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3.3.2011 Official
Journal
of
the
European
Union L
58/41
DIRECTIVES
COMMISSION DIRECTIVE 2011/19/EU
of 2 March 2011
amending Council Directive 91/414/EEC to include tau-fluvalinate as active substance and amending
Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of
Commission Regulation (EC) No 33/2008 of
17 January 2008 laying down detailed rules for the
Having regard to the Treaty on the Functioning of the European
application of Council Directive 91/414/EEC as regards
Union,
a regular and an accelerated procedure for the assessment
of active substances which were part of the programme
of work referred to in Article 8(2) of that Directive but
have not been included into its Annex I ( 5 ).
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,
(4) The
application
was
submitted
to
Denmark,
which
had
been designated rapporteur Member State by Regulation
Whereas:
(EC) No 451/2000. 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
also complies with the remaining substantive and
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
No 1490/2002 (
procedural requirements of Article 15 of Regulation

3 ) lay down the detailed rules for the
implementation of the third stage of the programme of
(EC) No 33/2008.
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 included tau-fluvalinate.
(5)
Denmark evaluated the additional data submitted by the
applicant and prepared an additional report. It
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
communicated that report to the European Food Safety
1490/2002 the notifier withdrew its support of the
Authority (hereinafter ‘the Authority’) and to the
inclusion of that active substance in Annex I to
Commission on 1 October 2009. The Authority
Directive 91/414/EEC within two months from receipt
communicated the additional report to the other
of the draft assessment report. Consequently,
Member States and the applicant for comments and
Commission Decision 2008/934/EC of 5 December
forwarded the comments it had received to the
2008 concerning the non-inclusion of certain active
Commission. In accordance with Article 20(1) of Regu
substances in Annex I to Council Directive 91/414/EEC
lation (EC) No 33/2008 and at the request of the
and the withdrawal of authorisations for plant protection
Commission, the Authority presented its conclusion on
products containing these substances (
tau-fluvalinate to the Commission on 17 June 2010 (

4 ) was adopted on

6 ).
the non-inclusion of tau-fluvalinate.
The draft assessment report, the additional report and the
conclusion of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 28 January 2011 in the format
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
of the Commission review report for tau-fluvalinate.
original notifier (hereinafter ‘the applicant’) submitted a
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 2 ) OJ L 55, 29.2.2000, p. 25.
the pesticide risk assessment of the active substance tau-fluvalinate.
( 3 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2010; 8(7):1645. [70 pp.]. doi:10.2903/j.efsa.
( 4 ) OJ L 333, 11.12.2008, p. 11.
2010.1645. Available online: www.efsa.europa.eu

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L 58/42
EN
Official Journal of the European Union
3.3.2011
(6)
It has appeared from the various examinations made that
of plant protection products on the market ( 1 ) has shown
plant protection products containing tau-fluvalinate may
that difficulties can arise in interpreting the duties of
be expected to satisfy, in general, the requirements laid
holders of existing authorisations in relation to access
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
to data. In order to avoid further difficulties it therefore
in particular with regard to the uses which have been
appears necessary to clarify the duties of the Member
examined and detailed in the Commission review report.
States, especially the duty to verify that the holder of
It is therefore appropriate to include tau-fluvalinate in
an authorisation demonstrates access to a dossier
Annex I, in order to ensure that in all Member States
satisfying the requirements of Annex II to that Directive.
the authorisations of plant protection products
However, this clarification does not impose any new
containing this active substance can be granted in
obligations on Member States or holders of author-
accordance with the provisions of that Directive.
isations compared to the Directives which have been
adopted until now amending Annex I.
(11) It is therefore appropriate to amend Directive
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
91/414/EEC accordingly.
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
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
conditions. Therefore, it is appropriate to require that the
tau-fluvalinate and the withdrawal of authorisations for
applicant submit further information confirming the
plant protection products containing that substance by
results of the risk assessment on the basis of most
31 December 2011. It is necessary to delete the line
recent scientific knowledge, as regards the risk to
concerning tau-fluvalinate in the Annex to that Decision.
aquatic organisms, the risk to non-target arthropods
and on the possible impact on the environment of the
potential enantio-selective degradation in environmental
(13) It is therefore appropriate to amend Decision
matrices.
2008/934/EC accordingly.
(14) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
(8) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I in order to
Committee on the Food Chain and Animal Health,
permit Member States and the interested parties to
prepare themselves to meet the new requirements
which will result from the inclusion.
HAS ADOPTED THIS DIRECTIVE:

