Commission Regulation (EC) No 1811/2005 of 4 November 2005 concerning the provisional and permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs   (Text with EEA relevance)
Date: 2005-11-04
Institutions: European Commission
Subjects: animal nutrition, enzyme, food additive, food safety, market approval, microorganism

L 291/12

EN

Official Journal of the European Union

5.11.2005

COMMISSION REGULATION (EC) No 1811/2005

of 4 November 2005

concerning the provisional and permanent authorisations of certain additives in feedingstuffs and
the provisional authorisation of a new use 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, 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:

Regulation (EC) No 1831/2003 provides for the author-
isation 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 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.

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)

(2)

(3)

(4)

(5)

(6)

(7)

data were submitted in support of an application for
authorisation without a time-limit of
enzyme
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 enzyme preparation, as specified in Annex I, should
be authorised without a time-limit.

that

The use of the enzyme preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma longibrachiatum (ATCC
2106) was provisionally authorised for the first time for
chickens for fattening by Commission Regulation (EC)
No 1411/1999 (4). 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, as specified in Annex I, should be authorised
without a time-limit.

authorisation
that
of

such
use

for

and

for chickens

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

The use of the enzyme preparation of endo-1,4-beta-
glucanase,
endo-1,4-
beta-xylanase produced by Trichoderma longibrachiatum
(ATCC 74 252) was provisionally
authorised for
turkeys for fattening by Commission Regulation (EC)
No 937/2001 (5) and for laying hens by Commission
Regulation (EC) No 2188/2002 (6) and was authorised
without a time-limit
fattening by
Commission Regulation (EC) No 1259/2004 (7) and for
turkey for fattening by Commission Regulation (EC) No
1206/2005 (8). New data were submitted in support of
an application to extend the authorisation of the use of
this enzyme preparation to ducks. 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 additional animal category. The
assessment shows that
the conditions laid down in
Article 9e(1) of Directive 70/524/EEC for an authori-
sation of
that preparation for that use are satisfied.
that enzyme preparation, as
Accordingly,
specified in Annex II, should be authorised for four years.

the use of

Data were submitted in support of an application for
authorisation of the use of the enzyme preparation of
endo-1,4-beta-xylanase produced by Trichoderma reesei
(CBS 529.94) and endo-1,3(4)-beta-glucanase produced
for
by Trichoderma reesei

(CBS 526.94)

for chickens

The use of the enzyme preparation of endo-1,3(4)-beta-
glucanase produced by Aspergillus aculeatus (CBS 589.94)
was provisionally authorised for the first time for piglets
by Commission Regulation (EC) No 1436/98 (3). New

(8)

(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).

(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 164, 30.6.1999, p. 56.
(5) OJ L 130, 12.5.2001, p. 25.
(6) OJ L 333, 10.12.2002, p. 5.
(7) OJ L 239, 9.7.2004, p. 8.
(8) OJ L 197, 28.7.2005, p. 12.

5.11.2005

EN

Official Journal of the European Union

L 291/13

for

turkeys

fattening. EFSA has
fattening and for
delivered an opinion on the use of
this preparation
which concludes that it does not present a risk for the
consumer, the user, the animal category or the envir-
onment. The assessment shows that the conditions laid
down in Article 9e(1) of Directive 70/524/EEC for an
that use are
authorisation of
satisfied. Accordingly,
enzyme
that
preparation,
should be
authorised for four years.

that preparation for
of

specified in Annex II,

use

the

as

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 (1).

(12)

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

opinion

the

the

of

(9)

(10)

cerevisiae

(NCYC Sc 47) was

The use of the micro-organism preparation of Sacchar-
provisionally
omyces
authorised, for the first time, for dairy cows by Regu-
lation (EC) No 937/2001. 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,
should be
as
authorised without a time-limit.

specified in Annex III,

cerevisiae

(CBS 493.94) was

The use of the micro-organism preparation of Sacchar-
provisionally
omyces
authorised, for the first time, for dairy cows by Regu-
lation (EC) No 937/2001. 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
should be
as
preparation,
authorised without a time-limit.

specified in Annex III,

HAS ADOPTED THIS REGULATION:

Article 1

The preparations belonging to the group ‘Enzymes’, 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 2

The preparations belonging to the group ‘Enzymes’, as specified
in Annex II, are authorised for use for four years as additives 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

(11)

The assessment of these applications shows that certain
procedures should be required to protect workers from

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, 4 November 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) 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).

L 291/14

EN

Official Journal of the European Union

5.11.2005

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5.11.2005

EN

Official Journal of the European Union

L 291/15

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EN

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5.11.2005

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