02001R2380 — EN — 12.11.2013 — 004.001


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►B

COMMISSION REGULATION (EC) No 2380/2001

of 5 December 2001

concerning the 10 year authorisation of an additive in feedingstuffs

(Text with EEA relevance)

(OJ L 321 6.12.2001, p. 18)

Amended by:

 

 

Official Journal

  No

page

date

 M1

COMMISSION REGULATION (EC) No 552/2008 of 17 June 2008

  L 158

3

18.6.2008

►M2

COMMISSION IMPLEMENTING REGULATION (EU) No 406/2011 of 27 April 2011

  L 108

11

28.4.2011

 M3

COMMISSION IMPLEMENTING REGULATION (EU) No 118/2012 of 10 February 2012

  L 38

36

11.2.2012

►M4

COMMISSION IMPLEMENTING REGULATION (EU) No 1014/2013 of 22 October 2013

  L 281

1

23.10.2013




▼B

COMMISSION REGULATION (EC) No 2380/2001

of 5 December 2001

concerning the 10 year authorisation of an additive in feedingstuffs

(Text with EEA relevance)



Article 1

The additive belonging to the ‘Coccidiostats and other medicinal substances’ listed in the Annex to the present Regulation is authorised for use as additive in animal nutrition under the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Communities.

It shall apply from 15 December 2001.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

▼M2




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

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Coccidiostats and other medicinal substances

E 770

►M4  Zoetis Belgium SA ◄

Maduramicin ammonium

alpha 1 g/100 g

(Cygro 1 %)

Additive composition

Maduramicin ammonium alpha: 1 g/100 g

Carboxymethylcellulose sodium: 2 g/100 g

Calcium sulphate dihydrate: 97 g/100 g

Active substance

Maduramicin ammonium α C47H83O17N

CAS number: 84878-61-5, ammonium salt of a polyether monocarboxylic acid produced by a fermentation process by the strain Actinomadura yumaensis (ATCC 31585) (NRRL 12515)

Related impurities:

Maduramicin ammonium β: < 10 %

Turkeys

16 weeks

5

5

1.  Use prohibited at least 5 days before slaughter.

2.  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’.

15.12.2011



( 1 )  OJ L 270, 14.12.1970, p. 1.

( 2 )  OJ L 234, 1.9.2001, p. 55.

( 3 )  OJ L 183, 29.6.1989, p. 1.