COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1379 
of 1 Oct ober 2020 
concer ning the author isation of L-cyst ine produced by Pantoea ananatis NITE BP-02525 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-cystine produced by Pantoea ananatis NITE BP-02525 as a feed additive in feed and wate r for drinking for 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 L-cystine produced by Pantoea ananatis NITE BP-02525 as a feed 
additive for all animal species to be classified in the additive categor y ‘nutr itional additives’, functional group ‘amino 
acids, their salts and analogues’, and in the additive categor y ‘sensor y additives ’, functional group ‘flavouri ng 
compo unds ’. 
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 28 Januar y 2020 (2) that, under the 
proposed conditions of use, L-cystine produced by Pantoea ananatis NITE BP-02525 does not have an adverse effect 
on animal health, consumers health or the environment, and that it is slightly irritating by inhalation. 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. Moreover , the Authority stated that the supplementation 
with L-cystine produced by fermentation with Pantoea ananatis NITE BP-02525 should respect the requirements for 
sulphur -containing amino acids. Theref ore, a respective labelling provision should be established. The Author ity 
also concluded that the additive may be considered efficacious to contr ibute to the requirements for sulphur - 
containing amino acids in all animal species and that for the supplemental L-cystine to be fully efficacious in 
ruminants, it should be prote cted against degradation in the rumen. The Author ity expressed in its opinion a 
concer n over poten tial nutr itional imbalances of when L-cystine is administe red as amino acid via water for 
drinking. However , no maximum cont ent for L-cystine is proposed by the Auth ority. Thus, in the case of 
supplementation of feed and water for drinking with L-cystine as amino acid, it is appropr iate to take into account 
the dietar y supply with all essential and conditionally essential amino acids. 
(5) As regards the use as flavouring, the Authority state s that no further demonstration of efficacy is necessar y when 
used at the recommended dose. The use of L-cystine as flavouri ng compo und is not author ised in water for 
drinking. At the recommended dose, L-cystine as flavouri ng compo und is unlikely to pose any concer n. The fact 
that the use of the L-cystine is not author ised as flavouring in water for drinking does not preclude its use in 
compo und feed which is administe red via wate r. 
(6) Restr ictions and conditions should be provid ed for to allow for a better control of L-cystine as flavouri ng 
compo und. For L-cystine, 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. 
(7) 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. 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Jour nal 2020; 18(2):6020 EN Offi cial Jour nal of the European Union L 319/36                                                                                                                                         2.10.2020   (8) The assessment of L-cystine shows that the conditions for author isation, as provi ded for in Article 5 of Regulation 
(EC) No 1831/2003, are satisfied. According ly, the use of this additive should be author ised as specifi ed in the 
Annex to this Regulation. 
(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 
1. The substance L-cystine produced by Pantoea ananatis NITE BP-02525 specifi ed in the Annex, belonging to the 
additive catego ry ‘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-cystine produced by Pantoea ananatis NITE BP-02525 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, 1 October 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 2.10.2020                                                                                                                                         L 319/37   ANNEX 
Identif ica-
tion 
number of 
the 
additiv e Name of 
the holder 
of 
author isa-
tion Additiv e Composition, chemical formula, 
descr iption, analytical method. Species or 
categor y of 
animal Maxi-
mum age Mini-
mum 
content Maxi-
mum 
content Other provisions End of period 
of 
author isation mg/kg of complete 
feed with a moistu re 
content of 12 % 
Categor y: nutr itional additiv es. Functional group: amino acids, their salts and analogues. 
3c392 - L-cystine Additiv e composition: 
Powder with a minimum content of 
98 % L-cys tine All animal 
species - - - 1. L-cys tine may be placed on the mark et and 
used as an additive consisting of a prepara­
tion. 
2. The additive can be also used via water for 
drinking. 
3. For users of the additive and premixture, 
feed business operators shall establish op­
erational procedures and organisational 
measures to address poten tial risks by in­
halation. Where those risks cannot be 
eliminated or reduced to a minimum by 
such procedures and measures, the addi­
tive and premixture shall be used with per­
sonal prote ctive equipment. 
4. In the directions for use of the additive and 
premixture, the storag e conditions, the sta­
bility to heat treatment and the stability in 
water for drinking shall be indicated . 
