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1.10.2011 Official
Journal
of
the
European
Union L
255/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 974/2011
of 29 September 2011
approving the active substance acrinathrin, 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
and Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
substances to be assessed, with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. That list
included acrinathrin.
Having regard to the Treaty on the Functioning of the European
Union,
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
lation (EC) No 1095/2007 of 20 September 2007
Having regard to Regulation (EC) No 1107/2009 of the
amending Regulation (EC) No 1490/2002 laying down
European Parliament and of the Council of 21 October 2009
further detailed rules for the implementation of the third
concerning the placing of plant protection products on the
stage of the programme of work referred to in
market and repealing Council Directives 79/117/EEC and
Article 8(2) of Council Directive 91/414/EEC and Regu
91/414/EEC ( 1 ), and in particular Article 13(2) and
lation (EC) No 2229/2004 laying down further detailed
Article 78(2) thereof,
rules for the implementation of the fourth stage of the
programme of work referred to in Article 8(2) of Council
Directive 91/414/EEC
( 6 ) the notifier withdrew its
Whereas:
support of the inclusion of that active substance in
Annex I to Directive 91/414/EEC within 2 months
from entry into force of that Regulation. Consequently,
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
Commission Decision 2008/934/EC of 5 December
1107/2009, Directive 91/414/EEC ( 2 ) is to apply to
2008 concerning the non-inclusion of certain active
active substances for which completeness has been estab
substances in Annex I to Council Directive 91/414/EEC
lished in accordance with Article 16 of Commission
and the withdrawal of authorisations for plant protection
Regulation (EC) No 33/2008 of 17 January 2008
products containing these substances ( 7 ) was adopted on
laying down detailed rules for the application of
the non-inclusion of acrinathrin.
Council Directive 91/414/EEC as regards a regular and
an accelerated procedure for the assessment of active
substances which were part of the programme of work
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
referred to in Article 8(2) of that Directive but have not
original notifier (hereinafter ‘the applicant’) submitted a
been included into its Annex I (
new application requesting the accelerated procedure to

3 ), with respect to the
procedure and the conditions for approval. Acrinathrin is
be applied, as provided for in Articles 14 to 19 of Regu
an active substance for which completeness has been
lation (EC) No 33/2008.
established in accordance with that Regulation.
(5) The
application
was
submitted
to
France,
which
had
been
designated rapporteur Member State by Regulation (EC)
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and
1490/2002 (
No 1490/2002. The time period for the accelerated

5 ) lay down the detailed rules for the imple
mentation of the second and third stages of the
procedure was respected. The specification of the active
programme of work referred to in Article 8(2) of
substance and the supported uses are the same as were
Directive 91/414/EEC and establish a list of active
the subject of Decision 2008/934/EC. That application
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
( 1 ) OJ L 309, 24.11.2009, p. 1.
(EC) No 33/2008.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 3 ) OJ L 15, 18.1.2008, p. 5.
( 4 ) OJ L 55, 29.2.2000, p. 25.
( 6 ) OJ L 246, 21.9.2007, p. 19.
( 5 ) OJ L 224, 21.8.2002, p. 23.
( 7 ) OJ L 333, 11.12.2008, p. 11.

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L 255/2
EN
Official Journal of the European Union
1.10.2011
(6) France
evaluated
the
additional
data
submitted
by
the
out in Directive 91/414/EEC, of each plant protection
applicant and prepared an additional report. It
product for each intended use in accordance with the
communicated that report to the European Food Safety
uniform principles.
Authority (hereinafter ‘the Authority’) and to the
Commission on 14 January 2010. The Authority
communicated the additional report to the other
(12) The
experience
gained
from
previous
inclusions
in
Annex
Member States and the applicant for comments and
I to Directive 91/414/EEC of active substances assessed
forwarded the comments it had received to the
in the framework of Commission Regulation (EEC) No
Commission. In accordance with Article 20(1) of Regu
3600/92 of 11 December 1992 laying down the detailed
lation (EC) No 33/2008 and at the request of the
rules for the implementation of the first stage of the
Commission, the Authority presented its conclusion on
programme of work referred to in Article 8(2) of
acrinathrin to the Commission on 21 October 2010 (
Council Directive 91/414/EEC concerning the placing

