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Document 02011R0388-20131112
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 Zoetis Belgium SA ) and amending Regulation (EC) No 2430/1999 (Text with EEA relevance)
Consolidated text: 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 Zoetis Belgium SA ) and amending Regulation (EC) No 2430/1999 (Text with EEA relevance)
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 Zoetis Belgium SA ) and amending Regulation (EC) No 2430/1999 (Text with EEA relevance)
02011R0388 — EN — 12.11.2013 — 002.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
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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 ►M2 Zoetis Belgium SA ◄ ) and amending Regulation (EC) No 2430/1999 (OJ L 104 20.4.2011, p. 3) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) No 118/2012 of 10 February 2012 |
L 38 |
36 |
11.2.2012 |
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COMMISSION IMPLEMENTING REGULATION (EU) No 1014/2013 of 22 October 2013 |
L 281 |
1 |
23.10.2013 |
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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 ►M2 Zoetis Belgium SA ◄ ) and amending Regulation (EC) No 2430/1999
(Text with EEA relevance)
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.
ANNEX
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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 |
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mg of active substance/kg of complete feedingstuff with a moisture content of 12 % |
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Coccidiostats and histomonostats |
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5 1 770 |
►M2 Zoetis Belgium SA ◄ |
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 (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 |
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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. |
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(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 |
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( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 296, 17.11.1999, p. 3.
( 4 ) OJ L 321, 6.12.2001, p. 18.
( 5 ) EFSA Journal 2011; 9(1):1952.