Commission Regulation (EC) No 521/2005 of 1 April 2005 concerning the permanent authorisation of an additive and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (Text with EEA relevance)
Date: 2005-04-01
Institutions: European Commission
Subjects: animal nutrition, enzyme, food additive, market approval, microorganism

2.4.2005

EN

Official Journal of the European Union

L 84/3

COMMISSION REGULATION (EC) No 521/2005

of 1 April 2005

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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,

(6)

Whereas:

(1)

(2)

(3)

(4)

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

application

Regulation

of

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.

by

subtilis

fattening,

produced

Trichoderma

the first
Commission

The use of the enzyme preparation of endo-1,3(4)-beta-
glucanase
longibrachiatum
(ATCC 2106),
endo-1,4-beta-xylanase produced by
Trichoderma longibrachiatum (ATCC 2105) and subtilisin
(ATCC 2107) was pro-
produced by Bacillus
time for chickens
visionally authorised for
for
(EC)
No 1636/1999 (3). 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.
Accordingly,
that enzyme preparation as
specified in Annex I, should be authorised without a
time limit.

such
the use of

Regulation

are

by

a

for

the

limit

oryzae

chickens

enzyme preparation of 6-phytase
The use of
(DSM 14223) was
produced by Aspergillus
authorised without
for
time
fattening, laying hens, turkeys for fattening, piglets, pigs
for fattening and sows by Commission Regulation (EC)
No 255/2005 (4). New data were submitted in support of
an application to extend the authorisation of the use of
that enzyme preparation to salmonids. The European
Food Safety Authority (EFSA) has delivered an opinion
on the use of that preparation which concludes that it
does not present
the
conditions set out in Annex II to this Regulation. The
assessment shows that
the conditions laid down in
Article 9e(1) of Directive 70/524/EEC for such authori-
sation are satisfied. Accordingly, the use of that enzyme
preparation as specified in Annex II, should be provi-
sionally authorised for four years.

risk to salmonids under

a

(7)

The use of the micro-organism preparation of Entero-
coccus faecium (DSM 7134) was provisionally authorised,
for the first time, for piglets and pigs for fattening by
Commission Regulation (EC) No 666/2003 (5). New data
were submitted in support of an application to extend
that micro-organism
the use of
the authorisation of
preparation to chickens for fattening. The EFSA has
delivered a favourable opinion on 28 October 2004 on
the safety of
that additive when used in the animal
category chickens for fattening, under the conditions of
use set out
to this Regulation. The
assessment shows that
the conditions laid down in
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 III, should be
provisionally authorised for four years.

in Annex III

(1) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission
Regulation (EC) No 1800/2004 (OJ L 317, 16.10.2004, p. 37).
(2) OJ L 268, 18.10.2003, p. 29. Regulation as amended by Regulation

(EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

(3) OJ L 194, 27.7.1999, p. 17.
(4) OJ L 45, 16.2.2005, p. 3.
(5) OJ L 96, 12.4.2003, p. 11.

L 84/4

EN

Official Journal of the European Union

2.4.2005

(8)

(9)

The assessment of those 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 (1).

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

The preparation belonging to the group ‘Enzymes’, as specified
in Annex I,
is authorised for use without a time limit as an
additive in animal nutrition under the conditions laid down in
that Annex.

Article 2

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

Article 3

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

Article 4

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, 1 April 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 Parliament and of the Council (OJ L 284,
31.10.2003, p. 1).

2.4.2005

EN

Official Journal of the European Union

L 84/5

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