Opinion of the Scientific Panel on additives and products or substances used in animal feed (FEEDAP) on the reevaluation of coccidiostat Elancoban in accordance with article 9G of Council Directive 70/524/EEC

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doi:10.2903/j.efsa.2004.42

Cited by 7 publications

(1 citation statement)

References 51 publications

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“…The lowest no observed effect level (NOEL) was identified in the developmental study in rabbits and it was 0.3 mg monensin sodium/kg body weight (bw) per day for maternal toxicity. The FEEDAP Panel notes that a pharmacological no observed adverse effect level (NOAEL) of 0.345 mg monensin sodium/kg bw per day was identified in a dog for acute pharmacological effects on the cardiovascular system and was considered appropriate for the establishment of an acute health‐based guidance value (acute reference dose – ARfD) of 0.003 mg monensin sodium/kg bw in an EFSA opinion adopted in 2004 (EFSA, 2004a , 2004b ).…”

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of monensin sodium (Coxidin®) for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding (Huvepharma N.V.)

Bampidis,

Azimonti,

Bastos

et al. 2024

EFS2

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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of monensin sodium (Coxidin®) as a coccidiostat for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. The additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel concluded that Coxidin® remains safe for turkeys for fattening (up to 16 weeks) and extends this conclusion to turkeys reared for breeding (up to 16 weeks). The Panel was not in the position to confirm that the current maximum authorised level of 125 mg monensin sodium/kg complete feed remains safe for chickens for fattening and chickens reared for laying. The use of monensin sodium from Coxidin® at the corresponding maximum authorised/proposed use levels in the target species is safe for the consumer. The existing maximum residue levels (MRLs) for poultry tissues ensure consumer safety. No withdrawal time is necessary. Both formulations of Coxidin® pose a risk by inhalation. The formulation with wheat bran as a carrier was neither irritant to the skin nor a skin sensitiser but it was irritant to the eyes. In the absence of data, no conclusions could be made on the potential of the formulation containing calcium carbonate to be irritant to skin and eyes and to be a skin sensitiser. The use of monensin sodium from Coxidin® in complete feed for the target species poses no risk for the terrestrial compartments and for sediment. No risk for groundwater is expected. For chickens for fattening the risk for aquatic compartment cannot be excluded, but no risks are expected for the other animal categories. There is no risk of secondary poisoning. Coxidin® is efficacious in controlling coccidiosis at a level of 100 mg/kg complete feed for chickens for fattening and at 60 mg/kg complete feed for turkeys for fattening. These conclusions are extended to chickens reared for laying and turkeys reared for breeding. The Panel noted that there are signs of development of resistance of Eimeria spp. to monensin sodium.

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Section: Assessmentmentioning

confidence: 99%