Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs - Text with EEA relevance
Date: 2004-12-16
Institutions: European Commission
Subjects: animal nutrition, enzyme, food additive, market approval, microorganism, veterinary inspection

L 370/24

EN

Official Journal of the European Union

17.12.2004

COMMISSION REGULATION (EC) No 2148/2004

of 16 December 2004

concerning the permanent and provisional authorisations of certain additives and the authorisation
of new uses of an additive already authorised in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 Articles 3 and 9d(1) and 9e(1) thereof,

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,

Whereas:

(1)

(2)

(3)

(4)

(5)

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

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

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

Initial comments by Member States on these applications
were issued under Article 4(4) of Directive 70/524/EEC
have been forwarded to the Commission before the date
of application of Regulation (EC) No 1831/2003. Such
applications therefore shall continue to be treated in
accordance with Article 4 of Directive 70/524/EEC.

The use of the product, clinoptilolite of volcanic origin,
as feed additive belonging to the category of ‘binders,
anti-caking agents and coagulants’, was provisionally
rabbits and
authorised,
time,
poultry
No
1245/1999 (3).

the first
Commission

for pigs,
Regulation

(EC)

for

by

(6)

(7)

(8)

(9)

(10)

(11)

New data were submitted in support of the application
for authorisation without a time limit. The assessment
shows
laid down in Directive
70/524/EEC for such authorisation have been satisfied.

the conditions

that

the use of

Accordingly,
this product, clinoptilolite of
volcanic origin, should be authorised without a time
limit, under certain conditions set out in Annex I to
this Regulation.

(DSM 5749)

The use of the micro-organism preparation of Bacillus
subtilis
licheniformis
(DSM 5750) was provisionally authorised for pigs for
fattening and without a time limit
for piglets by
Commission Regulation (EC) No 2437/2000 (4).

Bacillus

and

for

New data were submitted in support of the application
for authorisation without a time limit of that micro-
organism preparation for pigs
fattening. The
the conditions laid down in
assessment shows that
Directive 70/524/EEC for
are
satisfied. New data were submitted in support of the
application to modify the maximum age of that micro-
organism preparation for piglets. The assessment shows
that the conditions for such modification of the author-
isation are satisfied.

authorisation

such

The use of the micro-organism preparation of Sacchar-
(NCYC Sc 47) was provisionally
omyces
authorised, for the first time, for piglets by Commission
Regulation (EC) No 1436/98 (5).

cerevisiae

The use of the micro-organism preparation of Entero-
coccus faecium (DSM 7134) and Lactobacillus rhamnosus
(DSM 7133) was provisionally authorised, for the first
time,
for piglets by Commission Regulation (EC) No
2690/99 (6).

(12) New data were submitted in support of the application
those two
for authorisation without a time limit of
micro-organism preparations. The assessment
shows
that the conditions laid down in Directive 70/524/EEC
for such authorisation are satisfied.

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

last amended by
Commission Regulation 1800/2004 (OJ L 317, 16.10.2004, p. 37).

(2) OJ L 268, 18.10.2003, p. 29.
(3) OJ L 150, 17.6.1999, p. 15.

(4) OJ L 280, 4.11.2000, p. 28.
(5) OJ L 191, 7.7.1998, p. 15.
(6) OJ L 326, 18.12.1999, p. 33.

17.12.2004

EN

Official Journal of the European Union

L 370/25

the use of
(13) Accordingly,
preparations,
as
authorised without a time limit.

specified in Annex II,

those three micro-organism
should be

(21) Accordingly, the use of those three enzyme preparations
as specified in Annex IV, should be authorised without a
time limit.

(15)

(16)

(17)

(18)

(19)

(14) Data were submitted in support of an application to
obtain an authorisation for a new additive belonging to
the group micro-organisms, Kluyveromyces marxianus
variety lactisK1 (BCCM/MUCL 39434) for dairy cows.

(22)

the application for authorisation
The assessment of
submitted, in respect of the micro-organism preparation
specified in Annex III to this Regulation, shows that the
conditions
referred to in Article 9e(1) of Directive
70/524/EEC are satisfied.

