Commission Regulation (EC) No 2785/98 of 22 December 1998 concerning the modification of the period of authorisations of additives referred to in Article 9e(3) of Council Directive 70/524/EEC
Date: 1998-12-22
Institutions: European Commission
Subjects: animal nutrition, antibiotic, food additive, food chemistry, foodstuffs legislation, veterinary drug

23. 12. 98

EN

Official Journal of the European Communities

L 347/21

COMMISSION REGULATION (EC) No 2785/98

of 22 December 1998

concerning the modification of the period of authorisations of additives referred
to in Article 9e(3) of Council Directive 70/524/EEC

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 98/19/EC (2),
and in particular Articles 9j and 3 thereof,

Whereas Directive 70/524/EEC provides that new addi-
tives or uses of additives may be authorised,
taking
account of advances in scientific and technical know-
ledge;

the level permitted in feedingstuffs,

Whereas a provisional authorisation of new additives or
uses of additives may be given for a period of five years, if,
at
it does not
adversely affect human or animal health or the environ-
ment, nor harm the consumer by altering the characteris-
tics of livestock product, if its presence in feedingstuffs
can be controlled, and it is reasonable to assume, in view
of the available results, that it has a favourable effect on
the characteristics of those feedingstuffs or on livestock
production when incorporated in such feedingstuffs;

Whereas research into various additives referred to in
Article 9e(3) of Directive 70/524/EEC which can be
level until 30
authorised provisionally at national
November 1998 has not yet been completed; whereas,
therefore, the period of authorisation of these substances
should be extended taking into account that the period of

provisional authorisation of these additives can not exceed
five years;

Whereas the Commission has consulted the Scientific
Committee for animal nutrition concerning the author-
isation of the micro-organisms included in the Annex to
the present Regulation; whereas this Committee delivered
an opinion in particular with regard to the safety of these
additives;

Whereas the measures provided for in this Regulation are
the Standing
in accordance with the opinion of
Committee on Feedingstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

Additives referred to in the Annex to this Regulation may
be authorised in accordance with Directive 70/524/EEC
under the conditions laid down in this Annex.

Article 2

This Regulation shall enter into force on the third day
following its publication in the Official Journal of the
European Communities.

It shall apply with effect from 1 December 1998.

This Regulation shall be binding in its entirety and directly applicable in all Member
States.

Done at Brussels, 22 December 1998.

For the Commission

Franz FISCHLER

Member of the Commission

(1) OJ L 270, 14. 12. 1970, p. 1.
(2) OJ L 96, 28. 3. 1998, p. 39.

ANNEX

Binders, anti-caking agents and coagulants

Registration
number

Additive

Chemical formula, description

Species or category
of animal

Maximum
age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Duration of
authorisation

2

Natrolite-phonolite

Natural mixture of aluminium sili-
cates, alkalines and alkaline-earth
and aluminium hydrosilicates, na-
trolite (43 to 46,5 %) and feldspar

All animal species
and categories

—

—

25 000

All feedingstuffs

21.4.1999 (1)

Registration
number

Additive

Chemical formula, description

Species or category
of animal

Maximum
age

CFU/kg of complete
feedingstuffs

Minimum

Maximum

Other provisions

Micro-organisms

1

2

3

Bacillus cereus var. toy-
oi
(CNCM I-1012/
NCIB 40112)

Preparations of Bacillus cereus var.
toyoi containing a minimum 1010
CFU/g additive

licheniformis

Bacillus
(DSM 5749)/Bacillus
subtilis (DSM 5750)
(in a 1/1 ratio)

Mixture of Bacillus licheniformis
and Bacillus subtilis containing a
minimum 3,2 (cid:253) 109 CFU/g addi-
tive (1,6 (cid:253) 109 CFU/g of each bac-
teria)

Saccharomyces
siae (NCYC Sc 47)

cerevi-

Preparation of Saccharomyces cere-
visiae
a minimum
5 (cid:253) 109 CFU/g additive

containing

Pigs

Sows

Piglets

Piglets

2 months

109

4 months

0,5 (cid:253) 109

6 months

0,2 (cid:253) 109

109

109

109

—

0,5 (cid:253) 109

2 (cid:253) 109

4 months

1,28 (cid:253) 109

3,2 (cid:253) 109

Cattle for fattening

—

4 (cid:253) 109

8 (cid:253) 109

Duration of
authorisation

21.4.1999 (1)

