Commission Implementing Regulation (EU) 2024/754 of 29 February 2024 amending Implementing Regulation (EU) 2020/1762 as regards the terms of the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation: Chr. Hansen A/S)
Date: 2024-02-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, fattening, food additive, market approval, poultry, poultry farming








L_202400754EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2024/754


1.3.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/754
of 29 February 2024
         
amending Implementing Regulation (EU) 2020/1762 as regards the terms of the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation: Chr. Hansen A/S)
(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 13(3) 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 modifying such authorisation.












(2)


Commission Implementing Regulation (EU) 2020/1762 (2) authorised the use of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding for a 10-year period.












(3)


In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted on 24 April 2022 for the modification of the terms of the authorisation of the preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding, requesting to allow the simultaneous use of that preparation with the coccidiostats monensin, salinomycin, narasin, a combination of nicarbazin and narasin, and lasalocid, which are authorised as feed additives. The request was accompanied by the relevant supporting data.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2023 (3) that the proposed modification in the terms of the authorisation of the preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 would not modify the conclusions previously drawn regarding the safety of the additive. It also concluded that the use of that preparation is compatible with the coccidiostats monensin, salinomycin, narasin, a combination of nicarbazin and narasin, and lasalocid.












(5)


In view of the above, the Commission considers that the preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 still satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 when modifying the terms of the authorisation by specifying the compatibility of the use of that preparation with the coccidiostats monensin, salinomycin, narasin, a combination of nicarbazin and narasin, and lasalocid. In addition, considering that those coccidiostats may not be authorised as feed additives for each of the species or categories listed in the Annex, their simultaneous use with the preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 should only be possible in accordance with their respective conditions of authorisation as feed additives.












(6)


Implementing Regulation (EU) 2020/1762 should therefore be amended accordingly.












(7)


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

Amendment to Implementing Regulation (EU) 2020/1762

In the column ‘other provisions’ of the Annex to Implementing Regulation (EU) 2020/1762, point 3 is replaced by the following:






‘3.


The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, a combination of nicarbazin and narasin, and lasalocid.’






Article 2

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.

(2)  Commission Implementing Regulation (EU) 2020/1762 of 25 November 2020 concerning the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation Chr. Hansen A/S) (OJ L 397, 26.11.2020, p. 14; ELI: http://data.europa.eu/eli/reg_impl/2020/1762/oj).

(3)  
            EFSA Journal 2023;21(8):8179.


ELI: http://data.europa.eu/eli/reg_impl/2024/754/oj
ISSN 1977-0677 (electronic edition)