II 
(Non-legislative acts) 
REGUL ATIONS 
COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1090 
of 24 July 2020 
concer ning the author isation of L-hist idine monoh ydrochlor ide monohydrat e as a feed additiv e for 
all animal species 
(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 author isation. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 three applications were submitte d for the 
author isation of L-histidine monohydroc hlor ide monohydrat e. The applications were accompanied by the 
particulars and documents required under Article 7(3) of that Regulation. 
(3) The applications concer n the author isation of L-histi dine monohydroc hlor ide monohydrat e produced by Escher ichia 
coli NITE BP-02526, Corynebacter ium glutamicum KCCM 80172 or Corynebacter ium glutamicum KCCM 80179 as a feed 
additive for all animal species, to be classified in the additive catego ry ‘nutr itional additives ’. L-histi dine 
monoh ydrochlor ide monoh ydrate produced by Escher ichia coli NITE BP-02526 and Corynebacter ium glutamicum 
KCCM 80179 are also applied for the additive catego ry ‘sensor y additives ’. 
(4) The European Food Safety Authority (‘the Author ity’) concluded in its opinions of 2 July 2019 (2),(3),(4) that, under 
the proposed conditions of use, L-histidine monohydroc hlor ide monohydrat e produced by Escher ichia coli NITE BP- 
02526, Corynebacter ium glutamicum KCCM 80172 or Corynebacter ium glutamicum KCCM 80179, when supplemente d 
at levels appropr iate to the requirements of the targe t species, does not have an adverse effect on animal health, 
consumer safety or the environment. This conclusion covers also the use of L-histidine monohydroc hlor ide 
monoh ydrate produced by Escher ichia coli NITE BP-02526 or Corynebacter ium glutamicum KCCM 80179 as sensor y 
additive at the intended use level. With respect to the safety of the user of the additive, the Author ity stated only a 
mild irritation risk to the eyes for L-histidine monoh ydrochlori de monoh ydrate produced by Corynebacter ium 
glutamicum KCCM 80172 or Corynebacter ium glutamicum KCCM 80179. For L-histi dine monohydroc hlor ide 
monoh ydrate produced by fermentation with Escher ichia coli NITE BP-02526, the Author ity stated a risk by 
inhalation. Theref ore, appropr iate protective measures should be taken for this additive to prevent adverse effects 
on human health, in particular as rega rds the users of the additive. Further , the Author ity concluded that L-hi stidine 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Journal 2019; 17(7):5783. 
(3)EFSA Journal 2019; 17(7):5784. 
(4)EFSA Journal 2019; 17(8):5785. EN Offi cial Jour nal of the European Union 27.7.2020                                                                                                                                           L 241/1   monoh ydrochlor ide monohydrat e produced by Escher ichia coli NITE BP-02526, Corynebacter ium glutamicum KCCM 
80172 or Corynebacter ium glutamicum KCCM 80179 is an efficacious source of the essential amino acid L-histidine 
for animal nutr ition and that in order to be efficacious in ruminants, the additive should be prot ected against 
degradation in the rumen. Moreover , the Authority concluded that L-hi stidine monohydroc hlor ide monoh ydrate 
produced by Escher ichia coli NITE BP-02526 or Corynebacter ium glutamicum KCCM 80179 is efficacious as feed 
flavouring compo und. 
(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 t on the method of analysis of the feed additive in feed submitte d by the Reference Laboratory set 
up by Regulation (EC) No 1831/2003. 
(6) Restr ictions and conditions should be provided for to allow for a bette r control for those additives when used as 
flavourings. For these additives used as flavourings recommended contents should be indicated on the label. Where 
such contents are exceed ed, certain information should be indicated on the label of premixtures. The use of L- 
histidine monoh ydrochlori de monoh ydrate as a flavouri ng compo und is not author ised in water for drinking. The 
fact that L-hi stidine monohydroc hlor ide monohyd rate is not author ised for use as a flavouring in water for 
drinking, does not preclude its use in compo und feed, which is administe red via wate r. 
