Commission Implementing Regulation (EU) 2025/2175 of 29 October 2025 concerning the renewal of the authorisation of a preparation of Lactiplantibacillus plantarum CECT 4528 as a feed additive for all animal species and repealing Implementing Regulation (EU) No 399/2014

Official Journal EN of the European Union L series 2025/2175 30.10.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2175 of 29 October 2025 concerning the renewal of the authorisation of a preparation of Lactiplantibacillus plantarumCECT 4528 as a feed additive for all animal species and repealing Implementing Regulation (EU) No 399/2014 (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 authorisation. (2) The preparation of Lactiplantibacillus plantarum CECT 4528 (previously taxonomically identified as Lactobacillus plantarum CECT 4528) was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 399/2014(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 Lactiplantibacillus plantarum CECT 4528 as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. 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 28 January 2025(3) that the preparation of Lactiplantibacillus plantarum CECT 4528 remains safe for all animal species, the consumers and the environment. The Authority also concluded that the additive is not irritant to eyes, but it should be considered as a skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. It further indicated that there is no need for assessing the efficacy of the additive as the application for the renewal of its authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation which would have an impact on the efficacy of the additive. (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 Lactiplantibacillus plantarumCECT 4528 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(4), an evaluation report of the Reference Laboratory is therefore not required. (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 399/2014 of 22 April 2014 concerning the authorisation of the preparations of Lactobacillus brevis DSM 23231, Lactobacillus brevis DSMZ 16680, Lactobacillus plantarum CECT 4528 and Lactobacillus fermentum NCIMB 30169 as feed additives for all animal species (OJ L 119, 23.4.2014, p. 40, ELI: http://data.europa.eu/eli/reg_impl/2014/ 399/oj). (3) EFSA Journal2025; 23(2), e9247, https://doi.org/10.2903/j.efsa.2025.9247. (4) 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). ELI: http://data.europa.eu/eli/reg_impl/2025/2175/oj 1/3EN OJ L, 30.10.2025 (6) In view of the above, the Commission considers that the preparation of Lactiplantibacillus plantarum CECT 4528 satisfies the conditions, as 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 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 Lactiplantibacillus plantarumCECT 4528 as a feed additive, Implementing Regulation (EU) No 399/2014 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 Lactiplantibacillus plantarumCECT 4528, 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 the authorisation The authorisation of the preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is renewed subject to the conditions laid down in that Annex. Article 2 Repeal of Implementing Regulation (EU) No 399/2014 Implementing Regulation (EU) No 399/2014 is repealed. Article 3 Transitional measures The preparation specified in the Annex and feed containing it, which are produced and labelled before 19 November 2026 in accordance with the rules applicable 19 November 2025 may continue to be placed on the market and used until the stocks concerned 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 October 2025. For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg_impl/2025/2175/ojANNEX Minimum Maximum Identification Species or End of period Composition, chemical formula, Maximum content content number of the Additive category Other provisions of description, analytical method age feed additive of animal authorisation CFU/kg of fresh material Category: technological additives. Functional group: silage additives 1k20746 Lactiplantibacillus Additive composition All - - - 1. In the directions for use of 19 November plantarum Preparation of Lactiplantibacillus animal the additive and 2035 CECT 4528 plantarumCECT 4528 containing a species premixtures, the storage minimum of 2,5 × 1011CFU/g conditions shall be additive. indicated. Solid form 2. Minimum dose of the ————————— additive when it is not used Characterisation of the active substance in combination with other Viable cells of Lactiplantibacillus micro-organisms as silage plantarumCECT 4528 additives: 1 × 109CFU/kg ————————— fresh material. Analytical method(1) 3. For users of the additive and Identification of Lactiplantibacillus premixtures, feed business plantarumCECT 4528 in the feed operators shall establish additive: operational procedures and — Pulsed Field Gel Electrophoresis organisational measures to (PFGE) - CEN/TS 17697 or DNA address potential risks sequencing methods. resulting from their use. Enumeration of Lactiplantibacillus Where those risks cannot be plantarumCECT 4528 in the feed eliminated by such additive: procedures and measures, — Spread plate (or pour plate) the additive and method on MRS agar (EN 15787) premixtures shall be used with personal skin 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/2025/2175/oj 3/3 OJ L, 30.10.2025 EN