COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/649 
of 20 March 2023
concer ning the author isation of L-arginine produced by Cor ynebacter ium glutamicum CGMCC 20516 
as a feed additiv e 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-argi nine produced by Corynebacter ium glutamicum CGMCC 20516. That application was accompanied by the 
particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concer ns the author isation of L-arginine produced by Corynebacter ium glutamicum CGMCC 20516 as 
a feed additive for all animal species, to be classif ied in the additive catego ry ‘nutr itional additives ’ and in the 
functional group ‘amino acids, their salts and analogues’.
(4) The European Food Safet y Author ity (‘the Author ity’) concluded in its opinion of 29 June 2022 (2)that, under the 
proposed conditions of use, L-argi nine produced by Corynebacter ium glutamicum CGMCC 20516 does not have an 
adverse effect on consumer safety or the environment, or on animal health when supplement ed in appropr iate 
amounts to the diet according to the nutr itional needs of the target species and when nutr itional imbalances caused 
by the simultaneous administration of L-arginine via water for drinking and feed are prevented.
(5) The Author ity further concluded that exposure of users by inhalation is possible. The applicant provided the safety 
data sheet required in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council (3)whic h demonstrates that the additive may cause eyes and skin irritation.
(6) The Author ity concluded that the additive has 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 additive in feed submitted by the Reference Laborator y set up by 
Regulation (EC) No 1831/2003.
(7) The assessment of L-arginine produced by Corynebacter ium glutamicum CGMCC 20516 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 
that substance should be author ised. The Commission considers that appropr iate protect ive measures should be 
taken to prevent adverse effects on human health, in particular as regards the users of the additive.
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2022;20(7):7427.
(3)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concer ning the Registration, 
Evaluation, Author isation and Restr iction of Chemicals (REA CH), establishing a European Chemicals Agen cy, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as 
Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 
30.12.2006, p. 1).EN Offi cial Jour nal of the European Union 21.3.2023 L 81/13  (8) 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 substance specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional group 
‘amino acids, their salts and analogues’, is author ised as an additive 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, 20 Marc h 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 81/14 21.3.2023  ANNEX 
Identification 
number of 
the additiveAdditiveCompo sition, chemical formula, descr iption, analytical 
method.Species or 
categ ory of 
animalMaximum 
ageMinimum 
contentMaximum 
conten t
Other provisi onsEnd of period of 
author isationmg of additive/kg of 
compl ete feed with a 
moisture conten t of 
12 %
3c365 L-arginine Additive composition
≥ 98,5 % L-argi nine (on a dry matter basis) and ≤ 1 % 
of water
Solid formAll species — — — 1.The additive may be used via water for 
drinking.
2.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.
3.The label of the additive and premix ­
ture shall indicate the following: ‘The 
supplementation with L-arginine, in 
particular via wate r 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 premix ­
tures, feed business operat ors shall es­
tablish operational procedures and 
appropr iate organisational measures 
to address the poten tial risks. Where 
risks cannot be reduced to an accep ­
table level by these procedures and 
measures, the additive and premix ­
tures shall be used with appropr iate 
personal protective equipment, in­
cluding breathing, skin and eye pro­
tectio n.11.4.2033
Char acter isation of the active substance
L-argi nine ((S)-2-amino-5-guanidinopentanoic acid) 
produced by Corynebacter ium glutamicum CGMCC 
20516
Chemical formula: C6H14N4O2
CAS number: 74–79-3
Analytical method (1)
For the identification of L-argi nine in the feed 
additive:
— Food Chemical Codex ‘L-arginine monograph’.
For the determination of arginine in the feed additive 
and wate r:
— Ion-exc hang e chromat ography coupled with 
post-column derivatisation and optical detection 
(IEC- VIS).
For the deter mination of arginine in premixtures and 
compl ete feed:
— Ion exchange chromatograph y coupled with 
post-column derivatisation and optical detection 
(IEC- VIS), Commission Regulation (EC) 
No 152/2009 (Annex III, F).
(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_en .EN Offi cial Jour nal of the European Union 21.3.2023 L 81/15