COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/2080 
of 26 November 2021
concer ning the author isation of L-hist idine monohydrochloride monohydrate produced by 
ferment ation with Escherichia coli NITE SD 00268 as a feed additiv e for all animal species except 
finfish 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such an author isation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of the extension of use of L-histidine monohydroc hlor ide monohydrat e produced by fermentation with Escher ichia 
coli NITE SD 00268 as a feed additive from finfish to all animal species. That application was accompanied by the 
particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concer ns the author isation of the extensi on of use of L-hi stidine monohydroc hlor ide monoh ydrate 
produced by fermentation with Escher ichia coli NITE SD 00268 as a feed additive from finfish to all animal species to 
be classified in the additive cate gory ‘nutr itional additives ’, functional group ‘amino acids, their salts and analogues ’, 
and in the additive catego ry ‘sensor y additives’, functional group ‘flavouring compo unds ’.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 5 May 2021 (2)that, under the 
proposed conditions of use, L-histidine monohydroc hlor ide monohyd rate produced by fermentation with 
Escher ichia coli NITE SD 00268 does not have an adverse effect on animal health, consumers safet y or the 
environment. The Author ity also concluded for the additive in question that it was not possible to conclude on the 
poten tial for the additive to be toxic if inhaled, an irritant to eyes or a skin sensitiser . Theref ore, the Commission 
considers that appropr iate prote ctive measures should be take n to prevent adverse effects on human health, in 
particular as regards the users of the additive. The Authority also concluded that the additive is an efficacious source 
of the essential amino acid histidine and efficacious as a flavouring compound.
(5) The Author ity does not consider that there is a need for specif ic requirements of post-market monit oring. It also 
verified the repor ts on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set 
up by Regulation (EC) No 1831/2003.
(6) The assessment of L-histidine monohydroc hlor ide monohydrat e produced by fermentation with Escher ichia coli NITE 
SD 00268 shows that the conditions for author isation, as provided for in Article 5 of Regulation (EC) 
No 1831/2003, are satisfi ed. According ly, the use of this additive should be author ised as specified in the Annex to 
this Regulation.
(7) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2021; 19(5):6622.EN Offi cial Jour nal of the European Union 29.11.2021 L 426/23  HAS ADOPTED THIS REGUL ATION:
Article 1
1. The substance L-histidine monoh ydrochlor ide monoh ydrate produced by fermentation with Escher ichia coli NITE SD 
00268 specified in the Annex, belonging to the additive categor y ‘nutr itional additives’ and to the functional group ‘amino 
acids, their salts and analogues ’, is author ised as a feed additive in animal nutr ition subject to the conditions laid down in 
that Annex.
2. The substance L-histidine monoh ydrochlor ide monoh ydrate produced by fermentation with Escher ichia coli NITE SD 
00268 specifi ed in the Annex, belonging to the additive catego ry ‘sensor y additives’ and to the functional group 
‘flavouring compo unds ’ is author ised as a feed additive in animal nutr ition subject to the conditions laid down in that 
Annex.
Article 2
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 26 November 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 426/24 29.11.2021  ANNEX 
Identification 
number of the 
additiveName of the 
holder of 
author isationAdditiveCompo sition, chem ical formula, 
descr iption, analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisi onsEnd of period of 
author isation mg/kg of complet e feed 
with a moisture conten t 
of 12 %
Categor y: nutr itional additiv es
Functional group: amino acids, their salts and analogues
3c351i - L-hi stidine 
monoh y-
droch loride 
monoh ydrateAdditive composition
Powder with a minimum content of
98 % L-hi stidine monohydroc hlor ide 
monoh ydrate and
72 % histidine and
a maximum conte nt of 100 ppm 
histamineAll animal 
species excep t 
finfish- - - 1.In the directions for use of the 
additive and premixture, the sto­
rage conditions and the stability to 
heat treatment shall be indicated .
2.Declaration to be made on the la­
bel of the additive and premixture:
— ‘The supplementation with 
L-hi stidine monohydroc hlor ­
ide monoh ydrate shall be lim­
ited to the nutr itional require ­
ments of the target animal, 
which depend on the species, 
the physiological state of the 
animal, the performa nce level, 
the environmental condi ­
tions, the level of other 
amino acids in the diet and 
the level of essential trace ele­
ments, such as copper and 
zinc.’
