Commission Directive 2006/74/EC of 21 August 2006 amending Council Directive 91/414/EEC to include dichlorprop-P, metconazole, pyrimethanil and triclopyr as active substances   (Text with EEA relevance)
Date: 2006-08-21
Institutions: European Commission
Subjects: application of EU law, herbicide, marketing standard, pesticide, plant health legislation, plant health product

30.8.2006

EN

Official Journal of the European Union

L 235/17

COMMISSION DIRECTIVE 2006/74/EC

of 21 August 2006

amending Council Directive 91/414/EEC to include dichlorprop-P, metconazole, pyrimethanil and
triclopyr as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Member State was Ireland and all relevant information
was submitted on 21 November 2003.

Having regard to the Treaty
Community,

establishing the European

(3)

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:

(4)

(1)

(2)

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
to Directive 91/414/EEC. That
dichlorprop-P, metconazole, pyrimethanil and triclopyr.

list

the relevant assessment

laid down in Regulations

For those active substances the effects on human health
and the environment have been assessed in accordance
with the provisions
(EC)
No 451/2000 and (EC) No 703/2001 for a range of
uses proposed by the notifier. Moreover, those Regu-
lations designate the rapporteur Member States which
reports and
have to submit
Safety
recommendations
to
Authority (EFSA)
in accordance with Article 8(1) of
Regulation (EC) No 451/2000. For dichlorprop-P the
rapporteur Member State was Denmark and all relevant
information was submitted on 5 November 2003. For
metconazole the rapporteur Member State was Belgium
and all
submitted on 27
information was
January 2004. For pyrimethanil the rapporteur Member
State was Austria and all
information was
submitted on 15 April 2004. For triclopyr the rapporteur

European

relevant

relevant

Food

the

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

last amended by
Commission Directive 2006/64/EC (OJ L 206, 27.7.2006, p. 107).
(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.

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 14 December 2005 for triclopyr and
on 13 January 2006 for dichlorprop-P, metconazole
in the format of the EFSA Scientific
and pyrimethanil
Reports (4). These reports have been reviewed by the
Member
the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 23 May 2006 in the format of
the Commission review reports for dichlorprop-P, metco-
nazole, pyrimethanil and triclopyr.

States

and

and

in general,
5(1)(a)

It has appeared from the various examinations made that
containing dichlorprop-P,
plant protection products
triclopyr may
metconazole,
be
and
pyrimethanil
the requirements laid
expected to satisfy,
of Directive
in Article
down
91/414/EEC,
in particular with regard to the uses
which were examined and detailed in the Commission
review reports. It is therefore appropriate to include these
active substances in Annex I, in order to ensure that in
all Member States the authorisations of plant protection
products containing these active substances can be
granted in accordance with the provisions of
that
Directive.

(b)

(5) Without prejudice to that conclusion, it is appropriate to
obtain further information on certain specific points
concerning dichlorprop-P, pyrimethanil and triclopyr.
Article 6(1) of Directive 91/414/EEC provides
that
inclusion of a substance in Annex I may be subject to
conditions. Therefore it is appropriate to require that
should be
dichlorprop-P, pyrimethanil and triclopyr
subjected to further testing for confirmation of the risk
assessment for some issues and that such studies should
be presented by the notifiers.

(4) EFSA Scientific Report (2006) 52, 1-67, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
dichlorprop-P (finalised: 13 January 2006).
EFSA Scientific Report (2006) 64, 1-71, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
metconazole (finalised: 13 January 2006).
EFSA Scientific Report (2006) 61, 1-70, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
pyrimethanil (finalised: 13 January 2006).
EFSA Scientific Report (2005) 56, 1-103, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
triclopyr (finalised: 14 December 2005).

L 235/18

EN

Official Journal of the European Union

30.8.2006

(6)

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

(7) 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
authorisations of plant protection
review existing
products containing dichlorprop-P, metconazole, pyri-
methanil and triclopyr to ensure that the requirements
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
replace or
are satisfied. Member States should vary,
in
withdraw, as appropriate, existing authorisations,
accordance
Directive
91/414/EEC. By way of 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.

provisions

with

the

of

(8)

(9)

(10)

inclusions

The experience gained from previous
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 interpreting the duties of holders of existing
authorisations 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 demon-
strates 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
now
directives which
amending Annex I.

adopted

been

until

have

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

(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).

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

Member States shall adopt and publish by 30 November 2007
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 December 2007.

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 3

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
containing
authorisations
as
dichlorprop-P, metconazole, pyrimethanil
active substances by 30 November 2007.

and triclopyr

protection

products

plant

for

By that date they shall in particular verify that the conditions in
Annex I
to that Directive relating to dichlorprop-P, metco-
nazole, pyrimethanil and triclopyr are met, with the exception
of those identified in part B 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.

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing dichlorprop-P,
metconazole, pyrimethanil and triclopyr 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 2007 at the latest, Member States shall re-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 dichlorprop-P, metconazole, pyrimethanil
and triclopyr respectively. 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.

30.8.2006

EN

Official Journal of the European Union

L 235/19

Following that determination Member States shall:

Article 4

(a)

in the case of a product containing dichlorprop-P, metco-
nazole, pyrimethanil and triclopyr as
the only active
substance, where necessary, amend or withdraw the author-
isation by 31 May 2011 at the latest; or

This Directive shall enter into force on 1 June 2007.

Article 5

This Directive is addressed to the Member States.

(b) in the case of a product containing dichlorprop-P, metco-
nazole, pyrimethanil and triclopyr as one of several active
substances, where necessary, amend or withdraw the
authorisation by 31 May 2011 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,
or
whichever is the latest.

to Annex I

substances

Done at Brussels, 21 August 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 235/20

EN

Official Journal of the European Union

30.8.2006

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