Modification of the existing maximum residue levels (MRLs) for dimethomorph in various crops

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(1):4381 [19 pp.].
doi
10.2903/j.efsa.2016.4381
Type
Reasoned Opinion
Question Number
EFSA-Q-2015-00573
Approved
8 January 2016
Published
27 January 2016
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, the evaluating Member State (EMS) Germany received an application from BASF SE to modify the existing MRLs for dimethomorph in flowering brassica (except broccoli), spinaches and similar leaves and globe artichokes. Germany 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 0.6 mg/kg for cauliflowers and others (code 0241990) and 4 mg/kg for purslanes, chards/beet leaves and others (code 0252990). An amendment of the MRL is not necessary for spinaches and globe artichokes. Adequate analytical enforcement methods are available to control the residues of dimethomorph in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the intended uses of dimethomorph on the crops under consideration are not expected to result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a health risk to consumers.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Germany received an application from BASF SE to raise the existing MRLs for dimethomorph in various crops. In order to accommodate for the intended uses of dimethomorph, Germany proposed the MRLs of 0.6 mg/kg for flowering brassica (except broccoli), 3 mg/kg for spinaches and similar leaves and to maintain the existing MRL level of 2 mg/kg for globe artichokes. Germany 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 the European Food Safety Authority (EFSA) on 6 October 2015.

EFSA bases its assessment on the evaluation report, the draft assessment report (DAR) and its addendum prepared under Directive 91/414/EEC, the Commission review report on dimethomorph, the conclusion on the peer review of the pesticide risk assessment of the active substance dimethomorph, the JMPR evaluation report as well as the conclusions from previous EFSA opinions on dimethomorph, including the reasoned opinion on the review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (Article 12 MRL review).

The toxicological profile of dimethomorph was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.05 mg/kg bw per day and an acute reference dose (ARfD) of 0.6 mg/kg bw.

The metabolism of dimethomorph in primary crops was investigated in the fruit, root and leafy crop groups following foliar applications and through hydroponic systems (tomatoes). The residue definitions set during the peer review for enforcement and risk assessment were confirmed under the Article 12 MRL review as dimethomorph (sum of isomers) for all plant commodities, including the crops under consideration in this MRL application.

EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.6 mg/kg for cauliflowers and others (code 0241990) and 4 mg/kg for purslanes, chards/beet leaves and others (code 0252990). An amendment of the MRL for spinaches and globe artichokes is not necessary. Adequate analytical enforcement methods are available to monitor the residues of dimethomorph on the commodities under consideration at the validated LOQ of 0.01 mg/kg.

Studies investigating the nature of dimethomorph residues under standard hydrolysis conditions showed the active substance to be hydrolytically stable. Therefore, for processed commodities the same residue definition as for raw commodities (RAC) is applicable. Studies investigating the effect of processing on the magnitude of dimethomorph residues were not provided and are not requested due to the low contribution of the crops under consideration to the total consumer exposure.

The occurrence of dimethomorph residues in rotational crops was investigated in the framework of the peer review and the Article 12 MRL review. It was concluded that the nature of residues in rotational and primary crops is expected to be similar and thus the same residue definitions are applicable. Considering the available data, EFSA recommends introducing at national level plant-back restrictions when granting an authorisation for the intended uses of a dimethomorph-based product.

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

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA updated the long-term risk assessment performed in the latest issued reasoned opinion with the supervised trials median residue (STMR) related to certain Codex limits assessed in the framework of the 47th session of the Codex Committee on Pesticide Residues and the STMRs derived for the crops under consideration. The acute risk assessment was performed only with regard to the crops under consideration. The highest calculated long-term intake accounted for 16% of the ADI (French toddler). The contribution of residues in the crops under consideration to the total consumer exposure was below 0.1% of the ADI. An acute consumer risk was not identified in relation to the MRL proposals (maximum 7% for chards/beet leaves).

EFSA concludes that the intended uses of dimethomorph on flowering brassica different than broccoli, purslanes, chards/beet leaves and others (code 0252990) are not expected to result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a health risk to consumers.

Keywords
dimethomorph, vegetables, MRL application, consumer risk assessment
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Number of Pages
19