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6.8.2011 Official
Journal
of
the
European
Union L
203/21
COMMISSION IMPLEMENTING REGULATION (EU) No 788/2011
of 5 August 2011
approving the active substance fluazifop-P, 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 and
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
amending Regulation (EC) No 1490/2002 laying down
further detailed rules for the implementation of the third
stage of the programme of work referred to in
Article 8(2) of Council Directive 91/414/EEC and Regu
lation (EC) No 2229/2004 laying down further detailed
Having regard to the Treaty on the Functioning of the European
rules for the implementation of the fourth stage of the
Union,
programme of work referred to in Article 8(2) of Council
Directive 91/414/EEC
( 6 ) the notifier withdrew its
support of the inclusion of that active substance in
Annex I to Directive 91/414/EEC within 2 months
Having regard to Regulation (EC) No 1107/2009 of the
from entry into force of that Regulation. Consequently,
European Parliament and of the Council of 21 October 2009
Commission Decision 2008/934/EC of 5 December
concerning the placing of plant protection products on the
2008 concerning the non-inclusion of certain active
market and repealing Council Directives 79/117/EEC and
substances in Annex I to Council Directive 91/414/EEC
91/414/EEC (
and the withdrawal of authorisations for plant protection

1 ), and in particular Article 13(2) and
Article 78(2) thereof,
products containing these substances ( 7 ) was adopted on
the non-inclusion of fluazifop-P.
Whereas:
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
original notifier (hereinafter ‘the applicant’) submitted a
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of Regu
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
lation (EC) No 33/2008 laying down detailed rules for
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
the application of Council Directive 91/414/EEC as
to active substances for which completeness has been
regards a regular and an accelerated procedure for the
established in accordance with Article 16 of Commission
assessment of active substances which were part of the
Regulation (EC) No 33/2008 ( 3 ), with respect to the
programme of work referred to in Article 8(2) of that
procedure and the conditions for approval. Fluazifop-P
Directive but have not been included into its Annex I.
is an active substance for which completeness has been
established in accordance with that Regulation.
(5) The
application
was
submitted
to
France,
which
had
been
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
designated rapporteur Member State by Regulation (EC)
No 1490/2002 ( 5 ) lay down the detailed rules for the
No 1490/2002. The time period for the accelerated
implementation of the second and third stages of the
procedure was respected. The specification of the active
programme of work referred to in Article 8(2) of
substance and the supported uses are the same as were
Directive 91/414/EEC and establish a list of active
the subject of Decision 2008/934/EC. That application
substances to be assessed, with a view to their possible
also complies with the remaining substantive and
inclusion in Annex I to Directive 91/414/EEC. That list
procedural requirements of Article 15 of Regulation
included fluazifop-P.
(EC) No 33/2008.
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
lation (EC) No 1095/2007 of 20 September 2007
(6)
France evaluated the additional data submitted by the
applicant and prepared an additional report. It
communicated that report to the European Food Safety
( 1 ) OJ L 309, 24.11.2009, p. 1.
Authority (hereinafter ‘the Authority’) and to the
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 3 ) OJ L 15, 18.1.2008, p. 5.
( 4 ) OJ L 55, 29.2.2000, p. 25.
( 6 ) OJ L 246, 21.9.2007, p. 19.
( 5 ) OJ L 224, 21.8.2002, p. 23.
( 7 ) OJ L 333, 11.12.2008, p. 11.

