Proposal for a Council Regulation Concerning the authorisation of an additive in feedingstuffs
Date: 2003-01-29
Institutions: European Commission
Subjects: animal nutrition, antibiotic, food additive, poultry, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 29.1.2003
COM(2003) 39 final

Proposal for a

COUNCIL REGULATION

Concerning the authorisation of an additive in feedingstuffs

(presented by the Commission)

EXPLANATORY MEMORANDUM

The purpose of this Regulation is to extend the provisional authorisation for use of avilamycin
as a growth promoter in feed for turkeys. In application of Article 9 of Directive 70/524/EEC
this extension of this period is limited to a period 10 years.

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 Directive
70/524/EEC are satisfied, and the product may therefore be inscribed in Chapter I of the list
of the authorised additives in feedingstuffs in application of Article 9t (b).

Under the procedure laid down in Article 23 of Council Directive 70/524/EEC, concerning
additives in feedingstuffs, the Commission sought the opinion of the Standing Committee on
the Food Chain and Animal Health on a draft Commission Regulation, which authorises
avilamycin for a period of 10 years.

Owing to the fact that the Standing Committee on the Food Chain and Animal Health failed to
deliver an opinion on 20 December 2002, the Commission is required, under the above-
mentioned Article, to refer the proposed measures to the Council. The Council will have 3
months to decide. If the Council fails to reach a decision, the Commission will adopt the
measures, except where the Council has voted by a simple majority against such measures.

This proposal has no financial impact on the budget of the European Communities.

It is based on an exclusive Community competence.

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Proposal for a

COUNCIL REGULATION

Concerning the authorisation of an additive in feedingstuffs

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives
in feedingstuffs1, as last amended by Council Regulation N°1756/20022 and in particular
Article 9 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Article 2 (aaa) requires authorisations for antibiotics to be linked to the person
responsible for putting them into circulation.

Article 9 provides that a substance linked to a responsible for putting it into circulation
may be authorised for a period of ten years if all conditions laid down in Article 3a 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 are satisfied, and the product may therefore be inscribed in Chapter I of the
list of the authorised additives in feedingstuffs in application of Article 9t (b). This list
provides for additives authorised for a period of ten 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
antimicrobial resistance. One of these elements is the ban of the use of antibiotics in
feedingstuffs as growth promoters from 1 January 2006.

The Commission has submitted a proposal for a Regulation of the Parliament and of
the Council on additives for use in animal nutrition (COM (2002) 153-final) which
provides for the phasing out of the use of the last remaining antibiotics for growth
promotion from 1 January 2006. The duration of the authorisation provided for in the
present Regulation will therefore have to be kept under review to take account of steps
taken in that regard.

1

2

OJ L 270, 14.12.1970, p. 1.
OJ L 265, 3.10.2002, p. 1

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(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 Directive 70/524/EEC,

HAS ADOPTED THIS REGULATION:

Article 1

The additive belonging to the group “Antibiotics” listed in the Annex to the present
Regulation is authorised for use as additive in animal nutrition under the conditions laid down
in that Annex.

Article 2

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

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

Done at Brussels,

For the Council
The President
[…]

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Registration
number of additive

Antibiotics

E717

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

Lilly

Eli
Company Ltd.

and

ANNEX

Additive

Composition, chemical formula,
description

(trade name)

Species or
category
of animal

Maximum
age

Minimum
content

Maximum
content

Other
provisions

End of
authorisation
period

mg/kg of complete
feedingstuffs

5

x

10

x

-

x

20.01.2013

Additive composition:

Turkeys

-

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

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

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

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

Active substance:

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

Factor composition:
Avilamycin A: ‡ 60%.
Avilamycin B: £ 18%
Avilamycin A+B: ‡ 70%
Other single avilamycins £ 6%

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