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10.8.2011 Official
Journal
of
the
European
Union L
205/3
COMMISSION IMPLEMENTING REGULATION (EU) No 797/2011
of 9 August 2011
approving the active substance spiroxamine, 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,
azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl,
prohexadion-calcium and spiroxamine, and establishing
the list of the notifiers concerned ( 5 ).
Having regard to the Treaty on the Functioning of the European
Union,
(4) Within
the
time
period
provided
for
in
Article
6
of
Regulation (EC) No 737/2007, the notifier submitted
the data required in accordance with that Article
Having regard to Regulation (EC) No 1107/2009 of the
together with an explanation as regards the relevance
European Parliament and of the Council of 21 October 2009
of each new study submitted.
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 1 ), and in particular Article 13(2) and
(5) The
rapporteur
Member
State
prepared
an
assessment
Article 78(2) thereof,
report in consultation with the co-rapporteur Member
State and submitted it to the European Food Safety
Authority (hereinafter ‘the Authority’) and the
Commission on 17 September 2009. In addition to the
Whereas:
assessment of the active substance, that report includes a
list of the studies the rapporteur Member State relied on
for its assessment.
(1) In
accordance
with
Article
80(1)(b)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
to active substances listed in Annex I to Commission
(6) The
Authority
communicated
the
assessment
report
to
Regulation (EC) No 737/2007 of 27 June 2007 on
the notifier and to the Member States for comments
laying down the procedure of the renewal of the
and forwarded the comments received to the
inclusion of a first group of active substances in Annex
Commission. The Authority also made the assessment
I to Council Directive 91/414/EEC and establishing the
report available to the public.
list of those substances ( 3 ), with respect to the procedure
and the conditions for approval. Spiroxamine is listed in
Annex I to Regulation (EC) No 737/2007.
(7)
At the request of the Commission, the assessment report
was peer reviewed by the Member States and the
Authority. The Authority presented its conclusion on
(2) The
approval
of
spiroxamine,
as
set
out
in
Part
A
of
the
the peer review of the risk assessment of spiroxamine ( 6 )
Annex to Commission Implementing Regulation (EU) No
to the Commission on 1 September 2010. The
540/2011 of 25 May 2011 implementing Regulation
assessment report and the conclusion of the Authority
(EC) No 1107/2009 of the European Parliament and of
were reviewed by the Member States and the
the Council as regards the list of approved active
Commission within the Standing Committee on the
substances (
Food Chain and Animal Health and finalised on

4 ), expires on 31 December 2011. A notifi
cation was submitted in accordance with Article 4 of
17 June 2011 in the format of the Commission review
Regulation (EC) No 737/2007 for the renewal of the
report for spiroxamine.
inclusion of spiroxamine in Annex I to Directive
91/414/EEC within the time period provided for in
that Article.
(8)
It has appeared from the various examinations made that
plant protection products containing spiroxamine may be
expected to continue to satisfy, in general, the
requirements laid down in Article 5(1)(a) and (b) of
(3) That
notification
was
found
to
be
admissible
by
Directive 91/414/EEC, in particular as regards the uses
Commission Decision 2008/656/EC of 28 July 2008
which were examined and detailed in the Commission
on the admissibility of the notifications concerning the
review report. It is therefore appropriate to approve spir
renewal of the inclusion in Annex I to Council Directive
oxamine.
91/414/EEC of the active substances azimsulfuron,
( 5 ) OJ L 214, 9.8.2008, p. 70.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 6 ) Conclusion on the peer review of the pesticide risk assessment of the
( 2 ) OJ L 230, 19.8.1991, p. 1.
active substance spiroxamine. EFSA Journal 2010; 8(9)1719 [102
( 3 ) OJ L 169, 29.6.2007, p. 10.
pp.], doi:10.2903/j.efsa.2010 1719. Available online: www.efsa.
( 4 ) OJ L 153, 11.6.2011, p. 1.
europa.eu

