Commission Implementing Regulation (EU) 2024/997 of 3 April 2024 concerning the authorisation of L-valine produced by Corynebacterium glutamicum CGMCC 18932 as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2024/997
• 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 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

3c373

L-valine

Additive composition

L-valine with a minimum content of 98 % (on a dry matter basis) and a maximum content of 0,5 % water.

Solid form

Characterisation of the active substance

L-valine ((2S)-2-amino-3-methylbutanoic acid) produced by Corynebacterium glutamicum CGMCC 18932

Chemical formula: C 5 H 11 NO 2

CAS number: 72-18-4

Analytical method

( 1 )

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

—

Food Chemical Codex ‘L-valine monograph’

For the quantification of valine in the feed additive:

—

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

For the quantification of valine in premixtures and compound feed:

—

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

For the quantification of valine in water:

—

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

All animal species

—

—

—

1.

In the directions for use of the additive and premixtures, 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 premixtures:

‘The supplementation with L-valine, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

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 skin, eye and breathing protective equipment.

24 April 2034

( 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 ).