Commission Directive 2007/76/EC of 20 December 2007 amending Council Directive 91/414/EEC to include fludioxonil, clomazone and prosulfocarb as active substances (Text with EEA relevance )
Date: 2007-12-20
Institutions: European Commission
Subjects: exchange of information, herbicide, marketing standard, pesticide, pharmaceutical product, plant health control, plant health legislation, plant health product

L 337/100

EN

Official Journal of the European Union

21.12.2007

DIRECTIVES

COMMISSION DIRECTIVE 2007/76/EC

of 20 December 2007

amending Council Directive 91/414/EEC to include fludioxonil, clomazone and prosulfocarb as
active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

information was submitted on 5 April 2005 and 16
March 2005 respectively. For prosulfocarb the rapporteur
Member State was Sweden and all relevant information
was submitted on 20 April 2005.

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:

(1)

(2)

(EC) No 451/2000 (2) and
Commission Regulations
(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
includes
fludioxonil, clomazone and prosulfocarb.

to Directive 91/414/EEC. That

list

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 1490/2002 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 recommen-
dations to the European Food Safety Authority (EFSA) in
accordance with Article 10(1) of Regulation (EC) No
1490/2002.
the
rapporteur Member State was Denmark and all relevant

clomazone

fludioxonil

and

For

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

last amended by

Commission Directive 2007/52/EC (OJ L 214, 17.8.2007, p. 3).
(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).

(3)

(4)

(5)

on

27

for

2007

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission
fludioxonil,
July
clomazone and prosulfocarb, in the format of the EFSA
Scientific Reports (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 9 October 2007 in the format
of
fludioxonil,
clomazone and prosulfocarb.

the Commission review reports

for

the

products

protection

in general,

requirements

containing
and prosulfocarb may be

It has appeared from the various examinations made that
fludioxonil,
plant
clomazone
expected to
laid down in
satisfy,
Article 5(1)(a) and (b) of Directive 91/414/EEC,
in
particular with regard to the uses which were examined
is
and detailed in the Commission review reports.
therefore appropriate to include these active substances
in Annex I, in order to ensure that in all Member States
the
products
containing these active substances can be granted in
accordance with the provisions of that Directive.

authorisations

protection

plant

of

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

(4) EFSA Scientific Report (2007) 110, 1-85, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
fludioxonil (finalised 27 July 2007).
EFSA Scientific Report (2007) 109, 1-73, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
clomazone (finalised 27 July 2007), version of 3 August 2007.
EFSA Scientific Report (2007) 111, 1-81, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
prosulfocarb (finalised 27 July 2007).

21.12.2007

EN

Official Journal of the European Union

L 337/101

six months after

in Annex I, Member States

(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
products containing fludioxonil, clomazone and prosul-
focarb to ensure that the requirements laid down by
in particular in its Article 13
Directive 91/414/EEC,
in Annex I, are
and the relevant conditions set out
replace or
satisfied. Member
withdraw, as appropriate, existing authorisations,
in
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

should

States

vary,

with

the

of

(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 Regulation (EEC) No 3600/92 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
to a dossier
an authorisation demonstrates
to that
satisfying
Directive. However,
impose
any new obligations on Member States or holders of
authorisations compared to the directives which have
been adopted until now amending Annex I.

this clarification does not

requirements of Annex

access

the

II

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

They shall apply those provisions from 1 May 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 3

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations
containing
fludioxonil, clomazone and prosulfocarb as active substances
by 30 April 2009.

protection

products

plant

for

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to fludioxonil, clomazone and
prosulfocarb 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.

either

the only

and prosulfocarb as

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing fludioxonil,
clomazone
active
substance or as one of several active substances all of which
were listed in Annex I to Directive 91/414/EEC by 31 October
2008 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 fludioxonil, clomazone and prosulfocarb
they shall
respectively. On the basis of
determine whether the product satisfies the conditions set out
in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

that evaluation,

HAS ADOPTED THIS DIRECTIVE:

Following that determination Member States shall:

Article 1

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

(a)

in the case of a product containing fludioxonil, clomazone
or prosulfocarb as
substance, where
necessary, amend or withdraw the authorisation by 31
October 2012 at the latest; or

the only active

Article 2

the

laws,

regulations

Member States shall adopt and publish by 30 April 2009 at the
latest
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.

(b) in the case of a product containing fludioxonil, clomazone
or prosulfocarb as one of several active substances, where
necessary, amend or withdraw the authorisation by 31
October 2012 or by
such an
fixed for
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.

the date

L 337/102

EN

Official Journal of the European Union

21.12.2007

This Directive shall enter into force on 1 November 2008.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 20 December 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

21.12.2007

EN

Official Journal of the European Union

L 337/103

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