1. The substance L-cystine produced by Pantoea ananatis NITE BP-02525 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 L-cystine produced by Pantoea ananatis NITE BP-02525 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.
3c392
-
L-cystine
Additive composition:
Powder with a minimum content of 98 % L-cystine
All animal species
-
-
-
1.
L-cystine may be placed on the market and used as an additive consisting of a preparation.
2.
The additive can be also used via water for drinking.
3.
For users of the additive and premixture, 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 premixture shall be used with personal protective equipment.
4.
In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.
5.
Declaration to be made on the label of the additive and premixture:
‘-
The supplementation with L-cystine, shall depend on the requirements of the target animals for sulphur- containing amino acids and the level of other sulphur-containing amino acids in the ration.
-
The supplementation with L-cystine, in particular via water for drinking, should take into account all amino acids in the animals ‘diet in order to avoid imbalances.’
22.10.2030
Characterisation of the active substance:
L-cystine produced by fermentation with Pantoea ananatis NITE BP-02525
IUPAC name: (2R)-2-amino-3-[(2R)-2-amino-3-hydroxy-3-oxopropyl] disulfanyl-propanoic acid
CAS number: 56-89-3
Chemical formula: C 6 H 12 N 2 O 4 S 2
Analytical method
( 1 ) :
For the identification of L-cystine in the feed additive:
—
Food Chemical Codex ‘L-cystine monograph’
For the quantification of cystine in the feed additive and premixtures:
—
ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD), as described in EN ISO 17 180
For the quantification of cystine in premixtures, compound feed and feed materials:
—
ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 ( 2 ) (Annex III, F)
For the quantification of cystine in water:
—
ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), as described in EN ISO 13 903 or Commission Regulation (EC) No 152/2009 (Annex III, F)
Category: Sensory additives. Functional group: Flavouring compounds
3c392
-
L-cystine
Additive composition:
Powder with a minimum content of 98 % L-cystine
All animal species
-
-
-
1.
L-cystine 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.
6.
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.
22.10.2030
Characterisation of the active substance:
L-cystine produced by fermentation with Pantoea ananatis NITE BP-02525
IUPAC name: (2R)-2-amino-3-[(2R)-2-amino-3-hydroxy-3-oxopropyl] disulfanyl-propanoic acid
CAS number: 56-89-3
Chemical formula: C 6 H 12 N 2 O 4 S 2
Analytical method
( 3 ) :
For the determination of L-cystine in the feed additive:
—
Food Chemical Codex ‘L-cystine monograph’
For the quantification of cystine in the feed additive and premixtures:
—
ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD), as described in EN ISO 17 180
( 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 )
OJ L 54, 26.2.2009, p. 1 .
( 3 ) 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