5. Declaration to be made on the label of the 
additive and premixture: 
‘- The supplementation with L-cystine, 
shall depend on the requirements of 
the targe t animals for sulphur - contain­
ing amino acids and the level of other 
sulphur -containing amino acids in the 
ration. 22.10.2030 
Character isation of the activ e sub­
stance: 
L-cystine produced by fermentation with 
Pantoea ananatis NITE BP-02525 
IUPAC name: (2R)-2-amino-3-[(2R)-2- 
amino-3-h ydro xy-3-o xoprop yl] disulfa ­
nyl- propanoic acid 
CAS number: 56-89-3 
Chemical formula: C6H12N2O4S2 
Analytical method (1): 
For the identif ication of L-cystine in the 
feed additive: 
— Food Chemical Codex ‘L-cystine 
monograph’ 
For the quantifi cation of cystine in the 
feed additive and premixtures: 
— ion-ex chang e chromat ography 
coupled with post-column derivati­
sation and optical detection (IEC- 
VIS/FLD), as descr ibed in EN ISO 
17 180 
For the quantifi cation of cystine in pre­
mixtures, compound feed and feed ma­
terial s: 
— ion-ex chang e chromat ography 
coupled with post-column derivati­
sation and photometr ic detection 
(IEC- VIS), Commission Regulation 
(EC) No 152/2009 (2) (Annex III, F) 
For the quantif ication of cystine in water: EN Offi cial Jour nal of the European Union L 319/38                                                                                                                                         2.10.2020   Identif ica-
tion 
number of 
the 
additiv e Name of 
the holder 
of 
author isa-
tion Additiv e Composition, chemical formula, 
descr iption, analytical method. Species or 
categor y of 
animal Maxi-
mum age Mini-
mum 
content Maxi-
mum 
content Other provisions End of period 
of 
author isation mg/kg of complete 
feed with a moistu re 
content of 12 % 
- The supplementation with L-cystine, in 
particular via wate r for drinking, should 
take into account all amino acids in the 
animals ‘diet in order to avoid imbal­
ances.’ — ion-ex chang e chromat ography 
coupled with post-column derivati­
sation and photometr ic detection 
(IEC- VIS), as descr ibed in EN ISO 
13 903 or Commission Regulation 
(EC) No 152/2009 (Annex III, F) 
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds 
3c392 - L-cystine Additiv e composition: 
Powder with a minimum content of 
98 % L-cys tine All animal 
species - - - 1. L-cys tine may be placed on the mark et and 
used as an additive consisting of a prepara­
tion. 
2. The additive shall be incor porat ed into the 
feed in the form of a premixture. 
3. In the directions for use of the additive and 
premixture, the stora ge conditions and the 
stability to heat treatment shall be indi­
cated . 
4. On the label of the additive the following 
shall be indicate d: 
‘Recommended maximum content of the 
active substance of compl ete feedingstuff 
with a moisture content of 12 %: 25 
mg/kg’. 
5. The functional group, the identification 
number , the name and the added amount 
of the active substance shall be indicated 
on the label of the premixtures, if the fol­
lowing cont ent of the active substance in 
compl ete feedingstuff with a moisture con­
tent of 12 % is excee ded: 25 mg/kg. 22.10.2030 
Character isation of the activ e sub­
stance: 
L-cystine produced by fermentation with 
Pantoea ananatis NITE BP-02525 
IUPAC name: (2R)-2-amino-3-[(2R)-2- 
amino-3-h ydro xy-3-o xoprop yl] disulfa ­
nyl- propanoic acid 
CAS number: 56-89-3 
Chemical formula: C6H12N2O4S2 
Analytical method (3): 
For the determination of L-cys tine in the 
feed additive: 
— Food Chemical Codex ‘L-cystine 
monograph’ 
For the quantifi cation of cystine in the 
feed additive and premixtures: 
— ion-ex chang e chromat ography 
coupled with post-column derivati­
sation and optical detection (IEC- 
VIS/FLD), as descr ibed in EN ISO 
17 180 EN Offi cial Jour nal of the European Union 2.10.2020                                                                                                                                         L 319/39   Identif ica-
tion 
number of 
the 
additiv e Name of 
the holder 
of 
author isa-
tion Additiv e Composition, chemical formula, 
descr iption, analytical method. Species or 
categor y of 
animal Maxi-
mum age Mini-
mum 
content Maxi-
mum 
content Other provisions End of period 
of 
author isation mg/kg of complete 
feed with a moistu re 
content of 12 % 
6. For users of the additive and premixtures, 
feed business operators shall establish op­
erational procedures and organisational 
measures to address poten tial risks by in­
halation. Where those risks cannot be 
eliminated or reduced to a minimum by 
such procedures and measures, the addi­
tive and premixtures shall be used with 
personal protective equipment. 
(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) OJ L 54, 26.2.2009, p. 1. 
(3) 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 319/40                                                                                                                                         2.10.2020