Commission Regulation (EC) No 1289/2004 of 14 July 2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance)
Date: 2004-07-14
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, market approval, medicinal product

15.7.2004

EN

Official Journal of the European Union

L 243/15

COMMISSION REGULATION (EC) No 1289/2004

of 14 July 2004

concerning the authorisation for 10 years of the additive Deccox® 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), as
last amended by Council Regulation (EC) No 1756/2002 (2),
and in particular Article 9g(5)(b) thereof,

Whereas:

(1)

(2)

(3)

(4)

As provided for in Article 9g(1) of 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.

New applications for authorisation had to be submitted
for the abovementioned additives. Furthermore, Article
9g(4) of Directive 70/524/EEC required that
the
dossiers in respect of these applications be submitted
no later than 30 September 2000, with a view to re-
evaluation. The data had to be produced as provided for
in Article 4 of that Directive.

Article 9g(5) of Directive 70/524/EEC provides that, after
re-evaluation of the dossiers submitted, the provisional
authorisation of the additives concerned be withdrawn
or, as the case may be, be replaced by an authorisation
linked to the person responsible for putting them into
circulation for a period of 10 years through the adoption
of a regulation taking effect no later than 1 October
2003.

The person responsible for putting into circulation the
decoquinate product (Deccox®), an additive belonging to
the group ‘Coccidiostats and other medicinal substances’
listed in Chapter I of Annex B to Directive 70/524/EEC,
submitted an application for authorisation and a dossier,
in conformity with Article 9g(2) and (4) of that Directive.

(6)

(7)

(8)

The Parliament and Council Regulation (EC) No 178 of
28 January 2002 regarding the general principles and
requirements of
food law, establishing the European
Food Safety Authority and laying down procedures in
food safety (3), as amended by Regulation
matter of
(EC) No 1642/2003 (4), established the European Food
Safety Authority (EFSA)
the
Scientific Committees attached to the Commission in
issuing scientific opinions in its field of competences.
The Scientific Panel on Additives and Products or
Feed has delivered a
Substances used in Animal
favourable opinion with regard to the safety and to the
efficacy of Deccox® based on the decoquinate for chickens
for fattening.

the role of

took over

the relevant conditions

The Commission took all necessary measures to ensure
that re-evaluation of the decoquinate product (Deccox®) be
completed within the time-frame provided by Article
9g(5) of Directive 70/524/EEC. Their evaluation showed
that
laid down in Directive
70/524/EEC are satisfied in order to include Deccox®
based on the decoquinate
the list
I of
referred to Article 9t(b) of
the said Directive, as an
additive linked to the person responsible for putting it
into circulation authorised for a period of 10 years.

in Chapter

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 Deccox® based on the decoquinate. Several requests for
additional
re-
evaluation process, extending the evaluation period for
reason beyond the control of the person responsible for
putting into circulation the product concerned.

information were made during the

Article 9m of Directive 70/524/EEC foresees that an
additive may continue to be authorised in order to use
the stocks if the condition laid down in Article 3a(b) and
(e) continue to be met. Since there are no safety reasons
for withdrawing immediately the decoquinate product
from the market, it is appropriate to allow a transitional
period of six months for the disposal of existing stocks
of the additive.

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 265, 3.10.2002, p. 1.

(3) OJ L 31, 1.2.2002, p. 1.
(4) OJ L 245, 29.9.2003, p. 4.

L 243/16

EN

Official Journal of the European Union

15.7.2004

(9)

(10)

are

to Deccox® based

required to protect workers

the application shows that certain
The assessment of
from
procedures
decoquinate.
exposure
However, such protection is 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 (1).

the

on

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Chapter
I of Annex B to Directive 70/524/EEC shall be
amended as follows: the additive decoquinate, belonging to the
group ‘Coccidiostats and other medical substances’, shall be
deleted.

Article 2

The additive Deccox® belonging to the group ‘Coccidiostats and
other medical substances’
listed 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 deco-
quinate.

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

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

Done at Brussels, 14 July 2004.

For the Commission

David BYRNE
Member of the Commission

(1) OJ L 183, 29.6.1989, p. 1.

15.7.2004

EN

Official Journal of the European Union

L 243/17

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