
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 17 February 2012.
For the Commission
The President
José Manuel BARROSO
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
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
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. 
'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 + fat8 μg monensin sodium/kg of wet liver, wet kidney and wet muscle
