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27.7.2011 Official
Journal
of
the
European
Union L
195/37
COMMISSION IMPLEMENTING REGULATION (EU) No 736/2011
of 26 July 2011
approving the active substance fluroxypyr, 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,
azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl,
prohexadione and spiroxamine, and establishing the list
of the notifiers concerned ( 5 ).
Having regard to the Treaty on the Functioning of the European
Union,
(4) Within
the
time
period
provided
for
in
Article
6
of
Regulation (EC) No 737/2007, the notifier submitted
Having regard to Regulation (EC) No 1107/2009 of the
the data required in accordance with that Article
European Parliament and of the Council of 21 October 2009
together with an explanation as regards the relevance
concerning the placing of plant protection products on the
of each new study submitted.
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 1 ), and in particular Article 13(2) and
Article 78(2) thereof,
(5) The
rapporteur
Member
State
prepared
an
assessment
report in consultation with the co-rapporteur Member
State and submitted it to the European Food Safety
Whereas:
Authority (hereinafter ‘the Authority’) and the
Commission on 26 November 2009. In addition to the
assessment of the active substance, that report includes a
list of the studies the rapporteur Member State relied on
(1) In
accordance
with
Article
80(1)(b)
of
Regulation
(EC)
No
for its assessment.
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
to active substances listed in Annex I to Commission
Regulation (EC) No 737/2007 of 27 June 2007 on
laying down the procedure of the renewal of the
(6) The
Authority
communicated
the
assessment
report
to
inclusion of a first group of active substances in Annex
the notifier and to the Member States for comments
I to Council Directive 91/414/EEC and establishing the
and forwarded the comments received to the
list of those substances ( 3 ), with respect to the procedure
Commission. The Authority also made the assessment
and the conditions for approval. Fluroxypyr is listed in
report available to the public.
Annex I to Regulation (EC) No 737/2007.
(2)
The approval of fluroxypyr, as set out in Part A of the
(7)
At the request of the Commission, the assessment report
Annex to Commission Implementing Regulation (EU) No
was peer reviewed by the Member States and the
540/2011 of 25 May 2011 implementing Regulation
Authority. The Authority presented its conclusion on
(EC) No 1107/2009 of the European Parliament and of
the peer review of the risk assessment of fluroxypyr ( 6 )
the Council as regards the list of approved active
to the Commission on 24 February 2011. The
substances ( 4 ), expires on 31 December 2011. A notifi
assessment report and the conclusion of the Authority
cation was submitted in accordance with Article 4 of
were reviewed by the Member States and the
Regulation (EC) No 737/2007 for the renewal of the
Commission within the Standing Committee on the
inclusion of fluroxypyr in Annex I to Directive
Food Chain and Animal Health and finalised on
91/414/EEC within the time period provided for in
17 June 2011 in the format of the Commission review
that Article.
report for fluroxypyr.
(3) That
notification
was
found
to
be
admissible
by (8)
It has appeared from the various examinations made that
Commission Decision 2008/656/EC of 28 July 2008
plant protection products containing fluroxypyr may be
on the admissibility of the notifications concerning the
expected to continue to satisfy, in general, the
renewal of the inclusion in Annex I to Council Directive
requirements laid down in Article 5(1)(a) and (b) of
91/414/EEC of the active substances azimsulfuron,
( 5 ) OJ L 214, 9.8.2008, p. 70.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 2 ) OJ L 230, 19.8.1991, p. 1.
the pesticide risk assessment of the active substance fluroxypyr.
( 3 ) OJ L 169, 29.6.2007, p. 10.
EFSA Journal 2011;9(3):2091. [91 pp.]. doi:10.2903/j.efsa.2011.
( 4 ) OJ L 153, 11.6.2011, p. 1.
2091. Available online: www.efsa.europa.eu/efsajournal.htm

