Scientific Opinion on the modification of authorisation of the feed additive Monteban® G100 (narasin) for chickens for fattening

Following a request from the European Commission, the European Food Safety Authority (EFSA) was requested to deliver an opinion on the proposal made by the applicant for the modification of the withdrawal time for the existing additive Monteban® G100 from one to zero day. Monteban® G100 containing narasin is already authorised for use in chickens for fattening. The safety and efficacy of the product have already been assessed by the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) in a former opinion, establishing the ADI (0.005 mg narasin/kg bw) and a uniform MRL (0.05 mg narasin/kg for all (wet) tissues). Any eventual consequences of reducing the withdrawal time of Monteban® G100 from one to zero day would only concern consumer safety. Therefore, the former assessment of Monteban® G100 remains unchanged for the characterisation of the additive, its safety for the target animals, the user and the environment. A new marker residue study where the maximum content of narasin (70 mg/kg feed) has been administered was provided. The ratio of marker residue to total residue was calculated on that basis for a 0.25-day withdrawal. The FEEDAP Panel concluded that the request of the applicant to reduce the withdrawal time from one day to zero day for Monteban® G100 when fed to chickens for fattening at the maximum dose of 70 mg/kg feed could be accepted, considering that an experimental 0.25-day withdrawal reflects a zero-day withdrawal under field conditions.