Commission Implementing Regulation (EU) 2025/188 of 31 January 2025 concerning the authorisation of L-tryptophan produced with Escherichia coli CGMCC 7.460 as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2025/188
• Articles: 3

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 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 feed additive

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 12 % moisture content

Category: nutritional additives. Functional group: amino acids, their salts and analogues

3c442

L-tryptophan

Additive composition

Powder with a minimum content of L-tryptophan of 98 % (on a dry matter basis) and ≤ 0,5% water

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

Characterisation of the active substance

L-tryptophan produced with Escherichia coli CGMCC 7.460

Chemical formula: C 11 H 12 N 2 O 2

CAS number: 73-22-3

Analytical method

( 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:

—

High performance liquid chromatography with fluorescence detection (HPLC-FLD) – Commission Regulation (EC) No 152/2009  ( 2 )

All animal species

–

–

–

1.

In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and in water shall be indicated.

2.

The additive may be used via water for drinking.

3.

Feed business operators shall ensure that L-thryptophan is rumen protected, when fed to ruminants.

4.

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

—

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

5.

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

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

23 February 2035

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .

( 2 )   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 , ELI: http://data.europa.eu/eli/reg/2009/152/oj ).

( 3 )   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).