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Document 02010R0333-20200224

    Consolidated text: Commission Regulation (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) (Text with EEA relevance)Text with EEA relevance

    ELI: http://data.europa.eu/eli/reg/2010/333/2020-02-24

    02010R0333 — EN — 24.02.2020 — 002.001


    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 REGULATION (EU) No 333/2010

    of 22 April 2010

    concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation ►M2  Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U. ◄ )

    (Text with EEA relevance)

    (OJ L 102 23.4.2010, p. 19)

    Amended by:

     

     

    Official Journal

      No

    page

    date

     M1

    COMMISSION IMPLEMENTING REGULATION (EU) 2016/897 of 8 June 2016

      L 152

    7

    9.6.2016

    ►M2

    COMMISSION IMPLEMENTING REGULATION (EU) 2020/146 of 3 February 2020

      L 31

    3

    4.2.2020




    ▼B

    COMMISSION REGULATION (EU) No 333/2010

    of 22 April 2010

    concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation ►M2  Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U. ◄ )

    (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 20th day following 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

    4b1820

    ►M2  Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U. ◄

    Bacillus subtilis C-3102 (DSM 15544)

    Additive composition:

    Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g

    Characterisation of the active substance:

    Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)

    Analytical method (1):

    Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15874:2009)

    Identification: pulsed-field gel electrophoresis (PFGE).

    Piglets (weaned)

    3 × 108

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

    2.  For use in weaned piglets up to approximately 35 kg.

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

    13 May 2020

    (1)   Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.ec.europa.eu/crl-feed-additives

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