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Official Journal EN
of the European Union L series
2025/143 30.1.2025
COMMISSION IMPLEMENTING REGULATION (EU) 2025/143
of 29 January 2025
concerning the authorisation of L-isoleucine produced with Corynebacterium glutamicum CGMCC
20437 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-isoleucine produced with Corynebacterium glutamicum CGMCC 20437. 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-isoleucine produced with Corynebacterium glutamicum CGMCC
20437 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 12 March 2024(2)that, under the
proposed conditions of use, L-isoleucine produced with Corynebacterium glutamicum CGMCC 20437 is safe for the
target species, for the consumer and for the environment. Regarding the use in water, the Authority has concerns
on the safety for the target species of L-isoleucine resulting from the simultaneous oral administration of
L-isoleucine via water for drinking and feed, due to the risk of nutritional imbalances and hygienic reasons. In the
absence of data, the Authority was not in a position to conclude on the potential of L-isoleucine produced with
Corynebacterium glutamicum CGMCC 20437 to be irritant to skin and/or eyes, or as a dermal sensitiser. Due to the
high dusting potential, exposure by inhalation was considered likely. The Authority further concluded that the
substance is considered an efficacious source of the essential amino acid L-isoleucine 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-isoleucine produced with Corynebacterium glutamicum CGMCC
20437 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-isoleucine 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-isoleucine
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, 22(4), e8726.
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OJ L, 30.1.2025
(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, 29 January 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/143/ojANNEX
Maxi-
Minimum
mum
Identifica- content
Species or content
tion number Composition, chemical formula, description, analytical Maxi- End of period of
Additive category of Other provisions
of the feed method mum age authorisation
animal mg/kg of complete feed
additive
with 12 % moisture
content
Category: nutritional additives. Functional group: amino acids, their salts and analogues
3c385 L-isoleucine Additive composition All animal - - 1. In the directions for use 19 February 2035
Powder with a minimum content of L-isoleucine of species of the additive and
93,5 % (on a dry matter basis) and a maximum premixture, the storage
moisture content of 2 % conditions, the stability
to heat treatment and in
Characterisation of the active substance
water shall be indicated.
L-isoleucine produced with Corynebacterium
glutamicum CGMCC 20437
2. The additive may be used
Chemical formula: C H NO via water for drinking.
6 13 2
CAS number: 73-32-5 3. Feed business operators
shall ensure that
Analytical method(1)
L-isoleucine is rumen
For the identification of L- isoleucine in the feed
protected, when fed to
additive:
ruminants.
— Food Chemical Codex ‘L-isoleucine
monograph’; 4. The labelling of the
additive and
For the determination of isoleucine in the feed
premixtures shall
additive:
indicate the following:
— Ion-exchange chromatography coupled to
‘The supplementation
post-column derivatisation and optical
with L-isoleucine, in
detection (IEC-VIS/FLD or IEC-VIS);
particular via water for
For the determination of isoleucine in premixtures:
drinking, shall take into
— Ion-exchange chromatography coupled to account all essential and
post-column derivatisation and optical conditionally essential
detection (IEC-VIS/FLD) or amino acids in order to
avoid imbalances.’
— Ion-exchange chromatography coupled to
post-column derivatisation and optical
detection (IEC-VIS), Regulation (EC)
No 152/2009(2);
ELI:
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ENMaxi-
Minimum
mum
Identifica- content
Species or content
tion number Composition, chemical formula, description, analytical Maxi- End of period of
Additive category of Other provisions
of the feed method mum age authorisation
animal mg/kg of complete feed
additive
with 12 % moisture
content
Category: nutritional additives. Functional group: amino acids, their salts and analogues
For the determination of isoleucine in compound 5. For users of the additive
feed: and premixtures, feed
business operators shall
— Ion-exchange chromatography coupled to
establish operational
post-column derivatisation and optical
procedures and
detection (IEC-VIS), Regulation (EC)
organisational measures
No 152/2009;
to address potential risks
For the determination of isoleucine in water: resulting from their use.
Where those risks cannot
— Ion-exchange chromatography coupled to
be eliminated by such
post-column derivatisation and optical
procedures and
detection (IEC-VIS).
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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