COMMI SSION IMPLEMENTING REGUL ATION (EU) 2017/873 
of 22 May 2017 
concer ning the author isation of L-tryptop han produced by Escherichia coli as a feed additiv e for all 
animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provides for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation. Article 10 of that Regulation provides for the 
re-evaluation of additives author ised pursuant to Council Directive 82/471/EEC (2). 
(2)  L-tryptophan was author ised without a time limit pursuant to Directive 82/471/EEC by Commission Directive 
88/485/EEC (3). This feed additive was subsequently entered in the Regist er of feed additives as an existing 
product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. 
(3)  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, 
applications were submitted for the re-evaluation of L- tryptophan as feed additive for all animal species. 
Applications were also submitted for the author isation of L- tryptophan for all animal species in accordance with 
Article 7 of that Regulation. The applications were accompanied by the particulars and documents required 
under Article 7(3) of Regulation (EC) No 1831/2003. 
(4)  The applications concer n the author isation of L-tryptophan produced by Escher ichia coli KCCM 11132P , Escher ichia 
coli DSM 25084, Escher ichia coli FERM BP-11200, Escher ichia coli FERM BP-11354, Escher ichia coli CGMCC 7.59 or 
Escher ichia coli CGMCC 3667 as a feed additive for all animal species, to be classified in the additive categor y 
‘nutr itional additives’. 
(5)  The European Food Safet y Authority (‘the Author ity’) concluded in its opinions of 11 Sept ember 2013 (4), 
10 Apr il 2014 (5), 9 September 2014 (6), 29 Januar y 2015 (7), 10 September 2015 (8), 1 December 2015 (9), 
25 Januar y 2017 (10) and of 25 Januar y 2017 (11) that, under the proposed conditions of use, L-tryptophan 
produced by Escher ichia coli KCCM 11132P , Escher ichia coli DSM 25084, Escher ichia coli FERM BP-11200, 
Escher ichia coli FERM BP-11354, Escher ichia coli CGMCC 7.59 and Escher ichia coli CGMCC 3667 does not have an 
adverse effect on animal health, human health or the environment, and that it is considered an efficacious source 
of the essential amino acid tryptophan for animal nutr ition; the applicant for L-tryptophan produced by 
Escher ichia coli DSM 25084 provided evidence that, after a change of the manufa ctur ing process, the endoto xin 
level of the additive was reduced to an acceptable level; for the supplemental L- tryptophan to be fully efficacious 
in ruminants, it should be prot ected again st degradation in the rumen. 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 submitted by the Reference Laboratory set up by Regulation (EC) 
No 1831/2003. 23.5.2017 L 134/14 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Council Directive 82/471/EEC of 30 June 1982 concer ning certain products used in animal nutr ition (OJ L 213, 21.7.1982, p. 8). 
(3)Commission Directive 88/485/EEC of 26 July 1988 amending the Annex to Council Directive 82/471/EEC concer ning certain products 
used in animal nutr ition (OJ L 239, 30.8.1988, p. 36). 
(4)EFSA Jour nal 2013;11(10):3368. 
(5)EFSA Jour nal 2014;12(5):3673. 
(6)EFSA Jour nal 2014;12(10):3826. 
(7)EFSA Jour nal 2015;13(2):4015. 
(8)EFSA Jour nal 2015;13(9):4238. 
(9)EFSA Jour nal 2016;14(1):4343. 
(10)EFSA Jour nal 2017;15(2):4712. 
(11)EFSA Jour nal 2017;15(3):4705. (6)  The assessment of L-tryptophan 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) Since safety reasons do not require the immediate application of the modifications to the conditions of author i­
sation for L-tryptophan, it is appropr iate to allow a transitional period for interested parties to prepare 
themselves to meet the new requirements resulting from the author isation. 