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L 205/4
EN
Official Journal of the European Union
10.8.2011
(9) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No (15) The
measures
provided
for
in
this
Regulation
are
in
1107/2009 in conjunction with Article 6 thereof and in
accordance with the opinion of the Standing
the light of current scientific and technical knowledge, it
Committee on the Food Chain and Animal Health,
is, however, necessary to include certain conditions and
restrictions not provided for in the first inclusion in
Annex I to Directive 91/414/EEC.
HAS ADOPTED THIS REGULATION:
(10) Without
prejudice
to
the
conclusion
that
spiroxamine
Article 1
should be approved, it is, in particular, appropriate to
Approval of active substance
require further confirmatory information.
The active substance spiroxamine, as specified in Annex I, is
approved subject to the conditions laid down in that Annex.
(11) A
reasonable
period
should
be
allowed
to
elapse
before
approval in order to permit Member States and interested
Article 2
parties to prepare themselves to meet the new
requirements resulting from the approval.
Re-evaluation of plant protection products
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
(12) Without
prejudice
to
the
obligations
provided
for
by
authorisations for plant protection products containing spir
Regulation (EC) No 1107/2009 as a consequence of
oxamine as an active substance by 30 June 2012.
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
Regulation (EC) No 1107/2009 the following should,
By that date they shall in particular verify that the conditions in
however, apply. Member States should be allowed a
Annex I to this Regulation are met, with the exception of those
period of six months after approval to review authori
identified in Part B of the column on specific provisions of that
sations of plant protection products containing spir
Annex, and that the holder of the authorisation has, or has
oxamine. Member States should, as appropriate, vary,
access to, a dossier satisfying the requirements of Annex II to
replace or withdraw authorisations. By way of derogation
Directive 91/414/EEC in accordance with the conditions of
from that deadline, a longer period should be provided
Article 13(1) to (4) of that Directive and Article 62 of Regu
for the submission and assessment of the update of the
lation (EC) No 1107/2009.
complete Annex III dossier, as set out in Directive
91/414/EEC, of each plant protection product for each
intended use in accordance with the uniform principles.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing spiroxamine as
either the only active substance or as one of several active
substances all of which were listed in the Annex to Imple
(13) The
experience
gained
from
inclusions
in
Annex
I
to
menting Regulation (EU) No 540/2011 by 31 December
Directive 91/414/EEC of active substances assessed in
2011 at the latest, Member States shall re-evaluate the
the framework of Commission Regulation (EEC) No
product in accordance with the uniform principles, as referred
3600/92 of 11 December 1992 laying down the
to in Article 29(6) of Regulation (EC) No 1107/2009, on the
detailed rules for the implementation of the first stage
basis of a dossier satisfying the requirements of Annex III to
of the programme of work referred to in Article 8(2) of
Directive 91/414/EEC and taking into account Part B of the
Council Directive 91/414/EEC concerning the placing of
column on specific provisions of Annex I to this Regulation.
plant protection products on the market ( 1 ) has shown
On the basis of that evaluation, they shall determine whether
that difficulties can arise in interpreting the duties of
the product satisfies the conditions set out in Article 29(1) of
holders of existing authorisations in relation to access
Regulation (EC) No 1107/2009.
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
an authorisation demonstrates access to a dossier
Following that determination Member States shall:
satisfying the requirements of Annex II to that Directive.
However, this clarification does not impose any new
obligations on Member States or holders of authori
(a) in the case of a product containing spiroxamine as the only
sations compared to the directives which have been
active substance, where necessary, amend or withdraw the
adopted until now amending Annex I to that Directive
authorisation by 31 December 2015 at the latest; or
or the Regulations approving active substances.
(b) in the case of a product containing spiroxamine as one of
several active substances, where necessary, amend or
(14) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
withdraw the authorisation by 31 December 2015 or by
1107/2009 the Annex to Implementing Regulation (EU)
the date fixed for such an amendment or withdrawal in the
No 540/2011 should be amended accordingly.
respective act or acts which added the relevant substance or
substances to Annex I to Directive 91/414/EEC or approved
( 1 ) OJ L 366, 15.12.1992, p. 10.
that substance or substances, whichever is the latest.

