HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 205/22
EN
Official Journal of the European Union
10.8.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 800/2011
of 9 August 2011
approving the active substance tefluthrin, 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
amending Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
from entry into force of that Regulation. Consequently,
Commission Decision 2008/934/EC of 5 December
2008 concerning the non-inclusion of certain active
Having regard to the Treaty on the Functioning of the European
substances in Annex I to Council Directive 91/414/EEC
Union,
and the withdrawal of authorisations for plant protection
products containing these substances ( 7 ) was adopted on
the non-inclusion of tefluthrin.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
market and repealing Council Directives 79/117/EEC and
original notifier (hereinafter ‘the applicant’) submitted a
91/414/EEC ( 1 ), and in particular Article 13(2) and
new application requesting the accelerated procedure to
Article 78(2) thereof,
be applied, as provided for in Articles 14 to 19 of Regu
lation (EC) No 33/2008 laying down detailed rules for
the application of Directive 91/414/EEC as regards a
Whereas:
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
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC (
have not been included into its Annex I.

2 ) is to apply
to active substances for which completeness has been
established in accordance with Article 16 of Commission
Regulation (EC) No 33/2008 (
(5) The
application
was
submitted
to
Germany,
which
had

3 ), with respect to the
procedure and the conditions for approval. Tefluthrin is
been designated rapporteur Member State by Regulation
an active substance for which completeness has been
(EC) No 1490/2002. The time period for the accelerated
established in accordance with that Regulation.
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
(
also complies with the remaining substantive and

4 ) and (EC)
No 1490/2002 (
procedural requirements of Article 15 of Regulation

5 ) lay down the detailed rules for the
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
(6) Germany
evaluated
the
additional
data
submitted
by
the
inclusion in Annex I to Directive 91/414/EEC. That list
applicant and prepared an additional report. It
included tefluthrin.
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
Commission on 9 December 2009. 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
tefluthrin to the Commission on 20 August 2010 ( 8 ).
rules for the implementation of the fourth stage of the
The draft assessment report, the additional report and
programme of work referred to in Article 8(2) of Council
the conclusion of the Authority were reviewed by the
Directive 91/414/EEC
( 6 ) the notifier withdrew its
Member States and the Commission within the
support of the inclusion of that active substance in
Standing Committee on the Food Chain and Animal
Annex I to Directive 91/414/EEC within 2 months
Health and finalised on 17 June 2011 in the format of
the Commission review report for tefluthrin.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 7 ) OJ L 333, 11.12.2008, p. 11.
( 3 ) OJ L 15, 18.1.2008, p. 5.
( 8 ) European Food Safety Authority; Conclusion on the peer review of
( 4 ) OJ L 55, 29.2.2000, p. 25.
the pesticide risk assessment of the active substance tefluthrin. EFSA
( 5 ) OJ L 224, 21.8.2002, p. 23.
Journal 2010; 8(5):1592. [67 pp.]. doi:10.2903/j.efsa.2010.1592.
( 6 ) OJ L 246, 21.9.2007, p. 19.
Available online: www.efsa.europa.eu

