Commission Implementing Regulation (EU) 2025/277 of 12 February 2025 concerning the authorisation of a preparation of Loigolactobacillus coryniformis DSM 34345 as a feed additive for all animal species

Official Journal EN of the European Union L series 2025/277 13.2.2025 COMMISSION IMPLEMENTING REGULATION (EU) 2025/277 of 12 February 2025 concerning the authorisation of a preparation of Loigolactobacillus coryniformis DSM 34345 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 2003on 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 Loigolactobacillus coryniformis DSM 34345. 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 Loigolactobacillus coryniformis DSM 34345 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’) in its opinion of 26 June 2024(2)concluded that Loigolacto­ bacillus coryniformis DSM 34345 and the formulated additive are safe for all animal species, consumers and the environment. Regarding user safety, the Authority concluded that the additive should be considered as a potential skin and respiratory sensitiser, that any exposure through skin and respiratory tract is considered a risk and that one preparation was shown not to be irritant to skin or eyes. It further concluded that the addition of Loigolactobacillus coryniformis DSM 34345 at a minimum level of 1 × 108 CFU/kg fresh plant material has the potential to improve the production of silages from all fresh plant materials by enhancing the preservation of nutrients. 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 Loigolactobacillus coryniformis DSM 34345 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. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal. 2024;22:e8904. ELI: http://data.europa.eu/eli/reg_impl/2025/277/oj 1/3EN OJ L, 13.2.2025 (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 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, 12 February 2025. For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg_impl/2025/277/ojANNEX Identifica- Minimum Maximum tion Species or content content Composition, chemical formula, Maximum End of period of number of Additive category of Other provisions description, analytical method age authorisation the feed animal CFU/kg of fresh material additive Category: technological additives. Functional group: silage additives 1k21801 Loigolactobacillus Additive composition All animal - - - 1. In the directions for use of 5 March 2035 coryniformis DSM Preparation of Loigolactobacillus species the additive and 34345 coryniformis DSM 34345 containing a premixtures, the storage minimum of 2 × 1011 CFU/g additive conditions shall be indicated. Solid form ——————————————— 2. Minimum dose of the Characterisation of the active substance additive when it is not Viable cells of Loigolactobacillus used in combination with coryniformis DSM 34345 other micro-organisms as —————————————— silage additives: 1 × 108 Analytical method(1) CFU/kg fresh material. Enumeration in the feed additive of Loigolactobacillus coryniformis DSM 3. If used as a cryoprotectant, 34345: polyethylene glycol (PEG 4000) shall be used up to a — Spread plate (or pour plate) maximum concentration method on MRS agar – EN 15787 of 0,025 mg/kg silage. Identification of Loigolactobacillus 4. For users of the additive coryniformis DSM 34345: and premixtures, feed — Pulsed Field Gel Electrophoresis business operators shall (PFGE) – CEN/TS 17697 or DNA establish operational sequencing methods 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. (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/2025/277/oj 3/3 OJ L, 13.2.2025 EN