Commission Regulation (EC) No 971/2008 of 3 October 2008 concerning a new use of a coccidiostat as additive in feedingstuffs (Text with EEA relevance)
Date: 2008-10-03
Institutions: European Commission
Subjects: animal nutrition, food additive, market approval, rabbit, veterinary drug, veterinary inspection

4.10.2008

EN

Official Journal of the European Union

L 265/3

COMMISSION REGULATION (EC) No 971/2008

of 3 October 2008

concerning a new use of a coccidiostat as additive in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

regard

Having
of
23 November 1970 concerning additives in feedingstuffs (1),
and in particular Articles 3 and 9 thereof,

Council Directive

70/524/EEC

to

Having regard to Regulation (EC) No 1831/2003 of
the
the Council of 22 September
European Parliament and of
2003 on additives for use in animal nutrition (2), and in
particular Article 25 thereof,

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 1831/2003 provides for the autho­
risation of additives for use in animal nutrition.

Article 25 of Regulation (EC) No 1831/2003 lays down
transitional measures for applications for the authori­
sation of
feed additives submitted in accordance with
Directive 70/524/EEC before the date of application of
Regulation (EC) No 1831/2003.

The application for authorisation of the additive set out
in the Annex to this Regulation was submitted before the
date of application of Regulation (EC) No 1831/2003.

Initial comments on that application, as provided for in
Article 4(4) of Directive 70/524/EEC, were forwarded to
the Commission before the date of application of Regu­
lation (EC) No 1831/2003. That application is therefore
to continue to be treated in accordance with Article 4 of
Directive 70/524/EEC.

(5)

The additive diclazuril (Clinacox 0,5 % Premix) is already
(EC) No
by Commission Regulations
authorised

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 268, 18.10.2003, p. 29.

for

2430/1999 (3)
418/2001 (4)
162/2003 (5) for chickens reared for laying.

chickens
turkeys for

for
(EC) No
fattening and (EC) No

fattening,

for

(6)

(7)

New data were submitted by the holder of the authori­
sation of the additive in support of an application for
authorisation for ten years as coccidiostat for rabbits. The
(‘the Authority’)
European Food
Safety Authority
delivered two opinions (6) on the safety of the use of
that coccidiostat for humans, animals and environment,
under the conditions set out in the Annex to this Regu­
lation. The assessment shows that the conditions laid
down in Article 3a of Directive 70/524/EEC for such
authorisation are satisfied. Accordingly, the use of this
preparation, as specified in Annex, should be authorised
for ten years.

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

The preparation belonging to the group ‘Coccidiostats and other
medicinal substances’, as specified in the Annex, is authorised
for use for ten years as additive in animal nutrition under the
conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the 20th day following
the European
that of
Union.

its publication in the Official

Journal of

(3) OJ L 296, 17.11.1999, p. 3.
(4) OJ L 62, 2.3.2001, p. 3.
(5) OJ L 26, 31.1.2003, p. 3.
(6) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on a request from the European
Commission on the safety and efficacy of ‘Clinacox 0,5 %’ based on
diclazuril for rabbits for fattening and breeding, The EFSA Journal
(2007) 506, 1-32.
Updated Scientific Opinion of the Panel on Additives and Products
or Substances used in Animal Feed (FEEDAP) on a request from the
European Commission on the safety of ‘Clinacox 0,5 %’ (diclazuril)
used in rabbits for fattening and breeding, The EFSA Journal (2008)
697, 1-9.

L 265/4

EN

Official Journal of the European Union

4.10.2008

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

Done at Brussels, 3 October 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

4.10.2008

EN

Official Journal of the European Union

L 265/5

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