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Reasoned opinion on the modification of the existing MRLs for proquinazid in tomatoes, aubergines and cucurbits with edible peel

EFSA Journal 2012;10(9):2896[27 pp.]. doi:10.2903/j.efsa.2012.2896
European Food Safety Authority Contact pesticides.mrl@efsa.europa.eu
Type: Reasoned Opinion On request from: European Commission Question number: EFSA-Q-2012 -00351,EFSA-Q-2012 -00400 Approved: 24 September 2012 Published: 25 September 2012 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 two applications from Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen to modify the existing MRLs for the active substance proquinazid in tomatoes and aubergines and in cucurbits (edible peel), respectively. In order to accommodate for the intended uses of proquinazid, Germany proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.02 mg/kg to 0.15 mg/kg in tomatoes and aubergines and to 0.04 mg/kg in cucurbits with edible peel. Germany drafted two separate 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 of 0.15 mg/kg for the intended use on tomatoes and aubergines and of 0.05 mg/kg for the intended use on the whole group of cucurbits (edible peel). Adequate analytical enforcement methods are available to control the residues of proquinazid in the crops under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of proquinazid on tomatoes, aubergines and cucurbits with edible peel 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,2012

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received two applications from Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen to modify the existing MRLs for the active substance proquinazid in tomatoes and aubergines and in cucurbits (edible peel), respectively. In order to accommodate for the intended uses of proquinazid, Germany proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.02 mg/kg to 0.15 mg/kg in tomatoes and aubergines and to 0.04 mg/kg in cucurbits with edible peel. Germany drafted two separate evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA on 29 January 2012 and on 21 February 2012, respectively.

For reasons of efficiency EFSA combined both applications in one reasoned opinion. EFSA bases its assessment on the two evaluation reports, the Draft Assessment Report (DAR) and its addendum prepared under Council Directive 91/414/EEC, the Commission Review Report on proquinazid, EFSA conclusions from the peer review of the pesticide risk assessment of the active substance proquinazid and a previous EFSA opinion on proquinazid.

The toxicological profile of proquinazid was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.01 mg/kg bw per day and an ARfD of 0.2 mg/kg bw.

The metabolism of proquinazid in primary crops was investigated in grapes (fruits and fruiting group) and wheat (cereal group). From these studies the peer review concluded to establish the residue definition for enforcement as proquinazid and for risk assessment as sum of proquinazid and IN-MW977, expressed as proquinazid. The metabolite IN-MW977 was formed only in the metabolism of wheat and not found in grapes. An additional study on apples confirmed the metabolism observed on grapes. For the use on the crops under consideration, which belong to the fruits and fruiting vegetable group, EFSA concludes that the metabolism of proquinazid in primary crops is sufficiently addressed and that the derived residue definitions are applicable.

EFSA considers that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.15 mg/kg for the intended use on tomatoes and aubergines and of 0.05 mg/kg for the intended use on the whole group of cucurbits (edible peel). Adequate analytical enforcement methods are available to control the residues of proquinazid in the crops under consideration.

Proquinazid is hydrolytically stable under processing conditions representative for pasteurisation, boiling and sterilisation. Thus, for processed commodities the same residue definition as for raw agricultural commodities (RAC) is applicable. Specific studies investigating the magnitude of proquinazid residues in processed commodities were not provided and are not required.

The occurrence of proquinazid residues in rotational crops was investigated under the peer review. Based on the available information, the peer review could not completely exclude the presence of residues of proquinazid and its soil metabolite IN-MM671 in rotational crops. EFSA recommends providing additional rotational crop data to fully quantify the nature and magnitude of proquinazid residues in rotational crops for the MRL review under Article 12 of Regulation (EC) No 396/2005. Lacking the results from these studies, the Member States should ensure by imposing appropriate risk mitigation measures that no quantifiable residues occur in succeeding crops.

Residues of proquinazid in commodities of animal origin were not assessed in the framework of this application, since the products 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 derived from the submitted residue trials on tomatoes and cucumbers for tomatoes, aubergines and cucurbits (edible peel) and from a previously issued reasoned opinion for strawberries. The conversion factor (CF) of 1 from enforcement to risk assessment established during the peer review for grapes was applied to these crops. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes IIIA of Regulation (EC) No 396/2005 for proquinazid were used as input values. The estimated exposure was then compared with the toxicological reference values derived for proquinazid.
No long-term or short-term consumer intake concerns were identified for any of the European diets included in the EFSA PRIMo. The total calculated exposure was less than 23 % of the ADI and less than 5 % of the ARfD.

EFSA concludes that the proposed use of proquinazid on tomatoes, aubergines and cucurbits with edible peel 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

Proquinazid, tomatoes, aubergines, cucurbits, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, quinazolinones, IN-MM977