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21.7.2011 Official
Journal
of
the
European
Union L
190/33
COMMISSION IMPLEMENTING REGULATION (EU) No 703/2011
of 20 July 2011
approving the active substance azoxystrobin, 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,
(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 the Treaty on the Functioning of the European
together with an explanation as regards the relevance
Union,
of each new study submitted.
Having regard to Regulation (EC) No 1107/2009 of the
(5) The
rapporteur
Member
State
prepared
an
assessment
European Parliament and of the Council of 21 October 2009
report in consultation with the co-rapporteur Member
concerning the placing of plant protection products on the
State and submitted it to the European Food Safety
market and repealing Council Directives 79/117/EEC and
Authority (hereinafter ‘the Authority’) and the
91/414/EEC ( 1 ), and in particular Article 13(2) and
Commission on 10 June 2009. In addition to the
Article 78(2) thereof,
assessment of the active substance, that report includes
a list of the studies the rapporteur Member State relied
on for its assessment.
Whereas:
(1) In
accordance
with
Article
80(1)(b)
of
Regulation
(EC) (6) The
Authority
communicated
the
assessment
report
to
No 1107/2009, Council Directive 91/414/EEC (
the notifier and to the Member States for comments

2 ) is to
apply to active substances listed in Annex I to
and forwarded the comments received to the
Commission Regulation (EC) No 737/2007 of 27 June
Commission. The Authority also made the assessment
2007 on laying down the procedure of the renewal of
report available to the public.
the inclusion of a first group of active substances in
Annex I to Council Directive 91/414/EEC and estab
lishing the list of those substances (
(7)
At the request of the Commission, the assessment report

3 ), with respect to
the procedure and the conditions for approval. Azoxy
was peer reviewed by the Member States and the
strobin is listed in Annex I to Regulation (EC)
Authority. The Authority presented its conclusion on
No 737/2007.
the peer review of the risk assessment of azoxystrobin (


6 )
to the Commission on 12 March 2010. The assessment
report and the conclusion of the Authority were reviewed
(2)
The approval of azoxystrobin, as set out in Part A of the
by the Member States and the Commission within the
Annex to Commission Implementing Regulation (EU)
Standing Committee on the Food Chain and Animal
No 540/2011 of 25 May 2011 implementing Regulation
Health and finalised on 17 June 2011 in the format of
(EC) No 1107/2009 of the European Parliament and of
the Commission review report for azoxystrobin.
the Council as regards the list of approved active
substances ( 4 ), expires on 31 December 2011. A notifi
cation was submitted in accordance with Article 4 of
(8)
It has appeared from the various examinations made that
Regulation (EC) No 737/2007 for the renewal of the
plant protection products containing azoxystrobin may
inclusion of azoxystrobin in Annex I to Directive
be expected to continue to satisfy, in general, the
91/414/EEC within the time period provided for in
requirements laid down in Article 5(1)(a) and (b) of
that Article.
Directive 91/414/EEC, in particular as regards the uses
which were examined and detailed in the Commission
review report. It is therefore appropriate to approve
(3) That
notification
was
found
to
be
admissible
by
azoxystrobin.
Commission Decision 2008/656/EC of 28 July 2008
on the admissibility of the notifications concerning the
renewal of the inclusion in Annex I to Council Directive
(9) In
accordance
with
Article
13(2)
of
Regulation
(EC)
91/414/EEC of the active substances azimsulfuron,
No 1107/2009 in conjunction with Article 6 thereof
azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl,
and in the light of current scientific and technical
prohexadione and spiroxamine, and establishing the list
knowledge, it is, however, necessary to include certain
of the notifiers concerned ( 5 ).
conditions and restrictions not provided for in the first
inclusion in Annex I to Directive 91/414/EEC.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 169, 29.6.2007, p. 10.
the pesticide risk assessment of the active substance azoxystrobin.
( 4 ) OJ L 153, 11.6.2011, p. 1.
EFSA Journal 2010; 8(4):15421542. [110 pp.]. doi:10.2903/j.efsa.
( 5 ) OJ L 214, 9.8.2008, p. 70.
2010.1542. Available online: www.efsa.europa.eu

