Commission Regulation (EC) No 1847/2003 of 20 October 2003 concerning the provisional authorisation of a new use of an additive and the permanent authorisation of an additive already authorised in feedingstuffs (Text with EEA relevance)
Date: 2003-10-20
Institutions: European Commission
Subjects: animal nutrition, enzyme, food additive, market approval, marketing standard, microorganism

21.10.2003

EN

Official Journal of the European Union

L 269/3

COMMISSION REGULATION (EC) No 1847/2003

of 20 October 2003

concerning the provisional authorisation of a new use of an additive and the permanent authorisa-
tion of an additive already authorised 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 Directive 2003/7/EC (2), and in parti-
cular Article 3, Article 9d(1) and Article 9e(1) thereof,

Whereas:

Directive 70/524/EEC provides that a new use of an
additive
a Community
authorisation.

already authorised requires

In the case of additives referred to in Part II of Annex C
to Directive 70/524/EEC, which include enzymes, provi-
sional authorisation of a new use of an additive in
feedingstuffs may be given if the conditions laid down in
that Directive are satisfied and if
is reasonable 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 provisional author-
isation may be given for a period not exceeding four
years.

it

The enzyme referred to in Annex I to this Regulation
(the enzyme) was provisionally authorised for chickens
for fattening for the first time by Commission Regula-
tion (EC) No 1436/98 (3), following a favourable opinion
for Animal Nutrition
of
(SCAN),
in particular with regard to the safety of the
product. The provisional authorisation of that additive
was extended until 30 June 2004 by Commission Regu-
lation (EC) No 2200/2001 (4).

the Scientific Committee

(1)

(2)

(3)

(4)

(5)

New data were submitted by the producing company in
support of the application to extend the authorisation of
the use of the enzyme to turkeys for fattening.

(13)

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

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 22, 25.1.2003, p. 28.
(3) OJ L 191, 7.7.1998, p. 15.
(4) OJ L 299, 15.11.2001, p. 1.

(6)

(7)

(8)

(9)

(10)

On 27 March 2003, the SCAN delivered a favourable
opinion on the safety of the enzyme for turkeys for
fattening under the conditions laid down in this Regula-
tion.

Directive 70/524/EEC provides that additives referred to
in Part II of Annex C to that Directive may be authorised
without a time limit if
the conditions laid down in
Article 3(a) are satisfied.

The micro-organism referred to in Annex II to this Regu-
lation (the micro-organism) was provisionally authorised
for the first time by Commission Regulation (EC) No
1436/98, following a favourable opinion of the SCAN,
in particular with regard to the safety of the product.
The provisional authorisation of the micro-organism was
extended until 30 June 2004 by Regulation (EC) No
2200/2001.

New data were submitted by the producing company in
support of the application for authorisation without a
time limit of the micro-organism.

The assessment of
the application for authorisation
submitted in respect of the micro-organism, shows that
all the conditions required for an authorisation without
a time limit as provided for in Directive 70/524/EEC are
satisfied.

(11) On 2 December 2002, the SCAN delivered a favourable
opinion on the efficacy of the micro-organism under
certain conditions laid down in this Regulation.

(12) Accordingly, it is appropriate that the use of the enzyme
for turkeys for fattening should be authorised for a
period of four years, and the use of the micro-organism
for piglets up to 35 kg should be authorised without a
time limit.

The assessments of
the two applications shows that
certain procedures are required to protect workers from
exposure to the enzyme and the micro-organism.
However, such protection is assured by the application
of Council Directive 89/391/EEC of 12 June 1989 on
the introduction of measures to encourage improve-
ments in the safety and health of workers at work (5).

(14)

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

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

L 269/4

EN

Official Journal of the European Union

21.10.2003

HAS ADOPTED THIS REGULATION:

Article 2

Article 1

The additive belonging to the group ‘micro-organisms’ referred
to in Annex II is authorised for use as additive in feedingstuffs
under the conditions laid down in that Annex.

Article 3

The additive belonging to the group ‘enzymes’ referred to in
Annex I is authorised for use as an additive in feedingstuffs
under the conditions laid down in that 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, 20 October 2003.

For the Commission

David BYRNE

Member of the Commission

No (or
EC No)

‘Enzymes

14

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 I

Endo-1,4-beta-
xylanase
EC 3.2.1.8.

Preparation of endo-1,4-beta-xyla-
nase produced by Aspergillus niger
(CBS 520.94) having a minimum
activity of:

Solid form: 600 U/g (1)

Liquid form: 300 U/ml

Turkeys for fattening

—

300 U

—

24.10.2007

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

the
indicate
storage

2. Recommended dose per kg of

complete feedingstuff:

300 — 1 200 U

3. For use in compound feed rich in
non-starch polysaccharides, (mainly
arabinoxylans) e.g. containing more
than 40 % wheat.

(1) One U is the amount of enzyme which liberates 1 micromole of xylose from birchwood xylan per minute at pH 5,3 and 50 °C.’

ANNEX II

No (or
EC No)

Additive

Chemical formula, description

Species or cate-
gory of animal

Maximum age

Minimum content Maximum content

CFU/kg of complete feedingstuff

Other provisions

End of period of authorisation

‘Micro-organisms

E 1703

Saccharomyces
cerevisiae
CNCM I-1079

of

Preparation
Saccharo-
myces cerevisiae containing a
minimum of:

2 × 1010 CFU/g additive

Piglets

—

2 × 109

6 × 109

For piglets until approximately 35 kg.

Without a time limit’

In the direction for use of the additive and
premixture, indicate the storage tempera-
ture, storage life, and stability to pelleting.

.

2
1
1
0
2
0
0
3

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

L

2
6
9
/
5