Modification of the existing maximum residue levels for spirotetramat in various crops

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Austria, received an application from Bayer S.A.S Bayer CropScience to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in the group 'other small fruits and berries', kaki, kiwi fruits and globe artichokes. EFSA proposes to adopt in the EU legislation the enforcement residue definitions proposed in the conclusion of the peer review and also agreed at Codex level and defined as 'sum spirotetramat, spirotetramat-enol expressed as spirotetramat' for plant commodities and as 'spirotetramat-enol expressed as spirotetramat' for animal products. In addition to the crops included in the current MRL application, EFSA has reconsider all MRLs values reported for plant commodities in the EU legislation in order to express all values according to the enforcement residue proposed here above. According to EFSA the data are sufficient to derive MRL proposals of 0.5 mg/kg on 'other small fruits and berries', 0.3 mg/kg on kaki and 3 mg/kg for kiwi fruits according to the residue definition limited to spirotetramat and its enol metabolite. However, EFSA proposes not to implement the MRL proposals in the EU legislation for 'other small fruits and berries' and kiwi fruits as long as the stability of residues in high acid matrices has not been confirmed. An amendment of the MRL in globe artichokes is not necessary. An adequate analytical method is available to enforce spirotetramat residues in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the uses of spirotetramat do not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk. © European Food Safety Authority, 2016Keywords: spirotetramat, fruits, globe artichokes, MRL application, consumer risk assessment Reproduction is authorised provided the source is acknowledged.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. EFSA bases its assessment on the amended evaluation report and its addendum, the draft assessment report (DAR) and its addendum prepared under Directive 91/414/EEC, the Commission review report, the conclusion on the peer review of the pesticide risk assessment of the active substance, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) evaluation reports as well as the conclusions from previous EFSA opinions. Modification of existing MRLs for spirotetramat in various cropsThe toxicological profile of spirotetramat was assessed in the framework of the peer review under Regulation (EC) No 1107/2009 and the data were sufficient to derive an acceptable daily intake (ADI) of 0.05 mg/kg (body weight) bw per day and an acute reference dose (ARfD) of 1.0 mg/kg bw.The metabolism of spirotetramat in primary crops was investigated in fruit, root, leafy and pulses/oilseeds crop groups following foliar applications. Based on these studies, the plant residue defi...

Hapten Design and Antibody Generation for Immunoanalysis of Spirotetramat and Spirotetramat-enol

“…10 For risk assessment studies, both the parent compound and the metabolites are taken into consideration, whereas a common definition of SP residues for enforcement or compliance with the maximum residue limits in plant commodities is the sum of SP and SP-enol, expressed as SP concentration, because both compounds mostly constitute the bulk of the residues. 11,12 …”

“…10 For risk assessment studies, both the parent compound and the metabolites are taken into consideration, whereas a common definition of SP residues for enforcement or compliance with the maximum residue limits in plant commodities is the sum of SP and SP-enol, expressed as SP concentration, because both compounds mostly constitute the bulk of the residues. 11,12 Antibody-based analytical techniques are nowadays employed as complementary strategies for small chemical contaminant and residue monitoring. The competitive enzyme-linked immunosorbent assay (cELISA) is probably the most extended immunochemical method because of its large sample throughput and its ability to provide quantitative results.…”

“…Analysis of SP is commonly carried out by high-performance liquid chromatography with photometric , or mass spectrometry detection, frequently after quick, easy, cheap, effective, rugged, and safe extraction of samples. , However, the determination of SP residues in environmental and food samples can be quite complex because of the diversity of SP metabolites or degradates that can be present in the sample . For risk assessment studies, both the parent compound and the metabolites are taken into consideration, whereas a common definition of SP residues for enforcement or compliance with the maximum residue limits in plant commodities is the sum of SP and SP-enol, expressed as SP concentration, because both compounds mostly constitute the bulk of the residues. , …”