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8.3.2011 Official
Journal
of
the
European
Union L
61/9
DIRECTIVES
COMMISSION DIRECTIVE 2011/29/EU
of 7 March 2011
amending Council Directive 91/414/EEC to include etridiazole as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
original notifier (hereinafter ‘the applicant’) submitted a
new application requesting the accelerated procedure to
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
Having regard to the Treaty on the Functioning of the European
application of Council Directive 91/414/EEC as regards
Union,
a regular and an accelerated procedure for the assessment
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 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,
(4) The
application
was
submitted
to
the
Netherlands,
which
had been designated rapporteur Member State by Regu
lation (EC) No 1490/2002. The time period for the accel
erated procedure was respected. The specification of the
Whereas:
active substance and the supported uses are the same as
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.
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
No 1490/2002 ( 3 ) lay down the detailed rules for the
implementation of the third stage of the programme of
work referred to in Article 8(2) of Directive 91/414/EEC
and establish a list of active substances to be assessed,
(5) The
Netherlands
evaluated
the
additional
data
submitted
with a view to their possible inclusion in Annex I to
by the applicant and prepared an additional report. It
Directive 91/414/EEC. That list included etridiazole.
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
Commission on 2 December 2009. The Authority
communicated the additional report to the other
Member States and the applicant for comments and
forwarded the comments it had received to the
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
Commission. In accordance with Article 20(1) of Regu
1490/2002 the notifier withdrew its support of the
lation (EC) No 33/2008 and at the request of
inclusion of that active substance in Annex I to
the Commission, the Authority presented its conclusion
Directive 91/414/EEC within 2 months from receipt of
on etridiazole to the Commission on 24 September
the draft assessment report. Consequently, Commission
2010 ( 6 ). The draft assessment report, the additional
Decision 2008/934/EC of 5 December 2008 concerning
report and the conclusion of the Authority were
the non-inclusion of certain active substances in Annex I
reviewed by the Member States and the Commission
to Council Directive 91/414/EEC and the withdrawal of
within the Standing Committee on the Food Chain and
authorisations for plant protection products containing
Animal Health and finalised on 28 January 2011 in the
these substances ( 4 ) was adopted on the non-inclusion
format of the Commission review report for etridiazole.
of etridiazole.
( 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 etridiazole. EFSA
( 3 ) OJ L 224, 21.8.2002, p. 23.
Journal 2010;8(10):1823. [66 pp.]. doi:10.2903/j.efsa.2010.1823.
( 4 ) OJ L 333, 11.12.2008, p. 11.
Available online: www.efsa.europa.eu/efsajournal.htm

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L 61/10
EN
Official Journal of the European Union
8.3.2011
(6)
It has appeared from the various examinations made that
(10) The
experience
gained
from
previous
inclusions
in
Annex
plant protection products containing etridiazole may be
I to Directive 91/414/EEC of active substances assessed
expected to satisfy, in general, the requirements laid
in the framework of Commission Regulation (EEC)
down in Article 5(1)(a) and (b) of Directive
No 3600/92 of 11 December 1992 laying down the
91/414/EEC, in particular with regard to the uses
detailed rules for the implementation of the first stage
which have been examined and detailed in the
of the programme of work referred to in Article 8(2) of
Commission review report. It is therefore appropriate
Council Directive 91/414/EEC concerning the placing of
to include etridiazole in Annex I, in order to ensure
plant protection products on the market ( 1 ) has shown
that in all Member States the authorisations of plant
that difficulties can arise in interpreting the duties of
protection products containing this active substance can
holders of existing authorisations in relation to access
be granted in accordance with the provisions of that
to data. In order to avoid further difficulties it therefore
Directive.
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
an authorisation demonstrates access to a dossier
satisfying the requirements of Annex II to that Directive.
However, this clarification does not impose any new
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
obtain further information on certain specific points.
obligations on Member States or holders of authori
Article 6(1) of Directive 91/414/EEC provides that
sations compared to the directives which have been
inclusion of a substance in Annex I may be subject to
adopted until now amending Annex I.
conditions. Therefore, in assessing applications to
authorise plant protection products containing etridiazole
(11) It is therefore appropriate to amend Directive
for uses other than on ornamental plants, Member States
91/414/EEC accordingly.
shall ensure that any necessary information is provided
before such an authorisation is granted. Moreover, it is
appropriate to require that the applicant submit further
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
information confirming: the specification of the technical
etridiazole and the withdrawal of authorisations for plant
material as commercially manufactured by appropriate
protection products containing that substance by
analytical data, the relevance of the impurities, the equiv
31 December 2011. It is necessary to delete the line
alence between the specifications of the technical
concerning etridiazole in the Annex to that Decision.
material, as commercially manufactured, and those of
the test material used in the ecotoxicity dossiers, the
relevance of the plant metabolites 5-hydroxy-ethoxyetri
(13) It is therefore appropriate to amend Decision
diazole acid and 3-hydroxymethyletridiazole, the indirect
2008/934/EC accordingly.
exposure of groundwater and soil-dwelling organisms to
etridiazole and to its soil metabolites dichloro-etridiazole
and etridiazole acid, and the long-range and short-range
(14) The
measures provided for in this Directive are in
transport through the atmosphere of etridiazole acid.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
(8) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
Article 1
prepare themselves to meet the new requirements
which will result from the inclusion.
Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.
Article 2
(9) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
The line concerning etridiazole in the Annex to Decision
substance in Annex I, Member States should be
2008/934/EC is deleted.
allowed a period of 6 months after inclusion to review
existing authorisations of plant protection products
Article 3
containing etridiazole to ensure that the requirements
laid down by Directive 91/414/EEC, in particular in its
Member States shall adopt and publish by 30 November 2011
Article 13 and the relevant conditions set out in Annex I,
at the latest the laws, regulations and administrative provisions
are satisfied. Member States should vary, replace or
necessary to comply with this Directive. They shall forthwith
withdraw, as appropriate, existing authorisations, in
communicate to the Commission the text of those provisions
accordance with the provisions of Directive
and a correlation table between those provisions and this
91/414/EEC. By derogation from the above deadline, a
Directive.
longer period should be provided for the submission and
assessment of the complete Annex III dossier of each
plant protection product for each intended use in
They shall apply those provisions from 1 December 2011.
accordance with the uniform principles laid down in
Directive 91/414/EEC.
( 1 ) OJ L 366, 15.12.1992, p. 10.