1 ).
The draft assessment report, the additional report and the
of plant protection products on the market ( 2 ) has
conclusion of the Authority were reviewed by the
shown that difficulties can arise in interpreting the
Member States and the Commission within the
duties of holders of existing authorisations in relation
Standing Committee on the Food Chain and Animal
to access to data. In order to avoid further difficulties
Health and finalised on 17 June 2011 in the format of
it therefore appears necessary to clarify the duties of
the Commission review report for acrinathrin.
the Member 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
(7)
It has appeared from the various examinations made that
new obligations on Member States or holders of auth
plant protection products containing acrinathrin may be
orisations compared to the directives which have been
expected to satisfy, in general, the requirements laid
adopted until now amending Annex I.
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,

in particular as regards the uses which were examined
and detailed in the Commission review report. It is
(13) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
therefore appropriate to approve acrinathrin in
1107/2009, the Annex to Commission Implementing
accordance with Regulation (EC) No 1107/2009.
Regulation (EU) No 540/2011 of 25 May 2011 imple
menting Regulation (EC) No 1107/2009 of the European
Parliament and of the Council as regards the list of
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
approved active substances
( 3 ) should be amended
1107/2009 in conjunction with Article 6 thereof and in
accordingly.
the light of current scientific and technical knowledge, it
is, however, necessary to include certain conditions and
restrictions.
(14) Decision
2008/934/EC
provides
for
the
non-inclusion
of

acrinathrin and the withdrawal of authorisations for
plants protection products containing that substance by
31 December 2011. It is necessary to delete the line
(9) Without
prejudice
to
the
conclusion
that
acrinathrin
concerning acrinathrin in the Annex to that Decision.
should be approved, it is, in particular, appropriate to
It is therefore appropriate to amend Decision
require further confirmatory information.
2008/934/EC accordingly.
(10) A
reasonable
period
should
be
allowed
to
elapse
before
(15) The
measures
provided
for
in
this
Regulation
are
in
approval in order to permit Member States and the
accordance with the opinion of the Standing
interested parties to prepare themselves to meet the
Committee on the Food Chain and Animal Health,
new requirements resulting from the approval.
HAS ADOPTED THIS REGULATION:
(11) Without
prejudice
to
the
obligations
defined
by
Regu
lation (EC) No 1107/2009 as a consequence of the
Article 1
approval, taking into account the specific situation
Approval of active substance
created by the transition from Directive 91/414/EEC to
Regulation (EC) No 1107/2009 the following should,
The active substance acrinathrin, as specified in Annex I, is
however, apply. Member States should be allowed a
approved subject to the conditions laid down in that Annex.
period of 6 months after approval to review authori
sations of plant protection products containing acri
nathrin. Member States should, as appropriate, vary,
Article 2
replace or withdraw existing authorisations. By way of
Re-evaluation of plant protection products
derogation from the above deadline, a longer period
should be provided for the submission and assessment
1. Member
States
shall
in
accordance
with
Regulation
(EC)
of the update of the complete Annex III dossier, as set
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing acri
nathrin as an active substance by 30 June 2012.
( 1 ) European Food Safety Authority; Conclusion on the peer review of
the pesticide risk assessment of the active substance acrinathrin.
EFSA Journal 2010;8(12):1872 [72 pp.] doi:10.2903/j.efsa.
( 2 ) OJ L 366, 15.12.1992, p. 10.
2010.1872. Available online: www.efsa.europa.eu/efsajournal.htm
( 3 ) OJ L 153, 11.6.2011, p. 1.

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EN
1.10.2011 Official
Journal
of
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By that date they shall in particular verify that the conditions in
withdraw the authorisation by 31 December 2015 or by the
Annex I to this Regulation are met, with the exception of those
date fixed for such an amendment or withdrawal in the
identified in Part B of the column on specific provisions of that
respective act or acts which added the relevant substance
Annex, and that the holder of the authorisation has, or has
or substances to Annex I to Directive 91/414/EEC or
access to, a dossier satisfying the requirements of Annex II to
approved that substance or substances, whichever is the
Directive 91/414/EEC in accordance with the conditions of
latest.
Article 13(1) to (4) of that Directive and Article 62 of Regu
lation (EC) No 1107/2009.
Article 3
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
Amendments to Implementing Regulation (EU) No
orised plant protection product containing acrinathrin as either
540/2011
the only active substance or as one of several active substances
all of which were listed in the Annex to Implementing Regu
The Annex to Implementing Regulation (EU) No 540/2011 is
lation (EU) No 540/2011 by 31 December 2011 at the latest,
amended in accordance with Annex II to this Regulation.
Member States shall re-evaluate the product in accordance with
the uniform principles, as referred to in Article 29(6) of Regu
lation (EC) No 1107/2009, on the basis of a dossier satisfying
Article 4
the requirements of Annex III to Directive 91/414/EEC and
Amendments to Decision 2008/934/EC
taking into account Part B of the column on specific provisions
of Annex I to this Regulation. On the basis of that evaluation,
The line concerning acrinathrin in the Annex to Decision
they shall determine whether the product satisfies the conditions
2008/934/EC is deleted.
set out in Article 29(1) of Regulation (EC) No 1107/2009.
Following that determination Member States shall:
Article 5
(a) in the case of a product containing acrinathrin as the only
Entry into force and date of application
active substance, where necessary, amend or withdraw the
authorisation by 31 December 2015 at the latest; or
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
(b) in the case of a product containing acrinathrin as one of
several active substances, where necessary, amend or
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, 29 September 2011.
For the Commission
The President
José Manuel BARROSO

