Commission Regulation (EC) No 668/2003 of 11 April 2003 concerning the permanent authorisation of an additive in feedingstuffs (Text with EEA relevance)
Date: 2003-04-11
Institutions: European Commission
Subjects: animal nutrition, enzyme, food additive, foodstuffs legislation

L 96/14

EN

Official Journal of the European Union

12.4.2003

COMMISSION REGULATION (EC) No 668/2003

of 11 April 2003

concerning the permanent authorisation 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 Regulation (EC) No 1756/2002 (2), and in parti-
cular Articles 3 and 9d thereof,

Whereas:

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

Permanent authorisation of an already authorised addi-
tive for use in feedingstuffs may be given if the condi-
tions laid down in Article 3a of the Directive are satis-
fied.

The enzyme preparation set out in this Regulation was
provisionally authorised for the first time by Commis-
sion Regulation (EC) No 1436/98 (3) in accordance with
Council Directive 93/113/EC (4), further to a favourable
opinion of the Scientific Committee for Animal Nutri-
tion (SCAN), in particular with regard to the safety of
the product. The provisional authorisation of this addi-
tive was extended until 30 June 2004 (5) in accordance
with Directive 70/524/EEC.

New data were submitted by the producing company in
support of an application for authorisation without a
time limit of the enzyme preparation set out in this
Regulation.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

the SCAN,

the opinion of

Taking into account
the
assessment of the application for authorisation submitted
in respect of the enzyme preparation, shows that the
conditions provided for in Article 3a of Directive 70/
524/EEC are satisfied. That preparation should therefore
be authorised for an unlimited period of time.

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. However,
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 (6).

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 an additive in feedingstuffs
under the conditions laid down in the Annex.

Article 2

On 4 December 2002, the SCAN delivered a favourable
opinion on the efficacy of the enzyme preparation under
the conditions laid down in the Annex.

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, 11 April 2003.

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 191, 7.7.1998, p. 15.
(4) OJ L 334, 31.12.1993, p. 17.
(5) Last extension in Commission Regulation (EC) No 2200/2001 (OJ L

299, 15.11.2001, p. 1).

(6) OJ L 183, 29.6.1989, p. 1.

No (or
EC No)

Enzymes

1601

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

Endo-1,3(4)-beta-glucanase
EC 3.2.1.6
Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation
endo-1,3(4)-
of
beta-glucanase and endo-1,4-
beta-xylanase
by
Aspergillus niger) (NRRL 25541)
having a minimum activity of:

produced

Chickens
fattening

for

—

endo-1,3 (4)-beta-glucanase
1 100 U (1)/g

endo-1,4-beta-xylanase
1 600 U (2)/g

endo-1,3(4)-
beta-glucanase:
138 U

endo-1,4-beta-
xylanase:
200 U

—

1.

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

Without
limit

time

2. Recommended dose per kilogram of

complete feedingstuff:
endo-1,3(4)-beta-glucanase: 138 U
endo-1,4-beta-xylanase: 200 U.

3. For use in compound feed rich in non-
starch polysaccharides (mainly arabi-
noxylans
for
example mixed diet containing cereals
(e.g. barley, wheat, rye, triticale)

beta-glucans),

and

(1) 1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from oat beta-glucan per minute at pH 4,0 and 30 °C.
(2) 1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat xylan per minute at pH 4,0 and 30 °C.

.

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