Article 1
Annex I to Directive 91/414/EEC is amended as set out in the
(9) Without
prejudice
to
the
obligations
defined
by
Directive Annex to this Directive.
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
allowed a period of six months after inclusion to
Article 2
review existing authorisations of plant protection
products containing tau-fluvalinate to ensure that the
The line concerning tau-fluvalinate in the Annex to Decision
requirements laid down by Directive 91/414/EEC, in
2008/934/EC is deleted.
particular in its Article 13 and the relevant conditions
set out in Annex I, are satisfied. Member States should
vary, replace or withdraw, as appropriate, existing au-
Article 3
thorisations, in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
Member States shall adopt and publish by 30 November 2011
deadline, a longer period should be provided for the
at the latest the laws, regulations and administrative provisions
submission and assessment of the complete Annex III
necessary to comply with this Directive. They shall forthwith
dossier of each plant protection product for each
communicate to the Commission the text of those provisions
intended use in accordance with the uniform principles
and a correlation table between those provisions and this
laid down in Directive 91/414/EEC.
Directive.

They shall apply those provisions from 1 December 2011.
(10) The
experience
gained
from
previous
inclusions
in
Annex
I to Directive 91/414/EEC of active substances assessed
When Member States adopt those provisions, they shall contain
in the framework of Commission Regulation (EEC) No
a reference to this Directive or be accompanied by such a
3600/92 of 11 December 1992 laying down the detailed
reference on the occasion of their official publication. Member
rules for the implementation of the first stage of the
States shall determine how such reference is to be made.
programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing
( 1 ) OJ L 366, 15.12.1992, p. 10.

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EN
3.3.2011 Official
Journal
of
the
European
Union L
58/43
Article 4
Following that determination Member States shall:
1. Member States shall in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
(a) in the case of a product containing tau-fluvalinate as the
authorisations for plant protection products containing tau-
only active substance, where necessary, amend or withdraw
fluvalinate as an active substance by 30 November 2011.
the authorisation by 31 May 2015 at the latest; or
(b) in the case of a product containing tau-fluvalinate as one of
By that date they shall in particular verify that the conditions in
several active substances, where necessary, amend or
Annex I to that Directive relating to tau-fluvalinate are met,
withdraw the authorisation by 31 May 2015 or by the
with the exception of those identified in part B of the entry
date fixed for such an amendment or withdrawal in the
concerning that active substance, and that the holder of the
respective Directive or Directives which added the relevant
authorisation has, or has access to, a dossier satisfying the
substance or substances to Annex I to Directive
requirements of Annex II to that Directive in accordance with
91/414/EEC, whichever is the latest.
the conditions of Article 13 of that Directive.
Article 5
This Directive shall enter into force on 1 June 2011.
2. By
way
of
derogation
from
paragraph
1,
for
each
au-
thorised plant protection product containing tau-fluvalinate as
either the only active substance or as one of several active
Article 6
substances all of which were listed in Annex I to Directive
91/414/EEC by 31 May 2011 at the latest, Member States
This Directive is addressed to the 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
Done at Brussels, 2 March 2011.
III to that Directive and taking into account part B of the entry
in Annex I to that Directive concerning tau-fluvalinate. On the
For the Commission
basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c),
The President
(d) and (e) of Directive 91/414/EEC.
José Manuel BARROSO

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L 58/44
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
‘335 Tau-fluvalinate
(RS)-α-cyano-3-phenoxy ≥ 920 g/kg
1 June 2011 31
May
2021 PART
A

CAS No: 102851- benzyl N-(2-chloro- α,α (1:1 ratio of R-α-
06-9
α- trifluoro-p-tolyl)-D- cyano and S-α-
Only uses as insecticide and acaricide may be authorised.
CIPAC No: 786
valinate
cyano isomers)
(Isomer ratio 1:1)
Impurities:
PART B
Toluene: not more
than 5 g/kg
For the implementation of the uniform principles of Annex VI, the conclusions of
the review report on tau-fluvalinate, and in particular Appendices I and II thereof,
as finalised in the Standing Committee on the Food Chain and Animal Health on
28 January 2011 shall be taken into account.
Off
In this overall assessment Member States shall pay particular attention to:
icial
(a) the risk to aquatic organisms and ensure that conditions of use prescribe the
Jour
application of adequate risk mitigation measures;
nal
(b) the risk to non-target arthropods and ensure that conditions of use prescribe
the application of adequate risk mitigation measures;
of
the
(c) the test material used in the toxicity dossiers shall be compared and verified
European
against the specification of the technical material commercially manufactured.
The Member States concerned shall request the submission of confirmatory
information as regards:
Union
— the risk of bioaccumulation/biomagnification in the aquatic environment,
— the risk to non-target arthropods.
The Member States concerned shall ensure that the applicant submits such
confirmatory information to the Commission by 31 May 2013.
The Member States concerned shall ensure that the applicant submits
confirmatory information, two years after the adoption of specific guidance, as
regards:
the possible impact on the environment of the potential enantio-selective
degradation in environmental matrices.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
3.3.2011

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