ELI: http://data.europa.eu/eli/reg_impl/2024/777/oj 1/14COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/777 
of 5 March 2024
concer ning the author isation of L-lysine base, liquid, L-lysine monoh ydrochlor ide, liquid, and 
L-lysine monoh ydrochlor ide produced by Escherichia coli NITE BP-02917 as feed additiv es for all 
animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such an author isation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of concentrat ed liquid L-lysine, concentrat ed liquid L-lysine monoh ydrochlori de and L-lysine monohydroc hlor ide 
produced by Escher ichia coli NITE BP-02917. That application was accompanied by the particulars and documents 
required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concer ns the author isation of concentrat ed liquid L-lysine, concentrated liquid L-lysine 
monoh ydrochlor ide and L-lysine monoh ydrochlori de, produced by Escher ichia coli NITE BP-02917 as feed additives 
for all animal species, requesting those additives to be classified in the catego ry ‘nutr itional additives’, functional 
group ‘amino acids, their salts and analogues’ and in the catego ry ‘sensor y additives ’, functional group ‘flavouri ng 
compo unds ’.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinions of 27 Sept ember 2022 (2)and of 
11 May 2023 (3)that, under the proposed conditions of use, concentrat ed liquid L-lysine, concentrat ed liquid 
L-lys ine monoh ydrochlori de and L-lysine monoh ydrochlori de, produced by Escher ichia coli NITE BP-02917 are safe 
for the target species, consumers and the environment when used both as amino acids and as flavouring 
compo unds. The Author ity expressed concer ns on the simultaneous oral administration of these additives as amino 
acids in feed and in wate r for drinking. It also concluded that concentrat ed liquid L-lysine, concentrat ed liquid 
L-lys ine monohydroc hlor ide and L-lys ine monohydroc hlor ide are not considered to have the potential to cause 
respirato ry toxicity , or skin sensitisation. Concentrat ed liquid L-lysine monoh ydrochlori de and L-lysine 
monoh ydrochlor ide are not considered skin and eye irritants while concentrat ed liquid L-lysine, due to its high pH 
may be corrosive for skin and eyes. The Author ity further concluded that concentrated liquid L-lys ine, concentrated 
liquid L-lys ine monoh ydrochlor ide and L-lysine monoh ydrochlori de produced by Escher ichia coli NITE BP-02917 are 
an efficacious source of the essential amino acid L-lysine for non-r uminant animal species. For the supplemental 
L-lys ine to be as efficacious in ruminants as in non-r uminant species, it would require prote ction against 
degradation in the rumen. The three forms of the additive were also considered efficacious as feed flavouri ng 
compo unds under the proposed conditions of use. The Author ity did not consider that there is a need for specific 
requirements of post-market monitori ng. It also verified the repor t on the method of analysis of the feed additives 
in feed submitte d by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(1)OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj
(2)EFSA Journal 2022;20(10):7612.
(3)EFSA Journal 2023;21(6):8048.
Offi cial Jour nal  
of the European Union EN 
L series    
2024/777  6.3.2024ELI: http://data.europa.eu/eli/reg_im pl/2024/777/oj 2/14(5) The names ‘concentrate d liquid L-lysine ’ and ‘concentrated liquid L-lys ine monoh ydrochlor ide’ should be changed to 
‘L-lysine base, liquid’ and ‘L-lysine monoh ydrochlori de, liquid’ as the minimum conte nt of L-lysine of those additives 
is only 50 % and 22,4 % respectively .
(6) In view of the above, the Commission considers that L-lys ine base, liquid, L-lysine monoh ydrochlori de, liquid, and 
L-lys ine monoh ydrochlori de, produced by Escher ichia coli NITE BP-02917 satisfy the conditions provi ded for in 
Article 5 of Regulation (EC) No 1831/2003. According ly, the use of those additives should be author ised. The 
Commission considers that appropr iate protective measures should be taken to prevent adverse effects on the 
health of the users of L-lys ine base, liquid.
(7) The Commission considers that, when the additives are used as amino acids, and in particular in the case of 
supplementation via water for drinking, it is appropr iate to alert the user to take into account the dietar y supply 
with all the essential and conditionally essential amino acids.
(8) The Commission considers that the physical character istics of the powder of L-lysine monohydroc hlor ide in relation 
to the particle size distr ibution and the dusting pote ntial entails a risk of endoto xin exposure for users, theref ore, a 
limitation on the maximum endoto xin exposure should be set up.
