Choose the experimental features you want to try

This document is an excerpt from the EUR-Lex website

Document 02014R1108-20170714

Consolidated text: Commission Implementing Regulation (EU) No 1108/2014 of 20 October 2014 concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for turkeys for fattening and turkeys reared for breeding ( holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ) (Text with EEA relevance)

ELI: http://data.europa.eu/eli/reg_impl/2014/1108/2017-07-14

02014R1108 — EN — 14.07.2017 — 001.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B

COMMISSION IMPLEMENTING REGULATION (EU) No 1108/2014

of 20 October 2014

concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for turkeys for fattening and turkeys reared for breeding ( ►M1  holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ◄ )

(Text with EEA relevance)

(OJ L 301 21.10.2014, p. 16)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1126 of 23 June 2017

  L 163

13

24.6.2017




▼B

COMMISSION IMPLEMENTING REGULATION (EU) No 1108/2014

of 20 October 2014

concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for turkeys for fattening and turkeys reared for breeding ( ►M1  holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ◄ )

(Text with EEA relevance)



Article 1

The preparation specified in the Annex, 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 laid down in that Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.




ANNEX



Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1830

►M1  Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ◄

Clostridium butyricum

FERM BP-2789

Additive composition

Preparation of Clostridium butyricum FERM BP-2789 containing in solid form a minimum of 5 × 108 CFU/g of additive.

Characterisation of the active substance

Viable spores of Clostridium butyricum FERM BP-2789.

Analytical method (1)

Enumeration: pour plate method based on ISO 15213 standard.

Identification: pulsed-field gel electrophoresis (PFGE) method.

Turkeys for fattening

Turkeys reared for breeding

1,25 × 108

1.  In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.

2.  Use is allowed in feed containing (for the animal category) the authorised coccidiostats: monensin sodium, robenidine, maduramicin ammonium, lasalocid sodium or diclazuril.

3.  For safety: breathing protection and safety glasses shall be used during handling.

10 November 2024

(1)   Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

Top