2001/529/EC: Commission Decision of 12 July 2001 making it possible for Member States to extend provisional authorisations granted for the new active substances benzoic acid and BAS 615H (cinidon-ethyl) (Text with EEA relevance) (notified under document number C(2001) 1861)
Date: 2001-07-12
Institutions: European Commission
Subjects: acid, market approval, pharmaceutical product, plant health product

13.7.2001

EN

Official Journal of the European Communities

L 191/47

COMMISSION DECISION

of 12 July 2001

making it possible for Member States to extend provisional authorisations granted for the new
active substances benzoic acid and BAS 615H (cinidon-ethyl)

(notified under document number C(2001) 1861)

(Text with EEA relevance)

(2001/529/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 2001/
36/EC (2) and in particular Article 8(1), fourth subparagraph,
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 use in plant-protection
products.

The applicant Menno Chemie Vertriebs-Ges. submitted a
dossier for the new active substance benzoic acid to
Germany on 25 May 1998.

The applicant BASF Plc submitted a dossier for the new
active substance BAS 615H to the United Kingdom on
28 April 1997.

In accordance with the provisions of Article 6(3) of the
the Commission confirmed in its Decision
Directive,
98/676/EC (3) that the dossier submitted for benzoic
acid could be considered as satisfying, in principle, the
data and information requirements of Annex II and for a
plant
active
containing
substance, of Annex III to the Directive.

protection

product

this

In accordance with the provisions of Article 6(3) of the
Directive,
the Commission confirmed in its Decision
98/398/EC (4) that the dossier submitted for BAS 615H
(cinidon-ethyl) could be considered as satisfying, in prin-
ciple, the data and information requirements of Annex II
and for a plant-protection product containing this active
substance, of Annex III to the Directive.

Such confirmation of data and information is necessary
to permit a detailed examination of the dossier and to
allow Member States the possibility of granting provi-
sional authorisations, for a period up to three years, for
active
plant-protection

containing

products

the

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 164, 20.6.2001, p. 1.
(3) OJ L 317, 26.11.1998, p. 47.
(4) OJ L 176, 20.6.1998, p. 34.

substance concerned, while complying with the condi-
tions laid down in Article 8(1) of the Directive and, in
particular, the condition relating to the detailed assess-
ment of the active substance and the plant-protection
product in the light of the requirements laid down by
the Directive.

(7)

(8)

(9)

For benzoic acid the effects on human health and the
environment are being assessed, in accordance with the
provisions of Article 6(2) and (4) of the Directive, for the
uses proposed by the applicant. Germany acting as
nominated rapporteur Member State submitted to the
Commission on 12 December 2000 the draft assessment
is being
report
reviewed by the Member States and the Commission
within the framework of the Standing Committee on
Plant Health and in Working Groups thereof.

submitted report

concerned. The

For BAS 615H (cinidon-ethyl) the effects on human
health and the environment are being assessed,
in
accordance with the provisions of Article 6(2) and (4) of
the Directive, for the uses proposed by the applicant.
The United Kingdom acting as nominated rapporteur
Member State submitted to the Commission on 2
November 1998 the draft assessment report concerned.
The submitted report is being reviewed by the Member
States and the Commission within the framework of the
Standing Committee on Plant Health and in working
groups thereof.

It will not be possible to complete the evaluation of the
dossiers within three years of the adoption of the Deci-
sions on completeness referred to above because the
examination of the dossiers after submission of the draft
assessment reports by the respective rapporteur Member
States has taken longer than three years.

(10) Member States

should be given the possibility of
prolonging provisional authorisations granted of plant
protection products containing these active substances
for a period of 12 months in accordance with the provi-
sions of Article 8 of the Directive so as to enable exam-
ination of the dossiers to continue. It is expected that
within 12 months the completion of the evaluation and
decision-making process with respect to a decision on
possible Annex I
the active
substances concerned will have been completed.

inclusion for each of

L 191/48

EN

Official Journal of the European Communities

13.7.2001

(11)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
on Plant Health,

Article 2

This Decision is addressed to the Member States.

HAS ADOPTED THIS DECISION:

Article 1

Member States may extend provisional authorisations for plant-
protection products containing benzoic acid or BAS 615H
(cinidon-ethyl) for a period not exceeding 12 months from the
date of adoption of this Decision.

Done at Brussels, 12 July 2001.

For the Commission

David BYRNE

Member of the Commission