Preliminary evaluation of the safety and efficacy of paromomycin sulphate for turkeys for fattening and turkeys reared for breeding

SUMMARY Following a request from the European Commission (Article 15 of Regulation (EC) No 1831/2003), the European Food Safety Authority (EFSA) was asked to deliver a preliminary evaluation of the safety and efficacy of paromomycin sulphate when used as feed additive under the category coccidiostats/histomonostats. HistoBloc ® contains 8 % paromomycin sulphate, an aminoglycoside antibiotic, produced by fermentation of Streptomyces chrestomyceticus. It is applied to prevent histomoniasis in turkeys for fattening and turkeys reared for breeding at concentrations between 100 and 400 mg kg -1 complete feed. The safety for the target animal of paromomycin sulphate from histoBloc ® at the highest proposed dose (400 mg kg -1 diet) could not be established due to the absence of data. Paromomycin sulphate shows an antimicrobial effect on susceptible bacterial strains at levels considerably lower than those proposed for feed use. Even at the lowest proposed feed concentration (100 mg kg -1 diet), it selects for resistance and cross-resistances at high frequency against a variety of other aminoglycosides among intestinal bacteria. As aminoglycoside antibiotics are used in human and veterinary medicine, serious consequences