Commission Implementing Regulation (EU) 2021/2080 of 26 November 2021 concerning the authorisation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive for all animal species except finfish (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/2080 of 26 November 2021 concerning the authorisation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive for all animal species except finfish (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. The substance L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 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-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 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.
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
3c351i
-
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 except finfish
-
-
-
1.
In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.
2.
Declaration to be made on the label of the additive and premixture:
—
‘The supplementation with L-histidine monohydrochloride monohydrate shall be limited to the nutritional requirements of the target animal, which depend on the species, the physiological state of the animal, the performance level, the environmental conditions, the level of other amino acids in the diet and the level of essential trace elements, such as copper and zinc.’
—
‘Histidine content’.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks by inhalation or dermal 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 appropriate personal protective equipment, including eyes, skin and breathing protection.
19 December 2031
Characterisation of the active substance
L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268
Chemical formula: C 3 H 3 N 2 -CH 2 -CH(NH 2 )-COΟΗ·ΗCl·Η 2 O
CAS number: 5934-29-2
Einecs number 211-438-9
Analytical method
( 1 )
For the quantification of histidine in the feed additive:
—
high performance liquid chromatography coupled with spectrophotometric 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 optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F).
For the quantification of histamine in the feed additive:
—
high performance liquid chromatography coupled to a spectrophotometric detection (HPLC-UV).
Category: Sensory additives
Functional group: Flavouring compounds
3c351i
-
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.
The additive shall be incorporated into the feed in the form of a premixture.
2.
In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.
3.
On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance of complete feed with a moisture content of 12 %: 25 mg/kg.
4.
The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture, where the use level on the label of the premixture would result in exceeding the level of active substance in complete feed referred to in point 3.
5.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks by inhalation or dermal 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 appropriate personal protective equipment, including eyes, skin and breathing protection.
19 December 2031
Characterisation of the active substance
L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268
Chemical formula: C 3 H 3 N 2 -CH 2 -CH(NH 2 )-COΟΗ·ΗCl·Η 2 O
CAS number: 5934-29-2
Einecs number 211-438-9
Analytical method
( 1 )
For the quantification of histidine in the feed additive:
—
performance liquid chromatography coupled with spectrophotometric 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), Commission Regulation (EC) No 152/2009 (Annex III, F).
For the quantification of histamine in the feed additive:
—
high performance liquid chromatography coupled to a spectrophotometric detection (HPLC-UV).
( 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
