Commission Directive 2006/64/CE of  18 July 2006  amending Council Directive 91/414/EEC to include clopyralid, cyprodinil, fosetyl and trinexapac as active substances   (Text with EEA relevance)
Date: 2006-07-18
Institutions: European Commission
Subjects: administrative formalities, herbicide, marketing standard, pesticide, plant health product, testing

27.7.2006

EN

Official Journal of the European Union

L 206/107

COMMISSION DIRECTIVE 2006/64/CE

of 18 July 2006

amending Council Directive 91/414/EEC to include clopyralid, cyprodinil, fosetyl and trinexapac as
active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

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 mar-
ket (1), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

Commission Regulations (EC) No 451/2000 (2) and (EC)
No 703/2001 (3) lay down the detailed rules for the imple-
mentation 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 to Directive
91/414/EEC. That list includes clopyralid, cyprodinil, fos-
etyl and trinexapac.

For those active substances 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 notifier. Moreover, those Regulations des-
ignate the rapporteur Member States which have to sub-
mit the relevant assessment reports and recommendations
to the European Food Safety Authority (EFSA) in accor-
dance with Article 8(1) of Regulation (EC) No 451/2000.
For clopyralid the rapporteur Member State was Finland
and all relevant information was submitted on 2 Decem-
ber 2003. For cyprodinil and fosetyl the rapporteur Mem-
ber State was France and all relevant information was
submitted on 16 January 2004 and 20 October 2003
respectively. For trinexapac the rapporteur Member State
was The Netherlands and all relevant information was sub-
mitted on 7 November 2003.

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

Directive 2006/45/EC (OJ L 130, 18.5.2006, p. 27).

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

(EC) No 1 044/2003 (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 Com-
mission on 14 December 2005 in the format of the EFSA
Scientific Reports for clopyralid, cyprodinil, fosetyl and
trinexapac (4). These reports have been reviewed by the
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health and
finalised on 4 April 2006 in the format of the Commis-
sion review reports for clopyralid, cyprodinil, fosetyl and
trinexapac.

(4)

It has appeared from the various examinations made that
plant protection products containing clopyralid, cyprodi-
nil, fosetyl and trinexapac may be expected to satisfy, in
general, the requirements laid down in Article 5(1) (a)
and (b) of Directive 91/414/EEC, in particular with regard
to the uses which were examined and detailed in the Com-
therefore appropriate
It
mission review reports.
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.

is

(5) Without prejudice to that conclusion, it is appropriate to
obtain further information on certain specific points con-
cerning clopyralid, cyprodinil and fosetyl. Article 6(1) of
Directive 91/414/EC provides that inclusion of a sub-
stance in Annex I may be subject to conditions. Therefore
it is appropriate to require that clopyralid, cyprodinil and
fosetyl should be subjected to further testing for confirma-
tion of the risk assessment for some issues and that such
studies should be presented by the notifiers.

(4) EFSA Scientific Report (2005) 50, 1-65, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
clopyralid (finalised: 14 December 2005).
EFSA Scientific Report (2005) 51, 1-78, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
cyprodinil (finalised: 14 December 2005).
EFSA Scientific Report (2005) 54, 1-79, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
fosethyl (finalised: 14 December 2005).
EFSA Scientific Report (2005) 57, 1-70, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
trinexapac (finalised: 14 December 2005).

L 206/108

EN

Official Journal of the European Union

27.7.2006

(6)

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

(7) Without prejudice to the obligations defined by Directive
91/414/EEC as a consequence of including an active sub-
stance in Annex I, Member States should be allowed a
period of six months after inclusion to review existing
authorisations of plant protection products containing clo-
pyralid, cyprodinil, fosetyl and trinexapac 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, are satisfied. Member States should vary,
replace or withdraw, as appropriate, existing authorisa-
tions,
in accordance with the provisions of Directive
91/414/EEC. By way of derogation from the above dead-
line, a longer period should be provided for the submis-
sion 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.

(8)

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
interpreting the duties of holders of existing authorisa-
tions in relation to access to data. In order to avoid fur-
ther 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 authori-
sations compared to the directives which have been
adopted until now amending Annex I.

(9)

It is therefore appropriate to amend Directive 91/414/EEC
accordingly.

(10)

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

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

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

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 31 October 2007 at
the latest the laws, regulations and administrative provisions nec-
essary to comply with this Directive. They shall forthwith com-
municate 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 November 2007.

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

Article 3

shall

1. Member States
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing clopy-
ralid, cyprodinil, fosetyl and trinexapac as active substances by
31 October 2007.

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to clopyralid, cyprodinil, fos-
etyl and trinexapac are met, with the exception of those identi-
fied in part B of the entry concerning that active substance, and
that the holder of the authorisation has, or has access to, a dos-
sier satisfying the requirements of Annex II to that Directive in
accordance with the conditions of Article 13 of that Directive.

2.
By way of derogation from paragraph 1, for each autho-
rised plant protection product containing clopyralid, cyprodinil,
fosetyl and trinexapac 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 30 April 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 clopyralid,
cyprodinil, fosetyl and trinexapac respectively. On the basis of
that evaluation, they shall determine whether the product satis-
fies the conditions set out in Article 4(1)(b), (c), (d) and (e) of
Directive 91/414/EEC.

27.7.2006

EN

Official Journal of the European Union

L 206/109

Following that determination Member States shall:

Article 4

(a)

in the case of a product containing clopyralid, cyprodinil,
fosetyl and trinexapac as the only active substance, where
necessary, amend or withdraw the authorisation by 30 April
2011 at the latest;

This Directive shall enter into force on 1 May 2007.

Article 5

or

This Directive is addressed to the Member States.

(b)

in the case of a product containing clopyralid, cyprodinil,
fosetyl and trinexapac as one of several active substances,
where necessary, amend or withdraw the authorisation by
30 April 2011 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.

Done at Brussels, 18 July 2006.

For the Commission
Markos KYPRIANOU
Member of the Commission

L 206/110

EN

Official Journal of the European Union

27.7.2006

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EN

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L 206/111

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