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Document 02011R0887-20170628

    Consolidated text: Commission Implementing Regulation (EU) No 887/2011 of 5 September 2011 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening (holder of the authorisation Evonik Nutrition & Care GmbH ) (Text with EEA relevance)

    ELI: http://data.europa.eu/eli/reg_impl/2011/887/2017-06-28

    02011R0887 — EN — 28.06.2017 — 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 IMPLEMENTING REGULATION (EU) No 887/2011

    of 5 September 2011

    concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening (holder of the authorisation ►M1  Evonik Nutrition & Care GmbH ◄ )

    (Text with EEA relevance)

    (OJ L 229 6.9.2011, p. 7)

    Amended by:

     

     

    Official Journal

      No

    page

    date

    ►M1

    COMMISSION IMPLEMENTING REGULATION (EU) 2017/173 of 1 February 2017

      L 28

    5

    2.2.2017

    ►M2

    COMMISSION IMPLEMENTING REGULATION (EU) 2017/961 of 7 June 2017

      L 145

    7

    8.6.2017




    ▼B

    COMMISSION IMPLEMENTING REGULATION (EU) No 887/2011

    of 5 September 2011

    concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening (holder of the authorisation ►M1  Evonik Nutrition & Care GmbH ◄ )

    (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.

    ▼M2




    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

    4b1713

    Evonik Nutrition & Care GmbH)

    Enterococcus faecium

    CECT 4515

    Additive composition

    Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive

    Solid forms

    Characterisation of the active substance

    Viable cells of Enterococcus faecium CECT 4515

    Analytical method (1)

    Enumeration: spread plate method using bile esculin azide agar (EN 15788)

    Identification: Pulsed-Field Gel Electrophoresis (PFGE)

    Chickens for fattening

    1 × 109

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

    2.  The use is compatible in feed containing one of the following authorised coccidiostats: monensin sodium, diclazuril, nicarbazin, decoquinate, robenidine hydrochloride, semduramycin sodium, narasin, salinomicin sodium, lasalocid A sodium, narasin/nicarbazin or maduramycin ammonium.

    3.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 and skin protection.

    26 September 2021

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



    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/l of water for drinking

    Category of zootechnical additives. Functional group: gut flora stabilisers

    4b1713

    Evonik Nutrition & Care GmbH)

    Enterococcus faecium

    CECT 4515

    Additive composition

    Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive

    Solid forms.

    Characterisation of the active substance

    Viable cells of Enterococcus faecium CECT 4515

    Analytical method (1)

    Enumeration: spread plate method using bile esculin azide agar (EN 15788)

    Identification: Pulsed- Field Gel Electrophoresis (PFGE)

    Chickens for fattening

    5 × 108

    1.  The additive may be used in water for drinking.

    2.  In the directions for use of the additive and premixtures stability in water for drinking shall be indicated.

    3.  For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.

    4.  The use is compatible in feed containing one of the following authorised coccidiostats: monensin sodium, diclazuril, nicarbazin, decoquinate, robenidine hydrochloride, semduramycin sodium, narasin, salinomicin sodium, lasalocid A sodium, narasin/nicarbazin or maduramycin ammonium.

    5.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 and skin protection.

    28 June 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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