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Reasoned opinion on the modification of the existing MRLs for dimethomorph in seeds of spices and caraway

EFSA Journal 2013;11(2):3126 [27 pp.]. doi:10.2903/j.efsa.2013.3126
European Food Safety Authority Contact pesticides.mrl@efsa.europa.eu
Type: Reasoned Opinion On request from: European Commission Question number: EFSA-Q-2012-00676 Approved: 27 February 2013 Published: 28 February 2013 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from BASF SE to modify the existing MRLs for the active substance dimethomorph in spices. In order to accommodate for the intended uses of dimethomorph in seeds of spices and caraway, Germany proposed to raise the existing MRLs from the limit of quantification of 0.05 mg/kg to 30 mg/kg. 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 a MRL proposal of 30 mg/kg for the proposed use on the seeds of spices (except nutmeg seed) and on caraway fruits. 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 proposed use of dimethomorph on the spices under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

© European Food Safety Authority, 2013

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from BASF SE to modify the existing MRLs for the active substance dimethomorph in spices. In order to accommodate for the intended uses of dimethomorph in seeds of spices and caraway, Germany proposed to raise the existing MRLs from the limit of quantification of 0.05 mg/kg to 30 mg/kg. 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 on 28 June 2012.

EFSA bases its assessment on the evaluation report, the Draft Assessment Report prepared under Council 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 and the conclusions from previous EFSA reasoned opinions, including the EFSA reasoned opinion on the review of the existing MRLs for dimethomorph according to Article 12 of Regulation (EC) No 396/2005.

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 ADI of 0.05 mg/kg bw per day and an ARfD of 0.6 mg/kg bw.

The metabolism of dimethomorph in primary crops was investigated in three crop groups after foliar application and in tomatoes following application through a hydroponic system. The review of the existing MRLs for dimethomorph performed under Article 12 of Regulation (EC) No 396/2005 confirmed the conclusion of the peer review that the relevant residue definition for both enforcement and risk assessment in all plant commodities after foliar application is dimethomorph (sum of isomers). For the use on spices EFSA concludes that the metabolism of dimethomorph in primary crops is sufficiently addressed and that the derived residue definitions are applicable

EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 30 mg/kg for the proposed use on the seeds of spices (except nutmeg seed) and on caraway fruits. Adequate analytical enforcement methods are available to control the residues of dimethomorph in the commodities under consideration at the validated LOQ of 0.2 mg/kg.

The peer review concluded that the dimethomorph is hydrolytically stable during pasteurisation, baking, boiling, brewing and sterilisation and the same residue definition as for raw agricultural commodities (RAC) is applicable. Considering the insignificant contribution to the total consumer exposure, specific studies investigating the magnitude of dimethomorph residues in processed spice products are not required.

The occurrence of dimethomorph residues in rotational crops was investigated the during the peer review. Based on the available information on the nature and magnitude of residues in succeeding crops, EFSA concludes that residues in rotational crops resulting from the uses according to the proposed GAP (Good Agricultural Practice) are unlikely to occur but can not be excluded and plant-back restrictions should be considered when granting an authorisation for dimethomorph at national level.

Residues of dimethomorph in commodities of animal origin were not assessed in the framework of this application, since spices are normally not fed to livestock.

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 dimethomorph 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 dimethomorph at the EU level and the CXLs set for certain commodities. EFSA now updates this risk assessment with the median residue values for spices derived from the submitted supervised residue trials and the median residue values proposed by EFSA for several vegetables based on intended uses notified after the MRL review. The acute exposure assessment was performed only with regard to the commodities under consideration. The estimated exposure was then compared with the toxicological reference values derived for dimethomorph.

Under the assumption that the MRLs will be amended as proposed in the Article 12 review, no long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated exposure accounted for up to 11 % of the ADI (FR all population). The contribution of residues in each of the spices for which consumption data are available (anise, black caraway and fennel seeds) to the total consumer exposure accounted for a maximum of 0.02 % of the ADI (DE child diet).

No acute consumer risk was identified in relation to the MRL proposals for the spices under consideration. The calculated maximum exposure in percentage of the ARfD was 1.5 % for fennel seed, 0.1 % for black caraway seed and 0.03 % for anise and coriander seeds (DE child diet).

EFSA concludes that the proposed use of dimethomorph on the spices under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

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

Keywords

Dimethomorph, spices, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, morpholine fungicide