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11.8.2011 Official
Journal
of
the
European
Union L
206/39
COMMISSION IMPLEMENTING REGULATION (EU) No 806/2011
of 10 August 2011
approving the active substance fluquinconazole, in accordance with Regulation (EC) No 1107/2009
of the European Parliament and of the Council concerning the placing of plant protection products
on the market, and amending the Annex to Commission Implementing Regulation (EU) No
540/2011 and Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Directive 91/414/EEC
( 6 ) the notifier withdrew its
support of the inclusion of that active substance in
Annex I to Directive 91/414/EEC within 2 months
from entry into force of that Regulation. Consequently,
Having regard to the Treaty on the Functioning of the European
Commission Decision 2008/934/EC of 5 December
Union,
2008 concerning the non-inclusion of certain active
substances in Annex I to Council Directive 91/414/EEC
and the withdrawal of authorisations for plant protection
Having regard to Regulation (EC) No 1107/2009 of the
products containing these substances ( 7 ) was adopted on
European Parliament and of the Council of 21 October 2009
the non-inclusion of fluquinconazole.
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 1 ), and in particular Article 13(2) and
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
Article 78(2) thereof,
original notifier (hereinafter ‘the applicant’) submitted a
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of Regu
Whereas:
lation (EC) No 33/2008 laying down detailed rules for
the application of Directive 91/414/EEC as regards a
regular and an accelerated procedure for the assessment
of active substances which were part of the programme
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
of work referred to in Article 8(2) of that Directive but
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
have not been included into its Annex I.
to active substances for which completeness has been
established in accordance with Article 16 of Commission
Regulation (EC) No 33/2008 ( 3 ), with respect to the
procedure and the conditions for approval. Fluquin
(5) The
application
was
submitted
to
Ireland,
which
had
conazole is an active substance for which completeness
been designated rapporteur Member State by Regulation
has been established in accordance with that Regulation.
(EC) No 1490/2002. The time period for the accelerated
procedure was respected. The specification of the active
substance and the supported uses are the same as were
the subject of Decision 2008/934/EC. That application
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
also complies with the remaining substantive and
No 1490/2002 ( 5 ) lay down the detailed rules for the
procedural requirements of Article 15 of Regulation
implementation of the second and third stages of the
(EC) No 33/2008.
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
(6)
Ireland evaluated the additional data submitted by the
included fluquinconazole.
applicant and prepared an additional report. It
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
Commission on 13 April 2010. The Authority
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
communicated the additional report to the other
lation (EC) No 1095/2007 of 20 September 2007
Member States and the applicant for comments and
amending Regulation (EC) No 1490/2002 laying down
forwarded the comments it had received to the
further detailed rules for the implementation of the third
Commission. In accordance with Article 20(1) of Regu
stage of the programme of work referred to in
lation (EC) No 33/2008 and at the request of the
Article 8(2) of Council Directive 91/414/EEC and Regu
Commission, the Authority presented its conclusion on
lation (EC) No 2229/2004 laying down further detailed
fluquinconazole to the Commission on 25 February
rules for the implementation of the fourth stage of the
2011 ( 8 ). The draft assessment report, the additional
programme of work referred to in Article 8(2) of Council
( 6 ) OJ L 246, 21.9.2007, p. 19.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 7 ) OJ L 333, 11.12.2008, p. 11.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 8 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 15, 18.1.2008, p. 5.
the pesticide risk assessment of the active substance fluquinconazole.
( 4 ) OJ L 55, 29.2.2000, p. 25.
EFSA Journal 2011;9(5):2096. [112 pp.]. doi:10.2903/j.efsa.
( 5 ) OJ L 224, 21.8.2002, p. 23.
2011.2096. Available online: www.efsa.europa.eu

