Commission Implementing Regulation (EU) 2023/2583 of 20 November 2023 concerning the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80185 as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2023/2583
• Articles: 3

Article 1

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

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

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

3c384

L-isoleucine

Additive composition

Powder with a minimum content of L-isoleucine of 90 % (on a dry matter basis)

Characterisation of the active substance

L-isoleucine produced by fermentation with Corynebacterium glutamicum KCCM 80185

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 quantification of isoleucine in the feed additive:

—

ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or

—

ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS)

For the quantification of isoleucine in premixtures:

—

ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or

—

ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009  ( 2 ) (Annex III, F)

For the quantification of isoleucine in compound feed:

—

ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (Annex III, F)

For the quantification of isoleucine in water:

—

ion-exchange chromatography coupled to post-column derivatisation and photometric 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.

Declaration to be made on the label of the additive and premixture:

—

‘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.’

—

L-isoleucine content.

4.

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 breathing protective equipment.

11 December 2033

( 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 ).