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10.8.2011 Official
Journal
of
the
European
Union L
205/9
COMMISSION IMPLEMENTING REGULATION (EU) No 798/2011
of 9 August 2011
approving the active substance oxyfluorfen, 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,
support of the inclusion of that active substance in
Annex I to Directive 91/414/EEC within 2 months
from entry into force of that Regulation. Consequently,
Having regard to the Treaty on the Functioning of the European
Commission Decision 2008/934/EC of 5 December
Union,
2008 concerning the non-inclusion of certain active
substances in Annex I to Council Directive 91/414/EEC
and the withdrawal of authorisations for plant protection
Having regard to Regulation (EC) No 1107/2009 of the
products containing these substances ( 7 ) was adopted on
European Parliament and of the Council of 21 October 2009
the non-inclusion of oxyfluorfen.
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 1 ), and in particular Articles 13(2) and 78(2)
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
thereof,
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
Whereas:
lation (EC) No 33/2008 laying down detailed rules for
the application of Directive 91/414/EEC as regards a
regular and an accelerated procedure for the assessment
of active substances which were part of the programme
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC (
of work referred to in Article 8(2) of that Directive but

2 ) is to apply
to active substances for which completeness has been
have not been included into its Annex I.
established in accordance with Article 16 of Commission
Regulation (EC) No 33/2008 ( 3 ), with respect to the
procedure and the conditions for approval. Oxyfluorfen
(5) The
application
was
submitted
to
Spain,
which
had
been
is an active substance for which completeness has been
designated rapporteur Member State by Regulation (EC)
established in accordance with that Regulation.
No 1490/2002. The time period for the accelerated
procedure was respected. The specification of the active
substance and the supported uses are the same as were
(2) Commission
Regulations
(EC)
No
451/2000
(
the subject of Decision 2008/934/EC. That application

4 ) and (EC)
No 1490/2002 (
also complies with the remaining substantive and

5 ) lay down the detailed rules for the
implementation of the second and third stages of the
procedural requirements of Article 15 of Regulation
programme of work referred to in Article 8(2) of
(EC) No 33/2008.
Directive 91/414/EEC and establish a list of active
substances to be assessed, with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. That list
(6) Spain
evaluated
the
additional
data
submitted
by
the
included oxyfluorfen.
applicant and prepared an additional report. It
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
Commission on 13 January 2010. The Authority
lation (EC) No 1095/2007 of 20 September 2007
communicated the additional report to the other
amending Regulation (EC) No 1490/2002 laying down
Member States and the applicant for comments and
further detailed rules for the implementation of the third
forwarded the comments it had received to the
stage of the programme of work referred to in
Commission. In accordance with Article 20(1) of Regu
Article 8(2) of Council Directive 91/414/EEC and Regu
lation (EC) No 33/2008 and at the request of the
lation (EC) No 2229/2004 laying down further detailed
Commission, the Authority presented its conclusion on
rules for the implementation of the fourth stage of the
oxyfluorfen to the Commission on 23 November
programme of work referred to in Article 8(2) of Council
2010 ( 8 ). The draft assessment report, the additional
Directive 91/414/EEC
( 6 ) the notifier withdrew its
report and the conclusion of the Authority were
reviewed by the Member States and the Commission
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 7 ) OJ L 333, 11.12.2008, p. 11.
( 3 ) OJ L 15, 18.1.2008, p. 5.
( 8 ) European Food Safety Authority; Conclusion on the peer review of the
( 4 ) OJ L 55, 29.2.2000, p. 25.
pesticide risk assessment of the active substance oxyfluorfen. EFSA
( 5 ) OJ L 224, 21.8.2002, p. 23.
Journal 2010;8(11):1906. [78 pp.]. doi:10.2903/j.efsa.2010.1906.
( 6 ) OJ L 246, 21.9.2007, p. 19.
Available online: www.efsa.europa.eu

