Scientific Opinion on the safety and efficacy of Avatec® 150G (lasalocid A sodium) for turkeys

Avatec® 150G is an anticoccidial feed additive containing 15 % lasalocid A sodium, a polyether ionophore produced by fermentation of Streptomyces lasaliensis. The identity of the additive and the characterisation of the active substance, including quality control parameters (heavy metals, various organic contaminants), were considered appropriate in a former assessment. Lasalocid A sodium from Avatec® 150G is effective in controlling coccidiosis in turkeys at a minimum dose of 75 mg lasalocid A sodium/kg feed and safe for turkeys for fattening at the maximum dose applied (125 mg/kg feed) up to 16 weeks of age; a margin of safety cannot be given. It does not influence carcass characteristics of turkeys. No bacterial resistance and/or cross resistance to lasalocid A sodium was observed in experimental conditions. Increased shedding of Salmonella Typhimurium in chickens for fattening was shown in two studies. Newly submitted data allow establishing the similarity of the metabolic pathways in chickens, turkeys and rats. Unchanged lasalocid A is the marker residue. Lasalocid A sodium is not genotoxic, carcinogenic or teratogenic. A toxicological ADI of 0.005 mg/kg bw (or 0.3 mg/60 kg person/day) has been derived applying a safety factor of 100, based on a NOAEL (0.5 mg/kg bw/day) observed in a two-year oral toxicity study in rats and a maternal toxicity study in rabbits. At the highest dose proposed, consumer exposure after a one-day withdrawal period complies with the ADI. A five-day withdrawal period is appropriate to ensure compliance with the MRLs already in force in the EU. Handling Avatec® 150G would unlikely pose a risk to the user/worker. No safety concern for the environment resulting from the use of Avatec® 150G in turkeys, at the maximum recommended feed concentration, could be identified.