HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 97/38
EN
Official Journal of the European Union
12.4.2011
COMMISSION IMPLEMENTING DIRECTIVE 2011/41/EU
of 11 April 2011
amending Council Directive 91/414/EEC to include dithianon as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(EC) No 1490/2002. The time period for the accelerated
procedure was respected. The specification of the active
substance and the supported uses are the same as were
Having regard to the Treaty on the Functioning of the European
the subject of Decision 2008/934/EC. That application
Union,
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
(EC) No 33/2008.
Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular Article 6(1) thereof,
(5)
Greece evaluated the additional data submitted by the
applicant and prepared an additional report. It
communicated that report to the European Food Safety
Whereas:
Authority (hereinafter ‘the Authority’) and to the
Commission on 27 January 2010. The Authority
communicated the additional report to the other
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
Member States and the applicant for comments and
No 1490/2002 ( 3 ) lay down the detailed rules for the
forwarded the comments it had received to the
implementation of the third stage of the programme of
Commission. In accordance with Article 20(1) of Regu
work referred to in Article 8(2) of Directive 91/414/EEC
lation (EC) No 33/2008 and at the request of the
and establish a list of active substances to be assessed,
Commission, the Authority presented its conclusion on
with a view to their possible inclusion in Annex I to
dithianon to the Commission on 15 November 2010 ( 6 ).
Directive 91/414/EEC. That list included dithianon.
The draft assessment report, the additional report and the
conclusion of the Authority were reviewed by the
Member States and the Commission within the
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
Standing Committee on the Food Chain and Animal
No 1490/2002 the notifier withdrew its support of the
Health and finalised on 11 March 2011 in the format
inclusion of that active substance in Annex I to Directive
of the Commission review report for dithianon.
91/414/EEC within 2 months from receipt of the draft
assessment report. Consequently, Commission Decision
2008/934/EC of 5 December 2008 concerning the
(6)
It has appeared from the various examinations made that
non-inclusion of certain active substances in Annex I
plant protection products containing dithianon may be
to Council Directive 91/414/EEC and the withdrawal of
expected to satisfy, in general, the requirements laid
authorisations for plant protection products containing
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
these substances ( 4 ) was adopted on the non-inclusion
in particular with regard to the uses which have been
of dithianon.
examined and detailed in the Commission review report.
It is therefore appropriate to include dithianon in Annex
I, in order to ensure that in all Member States the au-
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
thorisations of plant protection products containing this
original notifier (hereinafter ‘the applicant’) submitted a
active substance can be granted in accordance with the
new application requesting the accelerated procedure to
provisions of that Directive.
be applied, as provided for in Articles 14 to 19 of
Commission Regulation (EC) No 33/2008 of
17 January 2008 laying down detailed rules for the
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
application of Council Directive 91/414/EEC as regards
obtain further information on certain specific points.
a regular and an accelerated procedure for the assessment
Article 6(1) of Directive 91/414/EC provides that
of active substances which were part of the programme
inclusion of a substance in Annex I may be subject to
of work referred to in Article 8(2) of that Directive but
conditions. Therefore, it is appropriate to require that the
have not been included into its Annex I ( 5 ).
applicant submit information confirming the storage
stability and the nature of residues in processed
products, the aquatic and groundwater exposure
(4) The
application
was
submitted
to
Greece,
which
had
assessment for phthalic acid and the risk assessment for
been designated rapporteur Member State by Regulation
aquatic organisms with respect to phthalic acid, phthal
aldehyde and 1,2 benzenedimethanol.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 55, 29.2.2000, p. 25.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 224, 21.8.2002, p. 23.
the pesticide risk assessment of the active substance dithianon. EFSA
( 4 ) OJ L 333, 11.12.2008, p. 11.
Journal 2010; 8(11):1904. [121 pp.]. doi:10.2903/j.efsa.2010.1904.
( 5 ) OJ L 15, 18.1.2008, p. 5.
Available online: www.efsa.europa.eu

