Commission Regulation (EC) No 1800/2004 of 15 October 2004 concerning the authorisation for 10 years of the additive Cycostat 66G in feedingstuffs, belonging to the group of coccidiostats and other medicinal substancesText with EEA relevance
Date: 2004-10-15
Institutions: European Commission
Subjects: animal nutrition, food additive, health control, veterinary drug

16.10.2004

EN

Official Journal of the European Union

L 317/37

COMMISSION REGULATION (EC) No 1800/2004

of 15 October 2004

concerning the authorisation for 10 years of the additive Cycostat 66G in feedingstuffs, belonging
to the group of coccidiostats and other medicinal substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), and
in particular Article 9g(5)(b) thereof,

Whereas:

(1)

(2)

(3)

In accordance with Directive 70/524/EEC, coccidiostats
included in Annex I to that Directive before 1 January
1988 were provisionally authorised as from 1 April
1998 and transferred to Chapter I of Annex B with a
view to their re-evaluation as additives linked to a person
responsible for putting them into circulation. The robe-
nidine product, Cycostat 66G, is an additive belonging to
the group ‘Coccidiostats and other medicinal substances’
listed in Chapter I of Annex B of Directive 70/524/EEC.

The person responsible for putting into circulation
Cycostat 66G submitted an application for authorisation
and a dossier, according to Article 9g(2) and (4) of that
Directive.

Article 9g(6) of Directive 70/524/EEC allows
the
automatic extension of the period of authorisation of
the additives concerned until the Commission takes a
decision in case of, for reasons beyond the control of
the authorisation holder, no decision may be taken on
the application before the expiry date of the authori-
sation. This provision is applicable to the authorisation
of Cycostat 66G. The Commission requested the
Scientific Committee for Animal Nutrition on 26 April
2001 a full risk evaluation and this request was conse-
transferred to the European Food Safety
quently
Authority. Several requests for additional
information
were made during the re-evaluation process making it
impossible to complete the re-evaluation within the
time limits required by Article 9g.

(1) OJ L 270, 14.12.1970, p. 1. Directive as

(EC) No 1464/2004 (OJ

last amended by
L 270,

Commission Regulation
18.8.2004, p. 8).

The Scientific Panel on Additives and Products or
Substances used in Animal
Feed attached to the
European Food Safety Authority has delivered a
favourable opinion with regard to the safety and to the
efficacy of Cycostat 66G for chickens for
fattening,
rabbits for fattening and for turkeys.

The re-evaluation of Cycostat 66G carried out by the
the relevant conditions laid
Commission showed that
down in Directive 70/524/EEC are satisfied. Cycostat
66G should therefore be authorised for ten years as an
additive linked to the person responsible for putting it
into circulation and included in Chapter I of the list
referred to Article 9t(b) of that Directive.

As the authorisation for the additive is now linked to a
person responsible for putting it into circulation, and
replaces
the previous authorisation which was not
linked to any specific person, it is appropriate to delete
the latter authorisation.

Since there are no safety reasons for withdrawing the
product robenidine from the market immediately,
it is
six
transitional period of
appropriate
months for the disposal of existing stocks of the additive.

to allow a

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

opinion

the

the

of

(5)

(6)

(7)

(8)

HAS ADOPTED THIS REGULATION:

Article 1

In chapter I of Annex B to Directive 70/524/EEC the additive
robenidine, belonging to the group ‘Coccidiostats and other
medical substances’, shall be deleted.

Article 2

The additive Cycostat 66G belonging to the group ‘Coccidiostats
and other medical substances’ as set out in the Annex to the
present Regulation is authorised for use in animal nutrition
under the conditions laid down in that Annex.

L 317/38

EN

Official Journal of the European Union

16.10.2004

Article 3

Article 4

A period of six months from the date of entry into force of this
Regulation is permitted to use up the existing stocks of robe-
nidine.

This Regulation shall enter into force on the third day following
the European
that of
Union.

its publication in the Official

Journal of

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

Done at Brussels, 15 October 2004.

For the Commission

David BYRNE
Member of the Commission

16.10.2004

EN

Official Journal of the European Union

L 317/39

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