(7) The assessment of that substance 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 that substance should be author ised as 
specifi ed in the Annex to this Regulation. 
(8) 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, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
1. L-hi stidine monoh ydrochlori de monoh ydrate produced by Escher ichia coli NITE BP-02526, Corynebacter ium 
glutamicum KCCM 80172 or Corynebacter ium glutamicum KCCM 80179 specified in the Annex, belonging to the additive 
catego ry ‘nutr itional additives ’ and to the functional group ‘amino acids, their salts and analogues’ are author ised as feed 
additives in animal nutr ition subject to the conditions laid down in that Annex. 
2. L-hi stidine monoh ydrochlor ide monohydrat e produced by Escher ichia coli NITE BP-02526 or Corynebacter ium 
glutamicum KCCM 80179 specifi ed in the Annex, belonging to the additive catego ry ‘sensor y additives ’ and to the 
functional group ‘flavouri ng 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, 24 July 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 241/2                                                                                                                                           27.7.2020   ANNEX 
Identif ica-
tion 
number of 
the 
additiv e Name of 
the 
holder of 
author i-
sation Additiv e Composition, chemical formula, 
descr iption, analytical method Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation mg/kg of complete feed 
with a moistu re content 
of 12 % 
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues 
3c352 - L-hi stidine 
monohy­
droc hlor ide 
monohydrat e Additiv e composition: 
Powder with a minimum conte nt of 
98 % L-hi stidine monoh ydrochlor ide 
monoh ydrate and 
72 % histidine and 
a maximum cont ent of 100 ppm hista­
mine All animal 
species - - - 1. L-hi stidine monoh ydrochlori de 
monoh ydrate may be placed on the 
mark et and used as an additive con­
sisting of a preparation. 
2. The additive can be also used via 
water for drinking. 
3.The endoto xin cont ent of the addi­
tive and its dusting potential shall 
ensure a maximal endoto xin expo­
sure of 1 600 IU endoto xins/m3 
air (2). 
4.For users of the additive and premix­
ture, feed business operators shall 
establish operational procedures 
and organisational measures to ad­
dress poten tial risks for the eyes and 
skin and by inhalation. Where those 
risks cannot be eliminated or re­
duced to a minimum by such proce­
dures and measures, the additive and 
premixture shall be used with perso­
nal protect ive equipment. 
5.In the directions for use of the addi­
tive and premixture, the storage con­
ditions, the stability to heat treat­
ment and the stability in wate r for 
drinking shall be indicated. 16.8.2030 
Character isation of the activ e sub­
stance: 
L-histidine monohydroc hlor ide mono­
hydrate produced by fermentation with 
Corynebacter ium glutamicum KCCM 
80172 or 
Corynebacter ium glutamicum KCCM 80179 
or 
Escher ichia coli NITE BP-02526 
Chemical formula: C3H3N2-CH2-CH 
(NH 2)-COΟΗ· HCl· H2O 
CAS number : 5934-29-2 
Analytical method (1): 
For the quantifi cation of histidine in the 
feed additive: 
—high performance liquid chromat o­
graph y coupled with photometr ic de­
tection (HPL C-UV) 
— ion exchang e chromat ography 
coupled with post-column derivatisa­
tion and optical detec tion (IEC- 
VIS/FLD) EN Offi cial Jour nal of the European Union 27.7.2020                                                                                                                                           L 241/3   6. Declaration to be made on the label 
of the additive and premixture: 
‘The supplementation with L-hi sti­
dine monohydroc hlor ide monohy­
drate, in particular via wate r for 
drinking, should take into account 
all essential and conditional essential 
amino acids in order to avoid imbal­
ances.’ 
