Commission Implementing Regulation (EU) 2023/2732 of 7 December 2023 concerning the authorisation of a preparation of Macleaya cordata mixture as a feed additive for all poultry species for fattening (holder of authorisation: Phytobiotics Futterzusatzstoffe GmbH)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of the additive/kg of complete feedingstuff with a moisture content of 12 % Category of zootechnical additives. Functional groups: other zootechnical additives (improvement of performance parameters) 4d26 Phytobiotics Futterzusatzstoffe GmbH Macleaya cordata mixture Additive composition: Preparation of: — Macleaya cordata (Willd.) R. Br. extract: 0,5-1,2 % — Macleaya cordata (Willd.) R. Br. processed leaves: 30-64 %. With the following concentrations: — sanguinarine: ≥ 0,4 % and ≤ 0,7 % — chelerythrine: ≥ 0,23 % and ≤ 0,34 % — sum of sanguinarine, chelerythrine, protopine and allocryptopine: ≤ 1,4 %. Solid form. Characterisation of the active substance: Macleaya cordata (Willd.) R. Br. extract and Macleaya cordata (Willd.) R. Br. processed leaves including: — Sanguinarine (CAS No 2447-54-3) — Chelerythrine (CAS No 34316-15-9) — Protopine (CAS No 130-86-9) — Allocryptopine (CAS No 485-91-6) Analytical method ( 1 ) Determination of sanguinarine (phytochemical marker) in the feed additive: reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FLD). Determination of sanguinarine (phytochemical marker) in premixtures and compound feed: reversed phase high performance liquid chromatography coupled to mass spectrometry detection (HPLC-MS/MS). All poultry species for fattening — 45 150 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. Mixture with other additives is permitted provided that the amounts of sanguinarine and chelerythrine added to feedingstuffs by such mixtures is lower than the one resulting from the use of a single additive at the maximum or recommended level for the species or category of animals. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and eye protective equipment. 28 December 2033 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.