HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
8.1.2011 Official
Journal
of
the
European
Union
L
5/7
DIRECTIVES
COMMISSION DIRECTIVE 2011/2/EU
of 7 January 2011
amending Council Directive 91/414/EEC to include myclobutanil as active substance and amending
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
Belgium,
which
had
been designated rapporteur Member State by Regulation
(EC) No 451/2000. The time period for the accelerated
procedure was respected. The specification of the active
Having regard to Council Directive 91/414/EEC of 15 July
substance and the supported uses are the same as were
1991 concerning the placing of plant protection products on
the subject of Decision 2008/934/EC. That application
the market ( 1 ), and in particular Article 6(1) thereof,
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
(EC) No 33/2008.
Whereas:
(5) Belgium
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 22 October 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 myclobutanil.
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
Commission, the Authority presented its conclusion on
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
myclobutanil to the Commission on 11 July 2010 (
1490/2002 the notifier withdrew its support of the

6 ).
The draft assessment report, the additional report and
inclusion of that active substance in Annex I to
the conclusion of the Authority were reviewed by the
Directive 91/414/EEC within two months from receipt
Member States and the Commission within the
of the draft assessment report. Consequently,
Standing Committee on the Food Chain and Animal
Commission Decision 2008/934/EC of 5 December
Health and finalised on 23 November 2010 in the
2008 concerning the non-inclusion of certain active
format of the Commission review report for
substances in Annex I to Council Directive 91/414/EEC
myclobutanil.
and the withdrawal of authorisations for plant protection
products containing these substances ( 4 ) was adopted on
the non-inclusion of myclobutanil.
(6)
It has appeared from the various examinations made that
plant protection products containing myclobutanil 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 Article 14 to 19 of
It is therefore appropriate to include myclobutanil 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
( 2 ) OJ L 55, 29.2.2000, p. 25.
of the pesticide risk assessment of the active substance myclobutanil’,
( 3 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2010 8(10) 1682 [83pp]. doi: 10.2903/jefsa.
( 4 ) OJ L 333, 11.12.2008, p. 11.
2010.1682. Available online: www.efsa.europa.eu/efsajournal.htm

---

L 5/8
EN
Official Journal of the European Union
8.1.2011
(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.
myclobutanil and the withdrawal of authorisations for
Article 6(1) of Directive 91/414/EC provides that
plant 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 myclobutanil in the Annex to that Decision.
applicant submit further information on the residues of
myclobutanil and its metabolites in following growing
seasons and information confirming that the available
(13) It is therefore appropriate to amend Decision
residue data cover all compounds of the residue defi
2008/934/EC accordingly.
nition.
(14) The
measures provided for in this Directive are in
(8) A
reasonable
period
should
be
allowed
to
elapse
before
accordance with the opinion of the Standing
an active substance is included in Annex I in order to
Committee on the Food Chain and Animal Health,
permit Member States and the interested parties to
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
Annex I to Directive 91/414/EEC is amended as set out in the
substance in Annex I, Member States should be
Annex to this Directive.
allowed a period of six months after inclusion to
review existing authorisations of plant protection
products containing myclobutanil to ensure that the
requirements laid down by Directive 91/414/EEC, in
Article 2
particular in its Article 13 and the relevant conditions
The line concerning myclobutanil in the Annex to Decision
set out in Annex I, are satisfied. Member States should
2008/934/EC is deleted.
vary, replace or withdraw, as appropriate, existing auth
orisations, in accordance with the provisions of Directive
91/414/EEC. By derogation from the above deadline, a
Article 3
longer period should be provided for the submission and
assessment of the complete Annex III dossier of each
Member States shall adopt and publish by 30 November 2011
plant protection product for each intended use in
at the latest the laws, regulations and administrative provisions
accordance with the uniform principles laid down in
necessary to comply with this Directive. They shall forthwith
Directive 91/414/EEC.
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
new obligations on Member States or holders of auth
myclobutanil as an active substance by 30 November 2011.
orisations 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 myclobutanil are met, with
the exception of those identified in Part B of the entry
(11) It is therefore appropriate to amend Directive
concerning that active substance, and that the holder of the
91/414/EEC accordingly.
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.

---

EN
8.1.2011 Official
Journal
of
the
European
Union
L
5/9
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
withdraw the authorisation by 31 May 2015 or by the
orised plant protection product containing myclobutanil 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 myclobutanil. 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),
Article 6
(d) and (e) of Directive 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 myclobutanil as the only
Done at Brussels, 7 January 2011.
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 myclobutanil as one of
The President
several active substances, where necessary, amend or
José Manuel BARROSO

---

L 5/10
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
‘324 Myclobutanil
(RS)-2-(4-chlorophenyl)-2-(1H-
≥ 925 g/kg
1 June 2011 31
May
2021 PART
A

1,2,4-triazol-1-ylmethyl)hexan
CAS No:
Only uses as fungicide may be authorised.
enitrile
The impurity 1-methyl
pyrrolidin-2-one shall
88671-89-0
not exceed 1g/kg in the
PART B
CIPAC No: 442
technical material
For the implementation of the uniform principles of Annex
VI, the conclusions of the review report on myclobutanil, 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.
Off
In this overall assessment Member States shall pay particular
icial
attention to the operator safety and ensure that conditions of
Jour
use prescribe the application of adequate personal protective
equipment where appropriate.
nal
of
Conditions of use shall include risk mitigation measures,
the
where appropriate.
European
The Member States concerned shall request the submission of
confirmatory information on the residues of myclobutanil
and its metabolites in following growing seasons and
Union
information confirming that the available residue data cover
all compounds of the residue definition.
The Member States concerned shall ensure that the applicant
submits such confirmatory information to the Commission
by 31 January 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
8.1.2011

---