Commission Regulation (EC) No 1455/2004 of 16 August 2004 concerning the authorisation for 10 years of the additive «Avatec 15 %» in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance)
Date: 2004-08-16
Institutions: European Commission
Subjects: animal nutrition, food additive, food safety, market approval, poultry, veterinary drug, veterinary inspection

L 269/14

EN

Official Journal of the European Union

17.8.2004

COMMISSION REGULATION (EC) No 1455/2004

of 16 August 2004
concerning the authorisation for 10 years of the additive ‘Avatec 15 %’ in feedingstuffs, belonging to
the group of coccidiostats and other medicinal substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), and
in particular Article 9g(5)(b) thereof,

Whereas:

In accordance with Directive 70/524/EEC, coccidiostats
included in Annex I to that Directive before 1 January
1988 were provisionally authorised as from 1 April
1998 and transferred to Chapter I of Annex B with a
view to their re-evaluation as additives linked to a person
for putting them into circulation. The
responsible
is an additive
lasalocid sodium product, Avatec 15 %,
belonging
and other
medicinal substances’ listed in Chapter I of Annex B to
Directive 70/524/EEC.

group ‘Coccidiostats

to the

The Scientific Panel on Additives and Products or
Substances used in Animal
Feed attached to the
European Food Safety Authority has delivered a
favourable opinion with regard to the safety and to the
efficacy of Avatec 15 % for chickens for fattening and
chickens reared for laying.

The re-evaluation of Avatec 15 % carried out by the
Commission showed that
the relevant conditions laid
down in Directive 70/524/EEC are satisfied. Avatec
15 % should therefore be authorised for 10 years as an
additive linked to the person responsible for putting it
into circulation and included in Chapter I of the list
referred to Article 9t(b) of that Directive.

As the authorisation for the additive is now linked to a
person responsible for putting it into circulation, and
replaces
the previous authorisation which was not
linked to any specific person, it is appropriate to delete
the latter authorisation.

Since there are no safety reasons for withdrawing the
product lasalocid sodium from the market immediately,
it is appropriate to allow a transitional period of six
months for the disposal of existing stocks of the additive.

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

opinion

the

the

of

(5)

(6)

(7)

(8)

The person responsible for putting into circulation
Avatec 15 % submitted an application for authorisation
and a dossier, according to Article 9g(2) and (4) of that
Directive.

Article 9g(6) of Directive 70/524/EEC allows
the
automatic extension of the period of authorisation of
the additives concerned until the Commission takes a
decision in the case where,
for reasons beyond the
control of the authorisation holder, no decision may be
taken on the application before the expiry date of the
authorisation. This provision is applicable to the author-
isation of Avatec 15 %. The Commission requested a full
risk evaluation from the Scientific Committee for Animal
Nutrition on 26 April 2001 and this request was conse-
transferred to the European Food Safety
quently
Authority. Several requests for additional
information
were made during the re-evaluation process, making it
impossible to complete the re-evaluation within the time
limits required by Article 9g.

HAS ADOPTED THIS REGULATION:

Article 1

Chapter I of Annex B to Directive 70/524/EEC is amended as
follows: The additive lasalocid sodium, belonging to the group
‘Coccidiostats and other medical substances’, shall be deleted.

Article 2

The additive Avatec 15 %, belonging to the group ‘Coccidiostats
and other medical substances’, as set out in the Annex to the
present Regulation,
is authorised for use in animal nutrition
under the conditions laid down in that Annex.

Article 3

A period of six months from the date of entry into force of this
Regulation is permitted to use up the existing stocks of lasalocid
sodium.

Article 4

(1) OJ L 270, 14.12.1970, p. 1. Directive as

(EC) No 1289/2004 (OJ

last amended by
L 243,

Commission Regulation
15.7.2004, p. 15).

This Regulation shall enter into force on the third day following
the European
that of
Union.

its publication in the Official

Journal of

(1)

(2)

(3)

17.8.2004

EN

Official Journal of the European Union

L 269/15

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

Done at Brussels, 16 August 2004.

For the Commission

David BYRNE
Member of the Commission

L 269/16

EN

Official Journal of the European Union

17.8.2004

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