21.4.1999 (1)

21.4.1999 (1)

21.4.1999 (1)

17.7.1999 (2)

20.2.2001 (3)

—

—

—

—

—

Indicate in the instructions
for use:
‘The quantity of
Saccharomyces cerevisiae in
the daily ration must not
exceed 2,5 (cid:253) 1010 CFU for
100
bodyweight;
0,5 (cid:253) 1010 CFU for each
additional 100 kg of body-
weight'

kg

of

L
3
4
7
/
2
2

E
N

O

f
f
i
c
i
a
l

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o
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n
a
l

o
f

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C
o
m
m
u
n
i
t
i
e
s

2
3

.

1
2

.

9
8

Registration
number

Additive

Chemical formula, description

Species or category
of animal

Maximum
age

CFU/kg of complete
feedingstuffs

Minimum

Maximum

Other provisions

4

Bacillus cereus (ATCC Preparation of Bacillus
14893/CIP 5832)

cereus
containing a minimum 1010 CFU/g
additive

Rabbits for fattening

Breeding rabbits

—

—

0,5 (cid:253) 109

2 (cid:253) 109

0,5 (cid:253) 109

2 (cid:253) 109

—

—

(1) First authorisation 22 April 1994, Commission Directive 94/17/EC (OJ L 105, 26. 4. 1994, p. 19).
(2) First authorisation 18 July 1994, Commission Directive 94/41/EC (OJ L 209, 12. 8. 1994, p. 18).
(3) First authorisation 21 February 1996, Commission Directive 96/7/EC (OJ L 51, 1. 3. 1996, p. 45).

1. Radioactive caesium binders (137Cs and 134Cs):

Radionuclide binders

Registration
number

Additive

Chemical formula, description

Species or category
of animal

Maximum
age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

1.1

Ferric (III) ammonium
hexacyanoferrat e (II)

Fe(III)[(Fe(II)(CN)
NH
6
4

)]

Ruminants (domestic
and wild)

—

50

500

Calves prior
start of rumination

to the

—

50

500

Lambs prior
start of rumination

to the

—

50

500

Indicate in the instructions
‘The quantity of
for use:
Ferric
ammonium
(III)
hexacyanoferrate (II) in the
be
ration must
daily
between 10 and 150 mg for
10 kg of body weight'

Indicate in the instructions
‘The quantity of
for use:
Ferric
ammonium
(III)
hexacyanoferrate (II) in the
daily
be
ration must
between 10 and 150 mg for
10 kg of body weight'

Indicate in the instructions
‘The quantity of
for use:
ammonium
(III)
Ferric
hexacyanoferrate (II) in the
daily
be
ration must
between 10 and 150 mg for
10 kg of body weight'

Duration of
authorisation

20.2.2001 (3)

20.2.2001 (3)

Duration of
authorisation

13.10.2001 (1)

13.10.2001 (1)

13.10.2001 (1)

2
3

.

1
2

.

9
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
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e
E
u
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p
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a
n
C
o
m
m
u
n
i
t
i
e
s

L
3
4
7
/
2
3

Registration
number

Additive

Chemical formula, description

Species or category
of animal

Maximum
age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Kids prior to the start
of rumination

—

50

500

(domestic

and

—

50

500

Pigs
wild)

Indicate in the instructions
‘The quantity of
for use:
Ferric
ammonium
(III)
hexacyanoferrate (II) in the
daily
be
ration must
between 10 and 150 mg for
10 kg of body weight'

Indicate in the instructions
‘The quantity of
for use:
Ferric
ammonium
(III)
hexacyanoferrate (II) in the
daily
be
ration must
between 10 and 150 mg for
10 kg of body weight'

(1) First authorisation 14 October 1996, Commission Directive 96/66/EC (OJ L 272, 25. 10. 1996, p. 32).

Duration of
authorisation

13.10.2001 (1)

13.10.2001 (1)

L
3
4
7
/
2
4

E
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E
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a
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C
o
m
m
u
n
i
t
i
e
s

2
3

.

1
2

.

9
8