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Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety of Coxidin® (monensin sodium)

The European Food Safety Authority received a request from the European Commission to issue an opinion on the safety for the consumers of Coxidin® (monensin sodium) when used as feed additive for chickens and turkeys for fattening, based on the new data provided by the applicant in the supplementary dossier. Data submitted by the applicant on Coxidin® were previously reviewed by the FEEDAP Panel in October 2005 and found to be insufficient for any conclusion to be reached on consumer safety. In response to this review the applicant has conducted further studies to address the inadequacies previously identified and the additional information is reviewed in the following opinion. Kinetics studies with labelled Mo-Na in chickens for fattening on the residue depletion of liver, kidney, muscle and skin/fat showed a rapid exponential decline for the liver (t1/2 = 0.9 day) and the much slower exponential decline for skin/fat (t1/2 = three days). The FEEDAP Panel considers skin/fat as the target tissue and Mo-Na as the marker residue. Marker residue concentrations in the recently submitted study are considerably lower, particularly in the proposed target tissue, than in a former study and published data with another source of Mo-Na, which is contrary to the known lipophilic nature of ionophores. To overcome this apparent anomaly in the data the FEEDAP Panel retained the data from the earlier residue study with Coxidin® 20%. The FEEDAP Panel recognizes that combining data from partly inadequate study with data from a previous study introduces a certain degree of uncertainty. Consumer exposure has been calculated with total residues including 2SD (95% confidence limit). It complies with the ADI (0.180 mg day-1) at a minimum of two-day withdrawal. However, the FEEDAP Panel based MRL calculations on three-day withdrawal because the ratio marker residue to total residue (RMTR) in skin/fat declined by 50% from day 2 to day 3 of withdrawal, whereas total residues kept very similar. A MRL of 0.05 mg kg-1 is proposed for the skin plus fat and consequently a three-day withdrawal period resulting in a daily exposure of 0.055 mg total residues from skin/fat. Because of the additional uncertainty introduced by the use of separate studies for total residues and Mo-Na residues, the FEEDAP Panel has adopted a conservative approach to the MRL calculations based on a three-day withdrawal period. As Mo-Na from Coxidin® cannot be detected (levels below the LOQ of 0.006 mg kg-1) at three-day withdrawal in the liver, kidney and muscle, no consistent ratios between Mo-Na levels and total residues can be established and the principles for setting MRLs cannot apply for these tissues. As no ratio between marker and total residues for these tissues could be established, the LOQ could be used as a substitute for an MRL. The detection of Mo-Na above LOQ (0.006 mg kg-1) would indicate that the withdrawal time was not respected.

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