Commission Implementing Regulation (EU) 2025/2566 of 18 December 2025 concerning the authorisation of L-lysine sulphate and L-lysine monohydrochloride produced with Corynebacterium glutamicum CGMCC 7.453 as feed additives for all animal species
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 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.
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 feed additive Name of the 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: nutritional additives. Functional group: amino acids, their salts and analogues 3c330 L-lysine sulphate Additive composition L-lysine sulphate with a minimum L-lysine content of 55 % and a maximum content of 21 % sulphate Solid form —————————— Characterisation of the active substance L-lysine sulphate produced with Corynebacterium glutamicum CGMCC 7.453 Chemical formula: C 12 H 28 N 4 O 4 -O 4 S CAS number: 60343-69-3 —————————— Analytical methods ( 1 ) For the identification of sulphate in the feed additive (L-lysine sulphate): — European Pharmacopoeia monograph 20301 For the determination of lysine in the feed additive: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD), EN ISO 17180 For the determination of lysine in premixtures: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD), EN ISO 17180 or — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) 152/2009 ( 2 ) For the determination of lysine in compound feed: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Regulation (EC) 152/2009 For the determination of lysine in water for drinking: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) All species - - 10 000 1. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated. 2. The additive may be used in water for drinking. 3. Feed business operators shall ensure that L-lysine sulphate is rumen protected, when fed to ruminants. 4. The moisture content shall be indicated on the labelling of the additive. 5. The label of the additive and premixtures shall indicate the following: ‘The supplementation with L-lysine sulphate, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid nutritional imbalances.’ 6. 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 skin, eyes and breathing protection. 8 January 2036 Identification number of the feed 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 additive/kg of complete feed with a moisture content of 12 % Category: nutritional additives. Functional group: amino acids, their salts and analogues 3c331 L-lysine monohydrochloride Additive composition L-lysine monohydrochloride with a minimum content of 78 % of L-Lysine on a dry matter basis Solid form —————————— Characterisation of the active substance L-lysine monohydrochloride produced with Corynebacterium glutamicum CGMCC 7.453 Chemical formula: C 6 H 14 N 2 O 2 CAS number: 657-27-2 —————————— Analytical methods ( 3 ) For the identification of L-lysine monohydrochloride in the feed additive: — Food Chemical Codex ‘L-lysine monohydrochloride monograph’ For the determination of lysine in the feed additive: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD), EN ISO 17180 For the determination of lysine in premixtures: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD), EN ISO 17180 or — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 For the determination of lysine in compound feed: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 For the determination of lysine in water for drinking: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) All species - - - 1. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated. 2. The additive may be used via water for drinking. 3. Feed business operators shall ensure that L-lysine monohydrochloride is rumen protected, when fed to ruminants. 4. The moisture content shall be indicated on the label of the additive. 5. The label of the additive and premixtures shall indicate the following: ‘The supplementation with L-lysine monohydrochloride, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid nutritional imbalances.’ 6. 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 skin, eyes and breathing protection. 8 January 2036 ( 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 ( 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 , ELI: http://data.europa.eu/eli/reg/2009/152/oj ). ( 3 ) 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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