II
(Non-legislative acts)
REGUL ATIONS
COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/2076 
of 26 November 2021
concer ning the author isation of L-tryptopha n produced by Escherichia coli KCCM 80210 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-tryptophan produced by Escher ichia coli KCCM 80210. The application was accompan ied by the particulars and 
documents required under Article 7(3) of that Regulation.
(3) The application concer ns the author isation of L-tryptophan produced by Escher ichia coli KCCM 80210 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’.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 27 Januar y 2021 (2)that, under the 
proposed conditions of use, L-tryptophan produced by Escher ichia coli KCCM 80210 does not have an adverse effect 
on the health of non-r uminant animals, consumer safety or the environment. To be safe for ruminants, the 
L-tryptophan should be prote cted against degradation in the rumen. The Author ity state d that the additive under 
assessment is considered a mild eye irritant. The endoto xin activity of the additive and its dusting poten tial indicate 
a risk by inhalation. Theref ore, the Commission considers that appropr iate prote ctive measures should be taken to 
prevent adverse effects on human health, in particular as regards the users of the additive.
(5) The Author ity considered that L-tryptophan produced by Escher ichia coli KCCM 80210 is an efficacious source of the 
essential amino acid tryptophan for non-r uminant animals; for the supplemental L-tryptophan produced by 
Escher ichia coli KCCM 80210 to be as efficacious in ruminants as in non-r uminants, it should be prot ected against 
degradation in the rumen. The Auth ority does not consider that there is a need for specific requirements of post- 
mark et monitoring. It also verified the repor t 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 Journal 2021;19(3):6425.EN Offi cial Jour nal of the European Union 29.11.2021 L 426/1  (6) The assessment of L-tryptophan produced by Escher ichia coli KCCM 80210 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 
that substance should be author ised as specifi ed 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, 26 November 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 426/2 29.11.2021  ANNEX 
Identification 
number of the 
additiveName of the 
holder of 
author isationAdditiveComposition, chemical formula, descr iption, 
analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
conten tMaximum 
conten t
Other provisionsEnd of period of 
author isation mg/kg of complet e feed 
with a moisture content 
of 12 %
Categor y: nutr itional additiv es
Functional group: amino acids, their salts and analogues
3c440i - L-tryptophan Additive composition
Powder with a minimum of 98 % 
L-tryptophan on a dry matte r basis and a 
maximum moisture cont ent of 1 %.
Maximum cont ent of 10 mg/kg 1,1′- 
ethyliden e-bis-L -tryptophan (EBT)All 
species- - - 1.The feed business operator placing 
the additive on the mark et shall en­
sure that its endoto xin cont ent and 
dusting pote ntial result in a maxi ­
mal endoto xin exposure of 1600 IU 
endoto xins/m3 air(2).
2.For ruminants, L-tryptophan shall 
be rumen prot ected.
3.The labelling of the additive and 
premixtures shall indicate the fol­
lowing:
‘The supplementation with L-tryp­
tophan shall take into account all 
essential and conditionally essential 
amino acids in order to avoid im­
balances.’
4.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, skin or eyes contact. Where 
those risks cannot be eliminated 
or reduced to a minimum by such 
procedures and measures, the addi ­
tive and premixtures shall be used 19 December 
2031
Char acter isation of the active substance
L-tryptophan produced by fermentation 
with Escher ichia coli KCCM 80210
Chemical formula: C11H12N2O2
CAS No: 73-22-3
Analytical methods (1)
For the identification of L-tryptophan in 
the feed additive:
— Food Chemical Codex ‘L-tr yptophan 
monograph’.
— For the determination of tryptophan 
in the feed additive and premixtures:
—High performa nce liquid chromat o­
graphy with fluorescence detection 
(HPL C-FLD) – EN ISO 13904.EN Offi cial Jour nal of the European Union 29.11.2021 L 426/3  with personal protective equip ­
ment, including eyes, skin and 
breathing protection.For the determination of tryptophan 
in compo und feed and feed mate ri­
als:
—High performa nce liquid chromat o­
graphy with fluorescence detection 
(HPL C-FLD); Commission Regula ­
tion (EC) No 152/2009 (3)(Annex 
III, G).
(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 calculated based on the endoto xin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2015;13(2):4015); analytical method: European Phar macopoeia 
2.6.14. (bacterial endoto xins).
(3)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 L 426/4 29.11.2021