SCHEDULE 7Authorisation of a preparation of Bacillus licheniformis (DSM 28710) (identification number 4b1828) as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds

Regulation 3

The preparation of Bacillus licheniformis (DSM 28710), belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table.

Additive

Bacillus licheniformis (DSM 28710)

Identification number of the additive

4b1828

Authorisation holder

HuvePharma N.V.

Additive category

Zootechnical additives

Functional group

Gut flora stabilisers

Additive composition

Solid form preparation of Bacillus licheniformis (DSM 28710) containing a minimum of 3.2 × 109 CFU/g additive.

Characterisation of the active substance(s)

Viable spores of Bacillus licheniformis DSM 28710.

Analytical methods(1)

For enumeration (colony count) in the feed additive, premixtures, feed materials and compound feed:

  • Spread plate method in accordance with BS EN 15784:2021(2).

For identification of bacterial strain:

  • Pulsed Field Gel Electrophoresis (PFGE).

Species or category of animal

  • Laying hens

  • Minor poultry species for laying

  • Poultry species for breeding

  • Ornamental birds

Maximum age

Not applicable

Minimum content(3)

1.6 x 10 9 CFU/kg

Maximum content(3)

No maximum

Other provisions

  1. 1

    In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.

  2. 2

    If Bacillus licheniformis (DSM 28710) is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria for: diclazuril or lasalocid A sodium.

(1)

Details of the analytical methods set out in the document referenced “Ares(2015)4524025 - 23/10/2015” and last updated 6th June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2015-0016.

(2)

BS EN 15784:2021. “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Bacillus spp. used as feed additive”. Published by British Standards Institution on 30th November 2021 (ISBN 978 0 580 99829 4). Available from the British Standards Institution https://knowledge.bsigroup.com.

(3)

Content of Bacillus licheniformis (DSM 28710): CFU/kg of complete feed with a moisture content of 12%.