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30.8.2013 Official
Journal
of
the
European
Union L
232/13
COMMISSION IMPLEMENTING REGULATION (EU) No 826/2013
of 29 August 2013
approving the active substance sedaxane, 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 Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
applicant. The designated rapporteur Member State
submitted a draft assessment report on 10 May 2011.
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
draft
assessment
report
was
reviewed
by
the
Member
States and the European Food Safety Authority (here
inafter ‘the Authority’). The Authority presented to the
Having regard to Regulation (EC) No 1107/2009 of the
Commission its conclusion on the review of the pesticide
European Parliament and of the Council of 21 October 2009
risk assessment of the active substance sedaxane ( 4 ) on
concerning the placing of plant protection products on the
6 July 2012.
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
thereof,
(5) In
November
2012,
the
Commission
requested
further
Whereas:
toxicological assessment from the Authority. The
rapporteur Member State submitted an addendum to its
draft assessment report. The Authority updated its
conclusion and undertook a final consultation with the
Member States.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
approval, to active substances for which a decision has
been adopted in accordance with Article 6(3) of that
Directive before 14 June 2011. For sedaxane the
(6) The
Authority
presented
to
the
Commission
its
updated
conditions of Article 80(1)(a) of Regulation (EC) No
conclusion on the review of the pesticide risk assessment
1107/2009 are fulfilled by Commission Decision
of the active substance sedaxane ( 5 ) on 18 December
2011/123/EU ( 3 ).
2012. The draft assessment report and the updated
conclusion of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
Health and the draft assessment report was finalised on
France received on 14 June 2010 an application from
16 July 2013 in the format of the Commission review
Syngenta Crop Protection AG for the inclusion of the
report for sedaxane.
active substance sedaxane in Annex I to Directive
91/414/EEC. Decision 2011/123/EU confirmed that the
dossier was ‘complete’ in the sense that it could be
considered as satisfying, in principle, the data and
information requirements of Annexes II and III to
Directive 91/414/EEC.
(7)
It has appeared from the various examinations made that
plant protection products containing sedaxane may be
expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) and Article 5(3) of
Directive 91/414/EEC, in particular with regard to the
(3) For
that
active
substance,
the
effects
on
human
and
uses which were examined and detailed in the
animal health and the environment have been assessed,
Commission review report. It is therefore appropriate
in accordance with the provisions of Article 6(2) and (4)
to approve sedaxane.
of Directive 91/414/EEC, for the uses proposed by the
( 4 ) EFSA Journal (2012); 10(7):2823. Available online: www.efsa.
( 1 ) OJ L 309, 24.11.2009, p. 1.
europa.eu
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 5 ) EFSA Journal (2012); 11(1):3057. Available online: www.efsa.
( 3 ) OJ L 49, 24.2.2011, p. 40.
europa.eu

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L 232/14
EN
Official Journal of the European Union
30.8.2013
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No HAS ADOPTED THIS REGULATION:
1107/2009 in conjunction with Article 6 thereof and in
the light of current scientific and technical knowledge, it
is, however, necessary to include certain conditions and
restrictions.
Article 1
Approval of active substance
(9) A
reasonable
period
should
be
allowed
to
elapse
before The active substance sedaxane, as specified in Annex I, is
approval in order to permit Member States and the
approved subject to the conditions laid down in that Annex.
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
Article 2
(10) Without
prejudice
to
the
obligations
provided
for
in
Regulation (EC) No 1107/2009 as a consequence of
Re-evaluation of plant protection products
approval, taking into account the specific situation
1. Member
States
shall
in
accordance
with
Regulation
(EC)
created by the transition from Directive 91/414/EEC to
No 1107/2009, where necessary, amend or withdraw existing
Regulation (EC) No 1107/2009, the following should,
authorisations for plant protection products containing
however, apply. Member States should be allowed a
sedaxane as an active substance by 31 July 2014.
period of six months after approval to review authori
sations of plant protection products containing sedaxane.
Member States should, as appropriate, vary, replace or
withdraw authorisations. By way of derogation from
By that date they shall in particular verify that the conditions in
that deadline, a longer period should be provided for
Annex I to this Regulation are met, with the exception of those
the submission and assessment of the update of the
identified in the column on specific provisions of that Annex,
complete Annex III dossier, as set out in Directive
and that the holder of the authorisation has, or has access to, a
91/414/EEC, of each plant protection product for each
dossier satisfying the requirements of Annex II to Directive
intended use in accordance with the uniform principles.
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
1107/2009.
(11) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
3600/92 of 11 December 1992 laying down the
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
detailed rules for the implementation of the first stage
orised plant protection product containing sedaxane as either
of the programme of work referred to in Article 8(2) of
the only active substance or as one of several active substances,
Council Directive 91/414/EEC concerning the placing of
all of which were listed in the Annex to Implementing Regu
plant protection products on the market (
lation (EU) No 540/2011 by 31 January 2014 at the latest,

