2003/636/EC: Commission Decision of 2 September 2003 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of potassium phosphite, acequinocyl and cyflufenamid 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(2003) 3128)
Date: 2003-09-02
Institutions: European Commission
Subjects: market approval, marketing standard, pharmaceutical product

L 221/42

EN

Official Journal of the European Union

4.9.2003

COMMISSION DECISION

of 2 September 2003

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

(notified under document number C(2003) 3128)

(Text with EEA relevance)

(2003/636/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 2003/
79/EC (2), and in particular Article 6(3) thereof,

Whereas:

(1)

(2)

(3)

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 potassium phosphite
was submitted by Luxembourg Industries (Pamol) Ltd to
the French authorities on 22 August 2002 with an appli-
cation to obtain its inclusion in Annex I to Directive 91/
414/EEC. For the active substance acequinocyl a dossier
was submitted by Agro-Kanesho Co. Ltd to the authori-
ties of the Netherlands on 17 March 2003 with an appli-
cation to obtain its inclusion in Annex I to Directive 91/
414/EEC. For cyflufenamid a dossier was submitted by
Nippon Soda Company Limited to the authorities of the
United Kingdom on 14 January 2003 with an applica-
tion to obtain its inclusion in Annex I to Directive 91/
414/EEC.

The authorities of France,
the Netherlands and the
United Kingdom have indicated to the Commission that,
on preliminary examination, the dossiers for the active
substances concerned appear to satisfy the data and
information requirements of Annex II to Directive 91/
414/EC. The dossiers submitted appear also to satisfy the
data and information requirements of Annex III to Direc-
tive 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/EC, 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.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 205, 14.8.2003, p. 16.

(4)

(5)

(6)

that

By this Decision it should be formally confirmed at
Community level
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/EC.

the
This Decision should not prejudice the right of
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.

The measures provided for in this Decision are in accor-
dance 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 inclu-
sion of those substances in Annex I to Directive 91/414/EEC,
satisfy in principle the data and information requirements 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 exami-
nation 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 to Directive 91/414/EEC and any condi-
tions related thereto to the Commission as soon as possible
and at the latest on 4 September 2004.

4.9.2003

EN

Official Journal of the European Union

L 221/43

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 2 September 2003.

For the Commission

David BYRNE

Member of the Commission

ANNEX

ACTIVE SUBSTANCES CONCERNED BY THIS DECISION

No

1

2

3

Common Name, CIPAC
identification number

Applicant

Date of application

Rapporteur Member State

Potassium phosphite
CIPAC-No 0756

Luxembourg
(Pamol) Ltd

Industries

22.8.2002

France

Acequinocyl
CIPAC-No not yet avail-
able

Agro-Kanesho Co. Ltd

17.3.2003

Netherlands

Cyflufenamid
CIPAC-No 0759

Nippon Soda Company
Limited

14.1.2003

United Kingdom