— Histidine conte nt. For the quantifi cation of histidine in pre­
mixtures, feed mater ials and compo und 
feed: 
— ion exchang e chromat ography 
coupled with post-column derivatisa­
tion and photome tric detection (IEC- 
VIS), Commission Regulation (EC) 
No 152/2009 (Annex III, F) 
For the quantification of histidine in 
water: 
— ion exchang e chromat ography 
coupled with post-column derivatisa­
tion and photome tric detection (IEC- 
VIS/FLD) 
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds 
3c352 - L-hi stidine 
monohy­
droc hlor ide 
monohydrat e Additiv e composition: 
Powder with a minimum conte nt of 
98 % L-hi stidine monoh ydrochlor ide 
monoh ydrate and 
72 % histidine and 
a maximum cont ent of 100 ppm hista­
mine All animal 
species - - - 1. L-hi stidine monoh ydrochlori de 
monoh ydrate may be placed on the 
mark et and used as an additive con­
sisting of a preparation. 
2. The additive shall be incor porate d 
into the feed in the form of a premix­
ture. 
3.The endoto xin cont ent of the addi­
tive and its dusting potential shall 
ensure a maximal endoto xin expo­
sure of 1 600 IU endoto xins/m3 
air (3). 
4.For users of the additive and premix­
ture, feed business operators shall 
establish operational procedures 
and organisational measures to ad­
dress poten tial risks for the eyes and 
skin and by inhalation. Where those 
risks cannot be eliminated or re­
duced to a minimum by such proce­
dures and measures, the additive and 
premixture shall be used with perso­
nal protect ive equipment. 16.8.2030 
Character isation of the activ e sub­
stance: 
L-histidine monohydroc hlor ide mono­
hydrate produced by fermentation with 
Corynebacter ium glutamicum KCCM 
80179 or 
Escher ichia coli NITE BP-02526. 
Chemical formula: C3H3N2-CH2-CH 
(NH 2-COΟΗ· HCl· H2O 
CAS number : 5934-29-2 
Analytical method (1): 
For the quantifi cation of histidine in the 
feed additive: 
—high performance liquid chromat o­
graph y coupled with photometr ic de­
tection (HPL C-UV) EN Offi cial Jour nal of the European Union L 241/4                                                                                                                                           27.7.2020   5.In the directions for use of the addi­
tive and premixture, the storage con­
ditions and the stability to heat treat­
ment shall be indicated. 
6.On the label of the additive the fol­
lowing shall be indicated: 
‘Recommended maximum content 
of the active substance of complet e 
feedingstuff with a moisture content 
of 12 %: 25 mg/kg ‘ 
— The histidine cont ent. 
7.The functional group, the identifica­
tion number , the name and the 
added amount of the active sub­
stance shall be indicate d on the label 
of the premixtures, if the followi ng 
conte nt of the active substance in 
compl ete feedingstuff with a moist­
ure content of 12 % is exceed ed: 25 
mg/kg. — ion exchang e chromat ography 
coupled with post-column derivatisa­
tion and optical detec tion (IEC- 
VIS/FLD) 
For the quantifi cation of histidine in pre­
mixtures: 
— ion exchang e chromat ography 
coupled with post-column derivatisa­
tion and optical detec tion (IEC- 
VIS/FLD) or 
— ion exchang e chromat ography 
coupled with post-column derivatisa­
tion and photome tric detection (IEC- 
VIS), Commission Regulation (EC) 
No 152/2009 (Annex III, F) 
For the quantif ication of histidine in feed 
mat erials and compo und feed: 
— ion exchang e chromat ography 
coupled with post-column derivatisa­
tion and photome tric detection (IEC- 
VIS), Commission Regulation (EC) 
No 152/2009 (Annex III, F) 
(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 ts 
(2) Exposure calculated based on the endoto xin level and the dusting potential of the additive according to the method used by EFSA (EFSA Jour nal 2017;15(3):4705); analytical method: European Phar macopoeia 
2.6.14. (bacterial endoto xins). 
(3) Exposure calculated based on the endoto xin level and the dusting potential of the additive according to the method used by EFSA (EFSA Jour nal 2017;15(3):4705); analytical method: European Phar macopoeia 
2.6.14. (bacterial endoto xins).   EN Offi cial Jour nal of the European Union 27.7.2020                                                                                                                                           L 241/5