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Reasoned opinion on the modification of the existing MRLs for azoxystrobin in lettuce, spinach, celery, cardoon, spices and rhubarb

EFSA Journal 2012;10(11):2991[27 pp.]. doi:10.2903/j.efsa.2012.2991
European Food Safety Authority Contact pesticides.mrl@efsa.europa.eu
Type: Reasoned Opinion On request from: European Commission Question number: EFSA-Q-2012-00356,EFSA-Q-2012-00401,EFSA-Q-2012-00677 Approved: 26 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, France received an application from the company Syngenta Agro SAS to modify the existing MRLs for the active substance azoxystrobin in lettuce, spinach, celery and cardoon. In order to accommodate for the intended use of azoxystrobin, France proposed to raise the existing MRLs to 15 mg/kg for spinach and similar, lettuces and other salad plants, celery and cardoon. Germany received an application from the plant protection service Landesamt für Landwirtschaft, Forsten und Gartenbau des Landes Sachesen-Anhalt to modify the existing MRLs for the active substance azoxystrobin in spices. In order to accommodate for the intended use Germany proposed to raise the existing MRLs to 0.3 mg/kg for spices/seeds and spices/fruits and berries. Belgium compiled an application to modify the existing MRL for the azoxystrobin in rhubarb. In order to accommodate for the intended use Belgium proposed to raise the existing MRLs to 0.5 mg/kg. France, Germany and Belgium 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 derive MRL proposals for lettuce, spinach and similar, cardoon, celery, rhubarb and spices. For other crops belonging to the group of lettuce and other salad plants the data were not sufficient to propose a MRL. Adequate analytical enforcement methods are available to control the residues of azoxystrobin on the commodities under consideration at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concludes that the proposed use of azoxystrobin on lettuce, spinach, celery, cardoon, spices and rhubarb 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, France, herewith referred to as the evaluating Member State France (EMS-FR), received an application from the company Syngenta Agro SAS to modify the existing MRLs for the active substance azoxystrobin in lettuce, spinach, celery and cardoon. In order to accommodate for the intended use of azoxystrobin, EMS-FR proposed to raise the existing MRLs to 15 mg/kg for spinach and similar, lettuces and other salad plants including Brassicacea, celery and cardoon respectively. Germany herewith referred to as the evaluating Member State Germany (EMS-DE), received an application from the plant protection service Landesamt für Landwirtschaft, Forsten und Gartenbau des Landes Sachesen-Anhalt to modify the existing MRLs for the active substance azoxystrobin in spices. In order to accommodate for the intended use of azoxystrobin, EMS-DE proposed to raise the existing MRLs from the limit of quantification to 0.3 mg/kg for spices/seeds and spices/fruits and berries. Belgium hereafter referred to as the evaluating Member State Belgium (EMS-BE), compiled an application to modify the existing MRL for the azoxystrobin in rhubarb. In order to accommodate for the intended use of azoxystrobin, EMS-BE proposed to raise the existing MRLs from the limit of quantification to 0.5 mg/kg. EMS-FR, EMS-DE and EMS-BE 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 28 June 2012, 21 March 2012 and 29 February 2012 respectively.

EFSA bases its assessment on the evaluation report submitted by the evaluating Member States France, Germany and Belgium, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the Assessment Report submitted for the Annex I renewal process, the conclusion on the peer review of the pesticide risk assessment of the active substance azoxystrobin, the JMPR Evaluation 2008 report as well as the conclusions from previous EFSA opinions on azoxystrobin.

The toxicological profile of azoxystrobin was assessed in the framework of the peer review under Regulation (EC) No 1107/2009 and the data were sufficient to derive an ADI of 0.2 mg/kg bw per day. No ARfD was deemed necessary.

The metabolism of azoxystrobin in primary crops was investigated in cereals (wheat), fruit and fruiting vegetables (grapes) and oilseeds (peanut). From these studies the peer review concluded to establish the residue definition for enforcement and risk assessment as azoxystrobin. For the use on lettuce, spinach, celery, cardoon, spices and rhubarb, EFSA concludes that the metabolism of azoxystrobin 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 15 mg/kg for the proposed uses on lettuce, spinach and similar, celery and cardoon; of 0.3 mg/kg for spices (seeds and fruits and berries) and of 0.6 mg/kg for rhubarb. The data were not sufficient to derive a MRL for the whole group of lettuce and other salad plants. Adequate analytical enforcement methods are available to control the residues of azoxystrobin on the commodities under consideration at the validated LOQ of 0.01 mg/kg.

Studies investigating the nature of azoxystrobin residues in processed commodities were assessed in the peer review and showed that the compound is hydrolytically stable under the processing conditions representative for pasteurisation, boiling/cooking and sterilisation. Therefore for processed commodities the same residue definition as for raw agricultural commodities (RAC) is applicable. In the framework of the current application the applicant did not submit specific studies investigating the effect of processing on the magnitude of azoxystrobin residues in lettuce, spinach, celery, cardoon, spices and rhubarb. Such studies however, are not necessary considering the low contribution of these crops to the total dietary intake.

The occurrence of azoxystrobin residues in rotational crops was investigated in the framework of the peer review. Based on the available information on the nature and magnitude of residues in succeeding crops, it was concluded that significant residue levels are unlikely to occur in rotational crops provided that the compound is used on lettuce, spinach, celery, cardoon, spices and rhubarb according to the proposed pattern.

Residues of azoxystrobin in commodities of animal origin were not assessed in the framework of this application, since the lettuce, spinach, celery, cardoon, spices and rhubarb 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, the median residue values as derived from the residue trials on lettuce, spinach, celery, cardoon, spices and rhubarb were used as input values. For several commodities the median residue values as reported in the previously issued EFSA reasoned opinions were available to refine the exposure calculations. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex II of Regulation (EC) No 396/2005 were used as input values. Acute consumer exposure was not performed due to the low acute toxicity of the active substance. The estimated chronic exposure was then compared with the toxicological reference value derived for azoxystrobin.

No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values ranged from 6 to 53% of the ADI (DE child diet). The contribution of residues in the crops under consideration to the total consumer exposure was very low (maximum 1.4% of the ADI for spinach; toddler).

EFSA concludes that the proposed use of azoxystrobin on lettuce, spinach, celery, cardoon, spices and rhubarb 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

Azoxystrobin, leafy and stem vegetables, spices, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, strobilurin fungicide.