2001/679/EC: Commission Decision of 29 August 2001 concerning the decision on the possible inclusion of certain active substances into Annex I to Directive 91/414/EEC (Text with EEA relevance) (notified under document number C(2001) 2495)
Date: 2001-08-29
Institutions: European Commission
Subjects: dangerous substance, marketing, pharmaceutical product, plant health product

7.9.2001

EN

Official Journal of the European Communities

L 239/39

COMMISSION DECISION

of 29 August 2001

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

(notified under document number C(2001) 2495)

(Text with EEA relevance)

(2001/679/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 2001/
49/EC (2),

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 Regulation (EC) No 2266/
2000 (4), and in particular Article 7(3A)(d) and (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 Regulation (EEC) No
3600/92 (5), as last amended by Regulation (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.

The rapporteur Member States have submitted such
reports and identified further data requirements in them.
On receipt of the reports on carbendazime and thiopha-
the Commission circulated them to the
natemethyl
Member States for information and undertook consulta-
tions with experts of the Member States as well as with
the main notifiers as provided for in Article 7(3) of
Regulation 3600/92. However it has not been possible

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 176, 29.6.2001, p. 61.
(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)

yet for the Commission to undertake consultations on
the reports or in particular on the data requirements for
the other active substances mentioned in Annex I to this
Decision with experts of the Member States or with any
notifier as permitted in Article 7(3) of Regulation (EEC)
No 3600/92.

Article 7(4) of Regulation (EEC) No 3600/92 requires
that all necessary data be submitted at the latest on 25
May 2002.
It is the responsibility of the notifier to
ensure that their dossiers are completed such that all
data requirements of Annex II and Annex III to Directive
91/414/EEC are satisfied for a limited range of repres-
entative uses. However, in order to assist the notifiers of
these substances when preparing the necessary studies to
complete
after
consulting the Standing Committee on Plant Health, has
identified certain studies and information which would
be necessary to assess the safety and efficacy of the
substances.

the Commission,

dossiers,

their

The information thus far submitted is not sufficient to
determine whether or not, under the proposed condi-
tions of use, plant-protection products containing the
active substances concerned would satisfy in general the
requirements laid down in Article 5(1)(a) and (b) of
Directive 91/414/EEC. Therefore it is not possible to
decide whether to include such active substances in
Annex I to Directive 91/414/EEC.

Article 8(3) of Directive 91/414/EEC provides
that
Member States should apply the requirements of Article
4(1)(b)(i) to (v), and (1)(c) to (f)
in accordance with
national provisions concerning the data to be provided.
The draft assessment reports referred to in recital 2 did
not identify concerns which can not be mitigated by
appropriate risk-management measures at Member State
level. Therefore it is not appropriate at this stage to
containing these
suspend plant-protection products
active substances before the additional required informa-
tion 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 Directive 91/414/EEC.

L 239/40

EN

Official Journal of the European Communities

7.9.2001

(7)

(8)

(9)

(10)

Following discussions in the Standing Committee on
Plant Health, and in accordance with the opinion of that
Committee, the Commission has determined the further
data required as a minimum to determine whether the
substances mentioned in recital 4 satisfy the require-
ments of Article 5 of Directive 91/414/EEC. The rappor-
teur Member States should therefore inform the notifiers
in detail about all additional studies and information
which would be required to demonstrate that
these
requirements are satisfied.

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
that
are not prevented from seeking inclusion of
substance in Annex I
in
accordance with the procedures under Article 6(2) of
that Directive at a later date.

to Directive 91/414/EEC,

This decision is without prejudice to any action the
Commission may undertake at a later stage relating to
these active substances within the framework of Council
Directive 79/117/EEC of 21 December 1978 prohibiting
the placing on the market and use of plant protection-
products containing certain active substances (1), as last
amended by the Act of Accession of Austria, Finland
and Sweden.

(11)

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

414/EEC is postponed, pending receipt of
referred to in Article 2 of this Decision.

the information

Article 2

inform the notifiers in
The rapporteur Member States shall
relation to each active substance listed in the Annex to this
Decision that they must complete their dossiers such that all
data requirements of Annex II and Annex III to Directive
91/414/EEC are satisfied for a limited range of representative
uses. The rapporteur Member States shall inform the notifiers
that, without prejudice to further requirements which may be
identified later, particular additional studies and information
identified by the Commission after consulting the Standing
Committee on Plant Health are required.

Each rapporteur Member State shall
inform each notifier
concerned that, if it wishes the rapporteur and Commission to
continue the review process with a view to including the
substance in Annex I to Directive 91/414/EEC, it must commu-
nicate to the rapporteur and to the Commission within three
months of the date of publication of this Decision an under-
taking to ensure that its dossier will satisfy at the latest by the
dates specified in the Annex to this Decision the requirements
of Annexes II and III to Directive 91/414/EEC, and submit the
studies and information referred to in the first paragraph as
soon as possible and at the latest by the dates specified in the
Annex to this Decision to the rapporteur.

Article 3

If for certain active substances the necessary information is not
received by the dates specified in the Annex the rapporteur
Member State shall inform the Commission as soon as possible
and at the latest within two months.

Article 4

The rapporteur Member States shall immediately inform the
notifiers for the active substances referred to in Article 1 about
the present Decision.

This Decision is addressed to the Member States.

Article 5

HAS ADOPTED THIS DECISION:

Done at Brussels, 29 August 2001.

Article 1

The decision on the possible inclusion of the active substances
referred to in the Annex hereto in Annex I to Directive 91/

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 33, 8.2.1979, p. 36.

7.9.2001

EN

Official Journal of the European Communities

L 239/41

ANNEX

Latest date for the
submission of studies

Latest date for the submission
of specified long-term studies

Carbendazime

Desmedipham

Mancozeb

Maneb

Metiram

Phenmedipham

Procymidone

Thiophanate-methyl

25.5.2002

25.5.2002

25.5.2002

25.5.2002

25.5.2002

25.5.2002

25.5.2002

25.5.2002

31.12.2002

30.4.2003