Commission Regulation (EC) No 358/2005 of 2 March 2005 concerning the authorisations without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffsText with EEA relevance
Date: 2005-03-02
Institutions: European Commission
Subjects: animal nutrition, food additive, market approval

3.3.2005

EN

Official Journal of the European Union

L 57/3

COMMISSION REGULATION (EC) No 358/2005

of 2 March 2005

concerning the authorisations without a time limit of certain additives and the authorisation of new
uses of additives 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:

(6)

(7)

(8)

(9)

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.

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

The European Food Safety Authority (EFSA) delivered a
favourable opinion on the toxin producing potential of
the micro-organism producing this enzyme preparation
dated 15 September 2004.

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

The use of the enzyme preparation of endo-1,3(4)-beta-
glucanase produced by Aspergillus aculeatus (CBS 589.94),
endo-1,4-beta-glucanase produced by Trichoderma longi-
brachiatum (CBS 592.94), alpha-amylase produced by
bacillolysin
Bacillus
produced by Bacillus amyloliquefaciens (DSM 9554) and
endo-1,4-beta-xylanase produced by Trichoderma viride
(NIBH FERM BP 4842) was provisionally authorised,
for chickens for fattening, by Commission Regulation
(EC) No 2437/2000 (4).

amyloliquefaciens

(DSM 9553),

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.

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

Initial comments by Member States on these applications
were issued under Article 4(4) of Directive 70/524/EEC
and 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.

(11)

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

The use of the enzyme preparation of alpha-amylase and
endo-1,3(4)-beta-glucanase produced by Bacillus amyloli-
quefaciens (DSM 9553) was provisionally authorised, for
the first time, for chickens for fattening, by Commission
Regulation (EC) No 654/2000 (3).

(12)

The use of the enzyme preparation of endo-1,3(4)-beta-
glucanase produced by Aspergillus aculeatus (CBS 589.94),
endo-1,4-beta-glucanase produced by Trichoderma longi-
brachiatum (CBS 592.94), alpha-amylase produced by
Bacillus amyloliquefaciens (DSM 9553) and endo-1,4-beta-
xylanase produced by Trichoderma viride (NIBH FERM BP
for chickens for
4842) was provisionally authorised,
fattening,
(EC)
by
No 2437/2000.

Commission

Regulation

(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 79, 30.3.2000, p. 26.

(4) OJ L 280, 4.11.2000, p. 28.

(1)

(2)

(3)

(4)

(5)

L 57/4

EN

Official Journal of the European Union

3.3.2005

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

(24)

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

(14)

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

(25)

The use of the substance ‘patent blue V’, was provi-
sionally authorised, as colourant, for grain-eating orna-
mental birds and small
rodents, by Regulation (EC)
No 2697/2000.

(15)

and

The use of the enzyme preparation of endo-1,3(4)-beta-
glucanase
endo-1,4-beta-xylanase produced by
Trichoderma longibrachiatum (CBS 357.94) was provi-
sionally authorised for the first time for chickens for
fattening,
(EC)
by
No 1436/98 (1).

Commission

Regulation

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

(17)

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

(18) Accordingly, the use of those four enzyme preparations
as specified in Annex I, should be authorised without a
time limit.

(19)

The use of the substance ‘tartrazine’ was provisionally
authorised, as colourant
for grain-eating ornamental
birds and small
rodents, by Commission Regulation
(EC) No 2697/2000 (2).

(26) New data were submitted in support of the application
for authorisation without a time limit of this colourant.

(27)

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

(28)

The use of the substance chlorophyll copper complex
was provisionally authorised as coulourant,
for grain-
eating ornamental birds and small rodents, by Regulation
(EC) No 2697/2000.

(29) New data were submitted in support of the application
for authorisation without a time limit of this colourant.

(30)

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

(31) Accordingly, the use of those four colourants as specified
in Annex II, should be authorised without a time limit.

(20) New data were submitted in support of the application
for authorisation without a time limit of this colourant.

(32)

(21)

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

(22)

The use of the substance ‘sunset yellow FCF’, was provi-
sionally authorised, as colourant, for grain-eating orna-
mental birds and small
rodents, by Regulation (EC)
No 2697/2000.

(23) New data were submitted in support of the application
for authorisation without a time limit of this colourant.

(1) OJ L 191, 7.7.1998, p. 15.
(2) OJ L 319, 16.12.2000, p. 1.

by

The use of the enzyme preparation of endo-1(4)-beta-
xylanase produced by Bacillus subtilis (LMG-15136)
is
authorised for chickens for fattening without a time
limit
(EC)
No 1259/2004 (3), and provisionally for piglets by
Commission Regulation (EC) No 937/2001 (4),
for
turkeys for fattening by Commission Regulation (EC)
No 2188/2002 (5),
fattening by
and for pigs
Commission Regulation (EC) No 261/2003 (6).

Commission

Regulation

for

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

the use of

extend the authorisation of
preparation to laying hens.

(3) OJ L 239, 9.7.2004, p. 8.
(4) OJ L 130, 12.5.2001, p. 25.
(5) OJ L 333, 10.12.2002, p. 5.
(6) OJ L 37, 13.2.2003, p. 12.

3.3.2005

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Official Journal of the European Union

L 57/5

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, under the conditions set out in
Annex III to this Regulation.

(43)

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

such preparation for

(34)

(35)

(36)

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

such preparation for

the

The use of
enzyme preparation of 3-phytase
produced by Trichoderma reesei (CBS 528.94) is authorised
for chickens for fattening by Commission Regulation
(EC) No 418/2001 (1).

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

extend the authorisation of
preparation to turkeys for fattening and sows.

the use of

(38)

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

(39) Accordingly, the use of these two enzyme preparations as
specified in Annex III, should be provisionally authorised
for four years.

(40)

The use of the micro-organism preparation of Entero-
coccus faecium is authorised for calves without a time
limit by Commission Regulation (EC) No 1288/2004 (2)
and provisionally until 30 June 2004, for chickens for
fattening, piglets, pigs for fattening, sows, and cattle for
(EC)
fattening
No 866/1999 (3).

Commission

Regulation

by

(41) New data were submitted in support of an application to
this micro-

extend the authorisation of
organism preparation to dogs and cats.

the use of

(42)

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, under the conditions set out in
Annex IV to this Regulation.

(1) OJ L 62, 2.3.2001, p. 3.
(2) OJ L 243, 15.7.2004, p. 10.
(3) OJ L 108, 27.4.1999, p. 21.

(44) Accordingly, the use of this micro-organism preparation
should be provisionally

specified in Annex IV,

as
authorised for four years.

(45)

(46)

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
accordance with
Standing
Committee on the Food Chain and Animal Health.

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

The preparations belonging to the group ‘Enzymes’ as set out 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 substances belonging to the group ‘Colourants,
including
pigments, other colourants’ as set out in Annex II 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 set out in
Annex III are authorised provisionally for four years as additives
in animal nutrition under the conditions laid down in that
Annex.

Article 4

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

Article 5

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

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

L 57/6

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Official Journal of the European Union

3.3.2005

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

Done at Brussels, 2 March 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

3.3.2005

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Official Journal of the European Union

L 57/7

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