Commission Implementing Regulation (EU) 2024/1750 of 24 June 2024 concerning the renewal of the authorisation of a preparation of Levilactobacillus brevis DSM 23231 as a feed additive for all animal species and amending Implementing Regulation (EU) No 399/2014
Date: 2024-06-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, food additive, market approval








L_202401750EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/1750


25.6.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/1750
of 24 June 2024
         
concerning the renewal of the authorisation of a preparation of Levilactobacillus brevis DSM 23231 as a feed additive for all animal species and amending Implementing Regulation (EU) No 399/2014
(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 preparation of Levilactobacillus brevis DSM 23231 (previously taxonomically identified as Lactobacillus brevis DSM 23231) was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 399/2014 (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 Levilactobacillus brevis DSM 23231 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 15 November 2023 (3) that the preparation of Levilactobacillus brevis DSM 23231 remains safe for all animal species, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additive should be considered a respiratory sensitiser and that on the basis of the studies submitted regarding user safety it was shown not to be a skin or eye irritant. The Authority was not in the position to conclude on the skin sensitisation potential of the additive. It also indicated that there is no need for assessing the efficacy of the additive as the application for 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 Levilactobacillus brevis DSM 23231 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 Levilactobacillus brevis DSM 23231 satisfies the conditions 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 Levilactobacillus brevis DSM 23231 as a feed additive, Implementing Regulation (EU) No 399/2014 should be amended.












(8)


Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Levilactobacillus brevis DSM 23231, 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 399/2014

In the Annex to Implementing Regulation (EU) No 399/2014, entry 1k20744 on ‘Lactobacillus brevis DSM 23231’ is deleted.


Article 3

Transitional measures

The preparation specified in the Annex and feed containing it, which are produced and labelled before 15 July 2025 in accordance with the rules applicable before 15 July 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, 24 June 2024.


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 399/2014 of 22 April 2014 concerning the authorisation of the preparations of Lactobacillus brevis DSM 23231, Lactobacillus brevis DSMZ 16680, Lactobacillus plantarum CECT 4528 and Lactobacillus fermentum NCIMB 30169 as feed additives for all animal species (OJ L 119, 23.4.2014, p. 40, ELI: http://data.europa.eu/eli/reg_impl/2014/399/oj).

(3)  
            EFSA Journal 2023;21:e8461.

(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 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





1k20744



Levilactobacillus brevis DSM 23231



Additive composition

Preparation of Levilactobacillus brevis DSM 23231 containing a minimum of 1 × 1010 CFU/g additive
Solid form

Characterisation of the active substance

Viable cells of Levilactobacillus brevis DSM 23231

Analytical method (1)


Enumeration in the feed additive of Levilactobacillus brevis DSM 23231:






—


Spread plate method on MRS agar (EN 15787)
Identification of Levilactobacillus brevis DSM 23231:










—


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






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 microorganisms as silage additives: 5 × 107 CFU/kg fresh 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 and breathing protective equipment.






15 July 2034






(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/2024/1750/oj
ISSN 1977-0677 (electronic edition)