SCHEDULE 6Renewal of authorisation (with modification) of a preparation of Bacillus velezensis ATCC PTA-6737 (formerly Bacillus Subtilis ATCC PTA-6737) (identification number 4b1823) as a feed additive for chickens for fattening, chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches, and its authorisation as a feed additive extending existing uses to cover all minor poultry species (except for laying), ornamental birds, sporting birds and game birds

Regulation 3(1)

The preparation specified in the table, 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 set out in the table16.

Additive

Bacillus velezensis ATCC PTA-6737

Identification number of the additive

4b1823

Authorisation holder

Kemin Europa N.V.

Additive category

Zootechnical additives

Functional group

Gut flora stabilisers

Additive composition

Preparation of Bacillus velezensis ATCC PTA-6737 containing a minimum of 8 x 1010 CFU/g additive

Characterisation of the active substance(s)

Viable spores of Bacillus velezensis ATCC PTA-6737

Analytical methods(1)

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

  • Spread plate method using tryptone soya agar with pre-heat treatment of feed samples(2).

For identification of bacterial strain:

Pulsed-field gel electrophoresis (PFGE).

Species or category of animal

  • Chickens for fattening

  • Chickens reared for laying

  • Minor poultry species (except for laying)

  • Ornamental birds

  • Sporting birds

  • Game birds

Maximum age

None

Minimum content(3)

1 x 107 CFU/kg

Maximum content(3)

None

Other provisions

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

2. If Bacillus velezensis ATCC PTA-6737 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:

  • Decoquinate

  • Diclazuril

  • Lasalocid A sodium

  • Maduramicin ammonium

  • Monensin sodium

  • Narasin

  • Narasin/Nicarbazin (as combined use only)

  • Robenidine hydrochloride

  • Salinomycin sodium

(1)

Details of the analytical methods set out in the document referenced “D08/FSQ/CVH/SY/Ares(2009)61627” and last updated 6 June 2016. This document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2008-0039.

(2)

This method is not suitable for the detection of Bacillus velezensis ATCC PTA-6737 in feed materials and compound feed at concentrations below the minimum content level.

(3)

Content of Bacillus velezensis ATCC PTA-6737 in CFU/kg of complete feed with a moisture content of 12%.