HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 108/30
EN
Official Journal of the European Union
28.4.2011
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2011/56/EU
of 27 April 2011
amending Council Directive 91/414/EEC to include cyproconazole as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
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
Ireland,
which
had
been designated rapporteur Member State by Regulation
(EC) No 1490/2002. 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 (
the subject of Decision 2008/934/EC. That application

1 ), and in particular Article 6(1) thereof,
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
Whereas:
(EC) No 33/2008.


(5)
Ireland 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 second and third stages of the
Authority (hereinafter ‘the Authority’) and to the
programme of work referred to in Article 8(2) of
Commission on 12 February 2010. The Authority
Directive 91/414/EEC and establish a list of active
communicated the additional report to the other
substances to be assessed, with a view to their possible
Member States and the applicant for comments and
inclusion in Annex I to Directive 91/414/EEC. That list
forwarded the comments it had received to the
included cyproconazole.
Commission. In accordance with Article 20(1) of Regu
lation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
cyproconazole to the Commission on 8 November
1490/2002 the notifier withdrew its support of the
2010 ( 6 ). The draft assessment report, the additional
inclusion of that active substance in Annex I to
report and the conclusion of the Authority were
Directive 91/414/EEC within two months from receipt
reviewed by the Member States and the Commission
of the draft assessment report. Consequently,
within the Standing Committee on the Food Chain and
Commission Decision 2008/934/EC of 5 December
Animal Health and finalised on 11 March 2011 in the
2008 concerning the non-inclusion of certain active
format of the Commission review report for cypro
substances in Annex I to Council Directive 91/414/EEC
conazole.
and the withdrawal of authorisations for plant protection
products containing these substances ( 4 ) was adopted on
the non-inclusion of cyproconazole.
(6)
It has appeared from the various examinations made that
plant protection products containing cyproconazole may
be expected to satisfy, in general, the requirements laid
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
original notifier (hereinafter ‘the applicant’) submitted a
in particular with regard to the uses which have been
new application requesting the accelerated procedure to
examined and detailed in the Commission review report.
be applied, as provided for in Articles 14 to 19 of
It is therefore appropriate to include cyproconazole in
Commission Regulation (EC) No 33/2008 of
Annex I, in order to ensure that in all Member States
17 January 2008 laying down detailed rules for the
the authorisations of plant protection products
application of Council Directive 91/414/EEC as regards
containing this active substance can be granted in
a regular and an accelerated procedure for the assessment
accordance with the provisions of that Directive.
of active substances which were part of the programme
( 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 cyproconazole.
( 3 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2010; 8(11):1897. [73 pp.]. doi:10.2903/
( 4 ) OJ L 333, 11.12.2008, p. 11.
j.efsa.2010.1897. Available online: www.efsa.europa.eu

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EN
28.4.2011 Official
Journal
of
the
European
Union L
108/31
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to (11) It is therefore appropriate to amend Directive
obtain further information on certain specific points.
91/414/EEC accordingly.
Article 6(1) of Directive 91/414/EEC provides that
inclusion of a substance in Annex I may be subject to
conditions. Therefore, it is appropriate to require that the
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
applicant submit further confirmatory information as
cyproconazole and the withdrawal of authorisations for
regards the toxicological relevance of the impurities in
plant protection products containing that substance by
the technical specification, analytical methods for the
31 December 2011. It is necessary to delete the line
monitoring of cyproconazole in soil, body fluids and
concerning cyproconazole in the Annex to that Decision.
tissues, the residues of triazole derivative metabolites
(TDMs) in primary crops, rotational crops and products
of animal origin, the long-term risk to herbivorous
(13) It is therefore appropriate to amend Decision
mammals and the possible environmental impact of the
2008/934/EC accordingly.
preferential degradation and/or conversion of the mixture
of isomers.
(14) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(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
HAS ADOPTED THIS DIRECTIVE:
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
(9) Without
prejudice
to
the
obligations
defined
by
Directive Annex to this Directive.
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
allowed a period of six months after inclusion to
Article 2
review existing authorisations of plant protection
The line concerning cyproconazole in the Annex to Decision
products containing cyproconazole 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
Article 3
vary, replace or withdraw, as appropriate, existing au
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.
They shall apply those provisions from 1 December 2011.
(10) The
experience
gained
from
previous
inclusions
in
Annex
I to Directive 91/414/EEC of active substances assessed
When Member States adopt those provisions, they shall contain
in the framework of Commission Regulation (EEC) No
a reference to this Directive or be accompanied by such a
3600/92 of 11 December 1992 laying down the detailed
reference on the occasion of their official publication. Member
rules for the implementation of the first stage of the
States shall determine how such reference is to be made.
programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing
of plant protection products on the market (
Article 4

