HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 312/28
EN
Official Journal of the European Union
21.11.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1177/2013
of 20 November 2013
approving the active substance spirotetramat, 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,
applicant. The designated rapporteur Member State
submitted a draft assessment report on 5 May 2008.
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
Commission its conclusion on the pesticide risk
Having regard to Regulation (EC) No 1107/2009 of the
assessment of the active substance spirotetramat (
European Parliament and of the Council of 21 October 2009

4 ) on
27 May 2013. The draft assessment report and the
concerning the placing of plant protection products on the
conclusion of the Authority were reviewed by the
market and repealing Council Directives 79/117/EEC and
Member States and the Commission within the
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
Standing Committee on the Food Chain and Animal
thereof,
Health and finalised on 3 October 2013 in the format
of the Commission review report for spirotetramat.
Whereas:
(5)
It has appeared from the various examinations made that
plant protection products containing spirotetramat may
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
be expected to satisfy, in general, the requirements laid
1107/2009, Council Directive 91/414/EEC (
down in Article 5(1)(a) and (b) and Article 5(3) of

2 ) is to apply,
with respect to the procedure and the conditions for
Directive 91/414/EEC, in particular with regard to the
approval, to active substances for which a decision has
use which was examined and detailed in the Commission
been adopted in accordance with Article 6(3) of that
review report. It is therefore appropriate to approve
Directive before 14 June 2011. For spirotetramat the
spirotetramat.
conditions of Article 80(1)(a) of Regulation (EC) No
1107/2009 are fulfilled by Commission Decision
2007/560/EC ( 3 ).
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No 1107/2009 in conjunction with Article 6 thereof
and in the light of current scientific and technical
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
knowledge, it is, however, necessary to include certain
Austria received on 9 October 2006 an application from
conditions and restrictions. It is, in particular, appropriate
Bayer CropScience AG for the inclusion of the active
to require further confirmatory information.
substance spirotetramat in Annex I to Directive
91/414/EEC. Decision 2007/560/EC confirmed that the
dossier was ‘complete’ in the sense that it could be
(7) A
reasonable
period
should
be
allowed
to
elapse
before
considered as satisfying, in principle, the data and
approval in order to permit Member States and the
information requirements of Annexes II and III to
interested parties to prepare themselves to meet the
Directive 91/414/EEC.
new requirements resulting from the approval.
(3) For
that
active
substance,
the
effects
on
human
and (8) Without
prejudice
to
the
obligations
provided
for
in
animal health and the environment have been assessed,
Regulation (EC) No 1107/2009 as a consequence of
in accordance with the provisions of Article 6(2) and (4)
approval, taking into account the specific situation
of Directive 91/414/EEC, for the uses proposed by the
created by the transition from Directive 91/414/EEC to
Regulation (EC) No 1107/2009, the following should,
however, apply. Member States should be allowed a
( 1 ) OJ L 309, 24.11.2009, p. 1.
period of six months after approval to review authori
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
sations of plant protection products containing spirotet
19.8.1991, p. 1).
ramat. Member States should, as appropriate, vary,
( 3 ) Commission Decision 2007/560/EC of 2 August 2007 recognising
replace or withdraw authorisations. By way of derogation
in principle the completeness of the dossiers submitted for detailed
from that deadline, a longer period should be provided
examination in view of the possible inclusion of chlorantraniliprole,
heptamaloxyglucan, spirotetramat and Helicoverpa armigera nucleo
polyhedrovirus in Annex I to Council Directive 91/414/EEC (OJ
( 4 ) EFSA Journal (2013) 11(6):3243. Available online: www.efsa.europa.
L 213, 15.8.2007, p. 29).
eu.

