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Commission Implementing Regulation (EU) 2020/1372 of 1 October 2020 concerning the authorisation of L-tryptophan produced by Escherichia coli CGMCC 7.267, CGMCC 11674 or KCCM 10534 as a feed additive for all animal species (Text with EEA relevance)

Commission Implementing Regulation (EU) 2020/1372 of 1 October 2020 concerning the authorisation of L-tryptophan produced by Escherichia coli CGMCC 7.267, CGMCC 11674 or KCCM 10534 as a feed additive for all animal species (Text with EEA relevance)

Implementing Regulation (EU) 2020/1372 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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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

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

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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. 3c441 - 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) 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 1600 IU endotoxins/m 3 air  ( 2 ) . 4. L-tryptophan may be used via water for drinking. 5. For ruminants, L-tryptophan shall be rumen protected. 6. 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.’ 7. Declarations to be made on the label of the additive: Moisture content. 22.10.2030 Characterisation of the active substance: L-tryptophan produced by fermentation with Escherichia coli CGMCC 7.267 or Escherichia coli KCCM 10 534 or Escherichia coli CGMCC 11674 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 13 904 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 (Annex III, G) For the determination of tryptophan in water: — High performance liquid chromatography with fluorescence detection (HPLC-FLD) ( 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 2020;18(2):6013 and EFSA Journal 2020;18(4):6071); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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