HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 176/46
EN
Official Journal of the European Union
6.7.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 595/2012
of 5 July 2012
approving the active substance fenpyrazamine, 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,
report was reviewed by the Member States and the
Commission within the Standing Committee on the
Having regard to the Treaty on the Functioning of the European
Food Chain and Animal Health and was finalised on
Union,
1 June 2012 in the format of the Commission review
report for fenpyrazamine.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
(5)
It has appeared from the various examinations made that
concerning the placing of plant protection products on the
plant protection products containing fenpyrazamine may
market and repealing Council Directives 79/117/EEC and
be expected to satisfy, in general, the requirements laid
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
down in Article 5(1)(a) and (b) and Article 5(3) of
thereof,
Directive 91/414/EEC, in particular with regard to the
uses which were examined and detailed in the
Whereas:
Commission review report. It is therefore appropriate

to approve fenpyrazamine.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
(6) Without
prejudice
to
the
obligations
provided
for
in
with respect to the procedure and the conditions for
Regulation (EC) No 1107/2009 as a consequence of
approval, to active substances for which a decision has
approval, taking into account the specific situation
been adopted in accordance with Article 6(3) of that
created by the transition from Directive 91/414/EEC to
Directive before 14 June 2011. For fenpyrazamine the
Regulation (EC) No 1107/2009, the following should,
conditions of Article 80(1)(a) of Regulation (EC) No
however, apply. Member States should be allowed a
1107/2009 are fulfilled by Commission Decision
period of six months after approval to review authori
2010/150/EU ( 3 ).
sations of plant protection products containing fenpyra
zamine. Member States should, as appropriate, vary,
replace or withdraw authorisations. By way of derogation
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
from that deadline, a longer period should be provided
Austria received on 3 September 2009 an application
for the submission and assessment of the update of the
from Sumitomo Chemical Agro Europe SAS for the
complete Annex III dossier, as set out in Directive
inclusion of the active substance fenpyrazamine in
91/414/EEC, of each plant protection product for each
Annex I to Directive 91/414/EEC. Decision 2010/150/EU
intended use in accordance with the uniform principles.
confirmed that the dossier was ‘complete’ in the sense

