COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/1163 
of 14 June 2023
concer ning the author isation of L-Lysine monoh ydrochlor ide and L-Lysine sulphate produced by 
Cor ynebacter ium glutamicum CGMCC 17927 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 author isation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of L-Lysine monohydroc hlor ide and L-Lysine sulphate produced by Corynebacter ium glutamicum CGMCC 17927. The 
application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) 
No 1831/2003.
(3) That application concer ns the author isation of L-Lysine monoh ydrochlori de and L-Lysine sulphat e produced by 
Corynebacter ium glutamicum CGMCC 17927 as feed additives for all animal species, to be classified in the additive 
catego ry ‘nutr itional additives ’ and in the functional group ‘amino acids, their salts and analogues’.
(4) The European Food Safety Author ity (‘the Auth ority’) concluded in its opinion of 27 September 2022 (2)that, under 
the proposed conditions of use L-Lysine monoh ydrochlori de and L-Lysine sulphate produced by Corynebacter ium 
glutamicum CGMCC 17927, do not have an adverse effect on animal health, consumer safety or the environment.
(5) The Authority concluded that exposure through inhalation to L-lysine monoh ydrochlor ide and L-Lysine sulphate 
produced with Corynebacter ium glutamicum CGMCC 17927 is considered very likely and that in the absence of data, 
it cannot conclude on the potential of both additives to be irritant for skin and eyes or to be dermal sensitisers.
(6) The Auth ority concluded that the additives have the poten tial to be efficacious for all animal species. The Author ity 
does not consider that there is a need for specifi c requirements of post-market monitori ng. It also verified the repor t 
on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation 
(EC) No 1831/2003.
(7) The assessment of L-lysine monohydroc hlor ide and L-Lysine sulphate produced with Corynebacter ium glutamicum 
CGMCC 17927 shows that the conditions for author isation, as provided for in Article 5 of Regulation (EC) 
No 1831/2003, are satisfi ed. According ly, the use of those substances should be author ised as specifi ed in the 
Annex to this Regulation. In addition, the Commission considers that appropr iate prot ective measures should be 
taken to prevent adverse effects on the health of users of the additives.
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2022;20(10):7613.EN Offi cial Jour nal of the European Union 15.6.2023 L 154/41  (8) In view of the Author ity’s opinion, the label of the additives and premixtures should raise awareness that the 
supplementation with L-lysine, in particular via wate r for drinking, should take into account all essential and 
conditionally essential amino acids in order to avoid imbalances. In addition, the Commission considers that a 
maximum level should be set up for L-lysine sulphat e due to the poten tial adverse effects from the intrinsic high 
sulphate content in the additive. The level of 10 000 mg/kg of compl ete feed was regarded as safe according to the 
Authority’s opinion of 16 June 2015 (3)issued for another L-lysine sulphat e.
(9) 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
Author isation
The substances specified in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional group 
‘amino acids, their salts and analogues’, are author ised as additives in animal nutr ition, subject to the conditions laid down 
in that Annex.
Article 2
Entr y into force
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, 14 June 2023 .
For the Commission
The President
Ursula VON DER LEYEN
(3)EFSA Journal 2015;13(7):4155EN Offi cial Jour nal of the European Union L 154/42 15.6.2023  ANNEX 
Identifica -
tion 
number of 
the additiveAdditiveCompo sition, chem ical formula, descr iption, 
analytical method.Species or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation mg of additive/kg of 
complet e feed with a 
moisture conten t of 12 %
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues
3c322IV L-lysine 
monoh y-
droch lorideAdditive composition
L-lysine monoh ydrochlor ide with a 
minimum cont ent of 78,8 % of L-Lysine on a 
dry matt er basis and maximum moisture 
conte nt of 1 %
Solid formAll species - 1.The lysine content shall be indicated 
on the labelling of the additive
2.The additive may be used via wate r for 
drinking.
3.The directions for use of the additive 
and premixture shall indicate the sto­
rage conditions, the stability to heat 
treatment and the stability in water 
for drinking.
4.The label of the additive and premix ­
ture shall indicate the following: ‘The 
supplementation with L-lysine 
monoh ydrochlor ide, in particular 
via water for drinking, should take 
into account all essential and condi ­
tionally essential amino acids in order 
to avoid imbalances.’