(9) The Commission considers that for the use of L-lysine base, liquid, L-lys ine monoh ydrochlori de, liquid, and L-lysine 
monoh ydrochlor ide, produced by Escher ichia coli NITE BP-02917 as flavouri ng compounds, safety reasons do not 
require the setting of maximum conte nts. In order to allow better control, the recommended maximum content 
should be indicated on the label of the feed additives. Where such contents are exceed ed, certain information should 
be indicated on the label of the premixtures concer ned.
(10) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
The substances specifi ed in the Annex, belonging to the categor y ‘nutr itional additives ’, functional group ‘amino acids, their 
salts and analogues’ and to the categor y ‘sensor y additives ’, functional group ‘flavouring compo unds ’, are author ised as 
additives in animal nutr ition, subject to the conditions laid down in that Annex.
Article 2
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 March 2024 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/777/oj 3/14ANNEX 
Identific ation 
number of 
the additiveName of the 
holder of 
author isationAdditiveComposition, chemical formula, descr iption, analytical 
method.Species or 
categor y 
of animalMaxi -
mum 
ageMinimum 
contentMaximum 
conten t
Other provisionsEnd of period of 
author isation mg/kg of complet e feed 
with a moisture 
content of 12 %
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues.
3c320i — L-Lysine 
base, liquidAdditive composition
Aqueous solution of L-lys ine with a minimum 
cont ent of 50 % L-lys ine
Liquid form
Char acter isation of the activ e substance
L-lysine produced by Escher ichia 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 quantif ication of lysine in premixtures and 
compo und feed:
— ion-ex change chromat ography 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-ex change chromat ography coupled with 
post-column derivatisation and optical detec ­
tion (IEC- VIS/FLD) – EN ISO 17180All 
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 premix ­
tures, the storage condi ­
tions and stability to heat 
treatment and the stability 
in wate r for drinking shall 
be indicated.
4. The label of the additive and 
premixture shall indicate 
the follo wing:
‘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.’26 Marc h 
2034OJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_im pl/2024/777/oj 4/14
For the quantifi cation of lysine in water:
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detec ­
tion (IEC- VIS/FLD); or
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detection 
(IEC- VIS)5. For users of the additive and 
premixtures, feed business 
operat ors shall establish op­
erational procedures and 
organisational measures to 
address poten tial risks re­
sulting from their use. 
Where those risks cannot 
be eliminated by such pro­
cedures and measures, the 
additive and premixtures 
shall be used with personal 
skin and eye protect ive 
equipment.
(1)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_en
(2)Commission Regulation (EC) No 152/2009 of 27 Januar y 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 ).OJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/777/oj 5/14Identific ation 
number of 
the additiveName of the 
holder of 
author isationAdditiveComposition, chemical formula, descr iption, analytical 
method.Species or 
categor y 
of animalMaxi -
mum 
ageMinimum 
contentMaximum 
conten t
Other provisionsEnd of period of 
author isation mg/kg of complet e feed 
with a moisture 
content of 12 %
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues.
3c321i — L-lysine 
monoh y-
droch loride, 
liquidAdditive composition
Aqueous solution of L-lysine monoh ydrochlor ide 
with a minimum conte nt of 22,4 % of L-Lysine and 
a maximum moisture cont ent of 65 %
Liquid form
Char acter isation of the activ e substance
L-lysine monoh ydrochlor ide, produced by Escher ichia 
coli NITE BP-02917
Chemical formula: NH 2-(CH2)4-CH (NH 2)-COOH - 
HCl
CAS number : 657–27-2
Analytical method (1)
For the identif ication of L-lysine monohydroc hlor ide 
in the feed additive:
—Food Chemical Codex ‘L-lysine monohy ­
droc hlor ide monograph’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 premix ­
tures, the storage condi ­
tions and stability to heat 
treatment and the stability 
in wate r for drinking shall 
be indicated.
4. The label of the additive and 
premixture shall indicate 
the follo wing:26 Marc h 
2034OJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_im pl/2024/777/oj 6/14
For the quantification of lysine in the feed additive 
and premixtures (containing more than 10 % lysine):
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detec ­
tion (IEC- VIS/FLD) – EN ISO 17180
For the quantif ication of lysine in premixtures and 
compo und feed:
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detection 
(IEC- VIS), Regulation (EC) No 152/2009 (Annex 
III, F)
For the quantifi cation of lysine in water:
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detec ­
tion (IEC- VIS/FLD); or
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detection 
(IEC- VIS).‘The supplementation with 
L-lysine 
monoh ydrochlor ide, in 
particular via water for 
drinking, should take into 
account all essential and 
conditional essential amino 
acids in order to avoid 
imbalances.’
(1)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enOJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/777/oj 7/14Identific ation 
number of 
the additiveName of the 
holder of 
author isationAdditiveComposition, chemical formula, descr iption, analytical 
method.Species or 
categor y 
of animalMaxi -
mum 
ageMinimum 
contentMaximum 
conten t
Other provisionsEnd of period of 
author isation mg/kg of complet e feed 
with a moisture 
content of 12 %
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues.
