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.
3c410
—
L-threonine
Additive composition:
Powder with a minimum of 98 % L-threonine (on a dry matter basis).
Characterisation of the active substance:
L-threonine produced by fermentation with
Escherichia coli CGMCC 7.232
Chemical formula: C 4 H 9 NO 3
CAS Number: 72-19-5.
Analytical methods
( 1 ) :
For the determination of L-threonine in the feed additive:
—
Food Chemical Codex ‘L-threonine monograph’ and
—
Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FD) – EN ISO 17180.
For the determination of threonine in premixtures:
—
ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FD) – EN ISO 17180 and
—
ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F).
For the determination of threonine in compound feed and feed materials:
—
Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS): Commission Regulation (EC) No 152/2009 (Annex III, F).
For the determination of threonine in water:
—
ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FD).
All species
—
—
—
1.
L- threonine 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. 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.
3.
The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air ( 2 ) .
4.
L-threonine may be used via water for drinking.
5.
The labelling of the additive shall indicate the moisture content.
6.
The labelling of the additive and premixtures shall indicate the following:
‘If the additive is administered via water for drinking, protein excess should be avoided.’
18 June 2029
( 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 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).