Commission Directive 2009/11/EC of 18 February 2009 amending Council Directive 91/414/EEC to include bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad as active substances (Text with EEA relevance)
Date: 2009-02-18
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

19.2.2009

EN

Official Journal of the European Union

L 48/5

DIRECTIVES

COMMISSION DIRECTIVE 2009/11/EC

of 18 February 2009

amending Council Directive 91/414/EEC to include bensulfuron, sodium 5-nitroguaiacolate, sodium
o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad as active substances

(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,

Whereas:

(1)

(2)

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
list
Directive 91/414/EEC. That
includes bensulfuron,
sodium 5-nitroguaiacolate,
sodium o-nitrophenolate,
sodium p-nitrophenolate and tebufenpyrad.

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. For bensulfuron the rapporteur Member
State was
information was
submitted on 11 September 2006. For sodium 5-nitro­
sodium o-nitrophenolate and sodium p-
guaiacolate,

Italy and all

relevant

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 55, 29.2.2000, p. 25.
(3) OJ L 224, 21.8.2002, p. 23.

(3)

(4)

all

relevant

nitrophenolate the rapporteur Member State was Greece
and
on
7 December 2005. For
tebufenpyrad the rapporteur
Member State was Germany and all relevant information
was submitted on 12 March 2007.

information was

submitted

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 26 September 2008 for bensulfuron,
on 30 September 2008 for sodium 5-nitroguaiacolate,
sodium o-nitrophenolate and sodium p-nitrophenolate
tebufenpyrad in the
and on 23 October 2008 for
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
2 December 2008 in the format of the Commission
review reports for sodium 5-nitroguaiacolate, sodium o-
nitrophenolate,
tebu­
fenpyrad and on 8 December 2008 in the format of
the Commission review reports for bensulfuron.

sodium p-nitrophenolate

and

containing

in general,
5(1)(a)

It has appeared from the various examinations made that
plant
bensulfuron,
products
protection
sodium o-nitrophenolate,
sodium 5-nitroguaiacolate,
and tebufenpyrad may be
sodium p-nitrophenolate
the requirements laid
expected to satisfy,
down
of Directive
in Article
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.

and

(b)

(4) EFSA Scientific Report (2008) 178, Conclusion regarding the peer review
of the pesticide risk assessment of the active substance bensulfuron (finalised
26 September 2008).
EFSA Scientific Report (2008) 191, Conclusion regarding the peer review
of the pesticide risk assessment of the active substance sodium (5-nitro­
guaiacolate, o-nitrophenolate, p-nitrophenolate)
(finalised 30 September
2008).
EFSA Scientific Report (2008) 192, Conclusion regarding the peer review
of
tebufenpyrad
(finalised 23 October 2008).

risk assessment of

the pesticide

the active

substance

L 48/6

EN

Official Journal of the European Union

19.2.2009

(5) Without prejudice to that conclusion, it is appropriate to
obtain further information on certain specific points.
Article 6(1) of Directive 91/414/EEC provides
that
inclusion of a substance in Annex I may be subject to
conditions. Therefore, the notifier should be required to
submit further information on the chemical specification,
information to further address the route and rate of
degradation of bensulfuron under aerobic flooded soil
conditions and information to address the relevance of
assessment.
metabolites
Furthermore, it is appropriate to require that sodium 5-
nitroguaiacolate, sodium o-nitrophenolate and sodium p-
nitrophenolate should be subjected to further testing for
confirmation of the risk assessment for groundwater and
such studies should be presented by the notifier. Finally,
it is appropriate as regards tebufenpyrad, to require the
to submit
notifier
information confirming that no
relevant
impurities are present and addressing further
the risk to insectivorous birds.

consumer

risk

the

for

(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

sodium o-nitrophenolate,

in Annex I, Member States

(7) 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
review existing
authorisations of plant protection
products containing bensulfuron, sodium 5-nitroguaia­
sodium p-nitrophe­
colate,
nolate and tebufenpyrad 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)

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

(1) OJ L 366, 15.12.1992, p. 10.

Directive. However, this clarification does not impose any
new obligations on Member States or holders of autho­
risations 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

(9)

(10)

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 April 2010 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.

They shall apply those provisions from 1 May 2010.

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
products
bensulfuron,
sodium o-nitrophe­
nolate, sodium p-nitrophenolate and tebufenpyrad as active
substances by 30 April 2010.

sodium 5-nitroguaiacolate,

protection

plant

for

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to bensulfuron, sodium 5-
nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophe­
nolate and tebufenpyrad are met, with the exception of those
the entry concerning that active
identified in part B of
substance, and that
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.

the holder of

19.2.2009

EN

Official Journal of the European Union

L 48/7

By way of derogation from paragraph 1,

for each
2.
authorised plant protection product containing bensulfuron,
sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium
p-nitrophenolate and tebufenpyrad 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 October
2009 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 bensulfuron, sodium 5-nitroguaiacolate,
sodium o-nitrophenolate, sodium p-nitrophenolate and tebu­
fenpyrad respectively. On the basis of
they
shall determine whether the product satisfies the conditions
set out
(d) and (e) of Directive
(c),
91/414/EEC.

in Article 4(1)(b),

that evaluation,

Following that determination Member States shall:

(a)

in the case of a product containing bensulfuron, sodium 5-
nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitro­
phenolate and tebufenpyrad as the only active substance,
where necessary, amend or withdraw the authorisation by
30 April 2014 at the latest; or

(b) in the case of a product containing bensulfuron, sodium 5-
nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitro­
phenolate and tebufenpyrad as one of
several active
substances, where necessary, amend or withdraw the au­
thorisation by 30 April 2014 or by the date fixed for
such an amendment or withdrawal
in the respective
Directive or Directives which added the relevant substance
or
to Directive 91/414/EEC,
whichever is the latest.

to Annex I

substances

This Directive shall enter into force on 1 November 2009.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 18 February 2009.

For the Commission

Androulla VASSILIOU
Member of the Commission

L 48/8

EN

Official Journal of the European Union

19.2.2009

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L 48/9

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