3c322v — L-lysine 
monoh y-
droch lorideAdditive composition
Powder of L-lysine monohydroc hlor ide with a 
minimum content of 78 % of L-Lysine and a 
maximum moisture conte nt of 1,5 %
Solid form
Char acter isation of the activ e substance
L-lysine monoh ydrochlor ide, produced by Escher ichia 
coli NITE BP-02917
Chemical formula: NH 2-(CH2)4-CH (NH 2)-COOH - 
HCl
CAS number : 657–27-2
Analytical method (1)
For the identif ication of L-lysine monohydroc hlor ide 
in the feed additive:
—Food Chemical Codex ‘L-lysine monohy ­
droc hlor ide monograph’
For the quantification of lysine in the feed additive 
and premixtures (containing more than 10 % lysine):
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detec ­
tion (IEC- VIS/FLD) – EN ISO 17180All 
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 premix ­
tures, the storage condi ­
tions and stability to heat 
treatment and the stability 
in wate r for drinking shall 
be indicated.
4. The label of the additive and 
premixture shall indicate 
the follo wing:
‘The supplementation with 
L-lysine 
monoh ydrochlor ide, in 
particular via water for 
drinking, should take into 
account all essential and 
conditional essential amino 
acids in order to avoid 
imbalances.’26 Marc h 
2034OJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_im pl/2024/777/oj 8/14
For the quantif ication of lysine in premixtures and 
compo und feed:
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detection 
(IEC- VIS), Regulation (EC) No 152/2009 (Annex 
III, F)
For the quantifi cation of lysine in water:
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detec ­
tion (IEC- VIS/FLD); or
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detection 
(IEC- VIS)5. The endoto xin conte nt of 
the additive and its dusting 
poten tial shall ensure a 
maximal endoto xin expo ­
sure of 1 600 IU endoto x
ins/m3 air(2).
(1)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_en
(2)Exposure calculated based on the endoto xin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2018;16(10):5458); analytical method: European 
Phar macopoeia 2.6.14. (bacterial endoto xins).OJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/777/oj 9/14Identific ation 
number of 
the additiveName of the 
holder of 
author isationAdditiveComposition, chemical formula, descr iption, analytical 
method.Species or 
categor y 
of animalMaxi -
mum 
ageMinimum 
contentMaximum 
conten t
Other provisionsEnd of period of 
author isation mg/kg of complet e feed 
with a moisture 
content of 12 %
Categor y: sensor y additiv es. Functional group: flavour ing compounds
3c320i — L-Lysine 
base, liquidAdditive composition
Aqueous solution of L-lys ine with a minimum 
cont ent of 50 % L-lys ine
Liquid form
Char acter isation of the activ e substance
L-lysine, produced by Escher ichia 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 quantifi cation of lysine in premixtures:
— ion-ex change chromat ography 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-ex change chromat ography coupled with 
post-column derivatisation and optical detec ­
tion (IEC- VIS/FLD) – EN ISO 17180All 
animal 
species— — — 1. The additive shall be incor ­
porate d into the feed in the 
form of a premixture.
2. In the directions for use of 
the additive and premix ­
tures, the storage condi ­
tions and stability to heat 
treatment shall be indicated .
3. On the label of the additive 
the following shall be indi ­
cated :
‘Recommended maximum 
conte nt of the active 
substance of compl ete 
feedingstuff with a 
moisture cont ent of 12 %: 
25 mg/kg.’
4. The functional group, the 
identif ication number , the 
name and the added 
amount of the active sub­
stance shall be indicate d 
on the label of the premix ­
ture where the use level on 
the label of the premixture 
would result in exceeding 
the content refer red to in 
point 3.26 Marc h 
2034OJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_im pl/2024/777/oj 10/14
5. For users of the additive and 
premixtures, feed business 
operat ors shall establish op­
erational procedures and 
organisational measures to 
address poten tial risks re­
sulting from their use. 
Where those risks cannot 
be eliminated by such pro­
cedures and measures, the 
additive and premixtures 
shall be used with personal 
skin and eye protect ive 
equipment.
