Commission Implementing Regulation (EU) 2021/2095 of 29 November 2021 concerning the authorisation of L-lysine base, L-lysine monohydrochloride and L-lysine sulphate 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 and preparations 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 additive/kg of complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: amino acids, their salts and analogues. 3c320 - L-lysine base, liquid Additive composition: Preparation (aqueous solution) of L-lysine with a minimum of 50 % L-lysine. All species - - - 1. The lysine content shall be indicated on the labelling of the additive. 2. The additive can be also used via water for drinking. 3. Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine, 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 organisational measures to address the potential risks by inhalation, eye or dermal contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including eyes, skin and breathing protection. 20.12.2031 Characterisation of the active substance: L-lysine produced by fermentation with Corynebacterium glutamicum KCCM 80183 Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH CAS Number: 56-87-1 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 optical 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 optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F). For the quantification of lysine in water: — ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD), or — ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS). 3c322ii 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. The additive can be also used via water for drinking. 3. Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine, 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 organisational measures to address the potential risks by inhalation, eye or dermal contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including eyes, skin and breathing protection. 20.12.2031 Characterisation of the active substance: L-lysine monohydrochloride produced by fermentation with Corynebacterium glutamicum KCCM 80183 or Corynebacterium glutamicum CCTCC M 2015595 Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH 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 optical 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 optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F). For the quantification of lysine in water: — ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD), or — ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS). 3c325i - L-lysine sulphate Additive composition: Granulated preparation of L-lysine sulphate with a minimum L-lysine content of 52 %, a maximum content of 24 % sulphate and a maximum content of 4 % moisture. All species - - 10 000 1. The L-lysine content shall be indicated on the labelling of the additive. 2. The additive may be also used via water for drinking. 3. Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine, 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 organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum level by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. 20.12.2031 Characterisation of the active substance: L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CCTCCM 2015595 Chemical formula: C 12 H 28 N 4 O 4 •H 2 SO 4 /[NH 2 -(C H 2 ) 4 -CH(NH 2 )-COOH] 2 SO 4 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 optical 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 optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F). For the quantification of lysine in water: — ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD). 3c324i - L-lysine sulphate Additive composition: Granulated preparation of L-lysine sulphate with a minimum L-lysine content of 52 %, a maximum content of 24 % sulphate and a maximum content of 4 % moisture. All species - - 10 000 1. The L-lysine content shall be indicated on the labelling of the additive. 2. 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.’ 20.12.2031 Characterisation of the active substance: L-lysine sulphate produced by fermentation with Corynebacterium glutamicum KCCM 80227 Chemical formula: C 12 H 28 N 4 O 4 •H 2 SO 4 /[NH 2 -(C H 2 ) 4 -CH(NH 2 )-COOH] 2 SO 4 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 optical 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 optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F). For the quantification of lysine in water: — ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD). ( 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
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