COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1761 
of 25 November 2020 
concer ning the author isation of L-cyst eine hydrochl oride monoh ydrate produced by fermenta tion 
with Escherichia coli KCCM 80109 and KCCM 80197 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 an application was submitted for the author isation 
of L-cysteine hydrochloride monoh ydrate produced by fermentation with Escher ichia coli KCCM 80109 and KCCM 
80197. This application was accompan ied by the particulars and documents required under Article 7(3) of 
Regulation (EC) No 1831/2003. 
(3) This application concer ns the author isation of L-cysteine hydroc hlor ide monohydrat e produced by fermentation 
with Escher ichia coli KCCM 80109 and KCCM 80197 as a feed additive for all animal species. The applicant 
requeste d this additive to be classified in the additive catego ry ‘sensor y additives’. 
(4) The applicant request ed the feed additive to be author ised for use also in wate r for drinking. Howe ver, Regulation 
(EC) No 1831/2003 does not allow the author isation of ‘flavouring compo unds ’ for use in water for drinking. 
Theref ore, the use of L-cysteine hydroc hlor ide monohydrat e produced by fermentation with Escher ichia coli KCCM 
80109 and KCCM 80197 in water for drinking should not be allowed. The fact that of L-cysteine hydroch loride 
monoh ydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 is not author ised for 
use as a flavouri ng in water for drinking does not preclude its use in compo und feed administered via water . 
(5) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 19 March 2020 (2) that, under the 
proposed conditions of use L-cyst eine hydroc hlor ide monohydrat e produced by fermentation with Escher ichia coli 
KCCM 80109 and KCCM 80197 do not have adverse effects on animal health, consumer health or the 
environment. The Author ity concluded for L-cys teine hydroc hlor ide monohydrat e produced by fermentation with 
Escher ichia coli KCCM 80109 and KCCM 80197 that although users’ exposure via inhalation is unlikely due to the 
low dusting poten tial, the product is proposed to be classified as respirator y irritant due to its low pH when in 
solution. In addition, based on the results of the studies provid ed, it should be classifie d as skin irritant and that it 
can cause serious eye damage. L-cys teine hydroch loride monoh ydrate is not a dermal sensitiser . The Authority also 
concluded, that since L-cys teine hydroc hlor ide monoh ydrate produced by fermentation with Escher ichia coli KCCM 
80109 and KCCM 80197 is used in food as flavouri ng, it is to be expecte d that it can provide a similar function in 
feed and no further demonstration of efficacy is necessar y when used in feed. The Author ity does not consider that 
there is a need for specifi c requirements of post-market monitori ng. It also verified the repor t on the method of 
analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) 
No 1831/2003. 
(6) The assessment of L-cysteine hydroc hlor ide monoh ydrate produced by fermentation with Escher ichia coli KCCM 
80109 and KCCM 80197 shows that the conditions for author isation, as provided for in Article 5 of Regulation 
(EC) No 1831/2003, are satisfied. According ly, the use of L-cyst eine hydroch loride monoh ydrate produced by 
fermentation with Escher ichia coli KCCM 80109 and KCCM 80197 should be author ised as specified in the Annex to 
this Regulation. 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Journal 2020;18(4):6101. EN Offi cial Jour nal of the European Union L 397/10                                                                                                                                       26.11.2020   (7) Restr ictions and conditions should be provid ed for to allow better control. In particular , a recommended content 
should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be 
indicated on the label of premixtures. 
(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 substance specified in the Annex, belonging to the additive cate gory ‘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, 25 November 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 26.11.2020                                                                                                                                       L 397/11   ANNEX 
Identif ica-
tion number 
of the 
additiv e Name 
of the 
holder 
of 
author -
isation 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 of activ e 
subst ance/kg of 
complete feedingstuf f 
with a moisture 
content of 12 % 
Categor y: Sensor y additives. Functional group: Flavouring compo unds 
2b920i - L-cys teine 
hydrochlori de 
monoh ydrate Additiv e composition 
L-cys teine hydrochloride monohydrat e 
Character isation of the activ e sub­
stance 
L-cys teine hydrochloride monohydrat e 
Produced by fermentation with Escher i­
chia coli KCCM 80109 and KCCM 80197 
Purity: ≥ 98,5 % assa y 
Chemical formula: C3H7NO 2S•HClH 2O 
CAS number: 7048-04-6. 
FLAVIS number: 17.032 
Method of analysis (1) 
For the identifi cation of L-cysteine hydro­
chloride monohy drate in the feed 
additive: ion-exc hange chromatog raphy 
coupled with post-column derivatisation 
and photometric detection (IEC- VIS), Ph. 
Eur. 6.6-2.2.56-Method 1 
For the quantif ication of L-cyst eine 
hydrochlori de monoh ydrate in the feed 
additive: ion-ex chang e chromat ography 
coupled with post-column derivatisa­
tion and optical detection (IEC- VIS/FD) 
For the quantif ication of L-cyst eine 
hydrochlori de monoh ydrate in premix­
tures: ion-ex change chromat ography 
coupled with post-column derivatisa­
tion and photometr ic detection (IEC- 
VIS), Commission Regulation (EC) 
No 152/2009 (2)Annex III, F) All animal 
species - - - 1. The additive shall be incor porated 
into the feed in the form of a premix­
ture. 
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 
follo wing shall be indicated: 
‘Recommended maximum content of 
the active substance of compl ete fee­
dingstuff with a moisture cont ent of 
12 %: 25 mg/kg’ 
4.The functional group, the identif ica­
tion number , the name and the added 
amount of the active substance shall 
be indicated on the label of the pre­
mixtures, if the following conte nt of 
the active substance in compl ete 
feedingstuff with a moisture conte nt 
of 12 % is excee ded: 25 mg/kg. 
5.For users of the additive and premix­
tures, feed business operators shall 
establish operational procedures and 
organisational measures to address 
poten tial risks by inhalation, dermal 
contact or eyes contact. Where those 16.12.2030 EN Offi cial Jour nal of the European Union L 397/12                                                                                                                                       26.11.2020   Identif ica-
tion number 
of the 
additiv e Name 
of the 
holder 
of 
author -
isation 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 of activ e 
subst ance/kg of 
complete feedingstuf f 
with a moisture 
content of 12 % 
risks cannot be eliminate d or reduced 
to a minimum by such procedures 
and measures, the additive and pre­
mixtures shall be used with personal 
prote ctive equipment, including 
breathing prote ction, safety glasses 
and gloves 
(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) Commission Regulation (EC) No 152/2009 of 27 Januar y 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).   EN Offi cial Jour nal of the European Union 26.11.2020                                                                                                                                       L 397/13