Commission Directive 2005/54/EC of 19 September 2005 amending Council Directive 91/414/EEC to include tribenuron as active substance   (Text with EEA relevance)
Date: 2005-09-19
Institutions: European Commission
Subjects: market approval, marketing standard, plant health product, toxicology

20.9.2005

EN

Official Journal of the European Union

L 244/21

COMMISSION DIRECTIVE 2005/54/EC

of 19 September 2005

amending Council Directive 91/414/EEC to include tribenuron as active substance

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Health and finalised on 15 February 2005 in the format
of the Commission review report for tribenuron.

Having regard to the Treaty
Community,

establishing the European

(4)

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:

(5)

(1)

(2)

(3)

Commission Regulations (EC) No 451/2000 (2) and (EC)
No 703/2001 (3)
lay down the detailed rules for the
implementation of the second stage of the programme
of work referred to in Article 8(2) of Directive
91/414/EEC and establish a list of active substances to
be assessed, with a view to their possible inclusion in
Annex I
includes
tribenuron.

to Directive 91/414/EEC. That

list

For tribenuron the effects on human health and the
environment have been assessed in accordance with the
provisions laid down in Regulations (EC) No 451/2000
and (EC) No 703/2001 for a range of uses proposed by
the notifiers. Moreover, those regulations designate the
Rapporteur Member States which have to submit the
relevant assessment
reports and recommendations to
the European Food Safety Authority (EFSA) in accordance
with Article 8(1) of Regulation (EC) No 451/2000. For
tribenuron (in the
the
Rapporteur Member State was Sweden and all relevant
information was submitted on 19 June 2003.

tribenuron-methyl)

form of

The assessment report has been peer reviewed by the
Member States and the EFSA within its Working Group
Evaluation and presented to the Commission on
19 October 2004 in the format of the EFSA Scientific
Report for tribenuron (4). This report has been reviewed
by the Member States and the Commission within the
Standing Committee on the Food Chain and Animal

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation
(EC) No 396/2005 of the European Parliament and of the Council
(OJ L 70, 16.3.2005, p. 1).

(2) OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regu-

lation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

(3) OJ L 98, 7.4.2001, p. 6.
(4) EFSA Scientific Report

the
pesticide risk assessment of tribenuron (finalised: 19 October 2004).

(2004) 15, 1-52o, Peer

review of

(b)

and

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

containing

substance

active

It

A reasonable period should be allowed to elapse before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
the new requirements
prepare
which will result from the inclusion.

themselves

to meet

six months after

in Annex I, Member States

containing tribenuron to ensure

(6) Without prejudice to the obligations defined by Directive
including an active
91/414/EEC as a consequence of
should be
substance
inclusion to
allowed a period of
authorisations of plant protection
review existing
the
products
in
requirements laid down by Directive 91/414/EEC,
particular in its Article 13 and the relevant conditions
set out in Annex I, are satisfied. Member States should
vary,
existing
authorisations,
in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
deadline, a longer period should be provided for the
submission and assessment of the complete Annex III
dossier of each plant protection product
for each
intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC.

replace or withdraw, as appropriate,

that

(7)

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Commission Regulation (EEC)
No 3600/92 (5) has shown that difficulties can arise in
interpreting the duties of holders of existing authori-
sations in relation to access to data. In order to avoid
further difficulties it therefore appears necessary to clarify
the duties of the Member States, especially the duty to
verify that the holder of an authorisation demonstrates
access to a dossier satisfying the requirements of Annex
II to that Directive. However, this clarification does not
impose any new obligations on Member States or holders
of authorisations compared to the directives which have
been adopted until now amending Annex I.

(5) OJ L 366, of 15.12.1992, p. 10. Regulation as last amended by
Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

L 244/22

EN

Official Journal of the European Union

20.9.2005

(8)

(9)

is

therefore
It
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

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

the latest, Member States

By derogation from paragraph 1, for each authorised plant
2.
protection product containing tribenuron as either the only
active substance or as one of several active substances all of
to Directive 91/414/EEC by
which were listed in Annex I
re-
28 February 2006 at
evaluate the product in accordance with the uniform principles
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 and taking into account part B of
the entry in
Annex I to that Directive concerning tribenuron. 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 Directive 91/414/EEC.

shall

Article 2

Following that determination Member States shall:

Member States shall adopt and publish by 31 August 2006 at
the latest 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 September 2006.

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

(a)

in the case of a product containing tribenuron as the only
active substance, where necessary, amend or withdraw the
authorisation by 28 February 2010 at the latest; or

active

substances, where necessary,

(b) in the case of a product containing tribenuron as one of
amend or
several
withdraw the authorisation by 28 February 2010 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.

Article 4

Article 3

This Directive shall enter into force on 1 March 2006.

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations
containing
tribenuron as an active substance by 31 August 2006.

protection

products

plant

for

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to tribenuron are met, with
the entry
the exception of
concerning that active substance, and that the holder of the
authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
the conditions of Article 13 of that Directive.

those identified in part B of

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 19 September 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

20.9.2005

EN

Official Journal of the European Union

L 244/23

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