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Abstract: Estudo comparativo entre ressonância magnética e ultra-sonografia com power-Doppler no estadiamento local do câncer prostático: correlação com resultados anatomopatológicos.
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<p>In accordance with Article 6 of Regulation (EC) No 396/2005, Spain received an application from the Spanish Federation of Associations of Producers and Exporters of Fruits, Vegetables, Flowers and Live Plants (FEPEX) to modify the existing MRLs for the active substance indoxacarb in raspberries and strawberries. In accordance with Article 6 of Regulation (EC) No 396/2005, The Netherlands received an application from DuPont Danmark to modify the existing MRLs for the active substance indoxacarb in several crops. Spain and The Netherlands drafted the 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 for the crops under consideration, except for strawberries, raspberries and witloof. The submitted residue data indicate no need to modify the existing EU MRLs for scarole and soya beans. Adequate analytical enforcement methods are available to control the residues of indoxacarb and its R-isomer on the commodities for which a MRL is proposed at the validated LOQ of 0.02 mg/kg. Based on the risk assessment results, EFSA concludes thatthe proposed uses of indoxacarb on Chinese cabbage, lamb’s lettuce, scarole, beans with pods, cardoons, fennel, rhubarb and soya beans will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.</p>
<p>In accordance with Article 6 of Regulation (EC) No 396/2005, Spain received an application from the Spanish Federation of Associations of Producers and Exporters of Fruits, Vegetables, Flowers and Live Plants (FEPEX) to modify the existing MRLs for the active substance indoxacarb in raspberries and strawberries. In accordance with Article 6 of Regulation (EC) No 396/2005, The Netherlands received an application from DuPont Danmark to modify the existing MRLs for the active substance indoxacarb in several crops. Spain and The Netherlands drafted the 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 for the crops under consideration, except for strawberries, raspberries and witloof. The submitted residue data indicate no need to modify the existing EU MRLs for scarole and soya beans. Adequate analytical enforcement methods are available to control the residues of indoxacarb and its R-isomer on the commodities for which a MRL is proposed at the validated LOQ of 0.02 mg/kg. Based on the risk assessment results, EFSA concludes thatthe proposed uses of indoxacarb on Chinese cabbage, lamb’s lettuce, scarole, beans with pods, cardoons, fennel, rhubarb and soya beans will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.</p>
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...
In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State, Italy, received an application from Syngenta to modify the existing maximum residue level (MRL) for the active substance penconazole in grapes. The data submitted in support of the request are sufficient to derive a MRL proposal of 0.4 mg/kg for the intended use on grapes. Adequate analytical enforcement methods are available to control the residues of penconazole in grapes. Based on the risk assessment results, EFSA concludes that the intended use of penconazole on grapes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. However, these results should be considered provisional due to the fact that the risk assessment for triazole derivate metabolites is still pending. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) (and its addendum) prepared under Council Directive 91/414/EEC, the Commission review report on penconazole, the conclusion on the peer review of the pesticide risk assessment of the active substance penconazole as well as the previous EFSA reasoned opinion on penconazole in raspberries and blackberries.The toxicological profile of penconazole was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.03 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.5 mg/kg bw.The metabolism of penconazole in primary crops was investigated in the fruit crop group (apples and tomatoes) following foliar applications. From these studies, the peer review established the residue definition for enforcement as penconazole and as sum of penconazole and its metabolites (CGA 132465, CGA 190503, CGA 127841) and the conjugates of the metabolites, expressed as penconazole for risk assessment purposes. For the uses on grapes, EFSA concludes that the metabolism of penconazole in primary crops has been addressed for the uses on grapes and the residue definitions derived are applicable. From the metabolism studies, a risk assessment conversion factor (CF) of 6 has been derived to consider the metabolites of penconazole relevant according to the reside definition for risk assessment.Adequate analytical enforcement methods are available to monitor the residues of penconazole in grapes at the validated limit of quantification (LOQ) of 0.01 mg/kg. EFSA concludes that the submitted residue trials are sufficient to derive a MRL proposal of 0.4 mg/kg on wine grapes, which can be extrapolated to table grapes.Studies investigating the natur...
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