Commission Implementing Regulation (EU) 2026/353 of 18 February 2026 concerning the authorisation of L-histidine and L-histidine monohydrochloride monohydrate, produced with Corynebacterium glutamicum KCCM 80389, as feed additives for all animal species

Official Journal EN of the European Union L series 2026/353 19.2.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/353 of 18 February 2026 concerning the authorisation of L-histidine and L-histidine monohydrochloride monohydrate, produced with Corynebacterium glutamicumKCCM 80389, as feed additives 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-histidine and L-histidine monohydrochloride monohydrate, produced with Corynebacterium glutamicum KCCM 80389. 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-histidine and L-histidine monohydrochloride monohydrate, produced with Corynebacterium glutamicum KCCM 80389, as feed additives for all animal species, requesting those additives to be classified in the category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’ and in the category ‘sensory additives’, functional group ‘flavouring compounds’. The applicant requested the additives to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the applicant withdrew the application for water for drinking as regards the functional group ‘flavouring compounds’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 24 June 2025(2) that, under the proposed conditions of use, L-histidine and L-histidine monohydrochloride monohydrate, produced by fermentation with Corynebacterium glutamicum KCCM 80389, in feed are safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. However, due to the risk of nutritional imbalances and hygienic reasons, the Authority has concerns on the use of L-histidine and L-histidine monohydrochloride monohydrate in water for drinking. The Authority concluded that the use of L-histidine and L-histidine monohydrochloride monohydrate, produced with Corynebacterium glutamicum KCCM 80389, in animal nutrition is safe for the consumers and the environment. It also concluded that L-histidine and L-histidine monohydrochloride monohydrate, produced with Corynebacterium glutamicumKCCM 80389, are not irritant to skin or eyes and are not skin sensitisers. The Authority further concluded that the substances are regarded as an efficacious source of the amino acid L-histidine for all non-ruminant species, but for the substances to be fully efficacious in ruminants they should be protected from ruminal degradation, and that they are considered efficacious when used as a flavouring compound in animal nutrition. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal2025, 23(7), e9535, https://doi.org/10.2903/j.efsa.2025.9535. ELI: http://data.europa.eu/eli/reg_impl/2026/353/oj 1/8EN OJ L, 19.2.2026 (5) In view of the above, the Commission considers that L-histidine and L-histidine monohydrochloride monohydrate, produced with Corynebacterium glutamicum KCCM 80389, satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances as feed additives should be authorised. The Commission considers that the safe use of those additives in water for drinking, with regard to possible hygiene risks, is to be considered within the scope of Regulation (EC) No 183/2005 of the European Parliament and of the Council(3) laying down requirements for feed hygiene. When fed to ruminants for the use under the functional group ‘amino acids, their salts and analogues’, L-histidine and L-histidine monohydrochloride monohydrate, produced with Corynebacterium glutamicumKCCM 80389, need protection against degradation in the rumen. It is also appropriate to alert the user 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-histidine and L-histidine monohydrochloride monohydrate via water for drinking. (6) The Commission considers that for the use of L-histidine and L-histidine monohydrochloride monohydrate, produced with Corynebacterium glutamicum KCCM 80389, as flavouring compounds, safety reasons do not require the setting of maximum contents. In order to allow for better control, the recommended maximum content should be indicated on the label of the feed additives. Where the recommended maximum contents are exceeded, certain information should be indicated on the label of the premixtures concerned. (7) 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 substances specified in the Annex, belonging to the category ‘nutritional additives’ and functional group ‘amino acids, their salts and analogues’, and to the category ‘sensory additives’ and functional group ‘flavouring compounds’, are authorised as additives 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, 18 February 2026. For the Commission The President Ursula VON DER LEYEN (3) Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/183/oj). 