Commission Directive 2008/41/EC of 31 March 2008 amending Council Directive 91/414/EEC to include chloridazon as active substance (Text with EEA relevance)
Date: 2008-03-31
Institutions: European Commission
Subjects: chemical product, marketing standard, pharmaceutical product, plant health control, plant health legislation, plant health product

L 89/12

EN

Official Journal of the European Union

1.4.2008

DIRECTIVES

COMMISSION DIRECTIVE 2008/41/EC

of 31 March 2008

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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,

(4)

Whereas:

Commission Regulations (EC) No 451/2000 (2) and (EC)
No 1490/2002 (3) lay down the detailed rules for the
implementation of the third 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 to
Directive 91/414/EEC. That list includes chloridazon.

(5)

(1)

(2)

For chloridazon 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 1490/2002 for a range of uses proposed by
the notifier. Moreover, those Regulations designate the
the
rapporteur Member States which have to submit
relevant assessment
reports and recommendations to
the European Food Safety Authority (EFSA) in accordance
with Article 10(1) of Regulation (EC) No 1490/2002. For
chloridazon the rapporteur Member State was Germany
and all relevant information was submitted on 16 March
2005.

(3)

The assessment report has been peer reviewed by the
Member States and the EFSA and presented to the
the
Commission on 27 July 2007 in the format of

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

last amended by

Commission Directive 2008/40/EC (OJ L 87, 29.3.2008, p. 5).
(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 224, 21.8.2002, p. 23. Regulation as last amended by Regu-

lation (EC) No 1095/2007 (OJ L 246, 21.9.2007, p. 19).

by

the Member

EFSA Scientific Report for chloridazon (4). This report has
the
been reviewed
Commission within the Standing Committee on the
Food Chain and Animal Health and finalised on
4 December 2007 in the format of the Commission
review report for chloridazon.

States

and

(b)

and

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

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
prepare
the new requirements
which will result from the inclusion.

themselves

to meet

six months after

in Annex I, Member States

(6) Without prejudice to the obligations defined by Directive
91/414/EEC as a consequence of
including an active
substance
should be
allowed a period of
inclusion to
review existing
authorisations of plant protection
products containing chloridazon to ensure that
the
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
in accordance with the provisions of
authorisations,
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,

(4) EFSA Scientific Report (2007) 108, 1-82, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
chloridazon (finalised 27 July 2007, version of 31 July 2007).

1.4.2008

EN

Official Journal of the European Union

L 89/13

(7)

(8)

(9)

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 (1) has shown that difficulties can arise in inter-
preting the duties of holders of existing authorisations in
relation to access to data. In order to avoid further diffi-
culties, 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 authori-
sations compared to the directives which have been
adopted until now amending Annex I.

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

Article 2

the

laws,

regulations

Member States shall adopt and publish by 30 June 2009 at the
and administrative provisions
latest
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.

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to chloridazon are met, with
the exception of
the entry
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

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing chloridazon as
either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
the latest, Member
91/414/EEC by 31 December 2008 at
in accordance with the
States shall re-evaluate the product
to Directive
uniform principles provided for
91/414/EEC, on the basis of
the
requirements of Annex III to that Directive and taking into
account part B of
to that Directive
the entry in Annex I
concerning chloridazon. 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.

in Annex VI
a dossier

satisfying

Following that determination Member States shall:

(a)

in the case of a product containing chloridazon as the only
active substance, where necessary, amend or withdraw the
authorisation by 31 December 2012 at the latest; or

active

substances, where necessary,

(b) in the case of a product containing chloridazon as one of
several
amend or
withdraw the authorisation by 31 December 2012 or by
the date fixed for such an amendment or withdrawal in the
respective Directive or Directives which added the relevant
substance
to Directive
91/414/EEC, whichever is the latest.

to Annex

substances

or

I

Article 4

They shall apply those provisions from 1 July 2009.

This Directive shall enter into force on 1 January 2009.

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.

Article 5

This Directive is addressed to the Member States.

Article 3

Done at Brussels, 31 March 2008.

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing chlo-
ridazon as an active substance by 30 June 2009.

For the Commission

Androulla VASSILIOU
Member of the Commission

(1) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regu-

lation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

L 89/14

EN

Official Journal of the European Union

1.4.2008

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