Commission Directive 2005/34/EC of 17 May 2005 amending Council Directive 91/414/EEC to include etoxazole and tepraloxydim as active substances  (Text with EEA relevance)
Date: 2005-05-17
Institutions: European Commission
Subjects: market approval, plant health product, product safety

18.5.2005

EN

Official Journal of the European Union

L 125/5

COMMISSION DIRECTIVE 2005/34/EC

of 17 May 2005

amending Council Directive 91/414/EEC to include etoxazole and tepraloxydim as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

the Commission review reports for etoxazole and

of
tepraloxydim.

Having regard to the Treaty
Community,

establishing the European

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:

In accordance with Article 6(2) of Directive 91/414/EEC,
France received on 21 April 1998 an application from
Sumitomo Chemical Agro Europe SA for the inclusion of
the active substance etoxazole,
formerly also called
‘etoxazol’,
to Directive 91/414/EEC.
in Annex
Commission Decision 1999/43/EC (2) confirmed that
the dossier was ‘complete’ in the sense that it could be
considered as satisfying, in principle, the data and infor-
mation requirements of Annexes II and III to Directive
91/414/EEC.

I

Spain received an application under Article 6(2) of
Directive 91/414/EEC on 11 September 1997 from
BASF AG for the inclusion of the active substance tepra-
loxydim in Annex
91/414/EEC.
Commission Decision 98/512/EC (3) confirmed that the
dossier was ‘complete’
it could be
considered as satisfying, in principle, the data and infor-
mation requirements of Annexes II and III to Directive
91/414/EEC.

in the sense that

to Directive

I

For those 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 applicants. The
designated rapporteur Member States submitted draft
assessment
reports concerning the substances to the
Commission on 8 October 2001 (etoxazole) and 21
January 2002 (tepraloxydim).

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

The review of etoxazole and tepraloxydim did not reveal
any open questions or concerns, which would have
required a consultation of the Scientific Committee on
Plants or of the European Food Safety Authority.

the

products

protection

containing

It has appeared from the various examinations made that
active
plant
substances concerned may be expected to satisfy,
in
general, the requirements laid down in Article 5(1)(a)
in
and (b) and Article 5(3) of Directive 91/414/EEC,
particular with regard to the uses which were examined
and detailed in the Commission review report.
is
therefore appropriate to include etoxazole and tepra-
loxydim in Annex I,
in all
Member States the authorisations of plant protection
products containing these active substances may be
granted in accordance with the provisions of
that
Directive.

in order to ensure that

It

After inclusion of etoxazole and tepraloxydim in Annex I
to Directive 91/414/EEC, Member States
should be
allowed a reasonable period to implement the provisions
of Directive 91/414/EEC as regards plant protection
products containing those substances 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 provisions of
Directive 91/414/EEC.

is

It
therefore
91/414/EEC accordingly.

appropriate

to

amend Directive

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

The draft assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health. The
review was finalised on 3 December 2004 in the format

HAS ADOPTED THIS DIRECTIVE:

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

2005/25/EC (OJ L 90, 8.4.2005, p. 1).

(2) OJ L 14, 19.1.1999, p. 30.
(3) OJ L 228, 15.8.1998, p. 35.

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

L 125/6

EN

Official Journal of the European Union

18.5.2005

Article 2

the latest

1. Member States shall adopt and publish by 30 November
2005 at
the laws, regulations and administrative
provisions necessary to comply with this Directive. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and
this Directive.

They shall apply those provisions from 1 December 2005.

When Member States adopt those provisions, they shall contain
a reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

1. Member States shall review the authorisation for each
plant protection product containing etoxazole or tepraloxydim
to ensure that the conditions relating to those active substances
set out in Annex I to Directive 91/414/EEC are complied with.
Where necessary, they shall amend or withdraw authorisations
in accordance with Directive 91/414/EEC by 30 November
2005 at the latest.

2.
For each authorised plant protection product containing
etoxazole or tepraloxydim as either the only active substance or
as one of several active substances all of which were listed in
Annex I to Directive 91/414/EEC by 31 May 2005 at the latest,
Member States shall re-evaluate the product in accordance with
the uniform principles provided for in Annex VI to Directive
the
91/414/EEC, on the basis of

a dossier

satisfying

requirements of Annex III to that Directive. On the basis of
that evaluation,
the product
satisfies the conditions set out in Article 4(1)(b), (c), (d) and
(e) of Directive 91/414/EEC.

they shall determine whether

Following that determination Member States shall:

(a)

in the case of a product containing etoxazole or tepra-
loxydim as the only active substance, where necessary,
amend or withdraw the authorisation by 30 November
2006 at the latest; or

(b) in the case of a product containing etoxazole or tepra-
substances, where
loxydim as one of
several
necessary, amend or withdraw the authorisation by 30
November 2006 or by the date fixed for
such an
amendment or withdrawal
in the respective Directive or
Directives which added the relevant substance or substances
to Annex I to Directive 91/414/EEC, whichever is the latest.

active

Article 4

This Directive shall enter into force on 1 June 2005.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 17 May 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

18.5.2005

EN

Official Journal of the European Union

L 125/7

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