
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 twentieth 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.Done at Brussels, 9 July 2020.
For the Commission
The President
Ursula VON DER LEYEN
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 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 
51776 Huvepharma NV. Monensin80 g/kgNicarbazin 80 g/kg (Monimax) Additive composition:Preparation of:Monensin (as monensin sodium) 80 g/kg(monensin A ≥ 90%, monensin A+B≥ 95%, monensin C 0.2-0.3%)Nicarbazin 80 g/kg(Ratio 1:1)Starch: 15 g/kg.Wheat meal: 580 g/kg.Calcium carbonate: q.s. 1000 gGranular form Chickens for fattening  40 mg monensin sodium40 mg nicarbazin 50 mg monensin sodium50 mg nicarbazin 
1.. The additive shall be incorporated in compound feed in the form of a premixture.
2.. The additive shall not be mixed with other coccidiostats.
3.. 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'.
4.. Post-market monitoring programmes shall be carried out by the holder of authorisation for:

— resistance to bacteria and Eimeria spp.;
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 eye, dermal and breathing protection. 30.7.2030 25 μg monensin sodium/kg of wet skin + fat;8 μg monensin sodium/kg of wet liver, kidney and muscle.15 000 μg of DNC/kg of wet liver;6 000 μg of DNC/kg of wet kidney;4 000 μg of DNC/kg for wet muscle and wet skin/fat.
Turkeys for fattening 16 weeks
Chickens reared for laying 16 weeks
Characterisation of the active substance:Monensin as monensin sodium technical substance (activity ≥ 27%)CAS number 22373-78-0 produced by Streptomyces cinnamonensis 28682 BCCM/LMG S-19095) consisting of:
— monensin A sodium:
sodium (2-[5-ethyltetrahydro-5-[tetrahydro-3-methyl-5-[tetrahydro-6-hydroxy-6-(hydroxymethyl)-3,5-dimethyl-
2H-pyran-2-yl]-2-furyl]-2-furyl]-9-hydroxy-β-methoxy-α,γ,2,8-tetramethyl-1,6-dioxaspiro-[4.5]decane-7-butyric acid; C36H61NaO11,
— monensin B sodium: sodium 4-(9-hydroxy-2-(5’-(6-hydroxy-
6-(hydroxymethyl)-3,5-dimethyltetrahydro-2H-pyran-2-yl)-2,3’-dimethyloctahydro-[2,2’-bifuran]-5-yl)-
2,8-dimethyl-1,6-dioxaspiro[4.5]decan-7-yl)-3-methoxy-2-methylpentanoate;
C35H59NaO11,
— monensin C sodium: sodium 2-ethyl-4-(2-(2-ethyl-5’-(6-hydroxy-6-(hydroxymethyl)-
3,5-dimethyltetrahydro-2H-pyran-2-yl)-3’-methyloctahydro-[2,2’-bifuran]-5-yl)-9-hydroxy-2,8-dimethyl-
1,6-dioxaspiro[4.5]decan-7-yl)-3-methoxypentanoate,; C37H63NaO11NicarbazinC19H 18N6O 6.CAS number: 330-95-0 equimolecular complex of:
— 4,4-dinitrocarbanilide (DNC) (67.4-73%)
C13H10N4O5,
— 2-hydroxy-4,6-dimethylpyrimidine
(HDP) (27-30%)
— free HDP ≤ 2.5%.
C6H8N2ORelated impurities:
— p-nitro- aniline (PNA): ≤ 0,1 %
— methyl(4-nitrophenyl) carbamate (M4NPC): ≤ 0.4 %.
Analytical methodQuantification of monensin in the feed additive:High Performance Liquid Chromatography using post-column derivatisation coupled to Visible detection (HPLC-VIS)Quantification of monensin in premixtures and feedingstuffs:High Performance Liquid Chromatography using post-column derivatisation coupled to Visible detection (HPLC-VIS) - EN ISO 14183Quantification of nicarbazin in the feed additive:High Performance Liquid Chromatography using post-column derivatisation coupled to UltraViolet detection (HPLC-UV)Quantification of nicarbazin in premixtures and feedingstuffs:High Performance Liquid Chromatography using post-column derivatisation coupled to UltraViolet detection (HPLC-UV) - EN ISO 15782For the quantification of monensin sodium and nicarbazin in tissues:Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods complying with the requirements set by Commission Decision 2002/657/EC
