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.
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.
ANNEXSupplementary provisions
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
3c375
L-valine
Additive composition
Fermentation product consisting of inactivated cells of Corynebacterium glutamicum KCCM 80366 with a minimum L-valine content of 72 % (on a dry matter basis).
Solid form.
Characterisation of the active substance
L-valine produced from Corynebacterium glutamicum KCCM 80366
IUPAC name: (2S)-2-amino-3-methylbutanoic acid
Chemical formula: C 5 H 11 NO 2
CAS number: 72-18-4
Analytical method
( 1 )
For the determination of valine in the feed additive:
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Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC—VIS)
For the determination of valine in premixtures and compound feed:
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Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC—VIS), Commission Regulation (EC) No 152/2009 ( 2 )
All animal species
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—
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1.
In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.
2.
Feed business operators shall ensure that L-valine is rumen protected, when fed to ruminants.
3.
The moisture content shall be indicated on the label of the additive.
4.
The label of the additive and premixtures shall indicate the following: ‘The supplementation with L-valine shall take into account all essential and conditionally essential amino acids in order to avoid nutritional imbalances.’
5.
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.
10 August 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 ).