ANNEXSupplementary provisions
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 % Wheat bran 55 – 60 % 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 detection (λ = 520nm) Chickens for fattening — 100 125 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 Turkeys 16 weeks 60 100 51701 Huvepharma 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 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 detection (EN ISO standard method 14183:2008) Chickens for fattening — 100 125 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 Turkeys 16 weeks 60 100 ( 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’