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Date: 2026-02-18 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2026/348 of 17 February 2026 concerning the authorisation of a preparation of Lacticaseibacillus huelsenbergensis DSM 115424 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) 2026/348, dated February 17, 2026, authorises the use of Lacticaseibacillus huelsenbergensis DSM 115424 as a feed additive for all animal species, classifying it as a 'technological additive' in the functional group 'silage additives'. The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union. The authorisation is valid until March 10, 2036. **Key Points / Main Content** * **Authorisation:** Lacticaseibacillus huelsenbergensis DSM 115424 is authorised as a feed additive for all animal species. * **Classification:** The additive belongs to the 'technological additives' category and 'silage additives' functional group. * **Composition:** The preparation contains a minimum of 4 × 10<sup>11</sup> CFU/g additive in solid form. * **Minimum Dose:** When not used in combination with other micro-organisms, the minimum dose of the additive is 1 × 10<sup>8</sup> CFU/kg fresh plant material. * **Cryoprotectants:** If used as a cryoprotectant, polyethylene glycol (PEG 4000) shall be used up to a maximum concentration of 0,025 mg/kg silage. * **Analytical Method:** Identification of the additive uses Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods. Enumeration is done using Spread plate (or pour plate) method on MRS agar (EN 15787). * **Storage:** Storage conditions must be indicated in the directions for use of the additive and premixtures. * **User Safety:** Feed business operators must establish operational procedures and organisational measures to address potential risks. Where risks cannot be eliminated, personal protective equipment is required. * **End of Authorisation Period:** The authorisation is valid until 10 March 2036. **Impact Analysis** **Stakeholder: Animal Feed Producers/Businesses** * **Impact:** Can now legally use Lacticaseibacillus huelsenbergensis DSM 115424 as a feed additive in accordance with the specified conditions. * **Action Required:** Must adhere to the specifications outlined in the Annex regarding composition, minimum dose, and usage conditions. Must establish operational procedures and organisational measures to address potential risks resulting from the use of the additive. **Stakeholder: Users of the Additive and Premixtures** * **Impact:** Need to be aware of the potential risks associated with the use of Lacticaseibacillus huelsenbergensis DSM 115424 and implement appropriate safety measures. * **Action Required:** Ensure the additive and premixtures are used with personal skin and breathing protective equipment if potential risks cannot be eliminated by operational procedures and organisational measures. **Stakeholder: European Food Safety Authority (EFSA)** * **Impact:** N/A * **Action Required:** N/A

Key Entities Referenced

Regulation (EC) No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition. Lacticaseibacillus huelsenbergensis DSM 115424: A preparation of this bacterium authorised as a feed additive. European Food Safety Authority: The entity providing an opinion on the safety and efficacy of the feed additive. Brussels: Location where the regulation was issued.
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Official Journal EN of the European Union L series 2026/348 18.2.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/348 of 17 February 2026 concerning the authorisation of a preparation of Lacticaseibacillus huelsenbergensisDSM 115424 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 Lacticaseibacillus huelsenbergensisDSM 115424. 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 Lacticaseibacillus huelsenbergensisDSM 115424 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 6 May 2025(2) concluded that the use of Lacticaseibacillus huelsenbergensis DSM 115424 as a silage additive is 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, and that inhalation and dermal exposure are considered a risk. It further concluded that the addition of Lacticaseibacillus huelsenbergensisDSM 115424 at a minimum level of 1 × 108CFU/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 Lacticaseibacillus huelsenbergensisDSM 115424 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(6), e9458. https://doi.org/10.2903/j.efsa.2025.9458. ELI: http://data.europa.eu/eli/reg_impl/2026/348/oj 1/4EN OJ L, 18.2.2026 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, 17 February 2026. For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/348/ojANNEX Minimum Maximum Identification Species or Name of the Composition, chemical formula, content content End of period of number of the category of Maximum age Other provisions additive description, analytical method authorisation additive animal CFU/kg of fresh material Category: technological additives. Functional group: silage additives 1k21702 Lacticaseibacillus Additive composition All animal - - - 1. In the directions for use of the 10 March huelsenbergensis Preparation of Lacticaseibacillus species additive and premixtures, the 2036 DSM 115424 huelsenbergensisDSM 115424, storage conditions shall be containing a minimum of 4 × 1011 indicated. CFU/g additive. 2. Minimum dose of the Solid form additive, when it is not used ————————— in combination with other Characterisation of the active micro-organisms as silage substance additives: 1 × 108CFU/kg Viable cells of Lacticaseibacillus fresh plant material. huelsenbergensisDSM 115424 ————————— 3. If used as a cryoprotectant, polyethylene glycol (PEG Analytical method(1) 4000) shall be used up to a Identification of Lacticaseibacillus maximum concentration of huelsenbergensisDSM 115424 in 0,025 mg/kg silage. the feed additive: — Pulsed Field Gel 4. Cryoprotectants used in the Electrophoresis (PFGE) – preparation of CEN/TS 17697 or DNA Lacticaseibacillus sequencing methods. huelsenbergensisDSM Enumeration of Lacticaseibacillus 115424 may include inter huelsenbergensisDSM 115424 in alia: the feed additive: — sodium citrate, — Spread plate (or pour plate) — mannitol, method on MRS agar (EN — sodium glutamate 15787) monohydrate. ELI: http://data.europa.eu/eli/reg_impl/2026/348/oj 3/4 OJ L, 18.2.2026 ENMinimum Maximum Identification Species or Name of the Composition, chemical formula, content content End of period of number of the category of Maximum age Other provisions additive description, analytical method authorisation additive animal CFU/kg of fresh material Category: technological additives. Functional group: silage additives 5. 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 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. 4/4 ELI: http://data.europa.eu/eli/reg_impl/2026/348/oj EN OJ L, 18.2.2026

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