Safety Assessment RP140-141-142-284 Monensin Sodium

Four applications were submitted to the Food Standards Agency between January 2021 and February 2021 from Huvepharma NV (“the applicant”) for the authorisation of an additive (Coxidin ®), under the category of ‘coccidiostats and histomonostats’, two using wheat bran as a carrier and two using calcium carbonate as a carrier. The additive is proposed to be used at doses of 100-125 mg/kg in chickens and 60-100 mg/kg in turkeys. To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. The AFFAJEG evaluated the identity and characterisation of the additive and concluded that the additive showed incompatibility with tiamulin, erythromycin, oleandomycin and furazolidone. The AFFAJEG concluded that the additive can be considered safe for the target species at the proposed dose of 100-125 mg/kg in chickens and 60-100 mg/kg in turkeys, although a margin of safety could not be established. There is evidence of safety for consumers at the 6-hour withdrawal mark prior to slaughter. There is no evidence of safety for consumers at the 3-hour withdrawal mark. The additive should be considered irritant to the eyes and highly toxic by inhalation. It was concluded that the additive poses an acceptable risk to the environment. Based on data presented in six efficacy trials, which showed reduction of lesions and higher weight gain for the treated groups, the AFFAJEG concluded that the product can be considered efficacious for reducing the impact of coccidia species in chickens and turkeys when used at the proposed doses. The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.