5.For users of the additive and premix ­
tures, feed business operators shall 
establish operational procedures and 
organisational measures to address 
the poten tial risks resulting from 
their use. Where those risks cannot 
be eliminated by such procedures 
and measures, the additive and pre­
mixtures shall be used with personal 
breathing eye and skin protective 
equipment.6 July 2033
Char acter isation of the active substance
L-lysine monoh ydrochlor ide produced by 
Corynebacter ium glutamicum CGMCC 17927]
Chemical formula: C6H14N2O2
CAS number: 657-27-2
Analytical method (1)
For the identification of L-lysine 
monoh ydrochlor ide in the feed additive: Food 
Chemical Codex ‘L-lysine 
monoh ydrochlor ide monograph’
For the quantification of lysine in the feed 
additives and premixtures (containing more 
than 10 % lysine): – ion-ex chang e 
chromatograph y coupled with post-column 
derivatisation and optical detection (IEC- 
VIS/FLD) – EN ISO 17180
For the quantif ication of lysine in premixtures 
and compo und feed: – ion-ex change 
chromatograph y coupled with post-column 
derivatisation and optical detec tion (IEC- VIS), 
Commission Regulation (EC) No 152/2009 
(Annex III, F)EN Offi cial Jour nal of the European Union 15.6.2023 L 154/43  For the quantification of lysine in wate r: – 
ion-ex chang e chromat ography coupled with 
post-column derivatisation and optical 
detection (IEC- VIS/FLD); or – ion-exc hange 
chromatograph y coupled with post-column 
derivatisation and optical detection (IEC- VIS)
(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_enEN Offi cial Jour nal of the European Union L 154/44 15.6.2023  Identifica -
tion 
number of 
the additiveAdditiveCompo sition, chem ical formula, descr iption, 
analytical method.Species or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation mg additive/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
3c329 L-lysine sulphate Additive composition
L-lysine sulphate with a minimum L-lysine 
conte nt of 55 % on dry matter basis and a 
maximum cont ent of:
— 4 % moisture;
— 26,5 % sulphate ;
— 0,8 % free amino acids other than lysine
Solid formAll species - - 10 000 1.The lysine content shall be indicated 
on the labelling of the additive.
2.The additive may be used via wate r for 
drinking.
3.The directions for use of the additive 
and premixture shall indicate the sto­
rage conditions, the stability to heat 
treatment and the stability in water 
for drinking.
4.The label of the additive and premix ­
ture shall indicate the following: ‘The 
supplementation with L-lysine sul­
phate , in particular via water for 
drinking, should take into account 
all essential and conditionally essen ­
tial amino acids in order to avoid im­
balances.’
5.For users of the additive and premix ­
tures, feed business operators shall 
establish operational procedures and 
organisational measures to address 
the poten tial risks resulting from 
their use. Where those risks cannot 
be eliminated by such procedures 
and measures, the additive and pre­
mixtures shall be used with personal 
breathing eye and skin protective 
equipment.6 July 2033
Char acter isation of the active substance
L-lysine sulphate produced by 
Corynebacter ium glutamicum CGMCC
17927
Chemical formula: C12H28N4O4-O 4S
CAS number: 60343-69-3
Analytical method (1)
For the identification of sulphate in the feed 
additive (L-lysine sulphate ): European 
Phar macopoeia monograph 20301
For the quantification of lysine in the feed 
additives and premixtures (containing more 
than 10 % lysine): – ion-ex chang e 
chromatograph y coupled with post-column 
derivatisation and optical detection (IEC- 
VIS/FLD) – EN ISO 17180EN Offi cial Jour nal of the European Union 15.6.2023 L 154/45  For the quantif ication of lysine in premixtures 
and compo und feed: – ion-ex change 
chromatograph y coupled with post-column 
derivatisation and optical detec tion (IEC- VIS), 
Commission Regulation (EC) No 152/2009 
(Annex III, F)
For the quantification of lysine in wate r: – 
ion-ex chang e chromat ography coupled with 
post-column derivatisation and optical 
detection (IEC- VIS/FLD); or – ion-exc hange 
chromatograph y coupled with post-column 
derivatisation and optical detection (IEC- VIS)
(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_enEN Offi cial Jour nal of the European Union L 154/46 15.6.2023  