1 ) has shown
that difficulties can arise in interpreting the duties of
Member States shall re-evaluate the product in accordance
holders of existing authorisations in relation to access
with the uniform principles, as referred to in Article 29(6) of
to data. In order to avoid further difficulties it therefore
Regulation (EC) No 1107/2009, on the basis of a dossier
appears necessary to clarify the duties of the Member
satisfying the requirements of Annex III to Directive
States, especially the duty to verify that the holder of
91/414/EEC and taking into account the column on specific
an authorisation demonstrates access to a dossier
provisions of Annex I to this Regulation. On the basis of that
satisfying the requirements of Annex II to that Directive.
evaluation, they shall determine whether the product satisfies
However, this clarification does not impose any new
the conditions set out in Article 29(1) of Regulation (EC) No
obligations on Member States or holders of authori
1107/2009.
sations compared to the Directives which have been
adopted until now amending Annex I to that Directive
or the Regulations approving active substances.
Following that determination Member States shall:
(12) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009, the Annex to Commission Implementing
(a) in the case of a product containing sedaxane as the only
Regulation (EU) No 540/2011 of 25 May 2011 imple
active substance, where necessary, amend or withdraw the
menting Regulation (EC) No 1107/2009 of the European
authorisation by 31 July 2015 at the latest; or
Parliament and of the Council as regards the list of
approved active substances
( 2 ) should be amended
accordingly.
(b) in the case of a product containing sedaxane as one of
several active substances, where necessary, amend or
(13) The
measures
provided
for
in
this
Regulation
are
in
withdraw the authorisation by 31 July 2015 or by the
accordance with the opinion of the Standing
date fixed for such an amendment or withdrawal in the
Committee on the Food Chain and Animal Health,
respective act or acts which added the relevant substance
or substances to Annex I to Directive 91/414/EEC or
( 1 ) OJ L 366, 15.12.1992, p. 10.
approved that substance or those substances, whichever is
( 2 ) OJ L 153, 11.6.2011, p. 1.
the latest.

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EN
30.8.2013 Official
Journal
of
the
European
Union L
232/15
Article 3
Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this
Regulation.
Article 4
Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
It shall apply from 1 February 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 August 2013.
For the Commission
The President
José Manuel BARROSO

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L 232/16
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Sedaxane
mixture of 2 cis-isomers
≥ 960 g/kg Sedaxane
1 February 2014 31
January
2024 PART
A
2′-[(1RS,2RS)-1,1′-
EN
CAS No 874967-67-6
bicycloprop-2-yl]-3-
(range 820-890 g/kg for the
Only uses for seed treatment may be authorised.

(difluoromethyl)-1-
2 trans-isomers 50:50
(trans isomer:
methylpyrazole-4-
mixture of enantiomers and
PART B
599197-38-3/cis
carboxanilide and
range 100-150 g/kg for the
isomer: 599194-51-1)
2 trans-isomers
2 cis-isomers 50:50 mixture
For the implementation of the uniform principles as referred to in
2′-[(1RS,2SR)-1,1′-
of enantiomers)
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions
CIPAC No 833
bicycloprop-2-yl]-3-
of the review report on sedaxane, and in particular Appendices I
(difluoromethyl)-1-
and II thereof, as finalised in the Standing Committee on the Food
methylpyrazole-4-
Chain and Animal Health on 16 July 2013 shall be taken into
carboxanilide
account.
Off
In this overall assessment Member States shall pay particular
icial
attention to:
Jour
(a) the protection of groundwater, when the substance is applied
in regions with vulnerable soil and/or climatic conditions;
nal
of
(b) the long-term risk to birds and mammals.
the
European
Conditions of authorisation shall include risk mitigation measures,
where appropriate.
The Member States concerned shall carry out monitoring
Union
programmes to verify potential groundwater contamination
from the metabolite CSCD465008 in vulnerable zones, where
appropriate.
The Member States concerned shall request the submission of
confirmatory information as regards the relevance of the meta
bolite CSCD465008, and the corresponding groundwater risk
assessment, if sedaxane is classified under Regulation (EC) No
1272/2008 as ‘suspected of causing cancer’.
The notifier shall submit to the Commission, the Member States
and the Authority the relevant information within six months
from the application date of the Regulation classifying sedaxane.
(1 ) Further details on identity and specification of active substance are provided in the review report.
30.8.2013

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30.8.2013 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common Name, Identification
Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
EN

‘48 Sedaxane
mixture of 2 cis-isomers 2′- ≥ 960 g/kg Sedaxane
1 February 2014 31
January
2024 PART
A
[(1RS,2RS)-1,1′-
CAS No 874967-67-6
bicycloprop-2-yl]-3-(difluor (range 820-890 g/kg for the
Only uses for seed treatment may be authorised.
omethyl)-1-methylpyrazole- 2 trans-isomers 50:50
(trans isomer:
4-carboxanilide and
mixture of enantiomers and
PART B
599197-38-3/cis
2 trans-isomers
range 100-150 g/kg for the
isomer: 599194-51-1)
2′-[(1RS,2SR)-1,1′-
2 cis-isomers 50:50 mixture
For the implementation of the uniform principles as referred
bicycloprop-2-yl]-3-(difluor of enantiomers)
to in Article 29(6) of Regulation (EC) No 1107/2009, the
CIPAC No 833
omethyl)-1-methylpyrazole-
conclusions of the review report on sedaxane, and in
4-carboxanilide
particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
on 16 July 2013 shall be taken into account.
icial
In this overall assessment Member States shall pay particular
Jour
attention to:
nal
(a) the protection of groundwater, when the substance is
of
applied in regions with vulnerable soil and/or climatic
the
conditions;
European
(b) the long-term risk to birds and mammals.
Conditions of authorisation shall include risk mitigation
measures, where appropriate.
Union
The Member States concerned shall carry out monitoring
programmes to verify potential groundwater contamination
from the metabolite CSCD465008 in vulnerable zones,
where appropriate.
The Member States concerned shall request the submission of
confirmatory information as regards the relevance of the
metabolite CSCD465008, and the corresponding
groundwater risk assessment, if sedaxane is classified under
Regulation (EC) No 1272/2008 as ‘suspected of causing
cancer’.
The notifier shall submit to the Commission, the Member
States and the Authority the relevant information within six
months from the application date of the Regulation clas
sifying sedaxane.’
L
(*) Further details on identity and specification of active substance are provided in the review report.
232/17

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