
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 19 April 2011.
For the Commission
The President
José Manuel BARROSO
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 C47H83O17N
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
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. 
‘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.
