2001/134/EC: Commission Decision of 14 February 2001 concerning the decision on the possible inclusion of certain active substances into Annex I to Council Directive 91/414/EEC (Text with EEA relevance) (notified under document number C(2001) 374)
Date: 2001-02-14
Institutions: European Commission
Subjects: exchange of information, marketing, pharmaceutical product, plant health product

20.2.2001

EN

Official Journal of the European Communities

L 49/13

COMMISSION

COMMISSION DECISION

of 14 February 2001

concerning the decision on the possible inclusion of certain active substances into Annex I to
Council Directive 91/414/EEC

(notified under document number C(2001) 374)

(Text with EEA relevance)

(2001/134/EC)

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/
80/EC (2) (hereinafter referred to as ‘the Directive’),

Having regard to 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 Commission Regulation (EC) No
2266/2000 (4), and in particular Article 7(3A)(d) and 7(4)
thereof,

Whereas:

(1)

(2)

(3)

Commission Regulation (EC) No 933/94 of 27 April
1994 laying down the active substances of plant-protec-
tion products and designating the rapporteur Member
States for the implementation of Commission Regula-
tion (EEC) No 3600/92 (5), as last amended by Regula-
tion (EC) No 2230/95 (6),
identified the rapporteur
Member States and notifiers for each active substance.

Article 7 of Regulation (EEC) No 3600/92 provided that
for each active substance for which it has been desig-
nated rapporteur, a Member State should examine the
dossiers and submit to the Commission the report of its
assessment of the information submitted by the notifiers
in accordance with the provisions of Article 6(1) of that
Regulation.

In accordance with the above Article, on receipt of the
reports of the rapporteur Member States, the Commis-
sion circulated them to the Member States for informa-

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 309, 9.12.2000, p. 14.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 107, 28.4.1994, p. 8.
(6) OJ L 225, 22.9.1995, p. 1.

(4)

(5)

(6)

tion and undertook consultations with experts of the
Member States as well as with the main notifiers as
provided for in Article 7(3) of Regulation (EEC) No
3600/92.

to determine whether or not, under

It appears from the assessments made on a number of
active substances that the submitted information is not
sufficient
the
proposed conditions of use, plant-protection products
containing the active substance concerned would satisfy
in general the requirements laid down in Article 5(1)(a)
and (b) of the Directive. Therefore it is not presently
possible to decide whether
to include such active
substances in Annex I to the Directive.

Article 8(3) of the Directive provides that Member States
should apply the requirements of Article 4(1)(b)(i) to (v),
and (c) to (f)
in accordance with national provisions
concerning the data to be provided. The assessments
referred to in recital 4 did not identify concerns which
can not be mitigated by appropriate risk-management
is not
measures at Member State level. Therefore it
appropriate at this stage to suspend plant-protection
products containing the active substances mentioned
before the additional required information has been
submitted and evaluated. Therefore a decision should be
taken to postpone a decision on the possible inclusion
of such active substances into Annex I to the Directive.

in

the

detailed

Following
Standing
discussions
Committee on Plant Health, and in accordance with the
opinion of that Committee, the Commission has deter-
mined the further data required to determine whether
the substances mentioned in recital 4 satisfy the require-
ments of Article 5 of
the Directive. The rapporteur
Member States should therefore inform the notifiers in
detail about all additional studies and information which
would be required to demonstrate that these require-
ments are satisfied.

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Official Journal of the European Communities

20.2.2001

(7)

(8)

(9)

To enable the Member States and the Commission to
programme their work, an unconditional undertaking to
submit the additional required information should be
provided by the notifier wishing the rapporteur Member
State and the Commission to continue the review
process. To enable the Commission to complete its work
on the programme established by Regulation (EEC) No
3600/92 within a reasonable time, a deadline should be
established within which notifiers of these substances
must complete their files. This deadline should be as
short as possible taking into account the time needed to
perform the necessary studies.

If, for a particular active substance, the requirements of
the present Decision concerning submission of
the
necessary information are not satisfied, interested parties
are not prevented from seeking inclusion of
that
substance in Annex I to the Directive,
in accordance
with the procedures under its Article 6(2) at a later date.

This Decision does not prejudice any action the
Commission may undertake at a later stage relating to
these active substances within the framework of Council
Directive 79/117/EEC (1), as last amended by Commis-
sion Directive 91/188/EEC (2),

HAS ADOPTED THIS DECISION:

Article 1

For the active substances referred to in the Annex hereto, the
decision on their possible inclusion in Annex I to Directive
91/414/EEC is postponed, pending receipt of the information
referred to in Article 2 below.

Article 2

The rapporteur Member States shall
inform the notifiers in
relation to each active substance listed in the Annex to this
Decision, of the additional studies and information identified

by the Commission after consulting the Standing Committee
on Plant Health as being required in order to complete their
dossier such that all data requirements of Annex II and Annex
III to the Directive are satisfied for a limited range of repres-
entative uses.

Each rapporteur Member State shall
inform each notifier
concerned that, if it wishes the rapporteur and the Commission
to continue the review process with a view to including the
substance in Annex I to the Directive, it must communicate to
the rapporteur and to the Commission, within three months of
the date of publication of this Decision, an undertaking to
ensure that its dossier will satisfy, at the latest by the dates
specified in the Annex hereto, the requirements of Annexes II
and III to the Directive, and submit the studies and information
referred to in the previous paragraph as soon as possible and at
the latest by the dates specified in the Annex.

Article 3

If for certain active substances the necessary information is not
received within the time limit referred to in Article 2 the
rapporteur Member State shall inform the Commission as soon
as possible and at the latest within two months.

Article 4

This Decision is addressed to the Member States. The rappor-
teur Member States shall immediately inform the notifiers for
the active substances referred to in Article 1 about the present
Decision.

Done at Brussels, 14 February 2001.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 33, 8.2.1979, p. 36.
(2) OJ L 92, 13.4.1991, p. 42.

20.2.2001

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Official Journal of the European Communities

L 49/15

ANNEX

Date for the submission of studies

Date for the submission of specified long-
term studies

2,4-DB

Acephate

Amitraz

Chlorpropham

Chlorpyrifos

Chlorpyrifos-methyl

Daminozide

Deltamethrin

Linuron

Mecoprop

Mecoprop-P

Molinate

Pendimethalin

Propiconazole

Propyzamide

Thiram

Ziram

31.10.2001

31.3.2001

31.8.2001

31.12.2001

30.4.2002

30.4.2002

31.12.2001

31.1.2002

31.12.2001

31.12.2001

31.3.2001

30.6.2001

31.10.2001

31.12.2001

31.12.2001

31.12.2001

31.3.2002

31.3.2002