Commission Implementing Regulation (EU) No 140/2012 of 17 February 2012 concerning the authorisation of monensin sodium as a feed additive for chickens reared for laying (holder of authorisation Huvepharma NV Belgium)  Text with EEA relevance

Article 1

The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’, 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 .

ANNEX

ANNEX
Identification number of the additive
Name of the holder of authorisation
Additive
(Trade name)
Composition, chemical formula, description, analytical method
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 with a moisture content of 12 %
Coccidiostats and histomonostats
51701
Huvepharma NV Belgium
Monensin sodium
(Coxidin)
Additive composition
Monensin sodium technical substance equivalent to monensin activity: 25 %
Perlite: 15 %–20 %
Calcium carbonate q.s.100 %
Active substance
C 36 H 61 O 11 Na
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
( 1 )
Method for determination of the active substance: high performance liquid chromatography (HPLC) with post-column derivatisation and UV-VIS (EN ISO standard method 14183:2008)
Chickens reared for laying
16 weeks
100
125
1.
Use prohibited at least 1 day before slaughter.
2.
The additive shall be incorporated in compound feedingstuffs in the form of a 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 premises, wear suitable respiratory equipment.
6.
A post-market monitoring programme on the resistance to Eimeria spp. shall be planned and executed by the holder of authorisation.
9 March 2022
25 μg monensin sodium/kg of wet skin + fat
8 μg monensin sodium/kg of wet liver, wet kidney and wet muscle
( 1 )   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

Commission Implementing Regulation (EU) No 140/2012 of 17 February 2012 concerning the authorisation of monensin sodium as a feed additive for chickens reared for laying (holder of authorisation Huvepharma NV Belgium) Text with EEA relevance

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