Safety and efficacy of COXAM (®) (amprolium hydrochloride) for chickens for fattening and chickens reared for laying

The coccidiostat amprolium hydrochloride from COXAM (®) is considered safe for chickens for fattening at 125 mg/kg complete feed. The margin of safety is at least 5. This conclusion is extended to chickens reared for laying. Amprolium hydrochloride does not possess any significant antibacterial activity. The applicant provided no information on the absorption, distribution, metabolism and excretion (ADME) and on the toxicology of the additive or active substance. Reference was made to the Committee for Medicinal Products for Veterinary Use (CVMP) summary reports from 1999 and 2001 citing studies used for the establishment of maximum residue limits (MRLs) for amprolium. However, the original data used in these assessments were not provided and the literature review covering the subsequent period was not made. Thus, the FEEDAP Panel cannot independently evaluate all data relevant to the current application and is therefore unable to conclude on the safety for the consumer of amprolium when used as a feed additive in chickens for fattening and chickens reared for laying. COXAM (®) is considered to be a skin and respiratory sensitiser. Inhalation exposure to dust from COXAM (®) may present a risk for the user. The use of amprolium hydrochloride from COXAM (®) in feed for chickens for fattening up to 125 mg/kg complete feed does not pose a risk for the environment. This conclusion can be extended to chickens reared for laying because of the lower predicted concentration in soil. COXAM (®) was effective as a coccidiostat in three floor pen studies and in two anticoccidial sensitivity tests. Since three anticoccidial sensitivity tests showing positive effects of the treatment are required, the FEEDAP Panel is not in the position to conclude on the efficacy of COXAM (®) for chickens for fattening under EU farming conditions. Consequently, a conclusion on the efficacy for chickens reared for laying is also not possible.