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18.4.2013 Official
Journal
of
the
European
Union L
108/9
COMMISSION IMPLEMENTING REGULATION (EU) No 350/2013
of 17 April 2013
approving the active substance bixafen, 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,
Standing Committee on the Food Chain and Animal
Health and the draft assessment report was finalised on
Having regard to the Treaty on the Functioning of the European
15 March 2013 in the format of the Commission review
Union,
report for bixafen.
Having regard to Regulation (EC) No 1107/2009 of the
(5)
It has appeared from the various examinations made that
European Parliament and of the Council of 21 October 2009
plant protection products containing bixafen may be
concerning the placing of plant protection products on the
expected to satisfy, in general, the requirements laid
market and repealing Council Directives 79/117/EEC and
down in Article 5(1)(a) and (b) and Article 5(3) of
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
Directive 91/414/EEC, in particular with regard to the
thereof,
uses which were examined and detailed in the
Commission review report. It is therefore appropriate
Whereas:
to approve bixafen.


(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No (6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
1107/2009 in conjunction with Article 6 thereof and in
with respect to the procedure and the conditions for
the light of current scientific and technical knowledge, it
approval, to active substances for which a decision has
is, however, necessary to include certain conditions and
been adopted in accordance with Article 6(3) of that
restrictions.
Directive before 14 June 2011. For bixafen the
conditions of Article 80(1)(a) of Regulation (EC) No
(7) A
reasonable
period
should
be
allowed
to
elapse
before
1107/2009 are fulfilled by Commission Decision
approval in order to permit Member States and the
2009/700/EC ( 3 ).
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
the United Kingdom received on 8 October 2008 an
application from Bayer CropScience for the inclusion of
(8) Without
prejudice
to
the
obligations
provided
for
in
the active substance bixafen in Annex I to Directive
Regulation (EC) No 1107/2009 as a consequence of
91/414/EEC. Decision 2009/700/EC confirmed that the
approval, taking into account the specific situation
dossier was ‘complete’ in the sense that it could be
created by the transition from Directive 91/414/EEC to
considered as satisfying, in principle, the data and
Regulation (EC) No 1107/2009, the following should,
information requirements of Annexes II and III to
however, apply. Member States should be allowed a
Directive 91/414/EEC.
period of six months after approval to review authori

