COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/2095 
of 29 November 2021
concer ning the author isation of L-lysine base, L-lysine monohydrochlor ide and L-lysine sulphate 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, applications were submitted for the author isation of 
L-lys ine base, L-lysine monohydroc hlor ide and L-lysine sulphat e. The applications were accompanied by the 
particulars and documents required under Article 7(3) of that Regulation.
(3) The applications concer n the author isation of L-lys ine base and L-lysine monoh ydrochlori de produced by 
Corynebacter ium glutamicum KCCM 80183, L-lysine monoh ydrochlori de and L-lys ine sulphate produced by 
Corynebacter ium glutamicum CCTCC M 2015595 and L-lysine sulphate produced by Corynebacter ium glutamicum 
KCCM 80227 as feed additives for all animal species, to be classif ied in the additive catego ry ‘nutr itional additives’, 
functional group ‘amino acids, their salts and analogues’.
(4) The European Food Safety Auth ority (‘the Auth ority’) concluded in its opinions of 17 March 2021 (2),(3)and 23 June 
2021 (4)that, under the proposed conditions of use, L-lysine base and L-lysine monoh ydrochlori de produced by 
Corynebacter ium glutamicum KCCM 80183, L-lysine monoh ydrochlori de and L-lys ine sulphate produced by 
Corynebacter ium glutamicum CCTCC M 2015595 and L-lysine sulphate produced by Corynebacter ium glutamicum 
KCCM 80227 do not have an adverse effect on animal health, consumer safety or the environment. For L-lysine 
sulphate produced by Corynebacter ium glutamicum KCCM 80227, the Author ity concluded that that active substance 
is not toxic by inhalation, not irritant to skin or eyes, and not a skin sensitiser . With respect to the safety of the user 
of L-lysine monohydroc hlor ide and L-lysine sulphate produced by Corynebacter ium glutamicum CCTCC M 2015595, 
the Author ity could neither excl ude a risk by inhalation, nor that the active substance might be irritant to skin or 
eyes, or a dermal sensitiser . Further , the Auth ority stated L-lysine base produced by Corynebacter ium glutamicum 
KCCM 80183 to be hazardous by inhalation and L-Lysine monohydroc hlor ide produced by Corynebacter ium 
glutamicum KCCM 80183 to be hazardous by inhalation and mildly irritant to eyes. Theref ore, the Commission 
considers that for the lysine forms produced by Corynebacter ium glutamicum CCTCC M 2015595 and Corynebacter ium 
glutamicum KCCM 80183, appropr iate protect ive measures should be taken to prevent adverse effects on human 
health, in particular as regar ds the users of the additive. The Author ity also concluded that all additives are 
efficacious sources of the amino acid L-lysine for all animal species and that in order to be as efficacious in 
ruminants as in non-r uminant species, the additives should be protect ed against degradation in the rumen. The 
Authority does not consider that there is a need for specific requirements of post-market monitori ng. It also verified 
the repor ts on the method of analysis of the feed additive in feed submitted by the Reference Laborat ory set up by 
Regulation (EC) No 1831/2003.
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2021;19(4):6520.
(3)EFSA Journal 2021;19(4):6537.
(4)EFSA Journal 2021;19(7):6706.EN Offi cial Jour nal of the European Union 30.11.2021 L 427/179  (5) The assessments of L-lysine base and L-lysine monohydroc hlor ide produced by Corynebacter ium glutamicum KCCM 
80183, L-lysine monoh ydrochlori de and L-lys ine sulphat e produced by Corynebacter ium glutamicum CCTCC M 
2015595 and L-lysine sulphat e produced by Corynebacter ium glutamicum KCCM 80227 show that the conditions for 
author isation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the use of 
these substances should be author ised as specifi ed in the Annex to this Regulation.
(6) 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 and preparations specifi ed in the Annex, belonging to the additive cate gory ‘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
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, 29 November 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 427/180 30.11.2021  ANNEX 
Identif i-
cation 
number 
of the 
additiv eName of 
the holder 
of 
author isa-
tionAdditiv eComposition, chemical formula, 
descr iption, analytical method.Species or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period 
of 
author isationmg additiv e/kg of 
complete feed with a 
moisture content of 
12 %
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues.
3c320 - L-lysine 
base, liquidAdditiv e composition:
Preparation (aqueous solution) of 
L-lysine with a minimum of 50 % 
L-lysine.All species - - - 1.The lysine content shall be indicate d 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 supple ­
mentation 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 op­
erational procedures and organisational 
measures to address the poten tial risks by 
inhalation, eye or dermal contact. Where 
those risks cannot be eliminated or reduced 
to a minimum by such procedures and mea ­
sures, the additive and premixtures shall be 
used with appropr iate personal prot ective 
equipment, including eyes, skin and breath ­
ing prote ction.20.12.2031
Character isation of the activ e 
subst ance:
L-lysine produced by fermentation 
with Corynebacter ium glutamicum 
KCCM 80183
Chemical formula: NH 2-(CH2)4-CH 
(NH 2)-COOH
CAS Number: 56-87-1
Analytical methods (1):
For the quantifi cation of lysine in the 
feed additive and premixtures 
containing more than 10 % lysine:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS/FLD) – EN ISO 17180.
