HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 28/36
EN
Official Journal of the European Union
2.2.2011
DIRECTIVES
COMMISSION DIRECTIVE 2011/9/EU
of 1 February 2011
amending Council Directive 91/414/EEC to include dodine 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
Portugal,
which
had
been designated rapporteur Member State by Regulation
(EC) No 451/2000. The time period for the accelerated
Having regard to Council Directive 91/414/EEC of 15 July
procedure was respected. The specification of the active
1991 concerning the placing of plant protection products on
substance and the supported uses are the same as were
the market ( 1 ), and in particular Article 6(1) thereof,
the subject of Decision 2008/934/EC. That application
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
Whereas:
(EC) No 33/2008.


(5) Portugal
evaluated
the
additional
data
submitted
by
the
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
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 14 August 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 dodine.
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
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
Commission, the Authority presented its conclusion on
1490/2002 the notifier withdrew its support of the
dodine to the Commission on 28 May 2010 ( 6 ). The
inclusion of that active substance in Annex I to
draft assessment report, the additional report and the
Directive 91/414/EEC within two months from receipt
conclusion of the Authority were reviewed by the
of the draft assessment report. Consequently,
Member States and the Commission within the
Commission Decision 2008/934/EC of 5 December
Standing Committee on the Food Chain and Animal
2008 concerning the non-inclusion of certain active
Health and finalised on 23 November 2010 in the
substances in Annex I to Council Directive 91/414/EEC
format of the Commission review report for dodine.
and the withdrawal of authorisations for plant protection
products containing these substances ( 4 ) was adopted on
the non-inclusion of dodine.
(6)
It has appeared from the various examinations made that
plant protection products containing dodine 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 dodine in Annex I,
be applied, as provided for in Articles 14 to 19 of
in order to ensure that in all Member States the au-
Commission Regulation (EC) No 33/2008 of
thorisations of plant protection products containing
17 January 2008 laying down detailed rules for the
this active substance can be granted in accordance with
application of Council Directive 91/414/EEC as regards
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 of
( 2 ) OJ L 55, 29.2.2000, p. 25.
the pesticide risk assessment of the active substance dodine. EFSA
( 3 ) OJ L 224, 21.8.2002, p. 23.
Journal 2010; 8(6):1631. [54 pp.]. doi:10.2903/j.efsa.2010.1631.
( 4 ) OJ L 333, 11.12.2008, p. 11.
Available online: www.efsa.europa.eu

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EN
2.2.2011 Official
Journal
of
the
European
Union L
28/37
(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.
dodine and the withdrawal of authorisations for plant
Article 6(1) of Directive 91/414/EEC provides that
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 dodine in the Annex to that Decision.
applicant submit further information to confirm the
long-term risk assessment for birds and mammals and
the risk assessment in natural surface water systems
(13) It is therefore appropriate to amend Decision
where major metabolites have potentially formed.
2008/934/EC accordingly.
(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 six months after inclusion to
Annex to this Directive.
review existing authorisations of plant protection
products containing dodine to ensure that the
requirements laid down by Directive 91/414/EEC, in
Article 2
particular in its Article 13 and the relevant conditions
set out in Annex I, are satisfied. Member States should
The line concerning dodine in the Annex to Decision
vary, replace or withdraw, as appropriate, existing au-
2008/934/EC is deleted.
thorisations, in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
deadline, a longer period should be provided for the
Article 3
submission and assessment of the complete Annex III
dossier of each plant protection product for each
Member States shall adopt and publish by 30 November 2011
intended use in accordance with the uniform principles
at the latest the laws, regulations and administrative provisions
laid down in Directive 91/414/EEC.
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
They shall apply those provisions from 1 December 2011.
3600/92 of 11 December 1992 laying down the detailed
rules for the implementation of the first stage of the
programme of work referred to in Article 8(2) of
When Member States adopt those provisions, they shall contain
Council Directive 91/414/EEC concerning the placing
a reference to this Directive or be accompanied by such a
of plant protection products on the market ( 1 ) has
reference on the occasion of their official publication. Member
shown that difficulties can arise in interpreting the
States shall determine how such reference is to be made.
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
Article 4
the Member States, especially the duty to verify that
the holder of an authorisation demonstrates access to a
1. Member States shall in accordance with Directive
dossier satisfying the requirements of Annex II to that
91/414/EEC, where necessary, amend or withdraw existing
Directive. However, this clarification does not impose any
authorisations for plant protection products containing dodine
new obligations on Member States or holders of au-
as an active substance by 30 November 2011.
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 dodine are met, with the
exception of those identified in Part B of the entry concerning
(11) It is therefore appropriate to amend Directive
that active substance, and that the holder of the authorisation
91/414/EEC accordingly.
has, or has access to, a dossier satisfying the requirements of
Annex II to that Directive in accordance with the conditions of
( 1 ) OJ L 366, 15.12.1992, p. 10.
Article 13 of that Directive.

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L 28/38
EN
Official Journal of the European Union
2.2.2011
2. By
way
of
derogation
from
paragraph
1,
for
each
au-
authorisation by 31 May 2015 or by the date fixed for such
thorised plant protection product containing dodine as either
an amendment or withdrawal in the respective Directive or
the only active substance or as one of several active substances
Directives which added the relevant substance or substances
all of which were listed in Annex I to Directive 91/414/EEC by
to Annex I to Directive 91/414/EEC, whichever is the latest.
31 May 2011 at the latest, Member States 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
Article 5
satisfying the requirements of Annex III to that Directive and
taking into account Part B of the entry in Annex I to that
This Directive shall enter into force on 1 June 2011.
Directive concerning dodine. On the 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
Article 6
91/414/EEC.
This Directive is addressed to the Member States.
Following that determination Member States shall:
(a) in the case of a product containing dodine as the only active
Done at Brussels, 1 February 2011.
substance, where necessary, amend or withdraw the au-
thorisation by 31 May 2015 at the latest; or
For the Commission
(b) in the case of a product containing dodine as one of several
The President
active substances, where necessary, amend or withdraw the
José Manuel BARROSO

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2.2.2011 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
‘326 Dodine
1-dodecylguanidinium
≥ 950 g/kg 1
June
2011 31
May
2021 PART
A

acetate
CAS No: 2439-10-3
Only uses as fungicide may be authorised.
CIPAC No: 101
PART B
For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on dodine, and in particular Appendices
I and II thereof, as finalised in the Standing Committee on the Food Chain
and Animal Health on 23 November 2010 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
icial
(a) the potential long-term risk to birds and mammals;
Jour
(b) the risk to aquatic organisms and ensure that conditions of use
impose adequate risk mitigation measures;
nal
of
(c) the risk to non-target plants in the off-field area and ensure that
the
conditions of use impose adequate risk mitigation measures;
European
(d) the monitoring of residue levels in pome fruit.
The Member States concerned shall request the submission of
confirmatory information as regards:
Union
(a) long-term risk assessment for birds and mammals;
(b) risk assessment in natural surface water systems where major
metabolites have potentially formed.
The Member States concerned shall ensure that the applicant submits
such confirmatory 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
28/39

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