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21.7.2011 Official
Journal
of
the
European
Union L
190/43
COMMISSION IMPLEMENTING REGULATION (EU) No 705/2011
of 20 July 2011
approving the active substance imazalil, 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 (
Commission on 9 June 2009. In addition to the

1 ), and in particular Article 13(2) and
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:
(6) The
Authority
communicated
the
assessment
report
to
the notifier and to the Member States for comments
(1) In
accordance
with
Article
80(1)(b)
of
Regulation
(EC)
No
and forwarded the comments received to the
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
Commission. The Authority also made the assessment
to active substances listed in Annex I to Commission
report available to the public.
Regulation (EC) No 737/2007 of 27 June 2007 on
laying down the procedure of the renewal of the
inclusion of a first group of active substances in Annex
(7)
At the request of the Commission, the assessment report
I to Council Directive 91/414/EEC and establishing the
was peer reviewed by the Member States and the
list of those substances ( 3 ), with respect to the procedure
Authority. The Authority presented its conclusion on
and the conditions for approval. Imazalil is listed in
the peer review of the risk assessment of imazalil ( 6 ) to
Annex I to Regulation (EC) No 737/2007.
the Commission on 4 March 2010. The assessment
report and the conclusion of the Authority were
reviewed by the Member States and the Commission
(2) The
approval
of
imazalil,
as
set
out
in
Part
A
of
the
within the Standing Committee on the Food Chain and
Annex to Commission Implementing Regulation (EU)
Animal Health and finalised on 17 June 2011 in the
No 540/2011 of 25 May 2011 implementing Regulation
format of the Commission review report for imazalil.
(EC) No 1107/2009 of the European Parliament and of
the Council as regards the list of approved active
substances ( 4 ), expires on 31 December 2011. A notifi
(8)
It has appeared from the various examinations made that
cation was submitted in accordance with Article 4 of
plant protection products containing imazalil may be
Regulation (EC) No 737/2007 for the renewal of the
expected to continue to satisfy, in general, the
inclusion of imazalil in Annex I to Directive 91/414/EEC
requirements laid down in Article 5(1)(a) and (b) of
within the time period provided for in 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
imazalil.
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)
No
91/414/EEC of the active substances azimsulfuron,
1107/2009 in conjunction with Article 6 thereof and in
azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl,
the light of current scientific and technical knowledge, it
prohexadione and spiroxamine, and establishing the list
is, however, necessary to include certain conditions and
of the notifiers concerned ( 5 ).
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 imazalil on
( 4 ) OJ L 153, 11.6.2011, p. 1.
request from the European Commission EFSA Journal 2010;
( 5 ) OJ L 214, 9.8.2008, p. 70.
8(3):1526.

