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3.7.2012 Official
Journal
of
the
European
Union L
173/3
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 582/2012
of 2 July 2012
approving the active substance bifenthrin, 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,
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of Regu
lation (EC) No 33/2008.
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
application
was
submitted
to
France,
which
had
been
Having regard to Regulation (EC) No 1107/2009 of the
designated rapporteur Member State by Regulation (EC)
European Parliament and of the Council of 21 October 2009
No 1490/2002. The time period for the accelerated
concerning the placing of plant protection products on the
procedure was respected. The specification of the active
market and repealing Council Directives 79/117/EEC and
substance and the supported uses are the same as were
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
the subject of Decision 2009/887/EC. That application
thereof,
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
(EC) No 33/2008.
Whereas:
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No (5) France evaluated the additional data submitted by the
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
applicant and prepared an additional report. It
to active substances for which completeness has been
communicated that report to the European Food Safety
established in accordance with Article 16 of Commission
Authority (hereinafter ‘the Authority’) and to the
Regulation (EC) No 33/2008 of 17 January 2008 laying
Commission on 6 August 2010. The Authority
down detailed rules for the application of Council
communicated the additional report to the other
Directive 91/414/EEC as regards a regular and an accel
Member States and the applicant for comments and
erated procedure for the assessment of active substances
forwarded the comments it had received to the
which were part of the programme of work referred to in
Commission. In accordance with Article 20(1) of Regu
Article 8(2) of that Directive but have not been included
lation (EC) No 33/2008 and at the request of the
into its Annex I ( 3 ), with respect to the procedure and the
Commission, the Authority presented its conclusion on
conditions for approval. Bifenthrin is an active substance
bifenthrin to the Commission on 11 May 2011 ( 7 ). The
for which completeness has been established in
draft assessment report, the additional report and the
accordance with that Regulation.
conclusion of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
Health and finalised on 1 June 2012 in the format of
No 1490/2002 ( 5 ) lay down the detailed rules for the
the Commission review report for bifenthrin.
implementation of the second and third stages of the
programme of work referred to in Article 8(2) of
Directive 91/414/EEC and establish a list of active
(6) The
additional
report
by
the
rapporteur
Member
State
substances to be assessed, with a view to their possible
and the new conclusion by the Authority concentrate
inclusion in Annex I to Directive 91/414/EEC. That list
on the concerns that led to the non-inclusion. Those
included bifenthrin. By Commission Decision
concerns were in particular the potential contamination
2009/887/EC ( 6 ) it was decided not to include bifenthrin
of groundwater by a major soil degradation product
in Annex I to Directive 91/414/EEC.
(TFP acid), a possible underestimation of the risk to
consumers, due to the limited number of residue data
(3) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
made available and the lack of investigation on the
original notifier (hereinafter ‘the applicant’) submitted a
metabolism pattern of the two isomers constituting
bifenthrin. As regards ecotoxicology, the risk for
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 7 ) European Food Safety Authority; ‘Conclusion on the peer review of
( 3 ) OJ L 15, 18.1.2008, p. 5.
the pesticide risk assessment of the active substance bifenthrin’.
( 4 ) OJ L 55, 29.2.2000, p. 25.
EFSA Journal 2011;9(5):2159. 0;8(11): [101 pp.] doi:10.2903/
( 5 ) OJ L 224, 21.8.2002, p. 23.
j.efsa.2011.2159. Available online: www.efsa.europa.eu/efsajournal.
( 6 ) OJ L 318, 4.12.2009, p. 41.
htm

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L 173/4
EN
Official Journal of the European Union
3.7.2012
mammals, aquatic organisms, earthworms, non-target
(12) Without prejudice
to the conclusion that bifenthrin
arthropods, non-target plants and non-target soil
should be approved, it is, in particular, appropriate to
macro-organisms had not been sufficiently addressed.
require further confirmatory information.
(7) The
new
information
submitted
by
the
applicant
shows
that the potential contamination of groundwater by
(13) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
bifenthrin and its metabolites, including TFP acid, is
1107/2009 the Annex to Commission Implementing
low. Adequate residue data and information as regards
Regulation (EU) No 540/2011 of 25 May 2011 imple
the metabolisation of the isomers have been submitted
menting Regulation (EC) No 1107/2009 of the European
and confirm an acceptable risk for consumers. As regards
Parliament and of the Council as regards the list of
ecotoxicology, the refined risk assessment for mammals,
approved active substances
( 1 ) should be amended
aquatic organisms, earthworms, non-target arthropods,
accordingly.
non-target macro-organisms and non-target plants
permitted to identify acceptable risk scenarios for the
(14) The
measures
provided
for
in
this
Regulation
are
in
concerned species.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(8) Consequently,
the
additional
information
provided
by
the
applicant permits to eliminate the specific concerns that
led to the non-inclusion. No other open scientific
HAS ADOPTED THIS REGULATION:
questions have arisen.
Article 1
(9)
It has appeared from the various examinations made that
plant protection products containing bifenthrin may be
Approval of active substance
expected to satisfy, in general, the requirements laid
The active substance bifenthrin, as specified in Annex I, is
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
approved subject to the conditions laid down in that Annex.
in particular as regards the uses which were examined
and detailed in the Commission review report. It is
therefore appropriate to approve bifenthrin in accordance
Article 2
with Regulation (EC) No 1107/2009.
Amendments to Implementing Regulation (EU) No
(10) The
acceptable
risk
scenarios
as
regards
ecotoxicology
540/2011
notwithstanding, the risk assessment revealed that
The Annex to Implementing Regulation (EU) No 540/2011 is
bifenthrin has a potential to show bioaccumulation
amended in accordance with Annex II to this Regulation.
effects. The approval period should therefore be seven
years rather than the possible maximum of 10 years.
Article 3
(11) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
Entry into force and date of application
1107/2009 in conjunction with Article 6 thereof and in
the light of current scientific and technical knowledge, it
This Regulation shall enter into force on the twentieth day
is, however, necessary to include certain conditions and
following that of its publication in the Official Journal of the
restrictions.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 July 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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3.7.2012 Off
ANNEX I
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
Bifenthrin
2-methylbiphenyl-3-
≥ 930 g/kg
1 August 2012 31
July
2019 PART
A
ylmethyl (1RS,3RS)-3-
EN
CAS No 82657-04-3 [(Z)-2-chloro-3,3,3-
Impurities:
Only uses as insecticide may be authorised.

