Scientific Opinion on the safety and efficacy of Coxiril<sup>®</sup>(diclazuril) for rabbits for fattening and breeding

,

doi:10.2903/j.efsa.2015.3968

Cited by 6 publications

(11 citation statements)

References 11 publications

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“…The FEEDAP Panel assessed the safety of Coxiril ® for the environment when fed to chickens for fattening (EFSA FEEDAP Panel, 2014a), turkeys for fattening (EFSA FEEDAP Panel, 2014b), guinea fowl (EFSA FEEDAP Panel, 2014c) and rabbits for fattening and rabbits for breeding (EFSA FEEDAP Panel, 2015).…”

Section: Safety For the Environmentmentioning

confidence: 99%

“…In its opinion on the use of diclazuril from Coxiril ® for rabbits. the FEEDAP Panel noted that values of K oc measured at pH not higher than 7.2 were available (EFSA FEEDAP Panel, 2015). The K oc lowest value used was 4,986.4 mL/g, obtained in five soil types (sand, loamy sand, sandy loam, loam and clay) at different pH values (5.1, 5.5, 6.8, 7.2 and 7.1); the geometric mean of five measurements was 8,822 mL/g.…”

Section: Adsorptionmentioning

confidence: 99%

Section: Degradationmentioning

confidence: 99%

“…The biodegradation of diclazuril was determined in a study performed according to OECD 307 (EFSA FEEDAP Panel, 2015). This study indicated that the biodegradation of diclazuril in soil shows marked pH dependence (EFSA FEEDAP Panel, 2015). At high pH, the anionic form of diclazuril is transformed with a DT 50 of 70 and 97 days (giving a mean value of 84 days).…”

Section: Degradationmentioning

confidence: 99%

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

Additives¹,

Rychen²,

Aquilina³

et al. 2018

EFS2

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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.

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Section: Safety For the Environmentmentioning

confidence: 99%

Section: Adsorptionmentioning

confidence: 99%

Section: Degradationmentioning

confidence: 99%

Section: Degradationmentioning

confidence: 99%

See 2 more Smart Citations

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

Additives¹,

Rychen²,

Aquilina³

et al. 2018

EFS2

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show abstract

“…The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted in 2014 four 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) and rabbits for fattening and rabbits for breeding (EFSA FEEDAP Panel, 2015). In 2018, the FEEDAP Panel adopted an opinion on the safety and efficacy of Coxiril ® for chickens reared for laying (EFSA FEEDAP Panel, 2018).…”

Section: Additional Informationmentioning

confidence: 99%

Safety and efficacy of Coxiril® (diclazuril) for pheasants

Additives¹,

Rychen²,

Aquilina³

et al. 2018

EFS2

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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 ® for pheasants. Coxiril ® , containing 0.5% diclazuril, is intended for the prevention of coccidiosis in pheasants at a dose range of 1.0-1.2 mg/kg of complete feed. Diclazuril from Coxiril ® is considered safe for pheasants at a level of 1.2 mg/kg complete feed. The conclusion was made by extrapolating the results of a tolerance study with turkeys for fattening. The FEEDAP Panel considered that the residues in pheasant tissues and eggs would be of the same magnitude as those measured in the physiologically similar major species chickens and turkeys for fattening. The use of diclazuril at a maximum concentration of 1.2 mg/kg complete fed for pheasants would be safe for the consumer, provided that the maximum residue limits (MRLs) established for poultry would not be exceeded. The conclusions on the safety of the additive for the target species and the consumer are made under the provision that Coxiril ® is not fed to laying birds. Coxiril ® is 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 pheasants does not pose a risk to the environment for neutral/alkaline soils (pH ≥ 7). A final conclusion on the risk resulting from the use of the additive in acid soil cannot be done due to the high uncertainties related to potential accumulation of diclazuril over time. The FEEDAP Panel concluded that diclazuril from Coxiril ® at a minimum dose of 1 mg/kg complete feed has the potential to control coccidiosis in pheasants.

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

Bampidis¹,

Azimonti²,

Bastos³

et al. 2023

EFS2

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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety for the environment of diclazuril (Coxiril ® ) as a coccidiostat feed additive for chickens reared for laying and pheasants. In its previous assessments, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not reach a final conclusion on the risk resulting from the use of diclazuril in acid soil from Coxiril ® . On the basis of the new data provided, the FEEDAP Panel updates the previous conclusions as follows: no risk is expected for the terrestrial compartment and for sediment when diclazuril is used in chickens reared for laying and to pheasants at the proposed condition of use (in both acidic and non-acidic soils). No concern for groundwater is expected for both acidic and non-acidic soils. Due to the lack of data, no conclusions can be drawn for the aquatic compartment. Diclazuril does not have the potential for bioaccumulation; therefore, a risk of secondary poisoning is unlikely.

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Scientific Opinion on the safety and efficacy of Coxiril^®(diclazuril) for rabbits for fattening and breeding

Abstract: Coxiril ® containing 0.5 % diclazuril is intended for the control of coccidiosis in rabbits for fattening at concentrations between 1.0 and 1.2 mg diclazuril/kg complete feed. The highest proposed concentration, 1.2 mg diclazuril from Coxiril ®

Cited by 6 publications

References 11 publications

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

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

Safety and efficacy of Coxiril® (diclazuril) for pheasants

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

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Scientific Opinion on the safety and efficacy of Coxiril®(diclazuril) for rabbits for fattening and breeding

Abstract: Coxiril ® containing 0.5 % diclazuril is intended for the control of coccidiosis in rabbits for fattening at concentrations between 1.0 and 1.2 mg diclazuril/kg complete feed. The highest proposed concentration, 1.2 mg diclazuril from Coxiril ®

Cited by 6 publications

References 11 publications

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

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

Safety and efficacy of Coxiril® (diclazuril) for pheasants

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

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Product

Resources

About

Scientific Opinion on the safety and efficacy of Coxiril^®(diclazuril) for rabbits for fattening and breeding