COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1372 
of 1 Oct ober 2020 
concer ning the author isation of L-tryptophan produced by Escherichia coli CGMCC 7.267, CGMCC 
11 674 or KCCM 10 534 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 applications were submitted for the author isation of 
L-tryptophan produced by Escher ichia coli CGMCC 7.267, Escher ichia coli CGMCC 11 674 or Escher ichia coli KCCM 
10 534. These applications were accompan ied by the particulars and documents required under Article 7(3) of that 
Regulation. 
(3) The applications concer n the author isation of L-tryptophan produced by Escher ichia coli CGMCC 7.267, Escher ichia 
coli CGMCC 11 674 or Escher ichia coli KCCM 10 534 as a feed additive for all animal species, to be classifie d in the 
additive catego ry ‘nutr itional additives ’, functional group ‘amino acids, their salts and analogues’. 
(4) The European Food Safety Author ity (‘the Authority’) concluded in its opinions of 26 Febr uary 2019 (2), 28 Januar y 
2020 (3), 18 Marc h 2020 (4) and 25 May 2020 (5) that, under the proposed conditions of use, L-tryptophan 
produced by Escher ichia coli CGMCC 7.267, Escher ichia coli CGMCC 11 674 or Escher ichia coli KCCM 10 534 does not 
have an adverse effect on the health of non-r uminant animals, consumer safety or the envi ronment. To be safe for 
ruminants, the L-tryptophan should be prote cted against degradation in the rumen. The Authority stated a risk for 
the users of the additive upon inhalation due to the endoto xin levels of the L-tryptophan produced by Escher ichia coli 
CGMCC 7.267, Escher ichia coli CGMCC 11 674 or Escher ichia coli KCCM 10 534 and could not excl ude a poten tial of 
L-tryptophan produced by Escher ichia coli CGMCC 11 674 or Escher ichia coli CGMCC 7.267 to be an irritant to skin 
and eyes or to be a skin sensitiser . 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. 
(5) The Author ity considered L-tryptophan produced by Escher ichia coli CGMCC 7.267, Escher ichia coli CGMCC 11 674 
or Escher ichia coli KCCM 10 534 an efficacious source of the essential amino acid tryptophan for non-r uminant 
animals; for the supplemental L-tryptophan produced by Escher ichia coli CGMCC 7.267, Escher ichia coli CGMCC 
11 674 or Escher ichia coli KCCM 10 534 to be fully efficacious in ruminants, it should be protect ed against 
degradation in the rumen. In its opinions, the Authority raised concer ns about poten tial nutr itional imbalances for 
amino acids, when they are administered via water for drinking. However , the Author ity did not propose a 
maximum conte nt for the supplementation with L-tryptophan produced by Escher ichia coli CGMCC 7.267, 
Escher ichia coli CGMCC 11 674 or Escher ichia coli KCCM 10 534. Thus, it is appropr iate to indicate on the label of the 
additive, and premixtures containing it, an alert to take into account the dietar y supply with all the essential and 
conditionally essential amino acids, particularly in the case of supplementation with L-tryptophan produced by 
Escher ichia coli CGMCC 7.267, Escher ichia coli CGMCC 11 674 or Escher ichia coli KCCM 10 534 as amino acid via 
water for drinking. The Auth ority does not consider that there is a need for specific requirements of post-market 
monitori ng. 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. 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Jour nal 2019; 17(3):5642. 
(3)EFSA Jour nal 2020;18(2):6013. 
(4)EFSA Jour nal 2020;18(4):6071. 
(5)EFSA Jour nal 2020;18(6):6168. EN Offi cial Jour nal of the European Union 2.10.2020                                                                                                                                         L 319/11   (6) The assessment of L-tryptophan produced by Escher ichia coli CGMCC 7.267, Escher ichia coli CGMCC 11 674 or 
Escher ichia coli KCCM 10 534 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 specified in the 
Annex to this Regulation. 
(7) 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 specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional group 
‘amino acids, their salts and analogues’, is author ised as an 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 L 319/12                                                                                                                                         2.10.2020   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 Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period 
of 
author isation mg/kg of complete feed 
with a moisture content 
of 12 % 
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues. 
3c441 - L-tryptophan Additiv e composition: 
Powder with a minimum of 98 % L- 
tryptophan (on a dry matte r basis) 
Maximum cont ent of 10 mg/kg 1,1′- 
ethyliden e-bis-L -tryptophan (EBT) All species - - - 1. L-tryptophan may be placed on the 
mark et and used as an additive con­
sisting of a preparation. 
2.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce­
dures and organisational measures 
to address poten tial risks by inhala­
tion, dermal contact or eyes con­
tact. Where those risks cannot be 
eliminated or reduced to a mini­
mum by such procedures and mea­
sures, the additive and premixtures 
shall be used with personal prote c­
tive equipment, including breath­
ing prot ection, safety glasses and 
gloves. 
3.The endoto xin cont ent of the addi­
tive and its dusting pote ntial shall 
ensure a maximal endoto xin expo­
sure of 1600 IU endoto xins/m3 
air (2). 
4. L-tryptophan may be used via 
water for drinking. 
5. For ruminants, L-tryptophan shall 
be rumen protect ed. 22.10.2030 
Character isation of the activ e sub­
stance: 
L-tryptophan produced by fermenta­
tion with Escher ichia coli CGMCC 
7.267 or Escher ichia coli KCCM 10 534 
or 
Escher ichia coli CGMCC 11674 
Chemical formula: C11H12N2O2 
CAS No: 73-22-3 
Analytical methods  (1): 
For the identif ication of L-tryptophan 
in the feed additive: 
—Food Chemical Codex ‘L-trypto­
phan monograph’ . 
For the deter mination of tryptophan in 
the feed additive and premixtures: 
—High performa nce liquid chroma­
tograph y with fluorescence detec ­
tion (HPLC-FLD) – EN ISO 13 904 
For the deter mination of tryptophan in 
compo und feed and feed mater ials: 
—High Performance Liquid Chroma­
tograph y with fluorescence detec ­
tion (HPLC-FL D) – Commission 
Regulation (EC) No 152/2009 (An­
nex III, G) EN Offi cial Jour nal of the European Union 2.10.2020                                                                                                                                         L 319/13   6. The labelling of the additive and 
premixtures shall indicate the fol­
lowing: 
‘The supplementation with L- tryp­
tophan, in particular via wate r for 
drinking, shall take into account all 
essential and conditionally essen­
tial amino acids in order to avoid 
imbalances.’ 
7.Declarations to be made on the la­
bel of the additive: Moisture con­
tent. For the deter mination of tryptophan in 
water: 
—High performa nce liquid chroma­
tograph y with fluorescence detec ­
tion (HPLC-FLD) 
(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 calculat ed based on the endoto xin level and the dusting potential of the additive according to the method used by EFSA (EFSA Jour nal 2020;18(2):6013 and EFSA Jour nal 2020;18(4):6071); 
analytical method: European Phar macopoeia 2.6.14. (bacterial endoto xins).   EN Offi cial Jour nal of the European Union L 319/14                                                                                                                                         2.10.2020