LegalizeCommission Implementing Regulation (EU) 2025/1504 of 25 July 2025 concerning the renewal of the authorisation of a preparation of Lactiplantibacillus plantarum NCIMB 40027 as a feed additive for all animal species and amending Implementing Regulation (EU) No 1113/2013
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| Image omitted; see official source | Official Journal of the European Union | EN L series |
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| 2025/1504 | 28.7.2025 |
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 and renewing such authorisation.
- (2) The preparation of Lactiplantibacillus plantarum NCIMB 40027 (previously taxonomically identified as Lactobacillus plantarum NCIMB 40027) was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 1113/2013 2.
- (3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of Lactiplantibacillus plantarum NCIMB 40027 as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 November 2024 3 that the preparation of Lactiplantibacillus plantarum NCIMB 40027 remains safe for all animal species, the consumers and the environment. The Authority also concluded that the additive is not irritant to skin or eyes but it should be considered a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. It further indicated that there is no need for assessing the efficacy of the additive as the application for the renewal of its authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation which would have an impact on the efficacy of the additive.
- (5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the preparation of Lactiplantibacillus plantarum NCIMB 40027 as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 4, an evaluation report of the Reference Laboratory is therefore not required.
- (6) In view of the above, the Commission considers that the preparation of Lactiplantibacillus plantarum NCIMB 40027 satisfies the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. 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. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.
- (7) As a consequence of the renewal of the authorisation of the preparation of Lactiplantibacillus plantarum NCIMB 40027 as a feed additive, Implementing Regulation (EU) No 1113/2013 should be amended accordingly.
- (8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Lactiplantibacillus plantarum NCIMB 40027, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
- (9) 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
Renewal of the authorisation
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is renewed subject to the conditions laid down in that Annex.
Article 2
Amendment to Implementing Regulation (EU) No 1113/2013
In the Annex to Implementing Regulation (EU) No 1113/2013, entry 1k20743 on ‘Lactobacillus plantarum NCIMB 40027’ is deleted.
Article 3
Transitional measures
The preparation of Lactobacillus plantarum NCIMB 40027, as authorised by Implementing Regulation (EU) No 1113/2013 and feed containing it, which are produced and labelled before 17 August 2026 in accordance with the rules applicable before 17 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.
Article 4
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, 25 July 2025.
For the Commission
The President
Ursula VON DER LEYEN
Commission Implementing Regulation (EU) No 1113/2013 of 7 November 2013 concerning the authorisation of preparations of Lactobacillus plantarum NCIMB 40027, Lactobacillus buchneri DSM 22501, Lactobacillus buchneri NCIMB 40788/CNCM I-4323, Lactobacillus buchneri LN 40177/ATCC PTA-6138, and Lactobacillus buchneri LN 4637/ATCC PTA-2494 as feed additives for all animal species (OJ L 298 8.11.2013, p. 29, ELI: http://data.europa.eu/eli/reg_impl/2013/1113/oj).
EFSA Journal 22(12), e9145. https://doi.org/10.2903/j.efsa.2024.9145.
Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/2005/378/oj).
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 |
|---|---|---|---|---|---|---|---|---|
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | CFU/kg of fresh material | CFU/kg of fresh material | Other provisions | End of period of authorisation |
| Category: technological additives. Functional group: silage additives | Category: technological additives. Functional group: silage additives | Category: technological additives. Functional group: silage additives | Category: technological additives. Functional group: silage additives | Category: technological additives. Functional group: silage additives | Category: technological additives. Functional group: silage additives | Category: technological additives. Functional group: silage additives | Category: technological additives. Functional group: silage additives | Category: technological additives. Functional group: silage additives |
| 1k20743 | Lactiplantibacillus plantarum NCIMB 40027 | Additive composition Preparation of Lactiplantibacillus plantarum NCIMB 40027 containing a minimum of 1 × 1011 CFU/g additive Solid form --------------------------------- Characterisation of the active substance Viable cells of Lactiplantibacillus plantarum NCIMB 40027 ---------------------------------- Analytical method 5 Identification of Lactiplantibacillus plantarum NCIMB 40027: — DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697) Enumeration of Lactiplantibacillus plantarum NCIMB 40027: — 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 × 108 CFU/kg fresh plant material in easy and moderately difficult to ensile material6 — 1 × 109 CFU/kg fresh plant material in difficult to ensile material7. 3. Cryoprotectants used in the preparation of Lactiplantibacillus plantarum NCIMB 40027 may include inter alia: — glycine ≤ 20 % — sodium erythorbate ≤ 20 % 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 and breathing protective equipment. | 17 August 2035 |
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.
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 2008 on 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).
Difficult to ensile forage: < 1,5 % soluble carbohydrates in fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008 on 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).
ELI: http://data.europa.eu/eli/reg_impl/2025/1504/oj
ISSN 1977-0677 (electronic edition)
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