2003/35/EC: Commission Decision of 10 January 2003 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of benalaxyl-M, benthiavalicarb, 1-methylcyclopropene, prothioconazole and fluoxastrobin 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) 5575)
Date: 2003-01-10
Institutions: European Commission
Subjects: exchange of information, marketing, pharmaceutical product, plant health product

L 11/52

EN

Official Journal of the European Communities

16.1.2003

COMMISSION DECISION

of 10 January 2003

recognising in principle the completeness of the dossiers submitted for detailed examination in
view of the possible inclusion of benalaxyl-M, benthiavalicarb, 1-methylcyclopropene, prothioco-
nazole and fluoxastrobin 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) 5575)

(Text with EEA relevance)

(2003/35/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/
81/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 benalaxyl-M was
submitted by Isagro, Italy, to the Portuguese authorities
on 22 February 2002 with an application to obtain its
inclusion in Annex I to Directive 91/414/EEC. A dossier
for the active substance benthiavalicarb was submitted
by Kumiai Chemicals Industry Co Ltd to the authorities
of Belgium on 19 April 2002. A dossier for the active
submitted by
substance 1-methylcyclopropene was
the United
Rohm and Haas,
Kingdom on 28 February 2002. A dossier for the active
substance prothioconazole was submitted by Bayer Crop
Science, to the authorities of the United Kingdom on 25
March 2002. A dossier for the active substance fluoxas-
to the
trobin was submitted by Bayer Crop Science,
authorities of the United Kingdom on 25 March 2002.

to the authorities of

The authorities of the Portugal, Belgium 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/EEC. The dossiers submitted appear to satisfy also
the data and information 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/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 276, 12.10.2002, p. 28.

(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/EEC.

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 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 European
Communities.

16.1.2003

EN

Official Journal of the European Communities

L 11/53

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 10 January 2003.

For the Commission

David BYRNE

Member of the Commission

ANNEX

ACTIVE SUBSTANCES CONCERNED BY THIS DECISION

No

Common name, CIPAC identification No

Applicant

Date of application

Rapporteur Member
State

1

2

3

4

5

Benalaxyl-M
not allocated

Benthiavalicarb
CIPAC No 744

1-methylcyclopropene
not allocated

Prothioconazole
CIPAC No 745

Fluoxastrobin
CIPAC No 746

Isagro, Italy

22.2.2002

Kumiai Chemicals
Industry Co Ltd

19.4.2002

Rohm and Haas

28.2.2002

Bayer AG

25.3.2002

Bayer AG

25.3.2002

PT

BE

UK

UK

UK