Preparation of macleaya cordata extract and leaves

Executive Summary

In the current application authorisation is sought under Article 4 for a preparation of macleaya cordata extract and leaves under the category / functional group (4 d) "zootechnical additives"/"other zootechnical additives", according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, the feed additive preparation is sought to be used for all avian species (excluding laying and breeding birds).
The feed additive (Sangrovit® extra) is a preparation of macleaya cordata extract and leaves containing a minimum of 0.4 % (w/w) of sanguinarine, which according to the Applicant is the phytochemical marker of Sangrovit® extra. The feed additive is intended to be incorporated directly into feedingstuffs or through premixtures with a minimum Sangrovit® extra content of 45 mg / kg up to a recommended maximum content of 150 mg / kg feedingstuffs, which would lead to sanguinarine contents ranging from 0.225 to 0.750 mg / kg feedingstuffs.
For the determination of sanguinarine in Sangrovit® extra the Applicant submitted a single-laboratory validated and further verified method based on reversed phase high performance liquid chromatography (HPLC) coupled to fluorescence detection (FLD).
For the determination of sanguinarine in premixtures and feedingstuffs the Applicant submitted another single-laboratory validated and further verified method based on HPLC coupled to tandem mass spectrometer (MS/MS).
Based on the acceptable performance characteristics presented the EURL recommends for official control (i) the single-laboratory validated and further verified method based on reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FLD) for the determination of sanguinarine in Sangrovit® extra and (ii) the single-laboratory validated and further verified method based on reversed phase high performance liquid chromatography coupled to tandem mass spectrometer (HPLC-MS/MS) for the determination of sanguinarine in premixtures 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.