Commission Implementing Regulation (EU) 2024/763 of 29 February 2024 concerning the renewal of the authorisation of preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 as feed additives for all animal species and repealing Implementing Regulation (EU) No 308/2013
Date: 2024-02-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: fodder, food additive, market approval








L_202400763EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2024/763


1.3.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/763
of 29 February 2024
         
concerning the renewal of the authorisation of preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 as feed additives for all animal species and repealing Implementing Regulation (EU) No 308/2013
(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)


Preparations of Lactiplantibacillus plantarum NCIMB 30083 (previously taxonomically identified as Lactobacillus plantarum NCIMB 30083) and Lactiplantibacillus plantarum NCIMB 30084 (previously taxonomically identified as Lactobacillus plantarum NCIMB 30084) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 308/2013 (2).












(3)


In accordance with Article 14(1) of Regulation (EC) No 1831/2003, applications were submitted for the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 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 4 July 2023 (3) that the preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 remain safe for all animal species, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additives should be considered as respiratory sensitisers and that no conclusions could be drawn on the skin sensitisation, and skin and eye irritancy potential of the additives. It also indicated that there is no need for assessing the efficacy of the additives as the applications for renewal of the authorisation do not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additives.












(5)


The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessments carried out regarding the method of analysis of the preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 as feed additives in the context of the previous authorisation are valid and applicable for the current applications. In accordance with Article 5(4), point (c) of Commission Regulation (EC) No 378/2005 (4), evaluation reports of the Reference Laboratory are therefore not required.












(6)


In view of the above, the Commission considers that the preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 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 Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084 as feed additives, Implementing Regulation (EU) No 308/2013 should be repealed.












(8)


Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of preparations of Lactiplantibacillus plantarum NCIMB 30083 and Lactiplantibacillus plantarum NCIMB 30084, 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 308/2013

Implementing Regulation (EU) No 308/2013 is repealed.


Article 3

Transitional measures

The preparations specified in the Annex and feed containing them, which are produced and labelled before 21 March 2025 in accordance with the rules applicable before 21 March 2024 may continue to be placed on the market and used until the existing stocks 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 February 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj

(2)  Commission Implementing Regulation (EU) No 308/2013 of 3 April 2013 concerning the authorisation of a preparation of Lactobacillus plantarum NCIMB 30083 and of a preparation of Lactobacillus plantarum NCIMB 30084 as feed additives for all animal species (OJ L 94, 4.4.2013, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2013/308/oj).

(3)  
            EFSA Journal 2023;21(8):8154.

EFSA Journal 2023;21(7):8167.

(4)  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 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





1k20736



Lactiplantibacillus plantarum NCIMB 30083



Additive composition

Preparation of Lactiplantibacillus plantarum NCIMB 30083 containing a minimum of 5 × 1010 CFU/g additive
Solid form


All animal species


—


 


—








1.


In the directions for use of the additive and premixtures, the storage conditions shall be indicated.










2.


Minimum content of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.










3.


The additive shall be used in easy and moderately difficult to ensile fresh material (2).










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, eye and breathing protective equipment.






21 March 2034





Characterisation of the active substance

Viable cells of Lactiplantibacillus plantarum NCIMB 30083





Analytical method
 (1)

Enumeration in the feed additive of Lactiplantibacillus plantarum NCIMB 30083:






—


Spread plate method on MRS agar (EN 15787)




Identification of Lactiplantibacillus plantarum NCIMB 30083:






—


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








1k20737



Lactiplantibacillus plantarum NCIMB 30084



Additive composition

Preparation of Lactiplantibacillus plantarum NCIMB 30084 containing a minimum of 5 × 1010 CFU/g additive
Solid form


All animal species


—


 


—








1.


In the directions for use of the additive and premixtures, the storage conditions shall be indicated.










2.


Minimum content of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.










3.


The additive shall be used in easy and moderately difficult to ensile fresh material (2)











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, eye and breathing protective equipment.






21 March 2034





Characterisation of the active substance

Viable cells of Lactiplantibacillus plantarum NCIMB 30084





Analytical method
 (1)

Enumeration in the feed additive of Lactiplantibacillus plantarum NCIMB 30084:






—


Spread plate method on MRS agar (EN 15787)




Identification of Lactiplantibacillus plantarum NCIMB 30084:






—


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










(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 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_impl/2024/763/oj
ISSN 1977-0677 (electronic edition)