COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/669 
of 23 Apr il 2021
concer ning the author isation of technically pure L-lysine monoh ydrochlor ide and liquid L-lysine 
base produced by Cor ynebacter ium casei KCCM 80190 or Cor ynebacter ium glutamicum KCCM 80216 
or Cor ynebacter ium glutamicum KCTC 12307BP 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(1) of Regulation (EC) No 1831/2003, applications were submitted for the author isation 
of liquid L-lysine base and technically pure L-lysine monoh ydrochlori de as nutr itional feed additives for use in feed 
and in water for drinking for all animal species. These applications were accompan ied by the particulars and 
documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The applications concer n the author isation of L-lys ine base, liquid, and L-lys ine monoh ydrochlori de, technically 
pure, produced by Corynebacter ium casei KCCM 80190 or Corynebacter ium glutamicum KCCM 80216 or 
Corynebacter ium glutamicum KCTC 12307BP as feed additives for all animal species to be classified in the additive 
catego ry ‘nutr itional additives ’, functional group ‘amino acids, their salts and analogues ’.
(4) The European Food Safet y Authority (‘the Author ity’) concluded in its opinions of 30 Septembe r 2020 (2)and 
18 November 2020 (3)(4)that, under the proposed conditions of use, L-lysine base, liquid, and L-lysine 
monoh ydrochlor ide, technically pure, produced by Corynebacter ium casei KCCM 80190 or Corynebacter ium 
glutamicum KCCM 80216 or Corynebacter ium glutamicum KCTC 12307BP do not have an adverse effect on animal 
health, consumer health or the envi ronment. The Author ity could conclude on the safety for the user of the L-lysine 
base, liquid, and L-lysine monohydroc hlor ide, technically pure, produced by Corynebacter ium glutamicum KCCM 
80216 and Corynebacter ium glutamicum KCTC 12307BP . It stated that of L-lys ine monoh ydrochlori de, technically 
pure, and L-lysine base, liquid, produced by Corynebacter ium casei KCCM 80190 are considered hazardous by 
inhalation and that L-lysine monoh ydrochlori de, technically pure, produced by Corynebacter ium casei KCCM 80190 
is a mild eye irritant. Theref ore, appropr iate prot ective measures should be taken to prevent adverse effects on 
human health, in particular as regar ds the users of the additive. The Author ity concluded that L-lysine base, liquid, 
and L-lys ine monohydroc hlor ide, technically pure, produced by Corynebacter ium casei KCCM 80190 or 
Corynebacter ium glutamicum KCCM 80216 or Corynebacter ium glutamicum KCTC 12307BP , are effective sources of the 
essential amino acid L-lysine for all animal species. For the supplemental L-lysine to be fully efficacious in ruminants, 
it should be prote cted against degradation in the rumen. In its opinions, the Author ity refer red to a previous 
state ment concer ning potential nutr itional imbalances for amino acids and hygienic concer ns, when they are 
administe red via water for drinking. However , the Authority did not propose a maximum content for the 
supplementation with L-lysine. Thus, it is appropr iate to indicate on the label of the additive, and premixtures 
containing it, an alert to take into account the dietar y supply with all the essential and conditionally essential amino 
acids, particularly in the case of supplementation with L-lysine as amino acid via wate r for drinking.
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2020;18(11):6285.
(3)EFSA Journal 2020;18(12): 6333.
(4)EFSA Journal 2020;18(12): 6334.EN Offi cial Jour nal of the European Union 26.4.2021                                                                                                                                           L 141/7  (5) The Author ity does not consider that there is a need for specif ic requirements of post-market monit oring. It also 
verified the repor ts on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set 
up by Regulation (EC) No 1831/2003.
(6) The assessment of L-lysine base, liquid, and L-lys ine monoh ydrochlori de, technically pure, produced by 
Corynebacter ium casei KCCM 80190 or Corynebacter ium glutamicum KCCM 80216 or Corynebacter ium glutamicum 
KCTC 12307BP 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 this additive should be author ised as specified in the Annex to 
this Regulation.
(7) 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 specified in the Annex, belonging to the categor y ‘nutr itional additives ’and the functional group ‘amino 
acids, their salts and analogues ’, are author ised as feed 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, 23 Apr il 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 141/8                                                                                                                                           26.4.2021  ANNEX 
Identification 
number of the 
additiveName of 
the 
holder of 
author i-
sationAdditiveCompo sition, chem ical formula, descr iption, 
analytical method.Species or categ ory 
of animalMaxi -
mum ageMini -
mum 
contentMaxi -
mum 
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.
