Scientific Opinion on the modification of the terms of authorisation of Avi-Deccox® 60G (decoquinate) for chickens for fattening

The additive under assessment, Avi-Deccox® 60G, contains the same active substance (decoquinate) in the same concentration (6 %) as the already authorised Deccox®. The differences between the two formulations are their different diluents (calcium sulphate dihydrate in Avi-Deccox® 60G, wheat middlings in Deccox®) and their physical forms (granulated product for Avi-Deccox® 60G, powder for Deccox®). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the differences in carriers and physical form between Avi-Deccox® 60G and Deccox® will not affect the safety for the target species, consumer, user and environment with respect of Deccox®. No in vivo bioequivalence study for decoquinate in Avi-Deccox® 60G has been provided. Instead, in vitro studies simulating gastric juice and measuring the release of decoquinate were submitted. The release of decoquinate from the granulated product was slower than from the powdered form. However, considering the transit time of feed from the crop to the small intestine, the FEEDAP Panel concludes that the observed differences are of no biological relevance and that Avi-Deccox® 60G is equivalent to decoquinate contained in Deccox® in terms of the capacity of the additives to control coccidiosis in chickens. It is noted that the current assessment applies only to the time period for which the Deccox® is authorised.