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8.11.2012 Official
Journal
of
the
European
Union L
308/15
COMMISSION IMPLEMENTING REGULATION (EU) No 1037/2012
of 7 November 2012
approving the active substance isopyrazam, 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,
Animal Health and was finalised on 28 September 2012
in the format of the Commission review report for isopy
Having regard to the Treaty on the Functioning of the European
razam.
Union,
(5)
It has appeared from the various examinations made that
Having regard to Regulation (EC) No 1107/2009 of the
plant protection products containing isopyrazam may be
European Parliament and of the Council of 21 October 2009
expected to satisfy, in general, the requirements laid
concerning the placing of plant protection products on the
down in Article 5(1)(a) and (b) and Article 5(3) of
market and repealing Council Directives 79/117/EEC and
Directive 91/414/EEC, in particular with regard to the
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
uses which were examined and detailed in the
thereof,
Commission review report. It is therefore appropriate
to approve isopyrazam.
Whereas:
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009 in conjunction with Article 6 thereof and in
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
the light of current scientific and technical knowledge, it
with respect to the procedure and the conditions for
is, however, necessary to include certain conditions and
approval, to active substances for which a decision has
restrictions. It is, in particular, appropriate to require
been adopted in accordance with Article 6(3) of that
further confirmatory information.
Directive before 14 June 2011. For isopyrazam the
conditions of Article 80(1)(a) of Regulation (EC) No
1107/2009 are fulfilled by Commission Decision
(7) Without
prejudice
to
the
obligations
provided
for
in
2010/132/EU (
Regulation (EC) No 1107/2009 as a consequence of

3 ).
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
Regulation (EC) No 1107/2009, the following should,
the United Kingdom received on 25 November 2008 an
however, apply. Member States should be allowed a
application from Syngenta Crop Protection AG for the
period of six months after approval to review authori
inclusion of the active substance isopyrazam in Annex I
sations of plant protection products containing isopy
to Directive 91/414/EEC. Decision 2010/132/EU
razam. Member States should, as appropriate, vary,
confirmed that the dossier was ‘complete’ in the sense
replace or withdraw authorisations. By way of derogation
that it could be considered as satisfying, in principle, the
from that deadline, a longer period should be provided
data and information requirements of Annexes II and III
for the submission and assessment of the update of the
to Directive 91/414/EEC.
complete Annex III dossier, as set out in Directive
91/414/EEC, of each plant protection product for each
(3) For
that
active
substance,
the
effects
on
human
and
intended use in accordance with the uniform principles.
animal health and the environment have been assessed,
in accordance with the provisions of Article 6(2) and (4)
of Directive 91/414/EEC, for the uses proposed by the
(8) The
experience
gained
from
inclusions
in
Annex
I
to
applicant. The designated rapporteur Member State
Directive 91/414/EEC of active substances assessed in
submitted a draft assessment report on 4 May 2010.
the framework of Commission Regulation (EEC) No
3600/92 of 11 December 1992 laying down the
detailed rules for the implementation of the first stage
(4) The
draft
assessment
report
was
reviewed
by
the
Member
of the programme of work referred to in Article 8(2) of
States and the European Food Safety Authority (here
Council Directive 91/414/EEC concerning the placing of
inafter ‘the Authority’). The Authority presented to the
plant protection products on the market (
Commission its conclusion on the review of the pesticide

5 ) has shown
that difficulties can arise in interpreting the duties of
risk assessment of the active substance isopyrazam ( 4 ) on
holders of existing authorisations in relation to access
27 February 2012. The draft assessment report was
to data. In order to avoid further difficulties it therefore
reviewed by the Member States and the Commission
appears necessary to clarify the duties of the Member
within the Standing Committee on the Food Chain and
States, especially the duty to verify that the holder of
an authorisation demonstrates access to a dossier
( 1 ) OJ L 309, 24.11.2009, p. 1.
satisfying the requirements of Annex II to that Directive.
( 2 ) OJ L 230, 19.8.1991, p. 1.
However, this clarification does not impose any new
( 3 ) OJ L 52, 3.3.2010, p. 51.
( 4 ) EFSA Journal 2012; 10(3):2600. Available online: www.efsa.europa.
eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 308/16
EN
Official Journal of the European Union
8.11.2012
obligations on Member States or holders of authori
the only active substance or as one of several active substances,
sations compared to the Directives which have been
all of which were listed in the Annex to Implementing Regu
adopted until now amending Annex I to that Directive
lation (EU) No 540/2011 by 31 March 2013 at the latest,
or the Regulations approving active substances.
Member States shall re-evaluate the product in accordance
with the uniform principles, as referred to in Article 29(6) of
(9) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No Regulation (EC) No 1107/2009, on the basis of a dossier
1107/2009, the Annex to Commission Implementing
satisfying the requirements of Annex III to Directive
Regulation (EU) No 540/2011 of 25 May 2011 imple
91/414/EEC and taking into account the column on specific
menting Regulation (EC) No 1107/2009 of the European
provisions of Annex I to this Regulation. On the basis of that
Parliament and of the Council as regards the list of
evaluation, they shall determine whether the product satisfies
approved active substances
( 1 ) should be amended
the conditions set out in Article 29(1) of Regulation (EC) No
accordingly.
1107/2009.
(10) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Following that determination Member States shall:
Committee on the Food Chain and Animal Health,
(a) in the case of a product containing isopyrazam as the only
HAS ADOPTED THIS REGULATION:
active substance, where necessary, amend or withdraw the
authorisation by 30 September 2014 at the latest; or
Article 1
Approval of active substance
(b) in the case of a product containing isopyrazam as one of
several active substances, where necessary, amend or
The active substance isopyrazam, as specified in Annex I, is
withdraw the authorisation by 30 September 2014 or by
approved subject to the conditions laid down in that Annex.
the date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance or
Article 2
substances to Annex I to Directive 91/414/EEC or approved
Re-evaluation of plant protection products
that substance or substances, whichever is the latest.
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Article 3
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing
Amendments to Implementing Regulation (EU) No
isopyrazam as an active substance by 30 September 2013.
540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is
By that date they shall in particular verify that the conditions in
amended in accordance with Annex II to this Regulation.
Annex I to this Regulation are met, with the exception of those
identified in the column on specific provisions of that Annex,
and that the holder of the authorisation has, or has access to, a
Article 4
dossier satisfying the requirements of Annex II to Directive
Entry into force and date of application
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
This Regulation shall enter into force on the twentieth day
1107/2009.
following that of its publication in the Official Journal of the
European Union.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing isopyrazam as either
It shall apply from 1 April 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 November 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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8.11.2012 Off
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Isopyrazam
A mixture of 3-(difluoromethyl)-1- ≥ 920 g/kg
1 April 2013 31
March
2023
For the implementation of the uniform principles as referred to in
methyl-N-[(1RS,4SR,9RS)-1,2,3,4-
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
EN
CAS No 881685-58-1
tetrahydro-9-isopropyl-1,4-methanon
In a range of 78:15 %
the review report on isopyrazam, and in particular Appendices I and