3c320 - L-lysine base, 
liquidAdditive composition:
Aqueous solution of L-lysine with a 
minimum of 50 % L-lysine.All species - - - 1.The lysine content shall be 
indicated on the labelling 
of the additive.
2.L-lys ine base, liquid, may 
be placed on the mark et 
and used as an additive 
consisting of a prepara ­
tion.
3.The additive can be also 
used via water for drink­
ing.
4.Declarations to be made 
on the labelling of the ad­
ditive and premixtures: 
‘The supplementation 
with L-lys ine, in particular 
via water for drinking, 
should take into account 
all essential and condition ­
ally essential amino acids 
in order to avoid imbal ­
ances. ’
5.For users of the additive 
and premixtures, feed 
business operat ors shall 
establish operational pro­
cedures and organisational 
measures to address the 
poten tial risks by inhala ­
tion, eye or dermal con­
tact. Where those risks 
cannot be eliminated or re­
duced to a minimum by 16 May 2031
Char acter isation of the active substance:
L-lysine produced by fermentation with 
Corynebacter ium casei KCCM 80190
Chemical formula: NH 2-(CH2)4-CH(NH 2)- 
COOH
CAS Number: 56-87-1
Analytical methods (1):
For the quantification of lysine in the feed 
additive and premixtures containing more 
than 10 % lysine:
— ion exchange chromat ography coupled 
with post-column derivatisation 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 derivatisation and 
optical detection (IEC- VIS), Commis ­
sion Regulation (EC) No 152/2009 
(Annex III, F).EN Offi cial Jour nal of the European Union 26.4.2021                                                                                                                                           L 141/9  such procedures and mea ­
sures, the additive and pre­
mixtures shall be used with 
appropr iate personal pro­
tective equipment, includ ­
ing breathing protection, 
safety glasses and gloves .For the quantification of lysine in wate r:
— ion exchange chromat ography coupled 
with post-column derivatisation and 
optical detection (IEC- VIS/FLD); or
— ion exchange chromat ography coupled 
with post-column derivatisation and 
optical detection (IEC- VIS).
3c326 - L-lysine base, 
liquidAdditive composition:
Aqueous solution of L-lysine with a 
minimum of 50 % L-lysine.All species - - - 1.The lysine content shall be 
indicated on the labelling 
of the additive.
2.L-lys ine base, liquid, may 
be placed on the mark et 
and used as an additive 
consisting of a prepara ­
tion.
3.For users of the additive 
and premixtures, feed 
business operat ors shall 
establish operational pro­
cedures and organisational 
measures to address the 
poten tial risks by inhala ­
tion. Where those risks 
cannot be eliminated or re­
duced to a minimum by 
such procedures and mea ­
sures, the additive and pre­
mixtures shall be used with 16 May 2031
Char acter isation of the active substance:
L-lysine produced by fermentation with 
Corynebacter ium glutamicum KCCM 80216 
or Corynebacter ium glutamicum KCTC 
12307BP
Chemical formula: NH 2-(CH2)4-CH(NH 2)- 
COOH
CAS Number: 56-87-1
Analytical methods (1):
For the quantification of lysine in the feed 
additive and premixtures containing more 
than 10 % lysine:
— ion exchange chromat ography coupled 
with post-column derivatisation and 
optical detection (IEC- VIS/FLD) – EN 
ISO 17180.EN Offi cial Jour nal of the European Union L 141/10                                                                                                                                         26.4.2021  appropr iate personal pro­
tective equipment, includ ­
ing breathing prot ection.For the quantification of lysine in 
premixtures, compo und feed and feed 
mater ials:
— ion exchange chromat ography coupled 
with post-column derivatisation and 
optical detection (IEC- VIS), Commis ­
sion Regulation (EC) No 152/2009 
(Annex III, F).
For the quantification of lysine in wate r:
— ion exchange chromat ography coupled 
with post-column derivatisation and 
optical detection (IEC- VIS/FLD); or
— ion exchange chromat ography coupled 
with post-column derivatisation and 
optical detection (IEC- VIS).
