Commission Implementing Regulation (EU) 2026/1117 of 26 May 2026 concerning the authorisation of L-isoleucine produced with Escherichia coli CCTCC M 20231916 as a feed additive for all animal species

Official Journal EN of the European Union L series 2026/1117 27.5.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/1117 of 26 May 2026 concerning the authorisation of L-isoleucine produced with Escherichia coliCCTCC M 20231916 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-isoleucine produced with Escherichia coli CCTCC M 20231916. 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-isoleucine produced with Escherichia coliCCTCC M 20231916 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 17 September 2025(2)that the use of L-isoleucine produced with Escherichia coli CCTCC M 20231916 in feed 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-isoleucine in water for drinking. The Authority also concluded that the use of L-isoleucine produced with Escherichia coli CCTCC M 20231916 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 additive to be irritant to skin and/or eyes and to be a potential skin sensitiser but identified an inhalation risk to endotoxins for the users of the additive. The Authority further concluded that the substance is regarded as an efficacious source of the amino acid L-isoleucine for non-ruminant nutrition. For the supplemental L-isoleucine 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(10):e9687, https://doi.org/10.2903/j.efsa.2025.9687.

ELI: http://data.europa.eu/eli/reg_impl/2026/1117/oj 1/4EN OJ L, 27.5.2026

(5) In view of the above, the Commission considers that L-isoleucine produced with Escherichia coliCCTCC M 20231916 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 possible hygiene risks related to the use of this amino acid in water for drinking, are to be addressed by feed business operators under their obligations to ensure compliance with the relevant hygiene requirements laid down in 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-isoleucine produced with Escherichia coli CCTCC M 20231916 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-isoleucine 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, 26 May 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/2026/1117/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 3c384i L-isoleucine Additive composition All animal — — — 1. In the directions for use of 16 June 2036 L-isoleucine species the additive and premixtures, the storage Solid form conditions and the stability to heat treatment Characterisation of the active substance and in water for drinking L-isoleucine ≥ 90 % (on a dry matter shall be indicated.

basis) produced with Escherichia coli CCTCC M 20231916

2. The additive may be used

IUPAC name: (2S,3S)-2-amino- via water for drinking.

3-methylpentanoic acid

3. Feed business operators

Chemical formula: C H NO 6 13 2 shall ensure that

CAS number: 73-32-5 L-isoleucine is rumen protected, when fed to Analytical method(1) ruminants.

For the identification of L-isoleucine in

the feed additive: 4. The moisture content — Food Chemical Codex ‘L-isoleucine shall be indicated on the monograph’; label of the additive.

For the determination of isoleucine in

the feed additive: 5. The labelling of the — Ion-exchange chromatography additive and premixtures coupled to post-column shall indicate the

derivatisation and optical detection following: ‘The (IEC-VIS/FLD or IEC-VIS); supplementation with L-isoleucine, in particular For the determination of isoleucine in via water for drinking,

premixtures: shall take into account all — Ion-exchange chromatography essential and coupled to post-column conditionally essential derivatisation and optical detection amino acids in order to (IEC-VIS/FLD) or avoid nutritional imbalances’.

ELI:

http://data.europa.eu/eli/reg_impl/2026/1117/oj 3/4 OJ L,

27.5.2026 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 — Ion-exchange chromatography 6. The endotoxin content of coupled to post-column the additive and its derivatisation and optical detection dusting potential shall (IEC-VIS), Commission Regulation ensure a maximal

(EC) No 152/2009(2); endotoxin exposure of 1 600 IU endotoxins/m3 For the determination of isoleucine in air(3).

compound feed: — Ion-exchange chromatography

7. For users of the additive coupled to post-column and premixtures, feed derivatisation and optical detection business operators shall (IEC-VIS), Regulation (EC) establish operational No 152/2009; procedures and For the determination of isoleucine in organisational measures

water for drinking: to address potential risks — Ion-exchange chromatography resulting from their use. coupled to post-column Where those risks cannot derivatisation and optical detection be eliminated by such (IEC-VIS). procedures and measures, the additive and premixtures shall be used with personal skin, 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.

(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).

(3) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).

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ELI:

http://data.europa.eu/eli/reg_impl/2026/1117/oj EN OJ L,

27.5.2026