Commission Implementing Regulation (EU) 2026/352 of 18 February 2026 concerning the authorisation of L-arginine produced with Escherichia coli CCTCC M 20231961 as a feed additive for all animal species

Official Journal EN of the European Union L series 2026/352 19.2.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/352 of 18 February 2026 concerning the authorisation of L-arginine produced with Escherichia coliCCTCC M 20231961 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 Escherichia coliCCTCC M 20231961. 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 Escherichia coliCCTCC M 20231961 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 additive 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 21 July 2025(2) that, under the proposed conditions of use, L-arginine produced with Escherichia coli CCTCC M 20231961 is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. However, due to the risk of nutritional imbalances and hygienic reasons, the Authority has concerns on the of use L-arginine in water for drinking. The Authority also concluded that the use of L-arginine produced with Escherichia coli CCTCC M 20231961 in animal nutrition is safe for the consumers and the environment. In the absence of data, it could not conclude on the potential of the substance to be an irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The Authority further concluded that the substance is regarded as an efficacious source of the amino acid L-arginine for non-ruminant nutrition. For the supplemental L-arginine to be as efficacious in ruminants as in non- ruminant species, it requires protection against degradation in the rumen. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It 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. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal2025;23(8);e9609, https://doi.org/10.2903/j.efsa.2025.9609. ELI: http://data.europa.eu/eli/reg_impl/2026/352/oj 1/4EN OJ L, 19.2.2026 (5) In view of the above, the Commission considers that L-arginine produced with Escherichia coliCCTCC M 20231961 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. The Commission considers that the safe use of this amino acid 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, L-arginine produced with Escherichia coli CCTCC M 20231961 should be protected 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 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, 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). 2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/352/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 3c366i L-arginine Additive composition All animal — — — 1. In the directions for use of the 11 March species additive and premixtures, the 2036 L-arginine storage conditions, the Solid form stability to heat treatment and Characterisation of the active in water for drinking shall be substance indicated. L-arginine ≥ 98,5 % (on a dry 2. The additive may be used via matter basis) produced with water for drinking. Escherichia coliCCTCC M 20231961 3. Feed business operators shall IUPAC name: (2S)-2-amino- ensure that L-arginine is 5-(diaminomethylideneamino) rumen protected, when fed to pentanoic acid ruminants. Chemical formula: C H N O 6 14 4 2 CAS number: 74–79-3 4. The moisture content shall be Analytical method(1) indicated on the label of the additive. For the identification of L-arginine in the feed additive: 5. The label of the additive and — Food Chemical Codex premixtures shall indicate the ‘L-arginine monograph’ following: ‘The For the determination of arginine supplementation with in the feed additive: L-arginine, in particular via — Ion-exchange water for drinking, shall take chromatography coupled to into account all essential and post-column derivatisation conditionally essential amino and optical detection (IEC- acids in order to avoid VIS/FLD or IEC-VIS) nutritional imbalances.’ ELI: http://data.europa.eu/eli/reg_impl/2026/352/oj 3/4 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 arginine 6. For users of the additive and in premixtures: premixtures, feed business — Ion-exchange operators shall establish chromatography coupled to operational procedures and post-column derivatisation organisational measures to and optical detection (IEC- address potential risks VIS/FLD) or resulting from their use. — Ion-exchange Where those risks cannot be chromatography coupled to eliminated by such procedures post-column derivatisation and measures, the additive and and optical detection (IEC-VIS) premixtures shall be used with – Commission Regulation (EC) personal skin and eye No 152/2009(2) protective equipment. For the determination of arginine in compound feed: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) – Regulation (EC) No 152/2009 For the determination of arginine in water for drinking: — Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) (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). 4/4 ELI: http://data.europa.eu/eli/reg_impl/2026/352/oj EN OJ L, 19.2.2026