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Document 02004R1356-20190219

    Consolidated text: Commission Regulation (EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive Elancoban in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)Text with EEA relevance

    ELI: http://data.europa.eu/eli/reg/2004/1356/2019-02-19

    02004R1356 — EN — 19.02.2019 — 003.001


    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 (EC) No 1356/2004

    of 26 July 2004

    concerning the authorisation for 10 years of the additive ‘Elancoban’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances

    (Text with EEA relevance)

    (OJ L 251 27.7.2004, p. 6)

    Amended by:

     

     

    Official Journal

      No

    page

    date

     M1

    COMMISSION REGULATION (EC) No 108/2007 of 5 February 2007

      L 31

    4

    6.2.2007

    ►M2

    COMMISSION REGULATION (EC) No 1096/2008 of 6 November 2008

      L 298

    5

    7.11.2008

    ►M3

    COMMISSION IMPLEMENTING REGULATION (EU) 2019/138 of 29 January 2019

      L 26

    1

    30.1.2019




    ▼B

    COMMISSION REGULATION (EC) No 1356/2004

    of 26 July 2004

    concerning the authorisation for 10 years of the additive ‘Elancoban’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances

    (Text with EEA relevance)



    Article 1

    Chapter I of Annex B to Directive 70/524/EEC is amended as follows:

    The additive monensin sodium, belonging to the group ‘Coccidiostats and other medical substances’, shall be deleted.

    Article 2

    The additive Elancoban belonging to the group ‘Coccidiostats and other medical substances’, as set out in the Annex to the present Regulation is authorised for use in animal nutrition under the conditions laid down in that Annex.

    Article 3

    A period of six months from the date of entry into force of this Regulation is permitted to use up the existing stocks of monensin sodium.

    Article 4

    This Regulation shall enter into force on the third 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.

    ▼M2




    ANNEX



    Registration number of additive

    Name and registration number of person responsible for putting additive into circulation

    Additive

    (Trade name)

    Composition, chemical formula, description

    Species or category of animal

    Maximum age

    Minimum content

    Maximum content

    Other provisions

    End of period of authorisation

    Provisional maximum residue limits (MRLs) in the relevant foodstuffs of animal origin

    mg of active substance/kg of complete feedingstuff

    Coccidiostats and other medicinal substances

    E 757

    ►M3  Elanco GmbH ◄

    Monensin sodium

    (Elancoban G100, Elancoban 100, Elancogran 100, Elancoban G200, Elancoban 200)

    Active substance

    C36H61O11Na

    sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis, ATCC 15413 in granular form.

    Factor composition:

    Monensin A: not less than 90 %

    Monensin A + B: not less than 95 %

    Additive composition

    Granular monensin (dried fermentation product) equivalent to Monensin activity 10 % w/w

    Mineral oil 1-3 % w/w

    Limestone granular 13-23 % w/w

    Rice hulls or limestone granular qs 100 % w/w

    Granular monensin (dried fermentation product) equivalent to Monensin activity 20 % w/w

    Mineral oil 1-3 % w/w

    Rice hulls or limestone granular qs 100 % w/w

    Chickens for fattening

    100

    125

    Use prohibited at least one day before slaughter.

    Indicate in the instructions for use:

    ‘Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances’

    30.7.2014

    25 μg/kg monensin sodium of wet skin + fat

    8 μg/kg monensin sodium of wet liver, wet kidney and wet muscle.

    Chickens reared for laying

    16 weeks

    100

    120

    Turkeys

    16 weeks

    60

    100

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