Commission Implementing Regulation (EU) 2017/873 of 22 May 2017 concerning the authorisation of L-tryptophan produced by Escherichia coli as a feed additive for all animal species (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/873
• Articles: 4

Article 1 Authorisation

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 Transitional measures

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 Entry 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 .

Schedules & Appendices

ANNEX

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

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L-tryptophan

Additive composition

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)

Characterisation of the active substance

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: C 11 H 12 N 2 O 2

CAS No: 73-22-3

Analytical methods

( 1 )

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

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Food Chemical Codex ‘L-tryptophan monograph’.

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

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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:

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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

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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/m 3 air  ( 2 ) .

4.

For ruminants, L-tryptophan shall be rumen protected.

5.

Declarations to be made on the label of the additive:

Moisture content.

12 June 2027

( 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-reports

( 2 )   Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2017;15(3):4705); analytical method: European Pharmacopoeia 2.6.14 (bacterial endotoxins).