Commission Implementing Regulation (EU) 2025/1915 of 25 September 2025 concerning the authorisation of L-tryptophan produced with Corynebacterium glutamicum KCCM 80346 as a feed additive for all animal species

Official Journal EN of the European Union L series 2025/1915 26.9.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1915 of 25 September 2025 concerning the authorisation of L-tryptophan produced with Corynebacterium glutamicumKCCM 80346 as a feed additive for all animal species (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof, Whereas: (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. (2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-tryptophan produced with Corynebacterium glutamicum KCCM 80346. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) The application concerns the authorisation of L-tryptophan produced with Corynebacterium glutamicumKCCM 80346 as a feed additive for use in feed and in water for drinking for all animal species, requesting that additive to be classified in the category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 March 2024(2)that, under the proposed conditions of use, L-tryptophan produced with Corynebacterium glutamicum KCCM 80346 does not pose any safety concerns regarding the production strain and is safe for non-ruminant target species. However, it concluded that there may be a risk for an increased production of the toxic metabolite skatole when unprotected tryptophan is used in ruminants. The Authority referred to concerns on the safety for the target species resulting from the simultaneous oral administration of L-tryptophan via water for drinking and feed due to possible amino acid imbalances and for hygienic reasons in case of use in water. It also concluded that the use of L-tryptophan produced with Corynebacterium glutamicum KCCM 80346 in animal nutrition is considered safe for the consumers and for the environment and that regarding user safety it is neither irritating to the eyes and skin, nor a skin sensitiser. The Authority further concluded that the substance is regarded as an efficacious source of the essential amino acid L-tryptophan for all non-ruminant species and that for the substance to be fully efficacious in ruminants, it should be protected from ruminal degradation. The Authority did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (5) In view of the above, the Commission considers that L-tryptophan produced with Corynebacterium glutamicumKCCM 80346 satisfies the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. When fed to ruminants, it is appropriate to provide for protective measures against its degradation in the rumen. It is appropriate to alert the users to take into account the dietary supply with all the essential and conditionally essential amino acids, in particular in the case of supplementation with L-tryptophan via water for drinking. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal, 23(4), e9327. https://doi.org/10.2903/j.efsa.2025.9327. ELI: http://data.europa.eu/eli/reg_impl/2025/1915/oj 1/4EN OJ L, 26.9.2025 (6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION: 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. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 25 September 2025. For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/1915/ojANNEX Identifica­ Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal mg/kg of complete feed with 12 authorisation additive % moisture content Category: nutritional additives. Functional group: amino acids, their salts and analogues 3c443 L-tryptophan Additive composition All - - - 1. In the directions for use of 16 October L-tryptophan ≥ 98 % (on a dry matter animal the additive and premixtures, 2035 basis) species the storage conditions, the stability to heat treatment Solid form and in water shall be indicated. Maximum content of 10 mg/kg 1,1′- 2. The additive may be used via ethylidene-bis-L-tryptophan (EBT) water for drinking. Characterisation of the active substance 3. Feed business operators shall L-tryptophan produced with ensure that L-tryptophan is Corynebacterium glutamicumKCCM rumen protected, when fed 80346 to ruminants. 4. The moisture content shall IUPAC name: (2S)-2-amino- be indicated on the label of 3-(1H-indol-3-yl) propanoic acid the additive. Chemical formula: C H N O 5. The labelling of the additive 11 12 2 2 and premixtures shall CAS number: 73-22-3 indicate the following: ‘The supplementation with L-tryptophan, in particular Analytical method(1) via water for drinking, shall take into account all essential For the identification of L-tryptophan and conditionally essential in the feed additive: amino acids in order to avoid imbalances.’ — 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 ELI: http://data.europa.eu/eli/reg_impl/2025/1915/oj 3/4 OJ L, 26.9.2025 ENIdentifica­ Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal mg/kg of complete feed with 12 authorisation additive % moisture content For the determination of tryptophan in compound feed: — High performance liquid chromatography with fluorescence detection (HPLC- FLD), Commission Regulation (EC) No 152/2009 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en. 4/4 ELI: http://data.europa.eu/eli/reg_impl/2025/1915/oj EN OJ L, 26.9.2025