2002/305/EC: Commission Decision of 19 April 2002 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of clothianidin and Pseudozyma flocculosa in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (Text with EEA relevance) (notified under document number C(2002) 1434)
Date: 2002-04-19
Institutions: European Commission
Subjects: Belgium, Netherlands, marketing standard, pharmaceutical product, plant health product

L 104/42

EN

Official Journal of the European Communities

20.4.2002

COMMISSION DECISION

of 19 April 2002

recognising in principle the completeness of the dossiers submitted for detailed examination in
view of the possible inclusion of clothianidin and Pseudozyma flocculosa in Annex I to Council
Directive 91/414/EEC concerning the placing of plant-protection products on the market

(notified under document number C(2002) 1434)

(Text with EEA relevance)

(2002/305/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 2002/
18/EC (2), and in particular Article 6(3) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Directive 91/414/EEC provides for the development of a
Community list of active substances authorised for
incorporation in plant protection products.

A dossier for the active substance clothianidin was
Industries Ltd, United
submitted by Takeda Chemical
Kingdom,
authorities of Belgium on 26
to the
September 2001 with an application to obtain its inclu-
sion in Annex I to Directive 91/414/EEC. A similar
application was submitted by Maasmond-Westland, the
Netherlands, on 6 March 2001 to the authorities of the
Netherlands concerning the microbial active substance
Pseudozyma flocculosa.

The authorities of Belgium and the Netherlands have
indicated to the Commission that, on preliminary exam-
ination, the dossiers for the active substances concerned
appear to satisfy the data and information requirements
of Annex II
to Directive 91/414/EEC. The dossiers
submitted appear also to satisfy the data and informa-
tion requirements of Annex III to Directive 91/414/EEC
in respect of one plant protection product containing
the active substance concerned.
In accordance with
Article 6(2) of Directive 91/414/EEC, the dossiers were
subsequently forwarded by the respective applicants to
the Commission and other Member States, and were
referred to the Standing Committee on the Food Chain
and Animal Health.

By this Decision it should be formally confirmed at
Community level that the dossiers are considered as
satisfying in principle the data and information require-
ments provided for in Annex II and, for at least one
plant protection product containing the active substance
concerned, the requirements of Annex III to Directive
91/414/EEC.

This Decision should not prejudice the right of
the
Commission to request the applicant to submit further
data or information to the Member State designated as

Rapporteur in respect of a given substance in order to
clarify certain points in the dossier.

(6)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

The dossiers concerning the active substances identified in the
Annex to this Decision, which were submitted to the Commis-
sion and the Member States with a view to obtaining the
inclusion of those substances in Annex I to Directive 91/
414/EEC, satisfy in principle the data and information require-
ments set out in Annex II to Directive 91/414/EEC.

The dossiers also satisfy the data and information requirements
set out in Annex III to Directive 91/414/EEC in respect of one
plant protection product containing the active substance,
taking into account the uses proposed.

Article 2

The rapporteur Member States shall pursue the detailed exam-
ination for the dossiers concerned and shall report the conclu-
sions of their examinations accompanied by any recommenda-
tions on the inclusion or non-inclusion of the active substance
concerned in Annex I of Directive 91/414/EEC and any condi-
tions related thereto to the Commission as soon as possible
and at the latest within a period of one year from the date of
publication of this Decision in the Official Journal of the Euro-
pean Communities.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 19 April 2002.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 55, 26.2.2002, p. 29.

20.4.2002

EN

Official Journal of the European Communities

L 104/43

ANNEX

ACTIVE SUBSTANCES CONCERNED BY THIS DECISION

No

1

2

Common Name, CIPAC
Identification Number

Applicant

Date of application

Rapporteur Member
State

Clothianidin
CIPAC No 738

Takeda Chemical
Industries Ltd
United Kingdom

26 September 2001

Pseudozyma flocculosa
CIPAC No 669

Maasmond-Westland,
The Netherlands

6 March 2001

BE

NL