Scientific Opinion on the safety and efficacy of diclazuril (Clinacox® 0.5 %) as feed additive for chickens reared for laying

Coccidiostat, diclazuril, Clinacox® 0.5 %, chickens reared for laying, safety, MRL, efficacy
First published in the EFSA Journal
8 March 2013
Adopted
31 January 2013
Type
Scientific Opinion

Abstract

Clinacox® 0.5 % is a feed additive containing 0.5 % diclazuril and is used to control coccidiosis in poultry. The previous conclusion on the safety of diclazuril in chickens for fattening at the use level of 1 mg/kg complete feed is extended to chickens reared for laying. Chickens reared for laying are in a similar physiological stage as chickens for fattening. The use level proposed for diclazuril in feed is the same for both categories of birds. Consequently, the metabolic fate and residue status of this additive described for chickens for fattening can be extrapolated to chickens reared for laying. Feeding diclazuril at 1 mg/kg complete feed to chickens reared for laying for the first 16 weeks of life would result in negligibly low or absent residues of diclazuril in the first eggs for production. Therefore, maximum residue levels (MRLs) for eggs are not necessary. The previous assessment of consumer safety for the use of diclazuril in chickens for fattening is confirmed and extended to chickens reared for laying. The same MRLs for tissues as already established can be applied. Clinacox® has a low irritation potential for the eye and skin. Skin sensitisation was not observed. Considering the particle size (particle of respirable size) and dusting potential, exposure by inhalation cannot be excluded, although workers’ exposure has been calculated to be low in comparison with the ADI. In the absence of any data on respiratory toxicity, a hazard from inhalation of dust cannot be entirely excluded and appropriate protective measures should be taken. The use of Clinacox® at 1 mg/kg complete feed does not pose a risk to the terrestrial or aquatic environment. One mg diclazuril/kg complete feed is effective in controlling coccidiosis in chickens reared for laying.

Panel members at the time of adoption

Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Gerhard Flachowsky, Josep Gasa-Gasó, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf.
Panel on Additives and Products or Substances used in Animal Feed
Contact
FEEDAP [at] efsa.europa.eu
doi
10.2903/j.efsa.2013.3106
EFSA Journal 2013;11(3):3106
Question Number
On request from
European Commission