HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 190/50
EN
Official Journal of the European Union
21.7.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 706/2011
of 20 July 2011
approving the active substance profoxydim, 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,
down in Article 5(1)(a) and (b) and Article 5(3) of
Directive 91/414/EEC, in particular with regard to the
Having regard to the Treaty on the Functioning of the European
uses which were examined and detailed in the
Union,
Commission review report. It is therefore appropriate
to approve profoxydim.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
(6) Without
prejudice
to
the
obligations
provided
for
by
Regulation (EC) No 1107/2009 as a consequence of
market and repealing Council Directives 79/117/EEC and
approval, taking into account the specific situation
91/414/EEC ( 1 ), and in particular Article 13(2) and
created by the transition from Directive 91/414/EEC to
Article 78(2) thereof,
Regulation (EC) No 1107/2009 the following should,
however, apply. Member States should be allowed a
Whereas:
period of 6 months after approval to review authori
sations of plant protection products containing
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
profoxydim. Member States should, as appropriate,
No 1107/2009, Council Directive 91/414/EEC ( 2 ) is to
vary, replace or withdraw authorisations. By way of dero
apply, with respect to the procedure and the conditions
gation from that deadline, a longer period should be
for approval, to active substances for which a decision
provided for the submission and assessment of the
has been adopted in accordance with Article 6(3) of that
update of the complete Annex III dossier, as set out in
Directive before 14 June 2011. For profoxydim the
Directive 91/414/EEC, of each plant protection product
conditions of Article 80(1)(a) of Regulation (EC)
for each intended use in accordance with the uniform
No 1107/2009 are fulfilled by Commission Decision
principles.
1999/43/EC ( 3 ).
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC (7) The
experience
gained
from
inclusions
in
Annex
I
to
Spain received on 2 April 1998 an application from
Directive 91/414/EEC of active substances assessed in
BASF SE for the inclusion of the active substance
the framework of Commission Regulation (EEC)
profoxydim in Annex I to Directive 91/414/EEC.
No 3600/92 of 11 December 1992 laying down the
Decision 1999/43/EC confirmed that the dossier was
detailed rules for the implementation of the first stage
‘complete’ in the sense that it could be considered as
of the programme of work referred to in Article 8(2) of
satisfying, in principle, the data and information
Council Directive 91/414/EEC concerning the placing of
requirements of Annexes II and III to Directive
plant protection products on the market ( 4 ) has shown
91/414/EEC.
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
(3) For
that
active
substance,
the
effects
on
human
and
appears necessary to clarify the duties of the Member
animal health and the environment have been assessed,
States, especially the duty to verify that the holder of
in accordance with the provisions of Article 6(2) and (4)
an authorisation demonstrates access to a dossier
of Directive 91/414/EEC, for the uses proposed by the
satisfying the requirements of Annex II to that Directive.
applicant. The designated rapporteur Member State
However, this clarification does not impose any new
submitted a draft assessment report on 28 March 2001.
obligations on Member States or holders of authori
sations compared to the directives which have been
(4) For
profoxydim
the
draft
assessment
report
was
reviewed
adopted until now amending Annex I to that Directive
by the Member States and the Commission within the
or the Regulations approving active substances.
Standing Committee on the Food Chain and Animal
Health. The review was finalised on 17 June 2011 in
the format of the Commission review report for
(8) In
accordance
with
Article
13(4)
of
Regulation
(EC)
profoxydim.
No 1107/2009, the Annex to Commission Implementing
Regulation (EU) No 540/2011 of 25 May 2011 imple
(5)
It has appeared from the various examinations made that
menting Regulation (EC) No 1107/2009 of the European
plant protection products containing profoxydim may be
Parliament and of the Council as regards the list of
expected to satisfy, in general, the requirements laid
approved active substances
( 5 ) should be amended
accordingly.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 4 ) OJ L 366, 15.12.1992, p. 10.
( 3 ) OJ L 14, 19.1.1999, p. 30.
( 5 ) OJ L 153, 11.6.2011, p. 1.