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L 203/22
EN
Official Journal of the European Union
6.8.2011
Commission on 19 February 2010. The Authority
derogation from the above deadline, a longer period
communicated the additional report to the other
should be provided for the submission and assessment
Member States and the applicant for comments and
of the update of the complete Annex III dossier, as set
forwarded the comments it had received to the
out in Directive 91/414/EEC, of each plant protection
Commission. In accordance with Article 20(1) of Regu
product for each intended use in accordance with the
lation (EC) No 33/2008 and at the request of the
uniform principles.
Commission, the Authority presented its conclusion on
fluazifop-P to the Commission on 17 November
2010 ( 1 ). The draft assessment report, the additional
report and the conclusion of the Authority were
(12) The
experience
gained
from
previous
inclusions
in
Annex
reviewed by the Member States and the Commission
I to Directive 91/414/EEC of active substances assessed
within the Standing Committee on the Food Chain and
in the framework of Commission Regulation (EEC) No
Animal Health and finalised on 17 June 2011 in the
3600/92 of 11 December 1992 laying down the detailed
format of the Commission review report for fluazifop-P.
rules for the implementation of the first stage of the
programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing
of plant protection products on the market ( 2 ) has
(7)
It has appeared from the various examinations made that
shown that difficulties can arise in interpreting the
plant protection products containing fluazifop-P may be
duties of holders of existing authorisations in relation
expected to satisfy, in general, the requirements laid
to access to data. In order to avoid further difficulties
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
it therefore appears necessary to clarify the duties of
in particular as regards the uses which were examined
the Member States, especially the duty to verify that
and detailed in the Commission review report. It is
the holder of an authorisation demonstrates access to a
therefore appropriate to approve fluazifop-P in
dossier satisfying the requirements of Annex II to that
accordance with Regulation (EC) No 1107/2009.
Directive. However, this clarification does not impose any
new obligations on Member States or holders of auth
orisations compared to the directives which have been
adopted until now amending Annex I.
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009 in conjunction with Article 6 thereof and in
the light of current scientific and technical knowledge, it
(13) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
is, however, necessary to include certain conditions and
1107/2009 the Annex to Commission Implementing
restrictions.
Regulation (EU) No 540/2011 ( 3 ) should be amended
accordingly.
(9) Without
prejudice
to
the
conclusion
that
fluazifop-P
should be approved, it is, in particular, appropriate to
(14) Decision
2008/934/EC
provides
for
the
non-inclusion
of
require further confirmatory information.
fluazifop-P and the withdrawal of authorisations for
plants protection products containing that substance by
31 December 2011. It is necessary to delete the line
concerning fluazifop-P in the Annex to that Decision.
(10) A
reasonable
period
should
be
allowed
to
elapse
before
It is therefore appropriate to amend Decision
approval in order to permit Member States and the
2008/934/EC accordingly.
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
(15) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(11) Without
prejudice
to
the
obligations
defined
by
Regu
lation (EC) No 1107/2009 as a consequence of the
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
HAS ADOPTED THIS REGULATION:
Regulation (EC) No 1107/2009 the following should,
however, apply. Member States should be allowed a
period of 6 months after approval to review authori
sations of plant protection products containing
Article 1
fluazifop-P. Member States should, as appropriate, vary,
replace or withdraw existing authorisations. By way of
Approval of active substance
The active substance fluazifop-P, as specified in Annex I, is
( 1 ) European Food Safety Authority; Conclusion on the peer review of
approved subject to the conditions laid down in that Annex.
the pesticide risk assessment of the active substance fluazifop-P-
butyl. EFSA Journal 2010;8(11): [24 pp.] doi:10.2903/
j.efsa.2010.1905. Available online: www.efsa.europa.eu/efsajournal.
( 2 ) OJ L 366, 15.12.1992, p. 10.
htm
( 3 ) OJ L 153, 11.6.2011, p. 1.

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EN
6.8.2011 Official
Journal
of
the
European
Union L
203/23
Article 2
(a) in the case of a product containing fluazifop-P as the only
active substance, where necessary, amend or withdraw the
Re-evaluation of plant protection products
authorisation by 31 December 2015 at the latest; or
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing
(b) in the case of a product containing fluazifop-P as one of
fluazifop-P as an active substance by 30 June 2012.
several active substances, where necessary, amend or
withdraw the authorisation by 31 December 2015 or by
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
By that date they shall in particular verify that the conditions in
that substance or substances, whichever is the latest.
Annex I to this Regulation are met, with the exception of those
identified in Part B of the column on specific provisions of that
Annex, and that the holder of the authorisation has, or has
Article 3
access to, a dossier satisfying the requirements of Annex II to
Amendments to Implementing Regulation (EU) No
Directive 91/414/EEC in accordance with the conditions of
540/2011
Article 13(1) to (4) of that Directive and Article 62 of Regu
lation (EC) No 1107/2009.
The Annex to Implementing Regulation (EU) No 540/2011 is
amended in accordance with Annex II to this Regulation.
Article 4
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing fluazifop-P as either
Amendments to Decision 2008/934/EC
the only active substance or as one of several active substances
The line concerning fluazifop-P in the Annex to Decision
all of which were listed in the Annex to Implementing Regu
2008/934/EC is deleted.
lation (EU) No 540/2011 by 31 December 2011 at the latest,
Member States shall re-evaluate the product in accordance with
the uniform principles, as referred to in Article 29(6) of Regu
Article 5
lation (EC) No 1107/2009, on the basis of a dossier satisfying
the requirements of Annex III to Directive 91/414/EEC and
Entry into force and date of application
taking into account Part B of the column on specific provisions
This Regulation shall enter into force on the 20th day following
of Annex I to this Regulation. On the basis of that evaluation,
its publication in the Official Journal of the European Union.
they shall determine whether the product satisfies the conditions
set out in Article 29(1) of Regulation (EC) No 1107/2009.
Following that determination Member States shall:
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, 5 August 2011.
For the Commission
The President
José Manuel BARROSO

