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Document 02013R0374-20170714

    Consolidated text: Commission Implementing Regulation (EU) No 374/2013 of 23 April 2013 concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens reared for laying ( holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ) (Text with EEA relevance)

    ELI: http://data.europa.eu/eli/reg_impl/2013/374/2017-07-14

    02013R0374 — 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 374/2013

    of 23 April 2013

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

    (Text with EEA relevance)

    (OJ L 112 24.4.2013, p. 13)

    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 374/2013

    of 23 April 2013

    concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens reared for laying ( ►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 additive.

    Characterisation of the active substance

    Viable spores of Clostridium butyricum FERM BP-2789.

    Analytical method (1)

    Quantification: pour plate method based on ISO 15213 standard.

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

    Chickens reared for laying

    2,5 × 108

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

    2.  The use is allowed in feed containing the authorised coccidiostats: monensin sodium, diclazuril, salinomycin sodium or lasalocid sodium.

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

    14 May 2023

    (1)   Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/crl-feed-additives

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