HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 196/6
EN
Official Journal of the European Union
28.7.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 740/2011
of 27 July 2011
approving the active substance bispyribac, 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,
(EFSA) in the format of the EFSA conclusion on the peer
review of the pesticide risk assessment of the active
substance bispyribac on 12 July 2010 ( 4 ). This report
Having regard to the Treaty on the Functioning of the European
was reviewed by the Member States and the Commission
Union,
within the Standing Committee on the Food Chain and
Animal Health and was finalised on 17 June 2011 in the
format of the Commission review report for bispyribac.
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
market and repealing Council Directives 79/117/EEC and
(5)
It has appeared from the various examinations made that
91/414/EEC (
plant protection products containing bispyribac may be

1 ), and in particular Article 13(2) and
Article 78(2) thereof,
expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) and Article 5(3) of
Directive 91/414/EEC, in particular with regard to the
Whereas:
uses which were examined and detailed in the

Commission review report. It is therefore appropriate
to approve bispyribac.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
(6) Without
prejudice
to
the
obligations
provided
for
by
approval, to active substances for which a decision has
Regulation (EC) No 1107/2009 as a consequence of
been adopted in accordance with Article 6(3) of that
approval, taking into account the specific situation
Directive before 14 June 2011. For bispyribac the
created by the transition from Directive 91/414/EEC to
conditions of Article 80(1)(a) of Regulation (EC) No
Regulation (EC) No 1107/2009 the following should,
1107/2009 are fulfilled by Commission Decision
however, apply. Member States should be allowed a
2003/305/EC ( 3 ).
period of 6 months after approval to review authori
sations of plant protection products containing
bispyribac. Member States should, as appropriate, vary,
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
replace or withdraw authorisations. By way of derogation
Italy received on 26 February 2002 an application from
from that deadline, a longer period should be provided
Bayer CropScience for the inclusion of the active
for the submission and assessment of the update of the
substance bispyribac (also called bispyribac sodium,
complete Annex III dossier, as set out in Directive
according to the form in which the active substance is
91/414/EEC, of each plant protection product for each
contained in the representative formulation on which the
intended use in accordance with the uniform principles.
dossier is based) in Annex I to Directive 91/414/EEC.
Decision 2003/305/EC confirmed that the dossier was
‘complete’ in the sense that it could be considered as
satisfying, in principle, the data and information
(7) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
requirements of Annexes II and III to Directive
the framework of Commission Regulation (EEC) No
91/414/EEC.
3600/92 of 11 December 1992 laying down the
detailed rules for the implementation of the first stage
of the programme of work referred to in Article 8(2) of
(3) For
that
active
substance,
the
effects
on
human
health
Council Directive 91/414/EEC concerning the placing of
and the environment have been assessed, in accordance
plant protection products on the market (
with the provisions of Article 6(2) and (4) of Directive

5 ) has shown
that difficulties can arise in interpreting the duties of
91/414/EEC, for the uses proposed by the applicant. The
holders of existing authorisations in relation to access
designated rapporteur Member State submitted a draft
to data. In order to avoid further difficulties it therefore
assessment report on 1 August 2003.
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder
(4) The
draft
assessment
report
was
peer
reviewed
by
the
Member States and the European Food Safety Authority
( 4 ) EFSA Journal (2010) 8(1):1692, Conclusion on the peer review of
the pesticide risk assessment of the active substance bispyribac
(unless otherwise stated all data evaluated refer to the variant
( 1 ) OJ L 309, 24.11.2009, p. 1.
bispyribac-sodium)). doi:10.2903/j.efsa.2010.1692. Available online:
( 2 ) OJ L 230, 19.8.1991, p. 1.
www.efsa.europa.eu
( 3 ) OJ L 112, 6.5.2003, p. 10.
( 5 ) OJ L 366, 15.12.1992, p. 10.

