SCHEDULE 6Renewal of authorisation (with modification) of a preparation of Bacillus velezensis (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(2)

AuthorisationI11

The preparation specified in the table in this schedule, 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 table in this schedule38.

Table

Column 1

Column 2

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 methods39

1. For enumeration (colony count) F1in the feed additive, premixtures, feed materials and compound feed :

  • Spread plate method using tryptone soya agar with pre-heat treatment of F2feed 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, sporting and game birds

Maximum age

Not applicable

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

Minimum content

1 x 107 CFU/kg

Maximum content

No maximum

Other provisions

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

2. Where 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 F3A sodium,

  • F4Maduramicin ammonium,

  • Monensin F5sodium,

  • Narasin,

  • Narasine/Nicarbazin (as combined use only),

  • Robenidine F6hydrochloride,

  • Salinomycin F7sodium.