Decoquinate (Deccox) - 51756i, Decoquinate (Avi-Deccox 60G) - 51756i0ii

Deccox^® is a feed additive currently authorized in chickens for fattening by Commission Regulation (EC) No 1289/2004 belonging to the group "Coccidiostats and other medicinal substances" listed in Chapter I of Annex B of Directive 70/524/EEC. In the current application an authorisation of an existing product under article 10 (2) of the Regulation (EC) No 1831/2003 is requested. Deccox^® consists of 6 % decoquinate, 0.6 % colloidal silica, 
2.85 % soya-bean oil on a wheat middlings carrier. The Deccox^® active substance is decoquinate, a quinoline coccidiostat, with a minimum purity of 98 %. Deccox^® is a 
buff-coloured coarse powder formulation to be incorporated in feedingstuffs through premixtures. The Applicant suggested a concentration of decoquinate in feedingstuffs ranging from 20-40 mg/kg.

For the determination of decoquinate in the feed additive, premixtures and feedingstuffs, the Applicant submitted the ring-trial validated CEN standard method (EN 16162:2012) based on Reversed Phase High Performance Liquid Chromatography coupled to fluorescence detection (RP-HPLC-FL). The experimental evidence provided, allows the EURL to recommend for official control this CEN standard method for the determination of decoquinate in the feed additive, in premixtures and feedingstuffs.

For the determination of decoquinate residues in tissues, the Applicant submitted a single laboratory validated and further verified method, based on Reversed Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer in electrospray ionisation mode (RP-HPLC-MS/MS) using matrix matched standards. The following performance characteristics are reported: precision (repeatability and/or intermediate precision) ranging from 0.9 to 7.2 % and a recovery rate ranging from 95 to 110 %. Based on the performance characteristics presented, the EURL recommends for official control the RP-HPLC-MS/MS method proposed by the Applicant to enforce the decoquinate MRLs in the relevant tissues.  

Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005) is not considered necessary.

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2021/2094

For the determination of decoquinate in feed additive, premixtures and feedingstuffs:

Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) – EN 16162