Commission Regulation (EC) No 278/2004 of 17 February 2004 concerning the provisional authorisation of a new use of an additive already authorised in feedingstuffs (Text with EEA relevance)
Date: 2004-02-17
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, laying poultry

L 47/22

EN

Official Journal of the European Union

18.2.2004

COMMISSION REGULATION (EC) No 278/2004

of 17 February 2004

concerning the provisional authorisation of a new use of an additive already authorised in feeding-
stuffs

(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 Council Regulation (EC) No 1756/2002 (2), and in
particular Article 3 and Article 9(e)(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

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

In the case of additives referred to in Part II of Annex C
to Directive 70/524/EEC, which includes enzymes,
provisional authorisation of a new use of an additive
already authorised may be given if the conditions laid
down in that Directive are satisfied, and if it is reason-
able to assume,
in view of the available results, that
when used in animal nutrition it has one of the effects
referred to in Article 2(a) of that Directive. Such provi-
sional authorisation may be given for a period not
exceeding four years in the case of additives referred to
in Part II of Annex C to that Directive.

The use of the enzyme preparation of endo-1,4-beta-
xylanase produced by Trichoderma longibrachiatum (ATCC
2105) and subtilisin produced by Bacillus subtilis (ATCC
2107), as set out in the Annex, has been provisionally
authorised for chickens for fattening and for turkeys by
Commission Regulation (EC) No 1636/1999 (3), for the
first time.

New data were submitted by the producing company in
support of an application to extend the authorisation of
this additive to laying hens.

The assessment of
the application for authorisation
submitted in respect of the new use of this additive
shows that the conditions provided for in Directive 70/
524/EEC for provisional authorisation are satisfied.

(6)

(7)

(8)

The European Food Safety Authority (Scientific Panel on
Additives and Products or substances used in Animal
Feed) delivered a favourable opinion of this additive on
the safety for laying hens under the conditions of use set
out in the Annex to this Regulation.

The use of this additive for laying hens should therefore
be provisionally authorised for a period of four years.

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 (4), as amended
the European
by Regulation (EC) No 1882/2003 of
Parliament and of the Council (5).

(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 provisionally 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 Communities.

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 265, 3.10.2002, p. 1.
(3) OJ L 194, 27.7.1999, p. 17.

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

18.2.2004

EN

Official Journal of the European Union

L 47/23

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

Additive

Chemical formula, description

Species or category of
animal

Maximum
age

ANNEX

No
(or EC
No)

‘Enzymes

Laying hens

—

37

Endo-1,4-beta-xyla-
nase

EC 3.2.1.8

Subtilisin

EC 3.4.21.62

[Avizyme 1300]

Preparation of endo-1,4-beta-xyla-
nase produced by Trichoderma long-
ibrachiatum (ATCC 2105)
and
subtilisin produced by Bacillus
(ATCC 2107), with a
subtilis
minimum activity of:

— endo-1,4-beta-xylanase:

2 500 U (1)/g

— subtilisin: 800 U (2)/g

Minimum content

Maximum
content

Units of activity/kg of complete
feedingstuff

endo-1,4-beta-xyla-
nase: 1 875 U

subtilisin: 600 U

—

—

(1) 1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50 °C.
(2) 1 U is the amount of enzyme which liberates 1 microgram of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.’

Other provisions

End of period of
authorisation

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

18.2.2008

2. Recommended

dose
complete feedingstuff:
— endo-1,4-beta-xylanase: 1 875 U

per

kg

of

— subtilisin: 600 U.

3. For

use

feed
containing more than 65 % wheat.

in compound

e.g.

L

4
7
/
2
4

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