Commission Implementing Regulation (EU) 2026/1117 of 26 May 2026 concerning the authorisation of L-isoleucine produced with Escherichia coli CCTCC M 20231916 as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2026/1117
• Articles: 3

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.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

Name of the 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

3c384i

L-isoleucine

Additive composition

L-isoleucine

Solid form

Characterisation of the active substance

L-isoleucine ≥ 90 % (on a dry matter basis) produced with Escherichia coli CCTCC M 20231916

IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid

Chemical formula: C 6 H 13 NO 2

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), Commission 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 for drinking:

—

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 premixtures, the storage conditions and the stability to heat treatment and in water for drinking 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 moisture content shall be indicated on the label of the additive.

5.

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 nutritional imbalances’.

6.

The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air  ( 3 ) .

7.

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.

16 June 2036

( 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 ).

( 3 )   Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).