BAKGRUNN (fra kommisjonsforordningen)

(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 authorisation. 

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Bacillus subtilis FERM BP‐07462, Enterococcus lactis FERM BP‐10867 and Clostridium butyricum FERM BP‐10866. 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 Bacillus subtilis FERM BP‐07462, Enterococcus lactis FERM BP‐10867 and Clostridium butyricum FERM BP‐10866 as a feed additive to be used in feed and water for drinking for chickens for fattening, chickens reared for laying or breeding, turkeys for fattening, turkeys reared for laying or breeding and all minor avian species, including sporting, exotic and all other ornamental birds, to slaughter or point of lay, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. 

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 4 May 20222 and 27 September 20233 that, under the proposed conditions of use, the preparation of Bacillus subtilis FERM BP‐07462, Enterococcus lactis FERM BP‐ 10867 and Clostridium butyricum FERM BP‐10866 is safe for the target species, the consumers and the environment. It also concluded that the preparation is not irritant to skin and eyes but is a respiratory sensitiser, while due to the lack of information provided no conclusion could be drawn on its potential to be a skin sensitiser. The Authority further concluded that the preparation is efficacious for the target species under the proposed conditions of use. The Authority concluded that the preparation is compatible with the coccidiostats diclazuril, decoquinate and halofuginone, while no conclusion could be drawn on the compatibility of that preparation with the coccidiostats monensin sodium, salinomycin sodium, narasin, robenidine hydrochloride and maduramicin ammonium. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed and water submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. 

(5) On 21 June 2024, the applicant withdrew the application as regards the recognition of the compatibility of use of the preparation of Bacillus subtilis FERM BP‐07462, Enterococcus lactis FERM BP‐10867 and Clostridium butyricum FERM BP‐10866 with the following coccidiostats: monensin sodium, salinomycin sodium, narasin, robenidine hydrochloride and maduramicin ammonium. 

(6) In view of the above, the Commission considers that the preparation of Bacillus subtilis FERM BP‐07462, Enterococcus lactis FERM BP‐10867 and Clostridium butyricum FERM BP‐10866 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that preparation should be authorised. It is appropriate to indicate that the preparation may be used simultaneously with the coccidiostats diclazuril, decoquinate and halofuginone. 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. 

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,