that it could be considered as satisfying, in principle, the
data and information requirements of Annexes II and III
(7) The
experience
gained
from
inclusions
in
Annex
I
to
to Directive 91/414/EEC.
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
(3) For
that
active
substance,
the
effects
on
human
and
3600/92 of 11 December 1992 laying down the
animal health and the environment have been assessed,
detailed rules for the implementation of the first stage
in accordance with the provisions of Article 6(2) and (4)
of the programme of work referred to in Article 8(2) of
of Directive 91/414/EEC, for the uses proposed by the
Council Directive 91/414/EEC concerning the placing of
applicant. The designated rapporteur Member State
plant protection products on the market ( 5 ) has shown
submitted a draft assessment report on 17 January 2011.
that difficulties can arise in interpreting the duties of
holders of existing authorisations in relation to access
to data. In order to avoid further difficulties it therefore
(4) The
draft
assessment
report
was
peer
reviewed
by
the
appears necessary to clarify the duties of the Member
Member States and the European Food Safety Authority
States, especially the duty to verify that the holder of
(hereinafter ‘the Authority’). The Authority presented to
an authorisation demonstrates access to a dossier
the Commission its conclusion on the peer review of the
satisfying the requirements of Annex II to that Directive.
pesticide risk assessment of the active substance fenpyra
However, this clarification does not impose any new
zamine ( 4 ) on 6 December 2011. This draft assessment
obligations on Member States or holders of authori
sations compared to the directives which have been
( 1 ) OJ L 309, 24.11.2009, p. 1.
adopted until now amending Annex I to that Directive
( 2 ) OJ L 230, 19.8.1991, p. 1.
or the Regulations approving active substances.
( 3 ) OJ L 61, 11.3.2010, p. 35.
( 4 ) EFSA Journal (2012) 10(1):2496. Available online: www.efsa.europa.
eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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EN
6.7.2012 Official
Journal
of
the
European
Union L
176/47
(8) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No menting Regulation (EU) No 540/2011 by 31 December 2012
1107/2009, the Annex to Commission Implementing
at the latest, Member States shall re-evaluate the product in
Regulation (EU) No 540/2011 of 25 May 2011 imple
accordance with the uniform principles, as referred to in
menting Regulation (EC) No 1107/2009 of the European
Article 29(6) of Regulation (EC) No 1107/2009, on the basis
Parliament and of the Council as regards the list of
of a dossier satisfying the requirements of Annex III to Directive
approved active substances
( 1 ) should be amended
91/414/EEC and taking into account the column on specific
accordingly.
provisions of Annex I to this Regulation. On the basis of that
evaluation, they shall determine whether the product satisfies
(9) The
measures
provided
for
in
this
Regulation
are
in the conditions set out in Article 29(1) of Regulation (EC) No
accordance with the opinion of the Standing
1107/2009.
Committee on the Food Chain and Animal Health,
Following that determination Member States shall:
HAS ADOPTED THIS REGULATION:
(a) in the case of a product containing fenpyrazamine as the
Article 1
only active substance, where necessary, amend or withdraw
the authorisation by 30 June 2014 at the latest; or
Approval of active substance
The active substance fenpyrazamine, as specified in Annex I, is
(b) in the case of a product containing fenpyrazamine as one of
approved subject to the conditions laid down in that Annex.
several active substances, where necessary, amend or
withdraw the authorisation by 30 June 2014 or by the
date fixed for such an amendment or withdrawal in the
Article 2
respective act or acts which added the relevant substance
Re-evaluation of plant protection products
or substances to Annex I to Directive 91/414/EEC or
approved that substance or substances, whichever is the
1. Member
States
shall
in
accordance
with
Regulation
(EC)
latest.
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing fenpy
razamine as an active substance by 30 June 2013.
Article 3
Amendments to Implementing Regulation (EU) No
By that date they shall in particular verify that the conditions in
540/2011
Annex I to this Regulation are met, with the exception of those
The Annex to Implementing Regulation (EU) No 540/2011 is
identified in the column on specific provisions of that Annex,
amended in accordance with Annex II to this Regulation.
and that the holder of the authorisation has, or has access to, a
dossier satisfying the requirements of Annex II to Directive
91/414/EEC in accordance with the conditions of Article 13(1)
Article 4
to (4) of that Directive and Article 62 of Regulation (EC) No
Entry into force and date of application
1107/2009.
This Regulation shall enter into force on the twentieth day
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
following that of its publication in the Official Journal of the
orised plant protection product containing fenpyrazamine as
European Union.
either the only active substance or as one of several active
substances, all of which were listed in the Annex to Imple
It shall apply from 1 January 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 July 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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L 176/48
ANNEX I
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Fenpyrazamine
S-allyl 5-amino-2,3-dihydro- ≥ 940 g/kg 1
January
2013 31
December
2022
For the implementation of the uniform principles as referred to in
2-isopropyl-3-oxo-4-(o-tolyl)
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions
EN
CAS No 473798-59-3
pyrazole-1-carbothioate
of the review report on fenpyrazamine, and in particular

CIPAC No 832
Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 1 June
2012 shall be taken into account.
The purity given in this entry is based on a pilot plant production.
The examining Member State shall inform the Commission in
accordance with Article 38 of Regulation (EC) No 1107/2009
on the specification of the technical material as commercially
manufactured.
Off
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
6.7.2012

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6.7.2012 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) 540/2011, the following entry is added:
Number
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘25 Fenpyrazamine
S-allyl 5-amino-2,3-dihydro-2- ≥ 940 g/kg 1
January
2013 31
December
2022 For
the
implementation
of
the
uniform
principles
as
referred
to
in
Article
29(6)

isopropyl-3-oxo-4-(o-tolyl)
of Regulation (EC) No 1107/2009, the conclusions of the review report on
CAS No 473798-59-3 pyrazole-1-carbothioate
fenpyrazamine, and in particular Appendices I and II thereof, as finalised in
CIPAC No 832
the Standing Committee on the Food Chain and Animal Health on 1 June
2012 shall be taken into account.
The purity given in this entry is based on a pilot plant production. The
examining Member State shall inform the Commission in accordance with
Article 38 of Regulation (EC) No 1107/2009 on the specification of the
technical material as commercially manufactured.’
(*) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
176/49

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Document Outline

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