2000/540/EC: Commission Decision of 6 September 2000 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of RH-7281 (zoxamide), B-41; E-187 (milbemectin), BAS500F (pyraclostrobin) and AEF130360 (foramsulfuron) in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (notified under document number C(2000) 2285)
Date: 2000-09-06
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health control, plant health product

L 230/14

EN

Official Journal of the European Communities

12.9.2000

COMMISSION

COMMISSION DECISION

of 6 September 2000

recognising in principle the completeness of the dossiers submitted for detailed examination in
view of the possible inclusion of RH-7281 (zoxamide), B-41; E-187 (milbemectin), BAS500F
(pyraclostrobin) and AEF130360 (foramsulfuron) in Annex I to Council Directive 91/414/EEC
concerning the placing of plant-protection products on the market

(notified under document number C(2000) 2285)

(2000/540/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/141/EEC of 15 July
1991 concerning the placing of plant-protection products on
the market (1) as last amended by Commission Directive 2000/
10/EC (2) and in particular Article 6(3) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Directive 91/414/EEC (hereinafter ‘the Directive’) has
provided for the development of a Community list of
active substances authorised for incorporation in plant-
protection products.

A dossier for the active substance RH-7281 (zoxamide)
was submitted by Rohm and Haas France SA to the
authorities of the United Kingdom on 2 June 1999 with
a view to obtaining its inclusion in Annex I to the
Directive.

A dossier for the active substance B-41; E-187 (milbe-
mectin) was submitted by Sankyo Company Limited to
the Dutch authorities on 6 March 2000 with a view to
obtaining its inclusion in Annex I to the Directive.

A dossier for the active substance BAS500F (pyraclos-
trobin) was submitted by BASF AG to the German
authorities on 28 February 2000 with a view to
obtaining its inclusion in Annex I to the Directive.

A dossier for the active substance AEF130360 (foram-
sulfuron) was submitted by Aventis GmbH to the
German authorities on 30 March 2000 with a view to
obtaining its inclusion in Annex I to the Directive.

The said authorities indicated to the Commission that,
on preliminary examination,
the dossier appears to
satisfy the data and information requirements of Annex
II to the Directive. Further, they believe that the dossier
contains data and information required by Annex III to
the Directive in respect of at least one plant-protection

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 57, 2.3.2000, p. 28.

(7)

(8)

(9)

(10)

(11)

product containing the active substances concerned.
Subsequently,
in accordance with the provisions of
Article 6(2), the dossiers were submitted by the appli-
cant to the Commission and other Member States.

for RH-7281 (zoxamide), B-41; E-187
The dossier
and
(milbemectin),
AEF130360 (foramsulfuron) were
referred to the
Standing Committee on Plant Health on 31 May 2000.

(pyraclostrobin)

BAS500F

Article 6(3) of the Directive requires it being confirmed
at the level of the Community that each dossier is to be
considered as satistying in principle the data and infor-
mation requirements provided for in Annex II and, for at
least one plant-protection product containing the active
substance concerned,

in Annex III to the Directive.

Such confirmation is necessary in order to pursue the
detailed examination of the dossier as well as in order to
open to Member States the possibility of granting provi-
sional
authorisation for plant-protection products
containing this active substance in due respect of the
conditions laid down in Article 8(1) of the Directive, and
in particular the condition to make a detailed assessment
of the active substances and the plant-protection prod-
ucts with regard to the requirements of the Directive.

Such Decision does not prejudice the right of
the
Commission to request the applicant to submit further
data or information, to the rapporteur Member State
in order to clarify certain points in the
concerned,
dossier, The submission of
further data necessary to
clarify the dossier shall not affect the time limit for the
submission of the report referred to under recital 12.

The Member States and the Commission agree that the
United Kingdom will pursue the detailed examination
for the dossier for RH-7281 (zoxamide), that the Nether-
lands will pursue the detailed examination for
the
dossier for B-41; E-187 (milbemectin) and that Germany
will pursue the detailed examination for the dosssiers
BAS500F (pyraclostrobin) and AEF130360 (foramsul-
furon).

12.9.2000

EN

Official Journal of the European Communities

L 230/15

(12)

The United Kingdom, the Netherlands and Germany will
report the conclusions of their examinations accompa-
nied by any recommendations on inclusion or non-
inclusion and any conditions 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.

(13)

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 following dossiers satisfy, in principle, the data and infor-
mation requirements provided for in Annex II and, for at least
one plant-protection product containing the active substance
concerned, in Annex III to the Directive, taking into account
the uses proposed:

1. the dossier submitted by Rohm and Haas France SA to the
Commission and the Member States with a view to the
inclusion of RH-7281 (zoxamide) as active substance in
Annex I to Directive 91/414/EEC and which was referred to
the Standing Committee on Plant Health on 31 May 2000;

2. the dossier submitted by Sankyo Company Limited on the
Commission and the Member States with a view to the
inclusion of B-41; E-187 (milbemectin) as active substance
in Annex I to Directive 91/414/EEC and which was referred
to the Standing Committee on Plant Health on 31 May
2000;

3. the dossier submitted by BASF AG to the Commission and
the Member States with a view to the inclusion of BAS500F
(pyraclostrobin) as active substance in Annex I to Directive
referred to the Standing
91/414/EEC and which was
Committee on Plant Health on 31 May 2000;

4. the dossier submitted by Aventis GmbH to the Commission
and the Member States with a view to the inclusion of
AEF130360 (foramsulfuron) as active substance in Annex I
to Directive 91/414/EEC and which was referred to the
Standing Committee on Plant Health on 31 May 2000.

This Decision is addressed to the Members States.

Article 2

Done at Brussels, 6 September 2000.

For the Commission

David BYRNE

Member of the Commission