Commission Decision of 18 December 2006 allowing Member States to extend provisional authorisations granted for the new active substance tritosulfuron (notified under document number C(2006) 6573) (Text with EEA relevance)
Date: 2006-12-18
Institutions: European Commission
Subjects: EU control, market approval, marketing, pharmaceutical product, plant health product

L 32/164

EN

Official Journal of the European Union

6.2.2007

COMMISSION DECISION

of 18 December 2006

allowing Member States to extend provisional authorisations granted for the new active substance
tritosulfuron

(notified under document number C(2006) 6573)

(Text with EEA relevance)

(2007/67/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Commu-
nity,

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 the fourth subparagraph of Article 8
(1) thereof,

Whereas:

(1)

In accordance with Article 6(2) of Directive 91/414/EEC, in
June 2001 Germany received an application from BASF AG
for the inclusion of the active substance tritosulfuron in
Annex I to Directive 91/414/EEC. Commission Decision
2002/268/EC (2) 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
that Directive.

(2) Confirmation of

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

(3)

For this active substance, 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 applicant. The rapporteur
Member State submitted the draft assessment report to the
Commission on 5 September 2002.

(4)

Following submission of the draft assessment report by the
rapporteur Member State, it has been found to be necessary
to request further information from the applicant and to

have the Rapporteur Member State examine that informa-
tion and submit its assessment. Therefore, the examination
of the dossier is still ongoing and it will not be possible to
complete the evaluation within the timeframe provided for
in Directive 91/414/EEC.

(5) 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
containing the active
for plant protection products
substance concerned for a period of 24 months in
accordance with the provisions of Article 8 of Directive
91/414/EEC so as to enable the examination of the dossier
to continue. It is expected that the evaluation and decision-
making process with respect to a decision on possible
Annex I
tritosulfuron will have been
completed within 24 months.

inclusion for

(6)

in this Decision are in
The measures provided for
accordance 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 tritosulfuron for a period not
exceeding 24 months from the date of adoption of this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 18 December 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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

2006/75/EC (OJ L 248, 12.9.2006, p. 3).

(2) OJ L 92, 9.4.2002, p. 34.