2002/658/EC: Commission Decision of 14 August 2002 allowing Member States to extend provisional authorisations granted for the new active substances benzoic acid, carvone, mepanipyrim, oxadiargyl and trifloxystrobin (Text with EEA relevance) (notified under document number C(2002) 3048)
Date: 2002-08-14
Institutions: European Commission
Subjects: market approval, pharmaceutical legislation, pharmaceutical product, plant health legislation, plant health product

17.8.2002

EN

Official Journal of the European Communities

L 221/37

COMMISSION DECISION

of 14 August 2002

allowing Member States to extend provisional authorisations granted for the new active substances
benzoic acid, carvone, mepanipyrim, oxadiargyl and trifloxystrobin

(notified under document number C(2002) 3048)

(Text with EEA relevance)

(2002/658/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/
37/EC (2), and in particular the fourth subparagraph of Article
8(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

In accordance with Article 6(2) of Directive 91/414/EEC,
in May 1998 Germany received an application from
Menno Chemie Vertriebsgesellschaft mbH for the inclu-
sion of the active substance benzoic acid in Annex I to
Directive 91/414/EEC. Commission Decision 98/676/
EC (3) confirmed that the dossier was complete and could
be considered as satisfying,
in principle, the data and
information requirements of Annex II and Annex III to
the Directive.

The Netherlands received a similar application in March
1997 from Luxan BV concerning carvone. This dossier
was declared complete by Commission Decision 1999/
610/EC (4).

Italy received a similar application in October 1997 from
Kumiai Chemical Industry Co., Ltd concerning mepani-
pyrim. This dossier was also declared complete by Deci-
sion 98/676/EC.

Furthermore, Italy received a similar application in June
1997 from Rhône Poulenc Agro SpA (now Bayer Crop
Sciences)
concerning oxadiargyl. This dossier was
declared complete by Commission Decision 98/398/
EC (5).

The United Kingdom received a similar application in
January 1998 from Novartis Crop Protection UK Ltd
(now Syngenta) concerning trifloxystrobin. This dossier
was declared complete by Commission Decision 1999/
43/EC (6).

Confirmation of the completeness of the dossiers was
necessary in order to allow them to be examined in
detail and to allow Member States the possibility of
granting provisional authorisations, for periods up to
three years, for plant protection products containing the
active substances concerned, while complying with the
conditions laid down in Article 8(1) of Directive 91/414/

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 117, 4.5.2002, p. 10.
(3) OJ L 317, 26.11.1998, p. 47.
(4) OJ L 242, 14.9.1999, p. 29.
(5) OJ L 176, 20.6.1998, p. 34.
(6) OJ L 14, 19.1.1999, p. 30.

(7)

(8)

(9)

in particular,

EEC and,
the condition relating to the
detailed assessment of the active substance and the plant
protection product in the light of the requirements laid
down by the Directive.

For these active substances, the effects on human health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of Directive
91/414/EEC, for the uses proposed by the respective
applicants. The rapporteur Member States submitted the
draft assessment reports to the Commission on 12
December 2000 for benzoic acid, on 16 October 2000
for carvone, on 12 July 2000 for mepanipyrim, on 20
July 1999 for oxadiargyl, and on 19 September 2000 for
trifloxystrobin.

It will not be possible to complete the evaluation of the
dossiers within the timeframe set by the relevant deci-
sions on completeness, because the examination of the
dossiers is still ongoing after submission of the draft
assessment reports by the respective rapporteur Member
States.

As the evaluation so far has not identified any reason for
immediate concern, Member States should be given the
possibility of prolonging provisional
authorisations
granted for plant protection products containing the
active substances concerned for a period of 24 months
in accordance with the provisions of Article 8 of Direc-
tive 91/414/EEC so as to enable the examination of the
dossiers to continue. It is expected that the evaluation
and decision-making process with respect to a decision
on possible Annex I inclusion for each of the active
substances concerned will have been completed within
24 months.

(10)

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

Member States may extend provisional authorisations for plant
protection products containing benzoic acid, carvone, mepani-
pyrim, oxadiargyl and trifloxystrobin for a period not exceeding
24 months from the date of adoption of this Decision.

L 221/38

EN

Official Journal of the European Communities

17.8.2002

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 14 August 2002.

For the Commission

David BYRNE

Member of the Commission