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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
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’.
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’.
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.
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.
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.
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 × 10 9 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 × 10 9 — 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 .
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.