Commission Implementing Regulation (EU) 2025/2176 of 29 October 2025 concerning 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 and repealing Implementing Regulation (EU) No 849/2014
Date: 2025-10-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: fodder, food additive, market approval, microorganism








L_202502176EN.000101.fmx.xml












Official Journal of the European Union


EN
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 acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 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 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 paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 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 paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 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 acidilactici NCIMB 30005, Lacticaseibacillus paracasei NCIMB 30151 and Lactiplantibacillus plantarum DSM 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 paracasei NCIMB 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.


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
            





(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 acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 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.

(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).




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




CFU/kg of fresh material





Category: technological additives. Functional group: silage additives





1k21013



Pediococcus acidilactici NCIMB 30005



Additive composition

Preparation of Pediococcus acidilactici NCIMB 30005 containing a minimum of 2,5 × 1010 CFU/g additive
Solid form
————————————

Characterisation of the active substance

Viable cells of Pediococcus acidilactici NCIMB 30005
————————————

Analytical method
 (1)

Identification of Pediococcus acidilactici NCIMB 30005:






—


DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697)




Enumeration of Pediococcus acidilactici NCIMB 30005:






—


Spread plate method on MRS agar (EN 15786)






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: 5 × 107 CFU/kg fresh plant material.










3.


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.






19 November 2035




1k20748



Lacticaseibacillus paracasei NCIMB 30151



Additive composition

Preparation of Lacticaseibacillus paracasei NCIMB 30151 containing a minimum of 2,5 × 1010 CFU/g additive Solid form
————————————

Characterisation of the active substance

Viable cells of Lacticaseibacillus paracasei NCIMB 30151
————————————

Analytical method
 (1)

Identification of Lacticaseibacillus paracasei NCIMB 30151:






—


DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697)




Enumeration of Lacticaseibacillus paracasei NCIMB 30151:






—


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: 5 × 107 CFU/kg fresh plant material.










3.


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.






19 November 2035




1k20749



Lactiplantibacillus plantarum DSM 16627



Additive composition

Preparation of Lactiplantibacillus plantarum DSM 16627 containing a minimum of 2,5 × 1010 CFU/g additive Solid form
———————————————

Characterisation of the active substance

Viable cells of Lactiplantibacillus plantarum DSM 16627
———————————————

Analytical method
 (1)

Identification of Lactiplantibacillus plantarum DSM 16627:






—


DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697)




Enumeration of Lactiplantibacillus plantarum DSM 16627:






—


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: 5 × 107 CFU/kg fresh plant material.










3.


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.






19 November 2035






(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.



ELI: http://data.europa.eu/eli/reg_impl/2025/2176/oj
ISSN 1977-0677 (electronic edition)