Commission Regulation (EC) No 2205/2001 of 14 November 2001 amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of certain additives (Text with EEA relevance)
Date: 2001-11-14
Institutions: European Commission
Subjects: animal nutrition, antibiotic, food additive, medicinal product

15.11.2001

EN

Official Journal of the European Communities

L 297/3

COMMISSION REGULATION (EC) No 2205/2001

of 14 November 2001

amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards with-
drawal of the authorisation of certain additives

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

far as data ranging from substance identification to
important toxicological

information were missing.

Having regard to the Treaty establishing the European
Community,

(6)

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), as last
amended by Directive 2001/46/EC of the European Parliament
and of the Council (2), and in particular Article 9g(4) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

in Article 9g(1) of Directive 70/
As provided for
524/EEC, antibiotics and 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
reevaluation as additives linked to a person responsible
for putting them into circulation.

New applications for authorisation had to be submitted
for the abovementioned additives. Furthermore, Article
9g(4) of Directive 70/524/EEC required that the dossiers
in respect of
these applications be submitted, as
provided for in Article 4 of that Directive and no later
than 30 September 2000, with a view to reevaluation.

Dossiers were submitted before 1 October 2000 for the
coccidiostats meticlorpindol, meticlorpindol/methylben-
zoquate, amprolium, amprolium/ethopabate, dimetrida-
zole and nicarbazin and for the antibiotic flavophospho-
lipol.

In accordance with Article 4(4) of Directive 70/524/EEC,
Member States checked the compliance of the dossiers
with Council Directive 87/153/EEC of 16 February 1987
fixing guidelines for the assessment of additives in
animal nutrition (3), as last amended by Commission
Directive 2001/79/EC (4), within a period of 60 days
from the date on which the dossiers were dispatched to
them.

the Standing Committee on
After consultation of
Feedingstuffs and in accordance with Article 4(5) of
Directive 70/524/EEC, the applicants for authorisation
of the abovementioned coccidiostats were notified by
the Commission that the rules on administrative presen-
tation of the dossiers had not been complied with, in so

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 234, 1.9.2001, p. 55.
(3) OJ L 64, 7.3.1987, p. 19.
(4) OJ L 267, 6.10.2001, p. 1.

(7)

(8)

(9)

(10)

(11)

(12)

(13)

Similarly, after consultation of the Standing Committee
on Feedingstuffs and in accordance with Article 4(5) of
Directive 70/524/EEC, the applicant for authorisation of
the abovementioned antibiotic was notified by the
Commission that the rules on administrative presenta-
tion of the dossier had not been complied with for
certain animal categories, in so far as efficacy data and
data related to tolerance tests were missing for these
categories.

In order to ensure that the deficiencies in submitting the
necessary data were not due to unforeseen delivery
reasons, an extra time of three weeks was given to allow
the above referred applicants to submit
the missing
information.

For several substances, complementary information was
submitted but this was not sufficient to comply with
Directive 87/153/EEC, while for the other substances
concerned, no complementary data were sent to the
Commission within the extra time given.

Since the requirements of Directive 70/524/EEC have
not been met for the abovementioned coccidiostats, the
authorisation granted to these additives should be with-
drawn and their entries deleted from Chapter I of Annex
B to the Directive.

Since the requirements of Directive 70/524/EEC have
not been met for the antibiotic flavophospholipol as
regards certain animal categories, the entry of the antibi-
otic in Chapter I of Annex B to the Directive should be
amended accordingly.

It is appropriate to allow a limited period of time within
which existing stocks of the coccidiostats and the antibi-
otic covered by this Regulation may be used.

The Standing Committee for Feedingstuffs has not given
the Commission has therefore proposed
an opinion,
these measures to the Council on 25 July 2001 in
accordance with Article 23 of Directive 70/524/EEC, the
Council being required to act within three months.

The Council has not acted within the required time limit.
The Council has not decided against the proposed meas-
ures by simple majority within the same time limit.
These measures should now be adopted by the Commis-
sion,

L 297/4

EN

Official Journal of the European Communities

15.11.2001

HAS ADOPTED THIS REGULATION:

2. The entries in relation to flavophospholipol are amended as

Article 1

Chapter I of Annex B to Directive 70/524/EEC shall be
amended as follows:

1. The following substances belonging to the group of cocci-
diostats and other medicinal substances shall be deleted:

— meticlorpindol,

— meticlorpindol/methylbenzoquate,

— amprolium,

— amprolium/ethopabate,

— dimetridazole,

— nicarbazin.

follows:

(a) the animal category ‘Animals bred for fur, excluding

rabbits’

is deleted;

(b) the animal category ‘Other poultry, excluding ducks,
is replaced by the animal category

geese, pigeons’
‘Chickens for fattening’.

Article 2

This Regulation shall enter into force six months after 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, 14 November 2001.

For the Commission

David BYRNE

Member of the Commission