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

2012 EFSA Journal  
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
more » ... ection 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. Modification of the existing MRLs for azoxystrobin in various crops EFSA Journal 2012;10(11):2991 2 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 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 Modification of the existing MRLs for azoxystrobin in various crops EFSA Journal 2012;10(11):2991
doi:10.2903/j.efsa.2012.2991 fatcat:24pmt2um5rd6ljhm2bwsrlp2jq