1. L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526, Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179 specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’ are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
2. L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526 or Corynebacterium glutamicum KCCM 80179 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 of nutritional additives. Functional group: amino acids, their salts and analogues
3c352
-
L-histidine monohydrochloride monohydrate
Additive composition:
Powder with a minimum content of
98 % L-histidine monohydrochloride monohydrate and
72 % histidine and
a maximum content of 100 ppm histamine
All animal species
-
-
-
1.
L-histidine monohydrochloride monohydrate 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.
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.
For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks for the eyes and skin and 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.
5.
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.
6.
Declaration to be made on the label of the additive and premixture:
‘The supplementation with L-histidine monohydrochloride monohydrate, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’
—
Histidine content.
16.8.2030
Characterisation of the active substance:
L-histidine monohydrochloride monohydrate produced by fermentation with Corynebacterium glutamicum KCCM 80172 or
Corynebacterium glutamicum KCCM 80179 or
Escherichia coli NITE BP-02526
Chemical formula: C 3 H 3 N 2 -CH 2 -CH(NH 2 )-COΟΗ· HCl· H 2 O
CAS number: 5934-29-2
Analytical method
( 1 ) :
For the quantification of histidine in the feed additive:
—
high performance liquid chromatography coupled with photometric detection (HPLC-UV)
—
ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)
For the quantification of histidine in premixtures, feed materials and compound feed:
—
ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)
For the quantification of histidine in water:
—
ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS/FLD)
Category: Sensory additives. Functional group: Flavouring compounds
3c352
-
L-histidine monohydrochloride monohydrate
Additive composition:
Powder with a minimum content of
98 % L-histidine monohydrochloride monohydrate and
72 % histidine and
a maximum content of 100 ppm histamine
All animal species
-
-
-
1.
L-histidine monohydrochloride monohydrate 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.
The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air ( 3 ) .
4.
For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks for the eyes and skin and 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.
5.
In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.
6.
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 ‘
—
The histidine content.
7.
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.
16.8.2030
Characterisation of the active substance:
L-histidine monohydrochloride monohydrate produced by fermentation with Corynebacterium glutamicum KCCM 80179 or
Escherichia coli NITE BP-02526.
Chemical formula: C 3 H 3 N 2 -CH 2 -CH(NH 2 -COΟΗ· HCl· H 2 O
CAS number: 5934-29-2
Analytical method
( 1 ) :
For the quantification of histidine in the feed additive:
—
high performance liquid chromatography coupled with photometric detection (HPLC-UV)
—
ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)
For the quantification of histidine in premixtures:
—
ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or
—
ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)
For the quantification of histidine in feed materials and compound feed:
—
ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F)
( 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).
( 3 ) 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).
