Commission Regulation (EC) No 1464/2004 of 17 August 2004 concerning the authorisation for 10 years of the additive «Monteban» in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance)
Date: 2004-08-17
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, market approval, plant health control, veterinary drug

L 270/8

EN

Official Journal of the European Union

18.8.2004

COMMISSION REGULATION (EC) No 1464/2004

of 17 August 2004
concerning the authorisation for 10 years of the additive ‘Monteban’ in feedingstuffs, belonging to
the group of coccidiostats and other medicinal substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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:

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 narasin
product, Monteban, is an additive belonging to the group
‘Coccidiostats and other medicinal substances’
listed in
Chapter I of Annex B to Directive 70/524/EEC.

The re-evaluation of Monteban carried out by the
Commission showed that
the relevant conditions laid
down in Directive 70/524/EEC are satisfied. Monteban
should therefore be authorised for 10 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 narasin from the market
is
appropriate
six
months for the disposal of existing stocks of the additive.

transitional period of

to allow a

immediately,

it

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

opinion

the

the

of

(6)

(7)

(8)

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

HAS ADOPTED THIS REGULATION:

Article 1

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 cases where, 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 Monteban. The Commission requested a full
risk
evaluation from the Scientific Committee for Animal
Nutrition on 26 April 2001 and this request was conse-
quently
transferred to the European Food Safety
information
Authority. Several requests for additional
were made during the re-evaluation process, making it
impossible to complete the re-evaluation within the time
limits required by Article 9g.

(4)

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 Monteban for chickens for fattening.

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

(EC) No 1289/2004 (OJ

last amended by
L 243,

Commission Regulation
15.7.2004, p. 15).

Chapter I of Annex B to Directive 70/524/EEC is amended as
follows:

the additive narasin, belonging to the group ‘Coccidiostats and
other medical substances’, is deleted.

Article 2

The additive Monteban 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.

Article 3

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

Article 4

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

its publication in the Official

Journal of

(1)

(2)

(3)

18.8.2004

EN

Official Journal of the European Union

L 270/9

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

Done at Brussels, 17 August 2004.

For the Commission

David BYRNE
Member of the Commission

L 270/10

EN

Official Journal of the European Union

18.8.2004

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