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EN
8.3.2011 Official
Journal
of
the
European
Union L
61/11
When Member States adopt those provisions, they shall contain
Following that determination Member States shall:
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(a) in the case of a product containing etridiazole as the only
active substance, where necessary, amend or withdraw the
Article 4
authorisation by 31 May 2015 at the latest; or
1. Member States shall in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
(b) in the case of a product containing etridiazole as one of
authorisations for plant protection products containing etri
several active substances, where necessary, amend or
diazole as an active substance by 30 November 2011.
withdraw the authorisation by 31 May 2015 or by the
date fixed for such an amendment or withdrawal in the
respective Directive or Directives which added the relevant
By that date they shall in particular verify that the conditions in
substance or substances to Annex I to Directive
Annex I to that Directive relating to etridiazole are met, with
91/414/EEC, whichever is the latest.
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
requirements of Annex II to that Directive in accordance with
Article 5
the conditions of Article 13 of that Directive.
This Directive shall enter into force on 1 June 2011.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing etridiazole as either
Article 6
the only active substance or as one of several active substances
This Directive is addressed to the Member States.
all of which were listed in Annex I to Directive 91/414/EEC by
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
Done at Brussels, 7 March 2011.
satisfying the requirements of Annex III to that Directive and
taking into account part B of the entry in Annex I to that
Directive concerning etridiazole. On the basis of that evaluation,
For the Commission
they shall determine whether the product satisfies the
conditions set out in Article 4(1)(b), (c), (d) and (e) of
The President
Directive 91/414/EEC.
José Manuel BARROSO

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L 61/12
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

‘332 Etridiazole
ethyl-3-trichloromethyl-1,2,4-thiadiazol-
≥ 970 g/kg 1
June
2011 31
May
2021 PART
A
CAS No: 2593-15-9 5-yl ether
Only uses as fungicide in non-soil bound systems in greenhouse
CIPAC No: 518
may be authorised.
PART B
In assessing applications to authorise plant protection products
containing etridiazole for uses other than on ornamental plants,
Off
Member States shall pay particular attention to the criteria in
icial
Article 4(1)(b), and shall ensure that any necessary information is
provided before such an authorisation is granted.
Jour
For the implementation of the uniform principles of Annex VI the
nal
conclusions of the review report on etridiazole, and in particular
of
Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 January 2011, shall be
the
taken into account.
European
In this overall assessment Member States shall:
1. pay particular attention to the risk to operators and workers and
Union
ensure that conditions of use include the application of appro
priate risk mitigation measures;
2. ensure that appropriate waste management practices are applied
as regards waste water from irrigation of non-soil bound
growing systems; Member States permitting the release of
waste water into the sewage system or into natural water
bodies, shall ensure that an appropriate risk assessment is
carried out;
3. pay particular attention to the risk to aquatic organisms and
ensure that conditions of use include the application of appro
priate risk mitigation measures.
The Member States concerned shall request the submission of
confirmatory information as regards:
1. the specification of the technical material, as commercially
manufactured, by appropriate analytical data;
8.3.2011
2. the relevance of the impurities;

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8.3.2011 Off
No
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Entry
into
force
Expiration of
inclusion
Specific provisions
3. the equivalence between the specifications of the technical
material, as commercially manufactured, and those of the test
material used in the ecotoxicity dossiers;
EN
4. the relevance of the plant metabolites 5-hydroxy-ethoxyetri

diazole acid and 3-hydroxymethyletridiazole;
5. indirect exposure of groundwater and soil-dwelling organisms to
etridiazole and to its soil metabolites dichloro-etridiazole and
etridiazole acid;
6. long-range and short-range transport through the atmosphere of
etridiazole acid.
The Member States concerned shall ensure that the applicant
submits to the Commission the information set out in points 1,
2 and 3 by 1 December 2011 and the information set out in points
icial
4, 5 and 6 by 31 May 2013.’
Jour
(1 ) Further details on identity and specification of active substance are provided in the review report.
nal
of
the
European
Union
L
61/13

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