Safety and efficacy of Coxiril® (diclazuril) for chickens reared for laying

Abstract

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Coxiril® (diclazuril) for chickens reared for laying. Coxiril®, containing 0.5% diclazuril, is intended for the prevention of coccidiosis in chickens reared for laying at a dose range of 0.8–1.2 mg diclazuril/kg of complete feed up to a maximum age of 12 weeks. Derived from data already assessed for chickens and turkeys for fattening, diclazuril from Coxiril® is safe for chickens reared for laying up to 1.2 mg/kg complete feed when applied until 12 weeks of age. The FEEDAP Panel extended its previous assessment of consumer safety for the use of diclazuril from Coxiril® in chickens for fattening to chickens reared for laying. No measurable diclazuril residues were found in the first eggs laid from chickens reared for laying fed diclazuril from Coxiril® at 1.2 mg/kg complete feed until 12 weeks of age. Coxiril® was considered as a non‐irritant to eyes and skin. It is not a potential skin sensitiser. User inhalation exposure to Coxiril®, as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. The use of diclazuril from Coxiril® in chickens reared for laying at the highest proposed feed concentration would not pose a risk to the environment for neutral/alkaline soils (pH ≥ 7). A final conclusion on the risk resulting from the use of diclazuril in acid soil from Coxiril® cannot be done due to the high uncertainties related to potential accumulation of diclazuril over time. Derived from data already assessed for chickens for fattening, diclazuril from Coxiril® has the potential to control coccidiosis in chickens reared for laying at a minimum concentration of 0.8 mg/kg complete feed.

Safety for the environment of a feed additive consisting of diclazuril (Coxiril®) for chickens reared for laying and pheasants (Huvepharma NV)

“…The FEEDAP Panel concluded as follows with regard to the use of Coxiril® in chickens reared for laying (EFSA FEEDAP Panel, 2018a): ‘The use of diclazuril from Coxiril® in chickens reared for laying at the highest proposed feed concentration would not pose a risk to the environment for neutral/alkaline soils (pH ≥ 7). A final conclusion on the risk resulting from the use of diclazuril in acid soil from Coxiril® cannot be done due to the high uncertainties related to potential accumulation of diclazuril over time’.…”

“…The FEEDAP Panel reviewed and updated the previous assessment of the safety of diclazuril from Coxiril® for the environment in its opinions on the use of the additive in chickens reared for laying and pheasants (EFSA FEEDAP Panel, 2018a,b). These new opinions took into consideration new information submitted by the applicant and considered the use of the additive in chickens reared for laying and pheasants.…”

“…The apparent pKa value of 8.62 derived from this study was not considered reliable since the study was performed in a mixture of different organic solvents and not in water. The pKa value of 5.89 used in a previous FEEDAP evaluation (EFSA FEEDAP Panel, 2018a) is used in the present assessment.…”

“…The same studies evaluated in 2018 (EFSA FEEDAP Panel, 2018a) were made available for the current assessment 10 . The studies were re‐evaluated for the present assessment (Table 3).…”

“…The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted in 2014 six opinions on the safety and efficacy of Coxiril® when used as a feed additive in chickens for fattening (EFSA FEEDAP Panel, 2014a), turkeys for fattening (EFSA FEEDAP Panel, 2014b), guinea fowl (EFSA FEEDAP Panel, 2014c), rabbits for fattening and rabbits for breeding (EFSA FEEDAP Panel, 2015), chickens reared for laying (EFSA FEEDAP Panel, 2018a) and pheasants (EFSA FEEDAP Panel, 2018b).…”