Regulation (EU) No 388/2011 – Belgium

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.

Article 2

In Annex I to Regulation (EC) No 2430/1999, the entry under the registration number of additive E 770, concerning Maduramicin ammonium alpha is deleted.

Article 3

Premixtures and compound feed containing maduramicin ammonium alpha labelled in accordance with Directive 70/524/EEC may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4

This Regulation shall enter into force on the 20th day following 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 5 1 770 Alpharma (Belgium) BVBA Maduramicin ammonium alpha 10 g/kg (Cygro 10 G) Additive Composition Maduramicin ammonium alpha: 10 g/kg Carboxymethylcellulose sodium: 20 g/kg Calcium sulphate dihydrate: 970 g/kg Active substance Maduramicin ammonium alpha C 47 H 83 O 17 N CAS number: 84878-61-5 (2R, 3S, 4S, 5R, 6S)-6[(1R)-1- [(2S,5R,7S,8R,9S)-2- [2S,2′R,3′S,5R,5 ′R)-3′-[(2,6-dideoxy-3,4-di- O-methyl-β-L-arabinohexopyra nosyl)oxy]-octahydro-2- methyl-5′-[(2S,3S,5R,6S)- tetrahydro-6-hydroxy-3,5,6- trimethyl-2H-pyran- 2-yl][2,2′-bifuran]-5-yl]-9- hydroxy-2,8-dimethy- 1,6dioxaspirol[4.5]dec-7- yl]ethyl]tetrahydro- 2-hydroxy-4,5- dimethoxy-3- methyl-3H-pyran-2-acetic acid, monoammonium salt produced by a fermentation process by the strain Actinomadura yumaensis NRRL 12515: ≥ 90 %. Related impurities: Maduramicin ammonium β: ≤ 1 % Analytical method ( 1 ) For the determination of maduramicin ammonium alpha in the additive, premixtures and feedingstuffs: reversed-phased high performance liquid chromatography (HPLC) using post-column derivatization with vanillin and detection at 520nm- EN 15781:2009. For the determination of residues of maduramicin ammonium alpha in liver and muscle: reversed-phased high performance liquid chromatography (HPLC) coupled to tandem mass spectrometry. Chickens for fattening — 5 6 1. The additive shall be incorporated in compound feed in form of a premixture. 2. Maduramicin ammonium alpha shall not be mixed with other coccidiostats. 3. Indicate in the instructions for use: ‘Dangerous for equines’. ‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated’. 4. For safety: breathing protection, glasses and gloves shall be used during handling. 5. A post-market monitoring program on the resistance to Eimeria spp. shall be planned and executed by the holder of authorisation. 6. The use is prohibited at least 3 days before slaughter 10 May 2021 150 μg of maduramycin ammonium/kg of fresh liver, skin and fat; 100 μg of maduramycin ammonium/kg of fresh kidney; 30 μg of maduramycin ammonium/kg of fresh muscle. ( 1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/eurl-feed-additives

Commission Implementing Regulation (EU) No 388/2011 of 19 April 2011 concerning the authorisation of maduramicin ammonium alpha as a feed additive for chickens for fattening (holder of authorisation Alpharma (Belgium) BVBA) and amending Regulation (EC) No 2430/1999 Text with EEA relevance