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12.8.2011 Official
Journal
of
the
European
Union L
207/7
COMMISSION IMPLEMENTING REGULATION (EU) No 810/2011
of 11 August 2011
approving the active substance kresoxim-methyl, 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 Articles 13(2) and 78(2)
Commission. In addition to the assessment of the
thereof,
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
(1) In
accordance
with
Article
80(1)(b)
of
Regulation
(EC)
No
the notifier and to the Member States for comments
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
and forwarded the comments received to the
to active substances listed in Annex I to Commission
Commission. The Authority also made the assessment
Regulation (EC) No 737/2007 of 27 June 2007 on
report available to the public.
laying down the procedure of the renewal of the
inclusion of a first group of active substances in Annex
I to Council Directive 91/414/EEC and establishing the
(7)
At the request of the Commission, the assessment report
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. Kresoxim-methyl is
the peer review of the risk assessment of kresoxim-
listed in Annex I to Regulation (EC) No 737/2007.
methyl ( 6 ) to the Commission. The assessment report
and the conclusion of the Authority were reviewed by
(2)
The approval of kresoxim-methyl, as set out in Part A of
the Member States and the Commission within the
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 kresoxim-methyl.
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 kresoxim-methyl
Regulation (EC) No 737/2007 for the renewal of the
may be expected to continue to satisfy, in general, the
inclusion of kresoxim-methyl in Annex I to Directive
requirements laid down in Article 5(1)(a) and (b) of
91/414/EEC within the time period provided for in
Directive 91/414/EEC, in particular as regards the uses
that Article.
which were examined and detailed in the Commission
review report. It is therefore appropriate to approve
kresoxim-methyl.
(3) That
notification
was
found
to
be
admissible
by
Commission Decision 2008/656/EC of 28 July 2008
on the admissibility of the notifications concerning the
(9) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
renewal of the inclusion in Annex I to Council Directive
1107/2009 in conjunction with Article 6 thereof and in
91/414/EEC of the active substances azimsulfuron,
the light of current scientific and technical knowledge, it
azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl,
is, however, necessary to include certain conditions and
prohexadione and spiroxamine, and establishing the list
restrictions not provided for in the first inclusion in
of the notifiers concerned ( 5 ).
Annex I to Directive 91/414/EEC.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 2 ) OJ L 230, 19.8.1991, p. 1.
the pesticide risk assessment of the active substance kresoxim-
( 3 ) OJ L 169, 29.6.2007, p. 10.
methyl. EFSA Journal 2010;8(11):1891. [88 pp.]. doi:10.2903/
( 4 ) OJ L 153, 11.6.2011, p. 1.
j.efsa.2010.1891. Available online: www.efsa.europa.eu/efsajournal.
( 5 ) OJ L 214, 9.8.2008, p. 70.
htm

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L 207/8
EN
Official Journal of the European Union
12.8.2011
(10) Without prejudice
to the conclusion that kresoxim-
HAS ADOPTED THIS REGULATION:
methyl should be approved, it is, in particular, appro
priate to require further confirmatory information.
Article 1
Approval of active substance
(11) A
reasonable
period
should
be
allowed
to
elapse
before
approval in order to permit Member States and interested
The active substance kresoxim-methyl, as specified in Annex I,
parties to prepare themselves to meet the new
is approved subject to the conditions laid down in that Annex.
requirements resulting from the approval.
Article 2
(12) 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
however, apply. Member States should be allowed a
kresoxim-methyl as an active substance by 30 June 2012.
period of 6 months after approval to review authori
sations of plant protection products containing
kresoxim-methyl. Member States should, as appropriate,
vary, replace or withdraw authorisations. By way of dero
By that date they shall in particular verify that the conditions in
gation from that deadline, a longer period should be
Annex I to this Regulation are met, with the exception of those
provided for the submission and assessment of the
identified in Part B of the column on specific provisions of that
update of the complete Annex III dossier, as set out in
Annex, and that the holder of the authorisation has, or has
Directive 91/414/EEC, of each plant protection product
access to, a dossier satisfying the requirements of Annex II to
for each intended use in accordance with the uniform
Directive 91/414/EEC in accordance with the conditions of
principles.
Article 13(1) to (4) of that Directive and Article 62 of Regu
lation (EC) No 1107/2009.
(13) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
the framework of Commission Regulation (EEC) No
orised plant protection product containing kresoxim-methyl as
3600/92 of 11 December 1992 laying down the
either the only active substance or as one of several active
detailed rules for the implementation of the first stage
substances all of which were listed in the Annex to Imple
of the programme of work referred to in Article 8(2) of
menting Regulation (EU) No 540/2011 by 31 December
Council Directive 91/414/EEC concerning the placing of
2011 at the latest, Member States shall re-evaluate the
plant protection products on the market (
product in accordance with the uniform principles, as referred

