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)

• CELEX: Implementing Regulation (EU) 2026/1036
• Articles: 7

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.

Schedules & Appendices

ANNEX

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 .