COMMISSION IMPLEMENTING REGULATION (EU) 2025/148

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2025/148 | 30.1.2025 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2025/148 of 29 January 2025 concerning the renewal of the authorisation of a preparation of Enterococcus lactis NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation: Chr. Hansen A/S) and repealing Implementing Regulation (EU) No 797/2013 (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 and renewing such an authorisation. ---|--- (2) | A preparation of Enterococcus faecium NCIMB 11181 was authorised for 10 years as a feed additive for calves for rearing and for fattening and weaned piglets by Commission Implementing Regulation (EU) No 797/2013 (2). ---|--- (3) | In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of Enterococcus lactis NCIMB 11181 as a feed additive, for calves for rearing and for fattening and weaned piglets, requesting the additive to be classified in the category of zootechnical additives and in the functional group of gut flora stabilisers. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. ---|--- (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 November 2023 (3) that the preparation of Enterococcus lactis NCIMB 11181 (strain originally taxonomically identified as Enterococcus faecium and reclassified as Enterococcus lactis) remains safe for calves for rearing and for fattening (up to 6 months) and weaned piglets (up to 35 kg), the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of Enterococcus lactis NCIMB 11181 in 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 for skin and eyes or on the potential of both formulations of the additive to cause skin sensitisation. The opinion also indicated that it is not necessary to assess the efficacy of the preparation of Enterococcus lactis NCIMB 11181 in the context of the renewal of the authorisation as the application for renewal of the authorisation does not include a proposal to amend or supplement the conditions of the original authorisation that would have an impact on the efficacy of the additive. According to the conclusions of the Authority in its opinion of 1 February 2012 (4), the preparation of Enterococcus lactis NCIMB 11181 is efficacious in improving zootechnical performance of piglets and calves, with the minimum effective dose for piglets being in the order of 1 × 1010 CFU/kg feed and for calves in the region of 2 × 109 CFU/kg milk replacer, independently of route of delivery provided that the same dose is given. The Authority did not consider that there is the need for specific requirements of post-market monitoring. ---|--- (5) | The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the preparation of Enterococcus lactis NCIMB 11181 as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (5), an evaluation report of the Reference Laboratory is therefore not required. ---|--- (6) | In view of the above, the Commission considers that the preparation of Enterococcus lactis NCIMB 11181 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. In addition, the Commission considers that the minimum contents specified in the Annex need to be adjusted to the effective dose of the additive, and that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law. ---|--- (7) | As a consequence of the renewal of the authorisation of the preparation of Enterococcus lactis NCIMB 11181 as a feed additive, Implementing Regulation (EU) No 797/2013 should be repealed. ---|--- (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Enterococcus lactis NCIMB 11181, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation. ---|--- (9) | 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 Renewal of authorisation The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex. Article 2 Repeal Implementing Regulation (EU) No 797/2013 is repealed. Article 3 Transitional measures 1\. The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 19 August 2025 in accordance with the rules applicable before 19 February 2025 may continue to be placed on the market and used until the existing stocks are exhausted. 2\. Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 19 February 2026 in accordance with the rules applicable before 19 February 2025 may continue to be placed on the market and used until the existing stocks are exhausted. Article 4 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, 29 January 2025. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) Commission Implementing Regulation (EU) No 797/2013 of 21 August 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation Chr. Hansen A/S) and repealing Regulation (EC) No 1333/2004 (OJ L 224, 22.8.2013, p. 6, ELI: http://data.europa.eu/eli/reg_impl/2013/797/oj). (3) EFSA Journal. 2023;21:e8466. (4) EFSA Journal 2012;10(2):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). * * * ANNEX Identification number of the feed additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|---|---|---|--- CFU/kg of complete feedingstuff with a moisture content of 12 % | CFU/l of water for drinking Category: zootechnical additives. Functional group: gut flora stabilisers 4b1708 | Chr. Hansen A/S | Enterococcus lactis NCIMB 11181 | Additive composition Preparation of Enterococcus lactis NCIMB 11181 containing a minimum of: Solid form: 5 × 1010 CFU/g additive; Solid water-soluble form: 2 × 1011 CFU/g additive. Characterisation of the active substance Viable cells of Enterococcus lactis NCIMB 11181 Analytical method (1) Enumeration of the active substance in the feed additive, premixtures, compound feed and water: spread plate method using Bile Esculin Azide agar – EN 15788 Identification: Pulsed-Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | Weaned piglets | — | 1 × 1010 | — | 5 ×109 | — | | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment and in water for drinking shall be indicated. ---|--- 2. | For weaned piglets up to 35 kg. ---|--- 3. | The water-soluble formulation of the additive shall be used via water for drinking. ---|--- 4. | For the use of the additive in water for drinking, a homogeneous dispersion of the additive shall be ensured. ---|--- 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. ---|--- 19 February 2035 Identification number of the feed additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|---|--- CFU/kg of complete feedingstuff with a moisture content of 12 % Category: zootechnical additives. Functional group: gut flora stabilisers 4b1708 | Chr. Hansen A/S | Enterococcus lactis NCIMB 11181 | Additive composition Preparation of Enterococcus lactis NCIMB 11181 containing a minimum of: Solid form: 5 × 1010 CFU/g additive; Solid water-soluble form: 2 × 1011 CFU/g additive. Characterisation of the active substance Viable cells of Enterococcus lactis NCIMB 11181 Analytical method (2) Enumeration of the active substance in the feed additive, premixtures, compound feed and water: spread plate method using Bile Esculin Azide agar – EN 15788 Identification: Pulsed-Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | Calves for rearing and for fattening | 6 months | 2 × 109 | — | | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. ---|--- 2. | The additive may be used in milk replacers for calves for rearing and for fattening. ---|--- 3. | 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. ---|--- 19 February 2035 * * * (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) 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/2025/148/oj ISSN 1977-0677 (electronic edition) * * *