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20.4.2011 Official
Journal
of
the
European
Union L
104/3
REGULATIONS
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)
THE EUROPEAN COMMISSION,
animal health, human health or the environment, and
that that additive is effective in controlling coccidiosis
Having regard to the Treaty on the Functioning of the European
in chickens for fattening ( 5 ). The Authority recommends
Union,
appropriate measures for user safety. It also verified the
report on the method of analysis of the feed additive in
feed submitted by the European Union Reference
Having regard to Regulation (EC) No 1831/2003 of the
Laboratory for Feed Additives set up by Regulation (EC)
European Parliament and of the Council of 22 September
No 1831/2003.
2003 on additives for use in animal nutrition ( 1 ), and in
particular Article 9(2) thereof,
(5) The
assessment
of
maduramicin
ammonium
alpha
shows
Whereas:
that the conditions for authorisation, as provided for in
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Accordingly, the use of that preparation should be au-
(1) Regulation
(EC)
No
1831/2003
provides
for
the
au-
thorised as specified in the Annex to this Regulation.
thorisation of additives for use in animal nutrition and
for the grounds and procedures for granting such au-
thorisation. Article 10 of that Regulation provides for
(6)
As a consequence of the granting of a new authorisation
the re-evaluation of additives authorised pursuant to
under Regulation (EC) No 1831/2003, the provisions on
Council Directive 70/524/EEC ( 2 ).
maduramicin ammonium alpha in Regulation (EC)
No 2430/1999 should be deleted.
(2) Maduramicin
ammonium
alpha,
CAS
number
84878-
61-5, was authorised for 10 years in accordance with
Directive 70/524/EEC as a feed additive for use on
(7)
Since the modifications on the conditions of the au-
chickens for fattening by Commission Regulation (EC)
thorisation are not related to safety reasons, it is appro
No 2430/1999
( 3 ) and for use on turkeys by
priate to allow a transitional period for the disposal of
Commission Regulation (EC) No 2380/2001 ( 4 ). That
existing stocks of the premixtures and compound feed.
additive was subsequently entered in the Community
Register of feed additives as an existing product, in
accordance with Article 10(1) of Regulation (EC)
(8) The
measures
provided
for
in
this
Regulation
are
in
No 1831/2003.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No 1831/2003 in conjunction with Article 7 of that
Regulation, an application was submitted for the re-
HAS ADOPTED THIS REGULATION:
evaluation of maduramicin ammonium alpha as a feed
additive for chickens for fattening, requesting that
additive to be classified in the additive category ‘cocci
Article 1
diostats and histomonostats’. That application was
The preparation specified in the Annex, belonging to the
accompanied by the particulars and documents required
additive category ‘coccidiostats and histomonostats’ is au-
under Article 7(3) of Regulation (EC) No 1831/2003.
thorised as an additive in animal nutrition subject to the
conditions laid down in that Annex.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 9 December 2010 that,
under the proposed conditions of use, maduramicin
Article 2
ammonium alpha does not have an adverse effect on
In Annex I to Regulation (EC) No 2430/1999, the entry under
the registration number of additive E 770, concerning
( 1 ) OJ L 268, 18.10.2003, p. 29.
Maduramicin ammonium alpha is deleted.
( 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.

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L 104/4
EN
Official Journal of the European Union
20.4.2011
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

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20.4.2011 Off
ANNEX
Minimum
Maximum
content
content
Maximum
Identification
Species or
End of period
Residue Limits
number of the
Name of the holder
category of Maximum mg of active substance/kg
Other provisions
of
(MRLs) in the
additive
of authorisation
Additive (trade name)
Composition, chemical formula,
description, analytical method
animal
age
of complete feedingstuff
authorisation
relevant
foodstuffs of
EN
with a moisture content
animal origin

of 12 %
Coccidiostats and histomonostats
5 1 770 Alpharma
(Belgium)
Maduramicin
Additive Composition
Chickens
—
5
6 1.
The
additive
shall
be
10 May
150 μg of
BVBA
ammonium alpha Maduramicin ammonium alpha: for
incorporated in
2021
maduramycin
10 g/kg
10 g/kg
fattening
compound feed in form
ammonium/kg
(Cygro 10 G)
Carboxymethylcellulose sodium:
of a premixture.
of fresh liver,
20 g/kg
skin and fat;
2. Maduramicin ammonium
icial
Calcium sulphate dihydrate:
alpha shall not be mixed
100 μg of
970 g/kg
with other coccidiostats.
maduramycin
Jour
ammonium/kg
nal
Active substance
3. Indicate
in
the
of fresh kidney;
Maduramicin ammonium alpha
instructions for use:
of
C
the

‘Dangerous for equines’.
30 μg of
47H 83O 17N
CAS number: 84878-61-5
maduramycin
European
‘This feedingstuff contains
ammonium/kg
(2R, 3S, 4S, 5R, 6S)-6[(1R)-1-
an ionophore: simul
of fresh
[(2S,5R,7S,8R,9S)-2-
taneous use with certain
muscle.
[2S,2′R,3′S,5R,5
medicinal substances
Union
′R)-3′-[(2,6-dideoxy-3,4-di-
(e.g. tiamulin) can be
O-methyl-β-L-arabinohexopyra
contraindicated’.
nosyl)oxy]-octahydro-2-
4. For safety: breathing
methyl-5′-[(2S,3S,5R,6S)-
protection, glasses and
tetrahydro-6-hydroxy-3,5,6-
gloves shall be used
trimethyl-2H-pyran-
during handling.
2-yl][2,2′-bifuran]-5-yl]-9-
5. A post-market moni
hydroxy-2,8-dimethy-
toring program on the
1,6dioxaspirol[4.5]dec-7-
resistance to Eimeria spp.
yl]ethyl]tetrahydro-
shall be planned and
executed by the holder
2-hydroxy-4,5-
of authorisation.
dimethoxy-3-
methyl-3H-pyran-2-acetic
6. The use is prohibited at
acid, monoammonium
least 3 days before
slaughter
salt produced by a fermentation
L
process by the strain Actinomadura
104/5
yumaensis NRRL 12515: ≥ 90 %.

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L 104/6
Minimum
Maximum
content
content
Maximum
Identification
Species or
End of period
Residue Limits
number of the
Name of the holder
category of Maximum mg of active substance/kg
Other provisions
of
(MRLs) in the
additive
of authorisation
Additive (trade name)
Composition, chemical formula,
description, analytical method
animal
age
of complete feedingstuff
authorisation
relevant
foodstuffs of
with a moisture content
animal origin
of 12 %
EN
Related impurities:

Maduramicin ammonium β: ≤ 1 %
Analytical method (1 )
For the determination of
maduramicin ammonium alpha in
the additive, premixtures and feed
ingstuffs: reversed-phased high
performance liquid chroma
tography (HPLC) using post-
column derivatization with
Off
vanillin and detection at 520nm-
icial
EN 15781:2009.
Jour
For the determination of residues
of maduramicin ammonium alpha
nal
in liver and muscle: reversed-
phased high performance liquid
of
chromatography (HPLC) coupled
the
to tandem mass spectrometry.
European
(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
Union
20.4.2011

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