Commission Implementing Regulation (EU) 2026/1122 of 26 May 2026 concerning the authorisation of a preparation of Enterococcus lactis NCIMB 11181 as a feed additive for poultry for fattening and reared for laying or reproduction and ornamental birds (holder of authorisation: Chr. Hansen A/S)

Official Journal EN of the European Union L series 2026/1122 27.5.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/1122 of 26 May 2026 concerning the authorisation of a preparation of Enterococcus lactisNCIMB 11181 as a feed additive for poultry for fattening and reared for laying or reproduction and ornamental birds (holder of

authorisation: Chr. Hansen A/S) (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 a preparation of Enterococcus lactis NCIMB 11181 (formerly identified as Enterococcus faecium NCIMB 11181). 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 the preparation of Enterococcus lactisNCIMB 11181 as a feed additive for use in feed and in water for drinking for chickens for fattening or reared for laying, other poultry species for fattening or reared for laying, and ornamental birds, requesting the simultaneous use of that preparation in feed with the coccidiostats monensin sodium and decoquinate, and for that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 January 2024(2) that the preparation of Enterococcus lactis NCIMB 11181 is safe for chickens for fattening or reared for laying, other poultry species for fattening or reared for laying, and ornamental birds, as well as for consumers and the environment. The Authority also concluded that the solid water-soluble formulation of the additive is considered not irritant to skin or eyes. Due to the proteinaceous nature of the active agent, both solid and solid water-soluble formulations of the additive are considered respiratory sensitisers. The Authority could not conclude on the potential of the solid formulation of the additive to be irritant to skin and eyes or on the potential of both formulations of the additive to cause skin sensitisation. Furthermore, it concluded that the use of Enterococcus lactis NCIMB 11181 is compatible with the coccidiostats monensin sodium and decoquinate. After the assessment of newly submitted data by the applicant, the Authority concluded in its opinion of 16 September 2025(3)that the additive has the potential to be efficacious as a zootechnical additive for chickens for fattening when supplemented at 3 × 1010 CFU/kg complete feed and in water for drinking at 1,5 × 1010CFU/L. The conclusion in chickens for fattening is extended to chickens reared for laying and extrapolated to all poultry for fattening, all poultry reared for laying and ornamental birds. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) EFSA Journal2024;22:e8623, https://doi.org/10.2903/j.efsa.2024.8623.

(3) EFSA Journal2025;23:e9680, https://doi.org/10.2903/j.efsa.2025.9680.

ELI: http://data.europa.eu/eli/reg_impl/2026/1122/oj 1/4EN OJ L, 27.5.2026

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 1 February 2012(4) are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(5), an evaluation report of the Reference Laboratory was therefore not required.

(6) In view of the above, the Commission considers that the preparation of Enterococcus lactisNCIMB 11181 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for poultry for fattening and reared for laying or reproduction and ornamental birds. 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.

(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 preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, 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

(4) EFSA Journal2012;10(2):2574, https://doi.org/10.2903/j.efsa.2012.2574.

(5) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/ 2005/378/oj).

2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/1122/ojANNEX Minimum Maximum Minimum Maximum content content content content Identification Name of the Composition, chemical Species or End of period Name of the Maximum number of holder of formula, description, analytical category of Other provisions of additive age CFU/kg of complete the additive authorisation method animal CFU/l of water for authorisation feed with a moisture drinking content of 12 %

Category: zootechnical additives. Functional group: gut flora stabilisers 4b1708 Chr. Hansen Enterococcus Additive composition Poultry for — 3 × 1010 — 1,5 ×1010 — 1. In the directions for 16 June A/S lactis Preparation of Enterococcus fattening and use of the additive and 2036 NCIMB lactisNCIMB 11181 reared for premixtures, the 11181 containing a minimum of: laying or storage conditions,

Solid form: 5 × 1010CFU/g reproduction the stability to heat additive; treatment and the Ornamental stability in water for Solid water-soluble form: birds drinking shall be 2 × 1011CFU/g additive. indicated.

Characterisation of the active

2. The additive may be substance used via water for Viable cells of Enterococcus drinking. lactis NCIMB 11181 3. The water-soluble formulation of the Analytical method(1) additive shall be used Enumeration of the active via water for drinking.

substance in the feed additive, premixtures, 4. The additive may be compound feed and water used simultaneously

for drinking: spread plate with the following method using Bile Esculin coccidiostats, in Azide agar – EN 15788 accordance with their

Identification: Pulsed-Field respective conditions Gel Electrophoresis (PFGE) of authorisation as – CEN/TS 17697 or DNA feed additives: sequencing methods monensin sodium and decoquinate.

ELI:

http://data.europa.eu/eli/reg_impl/2026/1122/oj 3/4 OJ L,

27.5.2026 ENMinimum Maximum Minimum Maximum content content content content Identification Name of the Composition, chemical Species or End of period Name of the Maximum number of holder of formula, description, analytical category of Other provisions of additive age CFU/kg of complete the additive authorisation method animal CFU/l of water for authorisation feed with a moisture drinking content of 12 %

5. For users of the additive and premixtures, feed business operators shall establish operational procedures and 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 (only for the solid formulation), breathing, and skin 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.

4/4

ELI:

http://data.europa.eu/eli/reg_impl/2026/1122/oj EN OJ L,

27.5.2026