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14.4.2011 Official
Journal
of
the
European
Union L
100/43
COMMISSION IMPLEMENTING DIRECTIVE 2011/44/EU
of 13 April 2011
amending Council Directive 91/414/EEC to include azadirachtin as active substance and amending
Commission Decision 2008/941/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
substance and the supported uses are the same as were
the subject of Decision 2008/941/EC. That application
also complies with the remaining substantive and
Having regard to the Treaty on the Functioning of the European
procedural requirements of Article 15 of Regulation
Union,
(EC) No 33/2008.
Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
(5) Germany
evaluated
the
additional
data
submitted
by
the
the market (
applicant and prepared an additional report. It

1 ), and in particular Article 6(1) thereof,
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
Whereas:
Commission on 10 December 2009. The Authority
communicated the additional report to the other
Member States and the applicant for comments and
(1) Commission
Regulations
(EC)
No
1112/2002
( 2 ) and (EC)
forwarded the comments it had received to the
No 2229/2004 ( 3 ) lay down the detailed rules for the
Commission. In accordance with Article 20(1) of Regu
implementation of the fourth stage of the programme
lation (EC) No 33/2008 and at the request of the
of work referred to in Article 8(2) of Directive
Commission, the Authority presented its conclusion on
91/414/EEC and establish a list of active substances to
azadirachtin to the Commission on 28 October 2010 ( 6 ).
be assessed, with a view to their possible inclusion in
The draft assessment report, the additional report and the
Annex I to Directive 91/414/EEC. That list included
conclusion of the Authority were reviewed by the
azadirachtin.
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
(2) In
accordance
with
Article
24e
of
Regulation
(EC)
Health and finalised on 11 March 2011 in the format
No 2229/2004 the applicant withdrew its support of
of the Commission review report for azadirachtin.
the inclusion of that active substance in Annex I to
Directive 91/414/EEC within 2 months from receipt of
(6)
It has appeared from the various examinations made that
the draft assessment report. Consequently, Commission
plant protection products containing azadirachtin may be
Decision 2008/941/EC of 8 December 2008 concerning
expected to satisfy, in general, the requirements laid
the non-inclusion of certain active substances in Annex I
down in Article 5(1)(a) and (b) of Directive
to Council Directive 91/414/EEC and the withdrawal of
91/414/EEC, in particular with regard to the uses
authorisations for plant protection products containing
which have been examined and detailed in the
these substances ( 4 ) was adopted on the non-inclusion
Commission review report. It is therefore appropriate
of azadirachtin.
to include azadirachtin in Annex I, in order to ensure
that in all Member States the authorisations of plant
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
protection products containing this active substance can
original notifier (hereinafter ‘the applicant’) submitted a
be granted in accordance with the provisions of that
new application requesting the application of the accel
Directive.
erated procedure provided for in Articles 14 to 19 of
Commission Regulation (EC) No 33/2008 of 17 January
2008 laying down detailed rules for the application of
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
obtain further information on certain specific points.
Council Directive 91/414/EEC as regards a regular and an
Article 6(1) of Directive 91/414/EC provides that
accelerated procedure for the assessment of active
inclusion of a substance in Annex I may be subject to
substances which were part of the programme of work
conditions. Therefore, it is appropriate to require that the
referred to in Article 8(2) of that Directive but have not
applicant submit further information to confirm the rela
been included into its Annex I ( 5 ).
tionship between azadirachtin A and the rest of the
active components in the neem seeds extract with
(4) The
application
was
submitted
to
Germany,
which
had
respect to amount, biological activity and persistence,
been designated rapporteur Member State by Regulation
in order to confirm the lead active compound
(EC) No 2229/2004. The time period for the accelerated
approach with regard to azadirachtin A and to confirm
procedure was respected. The specification of the active
specification of the technical material, residue definition
and groundwater risk assessment.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 168, 27.6.2002, p. 14.
( 6 ) European Food Safety Authority; Conclusion on the peer review of the
( 3 ) OJ L 379, 24.12.2004, p. 13.
pesticide risk assessment of the active substance azadirachtin.
( 4 ) OJ L 335, 13.12.2008, p. 91.
EFSA Journal 2011;9(3):2008[76pp.].doi:10.2903/j.efsa2011.2088.
( 5 ) OJ L 15, 18.1.2008, p. 5.
Available online: www.efsa.europa.eu

