(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 an authorisation. 

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351. 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 the preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying or breeding, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. 

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 September 20232 that, under the proposed conditions of use, the preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 are safe for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying or breeding, as well as for consumers and the environment. The Authority also concluded that the preparation of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 in both formulations is considered respiratory sensitiser but it is not irritant to the skin. No conclusion could be made on the potential of the additive to be an eye irritant or dermal sensitiser. After the assessment of supplementary information submitted by the applicant, the Authority concluded in its opinion of 6 May 20253 that the preparation of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 has the potential to be efficacious in all poultry for fattening and reared for laying or breeding at 1 × 108 CFU/kg complete feed and 5 × 107 CFU/L water for drinking. The Authority did not consider that there is a need for specific requirements of post-market monitoring. 

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 26 September 20232 are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/20054 , an evaluation report of the Reference Laboratory was therefore not required. 

(6) In view of the above, the Commission considers that the preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparations should be authorised for poultry for fattening and reared for laying or reproduction. 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,