HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 97/30
EN
Official Journal of the European Union
12.4.2011
COMMISSION IMPLEMENTING DIRECTIVE 2011/39/EU
of 11 April 2011
amending Council Directive 91/414/EEC to include fenazaquin as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) The
application
was
submitted
to
Greece,
which
had
been designated rapporteur Member State by Regulation
(EC) No 1490/2002. The time period for the accelerated
procedure was respected. The specification of the active
Having regard to the Treaty on the Functioning of the European
substance and the supported uses are the same as were
Union,
the subject of Decision 2008/934/EC. That application
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
Having regard to Council Directive 91/414/EEC of 15 July
(EC) No 33/2008.
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular Article 6(1) thereof,
(5)
Greece evaluated the additional data submitted by the
applicant and prepared an additional report. It
Whereas:
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
Commission on 28 January 2010. The Authority
communicated the additional report to the other
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
No 1490/2002 (
Member States and the applicant for comments and

3 ) lay down the detailed rules for the
implementation of the third stage of the programme of
forwarded the comments it had received to the
work referred to in Article 8(2) of Directive 91/414/EEC
Commission. In accordance with Article 20(1) of Regu
and establish a list of active substances to be assessed,
lation (EC) No 33/2008 and at the request of the
with a view to their possible inclusion in Annex I to
Commission, the Authority presented its conclusion on
Directive 91/414/EEC. That list included fenazaquin.
fenazaquin to the Commission on 28 October 2010 (


6 ).
The draft assessment report, the additional report and the
conclusion of the Authority were reviewed by the
Member States and the Commission within the
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
Standing Committee on the Food Chain and Animal
No 1490/2002 the notifier withdrew its support of the
Health and finalised on 11 March 2011 in the format
inclusion of that active substance in Annex I to Directive
of the Commission review report for fenazaquin.
91/414/EEC within 2 months from receipt of the draft
assessment report. Consequently, Commission Decision
2008/934/EC of 5 December 2008 concerning the
non-inclusion of certain active substances in Annex I
(6)
It has appeared from the various examinations made that
to Council Directive 91/414/EEC and the withdrawal of
plant protection products containing fenazaquin may be
authorisations for plant protection products containing
expected to satisfy, in general, the requirements laid
these substances ( 4 ) was adopted on the non-inclusion
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
of fenazaquin.
in particular with regard to the uses which have been
examined and detailed in the Commission review report.
It is therefore appropriate to include fenazaquin in Annex
I, in order to ensure that in all Member States the au-
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
original notifier (hereinafter ‘the applicant’) submitted a
thorisations of plant protection products containing this
new application requesting the accelerated procedure to
active substance can be granted in accordance with the
be applied, as provided for in Articles 14 to 19 of
provisions of that Directive.
Commission Regulation (EC) No 33/2008 of
17 January 2008 laying down detailed rules for the
application of Council Directive 91/414/EEC as regards
a regular and an accelerated procedure for the assessment
(7) A
reasonable
period
should
be
allowed
to
elapse
before
of active substances which were part of the programme
an active substance is included in Annex I in order to
of work referred to in Article 8(2) of that Directive but
permit Member States and the interested parties to
have not been included into its Annex I ( 5 ).
prepare themselves to meet the new requirements
which will result from the inclusion.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 55, 29.2.2000, p. 25.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 224, 21.8.2002, p. 23.
the pesticide risk assessment of the active substance fenazaquin.
( 4 ) OJ L 333, 11.12.2008, p. 11.
EFSA Journal 2010; 8(11):1892. [74 pp.]. doi:10.2903/j.efsa.
( 5 ) OJ L 15, 18.1.2008, p. 5.
2010.1892. Available online: www.efsa.europa.eu

