Commission Regulation (EC) No 277/2004 of 17 February 2004 concerning the authorisation without a time limit of an additive in feedingstuffs (Text with EEA relevance)
Date: 2004-02-17
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, poultry

L 47/20

EN

Official Journal of the European Union

18.2.2004

COMMISSION REGULATION (EC) No 277/2004

of 17 February 2004

concerning the authorisation without a time limit of an additive in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), as last
amended by Commission Regulation (EC) No 1756/2002 (2),
and in particular Article 3 and Article 9d(1) thereof,

(7)

(8)

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Directive 70/524/EEC provides that no additive may be
put into circulation unless a Community authorisation
has been granted.

Article 3a of Directive 70/524 lays down the require-
ments for Community authorisation of an additive in
feedingstuffs.

The use of the enzyme 3-phytase produced by Aspergillus
niger (CBS 114.94) is already authorised without a time
limit for the animal categories piglets, pigs for fattening,
sows, chickens for fattening and laying hens by Commis-
sion Regulation (EC) No 1353/2000 (3).

This additive was provisionally authorised for turkeys for
fattening by Commission Regulation (EC) No 2316/
98 (4).

New data were submitted by the producing company in
support of an application for authorisation without a
time limit of this additive for turkeys for fattening in
June 2003.

the use of

The assessment of this application for authorisation in
this additive for turkeys for
respect of
the conditions provided for in
fattening shows that
time
Directive 70/524/EEC for authorisation without
limit are satisfied.

The use of this additive for turkeys should therefore be
authorised without a time limit.

The assessment of the application shows that certain
procedures should be required to protect workers from
exposure to the additive set out in the Annex. 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 (5), as amended
the European
by Regulation (EC) No 1882/2003 of
Parliament and of the Council (6).

(9)

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation belonging to the group ‘Enzymes’ as set out in
the Annex is authorised for use as additive in animal nutrition
under the conditions laid down in that Annex.

Article 2

This Regulation shall enter
into force on the third day
following that of 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, 17 February 2004.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 265, 3.10.2002, p. 1.
(3) OJ L 155, 28.6.2000, p. 15.
(4) OJ L 289, 28.10.1998, p. 4.

(5) OJ L 183, 29.6.1989, p. 1.
(6) OJ L 284, 31.10.2003, p. 1.

No
(or EC No)

‘Enzymes

E 1600

Additive

Chemical formula, description

Species or category of
animal

Maximum
age

Minimum
content

Maximum
content

Units of activity/kg of
complete feedingstuff

Other provisions

End of period of
authorisation

ANNEX

3-phytase

EC 3.1.3.8

[Natuphos FTU-8]

Preparation of 3-phytase produced
by Aspergillus niger (CBS 114.94)
having a minimum activity of:

Turkeys
fattening

Solid form: 5 000 FTU (1)/g

Liquid form: 5 000 FTU/ml

for

—

250 FTU

—

Without a time limit

1. In the directions for use of the additive
and premixture,
indicate the storage
temperature, storage life, and the stabi-
lity to pelleting.

2. Recommended

dose

per

kg

of

complete feedingstuff: 500 FTU.

3. For use in compound feed containing
more than 0,23 % phytin-bound phos-
phorus.

(1) 1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °C’

.

.

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