Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2025/2176 30.10.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2176 of 29 October 2025 concerning the renewal of the authorisation of the preparations of Pediococcus acidilacticiNCIMB 30005, Lacticaseibacillus paracaseiNCIMB 30151 and Lactiplantibacillus plantarumDSM 16627 as feed additives for all animal species and repealing Implementing...
Official Journal EN of the European Union L series 2025/2176 30.10.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2176 of 29 October 2025 concerning the renewal of the authorisation of the preparations of Pediococcus acidilacticiNCIMB 30005, Lacticaseibacillus paracaseiNCIMB 30151 and Lactiplantibacillus plantarumDSM 16627 as feed additives for all animal species and repealing Implementing Regulation (EU) No 849/2014 (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 and renewing such authorisation.
(2) The preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 (previously taxonomically identified as Lactobacillus paracasei NCIMB 30151) and Lactiplantibacillus plantarum DSM 16627 (previously identified as Lactobacillus plantarum DSMZ 16627) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 849/2014(2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, three applications were submitted for the renewal of the authorisation of the preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 16627 as feed additives for all animal species, requesting the additives to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. Those applications were 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 opinions of 15 October 2024(3), 26 November 2024(4) and 28 January 2025(5) that the preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 16627 remain safe for the target species, the consumers and the environment, under the conditions of use currently authorised. It also concluded that the additives should be considered as potential skin and respiratory sensitisers and that any dermal and respiratory exposure is considered a risk. In the absence of data, the Authority could not conclude on their eye irritation potential. The Authority further concluded that there is no need for assessing the efficacy of the additives as the applications for renewal of their authorisation do not include a proposal for amending or supplementing the conditions of the original authorisation which would have an impact on the efficacy of the additives. It also indicated that values found for citrinin are high and deserve attention and monitoring during the production process.
(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 preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum
(1) OJ L 268, 18.10.2003, p. 29, ELI: https://eur-lex.europa.eu/eli/reg/2003/1831/oj.
(2) Commission Implementing Regulation (EU) No 849/2014 of 4 August 2014 concerning the authorisation of the preparations of Pediococcus acidilacticiNCIMB 30005, Lactobacillus paracaseiNCIMB 30151 and Lactobacillus plantarumDSMZ 16627 as feed additives for all animal species (OJ L 232, 5.8.2014, p. 16, ELI: http://data.europa.eu/eli/reg_impl/2014/849/oj).
(3) EFSA Journal, 22(11), e9074. https://doi.org/10.2903/j.efsa.2024.9074.
(4) EFSA Journal, 23(1), e9146. https://doi.org/10.2903/j.efsa.2025.9146.
(5) EFSA Journal, 23(2), e9248. https://doi.org/10.2903/j.efsa.2025.9248.
ELI: http://data.europa.eu/eli/reg_impl/2025/2176/oj 1/6EN OJ L, 30.10.2025 DSM 16627 as feed additives 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(6), an evaluation report of the Reference Laboratory is therefore not required.
(6) In view of the above, the Commission considers that the preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracaseiNCIMB 30151 and Lactiplantibacillus plantarumDSM 16627 satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those additives 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 additives. 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 preparations of Pediococcus acidilactici NCIMB 30005, Lacticaseibacillus paracaseiNCIMB 30151 and Lactiplantibacillus plantarumDSM 16627 as feed additives, Implementing Regulation (EU) No 849/2014 should be repealed.
(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparations of Pediococcus acidilacticiNCIMB 30005, Lacticaseibacillus paracaseiNCIMB 30151 and Lactiplanti bacillus plantarumDSM 16627, 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 preparations 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 Repeal of Implementing Regulation (EU) No 849/2014 Implementing Regulation (EU) No 849/2014 is repealed.
Article 3 Transitional measures The preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracaseiNCIMB 30151 and Lactobacillus plantarum DSMZ 16627 as authorised by Commission Implementing Regulation (EU) No 849/2014 and feed containing them, which are produced and labelled before 19 November 2026 in accordance with the rules applicable before 19 November 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.
(6) 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).
2/6 ELI: http://data.europa.eu/eli/reg_impl/2025/2176/ojEN OJ L, 30.10.2025 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, 29 October 2025.
