Commission Regulation (EC) No 255/2005 of 15 February 2005 concerning the permanent authorisations of certain additives in feedingstuffsText with EEA relevance
Date: 2005-02-15
Institutions: European Commission
Subjects: animal nutrition, enzyme, fattening, food additive, veterinary legislation

16.2.2005

EN

Official Journal of the European Union

L 45/3

COMMISSION REGULATION (EC) No 255/2005

of 15 February 2005

concerning the permanent authorisations of certain additives in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

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) 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 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.

The use of the micro-organism preparation of Entero-
coccus faecium (DSM 10663/NCIMB 10415) was provi-
sionally authorised,
for calves by
for
Commission Regulation (EC) No 1636/1999 (4).

the first

time,

New data were submitted in support of these applications
those two
for authorisation without a time limit of
to
micro-organism preparations specified in Annex I
this Regulation. The
the
laid down in Article 3a of Directive
conditions
70/524/EEC for such authorisation are satisfied.

assessment

shows

that

The use of the enzyme preparation of endo-1,3(4)-beta-
glucanase and endo-1,4-beta-xylanase produced by Asper-
gillus niger (NRRL 25541) was provisionally authorised,
for the first time, for laying hens, by Commission Regu-
lation (EC) No 1436/98 (5).

New data were submitted in support of the application
for authorisation without a time limit of this enzyme
preparation.

(7)

(8)

(9)

(10)

The European Food Safety Authority (EFSA) delivered an
opinion dated on 14 September 2004 about the efficacy
of the use of this preparation for laying hens.

(11)

The assessment shows that the conditions laid down in
Article 3a of Directive 70/524/EEC for such authorisation
are satisfied.

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.

(12)

The use of the micro-organism preparation of Bacillus
cereus var. toyoi (NCIMB 40112/CNCM I-1012) was provi-
for cattle for
sionally authorised,
fattening
(EC) No
by
1411/1999 (3).

for
Commission

time,
Regulation

the first

the

enzyme preparation of 6-phytase
The use of
produced by Aspergillus oryzae (DSM 11857) was provi-
sionally authorised, for the first time, for chickens for
fattening, laying hens, turkeys for fattening, piglets and
pigs for fattening by Commission Regulation (EC) No
1353/2000 (6), and for sows by Commission Regulation
(EC) No 261/2003 (7). The use of
enzyme
preparation was authorised without a time limit
for
these animal categories by Commission Regulation (EC)
No 1465/2004 (8).

this

(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.
(3) OJ L 164, 30.6.1999, p. 56.

(4) OJ L 194, 27.7.1999, p. 17.
(5) OJ L 191, 7.7.1998, p. 15.
(6) OJ L 155, 28.6.2000, p. 15.
(7) OJ L 37, 13.2.2003, p. 12.
(8) OJ L 270, 18.8.2004, p. 11.

(1)

(2)

(3)

(4)

(5)

L 45/4

EN

Official Journal of the European Union

16.2.2005

(13) New data were submitted in support of the application
for authorisation without a time limit of a preparation of
the same enzyme preparation produced by the strain
DSM 14223 of Aspergillus oryzae for the same animal
categories.

(14)

(15)

(16)

The European Food Safety Authority (EFSA) has delivered
an opinion on the use of this preparation when produced
from Aspergillus oryzae strain DSM 14223 instead of
strain DSM 11857 which concludes that this preparation
does not present a risk to human health, the animal
categories
the
conditions set out in the Annex II to this Regulation.

the environment, under

specified or

The assessment shows that the conditions laid down in
Article 3a of Directive 70/524/EEC for an authorisation
without a time limit of such preparation have been
satisfied.

The use of the enzyme preparation of endo-1,4-beta-
(CBS 270.95)
xylanase produced by Aspergillus niger
for
time,
was provisionally authorised,
chickens for fattening, by Commission Regulation (EC)
No 1436/98 and,
fattening, by
for
Commission Regulation (EC) No 654/2000 (1).

the first

turkeys

for

for

(17) New data were submitted in support of the application
for authorisation without a time limit of this enzyme
preparation.

(18)

The assessment shows that the conditions laid down in
Article 3a of Directive 70/524/EEC for such authorisation
are satisfied.

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

(20)

(21)

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 (2).

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 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 I.

Article 2

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 II.

Article 3

This Regulation shall enter into force on the third 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, 15 February 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 79, 30.3.2000, p. 26.

(2) OJ L 183, 29.6.1989, p. 1.

16.2.2005

EN

Official Journal of the European Union

L 45/5

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