HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 190/28
EN
Official Journal of the European Union
21.7.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 702/2011
of 20 July 2011
approving the active substance prohexadione, 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
European Parliament and of the Council of 21 October 2009
(5) The
rapporteur
Member
State
prepared
an
assessment
concerning the placing of plant protection products on the
report in consultation with the co-rapporteur Member
market and repealing Council Directives 79/117/EEC and
State and submitted it to the European Food Safety
91/414/EEC (
Authority (hereinafter ‘the Authority’) and the

1 ), and in particular Article 13(2) and
Article 78(2) thereof,
Commission on 5 June 2009. In addition to the
assessment of the active substance, that report includes
a list of the studies the rapporteur Member State relied
Whereas:
on for its assessment.
(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 ( 2 ) is to
the notifier and to the Member States for comments
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 ( 3 ), with respect to
the procedure and the conditions for approval. Prohex
(7)
At the request of the Commission, the assessment report
adione (formerly prohexadione-calcium) is listed in
was peer reviewed by the Member States and the
Annex I to Regulation (EC) No 737/2007.
Authority. The Authority presented its conclusion on
the peer review of the risk assessment of prohexadione ( 6 )
to the Commission on 12 March 2010. The assessment
(2) The
approval
of
prohexadione,
as
set
out
in
Part
A
of
the
report and the conclusion of the Authority were reviewed
Annex to Commission Implementing Regulation (EU)
by the Member States and the Commission within the
No 540/2011 of 25 May 2011 implementing Regulation
Standing Committee on the Food Chain and Animal
(EC) No 1107/2009 of the European Parliament and of
Health and finalised on 17 June 2011 in the format of
the Council as regards the list of approved active
the Commission review report for prohexadione.
substances ( 4 ), expires on 31 December 2011. A notifi
cation was submitted in accordance with Article 4 of
Regulation (EC) No 737/2007 for the renewal of the
(8)
It has appeared from the various examinations made that
inclusion of prohexadione in Annex I to Directive
plant protection products containing prohexadione may
91/414/EEC within the time period provided for in
be expected to continue to satisfy, in general, the
that Article.
requirements laid down in Article 5(1)(a) and (b) of
Directive 91/414/EEC, in particular as regards the uses
which were examined and detailed in the Commission
(3) That
notification
was
found
to
be
admissible
by
review report. It is therefore appropriate to approve
Commission Decision 2008/656/EC of 28 July 2008
prohexadione.
on the admissibility of the notifications concerning the
renewal of the inclusion in Annex I to Council Directive
91/414/EEC of the active substances azimsulfuron,
azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl,
(9) A
reasonable
period
should
be
allowed
to
elapse
before
prohexadione and spiroxamine, and establishing the list
approval in order to permit Member States and interested
of the notifiers concerned ( 5 ).
parties to prepare themselves to meet the new
requirements resulting from the approval.
( 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 prohexadione
( 4 ) OJ L 153, 11.6.2011, p. 1.
on request from the European Commission EFSA Journal 2010;
( 5 ) OJ L 214, 9.8.2008, p. 70.
8(3):1555.

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EN
21.7.2011 Official
Journal
of
the
European
Union L
190/29
(10) Without
prejudice
to
the
obligations
provided
for
by
Article 2
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
Re-evaluation of plant protection products
created by the transition from Directive 91/414/EEC to
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Regulation (EC) No 1107/2009 the following should,
No 1107/2009, where necessary, amend or withdraw existing
however, apply. Member States should be allowed a
authorisations for plant protection products containing prohex
period of 6 months after approval to review authori
adione as an active substance by 30 June 2012.
sations of plant protection products containing prohex
adione. Member States should, as appropriate, vary,
replace or withdraw authorisations. By way of derogation
By that date they shall in particular verify that the conditions in
from that deadline, a longer period should be provided
Annex I to this Regulation are met, with the exception of those
for the submission and assessment of the update of the
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.
(11) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC)
2. By way of derogation from paragraph 1, for each auth
No 3600/92 of 11 December 1992 laying down the
orised plant protection product containing prohexadione as
detailed rules for the implementation of the first stage
either the only active substance or as one of several active
of the programme of work referred to in Article 8(2) of
substances all of which were listed in the Annex to Imple
Council Directive 91/414/EEC concerning the placing of
menting Regulation (EU) No 540/2011 by 31 December
plant protection products on the market (
2011 at the latest, Member States shall re-evaluate the

