
Article 1 
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2 

1. The substance specified in the Annex authorised 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 stocks are exhausted.
2. Feed materials and compound feed containing the substance referred 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 market and used until the existing stocks are exhausted if they are intended for food producing animals.
3. Feed materials and compound 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 market and used until the existing stocks are exhausted if they are intended for non-food producing animals.
Article 3 
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 States.Done at Brussels, 22 May 2017.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation
mg/kg of complete feed with a moisture content of 12 %
Category of nutritional additives. Functional group: amino acids, their salts and analogues
3c440 — L-tryptophan 
Powder with a minimum of 98 % L-tryptophan (on a dry matter basis).

Maximum content of 10 mg/kg 1,1′-ethylidene-bis-L-tryptophan (EBT)

L-tryptophan produced by fermentation with Escherichia coli KCCM 11132P or

Escherichia coli DSM 25084 or

Escherichia coli FERM BP-11200 or

Escherichia coli FERM BP-11354 or

Escherichia coli CGMCC 7.59 or

Escherichia coli CGMCC 3667.

Chemical formula: C11H12N2O2

CAS No: 73-22-3

For the identification of L-tryptophan in the feed additive:


— Food Chemical Codex ‘L-tryptophan monograph’.

For the determination of tryptophan in the feed additive and premixtures:


— High performance liquid chromatography coupled to fluorescence detection (HPLC-FD) — EN ISO 13904-2016

For the determination of tryptophan in the feed additive, premixtures, compound feed and feed materials:


— High Performance Liquid Chromatography (HPLC) coupled with fluorescence detection, Commission Regulation (EC) No 152/2009 (OJ L 54, 26.2.2009, p. 1) (Annex III, G)
 All species — — — 
1. L-tryptophan may be placed on the market and used as an additive consisting of a preparation.

2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential 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 protective equipment, including breathing protection, safety glasses and gloves.

3. The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m3 air.

4. For ruminants, L-tryptophan shall be rumen protected.

5. 
Moisture content.
 12 June 2027

