Commission Regulation (EC) No 2786/98 of 22 December 1998 concerning the modification of the period of authorisations of additives referred to in Article 9i(1) 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 347/25

COMMISSION REGULATION (EC) No 2786/98

of 22 December 1998

concerning the modification of the period of authorisations of additives referred
to in Article 9i(1) 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 Regulation (EC) No
2785/98 (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 9i(1) of Directive 70/524/EEC and transferred to
Chapter III of Annex B to this Directive which can
accordingly be authorised provisionally at national level
until 30 November 1998 has not yet been completed;

whereas, therefore, the period of authorisation of these
substances should be extended for a determined period;

Whereas the Commission has consulted the Scientific
Committee for animal nutrition concerning the author-
isation of the antibiotics and the coccidiostats included in
this
the Annex to the present Regulation; whereas
Committee delivered an opinion with regard to the effi-
cacy, the safety and the controllability of these substances;

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

Chapter III of Annex B to Directive 70/524/EEC is
amended in accordance with the Annex to this Regula-
tion.

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) See page 21 of this Official Journal.

Chapter III of Annex B to Directive 70/524/EEC is amended as follows:

Additives linked to a person responsible for marketing, inserted in Annex II before 1 April 1998

ANNEX

A. Antibiotics

Registra-
tion
number

Name and
registration
number of
person
responsible for
marketing (1)

Additive

Chemical formula,
description

Species or
category of animal

Maximum
age

‘31

33

Bacitracin zinc

Avilamycin

Chickens
tening

Pigs

Turkeys

for

fat-

—

6 months

—

16

66

103

O

H

N

SZn

C
17
(polypeptide containing 12
to 20 % zinc)

O

31.32

82.90

57.62

H

Cl

C
1.2
(mixture of oligosacchar-
the orthosomycin
ides of
group produced by Strepto-
myces
viridochromogenes,
NRRL 2860)

Factor composition:

— Avilamycin A: not less

than 60 %
— Avilamycin

B:
more than 18 %

not

— Avilamycins A+B: not

less than 70 %

— Other

single avilamy-
than

cins: not more
6 %

Minimum
content

Maximum
content

mg/kg complete
feedingstuff

5

5

5

50

50

10

Other provisions

Duration of
authorisation

—

—

—

17. 7. 1999 (2)

17. 7. 1999 (2)

30. 9. 1999 (3)'

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C
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i
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s

2
3

.

1
2

.

9
8

B. Cooccidiostats and other medicinal substances

Name and
registration
number of
person
responsible for
marketing (1)

Registra-
tion
number

‘26

Additive

Chemical formula,
description

Species or
category of animal

Maximum
age

Minimum
content

Maximum
content

mg/kg complete
feedingstuff

Other provisions

Duration of
authorisation

Salinomycin
dium

so-

11

69

42

O

H

Na

C
(sodium salt of a polyether
monocarboxylic acid pro-
Streptomyces
duced
albus)

by

Rabbits
tening

for

fat-

—

20

25

Use prohibited at least five
days before slaughter.

30. 9. 1999 (4)

Elaiophylin content:
less
than 42 mg per kg of sali-
nomycin sodium

17-epi-20-desoxysalino-
mycin content:
than
40 g per kg of salinomycin
sodium

less

Chickens reared for
laying

12 weeks

30

50

Indicate in the instruc-
tions for use:

— “Dangerous

for equi-

nes”

— “This feedingstuff con-
an ionophore;
tains
simultaneous use with
certain medicinal sub-
stances (e.g.
tiamulin)
can be contra indic-
ated”

Indicate in the instruc-
tions for use:

— “Dangerous

for equi-

nes”

— “This feedingstuff con-
tains
an ionophore;
simultaneous use with
certain medicinal sub-
tiamulin)
stances (e.g.
can be contra indic-
ated”

30. 9. 1999 (5)

2
3

.

1
2

.

9
8

E
N

O

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2
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Registra-
tion
number

Name and
registration
number of
person
responsible for
marketing (1)

27

28

C. Growth promoters

Name and
registration
number of
person
responsible for
marketing (1)

Registra-
tion
number

‘—

Additive

Chemical formula,
description

Species or
category of animal

Maximum
age

Diclazuril

(5)-4-chlorphenyl(2,6-diclo-
ro-4-(2,3,4,5-tetrahydro-3,5-
dioxo-1,2,4-triazin-2yl-phe-
nyl)acetonitrile

Maduramycin am-
monium

17

83

47

O

H

N

C
(ammonium salt of a poly-
ether monocarboxylic acid
produced
by Actinoma-
dura yumaensis)

Turkeys

12 weeks

Chickens reared for
laying

16 weeks

Turkeys

16 weeks

Minimum
content

Maximum
content

mg/kg complete
feedingstuff

1

1

5

1

1

5

Other provisions

Duration of
authorisation

Use prohibited at least five
days before slaughter.

30. 9. 1999 (4)

—

30. 9. 1999 (3)

30. 9. 1999 (5)'

Use prohibited at least five
days before slaughter.

Indicate in the instruc-
tions for use:

— “Dangerous

for equi-

nes”

— “This feedingstuff con-
tains
an ionophore;
simultaneous use with
certain medicinal sub-
stances (e.g.
tiamulin)
can be contra indic-
ated”

Additive

Chemical formula,
description

Species or
category of animal

Maximum
age

Minimum
content

Maximum
content

mg/kg complete
feedingstuff

Other provisions

Duration of
authorisation

—

—

—

—

—

—

—

—'

(1) Authorisation linked to the person responsible with effect from 1 October 1999.
(2) First authorisation 18 July 1994, Commission Directive 94/41/EC (OJ L 209, 12. 8. 1994, p. 18).
(3) First authorisation 15 December 1997, Commission Directive 97/72/EC (OJ L 351, 23. 12. 1997, p. 55).
(4) First authorisation 21 February 1996, Commission Directive 96/7/EC (OJ L 51, 1. 3. 1996, p. 45).
(5) First authorisation 14 October 1996, Commission Directive 96/66/EC (OJ L 272, 25. 10. 1996, p. 32).

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1
2

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9
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