COMMISSION IMPLEMENTING REGUL ATION (EU) 2019/12 
of 3 Januar y 2019 
concer ning the author isation of L-arginine as a feed additiv e for all animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provi des 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 two applications were submitted for the 
author isation of L-arginine produced by Corynebacter ium glutamicum KCCM 10741P and by Escher ichia coli NITE 
BP-02186 as a feed additive for use in feed and in water for drinking for all animal species. Those 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-argi nine produced by Corynebacter ium glutamicum KCCM 10741P 
as a feed additive for all animal species to be classified in the additive catego ry ‘nutr itional additives ’ and of 
L-argi nine produced by Escher ichia coli NITE BP-02186 as a feed additive for all animal species to be classified in 
the additive cate gory ‘nutr itional additives ’, functional group ‘amino acids, their salts and analogues’, and in the 
additive cate gory ‘sensor y additives ’, functional group ‘flavouring compo unds ’. 
(4)  The European Food Safety Author ity (‘the Authority’) concluded in its opinions of 18 Apr il 2018 (2) and 
19 Apr il 2018 (3) that, under the proposed conditions of use, L-arginine produced by Escher ichia coli NITE 
BP-02186 and by Corynebacter ium glutamicum KCCM 10741P does not have an adverse effect on animal health, 
consumer health or the envi ronment and that no safet y concer ns for users would arise provi ded that appropr iate 
prot ective measures are take n. 
(5)  The Author ity also concluded that the additive is an effective source of the amino acid arginine for all animal 
species and that for the supplemental L-arginine to be fully efficacious in ruminants, it should be prot ected 
against degradation in the rumen. The Author ity expressed in its opinions a concer n over poten tial nutr itional 
imbalances of when L-arginine is administered as amino acid via water for drinking. However , no maximum 
cont ent for L-arginine is proposed by the Auth ority. Moreover , the Author ity recommends supplementation with 
L-argi nine in appropr iate amounts. Thus, in the case of supplementation with L-arginine as amino acid via 
drinking water 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. 
(6)  As regards the use as flavouring, the Auth ority states that no further demonstration of efficacy is necessar y when 
used at the recommended dose. The use of L-arginine as flavouring compo und is not author ised in water for 
drinking. At the recommended dose, L-arginine as flavouring compo und is unlikely to pose any concer n for the 
dietar y supply with all the essential and conditionally essential amino acids. 
(7)  The Auth ority does not consider that there is a need for specifi c requirements of post-market monitor ing. It also 
verified the repor ts on the method of analysis of the feed additive in feed submitte d by the Reference Laboratory 
set up by Regulation (EC) No 1831/2003. 
(8)  The assessment of L-arginine shows 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 this additive should be author ised as 
specified in the Annex to this Regulation. 
(9)  The fact that the use of the L-arginine is not author ised as flavouri ng in wate r for drinking does not preclude its 
use in compo und feed which is administ ered via water . 4.1.2019 L 2/21 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Jour nal 2018;16(5):5276 
(3)EFSA Jour nal 2018;16(5):5277 (10)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Author isation 
1. The substances L-argi nine produced by Corynebacter ium glutamicum KCCM 10741P and L-arginine produced by 
Escher ichia coli NITE BP-02186 specified 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 a feed additive in animal nutr ition subject 
to the conditions laid down in that Annex. 
2. The substance L-arginine produced by Escher ichia coli NITE BP-02186 specified in the Annex, belonging to the 
additive catego ry ‘sensor y additives ’ and to the functional group ‘flavouring compounds’ is author ised as a feed additive 
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 State s. 
Done at Brussels, 3 Januar y 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  4.1.2019 L 2/22 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author ­
isation Additive Composition, chemical formula, descr iption, 
analytical method. Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End 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. 
3c363 — L-arginine Additive composition 
Powder with a minimum conte nt of 
L-argi nine of 98 % (on a dry matter 
basis) and a maximum content of 
1,5 % water 
Char acter isation of the activ e substance 
L-argi nine ((S)-2-amino-5-guanidino ­
pentanoic acid) produced by fer­
mentation with Escher ichia coli NITE 
BP-02186. 
Chemical formula: C6H14N4O2 
CAS number: 74-79-3 
Analytical method (1) 
For the identif ication of L-arginine in 
the feed additive: 
—  Food Chemical Codex ‘L-arginine 
monograph’ 
For the quantification of arginine in 
the feed additive and water: 
—  ion exchang e chromat ography 
coupled with post-column derivat­
isation and phot ometr ic detection 
(IEC- VIS)  All animal 
species    1.  L-arginine may be placed on 
the mark et and used as an ad­
ditive consisting of a prepara ­
tion. 
2.  The additive can be also used 
via water for drinking. 
3.  In the directions for use of the 
additive and premixture, the 
storage conditions, the stability 
to heat treatment and the sta­
bility in water for drinking 
shall be indicate d. 
4.  The moisture cont ent shall be 
indicated on the label of the 
additive. 
