Preparation of macleaya cordata extract and leaves

In the current application an 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 is sought to be used for used for sucking and weaned piglets and other growing suidae.
The feed additive (Sangrovit® extra) is a preparation of macleaya cordata extract and leaves containing a minimum sanguinarine content of 4000 mg / kg which according to the Applicant is the active substance of Sangrovit® extra. The feed additive is intended to be incorporated directly into compound feed or through premixtures to supply sanguinarine contents ranging from 0.6 to 0.75 mg / kg compound feed.
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 compound feed the Applicant submitted another single-laboratory validated and further verified method based on HPLC coupled to tandem mass spectrometry (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 spectrometry (HPLC-MS/MS) for the determination of sanguinarine in premixtures and compound feed.
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.