Scientific Opinion on the modification of authorisation of the feed additive Cygro? 1% (maduramicin ammonium α) for turkeys for fattening regarding a new formulation (Cygro? 10G)

摘要

The currently authorised Cygro? 1% is a feed additive intended to be used for the control of Eimeria infection in chickens for fattening and in turkeys. It contains, as the active ingredient, the polyether ionophore maduramicin ammonium α. The applicant is now seeking authorisation for a new formulation, Cygro? 10G, to be used with turkeys. The new formulation contains the same concentration of active substance and will be used under the same conditions as specified for Cygro? 1%. Cygro? 10G, which differs only in the excipients used, was shown not to adversely influence the stability of maduramicin ammonium α and would be expected to behave as the existing formulation when incorporated into premixes and feeds. The exposure of the target animal to maduramicin ammonium α or its metabolites and the amount and pattern of tissue deposition would not be expected to differ from that which occurs with the existing authorised formulation. Consequently, the use of the new formulation would not be expected to introduce any additional concerns for the safety of turkeys, consumers of turkey products, those handling the product or the environment. Three floor pen studies using artificial infections supported by the results of a number of field trials demonstrated that the new formulation is effective in the control of Eimeria infections in chickens for fattening. The FEEDAP Panel considers that this provides adequate evidence for the bioequivalence of the Cygro? 10G with the authorised Cygro? 1%.