DuPont Danmark to modify the existing MRLs for the active substance indoxacarb in several crops. In order to accommodate for the intended uses, The Netherlands proposed the following MRLs: 0.5 mg/kg in beans with pods, 3 mg/kg in Chinese cabbage, 40 mg/kg in lamb’s lettuce and 2 mg/kg in cardoons, fennel and rhubarb, whereas no MRL amendment was found to be necessary for scarole and soya beans. The EMS-NL considered the intended use on witloof as not supported. The Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 6 January 2012.
For reasons of efficiency EFSA combined both applications in one reasoned opinion. EFSA bases its assessment on the evaluation reports submitted by the EMS-ES and EMS-NL, the Draft Assessment Report (DAR) and its addendum prepared under Council Directive 91/414/EEC, the Commission Review Report on indoxacarb, the JMPR Evaluation reports as well as the conclusions from previous EFSA opinions on indoxacarb, including the EFSA reasoned opinion on the review of the existing MRLs for indoxacarb according to Article 12 of Regulation (EC) No 396/2005.
The toxicological profile of indoxacarb was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.006 mg/kg bw per day and an ARfD of 0.125 mg/kg bw.
The metabolism of indoxacarb in primary crops was investigated in three different crop groups following foliar application. The review of the existing MRLs for indoxacarb performed under Article 12 of Regulation (EC) No 396/2005 confirmed the conclusion of the peer review that the relevant residue for enforcement and risk assessment in all plant commodities treated by foliar application is indoxacarb (S-enantiomer) and its R-enantiomer. EFSA proposed to reword the residue definition as “sum of indoxacarb and its R-enantiomer”. For the uses on crops under consideration EFSA concludes that the metabolism of indoxacarb in primary crops is sufficiently addressed and that the residue definitions as proposed during the MRL review are applicable.
EFSA considers that the submitted supervised residue trials are sufficient to derive MRL proposals for the crops under consideration, except for strawberries, raspberries and witloof. The submitted residue data indicate no need to modify the existing EU MRLs for scarole and soya beans. Adequate analytical enforcement methods are available to control the residues of indoxacarb and its R-isomer on the commodities for which a MRL is proposed at the validated LOQ of 0.02 mg/kg.
The peer review concluded that the indoxacarb and its R-enantiomer are hydrolytically stable under conditions representative of pasteurisation and baking/boiling and for processed commodities that are not subject to sterilisation the same residue definition as for raw agricultural commodities (RAC) is applicable. The nature of residues under conditions simulating sterilisation was not investigated and is considered required. Considering that the residue levels in raw agricultural commodities (RAC) exceeded the trigger value of 0.1 mg/kg in most of the crops and the total theoretical maximum daily intake (TMDI) amounts to more than 10 % of the ADI, it would be desirable to have additional processing studies.
Based on the available information on the occurrence of indoxacarb residues in rotational crops, EFSA concludes that relevant residue levels are unlikely to occur in rotational crops provided that the compound is used on the crops under consideration according to the proposed GAP (Good Agricultural Practice).
Since no amendment of the existing MRL on soya bean (the only product which is also used as feed item) is proposed, no further investigations on the nature and magnitude of residues in livestock are necessary.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the review of the existing MRLs for indoxacarb according to Article 12 of Regulation (EC) No 396/2005, a comprehensive long-term exposure assessment was performed taking into account the existing uses of indoxacarb at EU level and the existing acceptable CXLs supported by data. EFSA now updates this risk assessment with the median residue value as derived from the supervised residue trials on beans with pods, Chinese cabbage, lamb’s lettuce, celery (extrapolated to cardoons, fennel and rhubarb). The acute exposure assessment was performed only with regard to the commodities for which a change of the existing MRL is proposed. The estimated exposure was then compared with the derived toxicological reference values.
It is noted that the long-term consumer exposure calculation is based on the conclusions and recommendations derived in the review of the existing MRLs for indoxacarb under Article 12 of Regulation (EC) No 396/2005. Under the assumption that the MRLs will be amended as proposed in the Article 12 review, the total calculated intake accounted for 75 % of the ADI (DE child diet). Thus, no long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. No acute consumer risk was identified in relation to the MRL proposals.
EFSA concludes that the proposed uses of indoxacarb on Chinese cabbage, lamb’s lettuce, scarole, beans with pods, cardoons, fennel, rhubarb and soya beans will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.