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EN
21.11.2013 Official
Journal
of
the
European
Union L
312/29
for the submission and assessment of the complete
By that date they shall in particular verify that the conditions in
Annex III dossier, as set out in Directive 91/414/EEC,
Annex I to this Regulation are met, with the exception of those
of each plant protection product for each intended use
identified in the column on specific provisions of that Annex,
in accordance with the uniform principles.
and that the holder of the authorisation has, or has access to, a
dossier satisfying the requirements of Annex II to Directive
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC)
(9) The
experience
gained
from
inclusions
in
Annex
I
to No 1107/2009.
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
3600/92 ( 1 ) has shown that difficulties can arise in inter
preting the duties of holders of existing authorisations in
2. By way of derogation from paragraph 1, for each auth
relation to access to data. In order to avoid further
orised plant protection product containing spirotetramat as
difficulties it therefore appears necessary to clarify the
either the only active substance or as one of several active
duties of the Member States, especially the duty to
substances, all of which were listed in the Annex to Imple
verify that the holder of an authorisation demonstrates
menting Regulation (EU) No 540/2011 by 30 April 2014 at
access to a dossier satisfying the requirements of Annex
the latest, Member States shall re-evaluate the product in
II to that Directive. However, this clarification does not
accordance with the uniform principles, as referred to in
impose any new obligations on Member States or holders
Article 29(6) of Regulation (EC) No 1107/2009, on the basis
of authorisations compared to the Directives which have
of a dossier satisfying the requirements of Annex III to Directive
been adopted until now amending Annex I to that
91/414/EEC and taking into account the column on specific
Directive or the Regulations approving active substances.
provisions of Annex I to this Regulation. On the basis of that
evaluation, they shall determine whether the product satisfies
the conditions set out in Article 29(1) of Regulation (EC)
No 1107/2009.
(10) In
accordance
with
Article 13(4) of Regulation
(EC)
No 1107/2009, the Annex to Commission Implementing
Regulation (EU) No 540/2011 ( 2 ) should be amended
Following that determination Member States shall:
accordingly.
(a) in the case of a product containing spirotetramat as the
(11) The
measures
provided
for
in
this
Regulation
are
in
only active substance, where necessary, amend or
accordance with the opinion of the Standing
withdraw the authorisation by 31 October 2015 at the
Committee on the Food Chain and Animal Health,
latest; or
(b) in the case of a product containing spirotetramat as one of
HAS ADOPTED THIS REGULATION:
several active substances, where necessary, amend or
withdraw the authorisation by 31 October 2015 or by
the date fixed for such an amendment or withdrawal in
the respective act or acts which added the relevant
Article 1
substance or substances to Annex I to Directive 91/414/EEC
Approval of active substance
or approved that substance or those substances, whichever
is the latest.
The active substance spirotetramat, as specified in Annex I, is
approved subject to the conditions laid down in that Annex.
Article 3
Amendments to Implementing Regulation (EU)
Article 2
No 540/2011
Re-evaluation of plant protection products
The Annex to Implementing Regulation (EU) No 540/2011 is
1. Member
States
shall
in
accordance
with
Regulation
(EC) amended in accordance with Annex II to this Regulation.
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing spiro
tetramat as an active substance by 31 October 2014.
Article 4
Entry into force and date of application
( 1 ) Commission Regulation (EEC) No 3600/92 of 11 December 1992
laying down the detailed rules for the implementation of the first
This Regulation shall enter into force on the twentieth day
stage of the programme of work referred to in Article 8(2) of
following that of its publication in the Official Journal of the
Council Directive 91/414/EEC concerning the placing of plant
protection products on the market (OJ L 366, 15.12.1992, p. 10).
European Union.
( 2 ) Commission Implementing Regulation (EU) No 540/2011 of
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
approved active substances (OJ L 153, 11.6.2011, p. 1).
It shall apply from 1 May 2014.

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L 312/30
EN
Official Journal of the European Union
21.11.2013
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 November 2013.
For the Commission
The President
José Manuel BARROSO

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21.11.2013 Off
ANNEX I
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Spirotetramat
cis-4-(ethoxycarbonyloxy)-
≥ 970 g/kg 1
May
2014 30
April
2024
For the implementation of the uniform principles as referred to in
EN
8-methoxy-3-(2,5-xylyl)-1-
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
CAS No 203313-25-1

azaspiro[4.5]dec-3-en-2-one
the review report on spirotetramat, and in particular Appendices I
CIPAC No 795
and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 3 October 2013 shall be taken into
account.
In this overall assessment Member States shall pay particular
attention to the risk to insectivorous birds.
Conditions of use shall include risk mitigation measures, where
appropriate.
The applicant shall submit confirmatory information as regards the
potential for endocrine disruptor effects in birds and fish to the
icial
Commission, the Member States and the Authority within two
years after the adoption of the OECD test guidelines on endocrine
Jour
disruption or, alternatively, of Community agreed test guidelines.
nal
(1 ) Further details on identity and specification of active substance are provided in the review report.
of
the
European
Union
L
312/31

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L 312/32
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
‘60 Spirotetramat
cis-4-(ethoxycarbonyloxy)-8-
≥ 970 g/kg 1
May
2014 30
April
2024
For the implementation of the uniform principles as referred

methoxy-3-(2,5-xylyl)-1-
to in Article 29(6) of Regulation (EC) No 1107/2009, the
CAS No 203313-25-1
azaspiro[4.5]dec-3-en-2-one
conclusions of the review report on spirotetramat, and in
CIPAC No 795
particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
on 3 October 2013 shall be taken into account.
In this overall assessment Member States shall pay particular
attention to the risk to insectivorous birds.
Conditions of use shall include risk mitigation measures,
where appropriate.
Off
The applicant shall submit confirmatory information as
icial
regards the potential for endocrine disruptor effects in birds
Jour
and fish to the Commission, the Member States and the
Authority within two years after the adoption of the OECD
nal
test guidelines on endocrine disruption or, alternatively, of
Community agreed test guidelines.’
of

the
(*) Further details on identity and specification of active substance are provided in the review report.
European
Union
21.11.2013

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Document Outline

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