SCHEDULE 8Renewal of authorisation of a preparation of Clostridium butyricum FERM BP-2789 (identification number 4b1830) as a feed additive for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species, and its authorisation as a feed additive for chickens for fattening, suckling piglets and suckling minor porcine species

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 table17.

Additive

Clostridium butyricum FERM BP-2789

Identification number of the additive

4b1830

Authorisation holder

Miyarisan Pharmaceutical Co Ltd

Additive category

Zootechnical additive

Functional group

Gut flora stabilisers

Additive composition

Solid form preparation of Clostridium butyricum FERM BP-2789 containing a minimum of 5 × 108 CFU/g of additive

Characterisation of the active substance(s)

Viable spores of Clostridium butyricum FERM BP-2789

Analytical methods(1)

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

  • Pour plate method based on BS ISO 15213:2003(2).

For identification of bacterial strain:

  • Pulsed-field gel electrophoresis (PFGE).

Species or category of animal

  • Chickens for fattening

  • Chickens reared for laying

  • Turkeys for fattening

  • Turkeys reared for breeding

  • Minor avian species (excluding laying birds)

  • Piglets (suckling and weaned)

  • Minor porcine species (suckling and weaned)

Maximum age

None

Minimum content(3)

For turkeys for fattening and turkeys reared for breeding: 1.25 x 108 CFU/kg

For the other species/categories: 2.5 x 108 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 Clostridium butyricum FERM BP-2789 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)

  • Robenidine hydrochloride

  • Salinomycin sodium

  • Semduramicin sodium

(1)

Details of the analytical methods set out in the document referenced “JRC.DG.D.6.CvH/DM/hn/ARES (2010)-355411” and last updated 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2010-0005.

(2)

Under reference BS ISO 15213:2003 “Microbiology of food and animal feeding stuffs – Horizontal method for the enumeration of sulfite-reducing bacteria growing under anaerobic conditions”. Published by the British Standards Institution on 16 May 2003 (ISBN 0 580 41892 8). Available from the British Standards Institution https://knowledge.bsigroup.com.

(3)

Content of Clostridium butyricum FERM BP-2789 in CFU/kg of complete feed with a moisture content of 12%.