Commission Regulation (EC) No 1041/2002 of 14 June 2002 concerning the provisional authorisation of a new additive in feedingstuffs (Text with EEA relevance)
Date: 2002-06-14
Institutions: European Commission
Subjects: animal nutrition, antibiotic, food additive, medicinal product

15.6.2002

EN

Official Journal of the European Communities

L 157/41

COMMISSION REGULATION (EC) No 1041/2002

of 14 June 2002

concerning the provisional authorisation of a new additive in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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 Commission Regulation (EC) No 2205/2001 (2),
and in particular Articles 3 and 9a thereof,

Whereas:

(1)

(2)

(3)

(4)

Directive 70/524/EEC provides that new additives may
be authorised following the review of an application
made in accordance with Article 4 of the Directive.

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

Article 9a of Directive 70/524/EEC provides that provi-
sional authorisation of such substances, which are listed
in part I of Annex C to that Directive, may be given for
a period of up to four years from the date on which the
authorisation takes effect, if the conditions laid down in
Article 3a(b) to (e) of the Directive are met and if it is
reasonable to assume, in view of the available results,
that when used in animal nutrition it has one of the
effects referred to in Article 2(a).

The assessment of the dossier submitted in respect of the
‘Semduramicin sodium’ described in the
coccidiostat
Annex shows that
the above
mentioned requirements when used in the animal cate-
gory and under the conditions described in that Annex.

this additive satisfies

The assessment of the dossier shows that certain proce-
dures 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 measures 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 of
the above mentioned coccidiostat, under the conditions
described in the Annex.

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

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

Done at Brussels, 14 June 2002.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 297, 15.11.2001, p. 3.

(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, description

Species or
category of
animal

Maximum
age

Minimum
content

Maximum
content

mg of active substance/kg of
complete feedingstuff

Other provisions

End of
period of
authorisation

ANNEX

Chickens for
fattening

—

20

25

Use prohibited at
days before slaughter

least

five

1.6.2006’

‘Coccidiostats and other medicinal substances

29

Phibro Animal
Health, sprl

Semduramicin
sodium
(Aviax 5 %)

Additive composition:
Semduramicin sodium: 51,3 g/kg
Sodium carbonate: 40 g/kg
Mineral oil: 50 g/kg
Sodium aluminosilicate: 20 g/kg
Soybean mill run: 838,7 g/kg

Active substance:
Semduramicin sodium
C45H76O16Na
CAS number 113378-31-7

sodium salt of a monocarboxylic acid polyether
ionophore produced by Actinomadura roseorufa
(ATCC 53664)

Related impurities:
Descarboxylsemduramicin, ≤ 2 %
Desmethoxylsemduramicin, ≤ 2 %
Hydroxysemduramicin, ≤ 2 %
Total: ≤ 5 %

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