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

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 2003 on additives for use in animal nutrition OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. , 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 EFSA Journal. 2024;22:e8904. concluded that Loigolactobacillus 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. (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

Annex

ANNEX 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. Identification number of the feed additiveAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationCFU/kg of fresh materialCategory: technological additives. Functional group: silage additives1k21801Loigolactobacillus coryniformis DSM 34345 Additive composition Preparation of Loigolactobacillus coryniformis DSM 34345 containing a minimum of 2 × 1011 CFU/g additive Solid form ——————————————— Characterisation of the active substance Viable cells of Loigolactobacillus coryniformis DSM 34345 —————————————— Analytical method Enumeration in the feed additive of Loigolactobacillus coryniformis DSM 34345: Spread plate (or pour plate) method on MRS agar – EN 15787 Identification of Loigolactobacillus coryniformis DSM 34345: Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods 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 × 108 CFU/kg fresh material.
3. If used as a cryoprotectant, polyethylene glycol (PEG 4000) shall be used up to a maximum concentration of 0,025 mg/kg silage.
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. 5 March 2035