The Scientific Committee on Animal Nutrition (SCAN)
has delivered an opinion on the use of this additive in
feedingstuffs ‘Opinion on the use of certain micro-
organisms as additives in feedingstuffs’ on 25 April
2003, which concludes
this additive does not
that
present a risk to animal health, human health or the
environment, under the conditions set out in Annex III
to this Regulation.

(24)

produced

The use of the enzyme preparation of endo-1,3(4)-beta-
glucanase
longibrachiatum
(CNCM MA 6-10 W) was provisionally authorised for
the first time for chickens for fattening by Commission
Regulation (EC) No 1436/98.

Trichoderma

by

The use of the enzyme preparation of endo-1,4-beta-
glucanase produced by Trichoderma longibrachiatum (IMI
SD 142) was provisionally authorised for the first time
for chickens
fattening, by Regulation (EC) No
1436/98 (liquid form) and by Commission Regulation
(EC) No 1353/2000 (1) (solid form).

for

The use of the enzyme preparation of endo-1,4-beta-
xylanase produced by Trichoderma longibrachiatum (IMI
SD 135) was provisionally authorised,
the first
time, for chickens for fattening, by Regulation (EC) No
1436/98 (liquid form) and by Regulation (EC) No
1353/2000 (solid form).

for

(20) New data were submitted in support of the application
for authorisation without a time limit of those three
enzyme preparations. The assessment shows that
the
conditions
laid down in Article 3a of Directive
70/524/EEC for such authorisation are satisfied.

(1) OJ L 155, 28.6.2000 p. 15.

and

The use of the enzyme preparation of endo-1,3(4)-beta-
endo-1,4-beta-xylanase produced by
glucanase
authorised
Penicillium funiculosum (IMI SD 101)
is
without a time limit
fattening by
Commission Regulation (EC) No 1259/2004 (2). The
use of this preparation was provisionally authorised for
turkeys for fattening, for laying hens and for pigs for
(EC) No
by
fattening
418/2001 (3).

for chickens

Commission

Regulation

for

(23) New data were submitted in support of an application to
this enzyme

extend the authorisation of
preparation to piglets and ducks for fattening.

the use of

The European Food Safety Authority (EFSA) has delivered
this preparation which
an opinion on the use of
concludes that this preparation does not present a risk
for
the
categories, under
animal
conditions set out in Annex V to this Regulation.

additional

these

(25)

The assessment shows that the conditions laid down in
Article 9e(1) of Directive 70/524/EEC for an authori-
sation of such preparation have been satisfied.

(26) Accordingly,

the use of

this enzyme preparation as
specified in Annex V, should be provisionally authorised
for four years.

(27)

(28)

The assessment of these applications shows that certain
procedures should be required to protect workers from
exposure to the additives set out in the Annexes. 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 (4).

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

opinion

the

the

of

(2) OJ L 239, 9.7.2004, p. 8.
(3) OJ L 62, 2.3.2001, p. 3.
(4) OJ L 183, 29.6.1989, p. 1.

L 370/26

EN

Official Journal of the European Union

17.12.2004

HAS ADOPTED THIS REGULATION

Article 4

Article 1

The preparation belonging to the group ‘Binders, anti-caking
agents and coagulants’,
is authorised for use without a time
limit as additive in animal nutrition under the conditions laid
down in Annex I.

Article 2

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

The preparations belonging to the group ‘Enzymes’, are
authorised for use without a time limit as additives in animal
nutrition under the conditions laid down in Annex IV.

Article 5

The preparation belonging to the group ‘Enzymes’, is authorised
provisionally for four years as additive in animal nutrition under
the conditions laid down in Annex V.

Article 3

Article 6

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

This Regulation shall enter into force on the third day following
that of
the European
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, 16 December 2004.

For the Commission

Markos KYPRIANOU
Member of the Commission

17.12.2004

EN

Official Journal of the European Union

L 370/27

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L 370/28

EN

Official Journal of the European Union

17.12.2004

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EN

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EN

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