COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1033 
of 15 July 2020 
concer ning the renewal of the author isation of L-arginine produced by Cor ynebacter ium glutamicum 
ATCC 13870 and the author isation of L-arginine produced by Cor ynebacter ium glutamicum KCCM 
80182 as feed additiv es for all animal species, and repealing Regulation (EC) No 1139/2007 
(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 and renewing such author isation. 
(2) L-argi nine produced by Corynebacter ium glutamicum ATCC 13870 was author ised for 10 years as a feed additive for 
all animal species by Commission Regulation (EC) No 1139/2007 (2). 
(3) In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitte d for the renewal of 
the author isation of L-argi nine produced by Corynebacter ium glutamicum ATCC 13870 as feed additive for all animal 
species, requesting this additive to be classifie d in the additive categor y ‘nutr itional additives ’, functional group 
‘amino acids, their salts and analogues ’. This application was accompan ied by the particulars and documents 
required under Article 14(2) of Regulation (EC) No 1831/2003 and included a request to change the strain 
designation to Corynebacter ium glutamicum NITE SD 00285. 
(4) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the author isation 
of L-argi nine produced by Corynebacter ium glutamicum KCCM 80182 as a feed additive for use in feed and in water 
for drinking for all animal species. The application concer ns the author isation of L-arginine produced by 
Corynebacter ium glutamicum KCCM 80182 as a feed additive for all animal species to be classif ied in the additive 
catego ry ‘nutr itional additives’, functional group ‘amino acids, their salts and analogues’ and additive catego ry 
‘sensor y additives’, functional group ‘flavouri ng compo unds ’. This application was accompan ied by the particulars 
and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 
(5) The European Food Safety Author ity (‘the Author ity’) concluded in its opinions of 3 Apr il 2019 (3) and 14 May 
2019 (4) that, under the proposed conditions of use, L-arginine produced by Corynebacter ium glutamicum NITE SD 
00285 and by Corynebacter ium glutamicum KCCM 80182 does not have an adverse effect on animal health, 
consumer health or the environment. It also stated for L-arginine produced by Corynebacter ium glutamicum NITE SD 
00285 to be irritant to skin, corrosive to eyes and hazardous upon inhalation. For L-arginine produced by 
Corynebacter ium glutamicum KCCM 80182, it state d to be corrosive to skin and eyes. Theref ore, the Commission 
considers that appropr iate prote ctive measures should be take n to prevent adverse effects on human health, in 
particular as regards the users of the additive. 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-argi nine to be fully efficacious in 
ruminants, it should be protect ed again st degradation in the rumen. 
(6) The Auth ority expressed in its opinion on L-arginine produced by Corynebacter ium glutamicum KCCM 80182 a 
concer n on the safet y of the simultaneous oral administration of the amino acid via wate r for drinking and feed. 
However , the Author ity did not propose a maximum cont ent for L-arginine. Moreover , the Author ity recommends 
supplementation with L-arginine in appropr iate amounts. Thus, in the case of supplementation with L-arginine 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. 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Commission Regulation (EC) No 1139/2007 of 1 October 2007 concer ning the author isation of L-arginine as a feed additive 
(OJ L 256, 2.10.2007, p. 11). 
(3)EFSA Journal 2019;17(5):5696. 
(4)EFSA Journal 2019;17(6):5720. EN Offi cial Jour nal of the European Union 16.7.2020                                                                                                                                         L 227/27   (7) Restr ictions and conditions should be provided for to allow for a better control for L-arginine when used as 
flavouring. For L-arginine used as flavouring recommended cont ent should be indicated on the label. Where such 
conte nt is exceeded, certain information should be indicated on the label of premixtures. 
(8) As regar ds the use of L-argi nine as a flavouring, the Authority states that no further demonstration of efficacy is 
necessar y when the substance is used at the recommended dose level. The use of L-arginine as a flavouring 
compo und is not author ised in water for drinking. At the recommended dose, L-argi nine as flavouring compound 
is not likely to pose any concer n for the dietar y supply with all the essential and conditionally essential amino acids. 
(9) 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. 
(10) The assessment of L-argi nine produced by Corynebacter ium glutamicum NITE SD 00285 and by Corynebacter ium 
glutamicum KCCM 80182 shows that the conditions for author isation, as provid ed for in Article 5 of Regulation 
(EC) No 1831/2003, are satisfied. According ly, the use of this additive should be author ised as specifi ed in the 
Annex to this Regulation. 
