Commission Directive 2006/39/EC of  12 April 2006  amending Council Directive 91/414/EEC to include clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole as active substances   (Text with EEA relevance)
Date: 2006-04-12
Institutions: Council of the European Union
Subjects: exchange of information, market approval, marketing standard, plant health control, plant health legislation, plant health product

L 104/30

EN

Official Journal of the European Union

13.4.2006

COMMISSION DIRECTIVE 2006/39/EC

of 12 April 2006

amending Council Directive 91/414/EEC to include clodinafop, pirimicarb, rimsulfuron, tolclofos-
methyl and triticonazole as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

2003. For rimsulfuron the rapporteur Member State was
Germany and all relevant information was submitted on
6 August 2003. For
the rapporteur
Member State was Sweden and all relevant information
was submitted on 3 November 2003. For triticonazole
the rapporteur Member State was Austria and all relevant
information was submitted on 29 September 2003.

tolclofos-methyl

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,

(3)

Whereas:

rimsulfuron,

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 14 March and 10 August 2005 in the
format of the EFSA Scientific Reports for clodinafop,
pirimicarb,
tolclofos-methyl and tritico-
nazole (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 27 January 2006 in the format
of the Commission review reports for clodinafop, piri-
micarb, rimsulfuron, tolclofos-methyl and triticonazole.

States

and

(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
clodinafop, pirimicarb,
tolclofos-methyl
and triticonazole.

to Directive 91/414/EEC. That

rimsulfuron,

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 703/2001 for a range of uses
proposed by the notifier. 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 8(1) of Regulation (EC) No
451/2000. For clodinafop the rapporteur Member State
was The Netherlands and all relevant information was
submitted on 7 November 2003. For pirimicarb the
rapporteur Member State was United Kingdom and all
information was submitted on 4 November
relevant

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

last amended by

Commission Directive 2006/19/EC (OJ L 44, 15.2.2006, p. 15).
(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.

(4)

The review of pirimicarb revealed a number of open
questions which were addressed by the Scientific Panel
on Plant Health, Plant Protection Products and their
residues (PPR) of the European Food Safety Authority
(EFSA). The Scientific Panel was asked to give an
opinion on the use of a ‘time quotient approach’ in the
acute risk assessment for birds and on the assessment of
the acute risk for birds which had been carried out. In its
opinion to the first question the PPR Panel concluded
that the ‘time quotient approach’ suggested by OECD is
equivalent to the current European first tier acute avian
risk assessment except
that Annex VI of Directive
91/414/EEC stipulates a specific safety factor of 10.
analysis would be
Therefore,
required to assess whether
the current safety factor
takes appropriate account of all relevant issues. Since

a detailed scientific

(4) ‘EFSA Scientific Report (2005) 34, 1-78, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
clodinafop (finalised: 10 August 2005)’.
‘EFSA Scientific Report (2005) 43, 1-76, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
pirimicarb (finalised: 10 August 2005)’.
‘EFSA Scientific Report (2005) 45, 1-61, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
rimsulfuron (finalised: 10 August 2005)’.
‘EFSA Scientific Report (2005) 28, 1-77, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
triticonazole (finalised: 14 March 2005)’.
‘EFSA Scientific Report (2005) 28, 1-77, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
tolclofos-methyl (finalised: 14 March 2005)’.

13.4.2006

EN

Official Journal of the European Union

L 104/31

the opinion,

further work that

is
this would require substantial
beyond the scope of
the PPR Panel
suggests that a case by case approach should be used.
As result, on the second question, the PPR Panel carried
out a refined risk assessment and concluded that even at
the upper limit of credible exposures birds feeding on
insects in the field are unlikely to achieve a lethal dose
of pirimicarb (1).

(5)

(6)

The reviews of clodinafop, rimsulfuron, tolclofos-methyl
and triticonazole did not reveal any open question to be
addressed by the Scientific Panel on Plant Health, Plant
Protection Products and their
the
residues
European Food Safety Authority (EFSA).

(PPR) of

It has appeared from the various examinations made that
plant protection products containing clodinafop, piri-
tolclofos-methyl and triticonazole
micarb, rimsulfuron,
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 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.

(7) Without prejudice to that conclusion, it is appropriate to
obtain further
information on certain specific points
concerning pirimicarb and triticonazole. Article 6(1) of
Directive 91/414/EC provides
a
to conditions.
substance in Annex I may be subject
Therefore it
is appropriate to require that pirimicarb
and triticonazole should be subjected to further testing
for confirmation of the risk assessment for some issues
and that
should be presented by the
notifiers.

inclusion of

such studies

that

(10)

(11)

(12)

substance in Annex I, Member States should be allowed a
period of six months after inclusion to review existing
authorisations of plant protection products containing
clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or
triticonazole to ensure that the requirements laid down
by Directive 91/414/EEC, in particular in its Article 13
in Annex I, are
and the relevant conditions set out
replace or
satisfied. Member
in
withdraw, as appropriate, existing authorisations,
Directive
accordance
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

The experience gained from previous inclusions in An-
nex I
to Directive 91/414/EEC of active substances
assessed in the framework of Commission Regulation
(EEC) No 3600/92 (2) 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
directives which
now
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

(8)

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

HAS ADOPTED THIS DIRECTIVE:

(9) Without prejudice to the obligations defined by Directive
including an active

91/414/EEC as a consequence of

Article 1

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

(1) Opinion of the Scientific Panel on Plant Health, Plant protection
products and their residues on a request from EFSA related to the
evaluation of pirimicarb EFSA Journal (2005) 240, 1-21.

(2) 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 104/32

EN

Official Journal of the European Union

13.4.2006

Article 2

the

laws,

regulations

Member States shall adopt and publish by 31 July 2007 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.

concerning

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
rimsulfuron,
tolclofos-methyl and triticonazole respectively. On the basis of
the product
that evaluation,
satisfies the conditions set out in Article 4(1)(b), (c), (d) and
(e) of Directive 91/414/EEC.

they shall determine whether

clodinafop,

pirimicarb,

They shall apply those provisions from 1 August 2007.

Following that determination Member States shall:

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.

(a)

in the case of a product containing clodinafop, pirimicarb,
rimsulfuron, tolclofos-methyl or triticonazole as the only
active substance, where necessary, amend or withdraw the
authorisation by 31 January 2011 at the latest; or

Article 3

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations
containing
clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or tritico-
nazole as active substances by 31 July 2007.

protection

products

plant

for

active

substances, where necessary,

(b) in the case of a product containing clodinafop, pirimicarb,
tolclofos-methyl or triticonazole as one of
rimsulfuron,
several
amend or
withdraw the authorisation by 31 January 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, whichever is the latest.

to Annex

substances

or

I

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to clodinafop, pirimicarb,
rimsulfuron, tolclofos-methyl and triticonazole 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 clodinafop, piri-
micarb, rimsulfuron, tolclofos-methyl or triticonazole 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 January 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

Article 4

This Directive shall enter into force on 1 February 2007.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 12 April 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

13.4.2006

EN

Official Journal of the European Union

L 104/33

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