Commission Implementing Regulation (EU) 2024/2441 of 16 September 2024 concerning the renewal of the authorisation of a preparation of Enterococcus lactis DSM 22502 as a feed additive for all animal species and repealing Implementing Regulation (EU) No 304/2014
Date: 2024-09-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: fodder, food additive, market approval








L_202402441EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2441


17.9.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2441
of 16 September 2024
         
concerning the renewal of the authorisation of a preparation of Enterococcus lactis DSM 22502 as a feed additive for all animal species and repealing Implementing Regulation (EU) No 304/2014
(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 Enterococcus lactis DSM 22502 (previously taxonomically identified as Enterococcus faecium DSM 22502) was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 304/2014 (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 Enterococcus lactis DSM 22502 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 30 January 2024 (3) that the preparation of Enterococcus lactis DSM 22502 remains safe for all target animal species, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additive is not irritating to the skin or eyes but is considered a respiratory sensitiser. No conclusion could be drawn on its skin sensitisation potential. The Authority 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 Enterococcus lactis DSM 22502 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 Enterococcus lactis DSM 22502 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 Enterococcus lactis DSM 22502 as a feed additive, Implementing Regulation (EU) No 304/2014 should be repealed.












(8)


Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Enterococcus lactis DSM 22502, 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

Repeal of Implementing Regulation (EU) No 304/2014

Implementing Regulation (EU) No 304/2014 is repealed.


Article 3

Transitional measures

The preparation specified in the Annex and feed containing it, which are produced and labelled before 7 October 2025 in accordance with the rules applicable before 7 October 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, 16 September 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 304/2014 of 25 March 2014 concerning the authorisation of the preparations of Enterococcus faecium NCIMB 10415, Enterococcus faecium DSM 22502 and Pediococcus acidilactici CNCM I-3237 as feed additives for all animal species (OJ L 90, 26.3.2014, p. 8, ELI: http://data.europa.eu/eli/reg_impl/2014/304/2024-02-06).

(3)  
            EFSA Journal, 22(3), e8621.

(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





1k20602



Enterococcus lactis DSM 22502



Additive composition

Preparation of Enterococcus lactis DSM 22502 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 it is not used in combination with other micro-organisms as silage additives: 1×108 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.






7 October 2034





Characterisation of the active substance

Viable cells of Enterococcus lactis DSM 22502





Analytical method
 (1)

Enumeration in the feed additive of Enterococcus lactis DSM 22502:
Spread plate method using Bile Esculine Azide agar (EN 15788)
Identification of Enterococcus lactis DSM 22502:






—


Pulsed Field Gel Electrophoresis (PFGE) - CEN/TS 17697 or 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.



ELI: http://data.europa.eu/eli/reg_impl/2024/2441/oj
ISSN 1977-0677 (electronic edition)