sations of plant protection products containing bixafen.
Member States should, as appropriate, vary, replace or
(3) For
that
active
substance,
the
effects
on
human
and
withdraw authorisations. By way of derogation from
animal health and the environment have been assessed,
that deadline, a longer period should be provided for
in accordance with the provisions of Article 6(2) and (4)
the submission and assessment of the update of the
of Directive 91/414/EEC, for the uses proposed by the
complete Annex III dossier, as set out in Directive
applicant. The designated rapporteur Member State
91/414/EEC, of each plant protection product for each
submitted a draft assessment report on 19 July 2011.
intended use in accordance with the uniform principles.
(4) The
draft
assessment
report
was
reviewed
by
the
Member (9) The
experience
gained
from
inclusions
in
Annex
I
to
States and the European Food Safety Authority (here
Directive 91/414/EEC of active substances assessed in
inafter ‘the Authority’). The Authority presented to the
the framework of Commission Regulation (EEC) No
Commission its conclusion on the review of the pesticide
3600/92 of 11 December 1992 laying down the
risk assessment of the active substance bixafen ( 4 ) on
detailed rules for the implementation of the first stage
15 October 2012. The draft assessment report and the
of the programme of work referred to in Article 8(2) of
conclusion of the Authority were reviewed by the
Council Directive 91/414/EEC concerning the placing of
Member States and the Commission within the
plant protection products on the market ( 5 ) has shown
that difficulties can arise in interpreting the duties of
( 1 ) OJ L 309, 24.11.2009, p. 1.
holders of existing authorisations in relation to access
( 2 ) OJ L 230, 19.8.1991, p. 1.
to data. In order to avoid further difficulties it therefore
( 3 ) OJ L 240, 11.9.2009, p. 32.
( 4 ) EFSA Journal (2012); 10(11):2917. Available online: www.efsa.
europa.eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 108/10
EN
Official Journal of the European Union
18.4.2013
appears necessary to clarify the duties of the Member
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
States, especially the duty to verify that the holder of
orised plant protection product containing bixafen as either the
an authorisation demonstrates access to a dossier
only active substance or as one of several active substances, all
satisfying the requirements of Annex II to that Directive.
of which were listed in the Annex to Implementing Regulation
However, this clarification does not impose any new
(EU) No 540/2011 by 30 September 2013 at the latest,
obligations on Member States or holders of authori
Member States shall re-evaluate the product in accordance
sations compared to the Directives which have been
with the uniform principles, as referred to in Article 29(6) of
adopted until now amending Annex I to that Directive
Regulation (EC) No 1107/2009, on the basis of a dossier
or the Regulations approving active substances.
satisfying the requirements of Annex III to Directive
91/414/EEC and taking into account the column on specific
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
provisions of Annex I to this Regulation. On the basis of that
1107/2009, the Annex to Commission Implementing
evaluation, they shall determine whether the product satisfies
Regulation (EU) No 540/2011 of 25 May 2011 imple
the conditions set out in Article 29(1) of Regulation (EC) No
menting Regulation (EC) No 1107/2009 of the European
1107/2009.
Parliament and of the Council as regards the list of
approved active substances
( 1 ) should be amended
Following that determination Member States shall:
accordingly.
(11) The
measures
provided
for
in
this
Regulation
are
in
(a) in the case of a product containing bixafen as the only
accordance with the opinion of the Standing
active substance, where necessary, amend or withdraw the
Committee on the Food Chain and Animal Health,
authorisation by 31 March 2015 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing bixafen as one of several
active substances, where necessary, amend or withdraw the
Article 1
authorisation by 31 March 2015 or by the date fixed for
such an amendment or withdrawal in the respective act or
Approval of active substance
acts which added the relevant substance or substances to
Annex I to Directive 91/414/EEC or approved that
The active substance bixafen, as specified in Annex I, is
substance or substances, whichever is the latest.
approved subject to the conditions laid down in that Annex.
Article 2
Article 3
Re-evaluation of plant protection products
Amendments to Implementing Regulation (EU) No
540/2011
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
The Annex to Implementing Regulation (EU) No 540/2011 is
authorisations for plant protection products containing bixafen
amended in accordance with Annex II to this Regulation.
as an active substance by 31 March 2014.
Article 4
By that date they shall in particular verify that the conditions in
Annex I to this Regulation are met, with the exception of those
Entry into force and date of application
identified in the column on specific provisions of that Annex,
This Regulation shall enter into force on the twentieth day
and that the holder of the authorisation has, or has access to, a
following that of its publication in the Official Journal of the
dossier satisfying the requirements of Annex II to Directive
European Union.
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
1107/2009.
It shall apply from 1 October 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 April 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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18.4.2013 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Bixafen
N-(3′,4′-dichloro-5-fluor
≥ 950 g/kg 1
October
2013 30
September
2023
For the implementation of the uniform principles as referred
obiphenyl-2-yl)-3-(difluor
to in Article 29(6) of Regulation (EC) No 1107/2009, the
EN
CAS No 581809-46-3
omethyl)-1-methylpyrazole-
conclusions of the review report on bixafen, and in particular

CIPAC No 819
4-carboxamide
Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on
15 March 2013 shall be taken into account.
In this overall assessment Member States shall pay particular
attention to:
(a) the residues of bixafen and of its metabolites in rotational
crops;
(b) the protection of groundwater, when the substance is
applied in regions with vulnerable soil and/or climatic
icial
conditions;
(c) the risk to aquatic organisms;
Jour
(d) the risk to soil and sediment-dwelling organisms.
nal
Conditions of use shall include risk mitigation measures,
of
where appropriate.
the

European
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
L
108/11

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L 108/12
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
(*) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘43 Bixafen
N-(3′,4′-dichloro-5-
≥ 950 g/kg 1
October
2013 30
September
2023
For the implementation of the uniform principles as

CAS No 581809-46-3
fluorobiphenyl-2-yl)-3-
referred to in Article 29(6) of Regulation (EC) No
(difluoromethyl)-1-
1107/2009, the conclusions of the review report on
CIPAC No 819
methylpyrazole-4-carbo
bixafen, and in particular Appendices I and II thereof,
xamide
as finalised in the Standing Committee on the Food
Chain and Animal Health on 15 March 2013 shall be
taken into account.
In this overall assessment Member States shall pay
particular attention to:
(a) the residues of bixafen and of its metabolites in
Off
rotational crops;
icial
(b) the protection of groundwater, when the substance is
Jour
applied in regions with vulnerable soil and/or
climatic conditions;
nal
(c) the risk to aquatic organisms;
of
the
(d) the risk to soil and sediment-dwelling organisms.
European
Conditions of use shall include risk mitigation measures,
where appropriate.’
(*) Further details on identity and specification of active substance are provided in the review report.
Union
18.4.2013

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Document Outline

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