Commission Implementing Regulation (EU) 2021/2077 of 26 November 2021 concerning the authorisation of L-valine produced by Corynebacterium glutamicum CGMCC 7.366 as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/2077
• 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 a feed 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

Name of the holder of authorisation

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 a moisture content of 12 %

Category of nutritional additives

Functional group: amino acids, their salts and analogues

3c371i

-

L-valine

Additive composition

Powder with a minimum content of L-valine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water.

All species

-

1.

The additive may be used via water for drinking.

2.

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

3.

The label of the additive and premixture shall indicate the following: ‘The supplementation with L-valine, in particular via water for drinking, should take into account all essential and conditional 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 the potential risks by inhalation, eye or dermal contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including eyes, skin and breathing protection.

19 December 2031

Characterisation of the active substance

L-valine ((2S)-2-amino-3-methylbutanoic acid) produced by Corynebacterium glutamicum CGMCC 7.366

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 photometric detection (IEC-VIS)

For the quantification of valine in premixtures, feed materials and compound feed:

—

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

For the quantification of valine in water:

—

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

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports