COMMISSION IMPLEMENTING REGULATION (EU) 2026/1036

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2026/1036 | 8.5.2026 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2026/1036 of 7 May 2026 concerning the authorisation of a preparation of Bacillus velezensis CECT 5940 as a feed additive for poultry for laying (holder of authorisation: Evonik Operations GmbH), amending Implementing Regulation (EU) 2020/1395 as regards the terms of the authorisation of a preparation of Bacillus velezensis CECT 5940 as a feed additive for chickens for fattening and reared for laying and amending Implementing Regulation (EU) 2021/2050 as regards the terms of the authorisation of a preparation of Bacillus velezensis CECT 5940 as a feed additive for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for breeding and ornamental birds (except for reproduction) (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 2003 on additives for use in animal nutrition (1), and in particular Articles 9(2) and 13(3) 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 and modifying such an authorisation. ---|--- (2) | A preparation of Bacillus amyloliquefaciens CECT 5940 was authorised for a period of 10 years as a feed additive for use in feed for chickens for fattening and reared for laying by Commission Implementing Regulation (EU) 2020/1395 (2). ---|--- (3) | A preparation of Bacillus velezensis CECT 5940 was authorised for a period of 10 years as a feed additive for use in feed for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for breeding and ornamental birds (except for reproduction) by Commission Implementing Regulation (EU) 2021/2050 (3). ---|--- (4) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Bacillus velezensis CECT 5940. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. ---|--- (5) | The application concerns the authorisation of the preparation of Bacillus velezensis CECT 5940 as a feed additive for laying hens and other bird species kept for egg production purposes, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. ---|--- (6) | At the same time, the applicant requested modification of the terms of the authorisations granted by Implementing Regulations (EU) 2020/1395 and (EU) 2021/2050 in accordance with Article 13(3) of Regulation (EC) No 1831/2003, in order to consolidate the authorisations of Bacillus velezensis (CECT 5940), including to update the taxonomic identification of the strain from Bacillus amyloliquefaciens CECT 5940 to Bacillus velezensis CECT 5940. ---|--- (7) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 June 2025 (4) that, under the proposed conditions of use, the preparation of Bacillus velezensis CECT 5940 is considered safe for the target species, as well as for consumers and the environment. The Authority also concluded that the preparation of Bacillus velezensis CECT 5940 is not irritant to eyes but should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Authority further concluded that the preparation of Bacillus velezensis CECT 5940 has the potential to be efficacious in all laying hens and other birds for egg production when supplemented at 1,0 × 109 CFU/kg complete feed. Furthermore, the Authority confirmed the conclusions reached in its opinion of 5 May 2021 (5) that the active agent originally identified as Bacillus amyloliquefaciens was reclassified as Bacillus velezensis. The Authority did not consider that there is a need for specific requirements of post-market monitoring. ---|--- (8) | 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 16 July 2008 (6) are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005 (7), an evaluation report of the Reference Laboratory was therefore not required. ---|--- (9) | Following a request from the Commission, the Authority, in its reply dated 9 January 2026, confirmed that the conclusion on user safety of its opinion of 25 June 2025 applies to the opinions of 28 January 2020 (8) and 5 May 2021 (9) and should be reflected in the relevant authorisations. ---|--- (10) | In view of the above, the Commission considers that the preparation of Bacillus velezensis CECT 5940 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for poultry for laying. 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. ---|--- (11) | The Commission also considers that the preparation of Bacillus velezensis CECT 5940 still satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003, when modifying the terms of the authorisation laid down in Implementing Regulation (EU) 2020/1395 as regards the use for chickens for fattening and reared for laying, by the modification of the taxonomic identification of the strain from Bacillus amyloliquefaciens CECT 5940 to Bacillus velezensis CECT 5940 and the protective measures for users. ---|--- (12) | The Commission further considers that the preparation of Bacillus velezensis CECT 5940 still satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003, when modifying the terms of the authorisation laid down in Implementing Regulation (EU) 2021/2050 as regards the use for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for breeding and ornamental birds (except for reproduction), by the modification of the protective measures for users. ---|--- (13) | Implementing Regulations (EU) 2020/1395 and (EU) 2021/2050 should therefore be amended accordingly. ---|--- (14) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Bacillus amyloliquefaciens CECT 5940 for chickens for fattening and reared for laying, and of the preparation of Bacillus velezensis CECT 5940 for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for breeding and ornamental birds (except for reproduction), it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the modification of the authorisation concerned. ---|--- (15) | 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 Amendment to Implementing Regulation (EU) 2020/1395 Implementing Regulation (EU) 2020/1395 is amended as follows: (1) | the title is replaced by the following: ‘Commission Implementing Regulation (EU) 2020/1395 of 5 October 2020 concerning the renewal of the authorisation of Bacillus velezensis CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, and repealing Regulation (EC) No 1292/2008 (holder of the authorisation Evonik Operations GmbH)’; ---|--- (2) | the Annex is amended as follows: | (a) | in the column ‘Additive’, the expression ‘Bacillus amyloliquefaciens CECT 5940’ is replaced by ‘Bacillus velezensis CECT 5940’; ---|--- (b) | in the column ‘Composition, chemical formula, description, analytical method’, and in the sections ‘Additive composition’ and ‘Characterisation of the active substance’ thereof, the expression ‘Bacillus amyloliquefaciens CECT 5940’ is replaced by ‘Bacillus velezensis CECT 5940’; ---|--- (c) | in the column ‘Other provisions’, provision 3 is replaced by ‘For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment’. ---|--- Article 3 Amendment to Implementing Regulation (EU) 2021/2050 The Annex to Implementing Regulation (EU) 2021/2050 is amended as follows: (1) | in the column ‘Identification number of the additive’ the identification number is replaced by ‘4b1822’; ---|--- (2) | in the column ‘Other provisions’, provision 3 is replaced by ‘For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment’. ---|--- Article 4 Transitional measures related to the amendment to Implementing Regulation (EU) 2020/1395 1\. The feed additive Bacillus amyloliquefaciens CECT 5940, as authorised by Implementing Regulation (EU) 2020/1395 and premixtures containing that additive, which are intended for chickens for fattening and reared for laying, and which are produced and labelled before 28 November 2026 in accordance with the rules applicable before 28 May 2026 may continue to be placed on the market and used until the stocks concerned are exhausted. 2\. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for chickens for fattening and reared for laying, and which are produced and labelled before 28 May 2027 in accordance with the rules applicable before 28 May 2026 may continue to be placed on the market and used until the stocks concerned are exhausted. Article 5 Transitional measures related to the amendment to Implementing Regulation (EU) 2021/2050 1\. The feed additive Bacillus velezensis CECT 5940, as authorised by Implementing Regulation (EU) 2021/2050 and premixtures containing that additive, which are intended for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for breeding and ornamental birds (except for reproduction), and which are produced and labelled before 28 November 2026 in accordance with the rules applicable before 28 May 2026 may continue to be placed on the market and used until the stocks concerned are exhausted. 2\. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for breeding and ornamental birds (except for reproduction), and which are produced and labelled before 28 May 2027 in accordance with the rules applicable before 28 May 2026 may continue to be placed on the market and used until the stocks concerned are exhausted. Article 6 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 May 2026. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) Commission Implementing Regulation (EU) 2020/1395 of 5 October 2020 concerning the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, and repealing Regulation (EC) No 1292/2008 (holder of the authorisation Evonik Operations GmbH) (OJ L 324, 6.10.2020, p. 3, ELI: http://data.europa.eu/eli/reg_impl/2020/1395/oj). (3) Commission Implementing Regulation (EU) 2021/2050 of 24 November 2021 concerning the authorisation of the preparation of Bacillus velezensis CECT 5940 as a feed additive for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for breeding and ornamental birds (except for reproduction) (holder of authorisation: Evonik Operations GmbH) (OJ L 420, 25.11.2021, p. 16, ELI: http://data.europa.eu/eli/reg_impl/2021/2050/oj). (4) EFSA Journal 2025;23:e9554, https://doi.org/10.2903/j.efsa.2025.9554. (5) EFSA Journal 2021;19(6):6620, https://doi.org/10.2903/j.efsa.2021.6620. (6) EFSA Journal (2008) 773, 1-13, https://doi.org/10.2903/j.efsa.2008.773. (7) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/2005/378/oj). (8) EFSA Journal 2020;18(2):e6014, https://doi.org/10.2903/j.efsa.2020.6014. (9) EFSA Journal 2021;19(6):e6620, https://doi.org/10.2903/j.efsa.2021.6620. * * * ANNEX Identification number of the additive | Name of the holder of authorisation | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|---|--- CFU/kg of complete feed with a moisture content of 12 % Category: zootechnical additives. Functional group: gut flora stabilisers 4b1822 | Evonik Operations GmbH | Bacillus velezensis CECT 5940 | Additive composition Preparation of Bacillus velezensis CECT 5940 containing a minimum of 1 × 109 CFU/g additive. Solid form Characterisation of the active substance Viable spores of Bacillus velezensis CECT 5940 Analytical method (1) Enumeration: spread plate method using tryptone soya agar (EN 15784); Identification: DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE) (CEN/TS 17697) | Poultry for laying | — | 1 × 109 | — | | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. ---|--- 2. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment. ---|--- 28 May 2036 (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. * * * ELI: http://data.europa.eu/eli/reg_impl/2026/1036/oj ISSN 1977-0677 (electronic edition) * * *