Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the change of terms of the authorisation of “Avatec 15%” as a feed additive, regarding a new formulation (Avatec® 150G) in accordance with Regulation (EC) No 1831/2003

The currently authorised Avatec® 15 % is a feed additive intended for chickens for fattening, chickens reared for laying and turkeys for the control of Eimeria, a debilitating protozoal infection in poultry. It contains, as the active ingredient, the divalent polyether ionophore lasalocid sodium. The Applicant proposes a new formulation, Avatec®150G, in which the excipients (carrier, colourant and binder) are changed but the concentration of the active ingredient lasalocid sodium remains the same as that used in Avatec® 15 %. The European Food Safety Authority is requested to evaluate the new formulation and advise the Commission whether, as a consequence of this formulation change, any modification to the safety or the efficacy of the product would be expected when used under the conditions proposed by the Applicant. Evidence was provided that the new formulation does not adversely influence the stability of lasalocid sodium during storage or after inclusion in premixes or complete feeds. In addition, a dissolution test demonstrated that the release of the active substance from the new and existing formulations was essentially the same. Thus, the new formulation would be expected to behave as effectively as the existing formulation in the control of Eimeria. Validated analytical methods for monitoring lasalocid in premixtures, animal feed and tissues are available, as reviewed by the Community Reference Laboratory. As both the existing and new formulations contain equal concentrations of lasalocid sodium, the exposure of the target animal to lasalocid sodium or its metabolites and the amount and pattern of excretion and tissue deposition would not be expected to differ significantly from that which results from the use of the existing formulation. Consequently, the FEEDAP Panel concludes that the use of the new formulation would not be expected to introduce any additional risks or concerns for the safety of the target species, consumers of animal products, for those handling the product or for the wider environment.