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Commission Implementing Regulation (EU) No 495/2011Show full title

Commission Implementing Regulation (EU) No 495/2011 of 20 May 2011 amending Regulation (EC) No 109/2007 as regards the composition of the feed additive monensin sodium (Text with EEA relevance)

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ANNEXU.K.

‘ANNEX

a

Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx’

Identification number of the additiveName of the holder of authorisationAdditive(Trade name)Composition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationProvisional maximum residue limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
Coccidiostats and histomonostats
51701Huvepharma NV Belgium

Monensin sodium

(Coxidin)

  • Additive composition

    • Monensin sodium technical substance equivalent to monensin activity: 25 %

    • Perlite: 15 – 20 %

    • Wheat bran 55 – 60 %

  • Active substance

    C36H61O11Na

    Sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis 28682, LMG S-19095 in powder form

    Factor composition

    • Monensin A: not less than 90 %

    • Monensin A + B: not less than 95 %

    • Monensin C: 0,2 – 0,3 %

  • Analytical method a

    Method for determination of the active substance: high performance liquid chromatography (HPLC) with post-column derivatisation and UV detection (λ = 520nm)

Chickens for fattening100125
1.Use prohibited at least 1 day before slaughter.
2.The additive shall be incorporated in compound feedingstuffs in form a premixture.
3.Maximum permitted dose of monensin sodium in complementary feedingstuffs:
  • 625 mg/kg for chickens for fattening,

  • 500 mg/kg for turkeys.

4.Monensin sodium shall not be mixed with other coccidiostats.
5.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.

6.Wear suitable protective clothing, gloves and eye/face protection. In case of insufficient ventilation in the premise, wear suitable respiratory equipments.
6.2.2017

25 μg monensin sodium/kg of wet skin + fat

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

Turkeys16 weeks60100
51701Huvepharma NV Belgium

Monensin sodium

(Coxidin)

  • Additive composition

    • Monensin sodium technical substance equivalent to monensin activity: 25 %

    • Perlite: 15 – 20 %

    • Calcium Carbonate: qs. 100 %

  • Active substance

    C36H61O11Na

    Sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis 28682, LMG S-19095 in powder form

    Factor composition

    • Monensin A: not less than 90 %

    • Monensin A + B: not less than 95 %

    • Monensin C: 0,2 – 0,3 %

  • Analytical method a

    Method for determination of the active substance: high-performance liquid chromatography (HPLC) with post-column derivatisation and UV-VIS detection (EN ISO standard method 14183:2008)

Chickens for fattening100125
1.Use prohibited at least 1 day before slaughter.
2.The additive shall be incorporated in compound feedingstuffs in form of a granulated premixture.
3.Monensin sodium shall not be mixed with other coccidiostats.
4.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.

5.Wear suitable protective clothing, gloves and eye/face protection. In case of insufficient ventilation in the premise, wear suitable respiratory equipments.
10.6.2021

25 μg monensin sodium/kg of wet skin + fat

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

Turkeys16 weeks60100

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