EFSA Approves Avatec for Turkeys

EU - The European Food Safety Authority has published its opinion on the feed additive, Avatec 150G (lasalocid sodium), indicating that the product is both safe and effective against coccidiosis in turkeys.

30 April 2010

3 minute read

Following a request from European Commission, the European Food Safety Authority was asked to deliver an opinion on the safety and efficacy of Avatec®150G (containing 15 per cent lasalocid A sodium as active substance), a coccidiostat for turkeys for fattening to be used up to an age of 16 weeks, at a dose range of 75 to 125 mg lasalocid sodium per kilogram of complete feed.

Lasalocid A sodium from Avatec 150G was considered safe for turkeys for fattening at the maximum dose applied (125 mg/kg complete feed) up to 16 weeks of age. A margin of safety could not be determined.

Lasalocid sodium may be dangerous for equine species and its simultaneous use with certain medicinal substances could be contra-indicated in turkeys, as it is in chickens for fattening.

The additional data provided on the metabolic fate of lasalocid sodium in chickens and rats gave sufficient evidence to the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to conclude on the similarity of metabolic pathways in chickens, turkeys and rats. Unchanged lasalocid A is the marker residue.

In the absence of new data, the FEEDAP Panel reiterated its former conclusions that lasalocid A sodium is not genotoxic, carcinogenic or teratogenic. A lowest NOAEL of 0.5 mg/kg bw/day was established from the two-year chronic oral toxicity study in rats and maternal toxicity study in rabbits. A toxicological ADI of 0.005 mg/kg/person/day (or 0.3 mg/60 kg person/day) was derived applying a safety factor of 100.

Consumer exposure after a one-day withdrawal period complied with the ADI. Considering the slower decline of residues in kidney and skin/fat compared to liver and the inherent variation of data, the FEEDAP Panel concluded that a five-day withdrawal period is appropriate to ensure compliance with the MRLs already in force in the EU.

In the absence of new data, the FEEDAP Panel reiterated its former conclusions that it is unlikely that lasalocid A sodium from Avatec 150G would pose a risk to the user/worker handling the additive.

The FEEDAP Panel could not identify a safety concern for the environment resulting from the use of Avatec 150G in turkeys, at the maximum recommended feed concentration.

The FEEDAP Panel considered that Avatec®150G is effective in controlling coccidiosis in turkeys at a minimum dose of 75 mg lasalocid A sodium/kg complete feed.

The FEEDAP Panel made some recommendations concerning the antimicrobial and Eimeria resistance monitoring.