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L 255/4
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Acrinathrin
(S)-α-cyano-3-phenoxybenzyl
≥ 970 g/kg
1 January 2012 31
December
2021 PART
A
(Z)-(1R,3S)-2,2-dimethyl-3-[2-
EN
CAS No
(2,2,2-trifluoro-1-trifluor
Impurities:
Only uses as insecticide and acaricide may be authorised at rates

101007-06-1
omethylethoxy
not exceeding 22,5 g/ha per application.
1,3-dicyclohexylurea: not
CIPAC No 678
carbonyl)vinyl]cyclopropanecar more than 2 g/kg
PART B
boxylate or
For the implementation of the uniform principles as referred to in
(S)-α-cyano-3-phenoxybenzyl
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions
(Z)-(1R)-cis-2,2-dimethyl-3-[2-
of the review report on acrinathrin, and in particular Appendices I
(2,2,2-trifluoro-1-trifluor
and II thereof, as finalised in the Standing Committee on the Food
omethylethoxy
Chain and Animal Health on 15 July 2011 shall be taken into
carbonyl)vinyl]cyclopropanecar
account.
boxylate
Off
In this overall assessment Member States:
icial
(a) shall pay particular attention to the protection of operators
and workers and shall ensure that conditions of use include
Jour
the application of adequate personal protective equipment,
nal
where appropriate;
of
(b) shall pay particular attention to the risk to aquatic organisms,
the
in particular fish, and shall ensure that conditions of auth
European
orisation include risk mitigation measures, where appropriate;
(c) shall pay particular attention to the risk to non-target
arthropods and bees and shall ensure that conditions of auth
orisation include risk mitigation measures.
Union
The applicant shall submit confirmatory information as regards:
(1) the potential risk to groundwater from the metabolite
3-PBAld (*);
(2) the chronic risk to fish;
(3) the risk assessment for non-target arthropods;
(4) the possible impact on the worker, the consumer and the
environmental risk assessment of the potential stereo-
selective degradation of each isomer in plant, animals and
the environment.
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 December 2013 and the information set out in points 4 2
years after the adoption of specific guidance.
1.10.2011
(*) 3-phenoxybenzaldehyde.
(1 ) Further details on identity and specification of active substance are provided in the review report.

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1.10.2011 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011 the following entry is added:
No
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
EN
‘19 Acrinathrin
(S)-α-cyano-3-phen
≥ 970 g/kg
1 January 2012 31
December
2021 PART
A

oxybenzyl (Z)-(1R,3S)-
CAS No
2,2-dimethyl-3-[2-
Impurities:
Only uses as insecticide and acaricide may be authorised at rates not exceeding
101007-06-1
(2,2,2-trifluoro-1-
1,3-dicyclohexylurea:
22,5 g/ha per application.
CIPAC No 678
trifluoromethylethoxy not more than 2 g/kg
carbonyl)vinyl]cyclo
PART B
propanecarboxylate or
For the implementation of the uniform principles as referred to in Article 29(6) of
(S)-α-cyano-3-phen
Regulation (EC) No 1107/2009, the conclusions of the review report on acrinathrin,
oxybenzyl (Z)-(1R)-cis-
and in particular Appendices I and II thereof, as finalised in the Standing Committee
2,2-dimethyl-3-[2-
on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.
(2,2,2-trifluoro-1-
trifluoromethylethoxy
In this overall assessment Member States:
icial
carbonyl)vinyl]cyclo
(a) shall pay particular attention to the protection of operators and workers and
propanecarboxylate
Jour
shall ensure that conditions of use include the application of adequate personal
protective equipment, where appropriate;
nal
(b) shall pay particular attention to the risk to aquatic organisms, in particular fish,
of
and shall ensure that conditions of authorisation include risk mitigation
the
measures, where appropriate;
European
(c) shall pay particular attention to the risk to non-target arthropods and bees and
shall ensure that conditions of authorisation include risk mitigation measures.
The applicant shall submit confirmatory information as regards:
Union
(1) the potential risk to groundwater from the metabolite 3-PBAld (*);
(2) the chronic risk to fish;
(3) the risk assessment for non-target arthropods;
(4) the possible impact on the worker, the consumer and the environmental risk
assessment of the potential stereo-selective degradation of each isomer in plant,
animals and the environment.
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 December 2013 and the
information set out in point 4 2 years after the adoption of specific guidance.
(*) 3-phenoxybenzaldehyde.’
L
255/5

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