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EN
21.7.2011 Official
Journal
of
the
European
Union L
190/51
(9) In
the
interest
of
clarity,
Commission
Directive requirements of Annex III to Directive 91/414/EEC and taking
2011/14/EU of 24 February 2011 amending Council
into account Part B of the column on specific provisions of
Directive 91/414/EEC to include profoxydim as active
Annex I to this Regulation. On the basis of that evaluation,
substance ( 1 ) should be repealed.
they shall determine whether the product satisfies the conditions
set out in Article 29(1) of Regulation (EC) No 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 profoxydim as the only
HAS ADOPTED THIS REGULATION:
active substance, where necessary, amend or withdraw the
authorisation by 31 January 2013 at the latest; or
Article 1
Approval of active substance
(b) in the case of a product containing profoxydim as one of
several active substances, where necessary, amend or
The active substance profoxydim, as specified in Annex I, is
withdraw the authorisation by 31 January 2013 or by the
approved subject to the conditions laid down in that Annex.
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
Article 2
approved that substance or substances, whichever is the
Re-evaluation of plant protection products
latest.
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
Article 3
authorisations for plant protection products containing
profoxydim as active substance by 31 January 2012.
Amendments to Implementing Regulation (EU) No
540/2011
By that date, they shall in particular verify that the conditions in
The Annex to Implementing Regulation (EU) No 540/2011 is
Annex I to this Regulation are met, with the exception of those
amended in accordance with Annex II to this Regulation.
identified in Part B of the column on specific provisions of that
Annex, and that the holder of the authorisation has, or has
access to, a dossier satisfying the requirements of Annex II to
Article 4
Directive 91/414/EEC in accordance with the conditions of
Repeal
Article 13(1) to (4) of that Directive and Article 62 of
Regulation (EC) No 1107/2009.
Directive 2011/14/EU is repealed.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
Article 5
orised plant protection product containing profoxydim as either
Entry into force and date of application
the only active substance or as one of several active substances
all of which were listed in the Annex to Implementing Regu
This Regulation shall enter into force on the 20th day following
lation (EU) No 540/2011 by 31 July 2011 at the latest, Member
its publication in the Official Journal of the European Union.
States shall re-evaluate the product in accordance with the
uniform principles, as referred to in Article 29(6) of Regulation
(EC) No 1107/2009, on the basis of a dossier satisfying the
It shall apply from 1 August 2011.
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
( 1 ) OJ L 51, 25.2.2011, p. 16.

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L 190/52
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Profoxydim
2 - [(1 E/Z) - [(2 R S) – 2 - (4 – chloro ≥ 940 g/kg 1
August
2011 31
July
2021 PART
A
phenoxy) propoxyimino] butyl] – 3 –
EN
CAS No
hydroxy – 5 - [(3 R S; 3 S R) – tetrahydro
Only uses as herbicide in rice may be authorised.

139001-49-3
– 2 H – thiopyran – 3 – yl] cyclohex – 2 -
PART B
CIPAC No 621
enone
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
profoxydim, 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 pay
icial
particular attention to:
Jour
— the protection of groundwater when the active substance
nal
is applied in regions with vulnerable soil and/or climatic
conditions,
of
the
— the long-term risk to non-target organisms.
European
Conditions of authorisation shall include risk mitigation
measures where appropriate.
Union
(1 ) Further details on identity and specification of active substances are provided in the review report.
21.7.2011

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21.7.2011 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘2 Profoxydim
2 - [(1 E/Z) - [(2 R S) – 2 - (4 –
≥ 940 g/kg 1
August
2011 31
July
2021 PART
A

chlorophenoxy) propoxyimino] butyl] – 3 –
CAS No 139001- hydroxy – 5 - [(3 R S; 3 S R) – tetrahydro –
Only uses as herbicide in rice may be authorised.
49-3
2 H – thiopyran – 3 – yl] cyclohex – 2 -
PART B
CIPAC No 621
enone
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
profoxydim, 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
icial
account.
Jour
In this overall assessment, Member States shall pay
particular attention to:
nal
of
— the protection of groundwater when the active substance
the
is applied in regions with vulnerable soil and/or climatic
conditions,
European
— the long-term risk to non-target organisms.
Conditions of authorisation shall include risk mitigation
Union
measures where appropriate.’
(1 ) Further details on identity and specification of active substances are provided in the review report.
L
190/53

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