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EN
12.4.2011 Official
Journal
of
the
European
Union L
97/31
(8) Without
prejudice
to
the
obligations
defined
by
Directive HAS ADOPTED THIS DIRECTIVE:
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
allowed a period of 6 months after inclusion to review
existing authorisations of plant protection products
Article 1
containing fenazaquin to ensure that the requirements
Annex I to Directive 91/414/EEC is amended as set out in the
laid down by Directive 91/414/EEC, in particular in its
Annex to this Directive.
Article 13 and the relevant conditions set out in Annex I,
are satisfied. Member States should vary, replace or
withdraw, as appropriate, existing authorisations, in
accordance with the provisions of Directive 91/414/EEC.
Article 2
By derogation from the above deadline, a longer period
The line concerning fenazaquin in the Annex to Decision
should be provided for the submission and assessment of
2008/934/EC is deleted.
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.
Article 3
Member States shall adopt and publish by 30 November 2011
at the latest the laws, regulations and administrative provisions
(9) The
experience
gained
from
previous
inclusions
in
Annex necessary to comply with this Directive. They shall forthwith
I to Directive 91/414/EEC of active substances assessed
communicate to the Commission the text of those provisions
in the framework of Commission Regulation (EEC)
and a correlation table between those provisions and this
No 3600/92 of 11 December 1992 laying down the
Directive.
detailed rules for the implementation of the first stage
of the programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing of
They shall apply those provisions from 1 December 2011.
plant protection products on the market ( 1 ) 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
When Member States adopt those provisions, they shall contain
appears necessary to clarify the duties of the Member
a reference to this Directive or be accompanied by such a
States, especially the duty to verify that the holder of
reference on the occasion of their official publication. Member
an authorisation demonstrates access to a dossier
States shall determine how such reference is to be made.
satisfying the requirements of Annex II to that Directive.
However, this clarification does not impose any new
obligations on Member States or holders of author-
Article 4
isations compared to the Directives which have been
adopted until now amending Annex I.
1. Member States shall in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing
fenazaquin as an active substance by 30 November 2011.
(10) It is therefore appropriate to amend Directive
91/414/EEC accordingly.
By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to fenazaquin are met, with
the exception of those identified in part B of the entry
(11) Decision
2008/934/EC
provides
for
the
non-inclusion
of
concerning that active substance, and that the holder of the
fenazaquin and the withdrawal of authorisations for plant
authorisation has, or has access to, a dossier satisfying the
protection products containing that substance by
requirements of Annex II to that Directive in accordance with
31 December 2011. It is necessary to delete the line
the conditions of Article 13 of that Directive.
concerning fenazaquin in the Annex to that Decision.
2. By way of derogation from paragraph 1, for each au-
thorised plant protection product containing fenazaquin as
(12) It is therefore appropriate to amend Decision
either the only active substance or as one of several active
2008/934/EC accordingly.
substances all of which were listed in Annex I to Directive
91/414/EEC by 31 May 2011 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
(13) The
measures provided for in this Directive are in
III to that Directive and taking into account part B of the entry
accordance with the opinion of the Standing
in Annex I to that Directive concerning fenazaquin. On the
Committee on the Food Chain and Animal Health,
basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c),
( 1 ) OJ L 366, 15.12.1992, p. 10.
(d) and (e) of Directive 91/414/EEC.

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L 97/32
EN
Official Journal of the European Union
12.4.2011
Following that determination Member States shall:
Article 5
This Directive shall enter into force on 1 June 2011.
(a) in the case of a product containing fenazaquin as the only
active substance, where necessary, amend or withdraw the
Article 6
authorisation by 31 May 2015 at the latest; or
This Directive is addressed to the Member States.
(b) in the case of a product containing fenazaquin as one of
several active substances, where necessary, amend or
Done at Brussels, 11 April 2011.
withdraw the authorisation by 31 May 2015 or by the
date fixed for such an amendment or withdrawal in the
For the Commission
respective Directive or Directives which added the relevant
substance or substances to Annex I to Directive
The President
91/414/EEC, whichever is the latest.
José Manuel BARROSO

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12.4.2011 Off
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
No
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Entry
into
force Expiration
of
inclusion Specific
provisions
EN
‘345 Fenazaquin
4-tert-butylphenethyl
≥ 975 g/kg 1
June
2011 31
May
2021 PART
A

CAS No: 120928-09-8 quinazolin-4-yl ether
Only uses as acaricide on ornamentals in greenhouses may be authorised.
CIPAC No: 693
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of
the review report on fenazaquin, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health on
11 March 2011 shall be taken into account.
In this overall assessment Member States shall:
icial
(1) pay particular attention to the protection of aquatic organisms;
Jour
(2) pay particular attention to the risk to operators and ensure that conditions of
use include the application of adequate personal protective equipment;
nal
of
(3) pay particular attention to the protection of bees and ensure that conditions
the
of use include risk mitigation measures, where appropriate;
European
(4) provide for conditions of use which ensure that there are no residues of
fenazaquin in crops for human and animal consumption.’
Union
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
97/33

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