Commission Implementing Regulation (EU) 2023/2736 of 7 December 2023 concerning the authorisation of a preparation of Bacillus velezensis NITE BP-01844 as a feed additive for all poultry species for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species reared for laying or for breeding and ornamental birds (holder of authorisation: Toa Biopharma Co., Ltd)

Official Journal EN of the European Union L series 2023/2736 8.12.2023 COMMISSION IMPLEMENTING REGULATION (EU) 2023/2736 of 7 December 2023 concerning the authorisation of a preparation of Bacillus velezensis NITE BP-01844 as a feed additive for all poultry species for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species reared for laying or for breeding and ornamental birds (holder of authorisation: Toa Biopharma Co., Ltd) (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 2003on additives for use in animal nutrition(1), and in particular Article 9(2) 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 such an 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 velezensis NITE BP-01844 as a feed additive. 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 velezensis NITE BP-01844 as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and all minor avian species (including also sporting, ornamental and exotic birds) to slaughter or point of lay (‘the target species’), 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 26 January 2022(2) and of 12 May 2023(3)that, under the proposed conditions of use, the preparation of Bacillus velezensis NITE BP-01844 is safe for the target species, consumers and the environment. It also concluded that the preparation of Bacillus velezensis NITE BP-01844 is not irritant to skin but potentially irritant to eyes, and that it should be considered a respiratory sensitiser. Since no test of skin sensitisation was provided, the Authority could not draw conclusions on the skin sensitisation potential of that preparation. The Authority further concluded that the preparation of Bacillus velezensis NITE BP-01844, has the potential to be efficacious for the target species when supplemented at 2,0 × 108 CFU/kg complete feed, and is compatible with the coccidiostats diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, robenidine and maduramicin. 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 submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (5) In view of the above, the Commission considers that the preparation of Bacillus velezensis NITE BP-01844 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Furthermore, in accordance with the Authority’s guidance on the assessment of the efficacy of feed additives(4), it should be considered that that preparation has the potential to be efficacious for the target species when supplemented at 1,0 × 108 CFU/l drinking water. Accordingly, the use of the preparation of Bacillus velezensis NITE BP-01844 should be authorised for all poultry species for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species reared for laying or for breeding and ornamental birds, including when supplemented in the drinking water. 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. (1) OJ L 268, 18.10.2003, p. 29. (2) EFSA Journal 2022;20(2):7152. (3) EFSA Journal 2023;21(6):8053. (4) EFSA Journal 2018;16(5):5274. ELI: http://data.europa.eu/eli/reg_impl/2023/2736/oj 1/4EN OJ L, 8.12.2023 (6) 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 Authorisation The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. 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, 7 December 2023. For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2023/2736/ojELI: http://data.europa.eu/eli/reg_impl/2023/2736/oj 3/4 ANNEX Maxi- Maxi- Minimum Minimum mum mum content content Identifica- content content Name of the Species or tion Composition, chemical formula, Maxi- End of period of holder of Additive category of Other provisions number of description, analytical method mum age CFU/kg of complete authorisation authorisation animal the additive feedingstuff with a CFU/l of water for moisture content of drinking 12 % Category of zootechnical additives. Functional groups: gut flora stabilisers 4b1903 Toa Bacillus Additive composition: All poultry — 2 × 108 — 1 × 108 — 1. In the directions for use of 28 December Biopharma velezensis NITE Preparation of viable spores of species for the additive and premix­ 2033 Co., Ltd., BP-01844 Bacillus velezensis NITE fattening ture, the storage condi­ Japan, BP-01844 with a minimum tions and stability to heat represented concentration of 1 × 108 Chickens treatment shall be indi­ by Toa CFU/g of additive reared for cated. Biopharma Solid form laying 2. The additive may be used Co., Ltd., in compound feed con­ Characterisation of the active Turkeys Europe taining the following coc­ substance: reared for Representa- cidiostats, where Viable spores of Bacillus breeding tive Office authorised as feed addi­ velezensis NITE BP-01844 tives for the same animal Minor poultry Analytical method(1): species and categories: di­ species reared Identification: clazuril, decoquinate, ha­ for laying or — Pulsed Field Gel Electro­ lofuginone, monensin, for breeding phoresis (PFGE) – salinomycin, narasin, ro­ CEN/TS 17697, or Ornamental benidine and madurami­ — DNA sequencing meth­ birds cin. ods. Enumeration in the feed additive, premixtures, compound feed and water: spread-plate method on tryptone soya agar (EN 15784). OJ L, 8.12.2023 EN4/4 ELI: http://data.europa.eu/eli/reg_impl/2023/2736/oj 3. For users of the additive and premixtures, feed business operators shall establish operational pro­ cedures and organisa­ tional measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such proce­ dures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en EN OJ L, 8.12.2023