Details
- Publication date
- 17 August 2016 (Last updated on: 17 November 2016)
Description
In the current application authorisation is sought for Coxam®, under article 4(1), for the category “coccidiostats and histomonostats”, according to the classification system of article 6 of Regulation (EC) No 1831/2003. Authorisation is sought for chickens for fattening and reared for laying. Coxam® consists of 250 g/kg of amprolium hydrochloride complemented by liquid paraffin as antidusting agent, and rice hulls as carrier. Coxam® is intended to be incorporated in feedingstuffs through premixtures at a content of amprolium hydrochloride of 125 mg/kg feedingstuffs.
For the quantification of amprolium in the feed additive (Coxam®), the Applicant submitted a single-laboratory validated and further verified method based on Reversed-Phase High Performance Liquid Chromatography coupled to Ultraviolet detection (RP-HPLC-UV). The following performance characteristics were reported: - a precision ranging from 0.8 to 1.0 %; and - a recovery rate (RRec) ranging from 99 to 100 %.
For the quantification of amprolium in the premixtures and feedingstuffs the Applicant submitted the ring trial validated Community method (Commission Regulation (EC) No 152/2009) based on Cation Exchange High Performance Liquid Chromatography coupled to Ultraviolet detection IE-HPLC-UV. The following performance characteristics were reported: - a relative standard deviation for repeatability (RSDr) ranging from 1.9 to 5.0 % and a relative standard deviation for reproducibility (RSDR) ranging from 3.0 to 6.5 %, - RRec ranging from 91 to 103 % and - a limit of quantification (LOQ) of 5 mg/kg feedingstuffs. In addition, the Applicant provided experimental evidence demonstrating the applicability of the Community method for determining amprolium in premixtures and feedingstuffs samples containing Coxam®.
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) 2021/2047
For the quantification of amprolium in the feed additive:
Reversed-Phase High Performance Liquid Chromatography using Ultraviolet detection at 268 nm (RP-HPLC-UV)
For the quantification of amprolium in premixtures and feedingstuffs:
Cation exchange High Performance Liquid Chromatography using Ultraviolet detection at 264 nm (IE-HPLC-UV) – Regulation (EC) No 152/2009