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EN
10.8.2011 Official
Journal
of
the
European
Union L
205/23
(7)
It has appeared from the various examinations made that
obligations on Member States or holders of authori
plant protection products containing tefluthrin may be
sations compared to the directives which have been
expected to satisfy, in general, the requirements laid
adopted until now amending Annex I to that Directive
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
or the Regulations approving active substances.
in particular with regard to the uses which were
examined and detailed in the Commission review
report. It is therefore appropriate to approve tefluthrin
(13) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
in accordance with Regulation (EC) No 1107/2009.
1107/2009 the Annex to Commission Implementing
Regulation (EU) No 540/2011 of 25 May 2011 imple
menting Regulation (EC) No 1107/2009 of the European
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
Parliament and of the Council as regards the list of
1107/2009 in conjunction with Article 6 thereof and in
approved active substances
( 2 ) should be amended
the light of current scientific and technical knowledge, it
accordingly.
is, however, necessary to include certain conditions and
restrictions.
(14) Decision
2008/934/EC
provides
for
the
non-inclusion
of
tefluthrin and the withdrawal of authorisations for plant
protection products containing that substance by
(9) Without
prejudice
to
the
conclusion
that
tefluthrin
31 December 2011. It is necessary to delete the line
should be approved, it is, in particular, appropriate to
concerning tefluthrin in the Annex to that Decision. It
require further confirmatory information.
is therefore appropriate to amend Decision 2008/934/EC
accordingly.
(10) A
reasonable
period
should
be
allowed
to
elapse
before
approval in order to permit Member States and the
(15) The
measures
provided
for
in
this
Regulation
are
in
interested parties to prepare themselves to meet the
accordance with the opinion of the Standing
new requirements which will result from the approval.
Committee on the Food Chain and Animal Health,
(11) Without
prejudice
to
the
obligations
defined
by
Regu
HAS ADOPTED THIS REGULATION:
lation (EC) No 1107/2009 as a consequence of the
approval taking into account the specific situation
created by the transition from Directive 91/414/EEC to
Article 1
Regulation (EC) No 1107/2009, the following should,
however, apply. Member States should be allowed a
Approval of active substance
period of 6 months after approval to review authori
The active substance tefluthrin, as specified in Annex I, is
sations of plant protection products containing tefluthrin.
approved subject to the conditions laid down in that Annex.
Member States should, as appropriate, vary, replace or
withdraw existing authorisations in accordance with the
provisions of Directive 91/414/EEC. By way of dero
Article 2
gation from the above deadline, a longer period should
be provided for the submission and assessment of the
Re-evaluation of plant protection products
update of the complete Annex III dossier, as set out in
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Directive 91/414/EEC of each plant protection product
No 1107/2009, where necessary, amend or withdraw existing
for each intended use in accordance with the uniform
authorisations for plant protection products containing
principles.
tefluthrin 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
the Annex I to this Regulation are met, with the exception of
the framework of Commission Regulation (EEC) No
those identified in Part B of the column on specific provisions
3600/92 of 11 December 1992 laying down the
of that Annex, and that the holder of the authorisation has, or
detailed rules for the implementation of the first stage
has access to, a dossier satisfying the requirements of Annex II
of the programme of work referred to in Article 8(2) of
to 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.
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
2. By way of derogation from paragraph 1, for each auth
appears necessary to clarify the duties of the Member
orised plant protection product containing tefluthrin as either
States, especially the duty to verify that the holder of
the only active substance or as one of several active substances
an authorisation demonstrates access to a dossier
all of which were listed in the Annex to Implementing Regu
satisfying the requirements of Annex II to that Directive.
lation (EU) No 540/2011 by 31 December 2011 at the latest,
However, this clarification does not impose any new
Member States shall re-evaluate the product in accordance with
( 1 ) OJ L 366, 15.12.1992, p. 10.
( 2 ) OJ L 153, 11.6.2011, p. 1

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L 205/24
EN
Official Journal of the European Union
10.8.2011
the uniform principles, as referred to in Article 29(6) of Regu
Article 3
lation (EC) No 1107/2009, on the basis of a dossier satisfying
the requirements of Annex III to Directive 91/414/EEC and
Amendments to Implementing Regulation (EU) No
taking into account Part B of the column on specific provisions
540/2011
of Annex I to this Regulation. On the basis of that evaluation,
The Annex to Implementing Regulation (EU) No 540/2011 is
they shall determine whether the product satisfies the conditions
amended in accordance with Annex II to this Regulation.
set out in Article 29(1) of Regulation (EC) No 1107/2009.
Article 4
Following that determination Member States shall:
Amendments to Decision 2008/934/EC
(a) in the case of a product containing tefluthrin as the only
The line concerning tefluthrin in the Annex to Decision
active substance, where necessary, amend or withdraw the
2008/934/EC is deleted.
authorisation by 31 December 2015 at the latest; or
Article 5
(b) in the case of a product containing tefluthrin as one of
several active substances, where necessary, amend or
Entry into force and date of application
withdraw the authorisation by 31 December 2015 or by
This Regulation shall enter into force on the 20th day following
the date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance or
its publication in the Official Journal of the European Union.
substances to Annex I to Directive 91/414/EEC or approved
that substance or substances, whichever is the latest.
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, 9 August 2011.
For the Commission
The President
José Manuel BARROSO

