Reasoned opinion on the setting of MRLs for imazapyr in genetically modified soya bean and other oilseeds and in lentils

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an import tolerance application from Exponent International Ltd., on behalf of BASF Corporation, to set MRLs for the use of the active substance imazapyr in genetically modified soya bean grown in Brazil, imidazolinone-tolerant lentils, rape and mustard plants grown in Canada and sunflowers in Argentina. The United Kingdom proposed to set MRLs of 5 mg/kg in soya bean, 0.08 mg/kg in sunflower seed, 0.05 mg/kg in rape seed and mustard seed and 0.2 mg/kg in lentils. The United Kingdom 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 5 mg/kg on soya bean, 0.08 mg/kg on sunflower seed, the limit of quantification (LOQ) of 0.05 mg/kg on rape and mustard seed and 0.3 mg/kg on lentils. In the countries of origin the MRLs are set at 3 mg/kg on soya bean, 0.05 mg/kg on sunflower, rape and mustard seed and 0.2 mg/kg on lentils. Adequate analytical enforcement methods are available to control the residues of imazapyr in the crops under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of imazapyr in soya bean, sunflower seed, rape seed, mustard seed and lentils will not result in a consumer exposure exceeding the toxicological reference value and therefore are unlikely to pose a consumer health risk. EFSA bases its assessment on the evaluation report and the response to the EFSA request for additional information, the original data (dossier) submitted by the applicant, the comments received during the Member State consultation of the draft reasoned opinion and the JMPR evaluation report. © EuropeanThe toxicological profile of imazapyr was assessed in the framework of the import tolerance application. From these data, the United Kingdom proposed an ADI of 2.5 mg/kg bw per day, whereas no ARfD was deemed necessary. The proposal was accepted by EFSA and by Member States during the consultation.The metabolism of imazapyr in primary crops was investigated in genetically modified soya bean and imidazolinone-tolerant maize labelled in the pyridine ring after foliar application. From these studies the EMS proposed to establish the residue definition for enforcement and risk assessment as imazapyr. EFSA agrees with the proposed residue definitions for the crops under consideration (group of pulses and oilseeds).EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 5 mg/kg on soya bean, 0.08 mg/kg on sunflower seed, the limit of quantification (LOQ) of 0.05 mg/kg on rape and mustard seed and 0.3 mg/kg on lentils. In the countries of origin the MRLs are set at 3 mg/kg on soya bean, 0.05 mg/kg on sunflower, rape and mustard seed and 0.2 mg/kg on lentils. The validity of the residue data on rape seeds with regard to st...