2/8 ELI: http://data.europa.eu/eli/reg_impl/2026/353/ojANNEX Minimum Maximum Identification Species or content content Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method authorisation additive animal mg/kg of complete feed with 12 % moisture content Category: nutritional additives. Functional group: amino acids, their salts and analogues 3c353 L-histidine Additive composition All animal — — — 1. In the directions for use of the 11 March species additive and premixtures, the 2036 L-histidine storage conditions, the Solid form stability to heat treatment Characterisation of the active and in water for drinking substance shall be indicated. L-histidine ≥ 90 % (on a dry 2. The additive may be used via matter basis) produced with water for drinking. Corynebacterium glutamicumKCCM 80389 Histamine ≤ 100 ppm 3. Feed business operators shall ensure that L-histidine is IUPAC name: (2S)-2-amino- rumen protected, when fed 3-(1H-imidazol-5-yl) propanoic to ruminants. acid Chemical formula: C H N O 6 9 3 2 CAS number: 71-00-1 4. The moisture content shall be indicated on the label of Analytical method(1) the additive. For the determination of histidine in the feed additive: 5. The label of the additive and — Ion-exchange premixtures shall indicate chromatography coupled with the following: ‘The post-column derivatisation supplementation with and optical detection (IEC-VIS L-histidine, in particular via or IEC-VIS/FLD), or water for drinking, shall take — High performance liquid into account all essential and chromatography coupled with conditionally essential spectrophotometric detection amino acids in order to avoid (HPLC-UV) nutritional imbalances.’ ELI: http://data.europa.eu/eli/reg_impl/2026/353/oj 3/8 OJ L, 19.2.2026 ENMinimum Maximum Identification Species or content content Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method authorisation additive animal mg/kg of complete feed with 12 % moisture content For the determination of histidine in premixtures and compound feed: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC- VIS) – Commission Regulation (EC) No 152/2009(2) For the determination of histidine in water for drinking: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) For the determination of histamine in the feed additive: — High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV) 3c354 L-histidine Additive composition All animal — — — 1. In the directions for use of the 11 March monohy­ species additive and premixtures, the 2036 L-histidine monohydrochloride drochloride storage conditions, the monohydrate monohydrate stability to heat treatment Solid form and in water for drinking Characterisation of the active shall be indicated. substance 2. The additive may be used via L-histidine monohydrochloride water for drinking. monohydrate ≥ 98 % with a minimum content of 72 % 3. Feed business operators shall histidine (on a dry matter basis), ensure that L-histidine produced with Corynebacterium monohydrochloride glutamicumKCCM 80389 monohydrate is rumen Histamine ≤ 100 ppm protected, when fed to ruminants. 4/8 ELI: http://data.europa.eu/eli/reg_impl/2026/353/oj EN OJ L, 19.2.2026Minimum Maximum Identification Species or content content Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method authorisation additive animal mg/kg of complete feed with 12 % moisture content IUPAC name: (2S)-2-amino- 4. The moisture content shall 3-(1H-imidazol-5-yl) propanoic be indicated on the label of acid hydrate hydrochloride the additive. Chemical formula: C H N O ·HCl·H O 5. The label of the additive and 6 9 3 2 2 CAS number: 5934-29-2 premixtures shall indicate the following: ‘The Analytical method(1) supplementation with For the determination of histidine L-histidine in the feed additive: monohydrochloride — Ion-exchange monohydrate, in particular chromatography coupled with via water for drinking, shall post-column derivatisation take into account all essential and optical detection (IEC-VIS and conditionally essential or IEC-VIS/FLD), or amino acids in order to avoid — High performance liquid nutritional imbalances.’ chromatography coupled with spectrophotometric detection (HPLC-UV) For the determination of histidine in premixtures and compound feed: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC- VIS) – Regulation (EC) No 152/2009 For the determination of histidine in water for drinking: — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) ELI: http://data.europa.eu/eli/reg_impl/2026/353/oj 5/8 OJ L, 19.2.2026 ENMinimum Maximum Identification Species or content content Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method authorisation additive animal mg/kg of complete feed with 12 % moisture content For the determination of histamine in the feed additive: — High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV) Category: Sensory additives. Functional group: Flavouring compounds 3c353 L-histidine Additive composition All animal — — — 1. The additive shall be 11 March species incorporated into the feed in 2036 L-histidine the form of a premixture. Solid form Characterisation of the active 2. In the directions for use of the substance additive and premixtures, the L-histidine ≥ 90 % (on a dry storage conditions and the matter basis) produced with stability to heat treatment Corynebacterium glutamicumKCCM shall be indicated. 80389 Histamine ≤ 100 ppm 3. On the label of the additive IUPAC name: (2S)-2-amino- the following shall be 3-(1H-imidazol-5-yl) propanoic indicated: ‘Recommended acid maximum content of the Chemical formula: C H N O 6 9 3 2 active substance in complete CAS number: 71-00-1 feedingstuff with a moisture Analytical method(1) content of 12 %: 25 mg/kg.’ For the determination of histidine in the feed additive: 4. The functional group, the — Ion-exchange identification number, the chromatography coupled with name and the added amount post-column derivatisation of the active substance shall and optical detection (IEC-VIS be indicated on the label of or IEC-VIS/FLD) or the premixture where the use — High performance liquid level on the label of the chromatography coupled with premixture would result in spectrophotometric detection exceeding the content (HPLC-UV) referred to in point 3. 6/8 ELI: http://data.europa.eu/eli/reg_impl/2026/353/oj EN OJ L, 19.2.2026Minimum Maximum Identification Species or content content Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method authorisation additive animal mg/kg of complete feed with 12 % moisture content For the determination of histidine 5. The moisture content shall in premixtures: be indicated on the label of — Ion-exchange the additive. chromatography coupled with post-column derivatisation and optical detection (IEC- VIS) – Regulation (EC) No 152/2009 For the determination of histamine in the feed additive: — High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV) 3c354 L-histidine Additive composition All animal — — — 1. The additive shall be 11 March monohy­ species incorporated into the feed in 2036 L-histidine monohydrochloride drochloride the form of a premixture. monohydrate monohydrate Solid form Characterisation of the active substance 2. In the directions for use of the additive and premixtures, the L-histidine monohydrochloride storage conditions and the monohydrate ≥ 98 % with a stability to heat treatment minimum content of 72 % shall be indicated. histidine (on a dry matter basis), produced with Corynebacterium glutamicumKCCM 80389 Histamine ≤ 100 ppm 3. On the label of the additive IUPAC name: (2S)-2-amino- the following shall be 3-(1H-imidazol-5-yl) propanoic indicated: ‘Recommended acid hydrate hydrochloride maximum content of the Chemical formula: active substance in complete C H N O ·HCl·H O feedingstuff with a moisture 6 9 3 2 2 CAS number: 5934-29-2 content of 12 %: 25 mg/kg.’ ELI: http://data.europa.eu/eli/reg_impl/2026/353/oj 7/8 OJ L, 19.2.2026 ENMinimum Maximum Identification Species or content content Name of the Composition, chemical formula, End of period of number of the category of Maximum age Other provisions additive description, analytical method authorisation additive animal mg/kg of complete feed with 12 % moisture content Analytical method(1) 4. The functional group, the identification number, the For the determination of histidine name and the added amount in the feed additive: of the active substance shall — Ion-exchange be indicated on the label of chromatography coupled with the premixture where the use post-column derivatisation level on the label of the and optical detection (IEC-VIS premixture would result in or IEC-VIS/FLD), or exceeding the content — High performance liquid referred to in point 3. chromatography coupled with spectrophotometric detection (HPLC-UV) 5. The moisture content shall For the determination of histidine be indicated on the label of in premixtures: the additive. — Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC- VIS) – Regulation (EC) No 152/2009 For the determination of histamine in the feed additive: — High performance liquid chromatography coupled with spectrophotometric detection (HPLC-UV) (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). 8/8 ELI: http://data.europa.eu/eli/reg_impl/2026/353/oj EN OJ L, 19.2.2026