Commission Regulation (EC) No 2036/2005 of  14 December 2005  concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs   (Text with EEA relevance)
Date: 2005-12-14
Institutions: European Commission
Subjects: animal nutrition, enzyme, food additive, food safety, market approval, microorganism

15.12.2005

EN

Official Journal of the European Union

L 328/13

COMMISSION REGULATION (EC) No 2036/2005

of 14 December 2005

concerning the permanent authorisations of certain additives in feedingstuffs and the provisional
authorisation of a new use of certain additives already authorised in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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

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)

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

(2)

(3)

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

(5)

(6)

(7)

(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).

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.

cerevisiae

The use of the micro-organism preparation of Sacchar-
(CNCM I-1079) was provisionally
omyces
authorised, for the first time, for sows by Commission
Regulation (EC) No 1436/98 (3). New data were
submitted in support of an application for authorisation
without a time limit of that micro-organism preparation.
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 that micro-organism
preparation, as specified in Annex I, should be authorised
without a time limit.

The use of the micro-organism preparation of Pediococ-
(CNCM MA 18/5M) was provisionally
cus acidilactici
authorised, for the first time, for pigs for fattening by
Commission Regulation (EC) No 866/1999 (4). New data
were submitted in support of an application for author-
isation without a time limit of
that micro-organism
preparation. 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
that micro-organism preparation, as specified in Annex I,
should be authorised without a time limit.

The use of the micro-organism preparation of Entero-
coccus faecium (CECT 4515) was provisionally authorised,
for the first time, for piglets by Commission Regulation
(EC) No 654/2000 (5). New data were submitted in
support of an application for authorisation without a
that micro-organism preparation. The
time limit of
assessment shows that
the conditions laid down in
Article 3a of Directive 70/524/EEC for such authorisation
are satisfied. Accordingly, the use of that micro-organism
preparation, as specified in Annex I, should be authorised
without a time limit.

(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 108, 27.4.1999, p. 21.
(5) OJ L 79, 30.3.2000, p. 26.

L 328/14

EN

Official Journal of the European Union

15.12.2005

(8)

(9)

(10)

the first

The use of the enzyme preparation of endo-1,3(4)-beta-
(CBS 526.94)
glucanase produced by Trichoderma reesei
was provisionally authorised for
time for
chickens for fattening by Commission Regulation (EC)
No 2374/98 (1). New data were submitted in support
of an application for authorisation without a time limit
of that enzyme preparation. The assessment shows that
the conditions laid down in Article 3a of Directive
authorisation
70/524/EEC for
satisfied.
that enzyme preparation, as
Accordingly,
specified in Annex II, should be authorised without a
time limit.

such
the use of

are

amyloliquefaciens

endo-1,3(4)-beta-glucanase

The use of the enzyme preparation of endo-1,4-beta-
xylanase produced by Trichoderma longibrachiatum (ATCC
and alpha-amylase
2105),
produced by Bacillus
(DSM 9553),
subtilisin produced by Bacillus subtilis (ATCC 2107) and
polygalacturonase produced by Aspergillus aculeatus (CBS
589.94) was provisionally authorised for the first time
for chickens for fattening by Commission Regulation
(EC) No 418/2001 (2). New data were submitted in
support of an application for authorisation without a
time limit of that enzyme preparation. The assessment
shows that the conditions laid down in Article 3a of
are
Directive 70/524/EEC for
satisfied. Accordingly,
enzyme
the
preparation,
should be
as
authorised without a time limit.

authorisation
that
of

specified in Annex II,

such
use

for

and

piglets

turkeys

fattening

the use of

The use of the enzyme preparation of endo-1,4-beta-
xylanase produced by Aspergillus oryzae (DSM 10287)
was authorised without a time limit for chickens for
fattening,
by
Commission Regulation (EC) No 1332/2004 (3). New
data were submitted in support of an application to
this enzyme
extend the authorisation of
preparation to ducks
fattening. The
European Food Safety Authority (EFSA) has delivered
an opinion on the use of
this preparation which
concludes that it does not present a risk for this addi-
tional animal category. The assessment shows that the
conditions
laid down in Article 9e(1) of Directive
that preparation
70/524/EEC for an authorisation of
for that use are satisfied. Accordingly, the use of that
enzyme preparation, as specified in Annex III, should
be authorised for four years.

and pigs

for

(11)

The use of the enzyme preparation of endo-1,4-beta-
xylanase produced by Trichoderma longibrachiatum (ATCC

by

fattening

Regulation

Commission

2105) and subtilisin produced by Bacillus subtilis (ATCC
2107) was authorised without a time limit for chickens
for
(EC)
No 943/2005 (4). New data were submitted in support
of an application to extend the authorisation of the use
this enzyme preparation to ducks. The EFSA has
of
delivered an opinion on the use of
this preparation
which concludes that it does not present a risk for this
additional animal category. The assessment shows that
the conditions laid down in Article 9e(1) of Directive
70/524/EEC for an authorisation of
that preparation
for that use are satisfied. Accordingly, the use of that
enzyme preparation, as specified in Annex III, should
be authorised for four years.

amyloliquefaciens

endo-1,3(4)-beta-glucanase

The use of the enzyme preparation of endo-1,4-beta-
xylanase produced by Trichoderma longibrachiatum (ATCC
and alpha-amylase
2105),
(DSM 9553),
produced by Bacillus
subtilisin produced by Bacillus subtilis (ATCC 2107) and
polygalacturonase produced by Aspergillus aculeatus (CBS
589.94) was provisionally authorised for chickens for
fattening by Regulation (EC) No 418/2001. New data
to
were submitted in support of
extend the authorisation of
this enzyme
preparation to ducks and laying hens. The EFSA has
delivered an opinion on the use of this preparation on
each of the two animal categories which conclude in
it does not present a risk for them.
both cases that
The assessment shows that the conditions laid down in
Article 9e(1) of Directive 70/524/EEC for an authori-
that preparation for that use are satisfied.
sation of
that enzyme preparation for
Accordingly,
ducks and laying hens, as specified in Annex III, should
be authorised for four years.

two applications

the use of

the use of

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 (5).

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

opinion

the

the

of

(12)

(13)

(14)

(1) OJ L 295, 4.11.1998, p. 3.
(2) OJ L 62, 2.3.2001, p. 3.
(3) OJ L 247, 21.7.2004, p. 8.

(4) OJ L 159, 22.6.2005, p. 6.
(5) OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

15.12.2005

EN

Official Journal of the European Union

L 328/15

HAS ADOPTED THIS REGULATION:

Article 1

additives in animal nutrition under the conditions laid down
in that Annex.

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

Article 3

The preparations belonging to the group ‘Enzymes’, as specified
in Annex III, are authorised for use for four years as additives in
animal nutrition under the conditions laid down in that Annex.

Article 2

Article 4

The preparations belonging to the group ‘Enzymes’, as specified
in Annex II, are authorised for use without a time limit as

This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

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

Done at Brussels, 14 December 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 328/16

EN

Official Journal of the European Union

15.12.2005

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15.12.2005

EN

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L 328/17

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EN

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15.12.2005

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L 328/20

EN

Official Journal of the European Union

15.12.2005

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