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Scientific Opinion on the modification of the authorisation of the feed additive Coxidin® (monensin sodium) for chickens and turkeys for fattening

Coxidin® is based on the active ingredient monensin sodium and is intended to be used to control coccidiosis in poultry. The additive is presently authorised for use in feedingstuffs for chickens and turkeys for fattening at maximum doses of 125 mg and 100 mg, respectively. The applicant is now seeking authorisation for an additional formulation containing the same amount of monensin sodium and intended to deliver the same dose. The only change in composition proposed is the replacement of the wheat bran carrier used in the current formulation with calcium carbonate. In the view of the FEEDAP Panel, there is no reason to suppose that the proposed change in carrier would, in itself, constitute a hazard or alter the exposure of target species directly and consumers indirectly to the active substance. Similarly, the proposed change in formulation is not expected to measurably alter the environmental risk associated with the presently authorised form of the additive. The additive is non-irritant to skin and is not a skin sensitiser, but the presently authorised formulation is labelled as an eye irritant. In the absence of data, it should be assumed that the change in formulation will not exclude the risk to the eye. The dustiness of the new formulation and the observations that 50 % of the dust fraction consisists of potentially respirable particles and that monensin sodium is present as 24 % of the dust indicates a significant risk for users. Protective measures should be taken to avoid inhalation exposure. The new formulation is as effective as the authorised form in the control of Eimeria infections in chickens for fattening. Given the nature of the change introduced and the evidence for comparable effects in chickens, the FEEDAP Panel considers that this conclusion can be extended to turkeys for fattening.



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