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Scientific Opinion on the modification of the withdrawal period for Coxidin® (monensin sodium) for chickens for fattening and chickens reared for laying

EFSA Journal 2013;11(1):3045[2 pp.]. doi:10.2903/j.efsa.2013.3045
  EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel Members Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Gerhard Flachowsky, Josep Gasa-Gasó, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. Acknowledgment The Panel wishes to thank the members of the Working Group on Coccidiostats and Histomonostats, including Georges Bories and Jürgen Gropp, for the preparatory work on this scientific opinion. Contact FEEDAP@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2012-00557 Adopted: 12 December 2012 Published: 11 January 2013 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

No abstract available

Summary

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the modification of the withdrawal period for Coxidin® for chickens for fattening and chickens reared for laying.

Coxidin® contains monensin sodium as the active substance for prevention of coccidiosis in poultry. The applicant requested reduction of the authorised withdrawal period from one day to zero days. Such a modification would affect only consumer safety assessment.

The newly submitted study on marker residue in tissues of chickens for fattening at the maximum authorised monensin sodium concentration in feed from Coxidin® essentially did not add information to the already known residue status. It showed that maximum residue limits for liver, kidney and skin + fat are exceeded at zero-hour withdrawal.

Consumer exposure calculated with the newly submitted data at zero-, one- and three-hour withdrawal numerically exceeded the acceptable daily intake (0.267, 0.282 and 0.267, respectively, vs. 0.180 mg per person per day).

The monensin-related residues calculated from marker concentration in tissues could be reduced by 50 % when considering the total residues after 24 hours of withdrawal. Since the amount of toxicologically relevant residues at withdrawal times shorter than 24 hours is not known, no reduction could be applied to the values obtained after a zero-, one- and three-hour withdrawal.

The FEEDAP Panel does not support the reduction of the withdrawal period from one day to zero days for Coxidin® administered in feed for chickens for fattening and chickens reared for laying at the authorised concentration.