Commission Regulation (EC) No 2266/2000 of 12 October 2000 amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market
Date: 2000-10-12
Institutions: European Commission
Subjects: marketing, marketing standard, pharmaceutical product, plant health product

13.10.2000

EN

Official Journal of the European Communities

L 259/27

COMMISSION REGULATION (EC) No 2266/2000

of 12 October 2000

amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of
the first stage of the programme of work referred to in Article 8(2) of Council Directive
91/414/EEC concerning the placing of plant protection products on the market

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market (1), as last amended by Commission Directive 2000/
50/EC (2), and in particular Article 8(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

Commission Regulation (EEC) No 3600/92 of 11
December 1992 laying down the detailed rules for the
implementation of the first stage of the programme of
work referred to in Article 8(2) of Council Directive
91/414/EEC concerning the placing of plant protection
products on the market (3), as last amended by Commis-
sion Regulation (EC) No 1972/1999 (4), established rules
for the re-evaluation of 90 active substances already on
the market two years after notification of Directive 91/
414/EEC whose re-evaluation was considered a first
priority. This is organised by the Commission in a
collaborative and co-ordinated programme established in
the Regulation, within which Member States undertake
specific tasks contributing to the scientific and technical
assessments which are the basis for regulatory decisions
taken at Community level.

Commission Regulation (EC) No 451/2000 of 28
February 2000 laying down the detailed rules for the
implementation of the second and third stages of the
work programme referred to in Article 8(2) of Council
Directive 91/414/EEC (5) has laid down the detailed rules
for the implementation of the second and third stages of
the work programme.

Experience has shown that a decision on possible inclu-
sion of an active substance into Annex I to the Directive
can only be taken if a notifier has demonstrated that for
the limited range of uses supported and for one or more
preparations the requirements of the Directive in rela-
tion to the criteria referred to in Article 5 thereof can be
met. Therefore all information for each point of Annex
II and Annex III of the Directive has to be submitted for
the supported uses.

So far for most of the active substances examined insuf-
ficient information has been submitted. Therefore, to
enable the Commission to complete the programme of
work for these 90 active substances as soon as possible a
deadline should be established within which notifiers

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 198, 4.8.2000, p. 39.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 244, 16.9.1999, p. 41.
(5) OJ L 55, 29.2.2000, p. 25.

must complete their files, having regard to the data
requirements which were laid down in detail between
July 1993 and October 1996.

(5)

In order
to speed up the evaluation and decision
making, a decision on possible inclusion in Annex I
should be taken on the basis of the data submitted and
no further postponement of decisions
should be
provided. Therefore without prejudice to Article 7 of the
Directive, submission of new studies should only be
accepted if the rapporteur Member State, with the agree-
ment of
requests the notifiers to
submit further data necessary to clarify the dossier.

the Commission,

(6)

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on Plant Health,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EEC) No 3600/92 is amended as follows:

1. In Article 6(2)(b), the following is added at the end:

‘it has to be demonstrated by the notifier that, on the basis
of the information submitted for one or more preparations
for a limited range of representative uses, the requirements
of the Directive in relation to the criteria referred to in
Article 5 thereof can be met;’

2. In Article 7(4), the following is added at the end in the first

indent:

‘this time limit will be 25 May 2002 unless an earlier time
limit
is established by the Commission for a particular
active substance except for the results of long-term studies,
identified as being necessary by the rapporteur Member
State and the Commission during the examination of the
dossier and which are not expected to be fully completed by
the deadline established, provided that
the information
submitted contains evidence that such studies have been
commissioned and that their results will be submitted at the
latest on 25 May 2003. In exceptional cases, where it has
not been possible for the rapporteur Member State and the
Commission to identify such studies by 25 May 2001, an
alternative date may be established for the completion of
such studies, provided the notifier supplies the rapporteur
Member State with evidence that such studies have been
commissioned within three months of the request to under-
take the studies, and with a protocol and progress report of
the study by 25 May 2002.’

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Official Journal of the European Communities

13.10.2000

3. In Article 7(4), the following is added at the end:

‘Without prejudice to Article 7 of the Directive, submission
of new studies will not be accepted. The rapporteur Member
State, with the agreement of the Commission, may request
the notifiers to submit further data necessary to clarify the
dossier.

For active substances for which the results or information
referred to in the first indent have not been submitted
within the established time limit the rapporteur Member
immediately inform the Commission. The
State shall
Commission shall decide, as provided for in Article 8(2), last
subparagraph, of the Directive, not to include in Annex I to
the Directive such active substances mentioning the reasons
for the non-inclusion. Member States shall withdraw by 25
July 2003 authorisations of plant protection products
containing these active substances.’

4. Article 8(1)(c) shall be replaced by the following:

‘communicate to the Commission as quickly as possible,
and within six months at the latest following receipt of all
the required information, its evaluation of the dossier as an
addendum to the evaluation report already submitted to the
Commission. The report shall be presented in the format
recommended by the Commission in the framework of the
Standing Committee on Plant Health and shall
include a
recommendation:
— either to include the active substance in Annex I to the

Directive stating the conditions for inclusion,

— or not to include the active substance in Annex I to the
Directive, mentioning the reasons for the non-inclusion.’

Before referring the dossier and report to the Committee,
the Commission shall circulate the rapporteur's report to
the Member States for information and may organise a
consultation of experts from one or several Member States.
The Commission may consult some or all of the notifiers of
active substances on the report or parts of the report on the
relevant active substance. The rapporteur Member State
shall provide the necessary technical and scientific assistance
during these consultations.

Without prejudice to Article 7 of the Directive, submission
of new studies will not be accepted. The rapporteur Member
State, after consultation with the Commission, may request
the notifiers to submit further data necessary to clarify the
dossier.

After
the
the examination referred to in Article 7(3),
Commission shall, without prejudice to any proposal it may
submit with a view to amending the Annex to Directive
79/117/EEC, present to the Committee:

(a) a draft directive to include the active substance in Annex
I to the Directive, setting out where appropriate the
conditions, including the time limit, for such inclusion;
or

(b) a draft decision addressed to the Member States to
withdraw the authorisations of plant protection prod-
ucts containing the active substance, pursuant to the
fourth subparagraph of Article 8(2) of the Directive,
whereby that active substance is not included in Annex I
to the Directive, mentioning the reasons for the non-
inclusion.’

5. Article 8(3) shall be replaced by the following:

6. Article 8(4) is deleted.

‘After receiving the summary and the report referred to in
paragraph 1,
to the
Committee for examination.

the Commission shall

refer

it

This Regulation shall enter into force on 1 November 2000.

Article 2

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

Done at Brussels, 12 October 2000.

For the Commission

David BYRNE

Member of the Commission