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L 190/34
EN
Official Journal of the European Union
21.7.2011
(10) Based on the review report, which points out that for the
(16) In the interest of clarity, Commission Directive
active substance azoxystrobin notified by the main data
2010/55/EU of 20 August 2010 amending Annex I to
submitter the manufacturing impurity toluene is of toxi
Council Directive 91/414/EEC to renew the inclusion of
cological concern, a maximum level of 2 g/kg should,
azoxystrobin as active substance ( 2 ) should be repealed.
however, be set for that impurity in the technical
material.
(17) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(11) From
the
new
data
submitted,
it
appears
that
azoxy
Committee on the Food Chain and Animal Health,
strobin may cause risks for aquatic organisms. Without
prejudice to the conclusion that azoxystrobin should be
approved, it is, in particular, appropriate to require
further confirmatory information.
HAS ADOPTED THIS REGULATION:

(12) A
reasonable
period
should
be
allowed
to
elapse
before
Article 1
approval in order to permit Member States and interested
Approval of active substance
parties to prepare themselves to meet the new
requirements resulting from the approval.
The active substance azoxystrobin, as specified in Annex I, is
approved subject to the conditions laid down in that Annex.
(13) Without
prejudice
to
the
obligations
provided
for
by
Regulation (EC) No 1107/2009 as a consequence of
Article 2
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
Re-evaluation of plant protection products
Regulation (EC) No 1107/2009 the following should,
1. Member
States
shall
in
accordance
with
Regulation
(EC)
however, apply. Member States should be allowed a
No 1107/2009, where necessary, amend or withdraw existing
period of 6 months after approval to review authori
authorisations for plant protection products containing azoxy
sations of plant protection products containing azoxy
strobin as an active substance by 30 June 2012.
strobin. Member States should, as appropriate, vary,
replace or withdraw authorisations. By way of derogation
from that deadline, a longer period should be provided
By that date they shall in particular verify that the conditions in
for the submission and assessment of the update of the
Annex I to this Regulation are met, with the exception of those
complete Annex III dossier, as set out in Directive
identified in Part B of the column on specific provisions of that
91/414/EEC, of each plant protection product for each
Annex, and that the holder of the authorisation has, or has
intended use in accordance with the uniform principles.
access to, a dossier satisfying the requirements of
Article 13(1) to (4) of Directive 91/414/EEC and Article 62
of Regulation (EC) No 1107/2009.
(14) 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 azoxystrobin as
of the programme of work referred to in Article 8(2) of
either the only active substance or as one of several active
Council Directive 91/414/EEC concerning the placing of
substances all of which were listed in the Annex to Imple
plant protection products on the market (
menting Regulation (EU) No 540/2011 by 31 December

1 ) has shown
that difficulties can arise in interpreting the duties of
2011 at the latest, Member States shall re-evaluate the
holders of existing authorisations in relation to access
product in accordance with the uniform principles, as referred
to data. In order to avoid further difficulties it therefore
to in Article 29(6) of Regulation (EC) No 1107/2009, on the
appears necessary to clarify the duties of the Member
basis of a dossier satisfying the requirements of Annex III to
States, especially the duty to verify that the holder of
Directive 91/414/EEC and taking into account Part B of the
an authorisation demonstrates access to a dossier
column on specific provisions of Annex I to this Regulation.
satisfying the requirements of Annex II to that Directive.
On the basis of that evaluation, they shall determine whether
However, this clarification does not impose any new
the product still satisfies the conditions set out in Article 29(1)
obligations on Member States or holders of authori
of Regulation (EC) No 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:
(15) In
accordance
with
Article
13(4) of Regulation
(EC)
(a) in the case of a product containing azoxystrobin as the only
No 1107/2009, the Annex to Implementing Regulation
active substance, where necessary, amend or withdraw the
(EU) No 540/2011 should be amended accordingly.
authorisation by 31 December 2015 at the latest; or
( 1 ) OJ L 366, 15.12.1992, p. 10.
( 2 ) OJ L 220, 21.8.2010, p. 67.

