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Date: 13-Feb-2025 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2025/273 of 12 February 2025 concerning the authorisation of a preparation of Lactiplantibacillus plantarum DSM 34271 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

What it means

  • Commission Implementing Regulation (EU) 2025/273 authorises the use of a preparation of Lactiplantibacillus plantarum DSM 34271 as a feed additive for all animal species. It classifies this additive as a 'technological additive' within the functional group of 'silage additives'.

Key Changes

  • Authorizes the preparation of Lactiplantibacillus plantarum DSM 34271 as a feed additive for all animal species.
  • Classifies the additive as a 'technological additive' and a 'silage additive'.
  • Specifies a minimum content of 1 × 108 CFU/kg fresh plant material for improving silage production from fresh material with a DM content ranging from 30% to 35%.
  • Requires appropriate protective measures to prevent adverse health effects on users of the additive, considering it a potential skin and respiratory sensitiser.
  • Specifies that the additive shall only be used with easy and moderately difficult to ensile fresh plant material.
  • If used as a cryoprotectant, polyethylene glycol (PEG 4000) shall be used up to a maximum concentration of 0,025 mg/kg silage.
  • The authorisation is valid until 5 March 2035.

Impact Analysis

Animal Feed Producers

  • Where risks cannot be eliminated, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

Farmers/Animal Owners

  • Need to be aware of the potential sensitisation risks and use appropriate protective equipment if handling the additive directly.

Additive Manufacturers/Suppliers

  • Must provide information on analytical methods for enumeration and identification of the additive.

Regulatory Bodies

  • Enforce the conditions of authorisation, including safety measures for users.

Key Entities Referenced

European Commission: The governing body that adopted this implementing regulation. European Food Safety Authority (EFSA): Provided the scientific opinion on the safety and efficacy of Lactiplantibacillus plantarum DSM 34271 as a feed additive. Standing Committee on Plants, Animals, Food and Feed: Provided an opinion in accordance with which the measures in the Regulation were adopted. Regulation (EC) No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition. This regulation provides the legal framework for the authorisation of feed additives. Commission Regulation (EC) No 429/2008: Regulation on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. Lactiplantibacillus plantarum DSM 34271: The specific strain of bacteria authorised as a feed additive. Reference Laboratory: Responsible for verifying the methods of analysis of the feed additive.
Official Source Record View Original Source →
See Full Document Text
Official Journal EN of the European Union L series 2025/273 13.2.2025 COMMISSION IMPLEMENTING REGULATION (EU) 2025/273 of 12 February 2025 concerning the authorisation of a preparation of Lactiplantibacillus plantarum DSM 34271 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 Lactiplantibacillus plantarum DSM 34271. 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 plantarum DSM 34271 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 Lactiplanti­ bacillus plantarum DSM 34271 and the formulated additive are safe for all animal species, consumers and the environment. Regarding user safety, the additive should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. The addition of Lactiplantibacillus plantarum DSM 34271 at a minimum level of 1×108 CFU/ kg fresh plant material has the potential to improve the production of silage from fresh material with a DM content ranging from 30 % to 35 %. 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 plantarum DSM 34271 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. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal. 2024;22:e8903. ELI: http://data.europa.eu/eli/reg_impl/2025/273/oj 1/4EN OJ L, 13.2.2025 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 2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/273/ojANNEX Identifica- Minimum Maximum tion Species or content content End of period Composition, chemical formula, description, analytical Maximum number of Additive category Other provisions of method age the feed of animal authorisation CFU/kg of fresh material additive Category: technological additives. Functional group: silage additives 1k20763 Lactiplantibacillus Additive composition All - - - 1. In the directions for use of 5 March plantarum DSM Preparation of Lactiplantibacillus plantarum DSM animal the additive and 2035 34271 34271 containing a minimum of 4 × 1011 CFU/g species premixtures, the storage additive conditions shall be indicated. Solid form ————————————————- 2. The additive shall only be used with easy and Characterisation of the active substance moderately difficult to Viable cells of Lactiplantibacillus plantarum DSM ensile fresh plant 34271 material(2). ——————————————— 3. Minimum dose of the Analytical method(1) additive when it is not Enumeration in the feed additive of used in combination with Lactiplantibacillus plantarum DSM 34271: other micro-organisms as silage additives: 1 ×108 — Spread plate (or pour plate) method on MRS CFU/kg fresh material. agar – EN 15787 Identification of Lactiplantibacillus plantarum DSM 4. If used as a cryoprotectant, 34271: polyethylene glycol (PEG 4000) shall be used up to a — Pulsed Field Gel Electrophoresis (PFGE) – maximum concentration of CEN/TS 17697 or DNA sequencing methods 0,025 mg/kg silage. ELI: http://data.europa.eu/eli/reg_impl/2025/273/oj 3/4 OJ L, 13.2.2025 ENIdentifica- Minimum Maximum tion Species or content content End of period Composition, chemical formula, description, analytical Maximum number of Additive category Other provisions of method age the feed of animal authorisation CFU/kg of fresh material additive 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, 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. (2) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/429/oj). 4/4 ELI: http://data.europa.eu/eli/reg_impl/2025/273/oj EN OJ L, 13.2.2025

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