CIPAC No 415
trifluoroprop-1-enyl]-
2,2-dimethylcyclopro
Toluene: not more than 5 g/kg
PART B
panecarboxylate
For the implementation of the uniform principles as referred to in Article 29(6) of
or
Regulation (EC) No 1107/2009, the conclusions of the review report on bifenthrin, and
in particular Appendices I and II thereof, as finalised in the Standing Committee on the
2-methylbiphenyl-3-
Food Chain and Animal Health on 1 June 2012 shall be taken into account.
ylmethyl (1RS)-cis-3-
[(Z)-2-chloro-3,3,3-
In this overall assessment Member States shall pay particular attention to:
trifluoroprop-1-enyl]-
2,2-dimethylcyclopro
(a) the persistency in the environment;
panecarboxylate
icial
(b) the risk for bioaccumulation and biomagnification;
Jour
(c) the protection of operators and workers, ensuring that conditions of use include
the application of adequate personal protective equipment, where appropriate;
nal
(d) the risk to aquatic organisms, in particular fish and invertebrates, non-target arth
of
ropods and bees, ensuring that conditions of authorisation include risk mitigation
the
measures, where appropriate.
European
The applicant shall submit confirmatory information as regards:
(1) the residual toxicity for non-target arthropods and the potential for recolonisation;
Union
(2) the fate and behaviour of soil metabolite 4'-OH bifenthrin;
(3) the degradation in soil of the isomers which constitute bifenthrin, 4'-OH bifenthrin
and TFP acid.
The applicant shall submit to the Commission, the Member States and the Authority
the information set out in points 1, 2 and 3 by 31 July 2014.
The applicant shall present to the Commission, the Member States and the Authority a
monitoring programme to assess the potential for bioaccumulation and biomagnifi
cation in the aquatic and terrestrial environment by 31 July 2013. The results of that
monitoring programme shall be submitted as a monitoring report to the rapporteur
Member State, the Commission and the Authority by 31 July 2015.
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
173/5

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L 173/6
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) 540/2011, the following entry is added:
No
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘23 Bifenthrin
2-methylbiphenyl-3-ylmethyl (1RS,3RS)-
≥ 930 g/kg
1 August 2012 31
July
2019 PART
A

3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-
CAS No
2,2-dimethylcyclopropanecarboxylate
Impurities:
Only uses as insecticide may be authorised.
82657-04-3
or
Toluene: not more than
PART B
5 g/kg
CIPAC No 415
2-methylbiphenyl-3-ylmethyl (1RS)-cis-
For the implementation of the uniform principles as
3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-
referred to in Article 29(6) of Regulation (EC)
2,2-dimethylcyclopropanecarboxylate
No 1107/2009, the conclusions of the review report
on bifenthrin, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on
Off
the Food Chain and Animal Health on 1 June 2012
icial
shall be taken into account.
Jour
In this overall assessment Member States shall pay
nal
particular attention to:
of
(a) the persistency in the environment;
the
European
(b) the risk for bioaccumulation and biomagnification;
(c) the protection of operators and workers, ensuring
that conditions of use include the application of
Union
adequate personal protective equipment, where
appropriate;
(d) the risk to aquatic organisms, in particular fish and
invertebrates, non-target arthropods and bees,
ensuring that conditions of authorisation include
risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as
regards:
(1) the residual toxicity for non-target arthropods and
the potential for recolonisation;
(2) the fate and behaviour of soil metabolite 4'-OH
bifenthrin;
3.7.2012
(3) the degradation in soil of the isomers which
constitute bifenthrin, 4'-OH bifenthrin and TFP
acid.

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3.7.2012 Off
No
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
The applicant shall submit to the Commission, the
Member States and the Authority the information set
out in points 1, 2 and 3 by 31 July 2014.
The applicant shall present to the Commission, the
EN
Member States and the Authority a monitoring

programme to assess the potential for bioaccumulation
and biomagnification in the aquatic and terrestrial
environment by 31 July 2013. The results of that
monitoring programme shall be submitted as a moni
toring report to the rapporteur Member State, the
Commission and the Authority by 31 July 2015.’
(*) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
173/7

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