For the quantification of lysine in 
premixtures, compo und feed and 
feed mater ials:EN Offi cial Jour nal of the European Union 30.11.2021 L 427/181  — ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS), Commission Regula ­
tion (EC) No 152/2009 (Annex 
III, F).
For the quantification of lysine in 
water:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS/FLD), or
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS).
3c322ii L-lysine 
monohy -
drochlor -
ide, 
technically 
pureAdditiv e composition:
Powder of L-lysine 
monoh ydrochlor ide with a 
minimum of 78 % L-lysine and a 
maximum moisture conte nt of 1,5 %.All species - - - 1.The lysine content shall be indicate d 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 supple ­
mentation 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 op­
erational procedures and organisational 
measures to address the poten tial risks by 
inhalation, eye or dermal contact. Where 
those risks cannot be eliminated or reduced 20.12.2031
Character isation of the activ e 
subst ance:
L-lysine monoh ydrochlor ide 
produced by fermentation with
Corynebacter ium glutamicum KCCM 
80183 or Corynebacter ium glutamicum 
CCTCC M 2015595
Chemical formula: NH 2-(CH2)4-CH 
(NH 2)-COOH
CAS Number: 657-27-2EN Offi cial Jour nal of the European Union L 427/182 30.11.2021  to a minimum by such procedures and mea ­
sures, the additive and premixtures shall be 
used with appropr iate personal prot ective 
equipment, including eyes, skin and breath ­
ing prote ction.Analytical methods (1):
For the identification of L-lysine 
monoh ydrochlor ide in the feed 
additive:
— Food Chemical Codex ‘L-lysine 
monoh ydrochlor ide mono ­
graph’ .
For the quantifi cation of lysine in the 
feed additive and premixtures 
containing more than 10 % lysine:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS/FLD) – EN ISO 17180.
For the quantification of lysine in 
premixtures, compo und feed and 
feed mater ials:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS), Commission Regula ­
tion (EC) No 152/2009 (Annex 
III, F).
For the quantification of lysine in 
water:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS/FLD), or
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS).EN Offi cial Jour nal of the European Union 30.11.2021 L 427/183  3c325i - L-lysine 
sulphat eAdditiv e composition:
Granulate d preparation of L-lysine 
sulphate with a minimum L-lysine 
conte nt of 52 %, a maximum conte nt 
of 24 % sulphate and a maximum 
conte nt 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 wate r for 
drinking.
3.Declarations to be made on the labelling of 
the additive and premixtures: ‘The supple ­
mentation 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 op­
erational procedures and organisational 
measures to address potential risks by inha ­
lation. Where those risks cannot be elimi ­
nated or reduced to a minimum level by such 
procedures and measures, the additive and 
premixtures shall be used with personal pro­
tective equipment, including breathing pro­
tectio n.20.12.2031
Character isation of the activ e 
subst ance:
L-lysine sulphate produced by 
fermentation with Corynebacter ium 
glutamicum CCTCCM 2015595
Chemical formula: C12 H28 
N4O4•H 2SO 4/[NH 2-(C H2)4-CH 
(NH 2)-COOH] 2SO 4
CAS number: 60343-69-3
Analytical methods (1):
For the quantifi cation of lysine in the 
feed additive and premixtures 
containing more than 10 % lysine:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS/FLD) – EN ISO 17180.
For the identification of sulphate in 
the feed additive:
—European Phar macopoeia Mono ­
graph 20301.
For the quantification of lysine in 
premixtures, compo und feed and 
feed mater ials:EN Offi cial Jour nal of the European Union L 427/184 30.11.2021  — ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS) – Commission Regula ­
tion (EC) No 152/2009 (Annex 
III, F).
For the quantification of lysine in 
water:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS/FLD).
3c324i - L-lysine 
sulphat eAdditiv e composition:
Granulate d preparation of L-lysine 
sulphate with a minimum L-lysine 
conte nt of 52 %, a maximum conte nt 
of 24 % sulphate and a maximum 
conte nt 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 supple ­
mentation with L-lysine should take into ac­
count all essential and conditional essential 
amino acids in order to avoid imbalances.’20.12.2031
Character isation of the activ e 
subst ance:
L-lysine sulphate produced by 
fermentation with Corynebacter ium 
glutamicum KCCM 80227
Chemical formula: C12 H28 
N4O4•H 2SO 4/[NH 2-(C H2)4-CH 
(NH 2)-COOH] 2SO 4
CAS number: 60343-69-3
Analytical methods (1):
For the quantifi cation of lysine in the 
feed additive and premixtures 
containing more than 10 % lysine:EN Offi cial Jour nal of the European Union 30.11.2021 L 427/185  — ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS/FLD) – EN ISO 17180.
For the identification of sulphate in 
the feed additive:
—European Phar macopoeia Mono ­
graph 20301.
For the quantification of lysine in 
premixtures, compo und feed and 
feed mater ials:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS) – Commission Regula ­
tion (EC) No 152/2009 (Annex 
III, F).
For the quantification of lysine in 
water:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS/FLD).
(1)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor tsEN Offi cial Jour nal of the European Union L 427/186 30.11.2021