Council Regulation (EC) No 355/2003 of 20 February 2003 on the authorisation of the additive avilamycin in feedingstuffs (Text with EEA relevance)
Date: 2003-02-20
Institutions: Council of the European Union
Subjects: animal nutrition, antibiotic, food additive, foodstuffs legislation

28.2.2003

EN

Official Journal of the European Union

L 53/1

I

(Acts whose publication is obligatory)

COUNCIL REGULATION (EC) No 355/2003

of 20 February 2003

on the authorisation of the additive avilamycin in feedingstuffs

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

(5)

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), and in
particular Article 9 thereof,

Whereas:

The Commission has submitted a proposal for a Regula-
tion of the European Parliament and of the Council on
additives for use in animal nutrition which provides for
the phasing out of the use of antibiotics for growth
promotion. The European Parliament during its first
reading of the proposal supported a phasing out. The
Council reached in December 2002 a political agreement
in view of the adoption of a common position providing
for the discontinuation of
the use of antibiotics as
growth promoters by 1 January 2006. The duration of
the authorisation provided for in this Regulation is
therefore likely to be substantially reduced as an effect of
the adoption of the new Regulation governing the use of
additives in animal nutrition.

(1)

(2)

(3)

(4)

Article 2(aaa) of Directive 70/524/EEC requires authori-
sations for antibiotics to be linked to the person respon-
sible for putting them into circulation.

(6)

In the absence of a favourable opinion of the Standing
Committee on the Food Chain and Animal Health, the
Commission has been unable to adopt the provisions it
envisaged under the procedure laid down in Article 23
of the said Directive,

Article 9 of the said Directive provides that a substance
linked to the person responsible for putting it into circu-
lation may be authorised for a period of 10 years if all
conditions laid down in Article 3a of the said Directive
are met.

The assessment of the dossier submitted in respect of the
antibiotic preparation described in the Annex to this
Regulation, shows that
the conditions referred to in
Article 3a of the said Directive are satisfied, and the
product may therefore be entered in Chapter I of the list
of the authorised additives in feedingstuffs pursuant to
Article 9t(b) of the said Directive. This list provides for
additives authorised for a period of 10 years.

The Communication of the Commission of July 2001 on
a Community strategy against antimicrobial resistance
sets out the elements for an effective policy against anti-
microbial resistance. One of these elements is the ban of
the use of antibiotics in feedingstuffs as growth promo-
ters from 1 January 2006.

HAS ADOPTED THIS REGULATION:

Article 1

The additive avilamycin belonging to the group ‘Antibiotics’
listed in the Annex shall be authorised for use as an additive in
animal nutrition under the conditions laid down in the Annex.

Article 2

(1) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Council

Regulation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).

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

L 53/2

EN

Official Journal of the European Union

28.2.2003

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

Done at Brussels, 20 February 2003.

For the Council

The President

G. DRYS

Registration
number
of additive

Name and registration No of
person responsible for putting
additive into circulation

Additive
(trade name)

Composition, chemical formula, description

Species or
category of
animal

Maximum
age

Minimum
content

Maximum
content

mg/kg of complete
feedingstuffs

Other provisions

End of
authorisation
period

ANNEX

Turkeys

—

5

10

—

20.1.2013

Antibiotics

E 717

Eli Lilly and Company Ltd

Avilamycin:
200 g/kg (Maxus G200,
Maxus 200)

Avilamycin:
100 g/kg (Maxus G100,
Maxus 100)

Additive composition:
Avilamycin: 200 g activity/kg
Soyabean oil or mineral oil: 5 to 30 g/kg
Soyabean hulls qs 1 kg
Avilamycin: 100 g activity/kg
Soyabean oil or mineral oil: 5 to 30 g/kg
Soyabean hulls qs 1 kg

Active substance:
C57-62H82-90Cl1-2O31-32,
CAS No of avilamycin A: 69787-79-7
CAS No of avilamycin B: 73240-30-9
Mixture of oligosaccharides of the orthoso-
mycin group produced by Streptomyces viri-
dochromogenes,(NRRL 2860) in granular
form.

Factor composition:
Avilamycin A: ≥ 60 %
Avilamycin B: ≤ 18 %
Avilamycin A + B: ≥ 70 %
Other single avilamycins ≤ 6 %

.

.

2
8
2
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

5
3
/
3