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L 206/40
EN
Official Journal of the European Union
11.8.2011
report and the conclusion of the Authority were reviewed
that difficulties can arise in interpreting the duties of
by the Member States and the Commission within the
holders of existing authorisations in relation to access
Standing Committee on the Food Chain and Animal
to data. In order to avoid further difficulties it therefore
Health and finalised on 17 June 2011 in the format of
appears necessary to clarify the duties of the Member
the Commission review report for fluquinconazole.
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.
(7)
It has appeared from the various examinations made that
However, this clarification does not impose any new
plant protection products containing fluquinconazole
obligations on Member States or holders of authori
may be expected to satisfy, in general, the requirements
sations compared to the directives which have been
laid down in Article 5(1)(a) and (b) of Directive
adopted until now amending Annex I to that Directive
91/414/EEC, in particular as regards the uses which
or the Regulations approving active substances.
were examined and detailed in the Commission review
report. It is therefore appropriate to approve fluquin
conazole in accordance with Regulation (EC) No
(13) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009.
1107/2009 the Annex to Commission Implementing
Regulation (EU) No 540/2011 ( 2 ) should be amended
accordingly.
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009 in conjunction with Article 6 thereof and in
the light of current scientific and technical knowledge, it
(14) Decision
2008/934/EC
provides
for
the
non-inclusion
of
is, however, necessary to include certain conditions and
fluquinconazole and the withdrawal of authorisations for
restrictions.
plant protection products containing that substance by
31 December 2011. It is necessary to delete the line
concerning fluquinconazole in the Annex to that
(9) Without
prejudice
to
the
conclusion
that
fluquinconazole
Decision. It is therefore appropriate to amend Decision
should be approved, it is, in particular, appropriate to
2008/934/EC accordingly.
require further confirmatory information.
(15) The
measures
provided
for
in
this
Regulation
are
in
(10) A
reasonable
period
should
be
allowed
to
elapse
before
accordance with the opinion of the Standing
approval in order to permit Member States and the
Committee on the Food Chain and Animal Health,
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
HAS ADOPTED THIS REGULATION:
(11) Without
prejudice
to
the
obligations
defined
by
Regu
lation (EC) No 1107/2009 as a consequence of the
Article 1
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
Approval of active substance
Regulation (EC) No 1107/2009 the following should,
The active substance fluquinconazole, as specified in Annex I, is
however, apply. Member States should be allowed a
approved subject to the conditions laid down in that Annex.
period of 6 months after approval to review authori
sations of plant protection products containing fluquin
conazole. Member States should, as appropriate, vary,
replace or withdraw existing authorisations. By way of
Article 2
derogation from the above deadline, a longer period
Re-evaluation of plant protection products
should be provided for the submission and assessment
of the update of the complete Annex III dossier, as set
1. Member
States
shall
in
accordance
with
Regulation
(EC)
out in Directive 91/414/EEC, of each plant protection
No 1107/2009, where necessary, amend or withdraw existing
product for each intended use in accordance with the
authorisations for plant protection products containing fluquin
uniform principles.
conazole as an active substance by 30 June 2012.
(12) The
experience
gained
from
inclusions
in
Annex
I
to
By that date they shall in particular verify that the conditions in
Directive 91/414/EEC of active substances assessed in
Annex I to this Regulation are met, with the exception of those
the framework of Commission Regulation (EEC) No
identified in Part B of the column on specific provisions of that
3600/92 of 11 December 1992 laying down the
Annex, and that the holder of the authorisation has, or has
detailed rules for the implementation of the first stage
access to, a dossier satisfying the requirements of Annex II to
of the programme of work referred to in Article 8(2) of
Directive 91/414/EEC in accordance with the conditions of
Council Directive 91/414/EEC concerning the placing of
Article 13(1) to (4) of that Directive and Article 62 of Regu
plant protection products on the market ( 1 ) has shown
lation (EC) No 1107/2009.
( 1 ) OJ L 366, 15.12.1992, p. 10.
( 2 ) OJ L 153, 11.6.2011, p. 1.

