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 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
3c443
L-tryptophan
Additive composition
L-tryptophan ≥ 98 % (on a dry matter basis)
Solid form
Maximum content of 10 mg/kg 1,1′-ethylidene-bis-L-tryptophan (EBT)
Characterisation of the active substance
L-tryptophan produced with Corynebacterium glutamicum KCCM 80346
IUPAC name: (2S)-2-amino-3-(1H-indol-3-yl) propanoic acid
Chemical formula: C 11 H 12 N 2 O 2
CAS number: 73-22-3
Analytical method
( 1 )
For the identification of L-tryptophan in the feed additive:
—
Food Chemical Codex ‘L-tryptophan’ monograph
For the determination of tryptophan in the feed additive and premixtures:
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High performance liquid chromatography with fluorescence detection (HPLC-FLD) - EN ISO 13904
For the determination of tryptophan in compound feed:
—
High performance liquid chromatography with fluorescence detection (HPLC-FLD), Commission Regulation (EC) No 152/2009
For the determination of tryptophan in water:
—
High performance liquid chromatography with fluorescence detection (HPLC-FLD)
All animal species
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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.
Feed business operators shall ensure that L-tryptophan is rumen protected, when fed to ruminants.
4.
The moisture content shall be indicated on the label of the additive.
5.
The labelling of the additive and premixtures shall indicate the following: ‘The supplementation with L-tryptophan, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid imbalances.’
16 October 2035
( 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 .