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L 190/44
EN
Official Journal of the European Union
21.7.2011
(10) Based
on
the
review
report
which
supports
a
lower
level
(15) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
of purity compared to that set out in Part A of the
1107/2009, the Annex to Implementing Regulation (EU)
Annex to Commission Implementing Regulation (EU)
No 540/2011 should be amended accordingly.
No 540/2011, and taking into account that no toxico
logically or ecotoxicologically significant impurities are
present, the purity level should be modified.
(16) In the interest of clarity, Commission Directive
2010/57/EU of 26 August 2010 amending Annex I to
Council Directive 91/414/EEC to renew the inclusion of
imazalil as active substance ( 2 ) should be repealed.
(11) From
the
new
data
submitted,
it
appears
that
imazalil
and its degradation products in soil and surface water
systems may cause risks for soil micro-organisms and
(17) The
measures
provided
for
in
this
Regulation
are
in
aquatic organisms; negligible groundwater exposure
accordance with the opinion of the Standing
needs to be confirmed; further investigation is needed
Committee on the Food Chain and Animal Health,
on the nature of residues in processed commodities.
Without prejudice to the conclusion that imazalil
should be approved, it is, in particular, appropriate to
HAS ADOPTED THIS REGULATION:
require further confirmatory information.
Article 1
Approval of active substance
(12) A
reasonable
period
should
be
allowed
to
elapse
before
approval in order to permit Member States and interested
The active substance imazalil, as specified in Annex I, is
parties to prepare themselves to meet the new
approved subject to the conditions laid down in that Annex.
requirements resulting from the approval.
Article 2
(13) Without
prejudice
to
the
obligations
provided
for
by
Re-evaluation of plant protection products
Regulation (EC) No 1107/2009 as a consequence of
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 imazalil
however, apply. Member States should be allowed a
as an active substance by 30 June 2012.
period of 6 months after approval to review authori
sations of plant protection products containing imazalil.
By that date they shall in particular verify that the conditions in
Member States should, as appropriate, vary, replace or
Annex I to this Regulation are met, with the exception of those
withdraw authorisations. By way of derogation from
identified in Part B of the column on specific provisions of that
that deadline, a longer period should be provided for
Annex, and that the holder of the authorisation has, or has
the submission and assessment of the update of the
access to, a dossier satisfying the requirements of Annex II to
complete Annex III dossier, as set out in Directive
Directive 91/414/EEC in accordance with the conditions of
91/414/EEC, of each plant protection product for each
Article 13(1) to (4) of that Directive and Article 62 of Regu
intended use in accordance with the uniform principles.
lation (EC) No 1107/2009.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
(14) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
orised plant protection product containing imazalil as either the
the framework of Commission Regulation (EEC) No
only active substance or as one of several active substances all
3600/92 of 11 December 1992 laying down the
of which were listed in the Annex to Implementing Regulation
detailed rules for the implementation of the first stage
(EU) No 540/2011 by 31 December 2011 at the latest, Member
of the programme of work referred to in Article 8(2) of
States shall re-evaluate the product in accordance with the
Council Directive 91/414/EEC concerning the placing of
uniform principles, as referred to in Article 29(6) of Regulation
plant protection products on the market (
(EC) No 1107/2009, on the basis of a dossier satisfying the

1 ) has shown
that difficulties can arise in interpreting the duties of
requirements of Annex III to Directive 91/414/EEC and taking
holders of existing authorisations in relation to access
into account Part B of the column on specific provisions of
to data. In order to avoid further difficulties it therefore
Annex I to this Regulation. On the basis of that evaluation,
appears necessary to clarify the duties of the Member
they shall determine whether the product satisfies the conditions
States, especially the duty to verify that the holder of
set out in Article 29(1) of Regulation (EC) No 1107/2009.
an authorisation demonstrates access to a dossier
satisfying the requirements of Annex II to that Directive.
Following that determination Member States shall:
However, this clarification does not impose any new
obligations on Member States or holders of authori
sations compared to the directives which have been
(a) in the case of a product containing imazalil as the only
adopted until now amending Annex I to that Directive
active substance, where necessary, amend or withdraw the
or the Regulations approving active substances.
authorisation by 31 December 2015 at the latest; or
( 1 ) OJ L 366, 15.12.1992, p. 10.
( 2 ) OJ L 225, 27.8.2010, p. 5.

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EN
21.7.2011 Official
Journal
of
the
European
Union L
190/45
(b) in the case of a product containing imazalil 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 2010/57/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) No
its publication in the Official Journal of the European Union.
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 190/46
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Imazalil
(RS)-1-(β-allyloxy-2,4-
≥ 950 g/kg 1
January
2012 31
December
2021 PART
A
EN
CAS No 35554-44-0
dichlorophenethyl)
Only uses as fungicide may be authorised.