(11) As a consequence of the renewal of the author isation of L-arginine produced by Corynebacter ium glutamicum ATCC 
13870 as a feed additive under the conditions laid down in the Annex to this Regulation, 
Regulation (EC) No 1139/2007 should be repealed. 
(12) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
for L-arginine produced by Corynebacter ium glutamicum ATCC 13870, it is appropr iate to provide a transitional 
period for interest ed parties to prepare themselves to meet the new requirements resulting from the renewal of the 
author isation. 
(13) The fact that the use of the L-arginine is not author ised for use as a flavouring in wate r for drinking, does not 
preclude its use in compo und feed, which is administe red via water . 
(14) 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 
1. The author isation of L-arginine produced by Corynebacter ium glutamicum ATCC 13870, belonging to the additive 
catego ry ‘nutr itional additives’ and to the functional group ‘amino acids, their salts and analogues’, is renewed subject to 
the conditions laid down in the Annex. 
2. L-argi nine produced by Corynebacter ium glutamicum KCCM 80182, belonging to the additive catego ry ‘nutr itional 
additives ’ and to the functional group ‘amino acids, their salts and analogues’, and in the additive categor y ‘sensor y 
additives ’, functional group ‘flavouring compo unds ’ is author ised as an additive in animal nutr ition subject to the 
conditions laid down in the Annex. 
Article 2 
1. L-argi nine produced by Corynebacter ium glutamicum ATCC 13870 and premixtures containing it, whic h are produced 
and labelled before 5 Febr uary 2021 in accordance with the rules applicable before 5 August 2020 may continue to be 
placed on the market and used until the existing stoc ks are exhaust ed. 
2. Feed mater ials and compo und feed containing the substances refer red to in point 1, whic h are produced and labelled 
before 5 August 2021 in accordance with the rules applicable before 5 August 2020 may continue to be placed on the 
mark et and used until the existing stoc ks are exhaust ed if they are intended for food-producing animals. EN Offi cial Jour nal of the European Union L 227/28                                                                                                                                         16.7.2020   3. Feed mater ials and compo und feed containing the substances refer red to in point 1, whic h are produced and labelled 
before 5 August 2022 in accordance with the rules applicable before 5 August 2020 may continue to be placed on the 
mark et and used until the existing stoc ks are exhaust ed if they are intended for non-f ood-producing animals. 
Article 3 
Regulation (EC) No 1139/2007 is repealed. 
Article 4 
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, 15 July 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 16.7.2020                                                                                                                                         L 227/29   ANNEX 
Identif ica-
tion 
number of 
the additiv e Name of 
the holder 
of 
author isa-
tion Additiv e Composition, chemical formula, descr iption, 
analytical method. Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation mg/kg of complete feed 
with a moistu re 
content of 12 % 
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues 
3c364 - L-arginine Additiv e composition: 
Powder with a minimum content of L-argi­
nine of 98 % (on a dry matter basis) and a 
maximum conte nt of 15 % water All animal 
species - - - 1. L-argi nine may be placed on the 
mark et and used as an additive 
consisting of a preparation. 
2. In the directions for use of the 
additive and premixture, the sto­
rage conditions and the stability 
to heat treatment shall be indi­
cated . 
3. The moisture content shall be 
indicated on the label of the ad­
ditive. 
4.For users of the additive and pre­
mixture, feed business operators 
shall establish operational pro­
cedures and organisational mea­
sures to address poten tial risks 
for the eyes and skin and by in­
halation. Where those risks can­
not be eliminate d or reduced to a 
minimum by such procedures 
and measures, the additive and 
premixture shall be used with 
personal protective equipment. 5 August 2030 
Character isation of the activ e subs tance: 
L-arginine ((S)-2-amino-5-guanidinopenta­
noic acid) produced by fermentation with 
Corynebacter ium glutamicum NITE SD 
00285. 
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 quantifi cation of arginine in the feed 
additive: 
— ion exchange chromatograph y coupled 
with post-column derivatisation and 
phot ometr ic detec tion (IEC- VIS) 
For the quantification of arginine in premix­
tures, compo und feed and feed mate rials: 
— ion exchange chromatograph y coupled 
with post-column derivatisation and 
phot ometr ic detection (IEC- VIS) – Com­
mission Regulation (EC) No 152/2009 
(Annex III, F) EN Offi cial Jour nal of the European Union L 227/30                                                                                                                                         16.7.2020   3c362 - L-arginine Additiv e composition: 
Powder with a minimum content of L-argi­
nine of 98 % (on a dry matter basis) and a 
maximum conte nt of 0,5 % water All animal 
species - - - 1. L-argi nine may be placed on the 
mark et and used as an additive 
consisting of a preparation. 
