ANNEXSupplementary provisions
ANNEX Registration number of additive Name and registration number of person responsible for putting additive into circulation 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 E 1701 Huvepharma NV Belgium Monensin sodium Coxidin Active substance: C 36 H 61 O 11 Na Sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonnensis, 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 % Additive composition: Monensin sodium technical substance equivalent to monensin activity: 25 % Perlite: 15-20 % Wheat bran 55-60 % Analytical method ( 1 ) HPLC method Chickens for fattening — 100 125 1. Use prohibited at least three days before slaughter. 2. The additive shall be incorporated in compound feedingstuffs in form of 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 premises, wear suitable respiratory equipment. 6.2.2017 25 μg monensin sodium/kg of wet skin + fat. 8 μg monensin sodium/kg of wet liver, kidney and muscle. Turkeys 16 weeks 90 100 ( 1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/html/crlfaa/