COMMISSION IMPLEMENTING REGULATION (EU) 2025/1527

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2025/1527 | 30.7.2025 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2025/1527 of 29 July 2025 concerning the authorisation of a preparation of Lactiplantibacillus plantarum NCIMB 41028 and a preparation of Lactiplantibacillus plantarum NCIMB 30148 as feed additives 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 authorisation. ---|--- (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, two applications were submitted for the authorisation of a preparation of Lactiplantibacillus plantarum NCIMB 41028 and a preparation of Lactiplantibacillus plantarum NCIMB 30148. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. ---|--- (3) | The applications concern the authorisation of the preparation of Lactiplantibacillus plantarum NCIMB 41028 and the preparation of Lactiplantibacillus plantarum NCIMB 30148 as feed additives for all animal species, requesting those additives 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 opinions of 26 November 2024 (2) that the use of the preparations of Lactiplantibacillus plantarum NCIMB 41028 and of Lactiplantibacillus plantarum NCIMB 30148 is safe for all animal species, consumers and the environment. It also concluded that the additives are not irritant to skin, they should be considered as potential skin and respiratory sensitisers, that any exposure through skin and respiratory tract to those additives is to be considered a risk and could not conclude on their eye irritation potential. The Authority further concluded that the addition of Lactiplantibacillus plantarum NCIMB 41028 and of Lactiplantibacillus plantarum NCIMB 30148 at a minimum level of 1 × 109 CFU/kg fresh plant material has the potential to improve the production of silage from fresh material. ---|--- (5) | In view of the above, the Commission considers that the preparations of Lactiplantibacillus plantarum NCIMB 41028 and of Lactiplantibacillus plantarum NCIMB 30148 satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those preparations 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 additives. ---|--- (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 preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives 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, 29 July 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) EFSA Journal, 22(12), e9142. https://doi.org/10.2903/j.efsa.2024.9142. EFSA Journal, 22(12), e9143. https://doi.org/10.2903/j.efsa.2024.9143. * * * ANNEX Identification number of the feed additive | 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 fresh material Category: technological additives. Functional group: silage additives 1k20713 | Lactiplantibacillus plantarum NCIMB 41028 | Additive composition Preparation of Lactiplantibacillus plantarum NCIMB 41028 containing a minimum of 7 × 1010 CFU/g additive. Solid form ——————————————— Characterisation of the active substance Viable cells of Lactiplantibacillus plantarum NCIMB 41028 ——————————————— Analytical method (1) Identification of Lactiplantibacillus plantarum NCIMB 41028: | — | DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697) ---|--- Enumeration of Lactiplantibacillus plantarum NCIMB 41028: — | Spread plate (or pour plate) method on MRS agar (EN 15787) ---|--- All animal species | — | — | — | | 1. | In the directions for use of the additive and premixtures, the storage conditions shall be indicated. ---|--- 2. | Minimum dose of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 109 CFU/kg fresh plant material. ---|--- 3. | Cryoprotectants used in the preparation of Lactiplantibacillus plantarum NCIMB 41028 may include inter alia: | — | glycine ≤ 14 % ---|--- — | sodium erythorbate ≤ 14 % ---|--- 4. | 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 skin, eye and breathing protective equipment. ---|--- 19 August 2035 Identification number of the feed additive | 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 fresh material Category: technological additives. Functional group: silage additives 1k20714 | Lactiplantibacillus plantarum NCIMB 30148 | Additive composition Preparation of Lactiplantibacillus plantarum NCIMB 30148 containing a minimum of 7 × 1010 CFU/g additive Solid form ——————————————— Characterisation of the active substance Viable cells of Lactiplantibacillus plantarum NCIMB 30148 ——————————————— Analytical method (2) Identification of Lactiplantibacillus plantarum NCIMB 30148: | — | DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697) ---|--- Enumeration of Lactiplantibacillus plantarum NCIMB 30148: — | Spread plate (or pour plate) method on MRS agar (EN 15787) ---|--- All animal species | — | — | — | | 1. | In the directions for use of the additive and premixtures, the storage conditions shall be indicated. ---|--- 2. | Minimum dose of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 109 CFU/kg fresh plant material. ---|--- 3. | Cryoprotectants used in the preparation of Lactiplantibacillus plantarum NCIMB 30148 may include inter alia: | — | glycine ≤ 21 % ---|--- — | sodium erythorbate ≤ 21 % ---|--- 4. | 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 skin, eye and breathing protective equipment. ---|--- 19 August 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/2025/1527/oj ISSN 1977-0677 (electronic edition) * * *