Reasoned opinion on the modification of the existing maximum residue levels (MRLs) for dazomet in several vegetables

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(3):4049 [23 pp.].
doi
10.2903/j.efsa.2015.4049
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2014-00390
Approved
13 March 2015
Published
17 March 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), received an application from Kanesho Soil Treatment SPRL/BVBA to modify the existing maximum residue levels (MRLs) for the active substance dazomet in fruits and several vegetables. In order to accommodate for the pre-planting uses of dazomet, Belgium proposed a modification of the MRLs, as methyl isothiocyanate (MITC). Belgium 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. According to EFSA the data are sufficient to derive MRL proposals of 0.02 mg/kg on carrots, 0.05 mg/kg on radishes, 0.1 mg/kg on the group ‘fruiting vegetables’, except sweet corn, 0.03 mg/kg on the groups ‘leafy brassica’ and ‘lettuces and other salad plants’ and 0.15 mg/kg on the group ‘spinaches and similar leaves’. The proposed MRLs apply to the active substance metam as well. In contrast, EFSA does not recommend the lowering of the current MRL value from the limit of quantification (LOQ) of 0.02 mg/kg to the LOQ of 0.01 mg/kg in fruits, pending the Article 12 review. Adequate analytical methods are available to control residues of MITC for the proposed MRLs. Based on the risk assessment results, EFSA concludes that the proposed uses of dazomet on the vegetables under consideration will not result in a consumer exposure exceeding the toxicological reference values for MITC and therefore are unlikely to pose a consumer health risk.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), received an application from Kanesho Soil Treatment SPRL/BVBA to modify the existing maximum residue levels (MRLs) for the active substance dazomet in fruits and several vegetables. In order to accommodate for the pre-planting uses of dazomet, Belgium proposed a modification of the MRLs, as methyl isothiocyanate (MITC). Belgium 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 27 May 2014. 

EFSA bases its assessment on the evaluation report, the draft assessment report (DAR) and its addendum prepared under Council Directive 91/414/EEC, the Commission review report and the conclusion on the peer review of the pesticide risk assessment of the active substance dazomet.

The toxicological profile of dazomet was assessed in the framework of the peer review under Council Directive 91/414/EEC and the data were sufficient to derive specific acceptable daily intake (ADI) and acute reference dose (ARfD) for dazomet and its toxicological relevant metabolite MITC.

The metabolism of dazomet in primary crops was investigated after pre-plant application to soil on three crop groups (root/tuber, fruit and leafy crops). From these studies the peer review concluded to establish the residue definition for enforcement and risk assessment as MITC, which is applicable to the crops under consideration. This residue definition is in common with the pesticide metam.

EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.02 mg/kg on carrots, 0.05 mg/kg on radishes, 0.1 mg/kg on the group ‘fruiting vegetables’, except sweet corn, 0.03 mg/kg on the groups ‘leafy brassica’ and ‘lettuces and other salad plants’ and 0.15 mg/kg on the group ‘spinaches and similar leaves’. In contrast, EFSA does not recommend the lowering of the current MRL value from the limit of quantification (LOQ) of 0.02 mg/kg to the LOQ of 0.01 mg/kg in fruits, pending the Article 12 review. Adequate analytical methods are available to control residues of MITC for the proposed MRLs at the validated LOQ of 0.01 mg/kg. Since MITC is the enforcement and risk assessment residue definition of the active substance metam and the analytical method does not differentiate between MITC generated by dazomet or metam, the proposed MRLs apply to the active substance metam as well.

Studies on the nature and magnitude of residues in processed commodities are not required due to the low residues observed in the raw agricultural commodities (RAC) after the intended uses of dazomet.

Investigations on the nature and magnitude of residues in succeeding crops are not required due to the fast degradation rate of dazomet and its metabolite MITC in the soil. 

The possible carry-over of dazomet residues in commodities of animal origin was not assessed in the framework of this MRL application since the crops under consideration are not fed to livestock or the intended use on kale is not expected to have an impact on the livestock dietary burden.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the supervised trials median residue (STMR) values as derived from the residue trials submitted for the vegetables under consideration and the existing MRLs for as established in Annex IIIA of Regulation (EC) No 396/2005. The acute exposure assessment was performed only with regard to the commodities under consideration. 

No chronic consumer intake concerns were identified for any of the European diets incorporated in the PRIMo model. The total calculated intake accounted for up to 20 % of the ADI (British Toddler), the maximum contribution of the crops under consideration accounting for 0.8 % of the ADI (tomatoes). No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration. 

EFSA concludes that the proposed uses of dazomet on the vegetables under consideration will not result in a consumer exposure exceeding the toxicological reference values for MITC and therefore are unlikely to pose a consumer health risk. 

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

Keywords
dazomet, vegetables, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, carbamate, methyl isothiocyanate (MITC)
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Number of Pages
23