(8)  The measures provided 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 
Author isation 
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 
Transitional measures 
1. The substance specifi ed in the Annex author ised by Commission Directive 88/485/EEC and premixtures 
containing it may be placed on the market until 12 December 2017 in accordance with the rules applicable before 
12 June 2017 and used until the existing stoc ks are exhaust ed. 
2. Feed mat erials and compound feed containing the substance refer red to in paragraph 1 which are produced and 
labelled before 12 June 2018 in accordance with the rules applicable before 12 June 2017 may be placed on the mark et 
and used until the existing stocks are exhausted if they are intended for food producing animals. 
3. Feed mate rials and compo und feed containing the substances referred to in paragraph 1 which are produced and 
labelled before 12 June 2019 in accordance with the rules applicable before 12 June 2017 may be placed on the mark et 
and used until the existing stocks are exhausted if they are intended for non-f ood producing animals. 
Article 3 
Entr y into force 
This Regulation shall enter into force on the twentieth day following 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 State s. 
Done at Brussels, 22 May 2017. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  23.5.2017 L 134/15 Official Jour nal of the European Union EN     ANNEX 
Identifi ­
cation 
number 
of the 
additive Name of 
the holder 
of 
author i­
sation Additive Compo sition, chemical formula, descr iption, 
analytical method Species or 
categ ory of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of  
period of 
author isation mg/kg of complet e feed 
with a moisture content of 
12 % 
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues 
3c440 — L-tryptophan Additive composition 
Powder with a minimum of 98 % L-tryp­
tophan (on a dry matter basis). 
Maximum content of 10 mg/kg 
1,1′-ethylidene-bis-L-tr yptophan (EBT) 
Char acter isation of the activ e substance 
L-tryptophan produced by fermentation 
with Escher ichia coli KCCM 11132P or 
Escher ichia coli DSM 25084 or 
Escher ichia coli FERM BP-11200 or 
Escher ichia coli FERM BP-11354 or 
Escher ichia coli CGMCC 7.59 or 
Escher ichia coli CGMCC 3667. 
Chemical formula: C11H12N2O2 
CAS No: 73-22-3  All species — — — 1.  L-tryptophan may be placed 
on the market and used as an 
additive consisting of a prep ­
aration. 
2.  For users of the additive and 
premixtures, feed business 
operat ors shall establish 
operational procedures and 
organisational measures to 
address poten tial risks by 
inhalation, dermal contact or 
eyes contact. Where those 
risks cannot be eliminated or 
reduced to a minimum 
by such procedures and 
measures, the additive and 
premixtures shall be used 
with personal prot ective 
equipment, including breath ­
ing protection, safety glasses 
and gloves. 
3.  The endoto xin content of 
the additive and its dusting 
poten tial shall ensure a 
maximal endoto xin exposure 
of 1 600 IU endoto xins/m3 
air(2).  12 June 
2027 23.5.2017 L 134/16 Official Jour nal of the European Union EN     Identifi ­
cation 
number 
of the 
additive Name of 
the holder 
of 
author i­
sation Additive Compo sition, chemical formula, descr iption, 
analytical method Species or 
categ ory of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of  
period of 
author isation mg/kg of complet e feed 
with a moisture content of 
12 % 
Analytical methods (1) 
For the identif ication 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 performance liquid chromat o­
graphy coupled to fluorescence 
detection (HPL C-FD) — EN ISO 
13904-2016 
For the determination of tryptophan 
in the feed additive, premixtures, com ­
pound feed and feed mate rials: 
—High Performance Liquid Chromato ­
graphy (HPL C) coupled with fluores ­
cence detection, Commission Regu ­
lation (EC) No 152/2009 (OJ L 54, 
26.2.2009, p. 1) (Annex III, G) 4.  For ruminants, L-tryptophan 
shall be rumen prote cted. 
5.  Declarations to be made on 
the label of the additive: 
Moisture content. 
(1)  Details of the analytical methods are available at the following 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 Jour nal 2017;15(3):4705); analytical method: European 
Phar macopoeia 2.6.14 (bacterial endoto xins).   23.5.2017 L 134/17 Official Jour nal of the European Union EN