2004/131/EC: Commission Decision of 9 February 2004 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of FEN 560 and penoxsulam in Annex I to Council Directive 91/414/EEC (Text with EEA relevance) (notified under document number C(2004) 274)
Date: 2004-02-09
Institutions: European Commission
Subjects: marketing, marketing standard, pharmaceutical product, plant health product

L 37/34

EN

Official Journal of the European Union

10.2.2004

COMMISSION DECISION

of 9 February 2004

recognising in principle the completeness of the dossiers submitted for detailed examination in
view of the possible inclusion of FEN 560 and penoxsulam in Annex I to Council Directive 91/
414/EEC

(notified under document number C(2004) 274)

(Text with EEA relevance)

(2004/131/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), 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.

for

A dossier
the active substance FEN 560 was
submitted by Société occitane de fabrications et de tech-
nologies to the French authorities on 24 June 2003 with
an application to obtain its inclusion in Annex I to
Directive 91/414/EEC. For penoxsulam a dossier was
submitted by Dow AgroSciences to the authorities of
Italy on 29 November 2002 with an application to
obtain its inclusion in Annex I to Directive 91/414/EEC.

II

The French and the Italian authorities have indicated to
the Commission that, on preliminary examination, the
dossiers for the active substances concerned appear to
satisfy the data and information requirements set out in
Annex
to Directive 91/414/EEC. The dossiers
submitted appear also to 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 concerned. In accordance
with Article 6(2) of Directive 91/414/EEC, the dossiers
were subsequently forwarded by the respective appli-
cants to the Commission and other Member States, and
were referred to the Standing Committee on the Food
Chain and Animal Health.

ments provided for in Annex II and, for at least one
plant protection product containing the active substance
concerned,
the requirements set out in Annex III to
Directive 91/414/EEC.

(5)

(6)

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.

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 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

(4)

By this Decision it should be formally confirmed at
Community level
the dossiers are considered as
satisfying, in principle, the data and information require-

that

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation

(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

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 by 10 February 2005 at the latest.

10.2.2004

EN

Official Journal of the European Union

L 37/35

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 9 February 2004.

For the Commission

David BYRNE

Member of the Commission

ANNEX

Active substances concerned by this Decision

No

1

2

Common name, CIPAC identification
number

Applicant

Date of
application

Rapporteur
Member State

FEN 560
CIPAC-No not yet available

Société occitane de fabrications et
de technologies

24.6.2003

Penoxsulam
CIPAC-No not yet available

Dow AgroSciences

29.11.2002

FR

IT