Commission Implementing Regulation (EU) 2021/2076 of 26 November 2021 concerning the authorisation of L-tryptophan produced by Escherichia coli KCCM 80210 as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/2076
• Articles: 3

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

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: nutritional additives

Functional group: amino acids, their salts and analogues

3c440i

-

L-tryptophan

Additive composition

Powder with a minimum of 98 % L-tryptophan on a dry matter basis and a maximum moisture content of 1 %.

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

All species

-

-

-

1.

The feed business operator placing the additive on the market shall ensure that its endotoxin content and dusting potential result in a maximal endotoxin exposure of 1600 IU endotoxins/m 3 air  ( 2 ) .

2.

For ruminants, L-tryptophan shall be rumen protected.

3.

The labelling of the additive and premixtures shall indicate the following:

‘The supplementation with L-tryptophan shall take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, skin 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 eyes, skin and breathing protection.

19 December 2031

Characterisation of the active substance

L-tryptophan produced by fermentation with Escherichia coli KCCM 80210

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:

—

Food Chemical Codex ‘L-tryptophan monograph’.

—

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

—

High performance liquid chromatography with fluorescence detection (HPLC-FLD) – EN ISO 13904.

For the determination of tryptophan in compound feed and feed materials:

—

High performance liquid chromatography with fluorescence detection (HPLC-FLD); Commission Regulation (EC) No 152/2009  ( 3 ) (Annex III, G).

( 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 2015;13(2):4015); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).

( 3 )   Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( OJ L 54, 26.2.2009, p. 1 ).