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.
Commission Implementing Regulation (EU) 2020/994 of 9 July 2020 concerning the authorisation of monensin and nicarbazin (Monimax) as a feed additive for turkeys for fattening, chickens for fattening and chickens reared for laying (holder of authorisation Huvepharma NV) (Text with EEA relevance)
Commission Implementing Regulation (EU) 2020/994 of 9 July 2020 concerning the authorisation of monensin and nicarbazin (Monimax) as a feed additive for turkeys for fattening, chickens for fattening and chickens reared for laying (holder of authorisation Huvepharma NV) (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
Supplementary provisions
ANNEXSupplementary provisions
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. Monensin 80 g/kg Nicarbazin 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 g Granular form Chickens for fattening 40 mg monensin sodium 40 mg nicarbazin 50 mg monensin sodium 50 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; C 36 H 61 NaO 11 , — 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; C 35 H 59 NaO 11 , — 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,; C 37 H 63 NaO 11 Nicarbazin C 19 H 18 N 6 O 6. CAS number: 330-95-0 equimolecular complex of: — 4,4-dinitrocarbanilide (DNC) (67.4-73%) C 13 H 10 N 4 O 5 , — 2-hydroxy-4,6-dimethylpyrimidine (HDP) (27-30%) — free HDP ≤ 2.5%. C 6 H 8 N 2 O Related impurities: — p-nitro- aniline (PNA): ≤ 0,1 % — methyl(4-nitrophenyl) carbamate (M4NPC): ≤ 0.4 %. Analytical method ( 1 ) Quantification 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 14183 Quantification 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 15782 For 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 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
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