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EN
10.8.2011 Official
Journal
of
the
European
Union L
205/5
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 application
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.
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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L 205/6
ANNEX I
Common name,
identification
IUPAC name Purity
(1 ) Date
of
approval
Expiration of
numbers
approval
Specific provisions
Spiroxamine
8-tert-butyl-1,4-
≥ 940 g/kg
1 January
31 December
PART A
EN
dioxaspiro[4.5]
2012
2021

CAS No
decan-2-
(diastereomers A and B
Only uses as fungicide may be authorised.
1181134-30-8
combined)
ylmethyl(ethyl)
PART B
CIPAC No 572
(propyl)amine (ISO)
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 spiroxamine,
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 shall pay particular attention to:
Off
(1) the risk to operators and workers and ensure that conditions of use include the
icial
application of adequate personal protective equipment;
Jour
(2) the protection of the groundwater, when the active substance is applied in regions with
vulnerable soil and/or climatic conditions;
nal
(3) the risk to aquatic organisms.
of
the
Conditions of authorisation shall include risk mitigation measures, where appropriate.
European
The notifier shall submit confirmatory information as regards:
(a) the possible impact on the worker, the consumer and the environmental risk
assessment of the potential stereo-selective degradation of each isomer in plant,
Union
animals and the environment;
(b) the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis
of fruit crop residues in processed commodities;
(c) the groundwater exposure assessment for metabolite M03 (2 );
(d) the risk to aquatic organisms.
The notifier shall submit to the Member States, the Commission and the Authority the
information set out in point (a) by two years after the adoption of specific guidance and the
information set out in points (b), (c) and (d) by 31 December 2013.
(1 ) Further details on identity and specification of active substance are provided in the review report.
(2 ) M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide.
10.8.2011

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10.8.2011 Off
ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, the entry relating to spiroxamine is deleted;
(2) in Part B, the following entry is added:
EN

‘7 Spiroxamine
8-tert-butyl-1,4-dioxaspiro
≥ 940 g/kg
1 January
31 December PART A
[4.5]decan-2-ylmethyl(ethyl)
2012
2021
CAS No 1181134-30-8
(propyl)amine (ISO)
(diastereomers A and B
Only uses as fungicide may be authorised.
combined)
CIPAC No 572
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 spiroxamine, and in particular
Appendices I and II thereof, as finalised in the Standing
icial
Committee on the Food Chain and Animal Health on 17 June
2011 shall be taken into account.
Jour
nal
In this overall assessment Member States shall pay particular
attention to:
of
the
(1) the risk to operators and workers and ensure that conditions
European
of use include the application of adequate personal protective
equipment;
(2) the protection of the groundwater, when the active substance
Union
is applied in regions with vulnerable soil and/or climatic
conditions;
(3) the risk to aquatic organisms.
Conditions of authorisation shall include risk mitigation measures,
where appropriate.
The notifier shall submit confirmatory information as regards:
(a) the possible impact on the worker, the consumer and the
environmental risk assessment of the potential stereo-
selective degradation of each isomer in plant, animals and
the environment;
(b) the toxicity of the plant metabolites formed in fruit crops and
the potential hydrolysis of fruit crop residues in processed
commodities;
L
205/7
(c) the groundwater exposure assessment for metabolite M03 (*);

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L 205/8
(d) the risk to aquatic organisms.
The notifier shall submit to the Member States, the Commission
and the Authority the information set out in point (a) by two
years after the adoption of specific guidance and the information
set out in points (b), (c) and (d) by 31 December 2013.
(*) M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide.’
EN

Off
icial
Jour
nal
of
the
European
Union
10.8.2011

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