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 and renewing such authorisation.

(2) A preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 (previously taxonomically identified as Lactobacillus salivarius ssp. salivarius DSM 16351) and Enterococcus faecium DSM 21913 was authorised for 10 years as a feed additive for use in feed for chickens for fattening by Commission Implementing Regulation (EU) No 544/2013 (2) and, by Commission Implementing Regulation (EU) 2015/1105 (3) for use in feed and water for drinking for chickens reared for laying and minor poultry species other than laying, as well as for use in water for drinking for chickens for fattening.

(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 Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species other than laying, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. In accordance with Article 7 of Regulation (EC) No 1831/2003, that application also concerned the authorisation of new uses of the same preparation as a feed additive for use in feed and in water for drinking for chickens reared for breeding, turkeys for fattening and turkeys reared for breeding. The application was accompanied by the particulars and documents required under Article 14(2) and Article 7(3) of that Regulation.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 November 2023 (4) that the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913 is safe for the target species, the consumers and the environment under the authorised conditions of use and considered that this conclusion also applies to the target species for which a request for new uses was made. It also concluded that that preparation is non-irritant to skin or eyes but should be considered a respiratory sensitiser. The Authority indicated that there was no need for assessing the efficacy of the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913 in the context of the renewal of the authorisation for chickens for fattening, chickens reared for laying and minor poultry species other than laying. It further concluded that that preparation was considered to be efficacious in feed and water for drinking for all growing poultry species, including as regards the compatibility of the use of coccidiostats for which an authorisation exists. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(5) In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (5), an evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913 satisfies the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that preparation should be renewed for use in feed and water for drinking for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying or breeding, and the use of that preparation should be authorised for use in feed and water for drinking for chickens reared for breeding, turkeys for fattening and turkeys reared for breeding. It is appropriate to indicate the compatibility of the use of that preparation with the coccidiostats maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin, a combination of narasin with nicarbazin. 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 Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913 should only be possible in accordance with their respective conditions of authorisation as feed additives. Finally, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(7) As a consequence of the renewal of the authorisation of the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for use in feed and water for drinking for chickens for fattening, chickens reared for laying and minor poultry species reared for laying or breeding, Implementing Regulations (EU) No 544/2013 and (EU) 2015/1105 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 Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913 for use in feed and water for drinking for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying or breeding, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from 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,