- 11 november 2022 (Viimati ajakohastatud: 28 veebruar 2023)
- Teadusuuringute Ühiskeskus
In the current application an authorisation of a preparation of Quillaja saponaria and Yucca schidigera is sought under Article 4 under the category/functional group 4(a) "zootechnical additives"/"digestibility enhancers" according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for all avian species (excluding laying and breeding birds).
The product is intended to be marketed as preparation of Quillaja saponaria (85 % w/w) and Yucca schidigera (15 % w/w) with a guaranteed minimum saponins (active substance) content of 3.5 % (w/w). The preparation is meant to be incorporated directly into feedingstuffs in order to obtain a minimum content of 250 mg/kg in complete feedingstuffs.
For the determination of saponins in the feed additive the Applicant submitted a single-laboratory validated and further verified analytical method based on reversed-phase ultra-high performance liquid chromatography coupled with ultraviolet detection (UHPLC-UV). The following method performance characteristics were derived from the validation and verification studies (partially re-calculated by the EURL): a relative standard deviation for repeatability (RSDr) ranging from 1.3 to 6.5 %; a relative standard deviation for intermediate precision (RSDip) ranging from 2.3 to 6.3 %; and a recovery rate (RRec) ranging from 84 to 109 %. Based on the satisfactory performance characteristics presented, the EURL recommends for official control the single-laboratory validated and further verified analytical method based on reversed-phase ultra-high performance liquid chromatography coupled with ultraviolet detection (UHPLC-UV) for the determination of saponins in the feed additive.
In the frame of supplementary information to the original dossier, the Applicant submitted for the determination of saponins in the feed additive and in feedingstuffs two similar single-laboratory validated and further verified analytical methods based on reversed-phase high performance liquid chromatography coupled with a mass spectrometry detector (HPLC-MS). However, due to incomplete supporting studies provided, the EURL cannot recommend for official control the HPLC-MS methods for the quantification of saponins in the feed additive and feedingstuffs.
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, as last amended by Regulation (EU) 2015/1761) is not considered necessary.