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L 203/24
ANNEX I
Common Name,
Identification
IUPAC Name Purity
(
Expiration
1 )
Date of
Numbers
approval
of approval
Specific provisions
Fluazifop-P
(R)-2-{4-[5-
≥ 900 g/kg in fluazifop-
1 January
31
PART A
EN
(trifluoromethyl)-
P-butyl
2012
December

CAS No
2-pyridyloxy]phenoxy}
2021
Only uses as herbicide for orchards (basal application) with one application every year may be authorised.
83066-88-0
propionic acid
The following impurity
(fluazifop-P)
PART B
(fluazifop-P)
2-chloro-5-
(trifluoromethyl) pyridine
CIPAC No
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No
must not exceed 1,5 g/kg
467 (fluazifop-P)
1107/2009, the conclusions of the review report on fluazifop-P-butyl, and in particular Appendices I and
in the material as
II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011
manufactured.
shall be taken into account.
In this overall assessment Member States:
— shall pay particular attention to the operator safety and shall ensure that conditions of use include the
Off
application of adequate personal protective equipment, where appropriate,
icial
— shall pay particular attention to the protection of surface water and groundwater in vulnerable zones,
Jour
— shall pay particular attention to the risk for non-target plants.
nal
Conditions of use shall include risk mitigation measures, where appropriate.
of
The applicant shall submit confirmatory information as regards:
the
(1) the specification of the technical material, as commercially manufactured, including information on the
European
relevance of the impurity R154719;
(2) the equivalence between the specifications of the technical material, as commercially manufactured, and the
specifications of the test material used in the toxicity studies;
Union
(3) the potential long-term risk to herbivorous mammals;
(4) the fate and behaviour in the environment of the metabolite compounds X (2 ) and IV (3 );
(5) the potential risk to fish and aquatic invertebrates for the metabolite compound IV.
The applicant shall submit to the Commission, the Member States and the Authority the information set out in
points (1) and (2) by 30 June 2012 and the information set out in points (3), (4) and (5) by 31 December
2013.
(1 ) Further details on identity and specification of active substance are provided in the review report.
(2 ) 5-(trifluoromethyl)-2(1H)-pyridinone.
(3 ) 4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol.
6.8.2011

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6.8.2011 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
‘15 Fluazifop
P
(R)-2-{4-[5-
≥ 900 g/kg in fluazifop 1 January
31 December PART A
(trifluoromethyl)-2-
P-butyl
2012
2021
CAS No
pyridyloxy]phenoxy}
Only uses as herbicide for orchards (basal application) with one application every year may be
EN
83066-88-0
propionic acid
The following impurity
authorised.

(fluazifop-P)
(fluazifop-P)
2-chloro-5-
(trifluoromethyl)pyridine
PART B
CIPAC No
must not exceed 1,5
467 (fluazifop-P)
g/kg in the material as
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC)
manufactured.
No 1107/2009, the conclusions of the review report on fluazifop-P-butyl, 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.
In this overall assessment Member States:
— shall pay particular attention to the operator safety and shall ensure that conditions of use
include the application of adequate personal protective equipment, where appropriate,
icial
— shall pay particular attention to the protection of surface water and groundwater in vulnerable
Jour
zones,
nal
— shall pay particular attention to the risk for non-target plants.
of
Conditions of use shall include risk mitigation measures, where appropriate.
the
The applicant shall submit confirmatory information as regards:
European
(1) the specification of the technical material, as commercially manufactured, including information
on the relevance of the impurity R154719;
Union
(2) the equivalence between the specifications of the technical material, as commercially manu
factured, and the specifications of the test material used in the toxicity studies;
(3) the potential long-term risk to herbivorous mammals;
(4) the fate and behaviour in the environment of the metabolite compounds X (*) and IV (**);
(5) the potential risk to fish and aquatic invertebrates for the metabolite compound IV.
The applicant shall submit to the Commission, the Member States and the Authority the
information set out in points (1) and (2) by 30 June 2012 and the information set out in
points (3), (4) and (5) by 31 December 2013.
(*) 5-(trifluoromethyl)-2(1H)-pyridinone.
(**) 4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol.’
L
203/25

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