Commission Implementing Regulation (EU) 2023/649 of 20 March 2023 concerning the authorisation of L-arginine produced by Corynebacterium glutamicum CGMCC 20516 as a feed additive for all animal species (Text with EEA relevance)
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 ↗
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
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 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 additive/kg of complete feed with a moisture content of 12 % 3c365 L-arginine Additive composition ≥ 98,5 % L-arginine (on a dry matter basis) and ≤ 1 % of water Solid form All species — — — 1. The additive may be used via water for drinking. 2. The directions for use of the additive and premixture shall indicate the storage conditions, the stability to heat treatment and the stability in water for drinking. 3. The label of the additive and premixture shall indicate the following: ‘The supplementation with L-arginine, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’ 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing, skin and eye protection. 11.4.2033 Characterisation of the active substance L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by Corynebacterium glutamicum CGMCC 20516 Chemical formula: C 6 H 14 N 4 O 2 CAS number: 74–79-3 Analytical method ( 1 ) For the identification of L-arginine in the feed additive: — Food Chemical Codex ‘L-arginine monograph’. For the determination of arginine in the feed additive and water: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS). For the determination of arginine in premixtures and complete feed: — Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F). ( 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.
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