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Document 02017R2276-20230309

    Consolidated text: Commission Implementing Regulation (EU) 2017/2276 of 8 December 2017 concerning the authorisation of a new use of the preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive for sows (holder of the authorisation Kemin Europa N.V.) (Text with EEA relevance)Text with EEA relevance

    ELI: http://data.europa.eu/eli/reg_impl/2017/2276/2023-03-09

    02017R2276 — EN — 09.03.2023 — 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) 2017/2276

    of 8 December 2017

    concerning the authorisation of a new use of the preparation of ►M1   Bacillus velezensis ATCC PTA-6737 ◄ as a feed additive for sows (holder of the authorisation Kemin Europa N.V.)

    (Text with EEA relevance)

    (OJ L 326 9.12.2017, p. 50)

    Amended by:

     

     

    Official Journal

      No

    page

    date

    ►M1

    COMMISSION IMPLEMENTING REGULATION (EU) 2023/366 of 16 February 2023

      L 50

    59

    17.2.2023




    ▼B

    COMMISSION IMPLEMENTING REGULATION (EU) 2017/2276

    of 8 December 2017

    concerning the authorisation of a new use of the preparation of ►M1   Bacillus velezensis ATCC PTA-6737 ◄ as a feed additive for sows (holder of the authorisation Kemin Europa N.V.)

    (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

    4b1823

    Kemin Europa N.V.

    ►M1  Bacillus velezensis ATCC PTA-6737 ◄

    Additive composition:

    Preparation of ►M1  Bacillus velezensis ATCC PTA-6737 ◄ containing a minimum of 1 × 1010 CFU/g additive

    Solid form

    Characterisation of the active substance:

    Viable spores of ►M1  Bacillus velezensis ATCC PTA-6737 ◄

    Analytical method (1)

    Enumeration: spread plate method using tryptone soya agar with pre heat-treatment of feed samples.

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

    Sows

    1 × 108

    1.  In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

    2.  For the use in sows from three weeks before farrowing to whole lactation period.

    3.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

    29.12.2027

    (1)   

    Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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