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L 205/10
EN
Official Journal of the European Union
10.8.2011
within the Standing Committee on the Food Chain and
holders of existing authorisations in relation to access to
Animal Health and finalised on 17 June 2011 in the
data. In order to avoid further difficulties it therefore
format of the Commission review report for oxyfluorfen.
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
an authorisation demonstrates access to a dossier
satisfying the requirements of Annex II to that Directive.
(7)
It has appeared from the various examinations made that
However, this clarification does not impose any new
plant protection products containing oxyfluorfen may be
obligations on Member States or holders of authori
expected to satisfy, in general, the requirements laid
sations compared to the directives which have been
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
adopted until now amending Annex I to that Directive
in particular as regards the uses which were examined
or the Regulations approving active substances. In
and detailed in the Commission review report. It is
accordance with Article 13(4) of Regulation (EC) No
therefore appropriate to approve oxyfluorfen in
1107/2009 the Annex to Commission Implementing
accordance with Regulation (EC) No 1107/2009.
Regulation (EU) No 540/2011 ( 2 ) should be amended
accordingly.
(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) Decision
2008/934/EC
provides
for
the
non-inclusion
of
is, however, necessary to include certain conditions and
oxyfluorfen and the withdrawal of authorisations for
restrictions.
plants protection products containing that substance by

31 December 2011. It is necessary to delete the line
concerning oxyfluorfen in the Annex to that Decision.
It is therefore appropriate to amend Decision
(9) Without
prejudice
to
the
conclusion
that
oxyfluorfen
2008/934/EC accordingly.
should be approved, it is, in particular, appropriate to
require further confirmatory information.
(14) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(10) A
reasonable
period
should
be
allowed
to
elapse
before
Committee on the Food Chain and Animal Health,
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
HAS ADOPTED THIS REGULATION:
(11) Without
prejudice
to
the
obligations
defined
by
Regu
lation (EC) No 1107/2009 as a consequence of the
Article 1
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
Approval of active substance
Regulation (EC) No 1107/2009, the following should,
however, apply. Member States should be allowed a
The active substance oxyfluorfen, as specified in Annex I, is
period of 6 months after approval to review authori
approved subject to the conditions laid down in that Annex.
sations of plant protection products containing
oxyfluorfen. Member States should, as appropriate, vary,
replace or withdraw existing authorisations. By way of
derogation from the above deadline, a longer period
Article 2
should be provided for the submission and assessment
Re-evaluation of plant protection products
of the update of the complete Annex III dossier, as set
out in Directive 91/414/EEC, of each plant protection
1. Member
States
shall
in
accordance
with
Regulation
(EC)
product for each intended use in accordance with the
No 1107/2009, where necessary, amend or withdraw existing
uniform principles.
authorisations for plant protection products containing
oxyfluorfen as an active substance by 30 June 2012.
(12) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
By that date they shall in particular verify that the conditions in
the framework of Commission Regulation (EEC) No
Annex I to this Regulation are met, with the exception of those
3600/92 of 11 December 1992 laying down the
identified in Part B of the column on specific provisions of that
detailed rules for the implementation of the first stage
Annex, and that the holder of the authorisation has, or has
of the programme of work referred to in Article 8(2) of
access to, a dossier satisfying the requirements of Annex II to
Council Directive 91/414/EEC concerning the placing of
Directive 91/414/EEC in accordance with the conditions of
plant protection products on the market ( 1 ) has shown
Article 13(1) to (4) of that Directive and Article 62 of Regu
that difficulties can arise in interpreting the duties of
lation (EC) No 1107/2009.
( 1 ) OJ L 366, 15.12.1992, p. 10.
( 2 ) OJ L 153, 11.6.2011, p. 1.

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EN
10.8.2011 Official
Journal
of
the
European
Union L
205/11
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
Article 3
orised plant protection product containing oxyfluorfen as either
the only active substance or as one of several active substances
Amendments to Implementing Regulation (EU) No
all of which were listed in the Annex to Implementing Regu
540/2011
lation (EU) No 540/2011, by 31 December 2011 at the latest,
The Annex to Implementing Regulation (EU) No 540/2011 is
Member States shall re-evaluate the product in accordance with
amended in accordance with Annex II to this Regulation.
the uniform principles, as referred to in Article 29(6) of Regu
lation (EC) No 1107/2009, on the basis of a dossier satisfying
the requirements of Annex III to Directive 91/414/EEC and
taking into account Part B of the column on specific provisions
of Annex I to this Regulation. On the basis of that evaluation,
Article 4
they shall determine whether the product satisfies the conditions
Amendments to Decision 2008/934/EC
set out in Article 29(1) of Regulation (EC) No 1107/2009.
Following that determination Member States shall:
The line concerning oxyfluorfen in the Annex to Decision
2008/934/EC is deleted.
(a) in the case of a product containing oxyfluorfen as the only
active substance, where necessary, amend or withdraw the
authorisation by 31 December 2015 at the latest; or
Article 5
Entry into force and date of application
(b) in the case of a product containing oxyfluorfen as one of
several active substances, where necessary, amend or
This Regulation shall enter into force on the 20th day following
withdraw the authorisation by 31 December 2015 or by
its publication in the Official Journal of the European Union.
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
that substance or substances, whichever is the latest.
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, 9 August 2011.
For the Commission
The President
José Manuel BARROSO