5.  Declaration to be made on the 
label of the additive and 
premixture: ‘The supplementa ­
tion with L-argi nine, in par­
ticular via water for drinking, 
should take into account all es­
sential and conditional essen ­
tial amino acids in order to 
avoid imbalances.’  24 Januar y 
2029 4.1.2019 L 2/23 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author ­
isation Additive Composition, chemical formula, descr iption, 
analytical method. Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of 
period 
of author ­
isation mg/kg of complet e feed 
with a moisture content of 
12 % 
For the quantification of arginine in 
premixtures, compound feed and feed 
mater ials: 
—  ion exchang e chromat ography 
coupled with post-column derivat­
isation and phot ometr ic detection 
(IEC- VIS) – Commission Regulation 
(EC) No 152/2009 6.  For users of the additive and 
premixture, feed business oper ­
ator s shall establish operational 
procedures and organisational 
measures to address poten tial 
risks by inhalation. Where 
those risks cannot be elimin ­
ated or reduced to a minimum 
by such procedures and meas ­
ures, the additive and premix ­
ture shall be used with per­
sonal prot ective equipment, 
including breathing protection.           
3c362 — L-arginine Additive composition 
Powder with a minimum conte nt of 
L-argi nine of 98 % (on a dry matter 
basis) and a maximum content of 
0,5 % water 
Char acter isation of the activ e substance 
L-argi nine ((S)-2-amino-5-guanidino ­
pentanoic acid) produced by fermen ­
tation with Corynebacter ium glutamicum 
KCCM10741P 
Chemical formula: C6H14N4O2 
CAS number: 74-79-3 
Analytical method (1) 
For the identif ication of L-arginine in 
the feed additive: 
—  Food Chemical Codex ‘L-arginine 
monograph’  All animal 
species    1.  L-arginine may be placed on 
the mark et and used as an ad­
ditive consisting of a prepara ­
tion. 
2.  The additive can be also used 
via water for drinking. 
3.  In the directions for use of the 
additive and premixture, the 
storage conditions, the stability 
to heat treatment and the sta­
bility in water for drinking 
shall be indicate d. 
4.  Declaration to be made on the 
label of the additive and 
premixture: ‘The supplementa ­
tion with L-argi nine, in par­
ticular via water for drinking, 
should take into account all es­
sential and conditional essen ­
tial amino acids in order to 
avoid imbalances.’  24 Januar y 
2029 4.1.2019 L 2/24 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author ­
isation Additive Composition, chemical formula, descr iption, 
analytical method. Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of 
period 
of author ­
isation mg/kg of complet e feed 
with a moisture content of 
12 % 
For the quantification of arginine in 
the feed additive and water: 
—  ion exchang e chromat ography 
coupled with post-column derivat­
isation and phot ometr ic detection 
(IEC- VIS) 
For the quantification of arginine in 
premixtures, compound feed and feed 
mater ials: 
—  ion exchang e chromat ography 
coupled with post-column derivat­
isation and phot ometr ic detection 
(IEC- VIS) – Commission Regulation 
(EC) No 152/2009 5.  For users of the additive and 
premixture, feed business oper ­
ator s shall establish operational 
procedures and organisational 
measures to address poten tial 
risks by inhalation. Where 
those risks cannot be elimin ­
ated or reduced to a minimum 
by such procedures and meas ­
ures, the additive and premix ­
ture shall be used with per­
sonal prot ective equipment, 
including breathing protection. 
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds 
3c363 — L-Arginine Additive composition 
Powder with a minimum conte nt of 
L-argi nine of 98 % (on a dry matter 
basis) and a maximum content of 
1,5 % water 
Char acter isation of the activ e substance 
L-argi nine ((S)-2-amino-5-guanidino ­
pentanoic acid) produced by fer­
mentation with 
—  Escher ichia coli NITE BP-02186 
Chemical formula: C6H14N4O2 
CAS number 74-79-3 
FLAVIS No 17.003  All animal 
species — — — 1.  L-arginine may be placed on 
the mark et and used as an ad­
ditive consisting of a prepara ­
tion 
2.The additive shall be incor por­
ated into the feed in the form 
of a premixture. 
3.  In the directions for use of the 
additive and premixture, the 
storage conditions and the 
stability to heat treatment shall 
be indicated. 
4.  The moisture cont ent shall be 
indicated on the label of the 
additive.  24 Januar y 
2029 4.1.2019 L 2/25 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author ­
isation Additive Composition, chemical formula, descr iption, 
analytical method. Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of 
period 
of author ­
isation mg/kg of complet e feed 
with a moisture content of 
12 % 
Method of analys is(1) 
For the identif ication of L-arginine in 
the feed additive: 
—  Food Chemical Codex ‘L-arginine 
monograph’ 
For the quantification of arginine in 
the feed additive 
—  ion exchang e chromat ography 
coupled with post-column derivat­
isation and phot ometr ic detection 
(IEC- VIS) 
For the quantification of arginine in 
premixtures, compound feed and feed 
mater ials: 
—  ion exchang e chromat ography 
coupled with post-column derivat­
isation and phot ometr ic detection 
(IEC- VIS) – Commission Regulation 
(EC) No 152/2009 5.  On the label of the additive 
and premixture the followi ng 
shall be indicate d: 
‘Recommended maximum con­
tent of the active substance 
of complet e feedingstuff with 
a moisture content of 12 %: 
25 mg/kg.’ 
6.  For users of the additive and 
premixture, feed business oper ­
ator s shall establish operational 
procedures and organisational 
measures to address poten tial 
risks by inhalation. Where 
those risks cannot be elimin ­
ated or reduced to a minimum 
by such procedures and meas ­
ures, the additive and premix ­
ture shall be used with per­
sonal prot ective equipment, 
including breathing protection. 
(1)  Details of the analytical methods are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed-addi tives/evaluation-repor ts   4.1.2019 L 2/26 Official Jour nal of the European Union EN