HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 299/34
EN
Official Journal of the European Union
9.11.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1124/2013
of 8 November 2013
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substance bifenox
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) In
the
light
of
that
information
the
Commission
considered that there are indications that bifenox no
longer satisfies the approval criteria provided for in
Having regard to the Treaty on the Functioning of the European
Article 4 of Regulation (EC) No 1107/2009.
Union,
Having regard to Regulation (EC) No 1107/2009 of the
(6) The
Commission
invited
the
notifier
to
submit
its
European Parliament and of the Council of 21 October 2009
comments.
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 the first alternative of
(7) The
Commission
has
come
to
the
conclusion
that,
given
Article 21(3) and Article 78(2) thereof,
the fact that under certain environmental conditions the
use of bifenox has the potential to form nitrofen a risk
for the environment cannot be excluded except by
Whereas:
imposing further restrictions.
(1) Commission
Directive
2008/66/EC
( 2 ) included bifenox
as active substance in Annex I to Council Directive
(8)
It is confirmed that the active substance bifenox is to be
91/414/EEC ( 3 ).
deemed to have been approved under Regulation (EC) No
1107/2009. When assessing applications for authori
sation of plant protection products, Member States
(2) Active
substances
included
in
Annex
I
to
Directive
should pay particular attention to the potential of
91/414/EEC are deemed to have been approved under
bifenox to form nitrofen and impose restrictions as
Regulation (EC) No 1107/2009 and are listed in Part A
regards the conditions of use, where appropriate.
of the Annex to Commission Implementing Regulation
(EU) No 540/2011 ( 4 ).
(9) The
Annex
to
Implementing
Regulation
(EU)
No
(3) In
accordance
with
the
first
subparagraph
of
Article
21(1)
540/2011 should therefore be amended accordingly.
of Regulation (EC) No 1107/2009 Belgium submitted a
request to the Commission to review the approval of
bifenox in the light of new scientific and technical
(10) The
measures
provided
for
in
this
Regulation
are
in
knowledge resulting from information submitted to
accordance with the opinion of the Standing
that Member State by the notifier pursuant to
Committee on the Food Chain and Animal Health,
Article 56(1) of that Regulation. That information
concerned formation of nitrofen resulting from the appli
cation of bifenox.
HAS ADOPTED THIS REGULATION:
(4) Belgium
assessed
the
information
submitted
by
the
notifier. It submitted its assessment, in the form of an
addendum to the draft assessment report, to the other
Article 1
Member States, the Commission and the European Food
Amendment to Implementing Regulation (EU)
Safety Authority, hereinafter ‘the Authority’, on 21 March
No 540/2011
2013.
Part A of the Annex to Implementing Regulation (EU) No
540/2011 is amended in accordance with the Annex to this
( 1 ) OJ L 309, 24.11.2009, p. 1.
Regulation.
( 2 ) Commission Directive 2008/66/EC of 30 June 2008 amending
Council Directive 91/414/EEC to include bifenox, diflufenican,
fenoxaprop-P, fenpropidin and quinoclamine as active substances
(OJ L 171, 1.7.2008, p. 9).
( 3 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
Article 2
placing of plant protection products on the market (OJ L 230,
19.8.1991, p. 1).
Entry into force
( 4 ) Commission Implementing Regulation (EU) No 540/2011 of
This Regulation shall enter into force on the twentieth day
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
following that of its publication in the Official Journal of the
approved active substances (OJ L 153, 11.6.2011, p. 1).
European Union.

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EN
9.11.2013 Official
Journal
of
the
European
Union L
299/35
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 November 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX
The column ‘Specific provisions’ of row 180, bifenox, of Part A of the Annex to Implementing Regulation (EU) No
540/2011 is replaced by the following:
‘PART A
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 bifenox, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
(a) the operator safety and ensure that conditions of use prescribe the application of adequate personal protective
equipment where appropriate;
(b) the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational
crops;
(c) the environmental conditions leading to the potential formation of nitrofen.
Member States shall impose restrictions as regards the conditions of use, where appropriate in view of point (c).’

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Document Outline

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