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3.3.2011 Official
Journal
of
the
European
Union L
58/45
COMMISSION DIRECTIVE 2011/20/EU
of 2 March 2011
amending Council Directive 91/414/EEC to include fenoxycarb as active substance and amending
Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
of active substances which were part of the programme
of work referred to in Article 8(2) of that Directive but
have not been included into its Annex I ( 5 ).
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
application
was
submitted
to
the
Netherlands,
which
had been designated rapporteur Member State by Regu
lation (EC) No 451/2000. The time period for the accel
Having regard to Council Directive 91/414/EEC of 15 July
erated procedure was respected. The specification of the
1991 concerning the placing of plant protection products on
active substance and the supported uses are the same as
the market ( 1 ), and in particular Article 6(1) thereof,
were the subject of Decision 2008/934/EC. That appli
cation also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation (EC)
No 33/2008.
Whereas:
(5) The
Netherlands
evaluated
the
additional
data
submitted
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
by the applicant and prepared an additional report. It
No 1490/2002 ( 3 ) lay down the detailed rules for the
communicated that report to the European Food Safety
implementation of the third stage of the programme of
Authority (hereinafter ‘the Authority’) and to the
work referred to in Article 8(2) of Directive 91/414/EEC
Commission on 10 December 2009. The Authority
and establish a list of active substances to be assessed,
communicated the additional report to the other
with a view to their possible inclusion in Annex I to
Member States and the applicant for comments and
Directive 91/414/EEC. That list included fenoxycarb.
forwarded the comments it had received to the
Commission. In accordance with Article 20(1) of Regu
lation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
fenoxycarb to the Commission on 13 September
1490/2002 the notifier withdrew its support of the
2010 ( 6 ). The draft assessment report, the additional
inclusion of that active substance in Annex I to
report and the conclusion of the Authority were
Directive 91/414/EEC within 2 months from receipt of
reviewed by the Member States and the Commission
the draft assessment report. Consequently, Commission
within the Standing Committee on the Food Chain and
Decision 2008/934/EC of 5 December 2008 concerning
Animal Health and finalised on 28 January 2011 in the
the non-inclusion of certain active substances in Annex I
format of the Commission review report for fenoxycarb.
to Council Directive 91/414/EEC and the withdrawal of
authorisations for plant protection products containing
these substances ( 4 ) was adopted on the non-inclusion
of fenoxycarb.
(6)
It has appeared from the various examinations made that
plant protection products containing fenoxycarb may be
expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
in particular with regard to the uses which have been
original notifier (hereinafter ‘the applicant’) submitted a
examined and detailed in the Commission review report.
new application requesting the accelerated procedure to
It is therefore appropriate to include fenoxycarb in
be applied, as provided for in Articles 14 to 19 of
Annex I, in order to ensure that in all Member States
Commission Regulation (EC) No 33/2008 of
the authorisations of plant protection products
17 January 2008 laying down detailed rules for the
containing this active substance can be granted in
application of Council Directive 91/414/EEC as regards
accordance with the provisions of that Directive.
a regular and an accelerated procedure for the assessment
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review
( 2 ) OJ L 55, 29.2.2000, p. 25.
of the pesticide risk assessment of the active substance
( 3 ) OJ L 224, 21.8.2002, p. 23.
fenoxycarb. EFSA Journal 2010; 8(12):1779. [75 pp.].
( 4 ) OJ L 333, 11.12.2008, p. 11.
doi:10.2903/j.efsa.2010.1779. Available online: www.efsa.europa.eu

