(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 an authorisation.

(2) A preparation of Bacillus velezensis ATCC PTA-6737, previously taxonomically identified as Bacillus subtilis ATCC PTA-6737, was authorised for a period of 10 years as a feed additive for laying hens and minor poultry species for laying by Commission Implementing Regulation (EU) 2015/1020 (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 Bacillus velezensis ATCC PTA-6737 as a feed additive for laying hens and minor poultry species for laying, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. That application included a proposal for amending the conditions of the original authorisation, consisting in an increase of the minimum concentration of the active agent in the preparation from 1 × 1010 CFU/g additive to 8 × 1010 CFU/g additive. In accordance with Article 7 of Regulation (EC) No 1831/2003, that application also concerned the authorisation of a new use of the same preparation as a feed additive for other birds kept for egg production or breeding, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. That application was accompanied by the particulars and documents required under Article 14(2) and Article 7(3) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 May 2025 (3) that, under the current authorised conditions of use and considering the fact that the composition and manufacturing process of the additive has not been substantially modified, the preparation of Bacillus velezensis ATCC PTA-6737 remains safe for laying hens, minor poultry species for laying, as well as for the consumers and the environment. The requested modifications to the specifications of the additive do not introduce additional concerns. The Authority also concluded that the additive is safe for birds kept for egg production or breeding, and that the use of the additive in these new species/categories is safe for the consumers and the environment. It also concluded that the preparation is not irritant to skin and eyes but should be considered a skin and respiratory sensitiser, and inhalation and dermal exposure is considered a risk. The Authority considered that there is no need to assess the efficacy of the additive in the context of the renewal of the authorisation as the application does not include a proposal for amending or supplementing the conditions of use that would have an impact on the efficacy of the additive for those species/categories for which there is an authorisation. It also considered that the conclusions reached for those species can be extended to other species and therefore concluded that the additive has the potential to be efficacious in other birds kept for egg production or breeding at the minimum inclusion level of 1 × 108 CFU/kg complete feed. The Authority did not consider that there is a need for specific requirements for a post-market monitoring.

(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 Bacillus velezensis ATCC PTA-6737 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), points (a), (b) and (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 Bacillus velezensis ATCC PTA-6737 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed for laying hens and minor poultry species for laying. Furthermore, the use of the additive should be authorised for other birds kept for egg production or breeding. 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 Bacillus velezensis ATCC PTA-6737 as a feed additive for laying hens and minor poultry species for laying, Implementing Regulation (EU) 2015/1020 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 Bacillus velezensis ATCC PTA-6737 for laying hens and minor poultry species for laying, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal or the modification of that 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,