HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 206/44
EN
Official Journal of the European Union
11.8.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 807/2011
of 10 August 2011
approving the active substance triazoxide, 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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
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.
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
application
was
submitted
to
the
United
Kingdom,
which had been designated rapporteur Member State by
Having regard to Regulation (EC) No 1107/2009 of the
Regulation (EC) No 1490/2002. The time period for the
European Parliament and of the Council of 21 October 2009
accelerated procedure was respected. The specification of
concerning the placing of plant protection products on the
the active substance and the supported uses are the same
market and repealing Council Directives 79/117/EEC and
as those that were the subject of Decision 2009/860/EC.
91/414/EEC ( 1 ), and in particular Articles 13(2) and 78(3)
That application also complies with the remaining
thereof,
substantive and procedural requirements of Article 15
of Regulation (EC) No 33/2008.
Whereas:
(5) The
United
Kingdom
evaluated
the
new
information
and
data submitted by the applicant and prepared an addi
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
tional report. It communicated that report to the
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
European Food Safety Authority (hereinafter ‘the
to active substances for which completeness has been
Authority’) and to the Commission on 10 June 2010.
established in accordance with Article 16 of Commission

Regulation (EC) No 33/2008 ( 3 ), with respect to the
procedure and the conditions for approval. Triazoxide
is an active substance for which completeness has been
established in accordance with that Regulation.
(6) The
Authority
communicated
the
additional
report
to
the

other Member States and the applicant for comments
and forwarded the comments it had received to the
Commission. In accordance with Article 20(1) of Regu
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
lation (EC) No 33/2008 and at the request of the
No 1490/2002 ( 5 ) lay down the detailed rules for the
Commission, the additional report was peer reviewed
implementation of the third stage of the programme of
by the Member States and the Authority. The Authority
work referred to in Article 8(2) of Directive 91/414/EEC
then presented its conclusion on triazoxide to the
and establish a list of active substances to be assessed,
Commission on 15 February 2011
( 7 ). The draft
with a view to their possible inclusion in Annex I to
assessment report, the additional report and the
Directive 91/414/EEC. That list included triazoxide. By
conclusion of the Authority were reviewed by the
Commission Decision 2009/860/EC ( 6 ) it was decided
Member States and the Commission within the
not to include triazoxide in Annex I to Directive
Standing Committee on the Food Chain and Animal
91/414/EEC.
Health and finalised on 17 June 2011 in the format of
the Commission review report for triazoxide.
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
original notifier (hereinafter ‘the applicant’) submitted a
new application requesting the application of the accel
(7) The
additional
report
by
the
rapporteur
Member
State
erated procedure to be applied, as provided for in
and the new conclusion by the Authority concentrate
Articles 14 to 19 of Regulation (EC) No 33/2008
on the concerns that led to the non-inclusion. Those
laying down detailed rules for the application of
concerns were in particular that it was not possible to
Directive 91/414/EEC as regards a regular and an accel
perform a reliable consumer risk assessment as data were
erated procedure for the assessment of active substances
missing to determine the nature of residues in plant
commodities and the possible transfer of residues in
animal products.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 3 ) OJ L 15, 18.1.2008, p. 5.
( 7 ) European Food Safety Authority; Conclusion on the peer review of the
( 4 ) OJ L 55, 29.2.2000, p. 25.
pesticide risk assessment of the active substance triazoxide. EFSA Journal
( 5 ) OJ L 224, 21.8.2002, p. 23.
2011;9(3): [86 pp.] doi:10.2903/j.efsa.2011.2018. Available online:
( 6 ) OJ L 314, 1.12.2009, p. 81.
www.efsa.europa.eu/efsajournal.htm

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EN
11.8.2011 Official
Journal
of
the
European
Union L
206/45
(8) The
new
information
submitted
by
the
applicant
shows
Parliament and of the Council as regards the list of
that the exposure of consumers may be considered as
approved active substances
( 1 ), should be amended
acceptable.
accordingly.
(9) Consequently,
the
additional
information
provided
by
the (14) The measures provided for in this Regulation are in
applicant permit to eliminate the specific concerns that
accordance with the opinion of the Standing
led to the non-inclusion. No other open scientific
Committee on the Food Chain and Animal Health,
questions have arisen.
HAS ADOPTED THIS REGULATION:
(10) It has appeared from the various examinations made that
plant protection products containing triazoxide may be
expected to satisfy, in general, the requirements laid
Article 1
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
in particular as regards the uses which were examined
Approval of active substance
and detailed in the Commission review report. It is
The active substance triazoxide, as specified in Annex I, is
therefore appropriate to approve triazoxide in accordance
approved subject to the conditions laid down in that Annex.
with Regulation (EC) No 1107/2009.
Article 2
(11) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009 in conjunction with Article 6 thereof and in
Amendments to Implementing Regulation (EU)
the light of current scientific and technical knowledge, it
No 540/2011
is, however, necessary to include certain conditions and
restrictions.
The Annex to Implementing Regulation (EU) No 540/2011 is

amended in accordance with Annex II to this Regulation.
(12) Without prejudice
to the conclusion that triazoxide
should be approved, it is, in particular, appropriate to
Article 3
require further confirmatory information.
Entry into force and date of application
This Regulation shall enter into force on the 20th day following
(13) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
its publication in the Official Journal of the European Union.
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
It shall apply from 1 October 2011.
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
( 1 ) OJ L 153, 11.6.2011, p. 1.

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L 206/46
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Triazoxide
7-chloro-3-imidazol-1-
≥ 970 g/kg
1 October 2011 30
September
2021 PART
A
yl-1,2,4-benzotriazine
EN
CAS No 72459-58-6 1-oxide
Impurities:
Only uses as fungicide for seed treatment may be authorised.

toluene: not more
CIPAC No 729
than 3 g/kg
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
triazoxide, 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 protection of operators and workers and
icial
shall ensure that conditions of use include the application of adequate
personal protective equipment, where appropriate;
Jour
(b) shall pay particular attention to the risk to granivorous birds and shall ensure
nal
that conditions of authorisation include risk mitigation measures.
of
The applicant shall submit to the Commission, the Member States and the
the
Authority confirmatory information as regards the long-term risk to granivorous
European
mammals by 30 September 2013.
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
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:
No
Common Name,
Identification Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘17 Triazoxide
7-chloro-3-imidazol-
≥ 970 g/kg
1 October 2011 30
September
2021 PART
A

1-yl-1,2,4-benzo
CAS No 72459-58-6 triazine 1-oxide
Impurities:
Only uses as fungicide for use as seed treatment may be authorised.
toluene: not more than
CIPAC No 729
3 g/kg
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 triazoxide, 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:
icial
(a) shall pay particular attention to the protection of operators and workers
Jour
and shall ensure that conditions of use include the application of
adequate personal protective equipment, where appropriate;
nal
(b) shall pay particular attention to the risk to granivorous birds and shall
of
ensure that conditions of authorisation include risk mitigation measures.
the
European
The applicant shall submit to the Commission, the Member States and the
Authority confirmatory information as regards the long-term risk to
granivorous mammals by 30 September 2013.’
Union
(*) Further details on identity and specification of active substance are provided in the review report.
L
206/47

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