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Regulation 3(2)

SCHEDULE 8SRenewal 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 pigs and suckling minor porcine species

AuthorisationS

1.  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 schedule(1).

Table

Column 1Column 2
AdditiveClostridium butyricum (FERM BP-2789)
Identification number of the additive4b1830
Authorisation holderMiyarisan Pharmaceutical Co. Ltd
Additive categoryZootechnical additives
Functional groupGut flora stabilisers
Additive compositionSolid form preparation of Clostridium butyricum (FERM BP-2789) containing a minimum of 5 x 108 CFU/g additive
Characterisation of the active substance(s)Viable spores of Clostridium butyricum FERM BP-2789
Analytical methods(2)1. For enumeration (colony count):

  • Pour plate method in accordance with international standard BS ISO 15213:2003 entitled “Microbiology of food and animal feeding stuffs. Horizontal method for the enumeration of sulphite-reducing bacteria growing under anaerobic conditions”(3)

2. For identification of bacterial strain:

  • Pulsed-field gel electrophoresis (PFGE)

Species or category of animalTurkeys for fattening; turkeys reared for breeding; chickens for fattening; chickens reared for laying; minor avian species (excluding laying birds); piglets and piglets of minor porcine species
Maximum ageNot applicable
Content of Clostridium butyricum (FERM BP-2789) in CFU/kg of complete feed with a moisture content of 12%Minimum content

Turkeys: 1.25 x 108 CFU/kg

Chickens, minor avian species, piglets and minor porcine species: 2.5 x 108 CFU/kg

Maximum contentAll species and categories of animal as provided for above: 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 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,

  • Maduramicin ammonium,

  • Monensin sodium,

  • Narasin,

  • Narasin/Nicarbazin (as combined use only),

  • Robenidine,

  • Salinomycin sodium,

  • Semduramicin sodium.

Commencement Information

I1Sch. 8 para. 1 in force at 24.11.2022, see reg. 1(1)

(1)

This authorisation is a renewal of the authorisations granted under Commission Implementing Regulations (EU) No. 373/2011, 374/2013 and 1108/2014. Those Regulations are revoked by regulation 11 of these Regulations.

(2)

Details of the analytical methods are set out in the document referenced “JRC.DG.D.6.CvH/DM/hn/ARES (2010)-355411” and last updated on 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.

(3)

ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. Under reference BS ISO 15213:2003, it was published as a UK standard by the British Standards Institution on 16 May 2003 (ISBN 0 580 41892 8).