(1)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enOJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/777/oj 11/14Identific ation 
number of 
the additiveName of the 
holder of 
author isationAdditiveComposition, chemical formula, descr iption, analytical 
method.Species or 
categor y 
of animalMaxi -
mum 
ageMinimum 
contentMaximum 
conten t
Other provisionsEnd of period of 
author isation mg/kg of complet e feed 
with a moisture 
content of 12 %
Categor y: sensor y additiv es. Functional group: flavour ing compounds
3c321i — L-lysine 
monoh y-
droch loride, 
liquidAdditive composition
Aqueous solution of L-lysine monoh ydrochlor ide 
with a minimum conte nt of 22,4 % of L-Lysine and 
a maximum moisture cont ent of 65 %
Liquid form
Char acter isation of the activ e substance
L-lysine monoh ydrochlor ide, produced by Escher ichia 
coli NITE BP-02917
Chemical formula: NH 2-(CH2)4-CH (NH 2)-COOH - 
HCl
CAS number : 657–27-2
Analytical method (1)
For the identif ication of L-lysine monohydroc hlor ide 
in the feed additive:
—Food Chemical Codex ‘L-lysine monohy ­
droc hlor ide monograph’All 
animal 
species— — — 1. The additive shall be incor ­
porate d into the feed in the 
form of a premixture.
2. In the directions for use of 
the additive and premix ­
tures, the storage condi ­
tions and stability to heat 
treatment shall be indicated .
3. On the label of the additive 
the following shall be indi ­
cated :
‘Recommended maximum 
conte nt of the active 
substance of compl ete 
feedingstuff with a 
moisture cont ent of 12 %: 
25 mg/kg.’26 Marc h 
2034OJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_im pl/2024/777/oj 12/14
For the quantification of lysine in the feed additive 
and premixtures (containing more than 10 % lysine):
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detec ­
tion (IEC- VIS/FLD) – EN ISO 17180
For the quantifi cation of lysine in premixtures:
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detection 
(IEC- VIS), Regulation (EC) No 152/2009 (Annex 
III, F)4. The functional group, the 
identif ication number , the 
name and the added 
amount of the active sub­
stance shall be indicate d 
on the label of the premix ­
ture where the use level on 
the label of the premixture 
would result in exceeding 
the content refer red to in 
point 3.
(1)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enOJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/777/oj 13/14Identific ation 
number of 
the additiveName of the 
holder of 
author isationAdditiveComposition, chemical formula, descr iption, analytical 
method.Species or 
categor y 
of animalMaxi -
mum 
ageMinimum 
contentMaximum 
conten t
Other provisionsEnd of period of 
author isation mg/kg of complet e feed 
with a moisture 
content of 12 %
Categor y: sensor y additiv es. Functional group: flavour ing compounds
3c322v — L-lysine 
monoh y-
droch lorideAdditive composition
Powder of L-lysine monohydroc hlor ide with a 
minimum content of 78 % of L-Lysine and a 
maximum moisture conte nt of 1,5 %
Solid form
Char acter isation of the activ e substance
L-lysine monoh ydrochlor ide, produced by Escher ichia 
coli NITE BP-02917
Chemical formula: NH 2-(CH2)4-CH (NH 2)-COOH - 
HCl
CAS number : 657–27-2
Analytical method (1)
For the identif ication of L-lysine monohydroc hlor ide 
in the feed additive:
—Food Chemical Codex ‘L-lysine monohy ­
droc hlor ide monograph’All 
animal 
species— — — 1. The additive shall be incor ­
porate d into the feed in the 
form of a premixture.
2. In the directions for use of 
the additive and premix ­
tures, the storage condi ­
tions and stability to heat 
treatment shall be indicated .
3. On the label of the additive 
the following shall be indi ­
cated :
‘Recommended maximum 
conte nt of the active 
substance of compl ete 
feedingstuff with a 
moisture cont ent of 12 %: 
25 mg/kg.’26 Marc h 
2034OJ L, 6.3.2024 EN  ELI: http://data.europa.eu/eli/reg_im pl/2024/777/oj 14/14
For the quantification of lysine in the feed additive 
and premixtures (containing more than 10 % lysine):
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detec ­
tion (IEC- VIS/FLD) – EN ISO 17180
For the quantifi cation of lysine in premixtures:
— ion-ex change chromat ography coupled with 
post-column derivatisation and optical detection 
(IEC- VIS), Regulation (EC) No 152/2009 (Annex 
III, F)4. The functional group, the 
identif ication number , the 
name and the added 
amount of the active sub­
stance shall be indicate d 
on the label of the premix ­
ture where the use level on 
the label of the premixture 
would result in exceeding 
the content refer red to in 
point 3.
5. The endoto xin conte nt of 
the additive and its dusting 
poten tial shall ensure a 
maximal endoto xin expo ­
sure of 1 600 IU endoto x
ins/m3 air(2).
(1)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_en
(2)Exposure calculated based on the endoto xin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2018;16(10):5458); analytical method: European 
Phar macopoeia 2.6.14. (bacterial endoto xins).OJ L, 6.3.2024 EN