1 ) has
shown that difficulties can arise in interpreting the
1. Member States shall in accordance with Directive
duties of holders of existing authorisations in relation
91/414/EEC, where necessary, amend or withdraw existing
to access to data. In order to avoid further difficulties
authorisations for plant protection products containing cypro
it therefore appears necessary to clarify the duties of
conazole as an active substance by 30 November 2011.
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
By that date they shall in particular verify that the conditions in
Directive. However, this clarification does not impose any
Annex I to that Directive relating to cyproconazole are met,
new obligations on Member States or holders of au
with the exception of those identified in part B of the entry
thorisations compared to the Directives which have
concerning that active substance, and that the holder of the
been adopted until now amending Annex I.
authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
( 1 ) OJ L 366, 15.12.1992, p. 10.
the conditions of Article 13 of that Directive.

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L 108/32
EN
Official Journal of the European Union
28.4.2011
2. By
way
of
derogation
from
paragraph
1,
for
each
au
withdraw the authorisation by 31 May 2015 or by the
thorised plant protection product containing cyproconazole as
date fixed for such an amendment or withdrawal in the
either the only active substance or as one of several active
respective Directive or Directives which added the relevant
substances all of which were listed in Annex I to Directive
substance or substances to Annex I to Directive
91/414/EEC by 31 May 2011 at the latest, Member States
91/414/EEC, whichever is the latest.
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
Article 5
III to that Directive and taking into account part B of the entry
in Annex I to that Directive concerning cyproconazole. On the
This Directive shall enter into force on 1 June 2011.
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 91/414/EEC.
Article 6
This Directive is addressed to the Member States.
Following that determination Member States shall:
(a) in the case of a product containing cyproconazole as the
Done at Brussels, 27 April 2011.
only active substance, where necessary, amend or withdraw
the authorisation by 31 May 2015 at the latest; or
For the Commission
(b) in the case of a product containing cyproconazole as one of
The President
several active substances, where necessary, amend or
José Manuel BARROSO

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28.4.2011 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
‘358 Cyproconazole
(2RS,3RS;2RS,3SR)-2-(4-
≥ 940 g/kg 1
June
2011 31
May
2021 PART
A

chlorophenyl)-3-
CAS No: 94361-06-5 cyclopropyl-1-(1H-1,2,4-
Only uses as fungicide may be authorised.
CIPAC No: 600
triazol-1-yl)butan-2-ol
PART B
For the implementation of the uniform principles of Annex VI, the conclusions
of the review report on cyproconazole, 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 pay particular attention to:
icial
(a) the dietary exposure of consumers to the residues of triazole derivative
metabolites (TDMs);
Jour
(b) the risk to aquatic organisms.
nal
of
Conditions of use shall include risk mitigation measures, where appropriate.
the
The Member States concerned shall request the submission of confirmatory
European
information as regards:
(a) the toxicological relevance of the impurities in the technical specification;
Union
(b) analytical methods for the monitoring of cyproconazole in soil, body fluids
and tissues;
(c) residues of triazole derivative metabolites (TDMs) in primary crops,
rotational crops and products of animal origin;
(d) the long-term risk to herbivorous mammals;
(e) the possible environmental impact of the preferential degradation and/or
conversion of the mixture of isomers.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in point (a) by 1 December 2011, the
information set out in points (b), (c) and (d) by 31 May 2013 and the
information set out in point (e) within two years after the adoption of
specific guidance.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
108/33

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