ANNEXSupplementary provisions
ANNEX Identification number of the 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 Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin mg/kg of complete feedingstuff with a moisture content of 12 % Category of coccidiostats and histomonostats 5 1 763 Alpharma (Belgium) BVBA Lasalocid A sodium 15 g/100 g (Avatec 150 G) Additive composition: Lasalocid A sodium: 15 g/100 g Calcium sulphate dihydrate: 80,9 g/100 g Calcium lignosulphonate: 4 g/100 g Ferric oxide: 0,1 g/100 g Active substance: Lasalocid A sodium, C 34 H 53 NaO 8 , CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl—5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2 hydroxy-3-methyl benzoate, produced by Streptomyces lasaliensis subsp. Lasaliensis (ATCC 31180) Related impurities: Lasalocid sodium B-E: ≤ 10 % Analytical methods ( 1 ) : Reversed-phase high performance liquid chromatography (HPLC) with spectrofluorometric detector (Commission Regulation (EC) No 152/2009) ( 2 ) Pheasants, guinea fowl, quails and partridges except laying birds thereof. — 75 125 1. Use prohibited at least 5 days before slaughter. 2. Indicate in the instructions for use: ‘Dangerous for equine species’ ‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contra-indicated’. 3. A post-market monitoring program on the resistance to bacteria and Eimeria spp. shall be planned and executed by the holder of authorisation. 4. The additive shall be incorporated in compound feed in the form of a premixture. 5. Lasalocid A sodium shall not be mixed with other coccidiostats. 28 September 2021 Commission Regulation (EU) No 37/2010 ( 3 ) ( 1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx ( 2 ) OJ L 54, 26.2.2009, p. 1 . ( 3 ) OJ L 15, 20.1.2010, p. 1 .