imidazole
73790-28-0 (replaced)
or
CIPAC No 335
PART B
allyl (RS)-1-(2,4-dich
lorophenyl)-2-
For the implementation of the uniform principles, as referred to in
imidazol-1-ylethyl
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
ether
review report on imazalil, 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:
icial
Jour
(1) pay particular attention to the fact that the specification of the
technical material as commercially manufactured must be confirmed
nal
and supported by appropriate analytical data. The test material used in
of
the toxicity dossiers should be compared and verified against this
specification of the technical material;
the
European
(2) pay particular attention to the acute dietary exposure situation of
consumers in view of future revisions of maximum residue levels;
Union
(3) pay particular attention to the operators and workers safety. Authorised
conditions of use must prescribe the application of adequate personal
protective equipment and risk mitigation measures to reduce the
exposure;
(4) ensure that appropriate waste management practices to handle the
waste solution remaining after application, such as the cleaning
water of the drenching system and the discharge of the processing
waste are put in place. Prevention of any accidental spillage of
treatment solution. Member States permitting the release of waste
water into the sewage system shall ensure that a local risk assessment
is carried out;
(5) pay particular attention to risk to aquatic organisms and soil micro-
organisms and long-term risk to granivorous birds and mammals.
21.7.2011
Conditions of authorisation shall include risk mitigation measures, where
appropriate.

---

21.7.2011 Off
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
The notifier shall submit confirmatory information as regards:
(a) route of degradation of imazalil in soil and surface water systems;
EN
(b) environmental data to support the managing measures that Member

States have to put in place to ensure that groundwater exposure is
negligible;
(c) a hydrolysis study to investigate the nature of residues in processed
commodities.
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.
icial
Jour
nal
of
the
European
Union
L
190/47

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L 190/48
ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, the entry relating to imazalil 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
‘5 Imazalil
(RS)-1-(β-allyloxy-
≥ 950 g/kg 1
January
2012 31
December
2021 PART
A
CAS No 35554-44-0
2,4-dichlorop
henethyl)imidazole
Only uses as fungicide may be authorised.
73790-28-0 (replaced)
or
CIPAC No 335
PART B
allyl (RS)-1-(2,4-dich
Off
lorophenyl)-2-imidazol-1-
For the implementation of the uniform principles, as referred to in
icial
ylethyl ether
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
review report on imazalil, and in particular Appendices I and II thereof, as
Jour
finalised in the Standing Committee on the Food Chain and Animal Health on
nal
17 June 2011 shall be taken into account.
of
the
In this overall assessment Member States shall:
European
(1) pay particular attention to the fact that the specification of the technical
material as commercially manufactured must be confirmed and supported
by appropriate analytical data. The test material used in the toxicity
dossiers should be compared and verified against this specification of the
Union
technical material;
(2) pay particular attention to the acute dietary exposure situation of
consumers in view of future revisions of maximum residue levels;
(3) pay particular attention to the operators and workers safety. Authorised
conditions of use must prescribe the application of adequate personal
protective equipment and risk mitigation measures to reduce the exposure;
(4) ensure that appropriate waste management practices to handle the waste
solution remaining after application, such as the cleaning water of the
drenching system and the discharge of the processing waste are put in
place. Prevention of any accidental spillage of treatment solution. Member
States permitting the release of waste water into the sewage system shall
ensure that a local risk assessment is carried out;
21.7.2011
(5) pay particular attention to risk to aquatic organisms and soil micro-
organisms and long-term risk to granivorous birds and mammals.

---

21.7.2011 Off
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Conditions of authorisation shall include risk mitigation measures, where
appropriate.
The notifier shall submit confirmatory information as regards:
EN

(a) route of degradation of imazalil in soil and surface water systems;
(b) environmental data to support the managing measures that Member States
have to put in place to ensure that groundwater exposure is negligible;
(c) a hydrolysis study to investigate the nature of residues in processed
commodities.
The notifier shall submit to the Member States, the Commission and the
Authority such information by 31 December 2013.’
icial
(1 ) Further details on identity and specification of active substance are provided in the review report.
Jour
nal
of
the
European
Union
L
190/49

---