Commission Directive 2004/99/EC of 1 October 2004 amending Council Directive 91/414/EEC to include acetamiprid and thiacloprid as active substances(Text with EEA relevance)
Date: 2004-10-01
Institutions: European Commission
Subjects: marketing standard, pharmaceutical product, plant health product

L 309/6

EN

Official Journal of the European Union

6.10.2004

COMMISSION DIRECTIVE 2004/99/EC

of 1 October 2004

amending Council Directive 91/414/EEC to include acetamiprid and thiacloprid as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the
market (1), and in particular Article 6(1) thereof,

Whereas:

active

In accordance with Article 6(2) of Directive 91/414/EEC
Greece received on 22 October 1999 an application
from Nisso Chemical Europe GmbH for the inclusion
I
the
of
Commission Decision
to Directive
2000/390/EC (2)
dossier was
that
‘complete’
in the sense that it could be considered as
and information
satisfying,
in principle,
to Directive
requirements of Annexes
91/414/EEC.

substance
91/414/EEC.
confirmed

acetamiprid in Annex

the data

and III

the

II

thiacloprid.

The United Kingdom received an application under
Article 6(2) of Directive 91/414/EEC on 11 September
(now Bayer CropScience AG)
1998 from Bayer plc.
concerning
Decision
Commission
2000/181/EC (3)
dossier was
that
‘complete’
in the sense that it could be considered as
and information
in principle,
satisfying,
requirements of Annexes
to Directive
91/414/EEC.

confirmed

the data

and III

the

II

(7)

(8)

(9)

the

products

protection

containing

It has appeared from the various examinations made that
active
plant
substances concerned may be expected to satisfy,
in
general, the requirements laid down in Article 5(1)(a)
and (b) and Article 5(3) of Directive 91/414/EEC,
in
particular with regard to the uses which were examined
is
and detailed in the Commission review report.
therefore appropriate to include acetamiprid and thia-
cloprid in Annex I to that Directive, in order to ensure
that in all Member States the authorisations of plant
protection products containing these active substances
may be granted in accordance with the provisions of
that Directive.

It

After the inclusion of acetamiprid and thiacloprid in
to Directive 91/414/EEC, Member States
Annex I
should be allowed a reasonable period to implement
the provisions of
regards plant
that Directive
protection products containing those substances and in
particular to review existing provisional authorisations
to
and, by the end of
transform those authorisations into full authorisations,
to amend them or to withdraw them in accordance
with the provisions of Directive 91/414/EEC.

this period at

the latest,

as

is

It
therefore
91/414/EEC accordingly.

appropriate

to

amend Directive

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

For those active substances, the effects on human health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of Directive
91/414/EEC, for the uses proposed by the applicants. The
designated rapporteur Member States submitted draft
reports concerning the substances to the
assessment
Commission on 19 March 2001 (acetamiprid) and 22
November 2000 (thiacloprid).

The draft assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health. The
review was finalised on 29 June 2004 in the format of
the Commission review reports for acetamiprid and thia-
cloprid.

The review of acetamiprid and thiacloprid did not reveal
any open questions or concerns, which would have
required a consultation of the Scientific Committee on
Plants.

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

Article 2

1. Member States shall adopt and publish by 30 June 2005
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

They shall apply those provisions from 1 July 2005.

(1)

(2)

(3)

(4)

(5)

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by
Commission Directive 2004/71/EC (OJ L 127, 29.4.2004, p. 104).

(2) OJ L 145, 20.6.2000, p. 36.
(3) OJ L 57, 2.3.2000, p. 35.

When Member States adopt those provisions, they shall contain
a reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

6.10.2004

EN

Official Journal of the European Union

L 309/7

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

amend or withdraw the authorisation by 30 June 2006 at
the latest; or

Article 3

1. Member States shall review the authorisation for each
plant protection product containing acetamiprid or thiacloprid
to ensure that the conditions relating to these active substances
set out in Annex I to Directive 91/414/EEC are complied with.
Where necessary, they shall amend or withdraw authorisations
in accordance with Directive 91/414/EEC by 30 June 2005 at
the latest.

For each authorised plant protection product containing
2.
acetamiprid or thiacloprid as either the only active substance or
as one of several active substances all of which were listed in
Annex I to Directive 91/414/EEC by 31 December 2004 at the
latest, Member States shall re-evaluate the product in accordance
to
with the uniform principles provided for in Annex VI
Directive 91/414/EEC, on the basis of a dossier satisfying the
requirements of Annex III to that Directive. On the basis of that
evaluation, they shall determine whether the product satisfies
(d) and (e) of
the conditions set out in Article 4(1)(b),
Directive 91/414/EEC.

(c),

Following that determination Member States shall:

(a)

in the case of a product containing acetamiprid or thia-
the only active substance, where necessary,
cloprid as

(b) in the case of a product containing acetamiprid or thia-
cloprid as one of
substances, where
several
necessary, amend or withdraw the authorisation by 30
June 2006 or by the date fixed for such an amendment
in the respective Directive or Directives
or withdrawal
to
substance or
which added the relevant
Annex I to Directive 91/414/EEC, whichever is the latest.

substances

active

Article 4

This Directive shall enter into force on 1 January 2005.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 1 October 2004.

For the Commission

David BYRNE
Member of the Commission

L 309/8

EN

Official Journal of the European Union

6.10.2004

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