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Official Journal EN
of the European Union L series
2025/634 2.4.2025
COMMISSION IMPLEMENTING REGULATION (EU) 2025/634
of 1 April 2025
concerning the authorisation of L-arginine produced with Escherichia coli CGMCC 7.401 as a feed
additive for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003on
additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such an authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation
of L-arginine produced with Escherichia coli CGMCC 7.401. That application was accompanied by the particulars
and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concerns the authorisation of L-arginine produced with Escherichia coli CGMCC 7.401 as a feed
additive for use in feed and in water for drinking for all animal species, requesting that additive to be classified in the
category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 September 2024(2)that, under
the proposed conditions of use, L-arginine produced with Escherichia coli CGMCC 7.401 is safe for the target species
when supplemented in appropriate amounts to the diet according to their nutritional needs. However, the Authority
has concerns on the safety of the substance for the target species resulting from the simultaneous administration of
L-arginine via water for drinking and feed, due to possible amino acid imbalances and hygienic reasons. The
Authority concluded that the use of L-arginine produced with Escherichia coli CGMCC 7.401 in animal nutrition is
considered safe for the consumers and for the environment. In the absence of data, the Authority could not
conclude on the potential of the additive to be irritant to skin or eyes, or on its potential to be a dermal or
respiratory sensitiser. The Authority further concluded that the substance is regarded as an efficacious source of the
essential amino acid L-arginine for non-ruminant species and that for the substance to be fully efficacious in
ruminants, it should be protected against degradation in the rumen. The Authority did not consider that there is a
need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of
the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) In view of the above, the Commission considers that L-arginine produced with Escherichia coli CGMCC 7.401 satisfies
the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance as
a feed additive should be authorised. When fed to ruminants, L-arginine needs to be protected against degradation in
the rumen. It is appropriate to alert the user to take into account the dietary supply with all the essential and
conditionally essential amino acids, in particular in the case of supplementation with L-arginine via water for
drinking. In addition, the Commission considers that appropriate protective measures should be taken to prevent
adverse effects on the health of the users of the additive.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) EFSA Journal 2024, 22(10), e9028.
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OJ L, 2.4.2025
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Authorisation
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group
‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition, subject to the conditions laid down
in that Annex.
Article 2
Entry into force
This Regulation shall enter into force on the twentieth day following 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, 1 April 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/634/ojANNEX
Identifica- Minimum Maximum
tion Species or content content
Composition, chemical formula, Maximum End of period of
number of Additive category Other provisions
description, analytical method age authorisation
the feed of animal mg/kg of complete feed with
additive 12 % moisture content
Category: nutritional additives. Functional group: amino acids, their salts and analogues
3c366 L-arginine Additive composition: All — — — 1. In the directions for use of 22 April 2035
animal the additive and
L-arginine ≥ 98,5 % (on a dry matter
species premixtures, the storage
basis)
conditions, the stability to
heat treatment and in water
Solid form
shall be indicated.
2. The additive may be used via
Characterisation of the active substance: water for drinking.
3. Feed business operators shall
L-arginine ((S)-2-amino- ensure that L-arginine is
5-guanidinopentanoic acid) produced rumen protected, when fed
with Escherichia coli CGMCC 7.401 to ruminants.
Chemical formula: C 6H 14N 4O 2 4. The moisture content shall
CAS number: 74–79-3 be indicated on the label of
the additive.
Analytical method(1):
5. The label of the additive and
For the identification of L-arginine in premixtures shall indicate
the feed additive: the following:
— Food Chemical Codex ‘L-arginine ‘The supplementation with
monograph’ L-arginine, in particular via
water for drinking, shall take
For the determination of arginine in
into account all essential and
the feed additive and water:
conditionally essential
— Ion-exchange chromatography
amino acids in order to avoid
coupled with post-column
imbalances.’
derivatisation and optical
detection (IEC-VIS);
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ENIdentifica- Minimum Maximum
tion Species or content content
Composition, chemical formula, Maximum End of period of
number of Additive category Other provisions
description, analytical method age authorisation
the feed of animal mg/kg of complete feed with
additive 12 % moisture content
Category: nutritional additives. Functional group: amino acids, their salts and analogues
For the determination of arginine in 6. For users of the additive and
premixtures and compound feed: premixtures, feed business
— Ion-exchange chromatography operators shall establish
coupled with post-column operational procedures and
derivatisation and optical organisational measures to
detection (IEC-VIS), Commission address potential risks
Regulation (EC) 152/2009(2) resulting from their use.
Where those risks cannot be
eliminated by such
procedures and measures,
the additive and premixtures
shall be used with personal
skin, eye and breathing
protective equipment.
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-
evaluation-reports_en.
(2) Commission Regulation (EC) No 152/2009 of 27 January 2009laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1, ELI: http://data.europa.eu/eli/reg/
2009/152/oj).
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