Commission Regulation (EC) No 1453/2004 of 16 August 2004 concerning the permanent authorisation of certain additives in feedingstuffs(Text with EEA relevance)
Date: 2004-08-16
Institutions: European Commission
Subjects: animal nutrition, enzyme, fattening, food additive, veterinary legislation

17.8.2004

EN

Official Journal of the European Union

L 269/3

COMMISSION REGULATION (EC) No 1453/2004

of 16 August 2004

concerning the permanent authorisation of certain additives 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 Article 3 and Article 9d(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Directive 70/524/EEC provides for the authorisation of
additives to be used in the Community. The additives
referred to in Part II of Annex C to that Directive may
be authorised without a time limit subject to certain
conditions being satisfied.

The use of the micro-organism preparation of Bacillus
(DSM
(DSM 5749) and Bacillus
licheniformis
5750) was provisionally authorised, for the first time,
(EC) No
by Commission Regulation
sows,
for
2437/2000 (2).

subtilis

New data were submitted in support of the application
for authorisation without a time limit of that preparation.
The assessment shows that the conditions laid down in
Directive 70/524/EEC for such authorisation are satisfied.

Accordingly, the use of that preparation for sows, as
specified in the Annex I, should be authorised without
a time limit.

The use of the micro-organism preparation of Bacillus
(NCIMB 40112/CNCM I–1012) was
cereus var.
provisionally authorised, for the first time, for pigs for
fattening by Commission Directive 94/17/EC (3).

toyoi

toyoi

cereus var.

report on Bacillus

The Scientific Committee on Animal Nutrition (SCAN),
in its
(NCIMB
40112/CNCM I–1012) adopted on 5 December 2001,
confirmed that preparation, when used in the animal
categories piglets, pigs for fattening and sows, satisfies
the conditions of Article 3a(b) of Directive 70/524/EEC.
The SCAN report also concluded favourably on the
efficacy of that preparation when used in the animal
categories piglets to two months and sows.

(7)

(8)

(9)

(10)

(11)

(12)

(13)

(14)

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

The European Food Safety Authority (EFSA) was asked to
issue on opinion on the efficacy of
that preparation
when used as feed additive for pigs for fattening. In its
opinion adopted on 7 May 2004, the EFSA concluded
favourably on the efficacy regarding that preparation and
the whole assessment shows that
the conditions laid
down in Directive 70/524/EEC for such authorisation
are satisfied.

the use of

Accordingly,
that preparation for pigs for
fattening, as specified in Annex I, should be authorised
without a time limit.

The use of the enzyme preparation of endo-1,4-beta-
xylanase and endo-1,4-beta-glucanase produced by Asper-
gillus niger (CBS 600.94) set out in the first row of Annex
for
II was provisionally authorised,
chickens for fattening, turkeys for fattening and piglets
by Commission Regulation (EC) No 654/2000 (4).

for the first time,

The use of the enzyme preparation of endo-1,4-beta-
glucanase and endo-1,4-beta-xylanase produced by Asper-
gillus niger (CBS 600.94) set out in the second row of
Annex II was provisionally authorised, for the first time,
for chickens for fattening, by Commission Regulation
(EC) No 654/2000.

and

The use of the enzyme preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma longibrachiatum (ATCC
by
endo-1,4-beta-xylanase
2106)
Trichoderma longibrachiatum (IMI SD 135) and polygalac-
turonase produced by Aspergillus aculeatus (CBS 589.94)
was provisionally authorised, for the first time, for pigs
for
fattening by Commission Regulation (EC) No
2690/1999 (5).

produced

The use of the enzyme preparation of endo-1,3(4)-beta-
glucanase and endo-1,4-beta-xylanase produced by Asper-
gillus niger (phoenicis) (NRRL 25541) and of alpha-amylase
produced by Aspergillus oryzae (ATCC 66222) was provi-
sionally authorised,
for piglets by
for the first
Commission Regulation (EC) No 1636/1999 (6).

time,

The use of the enzyme preparation of endo-1,4-beta-
xylanase, produced from Trichoderma
longibrachiatum
(CNCM MA 6–10W) was provisionally authorised, for
the first time, for chickens for fattening by Commission
Regulation (EC) No 1436/98 (7).

(1) OJ L 270, 14.12.1970, p. 1 Directive as last amended by Commission

Regulation (EC) No 1289/2004 (OJ L 243, 15.7.2004, p. 15).

(2) OJ L 280, 4.11.2000, p. 28.
(3) OJ L 105, 26.4.1994, p. 19.

(4) OJ L 79, 30.3.2000, p. 26.
(5) OJ L 326, 18.12.1999, p. 33.
(6) OJ L 194, 27.7.1999, p. 17.
(7) OJ L 191, 7.7.1998, p. 15.

L 269/4

EN

Official Journal of the European Union

17.8.2004

(15) New data were submitted in support of the application
those five
for authorisation without a time limit of
enzyme preparations. The assessment shows that
the
conditions laid down in Directive 70/524/EEC for such
authorisation are satisfied.

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

(17)

The assessment of those seven 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).

(18)

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 groups ‘Micro-organisms’ and
‘Enzymes’, as set out in Annexes I and II are authorised for use
without a time limit as additives in animal nutrition under the
conditions laid down in those Annexes.

Article 2

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, 16 August 2004.

For the Commission

David BYRNE
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).

17.8.2004

EN

Official Journal of the European Union

L 269/5

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EN

Official Journal of the European Union

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17.8.2004

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