Commission Implementing Regulation (EU) 2024/777 of 5 March 2024 concerning the authorisation of L-lysine base, liquid, L-lysine monohydrochloride, liquid, and L-lysine monohydrochloride produced by Escherichia coli NITE BP-02917 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 ↗
The substances specified in the Annex, belonging to the category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’ and to the category ‘sensory additives’, functional group ‘flavouring compounds’, 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. 3c320i — L-Lysine base, liquid Additive composition Aqueous solution of L-lysine with a minimum content of 50 % L-lysine Liquid form Characterisation of the active substance L-lysine produced by Escherichia coli NITE BP-02917 Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH CAS number: 56-87-1 Analytical method ( 1 ) For the quantification of lysine in premixtures and compound feed: — ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 ( 2 ) (Annex III, F) 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 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) All species — — — 1. The lysine content shall be indicated on the labelling of the additive. 2. The additive may be used via water for drinking. 3. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment and the stability in water for drinking shall be indicated. 4. The label of the additive and premixture shall indicate the following: ‘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.’ 5. 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 skin and eye protective equipment. 26 March 2034 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. 3c321i — L-lysine monohydrochloride, liquid Additive composition Aqueous solution of L-lysine monohydrochloride with a minimum content of 22,4 % of L-Lysine and a maximum moisture content of 65 % Liquid form Characterisation of the active substance L-lysine monohydrochloride, produced by Escherichia coli NITE BP-02917 Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH-HCl CAS number: 657–27-2 Analytical method ( 3 ) 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 and compound feed: — ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), 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). All animal species — — — 1. The lysine content shall be indicated on the labelling of the additive. 2. The additive may be used via water for drinking. 3. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment and the stability in water for drinking shall be indicated. 4. The label of the additive and premixture shall indicate the following: ‘The supplementation with L-lysine monohydrochloride, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’ 26 March 2034 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. 3c322v — L-lysine monohydrochloride Additive composition Powder of L-lysine monohydrochloride with a minimum content of 78 % of L-Lysine and a maximum moisture content of 1,5 % Solid form Characterisation of the active substance L-lysine monohydrochloride, produced by Escherichia coli NITE BP-02917 Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH-HCl CAS number: 657–27-2 Analytical method ( 4 ) 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 and compound feed: — ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), 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) All animal species — — — 1. The lysine content shall be indicated on the labelling of the additive. 2. The additive may be used via water for drinking. 3. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment and the stability in water for drinking shall be indicated. 4. The label of the additive and premixture shall indicate the following: ‘The supplementation with L-lysine monohydrochloride, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’ 5. The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air ( 5 ) . 26 March 2034 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: sensory additives. Functional group: flavouring compounds 3c320i — L-Lysine base, liquid Additive composition Aqueous solution of L-lysine with a minimum content of 50 % L-lysine Liquid form Characterisation of the active substance L-lysine, produced by Escherichia coli NITE BP-02917 Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH CAS number: 56-87-1 Analytical method ( 6 ) For the quantification of lysine in premixtures: — ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Regulation (EC) No 152/2009 (Annex III, F) 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 All animal species — — — 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 3. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ 4. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the content referred to in point 3. 5. 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 skin and eye protective equipment. 26 March 2034 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: sensory additives. Functional group: flavouring compounds 3c321i — L-lysine monohydrochloride, liquid Additive composition Aqueous solution of L-lysine monohydrochloride with a minimum content of 22,4 % of L-Lysine and a maximum moisture content of 65 % Liquid form Characterisation of the active substance L-lysine monohydrochloride, produced by Escherichia coli NITE BP-02917 Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH-HCl CAS number: 657–27-2 Analytical method ( 7 ) 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: — ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Regulation (EC) No 152/2009 (Annex III, F) All animal species — — — 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 3. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ 4. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the content referred to in point 3. 26 March 2034 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: sensory additives. Functional group: flavouring compounds 3c322v — L-lysine monohydrochloride Additive composition Powder of L-lysine monohydrochloride with a minimum content of 78 % of L-Lysine and a maximum moisture content of 1,5 % Solid form Characterisation of the active substance L-lysine monohydrochloride, produced by Escherichia coli NITE BP-02917 Chemical formula: NH 2 -(CH 2 ) 4 -CH(NH 2 )-COOH-HCl CAS number: 657–27-2 Analytical method ( 8 ) 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: — ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Regulation (EC) No 152/2009 (Annex III, F) All animal species — — — 1. The additive shall be incorporated into the feed in the form of a premixture. 2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 3. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ 4. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the content referred to in point 3. 5. The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air ( 9 ) . 26 March 2034 ( 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 ( 4 ) 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 ( 5 ) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA ( EFSA Journal 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins). ( 6 ) 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 ( 7 ) 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 ( 8 ) 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 ( 9 ) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA ( EFSA Journal 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.