Updated Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed

SUMMARY Following a request from the European Commission the Panel on Additives and Products or Substances used in Animal Feed was asked to issue a scientific opinion on the safety of Kokcisan 120G for chickens for fattening, based on the new data provided by the applicant in the supplementary dossier. The chronic toxicity and carcinogenicity study in rats demonstrates that salinomycin sodium (SAL-Na) from Kokcisan is not carcinogenic and a LOEL of 1.5 mg SAL-Na kg -1 bw day 1 could be derived based on marginal, mostly pharmacological effects in haematology and blood biochemistry. This LOEL is three times higher than the lowest NOEL derived from previously submitted short-term studies (0.5 mg SAL-Na kg -1 bw day -1 ). By applying an uncertainty factor of 100, this NOEL can be taken to deduce an ADI of 0.005 mg SAL-Na from Kokcisan kg -1 bw day -1 (0.3 mg per 60 kg person and day).