HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 105/24
EN
Official Journal of the European Union
21.4.2011
COMMISSION IMPLEMENTING DIRECTIVE 2011/53/EU
of 20 April 2011
amending Council Directive 91/414/EEC to include dazomet as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
procedure was respected. The specification of the active
substance and the supported uses are the same as were
the subject of Decision 2008/934/EC. That application
Having regard to the Treaty on the Functioning of the European
also complies with the remaining substantive and
Union,
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 (
(5) Belgium
evaluated
the
additional
data
submitted
by
the

1 ), and in particular Article 6(1) thereof,
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 10 December 2009. 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 second and third stages of the
Commission. In accordance with Article 20(1) of Regu
programme of work referred to in Article 8(2) of
lation (EC) No 33/2008 and at the request of the
Directive 91/414/EEC and establish a list of active
Commission, the Authority presented its conclusion on
substances to be assessed, with a view to their possible
dazomet to the Commission on 30 September 2010 ( 6 ).
inclusion in Annex I to Directive 91/414/EEC. That list
The draft assessment report, the additional report and the
included dazomet.
conclusion of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
Health and finalised on 11 March 2011 in the format
No 1490/2002 the notifier withdrew its support of the
of the Commission review report for dazomet.
inclusion of that active substance in Annex I to Directive
91/414/EEC within 2 months from receipt of the draft
assessment report. Consequently, Commission Decision
(6)
It has appeared from the various examinations made that
2008/934/EC of 5 December 2008 concerning the
plant protection products containing dazomet may be
non-inclusion of certain active substances in Annex I
expected to satisfy, in general, the requirements
to Council Directive 91/414/EEC and the withdrawal of
laid down in Article 5(1)(a) and (b) of Directive
authorisations for plant protection products containing
91/414/EEC, in particular with regard to the uses
these substances ( 4 ) was adopted on the non-inclusion
which have been examined and detailed in the
of dazomet.
Commission review report. It is therefore appropriate
to include dazomet 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
original notifier (hereinafter ‘the applicant’) submitted a
protection products containing this active substance can
new application requesting the accelerated procedure to
be granted in accordance with the provisions of that
be applied, as provided for in Articles 14 to 19 of
Directive.
Commission Regulation (EC) No 33/2008 of
17 January 2008 laying down detailed rules for the
application of Council Directive 91/414/EEC as regards
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
a regular and an accelerated procedure for the assessment
obtain further information on certain specific points.
of active substances which were part of the programme
Article 6(1) of Directive 91/414/EC provides that
of work referred to in Article 8(2) of that Directive but
inclusion of a substance in Annex I may be subject to
have not been included into its Annex I (
conditions. Therefore, it is appropriate to require that the

5 ).
applicant submit further information to confirm the
potential groundwater contamination by methyl isothio
(4) The
application
was
submitted
to
Belgium,
which
had
cyanate, the assessment of the long range atmospheric
been designated rapporteur Member State by Regulation
transport potential of methyl isothiocyanate and related
(EC) No 1490/2002. The time period for the accelerated
environmental risks, the acute risk to insectivorous birds
and the long term risk to birds and mammals.
( 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 dazomet. EFSA
( 4 ) OJ L 333, 11.12.2008, p. 11.
Journal 2010; 8(10):1833. [91 pp.]. doi:10.2903/j.efsa.2010.1833.
( 5 ) OJ L 15, 18.1.2008, p. 5.
Available online: www.efsa.europa.eu

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EN
21.4.2011 Official
Journal
of
the
European
Union L
105/25
(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
Article 2
review existing authorisations of plant protection
The line concerning dazomet in the Annex to Decision
products containing dazomet to ensure that the
2008/934/EC is deleted.
requirements 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 au-
Article 3
thorisations, in accordance with the provisions of
Member States shall adopt and publish by 30 November 2011
Directive 91/414/EEC. By derogation from the above
at the latest the laws, regulations and administrative provisions
deadline, a longer period should be provided for the
necessary to comply with this Directive. They shall forthwith
submission and assessment of the complete Annex III
communicate to the Commission the text of those provisions
dossier of each plant protection product for each
and a correlation table between those provisions and this
intended use in accordance with the uniform principles
Directive.
laid down in Directive 91/414/EEC.
(10) The
experience
gained
from
previous
inclusions
in
Annex
They shall apply those provisions from 1 December 2011.
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 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 (
States shall determine how such reference is to be made.

1 ) has shown
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
Article 4
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
1. Member States shall in accordance with Directive
an authorisation demonstrates access to a dossier
91/414/EEC, where necessary, amend or withdraw existing
satisfying the requirements of Annex II to that Directive.
authorisations for plant protection products containing
However, this clarification does not impose any new
dazomet as an active substance by 30 November 2011.
obligations on Member States or holders of authori
sations 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 dazomet 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
Article 13 of that Directive.
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
dazomet 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 dazomet in the Annex to that Decision.
thorised plant protection product containing dazomet 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 dazomet. 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 105/26
EN
Official Journal of the European Union
21.4.2011
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 dazomet 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 dazomet as one of
several active substances, where necessary, amend or
Done at Brussels, 20 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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21.4.2011 Off
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
‘359 Dazomet
3,5-dimethyl-1,3,5-thiadia
≥ 950 g/kg 1
June
2011 31
May
2021 PART
A

zinane-2-thione
CAS No: 533-74-4
Only uses as nematicide, fungicide, herbicide and insecticide may be au-
or
CIPAC No: 146
thorised. Only application as soil fumigant may be authorised. Use shall be
tetrahydro-3,5-dimethyl-
limited to one application every third year.
1,3,5-thiadiazine-2-thione
PART B
For the implementation of the uniform principles of Annex VI, the conclusions
of the review report on dazomet, 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.
icial
In this overall assessment Member States shall pay particular attention to:
Jour
(a) the risk to operators, workers and bystanders;
nal
(b) the protection of groundwater, when the active substance is applied in
of
regions with vulnerable soil and/or climatic conditions;
the
(c) the risk to aquatic organisms.
European
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of confirmatory
Union
information as regards:
(a) the potential groundwater contamination by methyl isothiocyanate;
(b) the assessment of the long range atmospheric transport potential of methyl
isothiocyanate and related environmental risks;
(c) the acute risk to insectivorous birds;
(d) the long term risk to birds and mammals.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (a), (b), (c) and (d) by 31 May
2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
105/27

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