— ‘Histidine content’.
3.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational mea ­
sures to address the poten tial risks 
by inhalation or dermal contact. 
Where those risks cannot be 
eliminated or reduced to a mini ­
mum by such procedures and 19 December 
2031
Char acter isation of the active substance
L-hi stidine monoh ydrochlori de 
monoh ydrate produced by 
fermentation with Escher ichia coli 
NITE SD 00268
Chemical formula: C3H3N2-CH 2-CH 
(NH 2)-COΟΗ·ΗCl·Η 2O
CAS number: 5934-29-2
Einecs number 211-438-9
Analytical method (1)
For the quantification of histidine in 
the feed additive:
—high performa nce liquid chroma ­
tograph y coupled with spectro ­
photomet ric detection 
(HPL C-UV),EN Offi cial Jour nal of the European Union 29.11.2021 L 426/25  measures, the additive and pre­
mixtures shall be used with appro ­
priate personal protective equip ­
ment, including eyes, skin and 
breathing prot ection.— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS/FLD).
For the quantification of histidine in 
premixtures, feed mater ials and 
compo und feed:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS), Commission Regula ­
tion (EC) No 152/2009 (Annex 
III, F).
For the quantification of histamine in 
the feed additive:
—high performa nce liquid chroma ­
tograph y coupled to a spectro ­
photomet ric detection 
(HPL C-UV).
Categor y: Sensor y additiv es
Functional group: Flavour ing compounds
3c351i - L-hi stidine 
monoh y-
droch loride 
monoh ydrateAdditive composition
Powder with a minimum content of
98 % L-hi stidine monohydroc hlor ide 
monoh ydrate and
72 % histidine and
a maximum conte nt of 100 ppm 
histamineAll animal 
species- - - 1.The additive shall be incor porat ed 
into the feed in the form of a pre­
mixture.
2.In the directions for use of the 
additive and premixture, the sto­
rage conditions and the stability to 
heat treatment shall be indicated .
3.On the label of the additive the 
follo wing shall be indicated: ‘Re­
commended maximum cont ent 
of the active substance of com ­
plete feed with a moisture conte nt 
of 12 %: 25 mg/kg.19 December 
2031
Char acter isation of the active substance
L-hi stidine monoh ydrochlori de 
monoh ydrate produced by 
fermentation with Escher ichia coli 
NITE SD 00268EN Offi cial Jour nal of the European Union L 426/26 29.11.2021  4.The functional group, the identi ­
fication number , the name and the 
added amount of the active sub­
stance shall be indicated on the 
label of the premixture, where 
the use level on the label of the 
premixture would result in ex­
ceeding the level of active sub­
stance in complet e feed referred 
to in point 3.
5.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational mea ­
sures to address the poten tial risks 
by inhalation or dermal contact. 
Where those risks cannot be 
eliminated or reduced to a mini ­
mum by such procedures and 
measures, the additive and pre­
mixtures shall be used with appro ­
priate personal protective equip ­
ment, including eyes, skin and 
breathing prot ection.Chemical formula: C3H3N2-CH 2-CH 
(NH 2)-COΟΗ·ΗCl·Η 2O
CAS number: 5934-29-2
Einecs number 211-438-9
Analytical method (1)
For the quantification of histidine in 
the feed additive:
—performa nce liquid chromat o­
graphy coupled with spectropho ­
tometr ic detection (HPL C-UV),
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS/FLD).
For the quantification of histidine in 
premixtures:
— ion exchange chromat ography 
coupled with post-column deri­
vatisation and optical detection 
(IEC- VIS), Commission Regula ­
tion (EC) No 152/2009 (Annex 
III, F).
For the quantification of histamine in 
the feed additive:
—high performa nce liquid chroma ­
tograph y coupled to a spectro ­
photomet ric detection 
(HPL C-UV).
(1)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor tsEN Offi cial Jour nal of the European Union 29.11.2021 L 426/27