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.
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.
3c441
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L-tryptophan
Additive composition:
Powder with a minimum of 98 % L-tryptophan (on a dry matter basis).
Maximum content of 10 mg/kg 1,1′-ethylidene-bis-L-tryptophan (EBT).
All species
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1.
L-tryptophan may be placed on the market and used as an additive consisting of a preparation.
2.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes 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 personal protective equipment, including breathing protection, safety glasses and gloves.
3.
The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1600 IU endotoxins/m 3 air ( 2 ) .
4.
L-tryptophan may be used via water for drinking.
5.
For ruminants, L-tryptophan shall be rumen protected.
6.
The labelling of the additive shall indicate the moisture content.
7.
The labelling of the additive and premixtures shall indicate the following:
‘The supplementation with L- tryptophan, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’
11.3.2030
Characterisation of the active substance:
L-tryptophan produced by fermentation with Escherichia coli KCCM 80135 or
Escherichia coli KCCM 80152 or
Escherichia coli CGMCC 7.248 or
Corynebacterium glutamicum KCCM 80176.
Chemical formula: C 11 H 12 N 2 O 2
CAS No: 73-22-3
Analytical methods
( 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:
—
High performance liquid chromatography with fluorescence detection (HPLC-FLD) – EN ISO 13904
For the determination of tryptophan in compound feed and feed materials:
—
High Performance Liquid Chromatography with fluorescence detection (HPLC-FLD) – Commission Regulation (EC) No 152/2009 (Annex III, G)
For the determination of tryptophan in water:
—
High performance liquid chromatography with fluorescence detection (HPLC-FLD)
( 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
( 2 ) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2017;15(3):4705); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).