1 ) has shown
that difficulties can arise in interpreting the duties of
to in Article 29(6) of Regulation (EC) No 1107/2009, on the
holders of existing authorisations in relation to access
basis of a dossier satisfying the requirements of Annex III to
to data. In order to avoid further difficulties it therefore
Directive 91/414/EEC and taking into account Part B of the
appears necessary to clarify the duties of the Member
column on specific provisions of Annex I to this Regulation.
States, especially the duty to verify that the holder of
On the basis of that evaluation, they shall determine whether
an authorisation demonstrates access to a dossier
the product satisfies the conditions set out in Article 29(1) of
satisfying the requirements of Annex II to that Directive.
Regulation (EC) No 1107/2009.
However, this clarification does not impose any new
obligations on Member States or holders of authori
sations compared to the directives which have been
adopted until now amending Annex I to that Directive
Following that determination Member States shall:
or the Regulations approving active substances.
(a) in the case of a product containing kresoxim-methyl as the
only active substance, where necessary, amend or withdraw
(14) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
the authorisation by 31 December 2015 at the latest; or
1107/2009 the Annex to Implementing Regulation (EU)
No 540/2011 should be amended accordingly.
(b) in the case of a product containing kresoxim-methyl as one
of several active substances, where necessary, amend or
(15) The
measures
provided
for
in
this
Regulation
are
in
withdraw the authorisation by 31 December 2015 or by
accordance with the opinion of the Standing
the 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 approved
( 1 ) OJ L 366, 15.12.1992, p. 10.
that substance or substances, whichever is the latest.

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EN
12.8.2011 Official
Journal
of
the
European
Union L
207/9
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, 11 August 2011.
For the Commission
The President
José Manuel BARROSO

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L 207/10
ANNEX I
Conditions of approval as active substance under Regulation (EC) No 1107/2009:
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
EN
Kresoxim-methyl
methyl (E)-methoxyimino
≥ 910 g/kg
1 January 2012 31
December
2021 PART
A

[a-(o-tolyloxy)-o-tolyl]acetate
CAS No 143 390-89-0
Methanol: max. 5 g/kg
Only uses as fungicide may be authorised.
CIPAC No 568
Methyl chloride: max. 1 g/kg
PART B
Toluene: max. 1 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 kresoxim-methyl and in
particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
Off
on 17 June 2011, shall be taken into account.
icial
Member States shall pay particular attention to the protection
Jour
of groundwater under vulnerable conditions; the conditions
nal
of authorisation shall include, where appropriate, risk miti
gation measures.
of
the
The applicant shall submit confirmatory information as
European
regards:
Groundwater exposure risk assessment, and in particular:
Union
— on the lysimeter study to support the statement that the
two unidentified peaks observed do not correspond to
metabolites individually exceeding the trigger value of
0,1 μg/L,
— on the recovery of metabolite BF 490-5 in order to
confirm its absence in the lysimeter leachate at levels
exceeding 0,1 μg/L,
— on a groundwater exposure risk assessment for the late
application in apples, pears and grapes.
The applicant 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.
12.8.2011

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12.8.2011 Off
ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, the entry relating to kresoxim-methyl is deleted;
(2) in Part B, the following entry is added:
EN

No
Common Name,
Identification Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
‘8 Kresoxim-methyl
methyl (E)-methoxyimino
≥ 910 g/kg
1 January 2012 31
December
2021 PART
A
[a-(o-tolyloxy)-o-tolyl]acetate
CAS No 143 390-89-0
Methanol: max. 5 g/kg
Only uses as fungicide may be authorised.
CIPAC No 568
Methyl chloride: max. 1 g/kg
PART B
For the implementation of the uniform principles, as referred
Toluene: max. 1 g/kg
to in Article 29(6) of Regulation (EC) No 1107/2009, the
conclusions of the review report on kresoxim-methyl and in
particular Appendices I and II thereof, as finalised in the
icial
Standing Committee on the Food Chain and Animal Health
on 17 June 2011, shall be taken into account.
Jour
Member States shall pay particular attention to the protection
nal
of groundwater under vulnerable conditions; the conditions of
authorisation shall include, where appropriate, risk mitigation
of
measures.
the
The applicant shall submit confirmatory information as
European
regards:
Groundwater exposure risk assessment, and in particular:
— on the lysimeter study to support the statement that the
Union
two unidentified peaks observed do not correspond to
metabolites individually exceeding the trigger value of
0,1 μg/L,
— on the recovery of metabolite BF 490-5 in order to
confirm its absence in the lysimeter leachate at levels
exceeding 0,1 μg/L,
— on a groundwater exposure risk assessment for the late
application in apples, pears and grapes.
The applicant shall submit to the Member States, the
Commission and the Authority such information by
31 December 2013.’
(*) Further details on identity and specification of active substance are provided in the review report.
L
207/11

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