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EN
21.7.2011 Official
Journal
of
the
European
Union L
190/35
(b) in the case of a product containing azoxystrobin as one of
Article 4
several active substances, where necessary, amend or
withdraw the authorisation by 31 December 2015 or by
Repeal
the date fixed for such an amendment or withdrawal in the
Directive 2010/55/EU is repealed.
respective act or acts which added the relevant substance or
substances to Annex I to Directive 91/414/EEC or approved
that substance or substances, whichever is the latest.
Article 5
Entry into force and date of application
Article 3
This Regulation shall enter into force on the 20th day following
Amendments to Implementing Regulation (EU)
its publication in the Official Journal of the European Union.
No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is
amended in accordance with Annex II to this Regulation.
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, 20 July 2011.
For the Commission
The President
José Manuel BARROSO

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L 190/36
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Azoxystrobin
methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin- ≥ 930 g/kg
1 January 2012 31
December
PART A
4-yloxy]phenyl}-3-methoxyacrylate
2021
EN
CAS No 131860-33-8
Toluene maximum
Only uses as fungicide may be authorised.

content 2 g/kg
CIPAC No 571
PART B
Z-isomer maximum
content 25 g/kg
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 azoxystrobin 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.
Off
In this overall assessment Member States shall pay particular
attention to:
icial
Jour
(1) the fact that the specification of the technical material as
commercially manufactured must be confirmed and
nal
supported by appropriate analytical data. The test material
used in the toxicity dossiers should be compared and
of
verified against this specification of the technical material;
the
European
(2) the potential for groundwater contamination, when the active
substance is applied in regions with vulnerable soil and/or
climatic conditions;
Union
(3) the protection of aquatic organisms.
The Member States must ensure that the conditions of authori
sation include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of
confirmatory information as regards the risk assessment on
groundwater and aquatic organisms.
The notifier shall submit to the Member States, the Commission
and the Authority such information by 31 December 2013.
(1 ) Further details on identity and specification of active substance are provided in the review report.
21.7.2011

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21.7.2011 Off
ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, the entry relating to azoxystrobin is deleted;
(2) in Part B, the following entry is added:
EN
Common Name,

Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
‘4 Azoxystrobin
methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin- ≥ 930 g/kg
1 January 2012 31
December
PART A
CAS No 131860-33-8 4-yloxy]phenyl}-3-methoxyacrylate
Toluene maximum
2021
Only uses as fungicide may be authorised.
CIPAC No 571
content 2 g/kg
PART B
Z-isomer maximum
content 25 g/kg
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 azoxystrobin and in particular Appendices I and II
icial
thereof, as finalised in the Standing Committee on the
Food Chain and Animal Health on 17 June 2011 shall
Jour
be taken into account.
nal
In this overall assessment Member States shall pay
particular attention to:
of
the
(1) the fact that the specification of the technical
material as commercially manufactured must be
European
confirmed and supported by appropriate analytical
data. The test material used in the toxicity dossiers
should be compared and verified against this spec
ification of the technical material;
Union
(2) the potential for groundwater contamination, when
the active substance is applied in regions with
vulnerable soil and/or climatic conditions;
(3) the protection of aquatic organisms.
The Member States must ensure that the conditions of
authorisation include risk mitigation measures, where
appropriate.
The Member States concerned shall request the
submission of confirmatory information as regards
the risk assessment on groundwater and aquatic
organisms.
The notifier shall submit to the Member States, the
Commission and the Authority such information by
31 December 2013.’
L
190/37
(1 ) Further details on identity and specification of active substance are provided in the review report.

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