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Date: 2025-07-29 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2025/1523 of 28 July 2025 concerning the authorisation of a preparation of Lactiplantibacillus plantarum NCIMB 30094 as a feed additive for all animal species

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

Executive Summary: Commission Implementing Regulation (EU) 2025/1523 authorises the use of a preparation of Lactiplantibacillus plantarum NCIMB 30094 as a technological feed additive (silage additive) for all animal species. The authorisation is subject to specific conditions outlined in the Annex. The regulation enters into force on August 18, 2025, and the authorisation period ends on August 18, 2035. Key Points / Main Content: * **Authorisation:** * The preparation of Lactiplantibacillus plantarum NCIMB 30094 is authorised as a feed additive for all animal species. * It is classified as a technological additive within the functional group of silage additives. * **Conditions of Use:** * Storage conditions must be indicated in the directions for use of the additive and premixtures. * The minimum dose of the additive, when not combined with other microorganisms, is 1 x 10^9 CFU/kg of fresh plant material. * Cryoprotectants used in the preparation may include glycine and sodium erythorbate. * **Safety Measures:** * Users of the additive and premixtures must implement operational procedures and organizational measures to address potential risks. * Personal protective equipment (skin, eye, and breathing protection) must be used if risks cannot be eliminated. * **Analytical Methods:** * Methods for identification (DNA sequencing, PFGE) and enumeration (spread plate or pour plate method on MRS agar) of Lactiplantibacillus plantarum NCIMB 30094 are specified. * Details of analytical methods are available at the provided Reference Laboratory address. * **Duration:** * The authorisation is valid until August 18, 2035. Impact Analysis: **Feed Business Operators:** * Impact: Responsible for ensuring that storage conditions are indicated in the directions for use. Must establish operational procedures and organizational measures to mitigate potential risks to users. * Action Required: Update product information and safety protocols, provide appropriate personal protective equipment where necessary. **Users of the Additive/Premixtures:** * Impact: Need to follow the directions for use, including storage conditions and dosage. Required to use personal protective equipment if risks cannot be eliminated through operational procedures and organizational measures. * Action Required: Implement operational procedures and organizational measures to address potential risks. Use appropriate personal protective equipment. **All Animal Species** * Impact: May experience improved silage quality due to the additive's efficacy. * Action Required: No direct action required, but monitor animal health and performance.

Key Entities Referenced

European Union: A political and economic union of member states located primarily in Europe. European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU. Lactiplantibacillus plantarum NCIMB 30094: A strain of bacteria used as a feed additive for all animal species, classified as a technological additive and silage additive. Regulation (EC) No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition. European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain. Brussels: The location where the regulation was adopted. Ursula VON DER LEYEN: The President of the European Commission. Standing Committee on Plants, Animals, Food and Feed: A committee providing opinions to the European Commission.
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Official Journal EN of the European Union L series 2025/1523 29.7.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1523 of 28 July 2025 concerning the authorisation of a preparation of Lactiplantibacillus plantarumNCIMB 30094 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 a preparation of Lactiplantibacillus plantarumNCIMB 30094. 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 Lactiplantibacillus plantarumNCIMB 30094 as a feed additive for all animal species, requesting that additive to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 November 2024(2) that Lactiplantibacillus plantarum NCIMB 30094 is safe for the target species, consumers and the environment. It also concluded that the additive is not a skin irritant, but it is an eye irritant, it should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The Authority further concluded that Lactiplantibacillus plantarum NCIMB 30094 is efficacious as a silage additive at the proposed conditions of use. The Authority 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. (5) In view of the above, the Commission considers that the preparation of Lactiplantibacillus plantarumNCIMB 30094 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised. 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, (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal, 23(1), e9144. https://doi.org/10.2903/j.efsa.2025.9144. ELI: http://data.europa.eu/eli/reg_impl/2025/1523/oj 1/3EN OJ L, 29.7.2025 HAS ADOPTED THIS REGULATION: Article 1 Authorisation The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, 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, 28 July 2025. For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg_impl/2025/1523/ojANNEX Identifica­ Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal authorisation CFU/kg of fresh material additive Category: technological additives. Functional group: silage additives 1k20723 Lactiplantibacillus Additive composition All - - - 1. In the directions for use of the 18 August plantarumNCIMB animal additive and premixtures, the 2035 Preparation of Lactiplantibacillus 30094 species storage conditions shall be plantarumNCIMB 30094 indicated. containing a minimum of 5 × 1010 CFU/g additive 2. Minimum dose of the additive when it is not used in combination with Solid form other micro-organisms as silage additives: 1 × 109CFU/kg fresh plant ————————— material. Characterisation of the active substance 3. Cryoprotectants used in the Viable cells of Lactiplantibacillus preparation of Lactiplantibacillus plantarumNCIMB 30094 plantarumNCIMB 30094 may include inter alia: ————————— — glycine ≤ 18 % Analytical method(1) — sodium erythorbate ≤ 18 % Identification of Lactiplantibacillus 4. For users of the additive and plantarumNCIMB 30094: premixtures, feed business operators shall establish operational — DNA sequencing methods or procedures and organisational Pulsed Field Gel measures to address potential risks Electrophoresis (PFGE) (CEN/TS resulting from their use. Where 17697) those risks cannot be eliminated by Enumeration of Lactiplantibacillus such procedures and measures, the plantarumNCIMB 30094: additive and premixtures shall be used with personal skin, eye and — Spread plate (or pour plate) breathing protective equipment. method on MRS agar (EN 15787) (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/2025/1523/oj 3/3 OJ L, 29.7.2025 EN

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