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L 205/12
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Oxyfluorfen
2-chloro-α,α,α-trifluoro- ≥ 970 g/kg
1 January 2012 31
December
2021 PART
A
p-tolyl 3-ethoxy-4-nitro
EN
CAS No 42874-03-3 phenyl ether
Impurities:
Only uses as herbicide for banded applications close to ground from autumn to early

spring may be authorised.
CIPAC No 538
N,N-dimethylnitro
samine: not more than
PART B
50 μg/kg
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 oxyfluorfen,
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:
Off
(a) pay particular attention to the operator safety and ensure that conditions of use
icial
prescribe the application of adequate personal protective equipment where appro
priate;
Jour
(b) pay particular attention to the risks to aquatic organisms, earthworm-eating
nal
mammals, soil-living macro-organisms, non-target arthropods and non-target plants.
of
Conditions of use shall include risk mitigation measures, where appropriate.
the
European
The applicant shall submit confirmatory information as regards:
(1) the specification of the technical material, as commercially manufactured including
information on the relevance of the impurities;
Union
(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;
(3) the potential risk to aquatic organisms for the active substance and for the meta
bolites RH-45469 (2 ), MW 306 (3 ), MW 347 (4 ), MW 274 (5 ) and for the unidentified
metabolite Deg 27;
(4) the potential risk from bioaccumulation and biomagnification in the aquatic food
chain, including sediment dwellers;
(5) exposure data for banded application adequate for use as drift mitigation values.
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) to (5) by 31 December 2013.
(1 ) Further details on identity and specification of active substance are provided in the review report.
(2 ) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol.
10.8.2011
(3 ) 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid.
(4 ) 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene.
(5 ) 4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid.

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10.8.2011 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
‘11 Oxyfluorfen
2-chloro-α,α,α-trifluoro-p-tolyl
≥ 970 g/kg
1 January 2012 31
December
PART A
3-ethoxy-4-nitrophenyl ether
2021
EN
CAS No 42874-03-3
Impurities:
Only uses as herbicide for banded applications close to

CIPAC No 538
N,N-dimethylnitrosamine: not
ground from autumn to early spring may be authorised.
more than 50 μg/kg
PART B
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
oxyfluorfen, 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:
nal
of
(a) pay particular attention to the operator safety and
the
ensure that conditions of use prescribe the application
European
of adequate personal protective equipment where appro
priate;
(b) pay particular attention to the risks to aquatic
Union
organisms, earthworm-eating mammals, soil-living
macro-organisms, non-target arthropods and non-
target plants.
Conditions of use shall include risk mitigation measures,
where appropriate.
The applicant shall submit confirmatory information as
regards:
(1)
the specification of the technical material, as
commercially manufactured including information on
the relevance of the impurities;
(2) the equivalence between the specifications of the
L
technical material, as commercially manufactured, and
205/13
the specifications of the test material used in the
toxicity studies;

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L 205/14
(3) the potential risk to aquatic organisms for the active
substance and for the metabolites RH-45469 (*), MW
306 (**), MW 347 (***), MW 274 (****) and for the
unidentified metabolite Deg 27;
(4) the potential risk from bioaccumulation and biomagnifi
cation in the aquatic food chain, including sediment
dwellers;
EN

(5) exposure data for banded application adequate for use as
drift mitigation values.
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) to (5) by 31 December 2013.
(*) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol.
(**) 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid.
Off
(***) 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene.
(****) 4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid.’
icial
Jour
nal
of
the
European
Union
10.8.2011

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