Commission Regulation (EC) No 1463/2004 of 17 August 2004 concerning the authorisation for 10 years of the additive «Sacox 120 microGranulate» 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 nutrition, food additive, food safety, health control, market approval, veterinary drug, veterinary inspection

18.8.2004

EN

Official Journal of the European Union

L 270/5

COMMISSION REGULATION (EC) No 1463/2004

of 17 August 2004
concerning the authorisation for 10 years of the additive ‘Sacox 120 microGranulate’ in feeding-
stuffs, 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:

(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 sali-
nomycin sodium product, Sacox 120 microGranulate, is
an additive belonging to the group ‘Coccidiostats and
other medicinal
I of
Annex B to Directive 70/524/EEC.

listed in Chapter

substances’

The person responsible for putting Sacox 120 microGra-
nulate into circulation 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 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
The Commission
Sacox
risk evaluation from the Scientific
requested a full
Committee for Animal Nutrition on 26 April 2001
and this request was consequently transferred to the
European Food Safety Authority. Several requests for
re-
additional
impossible to complete
evaluation process making it
the re-evaluation within the time limit
required by
Article 9g.

information were made during the

120 microGranulate.

(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 Sacox 120 microGranulate 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).

The re-evaluation of Sacox 120 microGranulate carried
out by the Commission showed that
the relevant
conditions
laid down in Directive 70/524/EEC are
satisfied. Sacox 120 microGranulate should therefore be
authorised for 10 years as an additive linked to the
into circulation and
person responsible for putting it
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 salinomycin sodium from the market
imme-
diately,
it is appropriate to allow a transitional period
of six months for the disposal of existing stocks of the
additive.

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

opinion

the

the

of

(6)

(7)

(8)

HAS ADOPTED THIS REGULATION:

Article 1

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

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

Article 2

The additive Sacox 120 microGranulate 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 sali-
nomycin sodium.

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

L 270/6

EN

Official Journal of the European Union

18.8.2004

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

18.8.2004

EN

Official Journal of the European Union

L 270/7

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