Commission Regulation (EC) No 600/2005 of 18 April 2005 concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives in feedingstuffs (Text with EEA relevance)
Date: 2005-04-18
Institutions: European Commission
Subjects: animal nutrition, food additive, food inspection, market approval, microorganism, veterinary drug

19.4.2005

EN

Official Journal of the European Union

L 99/5

COMMISSION REGULATION (EC) No 600/2005

of 18 April 2005

concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the
provisional authorisation of an additive and the permanent authorisation of certain additives in
feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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, 9d(1) and 9e(1) thereof,

Council Directive

70/524/EEC

to

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

(6)

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 1831/2003 provides for the author-
isation of additives for use in animal nutrition.

(7)

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 applications for authorisation of the additives listed
in the Annexes to this Regulation were submitted before
the
(EC)
of
date
No 1831/2003.

application

Regulation

of

(8)

Initial comments on those applications, as provided for
in Article 4(4) of Directive 70/524/EEC, were forwarded
to the Commission before the date of application of
Regulation (EC) No 1831/2003. Those applications are
therefore to continue to be treated in accordance with
Article 4 of Directive 70/524/EEC.

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

(EC) No 1800/2004 (OJ

last amended by
L 317,

Commission Regulation
16.10.2004, p. 37).

The person responsible for putting into circulation
Salinomax 120G submitted an application for authori-
sation for 10 years, as a coccidiostat for chickens for
fattening, according to Article 4 of that Directive. The
European Food Safety Authority (EFSA) has delivered an
opinion on the safety of the use of this preparation for
humans,
the
conditions set out in Annex I to this Regulation. 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 I, should be authorised for 10 years.

environment, under

and the

animals

Data were submitted in support of an application of the
new additive Lactobacillus acidophilus DSM 13241 for dogs
and cats. The EFSA delivered favourable opinions on
15 April 2004 and 27 October 2004 on the safety for
the target animals, the user and the environment. The
the conditions laid down in
assessment shows that
Article 9e(1) of Directive 70/524/EEC for such authori-
sation are satisfied. Accordingly, the use of that micro-
organism preparation, as specified in Annex II, should be
provisionally authorised.

The use of the micro-organism preparation Enterococcus
faecium ATCC 53519 and Enterococcus
faecium ATCC
55593 was provisionally authorised, for the first time,
for chickens for fattening by Commission Regulation
(EC) No 1436/98 (3). New data were submitted in
support of an application for authorisation without
time limit of
that micro-organism preparation. The
the conditions laid down in
assessment shows that
Article 3a of Directive 70/524/EEC for such authorisation
are satisfied. Accordingly, the use of that micro-organism
preparation,
should be
as
authorised without a time limit.

specified in Annex III,

by

fattening

Regulation

Commission

The use of the micro-organism preparation Bacillus liche-
niformis DSM 5749 and Bacillus subtilis DSM 5750 was
provisionally authorised, for the first time, for turkeys
for
(EC)
No 2437/2000 (4) and for calves by Commission Regu-
lation (EC) No 418/2001 (5). New data were submitted in
support of an application for authorisation without time
limit of that micro-organism preparation. The assessment
shows that the conditions laid down in Article 3a of
Directive 70/524/EEC for
are
that micro-organism
satisfied. Accordingly,
should be
as
preparation,
authorised without a time limit.

such
the use of

specified in Annex III,

authorisation

(2) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

(3) OJ L 191, 7.7.1998, p. 15.
(4) OJ L 280, 4.11.2000, p. 28.
(5) OJ L 62, 2.3.2001, p. 3.

L 99/6

EN

Official Journal of the European Union

19.4.2005

(9)

(10)

(11)

for

time,

The use of the micro-organism preparation Saccharomyces
cerevisiae NCYC Sc 47 was provisionally authorised, for
the first
rabbits by the Regulation (EC)
No 1436/98. New data were submitted in support of
an application for authorisation without time limit of
that micro-organism preparation. The assessment shows
that the conditions laid down in Article 3a of Directive
70/524/EEC for
satisfied.
Accordingly, the use of that micro-organism preparation,
as specified in Annex III, should be authorised without a
time limit.

authorisation

such

are

The assessment of this application shows that certain
procedures should be required to protect workers from
exposure to the additive set out in the Annex. Such
protection should be 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 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 Annex I, is authorised for
use for 10 years as additive in animal nutrition under the
conditions laid down in that Annex.

Article 2

The preparation belonging to the group ‘Micro-organisms’, as
specified in Annex II, is authorised provisionally for four years
as an additive in animal nutrition under the conditions laid
down in that Annex.

Article 3

The preparations belonging to the group ‘Micro-organisms’, as
specified in Annex III, are authorised for use without a time
limit as additives in animal nutrition under the conditions laid
down in that Annex.

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, 18 April 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 183, 29.6.1989, p. 1. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

19.4.2005

EN

Official Journal of the European Union

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