3c322 L-lysine 
monoh ydrochlor -
ide, technically 
pureAdditive composition:
Powder of L-lysine monohydroc hlor ide 
with a minimum of 78 % L-lysine and a 
maximum moisture cont ent of 1,5 %.All species - - - 1.The lysine content shall be 
indicated on the labelling 
of the additive.
2.L-lys ine monohydroc hlor ­
ide, technically pure, may 
be placed on the mark et 
and used as an additive 
consisting of a prepara ­
tion.
3.The additive can be also 
used via water for drink­
ing.
4.Declarations to be made 
on the labelling of the ad­
ditive and premixtures: 
‘The supplementation 
with L-lys ine, in particular 
via water for drinking, 
should take into account 16 May 2031
Char acter isation of the active substance:
L-lysine monoh ydrochlor ide produced by 
fermentation with
Corynebacter ium casei KCCM 80190
Chemical formula: NH 2-(CH2)4-CH(NH 2)- 
COOH
CAS Number: 657-27-2
Analytical methods (1):EN Offi cial Jour nal of the European Union 26.4.2021                                                                                                                                         L 141/11  all essential and condition ­
ally essential amino acids 
in order to avoid imbal ­
ances. ’
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 xins/m3 air(2).
6.For users of the additive 
and premixtures, feed 
business operat ors shall 
establish operational pro­
cedures and organisational 
measures to address the 
poten tial risks by inhala ­
tion, eye or dermal con­
tact. Where those risks 
cannot be eliminated or re­
duced to a minimum by 
such procedures and mea ­
sures, the additive and pre­
mixtures shall be used with 
appropr iate personal pro­
tective equipment, includ ­
ing breathing protection, 
safety glasses and gloves .For the identification of L-lysine 
monoh ydrochlor ide in the feed additive:
—Food Chemical Codex ‘L-lysine mono ­
hydrochlori de monograph ’
For the quantification of lysine in the feed 
additive and premixtures containing more 
than 10 % lysine:
— ion exchange chromat ography coupled 
with post-column derivatisation 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 derivatisation and 
optical detection (IEC- VIS), Commis ­
sion Regulation (EC) No 152/2009 
(Annex III, F).
For the quantification of lysine in wate r:
— ion exchange chromat ography coupled 
with post-column derivatisation and 
optical detection (IEC- VIS/FLD); or
— ion exchange chromat ography coupled 
with post-column derivatisation and 
optical detection (IEC- VIS).
3c327 L-lysine 
monoh ydrochlor -
ide, technically 
pureAdditive composition:
Powder of L-lysine monohydroc hlor ide 
with a minimum of 78 % L-lysine and a 
maximum moisture cont ent of 1,5 %.All species - - - 1.The lysine content shall be 
indicated on the labelling 
of the additive.16 May 2031
Char acter isation of the active substance:
L-lysine monoh ydrochlor ide produced by 
fermentation with
Corynebacter ium glutamicum KCCM 80216 
or Corynebacter ium glutamicum KCTC 
12307BP
Chemical formula: NH 2-(CH2)4-CH(NH 2)- 
COOH
CAS Number: 657-27-2
Analytical methods (1):
For the identification of L-lysine 
monoh ydrochlor ide in the feed additive:EN Offi cial Jour nal of the European Union L 141/12                                                                                                                                         26.4.2021  2.L-lys ine monohydroc hlor ­
ide, technically pure, may 
be placed on the mark et 
and used as an additive 
consisting of a prepara ­
tion.
3.For users of the additive 
and premixtures, feed 
business operat ors shall 
establish operational pro­
cedures and organisational 
measures to address the 
poten tial risks by inhala ­
tion and eye contact. 
Where those risks cannot 
be eliminated or reduced 
to a minimum by such 
procedures and measures, 
the additive and premix ­
tures shall be used with ap­
propr iate personal prote c­
tive equipment, including 
breathing protect ion and 
safety glasses.—Food Chemical Codex ‘L-lysine mono ­
hydrochlori de monograph ’
For the quantification of lysine in the feed 
additive and premixtures containing more 
than 10 % lysine:
— ion exchange chromat ography coupled 
with post-column derivatisation 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 derivatisation and 
optical detection (IEC- VIS), Commis ­
sion Regulation (EC) No 152/2009 
(Annex III, F).
(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 ts
(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 2017;15(3):4705); analytical method: European Phar macopoeia 
2.6.14 (bacterial endoto xins).EN Offi cial Jour nal of the European Union 26.4.2021                                                                                                                                         L 141/13  