Safety and efficacy of Elancoban® G200 (monensin sodium) for chickens for fattening chickens reared for laying and turkeys

摘要

The feed additive Elancoban G200, containing the active substance monensin sodium, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening, chickens reared for laying and turkeys. The Panel cannot conclude on the safety of the additive for the target species, consumer, user and environment with regard to the safety of the production strain. The following conclusions apply to monensin sodium included in the additive. Based on the available data set, the Panel cannot conclude on the safety of Elancoban G200 for chickens for fattening. Monensin sodium is safe for turkeys for fattening with a margin of safety of 1.5. Monensin sodium is not genotoxic and not carcinogenic. The pharmacological no observed adverse effect level ( ) of 0.345 mg monensin sodium/kg body weight (bw) per day was identified in dog. The acceptable daily intake ( ) derived from this is 0.003 mg monensin sodium/kg bw applying an uncertainty factor of 100. Elancoban G200 is safe for the consumer. The existing maximum residue limits ( s) ensure consumer safety, provided that the withdrawal period of 1 day is respected. Elancoban G200 is very irritant for the eye, but it is not a skin irritant. Elancoban G200 should be regarded as a potential skin and respiratory sensitiser. Inhalation exposure is considered a risk to persons handling the additive. Elancoban G200 does not pose a risk for the terrestrial compartment, the aquatic compartment and the sediment. The bioaccumulation potential of monensin in the environment is low. Monensin sodium from Elancoban G200 has the potential to effectively control coccidiosis in chickens for fattening and chickens reared for laying. The Panel cannot conclude on the efficacy Elancoban G200 as a coccidiostat for turkeys for fattening.