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L 58/46
EN
Official Journal of the European Union
3.3.2011
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to (12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
obtain further information on certain specific points.
fenoxycarb and the withdrawal of authorisations for
Article 6(1) of Directive 91/414/EEC provides that
plant protection products containing that substance by
inclusion of a substance in Annex I may be subject to
31 December 2011. It is necessary to delete the line
conditions. Therefore, it is appropriate to require that the
concerning fenoxycarb in the Annex to that Decision.
applicant submit information confirming the risk
assessment for non-target arthropods and for bee brood.
(13) It is therefore appropriate to amend Decision
2008/934/EC accordingly.
(8) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I in order to
(14) The
measures provided for in this Directive are in
permit Member States and the interested parties to
accordance with the opinion of the Standing
prepare themselves to meet the new requirements
Committee on the Food Chain and Animal Health,
which will result from the inclusion.
HAS ADOPTED THIS DIRECTIVE:
(9) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
Article 1
substance in Annex I, Member States should be
Annex I to Directive 91/414/EEC is amended as set out in the
allowed a period of 6 months after inclusion to review
Annex to this Directive.
existing authorisations of plant protection products
containing fenoxycarb to ensure that the requirements
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
Article 2
are satisfied. Member States should vary, replace or
The line concerning fenoxycarb in the Annex to Decision
withdraw, as appropriate, existing authorisations, in
2008/934/EC is deleted.
accordance with the provisions of Directive 91/414/EEC.
By derogation from the above deadline, a longer period
should be provided for the submission and assessment of
Article 3
the complete Annex III dossier of each plant protection
product for each intended use in accordance with the
Member States shall adopt and publish by 30 November 2011
uniform principles laid down in Directive 91/414/EEC.
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.
(10) The
experience
gained
from
previous
inclusions
in
Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Commission Regulation (EEC) No
3600/92 of 11 December 1992 laying down the detailed
They shall apply those provisions from 1 December 2011.
rules for the implementation of the first stage of the
programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing
When Member States adopt those provisions, they shall contain
of plant protection products on the market ( 1 ) has
a reference to this Directive or be accompanied by such a
shown that difficulties can arise in interpreting the
reference on the occasion of their official publication. Member
duties of holders of existing authorisations in relation
States shall determine how such reference is to be made.
to access to data. In order to avoid further difficulties
it therefore appears necessary to clarify the duties of
the Member States, especially the duty to verify that
Article 4
the holder of an authorisation demonstrates access to a
dossier satisfying the requirements of Annex II to that
1. Member States shall in accordance with Directive
Directive. However, this clarification does not impose any
91/414/EEC, where necessary, amend or withdraw existing
new obligations on Member States or holders of au-
authorisations for plant protection products containing
thorisations compared to the Directives which have
fenoxycarb as an active substance by 30 November 2011.
been adopted until now amending Annex I.
By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to fenoxycarb are met, with
the exception of those identified in part B of the entry
(11) It is therefore appropriate to amend Directive
concerning that active substance, and that the holder of the
91/414/EEC accordingly.
authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
( 1 ) OJ L 366, 15.12.1992, p. 10.
the conditions of Article 13 of that Directive.

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EN
3.3.2011 Official
Journal
of
the
European
Union L
58/47
2. By
way
of
derogation
from
paragraph
1,
for
each
au-
withdraw the authorisation by 31 May 2015 or by the
thorised plant protection product containing fenoxycarb as
date fixed for such an amendment or withdrawal in the
either the only active substance or as one of several active
respective Directive or Directives which added the relevant
substances all of which were listed in Annex I to Directive
substance or substances to Annex I to Directive
91/414/EEC by 31 May 2011 at the latest, Member States
91/414/EEC, whichever is the latest.
shall re-evaluate the product in accordance with the uniform
principles provided for in Annex VI to Directive 91/414/EEC,
on the basis of a dossier satisfying the requirements of Annex
Article 5
III to that Directive and taking into account part B of the entry
in Annex I to that Directive concerning fenoxycarb. On the
This Directive shall enter into force on 1 June 2011.
basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c),
(d) and (e) of Directive 91/414/EEC.
Article 6
This Directive is addressed to the Member States.
Following that determination Member States shall:
(a) in the case of a product containing fenoxycarb as the only
Done at Brussels, 2 March 2011.
active substance, where necessary, amend or withdraw the
authorisation by 31 May 2015 at the latest; or
For the Commission
(b) in the case of a product containing fenoxycarb as one of
The President
several active substances, where necessary, amend or
José Manuel BARROSO

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L 58/48
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
No
Common name, identi
fication numbers
IUPAC name Purity
(1 ) Entry
into
force Expiration
of
inclusion Specific
provisions
EN
‘339 Fenoxycarb
Ethyl 2-(4-phenoxyphenoxy)ethyl-carbamate ≥ 970 g/kg
1 June 2011 31
May
2021 PART
A

CAS No:
Impurities:
Only uses as insecticide may be authorised.
79127-80-3
Toluene: max. 1 g/kg
CIPAC No: 425
PART B
For the implementation of the uniform principles of Annex
VI, the conclusions of the review report on fenoxycarb, and
in particular Appendices I and II thereto, as finalised in the
Standing Committee on the Food Chain and Animal Health
Off
on 28 January 2011 shall be taken into account.
icial
In this overall assessment Member States shall pay particular
Jour
attention to:
nal
— the protection of aquatic organisms. Conditions of au-
of
thorisation shall include risk mitigation measures, where
the
appropriate,
European
— the risk to bees and non-target arthropods. Conditions
of authorisation shall include risk mitigation measures,
where appropriate.
Union
The Member States concerned shall request the submission
of information confirming the risk assessment for non-
target arthropods and for bee brood.
The Member States concerned shall ensure that the
applicant submits such information to the Commission by
31 May 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
3.3.2011

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