1 ) has shown
that difficulties can arise in interpreting the duties of
product in accordance with the uniform principles, as referred
holders of existing authorisations in relation to access
to in Article 29(6) of Regulation (EC) No 1107/2009, on the
to data. In order to avoid further difficulties it therefore
basis of a dossier satisfying the requirements of Annex III to
appears necessary to clarify the duties of the Member
Directive 91/414/EEC and taking into account Part B of the
States, especially the duty to verify that the holder of
column on specific provisions of Annex I to this Regulation.
an authorisation demonstrates access to a dossier
On the basis of that evaluation, they shall determine whether
satisfying the requirements of Annex II to that Directive.
the product still satisfies the conditions set out in Article 29(1)
However, this clarification does not impose any new
of Regulation (EC) No 1107/2009.
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 prohexadione as the
(12) In
accordance
with
Article
13(4) of Regulation
(EC)
only active substance, where necessary, amend or
No 1107/2009 the Annex to Implementing Regulation
withdraw the authorisation by 31 December 2015 at the
(EU) No 540/2011 should be amended accordingly.
latest; or
(13) In the interest of clarity, Commission Directive
(b) in the case of a product containing prohexadione as one of
2010/56/EU of 20 August 2010 amending Annex I to
several active substances, where necessary, amend or
Council Directive 91/414/EEC to renew the inclusion of
withdraw the authorisation by 31 December 2015 or by
prohexadione as active substance ( 2 ) should be repealed.
the date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance or
substances to Annex I to Directive 91/414/EEC or approved
(14) The
measures
provided
for
in
this
Regulation
are
in
that substance or substances, whichever is the latest.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Article 3
HAS ADOPTED THIS REGULATION:
Amendments to Implementing Regulation (EU) No
540/2011
Article 1
The Annex to Implementing Regulation (EU) No 540/2011 is
amended in accordance with Annex II to this Regulation.
Approval of active substance
The active substance prohexadione, as specified in Annex I, is
approved subject to the conditions laid down in that Annex.
Article 4
Repeal
( 1 ) OJ L 366, 15.12.1992, p. 10.
( 2 ) OJ L 220, 21.8.2010, p. 71.
Directive 2010/56/EU is repealed.

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L 190/30
EN
Official Journal of the European Union
21.7.2011
Article 5
Entry into force and date of 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, 20 July 2011.
For the Commission
The President
José Manuel BARROSO

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21.7.2011 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Prohexadione
3,5-dioxo-4-propionylcyclohexanecar
≥ 890 g/kg
1 January 2012 31
December
2021 PART
A
boxylic acid
EN
CAS No 127277-53-6
(expressed as prohex
Only uses as plant growth regulator may be authorised.

(prohexadione-calcium)
adione-calcium)
PART B
CIPAC No 567
(prohexadione)
For the implementation of the uniform principles, as referred to in
No 567.020
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
(prohexadione-calcium)
the review report on prohexadione 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.
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
190/31

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L 190/32
ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, the entry relating to prohexadione 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
‘6 Prohexadione
3,5-dioxo-4-propionylcyclohex
≥ 890 g/kg
1 January 2012 31
December
2021 PART
A
anecarboxylic acid
CAS No 127277-53-6
(expressed as
Only uses as plant growth regulator may be authorised.
(prohexadione-calcium)
prohexadione-
calcium)
PART B
CIPAC No 567
(prohexadione)
For the implementation of the uniform principles, as
No 567.020
referred to in Article 29(6) of Regulation (EC)
Off
(prohexadione-calcium)
No 1107/2009, the conclusions of the review report on
icial
prohexadione and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the
Jour
Food Chain and Animal Health on 17 June 2011 shall be
taken into account.’
nal
of
(1 ) Further details on identity and specification of active substance are provided in the review report.
the
European
Union
21.7.2011

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