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.
2. The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ 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: nutritional additives. Functional group: amino acids, their salts and analogues
3c451
-
L-glutamine
Additive composition:
Powder with a minimum content of 98 % L-glutamine
Characterisation of the active substance:
L-glutamine produced by fermentation with Corynebacterium glutamicum NITE BP-02524
IUPAC name: (2S)-2,5-diamino-5-oxopentanoic acid
CAS number: 56-85-9
Einecs number: 200-292-1
Chemical formula: C 5 H 10 N 2 O 3
Analytical method
( 1 ) :
For the identification of L-glutamine in the feed additive:
—
Food Chemical Codex ‘L-glutamine monograph’
For the quantification of glutamine in the feed additive, premixtures, compound feed and feed materials:
—
Ion exchange chromatography coupled to post-column derivatisation and optical detection) (IEC-VIS/FLD).
All animal species
-
-
-
1.
L-glutamine may be placed on the market and used as an additive consisting of a preparation.
2.
In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.
3.
Declaration to be made on the label of the additive and premixture:
‘The supplementation with L-glutamine shall ensure an adequate amino acid profile in feed and address potential glutamine shortages during critical periods of life.’
21.12.2030
Category: Sensory additives. Functional group: Flavouring compounds
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 of active substance/kg of complete feed with a moisture content of 12 %
3c451
-
L-glutamine
Additive composition:
Powder with a minimum content of
98 % L-glutamine
Characterisation of the active substance:
L-glutamine produced by fermentation with Corynebacterium glutamicum NITE BP-02524
IUPAC name: (2S)-2,5-diamino-
5-oxopentanoic acid
CAS number: 56-85-9
Einecs number: 200-292-1
Chemical formula: C 5 H 10 N 2 O 3
Flavis number: 17.007
Analytical method
( 1 ) :
For the identification of L-glutamine in the feed additive:
—
Food Chemical Codex ‘L-glutamine monograph’
For the quantification of glutamine in the feed additive and premixtures:
—
Ion exchange chromatography coupled to visible or fluorescence detection with post-column derivatisation and optical detection) (IEC-VIS/FLD), as described in EN ISO 17180:2013
All animal species
-
-
-
1.
L-glutamine may be placed on the market and used as an additive consisting of a preparation.
2.
The additive shall be incorporated into the feed in the form of a premixture.
3.
In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.
4.
On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’.
5.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.
21.12.2030
( 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
