COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/2116 
of 16 December 2020 
concer ning the renewal of the author isation of L-histidine monoh ydrochlor ide monohydrate 
produced by Escherichia coli ATCC 9637 as a feed additiv e for salmonids and its extension of use to 
other finfish, and repealing Regulation (EC) No 244/2007 
(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 and renewing such author isation. 
(2) L-hi stidine monoh ydrochlori de monohydrat e produced by Escher ichia coli ATCC 9637 was author ised for 10 years as 
a feed additive for salmonids by Commission Regulation (EC) No 244/2007 (2). 
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of 
the author isation of L-histidine monoh ydrochlori de monohydrat e produced by Escher ichia coli ATCC 9637 as a feed 
additive for salmonids. The application included a request to change the strain designation to Escher ichia coli NITE SD 
00268 and was accompanied by the particulars and documents required under Article 14(2) of that Regulation. In 
addition, in accordance with Article 7 of that Regulation, the application requeste d an extension of use to other 
finfish. The application was accompanied by the particulars and documents required under Article 7(3) of 
Regulation (EC) No 1831/2003. 
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 18 March 2020 (3) that, under the 
proposed conditions of use, L-hi stidine monoh ydrochlori de monoh ydrate produced by Escher ichia coli NITE SD 
00268, when supplement ed at levels appropr iate to the requirements of the target species, does not have an adverse 
effect on animal health, consumer health or the environment. The Author ity also concluded that while the additive 
in question is not a skin irritant, 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 prot ective 
measures should be take n to prevent adverse effects on human health, in particular as regards the users of the 
additive. The Author ity also concluded that the additive is an efficacious source of the amino acid histidine for fish 
species. The Author ity does not consider that there is a need for specif ic requirements of post-market monitori ng. It 
also verified the repor ts on the method of analysis of the feed additive in feed submitted by the Reference Laborat ory 
set up by Regulation (EC) No 1831/2003. 
(5) The assessment of L-histidine monohydroc hlor ide monoh ydrate produced by Escher ichia coli NITE SD 00268 shows 
that the conditions for author isation, as provi ded 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 specifi ed in the Annex to this Regulation. 
(6) As a consequence of the renewal of the author isation of L-histi dine monoh ydrochlori de monoh ydrate produced by 
Escher ichia coli ATCC 9637 as a feed additive under the conditions laid down in the Annex to this Regulation, 
Regulation (EC) No 244/2007 should be repealed. 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Commission Regulation (EC) No 244/2007 of 7 March 2007 concer ning the author isation of L-histidine monohy drochlor ide 
monoh ydrate as feed additive (OJ L 73, 13.3.2007, p. 6.). 
(3)EFSA Journal 2020;18(4):6072. EN Offi cial Jour nal of the European Union 17.12.2020                                                                                                                                         L 426/7   (7) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
for L-histidine monoh ydrochlori de monohydrat e produced by Escher ichia coli ATCC 9637, it is appropr iate to 
provid e for a transitional period to allow inter ested parties to prepare to meet the new requirements resulting from 
the renewal of the author isation. 
(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 
The author isation of L-histidine monoh ydrochlori de monoh ydrate produced by Escher ichia coli ATCC 9637, belonging to 
the additive catego ry ‘nutr itional additives ’ and to the functional group ‘amino acids, their salts and analogues ’, is renewed 
subject to the conditions laid down in the Annex. 
Article 2 
1. L-hi stidine monoh ydrochlor ide monohydrat e produced by Escher ichia coli ATCC 9637 and premixtures containing it, 
which are produced and labelled before 6 July 2021 in accordance with the rules applicable before 6 Januar y 2021 may 
continue to be placed on the mark et and used until the existing stoc ks are exhaust ed. 
2. Feed mater ials and compo und feed containing the substances refer red to in point 1, whic h are produced and labelled 
before 6 Januar y 2022 in accordance with the rules applicable before 6 Januar y 2021 may continue to be placed on the 
mark et and used until the existing stoc ks are exhaust ed if they are intended for salmonids. 
Article 3 
Regulation (EC) No 244/2007 is repealed. 
Article 4 
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, 16 December 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 426/8                                                                                                                                         17.12.2020   ANNEX 
Identifica-
tion 
number of 
the additive Name of 
the holder 
of 
author isa-
tion Additive Composition, chemical formula, descr iption, 
analytical method. Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation mg/kg of compl ete feed 
with a moisture conten t 
of 12 % 
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues. 
3c351 - L-hi stidine 
monoh ydrochlor ide 
monoh ydrate Additive composition: 
Powder with a minimum content of 
98 % L-hi stidine monoh ydrochlori de 
monoh ydrate and 
72 % histidine and 
a maximum conte nt of 100 ppm 
histamine Finfi sh - - - 1. L-hi stidine monoh ydrochlor ide 
monoh ydrate may be placed on 
the mark et and used as an additive 
consisting of a preparation. 
2. In the directions for use of the 
additive and premixture, the 
stora ge conditions and the 
stability to heat treatment shall be 
indicated . 
3. Declaration to be made on the 
label of the additive and 
premixture: 
— ‘The supplementation with 
L-hi stidine 
monoh ydrochlor ide 
monoh ydrate shall be limited 
to the nutr itional 
requirements of the target 
animal, which depend on the 
species, the physiological 
state of the animal, the 
performa nce level, the 
environmental conditions, 
the level of other amino acids 
in the diet and the level 
essential trace elements such 
as copper and zinc.’ 
— Histidine conte nt. 6 Januar y 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-CH2-CH 
(NH 2)-COΟΗ· HCl· H2O 
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 
chromatograph y coupled with 
photomet ric detection (HPLC-UV) 
— ion exchange chromat ography 
coupled with post-column 
derivatisation and optical detection 
(IEC- VIS/FLD) 
For the quantification of histidine in 
premixtures, feed mater ials and 
compo und feed: EN Offi cial Jour nal of the European Union 17.12.2020                                                                                                                                         L 426/9   4. For users of the additive and 
premixture, feed business 
operat ors 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 
premixtures shall be used with 
personal protective equipment. — ion exchange chromat ography 
coupled with post-column derivati­
sation and photome tric detection 
(IEC- VIS), Commission Regulation 
(EC) No 152/2009 (Annex III, F) 
For the quantifi cation of histamine in the 
feed additive: 
— high performa nce liquid 
chromatograph y coupled to a 
spectrophotometr ic 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 ts   EN Offi cial Jour nal of the European Union L 426/10                                                                                                                                       17.12.2020