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 2003 on 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.

(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

(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.

ANNEX

Identification number of the feed additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg/kg of complete feed with 12 % moisture content

Category: nutritional additives. Functional group: amino acids, their salts and analogues

3c385

L-isoleucine

Additive composition

Powder with a minimum content of L-isoleucine of 93,5 % (on a dry matter basis) and a maximum moisture content of 2 %

Characterisation of the active substance

L-isoleucine produced with Corynebacterium glutamicum CGMCC 20437

Chemical formula: C6H13NO2

CAS number: 73-32-5

Analytical method (1)

For the identification of L- isoleucine in the feed additive:

—	Food Chemical Codex ‘L-isoleucine monograph’;

For the determination of isoleucine in the feed additive:

—	Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD or IEC-VIS);

For the determination of isoleucine in premixtures:

—	Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD) or

—	Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Regulation (EC) No 152/2009(2);

For the determination of isoleucine in compound feed:

—	Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS), Regulation (EC) No 152/2009;

For the determination of isoleucine in water:

—	Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS).

All animal species

1.	In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and in water shall be indicated.

2.	The additive may be used via water for drinking.

3.	Feed business operators shall ensure that L-isoleucine is rumen protected, when fed to ruminants.

4.	The labelling of the additive and premixtures shall indicate the following: ‘The supplementation with L-isoleucine, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks 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.

19 February 2035

(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 2009 laying 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

ELI: http://data.europa.eu/eli/reg_impl/2025/143/oj

ISSN 1977-0677 (electronic edition)