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L 100/44
EN
Official Journal of the European Union
14.4.2011
(8) A
reasonable
period
should
be
allowed
to
elapse
before (14) The measures provided for in this Directive are in
an active substance is included in Annex I in order to
accordance with the opinion of the Standing
permit Member States and the interested parties to
Committee on the Food Chain and Animal Health,
prepare themselves to meet the new requirements
which will result from the inclusion.
HAS ADOPTED THIS DIRECTIVE:
(9) Without
prejudice
to
the
obligations
defined
by
Directive
Article 1
91/414/EEC as a consequence of including an active
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 azadirachtin to ensure that the requirements
Article 2
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
The line concerning azadirachtin in the Annex to Decision
are satisfied. Member States should vary, replace or
2008/941/EC is deleted.
withdraw, as appropriate, existing authorisations, in
accordance with the provisions of Directive
91/414/EEC. By derogation from the above deadline, a
Article 3
longer period should be provided for the submission and
assessment of the complete Annex III dossier of each
Member States shall adopt and publish by 30 November 2011
plant protection product for each intended use in
at the latest the laws, regulations and administrative provisions
accordance with the uniform principles laid down in
necessary to comply with this Directive. They shall forthwith
Directive 91/414/EEC.
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
They shall apply those provisions from 1 December 2011.
in the framework of Commission Regulation (EEC)
No 3600/92 of 11 December 1992 laying down the
detailed rules for the implementation of the first stage
When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
of the programme of work referred to in Article 8(2) of
reference on the occasion of their official publication. Member
Council Directive 91/414/EEC concerning the placing of
States shall determine how such reference is to be made.
plant protection products on the market ( 1 ) has shown
that difficulties can arise in interpreting the duties of
holders of existing authorisations in relation to access
Article 4
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
1. Member States shall in accordance with Directive
States, especially the duty to verify that the holder of
91/414/EEC, where necessary, amend or withdraw existing
an authorisation demonstrates access to a dossier
authorisations for plant protection products containing azadi
satisfying the requirements of Annex II to that Directive.
rachtin as an active substance by 30 November 2011.
However, this clarification does not impose any new
obligations on Member States or holders of authori
sations compared to the directives which have been
By that date they shall in particular verify that the conditions in
adopted until now amending Annex I.
Annex I to that Directive relating to azadirachtin are met, with
the exception of those identified in Part B of the entry
concerning that active substance, and that the holder of the
authorisation has, or has access to, a dossier satisfying the
(11) It is therefore appropriate to amend Directive
requirements of Annex II to that Directive in accordance with
91/414/EEC accordingly.
the conditions of Article 13 of that Directive.
2. By way of derogation from paragraph 1, for each au-
(12) Decision
2008/941/EC
provides
for
the
non-inclusion
of
thorised plant protection product containing azadirachtin as
azadirachtin and the withdrawal of authorisation of plant
either the only active substance or as one of several active
protection products containing that substance by
substances all of which were listed in Annex I to Directive
31 December 2011. It is necessary to delete the line
91/414/EEC by 30 April 2011 at the latest, Member States
concerning azadirachtin in the Annex to that Decision.
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
III to that Directive and taking into account Part B of the entry
(13) It is therefore appropriate to amend Decision
in Annex I to that Directive concerning azadirachtin. On the
2008/941/EC accordingly.
basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c),
( 1 ) OJ L 366, 15.12.1992, p. 10.
(d) and (e) of Directive 91/414/EEC.

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EN
14.4.2011 Official
Journal
of
the
European
Union L
100/45
Following that determination Member States shall:
Article 5
This Directive shall enter into force on 1 June 2011.
(a) in the case of a product containing azadirachtin as the only
active substance, where necessary, amend or withdraw the
Article 6
authorisation by 31 May 2015 at the latest; or
This Directive is addressed to the Member States.
(b) in the case of a product containing azadirachtin as one of
several active substances, where necessary, amend or
Done at Brussels, 13 April 2011.
withdraw the authorisation by 31 May 2015 or by the
date fixed for such an amendment or withdrawal in the
For the Commission
respective Directive or Directives which added the relevant
substance or substances to Annex I to Directive
The President
91/414/EEC, whichever is the latest.
José Manuel BARROSO

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L 100/46
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EC:
No
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Entry
into
force
Expiration of
inclusion
Specific provisions
EN
‘350 Azadirachtin
Azadirachtin A:
Expressed as azadi
1 June 2011 31
May
2021 PART
A

rachtin A:
CAS No: 11141-17-6 dimethyl
Only uses as insecticide may be authorised.
as azadirachtin A
(2aR,3S,4S,4aR,5S,7aS,8S,
≥ 111 g/kg
10R,10aS,10bR)-10-
PART B
CIPAC No: 627 as acetoxy-3,5-dihydroxy-4-
Sum of the
azadirachtin A
[(1aR,2S,3aS,6aS,7S,7aS)-
aflatoxins B 1, B 2, G 1
For the implementation of the uniform principles of Annex VI the conclusions
6a-hydroxy-7a-methyl-
and G 2 must not
of the review report on azadirachtin, and in particular Appendices I and II
3a,6a,7,7a-tetrahydro-2,7-
exceed 300 μg/kg of
thereof, as finalised in the Standing Committee on the Food Chain and Animal
methanofuro[2,3-b]
the azadirachtin A
Health on 11 March 2011, shall be taken into account.
oxireno[e]oxepin-1a(2H)-
content.
Off
yl]-4-methyl-8-{[(2E)-2-
In this overall assessment Member States shall pay particular attention to:
methylbut-2-enoyl]
icial
oxy}octahydro-1H-
— the dietary exposure of consumers in view of future revisions of Maximum
naphtho[1,8a-c:4,5-b′c′]
Residue Levels,
Jour
difuran-5,10a(8H)-dicar
nal
boxylate.
— the protection of non-target arthropods and aquatic organisms. Risk miti
gation measures shall be applied where appropriate.
of
the
The Member States concerned shall request the submission of confirmatory
information as regards:
European
— the relationship between azadirachtin A and the rest of the active
components in the neem seeds extract with respect to amount, biological
activity and persistence, in order to confirm the lead active compound
Union
approach with regard to azadirachtin A and to confirm specification of the
technical material, residue definition and groundwater risk assessment.
The Member States concerned shall ensure that the applicant submits such
information to the Commission by 31 December 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
14.4.2011

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