2001/861/EC: Commission Decision of 27 November 2001 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of Laminarin and Novaluron 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(2001) 3761)
Date: 2001-11-27
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

L 321/34

EN

Official Journal of the European Communities

6.12.2001

COMMISSION DECISION

of 27 November 2001

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

(notified under document number C(2001) 3761)

(Text with EEA relevance)

(2001/861/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), 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.

for

the active substance Novaluron was
A dossier
submitted by Makhteshim Agan Ltd, United Kingdom, to
the authorities of the United Kingdom on 29 March
2001 with an application to obtain its inclusion in
Annex I
the active
to Directive 91/414/EEC. For
substance Laminarin an application was submitted by
Laboratoires Goëmar SA, France, to the authorities of
Belgium on 29 March 2001.

The British and Belgian authorities have indicated to the
the
Commission that, on preliminary examination,
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 information require-
ments 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 Commis-
sion and other Member States, and were referred to the
Standing Committee on Plant 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 Plant 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, 27 November 2001.

For the Commission

David BYRNE

Member of the Commission

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

6.12.2001

EN

Official Journal of the European Communities

L 321/35

ANNEX

ACTIVE SUBSTANCES CONCERNED BY THIS DECISION

Nο

1

2

Common name, CIPAC
identification No

Notifier

Date of application Rapporteur Member State

Novaluron
CIPAC No 672

Laminarin
CIPAC No 671

Makhteshim Agan Ltd
United Kingdom

29 March 2001

United Kingdom

Laboratoires Goëmar SA,
France

29 March 2001

Belgium