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EN
11.8.2011 Official
Journal
of
the
European
Union L
206/41
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
substances to Annex I to Directive 91/414/EEC or approved
orised plant protection product containing fluquinconazole as
that substance or substances, whichever is the latest.
either the only active substance or as one of several active
substances all of which were listed in the Annex to Imple
Article 3
menting Regulation (EU) No 540/2011 by 31 December
2011 at the latest, Member States shall re-evaluate the
Amendments to Implementing Regulation (EU) No
product in accordance with the uniform principles, as referred
540/2011
to in Article 29(6) of Regulation (EC) No 1107/2009, on the
basis of a dossier satisfying the requirements of Annex III to
The Annex to Implementing Regulation (EU) No 540/2011 is
Directive 91/414/EEC and taking into account Part B of the
amended in accordance with Annex II to this Regulation.
column on specific provisions of Annex I to this Regulation.
On the basis of that evaluation, they shall determine whether
Article 4
the product satisfies the conditions set out in Article 29(1) of
Regulation (EC) No 1107/2009. Following that determination
Amendments to Decision 2008/934/EC
Member States shall:
The line concerning fluquinconazole in the Annex to Decision
2008/934/EC is deleted.
(a) in the case of a product containing fluquinconazole as the
only active substance, where necessary, amend or withdraw
Article 5
the authorisation by 31 December 2015 at the latest; or
Entry into force and date of application
(b) in the case of a product containing fluquinconazole as one
of several active substances, where necessary, amend or
This Regulation shall enter into force on the 20th day following
withdraw the authorisation by 31 December 2015 or by
its publication in the Official Journal of the European Union.
the date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance or
It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 August 2011.
For the Commission
The President
José Manuel BARROSO

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L 206/42
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Fluquinconazole
3-(2,4-dichlorophenyl)-6-
≥ 955 g/kg 1
January
2012 31
December
2021 PART
A
fluoro-2-(1H-1,2,4-triazol-1-
EN
CAS No 136426-54-5 yl)quinazolin-4(3H)-one
Only uses as fungicide may be authorised

CIPAC No 474
PART B
For the implementation of the uniform principles, as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fluquin
conazole, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into
account.
In this overall assessment Member States:
Off
(a) shall pay particular attention to the risk to operators and workers and shall ensure
icial
that conditions of use include the application of adequate personal protective
equipment, where appropriate;
Jour
nal
(b) shall pay particular attention to the dietary exposure of consumers to the residues
of triazole derivative metabolites (TDMs);
of
the
(c) shall pay particular attention to the risk to birds and mammals.
European
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:
Union
(1) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops
and products of animal origin;
(2) the contribution of the potential residues of the metabolite dione in rotational
crops to the overall consumer exposure;
(3) the acute risk to insectivorous mammals;
(4) the long-term risk to insectivorous and herbivorous birds and mammals;
(5) the risk to earthworm-eating mammals;
(6) the endocrine disruption potential in aquatic organisms (fish full life cycle study).
The applicant shall submit to the Commission, the Member States and the Authority
such information by 31 December 2013.
(1 ) Further details on identity and specification of active substance are provided in the review report.
11.8.2011

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11.8.2011 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common Name,
Expiration of
Identification Numbers
IUPAC Name Purity
(*)
Date of
approval
approval
Specific provisions
EN
‘14 Fluquinconazole
3-(2,4-dichlorophenyl)-6-
≥ 955 g/kg 1
January
31 December
PART A

fluoro-2-(1H-1,2,4-triazol-1-
2012
2021
CAS No 136426-54-5
yl)quinazolin-4(3H)-one
Only uses as fungicide may be authorised
CIPAC No 474
PART B
For the implementation of the uniform principles, as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
review report on fluquinconazole, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health on 17 June 2011 shall be taken into account.
icial
In this overall assessment Member States:
Jour
(a) shall pay particular attention to the risk to operators and workers and
shall ensure that conditions of use include the application of adequate
nal
personal protective equipment, where appropriate;
of
(b) shall pay particular attention to the dietary exposure of consumers to the
the
residues of triazole derivative metabolites (TDMs);
European
(c) shall pay particular attention to the risk to birds and mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
Union
The applicant shall submit confirmatory information as regards:
(1) residues of triazole derivative metabolites (TDMs) in primary crops,
rotational crops and products of animal origin;
(2) the contribution of the potential residues of the metabolite dione in
rotational crops to the overall consumer exposure;
(3) the acute risk to insectivorous mammals;
(4) the long-term risk to insectivorous and herbivorous birds and mammals;
(5) the risk to earthworm-eating mammals;
(6) the endocrine disruption potential in aquatic organisms (fish full life cycle
study).
The applicant shall submit to the Commission, the Member States and the
L
Authority such information by 31 December 2013.’
206/43
(*) Further details on identity and specification of active substance are provided in the review report.

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