2. The additive may also be used via 
water for drinking. 
3. In the directions for use of the 
additive and premixture, the sto­
rage conditions, the stability to 
heat treatment and the stability 
in wate r for drinking shall be in­
dicated. 
4. Declaration to be made on the 
label of the additive and premix­
ture: ‘The supplementation with 
L-argi nine, in particular via 
water for drinking, should take 
into account all essential and 
conditionally essential amino 
acids in order to avoid imbal­
ances.’ 
5.For users of the additive and pre­
mixture, feed business operators 
shall establish operational pro­
cedures and organisational mea­
sures to address poten tial risks 
for skin and eyes. Where those 
risks cannot be eliminated or re­
duced to a minimum by such 
procedures and measures, the 
additive and premixture shall 
be used with personal protect ive 
equipment. 5 August 2030 
Character isation of the activ e subs tance: 
L-arginine ((S)-2-amino-5-guanidinopenta­
noic acid) produced by fermentation with 
Corynebacter ium glutamicum KCCM 80182 
Chemical formula: C6H14N4O2 
CAS number : 74-79-3 
Analytical method (2): 
For the identif ication of L-arginine in the 
feed additive: 
— Food Chemical Codex ‘L-arginine 
monograph’ 
For the quantifi cation of arginine in the feed 
additive and water: 
— ion exchange chromatograph y coupled 
with post-column derivatisation and 
phot ometr ic detec tion (IEC- VIS) 
For the quantification of arginine in premix­
tures, compo und feed and feed mate rials: 
— ion exchange chromatograph y coupled 
with post-column derivatisation and 
phot ometr ic detection (IEC- VIS) – Com­
mission Regulation (EC) No 152/2009 
(Annex III, F) EN Offi cial Jour nal of the European Union 16.7.2020                                                                                                                                         L 227/31   Categor y: Sensor y additiv es. Functional group: Flavour ing compounds 
3c362 - L-arginine Additiv e composition: 
Powder with a minimum content of L-argi­
nine of 98 % (on a dry matter basis) and a 
maximum conte nt of 0,5 % water All animal 
species  - - 1. L-argi nine may be placed on the 
mark et and used as an additive 
consisting of a preparation. 
2.The additive shall be incor po­
rated into the feed in the form 
of a premixture. 
3. In the directions for use of the 
additive and premixture, the sto­
rage conditions and the stability 
to heat treatment shall be indi­
cated . 
4. On the label of the additive the 
follo wing shall be indicated: 
‘Recommended maximum con­
tent of the active substance of 
compl ete feedingstuff with a 
moisture conte nt of 12 %: 25 
mg/kg.’ 
5.The functional group, the identi­
fication number , the name and 
the added amount of the active 
substance shall be indicated on 
the label of the premixtures, if 
the followi ng conte nt of the ac­
tive substance in compl ete fee­
dingstuff with a moisture con­
tent of 12 % is exceed ed: 25 
mg/kg. 
6.For users of the additive and pre­
mixture, feed business operators 
shall establish operational pro­
cedures and organisational mea­
sures to address poten tial risks 
for skin and eyes. Where those 
risks cannot be eliminated or re­
duced to a minimum by such 
procedures and measures, the 
additive and premixture shall 
be used with personal protect ive 
equipment. 5 August 2030 
Character isation of the activ e subs tance: 
L-arginine ((S)-2-amino-5-guanidinopenta­
noic acid) produced by fermentation with 
Corynebacter ium glutamicum KCCM 80182 
Chemical formula: C6H14N4O2 
CAS number : 74-79-3 
Flavis 17.003 
Analytical method (3): 
For the identif ication of L-arginine in the 
feed additive: 
— Food Chemical Codex ‘L-arginine 
monograph’ 
For the quantifi cation of arginine in the feed 
additive: 
— ion exchange chromatograph y coupled 
with post-column derivatisation and 
phot ometr ic detec tion (IEC- VIS) 
For the quantification of arginine in premix­
tures, compo und feed and feed mate rials: 
— ion exchange chromatograph y coupled 
with post-column derivatisation and 
phot ometr ic detection (IEC- VIS) – Com­
mission Regulation (EC) No 152/2009 
(Annex III, F). EN Offi cial Jour nal of the European Union L 227/32                                                                                                                                         16.7.2020   (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) 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 
(3) 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   EN Offi cial Jour nal of the European Union 16.7.2020                                                                                                                                         L 227/33