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.
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 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.
3c371ii
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L-valine
Additive composition
L-valine with a minimum content of 98 % (on a dry matter basis) and a maximum content of 1,5 % water.
Powder form
All species
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1.
The additive may be used via water for drinking.
2.
The directions for use of the additive and premixture shall indicate the storage conditions, the stability to heat treatment and the stability in water for drinking.
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 appropriate organisational measures to address the potential risks. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing, skin and eye protection.
29 September 2032
Characterisation of the active substance
L-valine ((2S)-2-amino-3-methylbutanoic acid) produced by Escherichia coli CCTCC M2020321
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, feed materials and compound feed:
—
ion exchange chromatography coupled with post-column derivatisation and optical 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 or IEC-VIS/FLD)
( 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