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EN
28.7.2011 Official
Journal
of
the
European
Union L
196/7
of an authorisation demonstrates access to a dossier
2. By way of derogation from paragraph 1, for each auth
satisfying the requirements of Annex II to that Directive.
orised plant protection product containing bispyribac as either
However, this clarification does not impose any new
the only active substance or as one of several active substances
obligations on Member States or holders of authori
all of which were listed in the Annex to Implementing Regu
sations compared to the directives which have been
lation (EU) No 540/2011 by 31 July 2011 at the latest, Member
adopted until now amending Annex I to that Directive
States shall re-evaluate the product in accordance with the
or the Regulations approving active substances.
uniform principles, as referred to in Article 29(6) of Regulation
(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
(8) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No Annex I to this Regulation. On the basis of that evaluation,
1107/2009, the Annex to Commission Implementing
they shall determine whether the product satisfies the conditions
Regulation (EU) No 540/2011 of 25 May 2011 imple
set out in Article 29(1) of Regulation (EC) No 1107/2009.
menting Regulation (EC) No 1107/2009 of the European
Parliament and of the Council as regards the list of
approved active substances
( 1 ) should be amended
accordingly.
Following that determination Member States shall:
(9) In
the
interest
of
clarity,
Commission
Directive
2011/22/EU of 3 March 2011 amending Council
(a) in the case of a product containing bispyribac as the only
Directive 91/414/EEC to include bispyribac as active
active substance, where necessary, amend or withdraw the
substance ( 2 ) should be repealed.
authorisation by 31 January 2013 at the latest; or
(10) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(b) in the case of a product containing bispyribac as one of
Committee on the Food Chain and Animal Health,
several active substances, where necessary, amend or
withdraw the authorisation by 31 January 2013 or by the
date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance
HAS ADOPTED THIS REGULATION:
or substances to Annex I to Directive 91/414/EEC or
approved that substance or substances, whichever is the
latest.
Article 1
Approval of active substance
Article 3
The active substance bispyribac, as specified in Annex I, is
approved subject to the conditions laid down in that Annex.
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 2
Re-evaluation of plant protection products
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
Article 4
authorisations for plant protection products containing
Repeal
bispyribac as active substance by 31 January 2012.
Directive 2011/22/EU is repealed.
By that date, they shall in particular verify that the conditions in
Annex I to this Regulation are met, with the exception of those
Article 5
identified in Part B of the column on specific provisions of that
Annex, and that the holder of the authorisation has, or has
Entry into force and date of application
access to, a dossier satisfying the requirements of Annex II to
Directive 91/414/EEC in accordance with the conditions of
This Regulation shall enter into force on the 20th day following
Article 13(1) to (4) of that Directive and Article 62 of Regu
its publication in the Official Journal of the European Union.
lation (EC) No 1107/2009.
( 1 ) OJ L 153, 11.6.2011, p. 1.
( 2 ) OJ L 59, 4.3.2011, p. 26.
It shall apply from 1 August 2011.

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L 196/8
EN
Official Journal of the European Union
28.7.2011
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 July 2011.
For the Commission
The President
José Manuel BARROSO

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28.7.2011 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Bispyribac
2,6-bis(4,6-dimethoxy
≥ 930 g/kg
1 August 2011 31
July
2021 PART
A
CAS No
pyrimidin-2-yloxy)
(referred to as
EN
125401-75-4
benzoic acid
bispyribac-
Only uses as herbicide in rice may be authorised.

CIPAC No
sodium)
748
PART B
For the implementation of the uniform principles, as referred to in Article 29(6) of Regu
lation (EC) No 1107/2009, the conclusions of the review report on bispyribac, 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 protection of
groundwater, when the active substance is applied in regions with vulnerable soil and/or
climatic conditions.
icial
Jour
Conditions of authorisation shall include risk mitigation measures where appropriate.
nal
The Member States concerned shall request the submission of further information as regards
of
the possible groundwater contamination by metabolites M03 (2 ), M04 (3 ) and M10 (4 ).
the
They shall ensure that the applicant provides such information to the Commission by
European
31 July 2013.
(1 ) Further details on identity and specification of active substances are provided in the review report.
Union
(2 ) 2-hydroxy-4,6-dimethoxypyrimidine.
(3 ) 2,4-dihydroxy-6-methoxypyrimidine.
(4 ) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.
L
196/9

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L 196/10
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
‘1 Bispyribac
2,6-bis(4,6-dimethoxypyrimidin-2-
≥ 930 g/kg (referred to as
1 August 2011 31
July
2021 PART
A
yloxy)benzoic acid
bispyribac-sodium)
CAS No
Only uses as herbicide in rice may be authorised.
EN
125401-75-4

PART B
CIPAC No
For the implementation of the uniform principles, as
748
referred to in Article 29(6) of Regulation (EC) No
1107/2009, the conclusions of the review report on
bispyribac, 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
particular attention to the protection of groundwater,
icial
when the active substance is applied in regions with
Jour
vulnerable soil and/or climatic conditions.
nal
Conditions of authorisation shall include risk mitigation
measures where appropriate.
of
the
The Member States concerned shall request the submission
European
of further information as regards the possible groundwater
contamination by metabolites M03
(*), M04
(**) and
M10 (***).
Union
They shall ensure that the applicant provides such
information to the Commission by 31 July 2013.
(*) 2-hydroxy-4,6-dimethoxypyrimidine.
(**) 2,4-dihydroxy-6-methoxypyrimidine.
(***) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.’
28.7.2011

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