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

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Article
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.
Acknowledgement

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.

Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2012-00557
Adopted
12 Décembre 2012
Published
11 Janvier 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
The full opinion will be published in accordance with article 8(6) of Regulation (EC) No 1831/2003 once the decision on confidentiality, in line with article 18(2) of the Regulation, will be received from the European Commission.
Article (49.39 KB)49.39 KB
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.
 

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Number of Pages
2