Commission Implementing Regulation (EU) 2020/1798 of 30 November 2020 concerning the authorisation of L-lysine monohydrochloride produced by Corynebacterium glutamicum DSM 32932 and L-lysine sulphate produced by Corynebacterium glutamicum KFCC 11043 as feed additives 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 substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, are authorised as additives 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 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/kg of complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: amino acids, their salts and analogues 3c322i L-lysine monohydrochloride, technically pure Additive composition Powder of L-lysine monohydrochloride with a minimum of 78 % L-lysine and a maximum moisture content of 1,5 %. All species - - - 1. The lysine content shall be indicated on the labelling of the additive. 2. L-lysine monohydrochloride, technically pure, may be placed on the market and used as an additive consisting of a preparation. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks for the eyes. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment. 4. Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine should take into account all essential and conditional essential amino acids in order to avoid imbalances.’ 21.12.2030 Characterisation of the active substance L-lysine monohydrochloride produced by fermentation with Corynebacterium glutamicum DSM 32932. Chemical formula: C 6 H 15 ClN 2 O 2 CAS Number: 657-27-2 Analytical methods ( 1 ) For the identification of L-lysine monohydrochloride in the feed additive: — Food Chemical Codex ‘L-lysine monohydrochloride monograph’ For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine: — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS/FLD) – EN ISO 17180. For the quantification of lysine in premixtures, compound feed and feed materials: — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 ( 2 ) (Annex III, F). 3c323 L-lysine sulphate Additive composition Granulate with a minimum L-lysine content of 55 % and a maximum content of 22 % sulphate and 4 % moisture All species - - 10 000 1. The L-lysine content shall be indicated on the labelling of the additive. 2. L-lysine sulphate may be placed on the market and used as an additive consisting of a preparation. 3. Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine should take into account all essential and conditional essential amino acids in order to avoid imbalances.’ 21.12.2030 Characterisation of the active substance L-lysine sulphate produced by fermentation with Corynebacterium glutamicum KFCC 11043 Chemical formula: C 12 H 30 N 4 O 8 S CAS number: 60343-69-3 Analytical methods ( 1 ) For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine: — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS/FLD) – EN ISO 17180 For the identification of sulphate in the feed additive: — European Pharmacopoeia Monograph 20301 For the quantification of lysine in premixtures, compound feed and feed materials: — ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), 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://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports ( 2 ) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( OJ L 54, 26.2.2009, p. 1 ).
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