Safety Assessment RP748 Coxam

An application was submitted to the Food Standards Agency in March 2021 from Huvepharma NV (“the applicant”) for the new authorisation of an additive (amprolium hydrochloride-Coxam®), under the category of ‘coccidiostats and histomonostats’. The additive is proposed to be used at doses of 500 mg/kg of complete feedingstuffs at 12% moisture, aiming to reduce parasitic infestation levels of Eimeria spp. in chickens for fattening and chickens reared for laying. To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. The Committee evaluated the evidence provided by the applicant in the form of a report by the CVMP2 . The original studies referenced in the report could not be accessed, therefore, the Committee was unable to conclude on the safety of the additive for consumers. The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.