Commission Regulation (EC) No 2380/2001 of 5 December 2001 concerning the 10 year authorisation of an additive in feedingstuffs (Text with EEA relevance)
Date: 2001-12-05
Institutions: European Commission
Subjects: animal nutrition, food additive, toxic substance, veterinary drug

L 321/18

EN

Official Journal of the European Communities

6.12.2001

COMMISSION REGULATION (EC) No 2380/2001

of 5 December 2001

concerning the 10 year authorisation of an additive in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), as last
amended by Directive 2001/46/EC of the European Parliament
and of the Council (2), and in particular Article 4 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Article 2(aaa) of Directive 70/524/EEC requires author-
isations for coccidiostats to be linked to the person
responsible for putting them into circulation.

Article 9 of Directive 70/524/EEC provides that a
substance may be authorised if all conditions laid down
in Article 3a of that Directive are met.

The assessment of the dossier submitted shows that the
coccidiostat described in the Annex satisfies all
the
requirements of Article 3a of Directive 70/524/EEC,
when used for the animal category and under the condi-
tions described in the Annex to this Regulation: the
substance should therefore be authorised under those
conditions.

Article 9b of Directive 70/524/EEC provides that the
authorisations of such substances shall be given for a
period of 10 years from the date on which the final
authorisation takes effect.

The assessment of the dossier shows that certain proced-
ures may be required to protect workers from exposure
to the additives. Such protection should however be

assured by the application of Council Directive 89/
391/EEC of 12 June 1989 on the introduction of meas-
ures to encourage improvements in the safety and health
of workers at work (3).

(6)

(7)

The Scientific Committee for Animal Nutrition has deliv-
ered a favourable opinion with regard to the safety and
with regard to the favourable effect on animal produc-
tion of the coccidiostat under the conditions described
in the said Annex.

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
for Feedingstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

The additive belonging to the ‘Coccidiostats and other medi-
cinal 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.

Done at Brussels, 5 December 2001.

For the Commission

David BYRNE

Member of the Commission

(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.

Registration
number of
additive

Name and registration
number of person
responsible for putting
additive into circulation

Additive
(trade name)

Composition, chemical formula and
description

Species or cate-
gory of animal

Maximum age

Minimum
content

Maximum
content

mg of active substance/kg of
complete feedingstuff

Other provisions

End of period of
authorisation

ANNEX

.

.

6
1
2
2
0
0
1

‘Coccidiostats and other medicinal substances

E 770

Alpharma AS

Maduramicin ammonium
alpha 1 g/100 g
(Cygro 1 %)

Additive composition:

Turkeys

ammonium

Maduramicin
alpha: 1 g/100 g
Benzyl alcohol: 5 g/100 g
Corn cob grits qs 100 g

Active substance:

17

83

O

ammonium

Maduramicin
alpha,
N,
H
C47
CAS No: 84878-61-5
ammonium salt of a polyether
monocarboxylic acid produced
by
yumaensis
(ATCC 31585) (NRRL 12515).

Actinomadura

Related impurities:

Maduramicin ammonium beta:
< 10 %

16
weeks

5

5

Use prohibited at least five
days before slaughter.

15.12.2011’

Indicate in the instructions
for use:

“Dangerous for equines”.
“This
contains
feedingstuff
an ionophore: simultaneous
use with certain medicinal
substances (e.g. tiamulin) can
be contraindicated”

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