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Reasoned opinion on the modification of the existing MRLs for chlorantraniliprole in carrots, parsnips, parsley root and celeriac

EFSA Journal 2012;10(11):2988[24 pp.]. doi:10.2903/j.efsa.2012.2988
European Food Safety Authority Contact pesticides.mrl@efsa.europa.eu
Type: Reasoned Opinion On request from: European Commission Question number: EFSA-Q-2012-00611 Approved: 27 November 2012 Published: 28 November 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, herewith referred to as the evaluating Member State (EMS), received an application from the Horticultural Development Company to modify the existing MRL for chlorantraniliprole in carrots, parsnips, celeriac and parsley root. In order to accommodate the intended use in the NEU, the EMS proposed to set the MRL for chlorantraniliprole in the crops under consideration at 0.04 mg/kg. The existing MRL for carrots is set at the level of 0.08 mg/kg. This MRL will expire on 1 January 2013 and after that date a MRL of 0.02 mg/kg will be applicable unless modified by a Regulation. The EMS 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. According to EFSA, the data are sufficient to extrapolate residue data from carrots to parsnips, parsley root and celeriac and to derive MRL proposals for all these crops in support of the NEU use. Member States granting authorisations of the use of chlorantraniliprole should implement necessary risk mitigation measures to ensure that residues do not occur in rotational/succeeding crops. Based on the risk assessment results, EFSA concludes that the intended use of chlorantraniliprole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a public health concern. Since the peer review is not yet finalised, the conclusions reached in this reasoned opinion should be taken as provisional and might need to be reconsidered in the light of the outcome of the peer review.

© European Food Safety Authority,2012

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, herewith referred to as the evaluating Member State (EMS), received an application from the Horticultural Development Company to modify the existing MRL for chlorantraniliprole in carrots, parsnips, celeriac and parsley root. In order to accommodate the intended use in the NEU, the EMS proposed to set the MRL for chlorantraniliprole in the crops under consideration at 0.04 mg/kg. The existing MRL for carrots is set at the level of 0.08 mg/kg. This MRL will expire on 1 January 2013 and after that date a MRL of 0.02 mg/kg will be applicable unless modified by a Regulation. The EMS 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 24 May 2012.

EFSA bases its assessment on the evaluation report submitted by the EMS United Kingdom, the Draft Assessment Report (DAR) and its addenda prepared under Council Directive 91/414/EEC well as the conclusions from previous EFSA opinions on chlorantraniliprole.

The toxicological profile of chlorantraniliprole has been evaluated in the DAR and the data were sufficient to propose an ADI of 1.58 mg/kg bw/day. Due to the low acute toxicity of the active substance, the setting of an ARfD was considered not necessary. Pending the finalisation of the peer review process, the assessment and the derived toxicological reference value should be considered provisional.

The metabolism of chlorantraniliprole in primary crops was investigated in fruits and fruiting vegetables, leafy vegetables, pulses and oilseeds, and cereals. Based on the results from these studies, the RMS proposed to establish a general residue definition for risk assessment and enforcement as chlorantraniliprole. For the uses assessed in this reasoned opinion, EFSA concludes that the metabolism of chlorantraniliprole is sufficiently elucidated and the proposed residue definitions are appropriate. EFSA notes that the derived residue definitions have to be considered provisional pending the outcome of the peer review.

EFSA concludes that the submitted data are sufficient to extrapolate residue data from carrots to parsnips, parsley root and celeriac and to derive MRL proposals for all these crops in support of the NEU use. Adequate analytical enforcement methods are available to control the residues of chlorantraniliprole in the crops under consideration at the validated LOQ of 0.01 mg/kg.

Specific studies investigating the magnitude of chlorantraniliprole residues in processed commodities are not required, as the residues expected in primary crops are low and the total theoretical maximum daily intake (TMDI) is below the trigger value of 10% of the ADI.

The occurrence of chlorantraniliprole residues in rotational crops was investigated in the DAR. The RMS concluded that the metabolism of chlorantraniliprole in rotational crops proceeds in a similar pathway as in primary crops and proposed to define the residue for risk assessment and enforcement as parent chlorantraniliprole. EFSA agrees with the proposal of the RMS, but notes that the derived residue definitions are provisional, pending the outcome of the peer review. From the soil accumulation studies as well as from the rotational crop field studies it is not possible to exclude that residues of chlorantraniliprole will occur in rotational crops over multiple years of consecutive applications of chlorantraniliprole on primary crop. Thus, Member States granting authorisations of the use of chlorantraniliprole should implement necessary risk mitigation measures to ensure that residues do not occur in rotational/succeeding crops.

Residues of chlorantraniliprole in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration are normally not fed to livestock.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the median residue values as derived from the residue trials on carrots and these values were used as input values also for parsnips, parsley root and celeriac. The median residue values for several other crops as reported in previously issued EFSA reasoned opinions were available to refine the exposure calculation. 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 estimated long-term exposure was then compared with the toxicological reference value derived for chlorantraniliprole. Acute consumer exposure was not performed due to the low acute toxicity of the active substance.

No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 1.9% of the ADI (NL child diet). The contribution of residues in the crops under consideration to the total consumer exposure was insignificant (below 0.01% of the ADI).

EFSA concludes that the intended use of chlorantraniliprole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a public health concern. Since the peer review is not yet finalised, the conclusions reached in this reasoned opinion should be taken as provisional and might need to be reconsidered in the light of the outcome of the peer review.

Thus EFSA proposes to amend the existing MRLs as reported in the summary table.
 

Keywords

Chlorantraniliprole, root crops, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, anthranilic diamide insecticide