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L 195/38
EN
Official Journal of the European Union
27.7.2011
Directive 91/414/EEC, in particular as regards the uses
(15) The
measures
provided
for
in
this
Regulation
are
in
which were examined and detailed in the Commission
accordance with the opinion of the Standing
review report. It is therefore appropriate to approve flur
Committee on the Food Chain and Animal Health,
oxypyr.
(9) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No HAS ADOPTED THIS REGULATION:
1107/2009 in conjunction with Article 6 thereof and in
the light of current scientific and technical knowledge, it
is, however, necessary to include certain conditions and
Article 1
restrictions not provided for in the first inclusion in
Approval of active substance
Annex I to Directive 91/414/EEC.
The active substance fluroxypyr, as specified in Annex I, is
approved subject to the conditions laid down in that Annex.
(10) Without
prejudice
to the conclusion that fluroxypyr
should be approved, it is, in particular, appropriate to
require further confirmatory information.
Article 2
Re-evaluation of plant protection products
(11) A
reasonable
period
should
be
allowed
to
elapse
before
approval in order to permit Member States and interested
1. Member
States
shall
in
accordance
with
Regulation
(EC)
parties to prepare themselves to meet the new
No 1107/2009, where necessary, amend or withdraw existing
requirements resulting from the approval.
authorisations for plant protection products containing flur
oxypyr as an active substance by 30 June 2012.
(12) Without
prejudice
to
the
obligations
provided
for
by
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
By that date they shall in particular verify that the conditions in
created by the transition from Directive 91/414/EEC to
Annex I to this Regulation are met, with the exception of those
Regulation (EC) No 1107/2009 the following should,
identified in Part B of the column on specific provisions of that
however, apply. Member States should be allowed a
Annex, and that the holder of the authorisation has, or has
period of 6 months after approval to review authori
access to, a dossier satisfying the requirements of Annex II to
sations of plant protection products containing flur
Directive 91/414/EEC in accordance with the conditions of
oxypyr. Member States should, as appropriate, vary,
Article 13(1) to (4) of that Directive and Article 62 of Regu
replace or withdraw authorisations. By way of derogation
lation (EC) No 1107/2009.
from that deadline, a longer period should be provided
for the submission and assessment of the update of the
complete Annex III dossier, as set out in Directive
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
91/414/EEC, of each plant protection product for each
orised plant protection product containing fluroxypyr as either
intended use in accordance with the uniform principles.
the only active substance or as one of several active substances
all of which were listed in the Annex to Implementing Regu
lation (EU) No 540/2011 by 31 December 2011 at the latest,
(13) The
experience
gained
from
inclusions
in
Annex
I
to
Member States shall re-evaluate the product in accordance with
Directive 91/414/EEC of active substances assessed in
the uniform principles, as referred to in Article 29(6) of Regu
the framework of Commission Regulation (EEC) No
lation (EC) No 1107/2009, on the basis of a dossier satisfying
3600/92 of 11 December 1992 laying down the
the requirements of Annex III to Directive 91/414/EEC and
detailed rules for the implementation of the first stage
taking into account Part B of the column on specific provisions
of the programme of work referred to in Article 8(2) of
of Annex I to this Regulation. On the basis of that evaluation,
Council Directive 91/414/EEC concerning the placing of
they shall determine whether the product still satisfies the
plant protection products on the market ( 1 ) has shown
conditions set out in Article 29(1) of Regulation (EC) No
that difficulties can arise in interpreting the duties of
1107/2009.
holders of existing authorisations in relation to access
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
Following that determination Member States shall:
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.
However, this clarification does not impose any new
(a) in the case of a product containing fluroxypyr as the only
obligations on Member States or holders of authori
active substance, where necessary, amend or withdraw the
sations compared to the directives which have been
authorisation by 31 December 2015 at the latest; or
adopted until now amending Annex I to that Directive
or the Regulations approving active substances.
(b) in the case of a product containing fluroxypyr as one of
several active substances, where necessary, amend or
(14) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
withdraw the authorisation by 31 December 2015 or by
1107/2009 the Annex to Implementing Regulation (EU)
the date fixed for such an amendment or withdrawal in the
No 540/2011 should be amended accordingly.
respective act or acts which added the relevant substance or
substances to Annex I to Directive 91/414/EEC or approved
( 1 ) OJ L 366, 15.12.1992, p. 10.
that substance or substances, whichever is the latest.

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EN
27.7.2011 Official
Journal
of
the
European
Union L
195/39
Article 3
Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this
Regulation.
Article 4
Entry into force and 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, 26 July 2011.
For the Commission
The President
José Manuel BARROSO

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L 195/40
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Fluroxypyr
4-amino-3,5-dichloro- ≥ 950 g/kg
1 January 2012 31
December
2021 PART
A
CAS No 69377-81-7
6-fluoro-2-pyridylo
(fluroxypyr-meptyl)
EN
CIPAC No 431
xyacetic acid
Only uses as herbicide may be authorised.

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 flur
oxypyr, 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
icial
(1) pay particular attention to the potential contamination of groundwater by
metabolite fluroxypyr pyridinol, when the active substance is applied in
Jour
regions with alkaline or vulnerable soil and/or with vulnerable climatic
conditions;
nal
(2) pay particular attention to the risk to aquatic organisms.
of
the
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
European
The notifier shall submit confirmatory information as regards:
(a) the relevance of the impurities present in the technical specifications;
Union
(b) the relevance of the test material used in the toxicity dossiers in view of the
specification of the technical material;
(c) the toxicological relevance of the metabolites fluroxypyr pyridinol and flur
oxypyr methoxypyridine;
(d) the residue analytical methods for plants;
(e) the fate of fluroxypyr esters in animal matrices;
(f) the long-term risk for earthworms and soil organisms.
The notifier shall submit to the Member States, the Commission and the
Authority the information set out in point (a) and (b) by 1 July 2012 and the
information set out in points (c), (d), (e) and (f) by 31 December 2013.
(1 ) Further details on identity and specification of active substance are provided in the review report.
27.7.2011

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27.7.2011 Off
ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, the entry relating to fluroxypyr is deleted;
(2) in Part B, the following entry is added:
EN

No
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
‘9 Fluroxypyr
4-amino-3,5-
≥ 950 g/kg
1 January 2012 31
December
2021 PART
A
dichloro-6-
CAS No 69377-81-7 fluoro-2-pyridy (fluroxypyr-meptyl)
Only uses as herbicide may be authorised.
CIPAC No 431
loxyacetic acid
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 fluroxypyr, 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.
icial
In this overall assessment Member States shall:
Jour
(1) pay particular attention to the potential contamination of groundwater by meta
bolite fluroxypyr pyridinol, when the active substance is applied in regions with
nal
alkaline or vulnerable soil and/or with vulnerable climatic conditions;
of
the
(2) pay particular attention to the risk to aquatic organisms.
European
Conditions of authorisation shall include risk mitigation measures, where appropriate.
The notifier shall submit confirmatory information as regards:
(a) the relevance of the impurities present in the technical specifications;
Union
(b) the relevance of the test material used in the toxicity dossiers in view of the
specification of the technical material;
(c) the toxicological relevance of the metabolites fluroxypyr pyridinol and fluroxypyr
methoxypyridine;
(d) the residue analytical methods for plants;
(e) the fate of fluroxypyr esters in animal matrices;
(f) the long-term risk for earthworms and soil organisms.
The notifier shall submit to the Member States, the Commission and the Authority the
information set out in point (a) and (b) by 1 July 2012 and the information set out in
points (c), (d), (e) and (f) by 31 December 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
195/41

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