COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1175 
of 7 August 2020 
concer ning the author isation of L-cyst eine hydrochl oride monoh ydrate produced by fermenta tion 
with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 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-cyst eine hydrochlori de monoh ydrate produced by fermentation with Escher ichia coli KCCM 80180 and 
Escher ichia coli KCCM 80181. 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 80180 and Escher ichia coli KCCM 80181 as a feed additive for all animal species. The 
applicant requested this additive to be classifie d in the additive catego ry ‘sensor y additives ’. 
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 10 Januar y 2020 (2) that, under the 
proposed conditions of use in feed L-cys teine hydrochloride monohydrat e produced by fermentation with Escher ichia 
coli KCCM 80180 and Escher ichia coli KCCM 80181 does not have adverse effects on animal health, consumer safety 
or the environment. In its conclusions it also considered that the applicant proposes to label the additive with the 
hazard statement H335 (may cause respirato ry irritation) under the Regulation (EC) No 1272/2008 (3). Theref ore, 
the Commission considers that appropr iate prot ective measures should be taken to prevent adverse effects on 
human health, in particular , as regar ds the users of the additive. The Author ity further concluded that since the 
substance is used in food and its function in feed is the same as that in food, no further demonstration of efficacy in 
feed is necessar y. 
(5) Restr ictions and conditions should be provid ed for to allow for a better control. For L-cysteine hydrochlori de 
monoh ydrate, recommended contents should be indicated on the label of the additive. Where such conte nts are 
exceed ed, certain information should be indicated on the label of premixtures. 
(6) 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 additives in feed submitte d by the Reference Laboratory set 
up by Regulation (EC) No 1831/2003. 
(7) The assessment of L-cysteine hydroc hlor ide monoh ydrate produced by fermentation with Escher ichia coli KCCM 
80180 and Escher ichia coli KCCM 80181 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 this substance should be author ised as 
specifi ed in the Annex to this Regulation. 
(8) The fact that L-cys teine hydroch loride monohydrat e produced by fermentation with Escher ichia coli KCCM 80180 
and Escher ichia coli KCCM 80181 is not author ised for use as a flavouring in water for drinking, does not preclude 
its use in compo und feed, which is administered via water . 
(1)OJ L 268, 18.10.2003, p. 29.. 
(2)EFSA Jour nal 2020;18(2):6003. 
(3)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classificati on, labelling and 
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation 
(EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). EN Offi cial Jour nal of the European Union L 259/6                                                                                                                                           10.8.2020   (9) 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 substances specifi ed in the Annex, belonging to the additive cate gory ‘sensor y additives ’ and to the functional group 
‘flavouring compo unds ’, are author ised as feed additives 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, 7 August 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 10.8.2020                                                                                                                                           L 259/7   ANNEX 
Identification 
number of the 
additive Name of the 
holder of 
author isation Additive Composition, chem ical 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 of active substance/kg of 
compl ete feedingstuff with a 
moisture content of 12 % 
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds 
2b920i - L-cysteine  
hydroc hlor ide 
monohydrat e Additive composition: 
L-cys teine hydrochloride monoh y­
drate 
Char acter isation of the active substance: 
L-cys teine hydrochloride monoh y­
drate 
Produced by fermentation with Es­
cherichia coli KCCM 80180 and Escher­
ichia coli KCCM 80181 
Purity: min. 98,5 % 
Chemical formula:  
C3H7NO 2S •HClH 2O. 
CAS number 7048-04-6 
FLAVIS 17.032 
Method of analysis (1): 
For the identif ication of L-cyst eine 
hydrochlori de monoh ydrate in the 
feed additive: 
— ion-ex chang e chromat ography 
coupled with post-column deri­
vatisation and photometr ic de­
tectio n (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 deri­
vatisation and optical detection 
(IEC- VIS/FD) 
For the quantif ication of L-cyst eine 
hydrochlori de  
monoh ydrate in premixtures: All animal 
species - - - 1.The additive shall be incor po­
rated into the feed in the form 
of a premixture. 
2. In the directions for use of the 
additive and premixture, the 
stora ge conditions and the sta­
bility to heat treatment shall 
be indicated. 
3. On the label of the additive the 
follo wing shall be indicated: 
‘Recommended maximum 
conte nt of the active sub­
stance of compl ete feeding­
stuff with a moisture conte nt 
of 12 %: 25 mg/kg’. 
4. The functional group, the 
identif ication number , the 
name and the added amount 
of the active substance shall be 
indicated on the label of the 
premixtures, if the following 
conte nt of the active sub­
stance in complet e feeding­
stuff with a moisture conte nt 
of 12 % is exceed ed: 25 mg/kg. 
5. For users of the additive and 
premixtures, feed business op­
erators shall establish opera­
tional procedures and organi­
sational measures to address 
poten tial risks by inhalation. 
Where those risks cannot be 
eliminated or reduced to a 
minimum by such procedures 30.9.2030 EN Offi cial Jour nal of the European Union L 259/8                                                                                                                                           10.8.2020   — ion-ex chang e chromat ography 
coupled with post-column deri­
vatisation and photometr ic de­
tectio n (IEC- VIS), Commission 
Regulation (EC) No 152/2009  
(Annex III, F) and measures, the additive 
and premixtures shall be used 
with personal prot ective 
equipment, including breath­
ing prote ction. 
(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 10.8.2020                                                                                                                                           L 259/9