For the Commission The President Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_impl/2025/2176/oj 3/6ANNEX Identifica Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal authorisation CFU/kg of fresh material additive
Category: technological additives. Functional group: silage additives 1k21013 Pediococcus acidilactici Additive composition All - - - 1. In the directions for use of 19 November NCIMB 30005 animal the additive and premixtures, 2035 Preparation of Pediococcus acidilactici species the storage conditions shall NCIMB 30005 containing a be indicated.
minimum of 2,5 × 1010CFU/g additive 2. Minimum dose of the additive when it is not used in Solid form combination with other ———————————— micro-organisms as silage
additives: 5 × 107CFU/kg Characterisation of the active substance fresh plant material.
Viable cells of Pediococcus acidilactici 3. For users of the additive and NCIMB 30005 premixtures, feed business operators shall establish ———————————— operational procedures and organisational measures to Analytical method(1) address potential risks Identification of Pediococcus acidilactici resulting from their use.
NCIMB 30005: Where those risks cannot be eliminated by such — DNA sequencing methods or procedures and measures, Pulsed Field Gel Electrophoresis the additive and premixtures
(PFGE) (CEN/TS 17697) shall be used with personal Enumeration of Pediococcus acidilactici skin, eye and breathing NCIMB 30005: protective equipment. — Spread plate method on MRS agar (EN 15786) 4/6
ELI:
http://data.europa.eu/eli/reg_impl/2025/2176/oj EN OJ L,
30.10.2025Identifica Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal authorisation CFU/kg of fresh material additive 1k20748 Lacticaseibacillus Additive composition All - - - 1. In the directions for use of 19 November paracaseiNCIMB animal the additive and premixtures, 2035 Preparation of Lacticaseibacillus 30151 species the storage conditions shall paracaseiNCIMB 30151 containing a be indicated.
minimum of 2,5 × 1010CFU/g additive Solid form 2. Minimum dose of the additive when it is not used in ———————————— combination with other micro-organisms as silage Characterisation of the active substance
additives: 5 × 107CFU/kg Viable cells of Lacticaseibacillus fresh plant material. paracaseiNCIMB 30151
3. For users of the additive and ———————————— premixtures, feed business operators shall establish Analytical method(1) operational procedures and Identification of Lacticaseibacillus organisational measures to paracaseiNCIMB 30151: address potential risks resulting from their use.
— DNA sequencing methods or Where those risks cannot be Pulsed Field Gel Electrophoresis eliminated by such
(PFGE) (CEN/TS 17697) procedures and measures, Enumeration of Lacticaseibacillus the additive and premixtures paracaseiNCIMB 30151: shall be used with personal — Spread plate (or pour plate) skin, eye and breathing method on MRS agar (EN 15787) protective equipment.
ELI:
http://data.europa.eu/eli/reg_impl/2025/2176/oj 5/6 OJ L, 30.10.2025 ENIdentifica Minimum Maximum tion Species or content content End of period Composition, chemical formula, Maximum number of Additive category Other provisions of description, analytical method age the feed of animal authorisation CFU/kg of fresh material additive 1k20749 Lactiplantibacillus Additive composition All - - - 1. In the directions for use of 19 November plantarumDSM animal the additive and premixtures, 2035 Preparation of Lactiplantibacillus 16627 species the storage conditions shall plantarumDSM 16627 containing a be indicated.
minimum of 2,5 × 1010CFU/g additive Solid form 2. Minimum dose of the additive when it is not used in ——————————————— combination with other micro-organisms as silage Characterisation of the active substance
additives: 5 × 107CFU/kg Viable cells of Lactiplantibacillus fresh plant material. plantarumDSM 16627
3. For users of the additive and ——————————————— premixtures, feed business operators shall establish Analytical method(1) operational procedures and organisational measures to Identification of Lactiplantibacillus address potential risks plantarumDSM 16627: resulting from their use.
— DNA sequencing methods or Where those risks cannot be Pulsed Field Gel Electrophoresis eliminated by such
(PFGE) (CEN/TS 17697) procedures and measures, the additive and premixtures Enumeration of Lactiplantibacillus shall be used with personal plantarumDSM 16627: skin, eye and breathing — Spread plate (or pour plate) protective equipment.
method on MRS agar (EN 15787)
(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.
6/6
ELI:
http://data.europa.eu/eli/reg_impl/2025/2176/oj EN OJ L,
30.10.2025