Commission Implementing Regulation (EU) 2025/1787 of 8 September 2025 concerning the authorisation of L-arginine produced with Corynebacterium glutamicum KCCM 80387 as a feed additive for all animal species

Official Journal EN of the European Union L series 2025/1787 9.9.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1787 of 8 September 2025 concerning the authorisation of L-arginine produced with Corynebacterium glutamicumKCCM 80387 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-arginine produced with Corynebacterium glutamicum KCCM 80387. 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-arginine produced with Corynebacterium glutamicumKCCM 80387 as a feed additive for all animal species, requesting that additive 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 for the functional group ‘flavouring compounds’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 January 2025(2)that, under the proposed conditions of use, L-arginine produced with Corynebacterium glutamicumKCCM 80387 does not pose any safety concerns regarding the production strain and that the additive is safe for the target species, the consumers and the environment. The Authority has concerns on the use of L-arginine in water for drinking. It also concluded that L-arginine produced with Corynebacterium glutamicumKCCM 80387 is not irritant to skin, and not a dermal sensitiser but is irritant to the eyes and respiratory tract. The Authority further concluded that the substance is regarded as an efficacious source of the amino acid L-arginine for all non-ruminant species, but for the substance to be fully efficacious in ruminants, it should be protected from ruminal degradation and that it is 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 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-arginine produced with Corynebacterium glutamicum KCCM 80387 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance as a feed additive should be authorised. When fed to ruminants for the use under the functional group ‘amino acids, their salts and analogues’, L-arginine produced with Corynebacterium glutamicum KCCM 80387 needs protection against degradation in the rumen. It is 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-arginine 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. (6) The Commission considers that for the use of L-arginine produced with Corynebacterium glutamicumKCCM 80387 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 such 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, (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal2025; 23(2), e9258, https://doi.org/10.2903/j.efsa.2025.9258. ELI: http://data.europa.eu/eli/reg_impl/2025/1787/oj 1/5EN OJ L, 9.9.2025 HAS ADOPTED THIS REGULATION: Article 1 Authorisation The substance specified in the Annex, belonging to the category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’ and to the category ‘sensory additives’, functional group ‘flavouring compounds’, 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, 8 September 2025. For the Commission The President Ursula VON DER LEYEN 2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/1787/ojANNEX Minimum Maximum Identification Species or content content number of Composition, chemical formula, Maximum End of period of Additive category Other provisions the feed description, analytical method age authorisation of animal mg/kg of complete feed with additive 12 % moisture content Category: nutritional additives. Functional group: amino acids, their salts and analogues 3c367 L-arginine Additive composition All – – – 1. In the directions for use of the 29 September animal additive and premixtures, the 2035 L-arginine ≥ 98 % (on a dry matter species storage conditions, the stability basis) to heat treatment and in water Solid form shall be indicated. 2. The additive may be used via Characterisation of the active substance water for drinking. L-arginine produced with 3. Feed business operators shall Corynebacterium glutamicumKCCM ensure that L-arginine is rumen 80387 protected, when fed to IUPAC name: (S)-2-amino- ruminants. 5-guanidinopentanoic acid Chemical formula: C H N O 4. The moisture content shall be 6 14 4 2 CAS number: 74–79-3 indicated on the label of the additive. Analytical method(1) 5. The label of the additive and For the identification of L-arginine in premixtures shall indicate the the feed additive: following: ‘The supplementation with L-arginine, in particular via — Food Chemical Codex ‘L-arginine water for drinking, shall take into monograph’; account all essential and For the determination of arginine in conditionally essential amino the feed additive and water: acids in order to avoid — Ion-exchange chromatography imbalances.’ coupled with post-column derivatisation and optical detection (IEC-VIS); ELI: http://data.europa.eu/eli/reg_impl/2025/1787/oj 3/5 OJ L, 9.9.2025 ENMinimum Maximum Identification Species or content content number of Composition, chemical formula, Maximum End of period of Additive category Other provisions the feed description, analytical method age authorisation of animal mg/kg of complete feed with additive 12 % moisture content For the determination of arginine in 6. For users of the additive and premixtures and compound feed: premixtures, feed business — Ion-exchange chromatography operators shall establish coupled with post-column operational procedures and derivatisation and optical organisational measures to detection (IEC-VIS), Commission address potential risks resulting Regulation (EC) No 152/2009. from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal eye and breathing protective equipment. (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. Minimum Maximum Identification Species or content content number of Composition, chemical formula, Maximum End of period of Additive category of Other provisions the feed description, analytical method age authorisation animal mg/kg of complete feed with additive 12 % moisture content Category: Sensory additives. Functional group: Flavouring compounds 3c367 L-arginine Additive composition All – – – 1. The additive shall be 29 September animal incorporated into the feed in the 2035 L-arginine ≥ 98 % (on a dry matter species form of a premixture. basis) 2. In the directions for use of the Solid form additive and premixtures, the storage conditions and the Characterisation of the active substance stability to heat treatment shall be L-arginine produced with indicated. Corynebacterium glutamicumKCCM 80387 4/5 ELI: http://data.europa.eu/eli/reg_impl/2025/1787/oj EN OJ L, 9.9.2025Minimum Maximum Identification Species or content content number of Composition, chemical formula, Maximum End of period of Additive category of Other provisions the feed description, analytical method age authorisation animal mg/kg of complete feed with additive 12 % moisture content IUPAC name: (S)-2-amino- 3. On the label of the additive and 5-guanidinopentanoic acid premixture the following shall be Chemical formula: C H N O indicated: ‘Recommended 6 14 4 2 CAS number: 74–79-3 maximum content of the active substance of complete Analytical method(1) feedingstuff with a moisture content of 12 %: 25 mg/kg.’ For the identification of L-arginine in the feed additive: 4. The functional group, the identification number, the name — Food Chemical Codex ‘L-arginine and the added amount of the monograph’; active substance shall be For the determination of arginine in indicated on the label of the the feed additive: premixture where the use level on — Ion-exchange chromatography the label of the premixture would coupled with post-column result in exceeding the content derivatisation and optical referred to in point 3. detection (IEC-VIS); 5. The moisture content shall be For the determination of arginine in indicated on the label of the premixtures: additive. — Ion-exchange chromatography 6. For users of the additive and coupled with post-column premixtures, feed business derivatisation and optical operators shall establish detection (IEC-VIS), Commission operational procedures and Regulation (EC) No 152/2009. 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 eye and breathing protective equipment. (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. ELI: http://data.europa.eu/eli/reg_impl/2025/1787/oj 5/5 OJ L, 9.9.2025 EN