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10.8.2011 Off
ANNEX I
Conditions of approval as active substance under Regulation (EC) No 1107/2009:
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
EN
Tefluthrin
2,3,5,6-tetrafluoro-4-methyl ≥ 920 g/kg
1 January 2012 31
December
2021 PART
A

benzyl (1RS, 3RS)-3-[(Z)-2-
CAS No: 79538-32-2 chloro-3,3,3-trifluoroprop- Hexachloro
Only uses as insecticide may be authorised.
benzene: not
CIPAC No: 451
1-enyl]-2,2-dimethylcyclo
The seed coating shall only be performed in professional seed treatment facilities. These facilities
propanecarboxylate
more than
1 mg/kg
shall apply the best available techniques in order to exclude the release of dust clouds during
Tefluthrin is a 1:1 mixture
storage, transport and application.
of Z-(1R, 3R) and Z-(1S, 3S)
PART B
enantiomers.
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 tefluthrin, 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 shall pay particular attention to:
Jour
— the operators and workers safety and include among the authorised conditions of use the
application of adequate personal protective equipment as well as respiratory protective
nal
equipment,
of
the
— the risk to birds and mammals. Risk mitigation measures should be applied to grant a high
degree of incorporation in soil and avoidance of spillage,
European
— ensure that the label of treated seed includes the indication that the seeds were treated with
tefluthrin and sets out the risk mitigation measures provided for in the authorisation.
The applicant shall submit confirmatory information as regards:
Union
(1) the specification of the technical material, as commercially manufactured;
(2) a validated analytical method for water;
(3) the possible environmental impact of the preferential degradation/conversion of the isomers
and an estimation of the relative toxicity and risk assessment for the workers.
The applicant shall submit to the Commission, the Member States and the Authority the
information set out in point (1) by 30 June 2012, the information set out in point (2) by
31 December 2012, and the information set out in point (3) 2 years after the adoption of a
specific guidance document on evaluation of isomers mixture.
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
205/25

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L 205/26
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011 the following entry is added:
‘10 Tefluthrin
2,3,5,6-tetrafluoro-4-methyl
≥ 920 g/kg
1 January 2012 31
December PART A
benzyl (1RS, 3RS)-3-[(Z)-2-
2021
CAS No: 79538-32-2 chloro-3,3,3-trifluoroprop-1- Hexachlorobenzene:
Only uses as insecticide may be authorised.
EN
enyl]-2,2-dimethylcyclopro
not more than 1 mg/kg

CIPAC No: 451
panecarboxylate
The seed coating shall only be performed in professional seed treatment
facilities. These facilities shall apply the best available techniques in order
Tefluthrin is a 1:1 mixture of
to exclude the release of dust clouds during storage, transport and appli
Z-(1R, 3R) and Z-(1S, 3S)
cation.
enantiomers.
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 tefluthrin, and in particular Appendices I and II thereof,
as finalised in the Standing Committee on the Food Chain and Animal Health
Off
on 17 June 2011 shall be taken into account.
icial
In this overall assessment Member States shall pay particular attention to:
Jour
— the operators and workers safety and include among the authorised
nal
conditions of use the application of adequate personal protective
of
equipment as well as respiratory protective equipment,
the
— the risk to birds and mammals. Risk mitigation measures should be
European
applied to grant a high degree of incorporation in soil and avoidance
of spillage,
— ensure that the label of treated seed includes the indication that the seeds
Union
were treated with tefluthrin and sets out the risk mitigation measures
provided for in the authorisation.
The applicant shall submit confirmatory information as regards:
(1) the specification of the technical material, as commercially manufactured;
(2) a validated analytical method for water;
(3) the possible environmental impact of the preferential degradation/
conversion of the isomers and an estimation of the relative toxicity and
risk assessment for the workers.
The applicant shall submit to the Commission, the Member States and the
Authority the information set out in point (1) by 30 June 2012, the
information set out in point (2) by 31 December 2012, and the information
set out in point (3) 2 years after the adoption of a specific guidance
document on evaluation of isomers mixture.’
10.8.2011

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