Commission Implementing Regulation (EU) 2023/2646 of 28 November 2023 concerning the authorisation of a preparation of Lentilactobacillus buchneri DSM 32650 as a feed additive for all animal species
Date: 2023-11-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: fodder, food additive, market approval








L_202302646EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2023/2646


29.11.2023







            COMMISSION IMPLEMENTING REGULATION (EU) 2023/2646
of 28 November 2023
         
concerning the authorisation of a preparation of Lentilactobacillus buchneri DSM 32650 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 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 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 Lentilactobacillus buchneri DSM 32650. 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 a preparation of Lentilactobacillus buchneri DSM 32650 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’) concluded in its opinion of 12 May 2023 (2) that, under the proposed conditions of use, the preparation of Lentilactobacillus buchneri DSM 32650 is safe for the target species, consumers and the environment. In the absence of data, no conclusion could be drawn on the potential of the additive to be a skin and eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The Authority further concluded that Lentilactobacillus buchneri DSM 32650 at the proposed inclusion rate may extend the aerobic stability of silage prepared from easy and moderately difficult to ensile forage material with a dry matter range of 28–45 %. 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 Lentilactobacillus buchneri DSM 32650 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
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.


Article 2
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, 28 November 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  
            EFSA Journal 2023;21(6):8055.




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





1k21902



Lentilactobacillus buchneri DSM 32650



Additive composition

Preparation of Lentilactobacillus buchneri DSM 32650 containing a minimum of 1 × 1011 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 dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg of easy and moderately difficult to ensile fresh material (2).










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 December 2033





Characterisation of the active substance

Viable cells of Lentilactobacillus buchneri DSM 32650





Analytical method
 (1)

Enumeration in the feed additive of Lentilactobacillus buchneri DSM 32650:






—


Spread plate (or pour plate) method on MRS Agar (EN 15787)




Identification of Lentilactobacillus buchneri DSM 32650:






—


Enterobacterial Repetitive Intergenic Consensus – Polymerase Chain Reactions (ERIC-PCR) or DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE) – CEN/TS 17697










(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/2023/2646/oj
ISSN 1977-0677 (electronic edition)