Commission Regulation (EC) No 1443/2006 of 29 September 2006 concerning the permanent authorisations of certain additives in feedingstuffs and an authorisation for 10 years for a coccidiostat   (Text with EEA relevance)
Date: 2006-09-29
Institutions: European Commission
Subjects: animal feedingstuffs, enzyme, fattening, food additive, market approval, veterinary drug

L 271/12

EN

Official Journal of the European Union

30.9.2006

COMMISSION REGULATION (EC) No 1443/2006

of 29 September 2006

concerning the permanent authorisations of certain additives in feedingstuffs and an authorisation
for 10 years for a coccidiostat

(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, 9 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:

(1)

(2)

(3)

(4)

(5)

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

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.

Data were submitted in support of an application for
authorisation without a time limit of
the enzyme
preparation of 3-phytase produced by Hansenula poly-
morpha (DSM 15087) for chickens for fattening, turkeys

(6)

(7)

(8)

(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).

for fattening, laying hens, piglets, pigs for fattening and
sows. On 7 March 2006 the European Food Safety
Authority (the Authority) delivered its opinion on the
it does
use of
this preparation which concludes that
not present a risk for
the
the user,
environment. The
animal
assessment shows that
the conditions laid down in
Article 3a of Directive 70/524/EEC for such authorisation
are satisfied. Accordingly,
that enzyme
preparation, as specified in Annex I to this Regulation,
should be authorised without a time limit.

the consumer,
the

category targeted or

the use of

by

Regulation

Commission

The use of the enzyme preparation of endo-1,4-beta-
xylanase produced by Trichoderma longibrachiatum (ATCC
2105) was provisionally authorised for the first time for
piglets
No
1411/1999 (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
laid down in Article 3a of Directive
conditions
authorisation
70/524/EEC for
satisfied.
that enzyme preparation, as
Accordingly,
should be
specified in Annex I
authorised without a time limit.

such
the use of

to this Regulation,

(EC)

are

The use of the coccidiostat preparation of semduramicin
sodium (AVIAX 5 %) was provisionally authorised for the
first
time for chickens for fattening, by Commission
Regulation (EC) No 1041/2002 (4). New data were
submitted in support of an application for authorisation
for 10 years of that coccidiostat. The assessment shows
that the conditions laid down in Article 3a of Directive
70/524/EEC for
satisfied.
Accordingly, the use of that substance, as specified in
the Annex II, should be authorised for 10 years.

authorisation

such

are

for

fattening,

for chickens

Data were submitted in support of an application for
authorisation without a time limit of 25-hydroxychole-
calciferol, belonging to the group ‘Vitamins, provitamins
and chemically well-defined substances having similar
effect’
laying hens and
turkeys. On 26 May 2005 the Authority has delivered
an opinion on the use of
this preparation which
the
concludes
consumer, the user, the animal category targeted or the
environment. The assessment shows that the conditions
laid down in Article 3a of Directive 70/524/EEC for such
authorisation are satisfied. Accordingly, the use of that
vitamin preparation, as specified in Annex III, should be
authorised without time limit.

it does not present a risk for

that

(2) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

(3) OJ L 164, 30.6.1999, p. 56.
(4) OJ L 157, 15.6.2002, p. 41.

30.9.2006

EN

Official Journal of the European Union

L 271/13

(9)

(10)

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 (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

Article 2

The preparation belonging to the group ‘Coccidiostat and other
medicinal substances’, as specified in Annex II, is authorised for
10 years as additive in animal nutrition under the conditions
laid down in that Annex.

Article 3

The preparation belonging to the group ‘Vitamins, provitamins
and chemically well-defined substances having similar effect’, as
specified in Annex III,
is authorised without a time limit as
additive in animal nutrition under the conditions laid down
in that Annex.

The preparations belonging to the group ‘Enzymes’, as specified
in Annex I, are authorised without a time limit as additives in
animal nutrition under the conditions laid down in that Annex.

Article 4

This Regulation shall enter into force on the 20th 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, 29 September 2006.

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

L 271/14

EN

Official Journal of the European Union

30.9.2006

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