to 100:0 % syn- to
(syn-isomer: 683777-13-1/ aphthalen-5-yl]pyrazole-4-carboxamide
II thereof, as finalised in the Standing Committee on the Food Chain
anti-isomers
anti-isomer: 683777-14-2)
and Animal Health on 28 September 2012 shall be taken into
(syn-isomer – 50:50 mix of two enanti
account.
CIPAC No 963
omers)
In this overall assessment Member States shall pay particular
and
attention to:
3-(difluoromethyl)-1-methyl-N-
(a) the risk to aquatic organisms;
[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-
isopropyl-1,4-methanonaphthalen-5-
(b) the risk to earthworms if the substance is applied in the
yl]pyrazole-4-carboxamide
framework of no cultivation/minimum cultivation practices;
(anti-isomer– 50:50 mix of two enanti
(c) the protection of groundwater, when the substance is applied in
icial
omers)
regions with vulnerable soil and/or climatic conditions.
Jour
In a range of 78:15 % to 100:0 % syn to
Conditions of use shall include risk mitigation measures, like the
anti.
exclusion of no cultivation/minimum cultivation practices, and the
nal
obligation to carry out monitoring programmes to verify potential
of
groundwater contamination in vulnerable zones, where appropriate.
the
The applicant shall submit confirmatory information as regards the
European
relevance of the metabolites CSCD 459488 and CSCD 459489 for
groundwater.
The applicant shall submit to the Commission, the Member States
and the Authority this information by 31 March 2015.
Union

(1 ) Further details on identity and specification of active substance are provided in the review report.
L
308/17

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L 308/18
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Common Name,
Number
Identification
IUPAC Name Purity
(1 ) Date
of
approval
Expiration of
Numbers
approval
Specific provisions
EN

‘27 Isopyrazam A mixture of 3-(difluoromethyl)-1-methyl-N- ≥ 920 g/kg
1 April 2013 31
March
2023 For the implementation of the uniform principles as referred
[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-
to in Article 29(6) of Regulation (EC) No 1107/2009, the
CAS No
isopropyl-1,4-methanonaphthalen-5-yl]
In a range of 78:15 % to
conclusions of the review report on isopyrazam, and in
881685-58-1
pyrazole-4-carboxamide
100:0 % syn- to anti-
particular Appendices I and II thereof, as finalised in the
isomers
(syn-isomer:
Standing Committee on the Food Chain and Animal Health
(syn-isomer – 50:50 mix of two enantiomers)
683777-13-1/
on 28 September 2012 shall be taken into account.
anti-isomer:
and
In this overall assessment Member States shall pay particular
683777-14-2)
3-(difluoromethyl)-1-methyl-N-
attention to:
CIPAC No 963 [(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-
(a) the risk to aquatic organisms;
Off
isopropyl-1,4-methanonaphthalen-5-yl]
pyrazole-4-carboxamide
(b) the risk to earthworms if the substance is applied in the
icial
framework of no cultivation/minimum cultivation prac
(anti-isomer– 50:50 mix of two enantiomers)
Jour
tices;
In a range of 78:15 % to 100:0 % syn to anti.
nal
(c) the protection of groundwater, when the substance is
applied in regions with vulnerable soil and/or climatic
of
conditions.
the
Conditions of use shall include risk mitigation measures, like
European
the exclusion of no cultivation/minimum cultivation practices,
and the obligation to carry out monitoring programmes to
verify potential groundwater contamination in vulnerable
zones, where appropriate.
Union
The applicant shall submit confirmatory information as
regards the relevance of the metabolites CSCD 459488 and
CSCD 459489 for groundwater.
The applicant shall submit to the Commission, the Member
States and the Authority this information by 31 March 2015.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
8.11.2012

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