ANNEX IISupplementary provisions
ANNEX II Identification number of additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of active substance/kg of complete feedingstuff with a moisture content of 12 % Additive category: coccidiostats and histomonostats 51756ii Zoetis Belgium SA Decoquinate (Avi-Deccox 60G) Additive composition Decoquinate: 60,0 g/kg Colloidal silica: 0,6 g/kg Silicon dioxide: 4,0 g/kg Carboximethylcellulose sodium 30,0 g/kg Calcium sulphate dihydrate q.s. ad 1 000,0 g Characterisation of the active substance Decoquinate C 24 H 35 NO 5 Ethyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate CAS number: 18507-89-6 Related impurities: 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylic acid: < 0,5 % Methyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate: < 1,0 % Diethyl-4-decycloxy-3-ethoxyanilinomethylenemalonate (aniline compound) < 0,5 % Analytical method ( 1 ) For the determination of decoquinate in feed additive, premixtures and feedingstuffs: — Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) – EN 16162 Chickens for fattening 30 40 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. The additive shall be incorporated in compound feed in the form of a premixture. 3. The additive shall not be mixed with other coccidiostats. 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 of 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. 20.12.2031 ( 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