Commission Regulation (EC) No 1288/2004 of 14 July 2004 concerning the permanent authorisation of certain additives and the provisional authorisation of a new use of an additive already authorised in feedingstuffs(Text with EEA relevance)
Date: 2004-07-14
Institutions: European Commission
Subjects: animal nutrition, food colouring, foodstuffs legislation, market approval, microorganism

L 243/10

EN

Official Journal of the European Union

15.7.2004

COMMISSION REGULATION (EC) No 1288/2004

of 14 July 2004

concerning the permanent authorisation of certain additives 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,

(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), as
last amended by Regulation (EC) No 1756/2002 (2) and in
particular Article 3, and Articles 9d(1) and 9e(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

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 astaxanthin-rich Phaffia rhodozyma (ATCC
74219) as a colourant for salmon and trout has been
provisionally authorised by Commission Regulation (EC)
No 2316/98 (3).

New data were submitted in support of an application
for an authorisation without a time limit
that
for
colourant. The assessment shows that
the conditions
laid down in Directive 70/524/EEC for such an author-
isation have been satisfied.

The Scientific Panel on Additives and Products or
Substances Used in Animal Feed of the European Food
Safety Authority (EFSA) delivered a favourable opinion
on 22 January 2003 on the efficacy of that additive
when used in the animal category salmon and trout. In
a second opinion adopted on 1 April 2004, the EFSA
concluded that the yeast in that product is not a living
organism and it is not expected to have any consequence
on the environment, under the conditions of use set out
in Annex I to this Regulation.

(5)

The use of the micro-organism preparation of Sacchar-
omyces cerevisiae (NCYC Sc 47) has been provisionally
authorised, for the first time, for sows by Commission
Regulation (EC) No 1436/98 (4).

cerevisiae

The use of the micro-organism preparation of Sacchar-
omyces
(CBS 493.94) has been provisionally
authorised, for the first time, for calves by Commission
Regulation (EC) No 1436/98 and for cattle for fattening
by Commission Regulation (EC) No 866/1999 (5).

The use of the micro-organism preparation of Entero-
coccus
faecium (NCIMB 10415) has been provisionally
authorised, for the first time, for calves by Commission
Regulation (EC) No 866/1999.

The use of the micro-organism preparation of Entero-
coccus faecium (DSM 7134) and Lactobacillus rhamnosus
(DSM 7133) has been provisionally authorised, for the
first time, for calves by Commission Regulation (EC) No
2690/1999 (6).

New data were submitted in support of applications for
authorisation without a time limit
those micro-
organisms. The assessment of those applications shows
that the conditions laid down in Directive 70/524/EEC
for such authorisations have been satisfied.

for

(7)

(8)

(9)

(10) Accordingly, the use of those additives without a time

limit should be authorised.

(11)

(12)

In addition, Directive 70/524/EEC provides
the
authorisation on a provisional basis of a new use of an
additive already authorised to be granted for a period not
exceeding four years, subject to certain conditions.

for

The use of the micro-organism preparation of Entero-
faecium (DSM 10663/NCIMB 10415) has been
coccus
provisionally authorised,
for piglets
by Commission Regulation (EC) No 1411/1999 (7), for
calves and chickens for fattening by Commission Regu-
lation (EC) No 1636/1999 (8) and for
for
fattening
(EC) No
Regulation
by
1801/2003 (9).

for the first time,

Commission

turkeys

(13) New data were submitted in support of an application to
extend the authorisation of the use of that additive to
dogs. The assessment shows that
the conditions laid
down in Directive 70/524/EEC for such an authorisation
have been satisfied.

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 265, 3.10.2002, p. 1.
(3) OJ L 289, 28.10.1998, p. 4.
(4) OJ L 191, 7.7.1998, p. 15.

(5) OJ L 108, 27.4.1999, p. 21.
(6) OJ L 326, 18.12.1999, p. 33.
(7) OJ L 164, 30.6.1999, p. 56.
(8) OJ L 194, 27.7.1999, p. 17.
(9) OJ L 264, 15.10.2003, p. 16.

15.7.2004

EN

Official Journal of the European Union

L 243/11

(14)

The EFSA delivered a favourable opinion on 15 April
2004 on the safety of that additive when used in the
animal category dogs, under the conditions of use set out
in Annex II to this Regulation.

(15) Accordingly,

the use of

faecium, as
specified in Annex II, should be authorised for a period
not exceeding four years.

the Enterococcus

(16)

(17)

The assessment of the applications shows that certain
procedures should be required to protect workers from
exposure to the additives set out in Annexes I and II to
this Regulation. 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
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 ‘Colourants, including
pigments’ and ‘Micro-organisms’, 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 preparation belonging to the group ‘micro-organisms’, as
set out in Annex II, is provisionally authorised for use as an
additive in animal nutrition under the conditions laid down in
that Annex.

Article 3

This Regulation shall enter into force on the third day following
the European
that of
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, 14 July 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).

L 243/12

EN

Official Journal of the European Union

15.7.2004

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EN

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EN

Official Journal of the European Union

15.7.2004

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