Commission Directive 2004/65/EC of 26 April 2004 amending Directive 2003/68/EC as regards time limits (Text with EEA relevance)
Date: 2004-04-26
Institutions: European Commission
Subjects: market approval, plant health product

28.4.2004

EN

Official Journal of the European Union

L 125/43

COMMISSION DIRECTIVE 2004/65/EC

of 26 April 2004

amending Directive 2003/68/EC as regards time limits

(Text with EEA relevance)

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(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Commission Directive 2003/68/EC (2) amends Council
Directive 91/414/EEC to include trifloxystrobin, carfen-
trazone-ethyl, mesotrione, fenamidone and isoxaflutole
as active substances in Annex I to that Directive.

After inclusion of a new active substance, Member States
should be allowed a reasonable period to implement the
provisions of Directive 91/414/EEC as regards plant
protection products containing this active substance and
in particular to review existing provisional authorisations
and, by the end of this period at the latest, to transform
those authorisations into full authorisations, to amend
them or to withdraw them in accordance with the provi-
sions of Directive 91/414/EEC.

The timelines for the implementation given in Directive
2003/68 are not in line with the timelines given for
other new active substances. In order to harmonise the
approach for all substances under the current review
phase, any considerable difference between the timelines
applicable for different new active substances should be
avoided.

It is therefore appropriate to amend Directive 2003/68/
EC accordingly.

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Article 3 of Directive 2003/68/EC is amended as follows:

Paragraph 2 is replaced by the following:

For

‘2.
each authorised plant protection product
containing trifloxystrobin, carfentrazone-ethyl, mesotrione,
the only active
isoxaflutole as either
fenamidone or

substance or as one of several active substances, all of
which were listed in Annex I to Directive 91/414/EEC, by
30 September 2003 at the latest, Member States shall re-
evaluate the product in accordance with the uniform prin-
ciples provided for in Annex VI to Directive 91/414/EEC,
on the basis of a dossier satisfying the requirements of
Annex III to that Directive. On the basis of that evaluation,
they shall determine whether the product satisfies the
conditions set out in Article 4(1)(b), (c), (d) and (e) of Direc-
tive 91/414/EEC.

Following that determination Member States shall:
(a) in the case of a product containing trifloxystrobin,
carfentrazone-ethyl, mesotrione, fenamidone or isoxa-
flutole as the only active substance, where necessary,
amend or withdraw the authorisation by 31 March
2005 at the latest; or

(b) in the case of a product containing trifloxystrobin,
carfentrazone-ethyl, mesotrione, fenamidone or isoxa-
flutole as one of several active substances, where neces-
sary, amend or withdraw the authorisation by 31
March 2005 or by the date fixed for such an amend-
in the respective Directive or
ment or withdrawal
Directives which added the relevant
substance or
substances to Annex I to Directive 91/414/EEC, which-
ever is the latest.’

Article 2

This Directive shall enter into force on the 20th day after the
date of publication.

Article 3

This Directive is addressed to the Member States.

Done at Brussels, 26 April 2004.

For the Commission

David BYRNE

Member of the Commission

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

sion Directive 2004/30/EC (OJ L 77, 13.3.2004, p. 50).

(2) OJ L 177, 16.7.2003, p. 12.