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EN
12.4.2011 Official
Journal
of
the
European
Union L
97/39
(8) A
reasonable
period
should
be
allowed
to
elapse
before HAS ADOPTED THIS DIRECTIVE:
an active substance is included in Annex I in order to
permit Member States and the interested parties to
prepare themselves to meet the new requirements
which will result from the inclusion.
Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.
(9) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
allowed a period of 6 months after inclusion to review
Article 2
existing authorisations of plant protection products
The line concerning dithianon in the Annex to Decision
containing dithianon to ensure that the requirements
2008/934/EC is deleted.
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
are satisfied. Member States should vary, replace or
withdraw, as appropriate, existing authorisations, in
Article 3
accordance with the provisions of Directive 91/414/EEC.
Member States shall adopt and publish by 30 November 2011
By derogation from the above deadline, a longer period
at the latest the laws, regulations and administrative provisions
should be provided for the submission and assessment of
necessary to comply with this Directive. They shall forthwith
the complete Annex III dossier of each plant protection
communicate to the Commission the text of those provisions
product for each intended use in accordance with the
and a correlation table between those provisions and this
uniform principles laid down in Directive 91/414/EEC.
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
of the programme of work referred to in Article 8(2) of
a reference to this Directive or be accompanied by such a
Council Directive 91/414/EEC concerning the placing of
reference on the occasion of their official publication. Member
plant protection products on the market ( 1 ) has shown
States shall determine how such reference is to be made.
that difficulties can arise in interpreting the duties of
holders of existing authorisations in relation to access
to data. In order to avoid further difficulties, it
therefore appears necessary to clarify the duties of the
Article 4
Member States, especially the duty to verify that the
1. Member States shall in accordance with Directive
holder of an authorisation demonstrates access to a
91/414/EEC, where necessary, amend or withdraw existing
dossier satisfying the requirements of Annex II to that
authorisations for plant protection products containing
Directive. However, this clarification does not impose any
dithianon as an active substance by 30 November 2011.
new obligations on Member States or holders of au-
thorisations compared to the Directives which have
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 dithianon are met, with the
(11) It is therefore appropriate to amend Directive
exception of those identified in Part B of the entry concerning
91/414/EEC accordingly.
that active substance, and that the holder of the authorisation
has, or has access to, a dossier satisfying the requirements of
Annex II to that Directive in accordance with the conditions of
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
Article 13 of that Directive.
dithianon and the withdrawal of authorisations for plant
protection products containing that substance by
31 December 2011. It is necessary to delete the line
2. By way of derogation from paragraph 1, for each au-
concerning dithianon in the Annex to that Decision.
thorised plant protection product containing dithianon as
either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
(13) It is therefore appropriate to amend Decision
91/414/EEC by 31 May 2011 at the latest, Member States
2008/934/EC accordingly.
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
(14) The
measures provided for in this Directive are in
III to that Directive and taking into account Part B of the entry
accordance with the opinion of the Standing
in Annex I to that Directive concerning dithianon. On the basis
Committee on the Food Chain and Animal Health,
of that evaluation, they shall determine whether the product
satisfies the conditions set out in Article 4(1)(b), (c), (d) and
( 1 ) OJ L 366, 15.12.1992, p. 10.
(e) of Directive 91/414/EEC.

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L 97/40
EN
Official Journal of the European Union
12.4.2011
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 dithianon as the only
Article 6
active substance, where necessary, amend or withdraw the
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 dithianon as one of
several active substances, where necessary, amend or
Done at Brussels, 11 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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12.4.2011 Off
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
No
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Entry
into
force Expiration
of
inclusion Specific
provisions
EN
‘344 Dithianon
5,10-dihydro-5,10-
≥ 930 g/kg 1
June
2011 31
May
2021 PART
A

dioxonaphtho[2,3-b]-1,4-
CAS No: 3347-22-6
dithiine-2,3-dicarbonitrile
Only uses as fungicide may be authorised.
CIPAC No: 153
PART B
For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on dithianon, and in particular Appendices
I and II thereof, as finalised in the Standing Committee on the Food Chain
and Animal Health on 11 March 2011 shall be taken into account.
In this overall assessment Member States shall:
(a) pay particular attention to the protection of aquatic organisms; conditions
icial
of use shall include risk mitigation measures, where appropriate;
Jour
(b) pay particular attention to the operator safety; conditions of use shall
include the application of adequate personal protective equipment,
nal
where appropriate;
of
(c) pay particular attention to the long-term risks to birds; conditions of use
the
shall include risk mitigation measures, where appropriate.
European
The Member States concerned shall request the submission of confirmatory
information as regards:
(a) the storage stability and the nature of residues in processed products;
Union
(b) the aquatic and groundwater exposure assessment for phthalic acid;
(c) the risk assessment for aquatic organisms with respect to phthalic acid,
phthalaldehyde and 1,2 benzenedimethanol.
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.
L
97/41

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