HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 61/14
EN
Official Journal of the European Union
8.3.2011
COMMISSION DIRECTIVE 2011/30/EU
of 7 March 2011
amending Council Directive 91/414/EEC to include fenbutatin oxide as active substance and
amending Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
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 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
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
(EC) No 33/2008.
Whereas:
(5) Belgium
evaluated
the
additional
data
submitted
by
the
applicant and prepared an additional report. It
communicated that report to the European Food Safety
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
Authority (hereinafter ‘the Authority’) and to the
No 1490/2002 ( 3 ) lay down the detailed rules for the
Commission on 1 December 2009. The Authority
implementation of the third stage of the programme of
communicated the additional report to the other
work referred to in Article 8(2) of Directive 91/414/EEC
Member States and the applicant for comments and
and establish a list of active substances to be assessed,
forwarded the comments it had received to the
with a view to their possible inclusion in Annex I to
Commission. In accordance with Article 20(1) of Regu
Directive 91/414/EEC. That list included fenbutatin oxide.
lation (EC) No 33/2008 and at the request of
the Commission, the Authority presented its conclusion
on fenbutatin oxide to the Commission on 23 August
2010 ( 6 ). The draft assessment report, the additional
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
report and the conclusion of the Authority were
No 1490/2002 the notifier withdrew its support of the
reviewed by the Member States and the Commission
inclusion of that active substance in Annex I to Directive
within the Standing Committee on the Food Chain and
91/414/EEC within 2 months from receipt of the draft
Animal Health and finalised on 28 January 2011 in the
assessment report. Consequently, Commission Decision
format of the Commission review report for fenbutatin
2008/934/EC of 5 December 2008 concerning the
oxide.
non-inclusion of certain active substances in Annex I
to Council Directive 91/414/EEC and the withdrawal of
authorisations for plant protection products containing
these substances (
(6)
It has appeared from the various examinations made that

4 ) was adopted on the non-inclusion
of fenbutatin oxide.
plant protection products containing fenbutatin oxide
may be expected to satisfy, in general, the requirements
laid down in Article 5(1)(a) and (b) of Directive
91/414/EEC, in particular with regard to the uses
which have been examined and detailed in the
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
Commission review report. It is therefore appropriate
original notifier (hereinafter ‘the applicant’) submitted a
to include fenbutatin oxide in Annex I, in order to
new application requesting the accelerated procedure to
ensure that in all Member States the authorisations of
be applied, as provided for in Articles 14 to 19 of
plant protection products containing this active
Commission Regulation (EC) No 33/2008 of
substance can be granted in accordance with the
17 January 2008 laying down detailed rules for the
provisions of that Directive.
application of Council Directive 91/414/EEC as regards
( 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 fenbutatin
( 3 ) OJ L 224, 21.8.2002, p. 23.
oxide. EFSA Journal 2010; 8(9):1711. [73 pp.]. doi:10.2903/j.efsa.
( 4 ) OJ L 333, 11.12.2008, p. 11.
2010.1711. Available online: www.efsa.europa.eu

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EN
8.3.2011 Official
Journal
of
the
European
Union L
61/15
(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.
fenbutatin oxide 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 fenbutatin oxide in the Annex to that
applicant submit further information confirming
Decision.
the results of the risk assessment, on the basis of
most recent scientific knowledge; as regards the
relevant impurity bis[hydroxybis(2-methyl-2- (13) It is therefore appropriate to amend Decision
phenylpropyl)tin]oxide (SD 31723). That information
2008/934/EC accordingly.
should concern the following points: genotoxicological
potential, ecotoxicological relevance, as well as spectra,
storage stability of the impurity and methods of analysis
(14) The
measures provided for in this Directive are in
in plant protection products.
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
(9) Without
prejudice
to
the
obligations
defined
by
Directive Annex I to Directive 91/414/EEC is amended as set out in the
91/414/EEC as a consequence of including an active
Annex to this Directive.
substance in Annex I, Member States should be
allowed a period of 6 months after inclusion to review
existing authorisations of plant protection products
Article 2
containing fenbutatin oxide to ensure that the
requirements laid down by Directive 91/414/EEC, in
The line concerning fenbutatin oxide in the Annex to Decision
particular in its Article 13 and the relevant conditions
2008/934/EC is deleted.
set out in Annex I, are satisfied. Member States should
vary, replace or withdraw, as appropriate, existing auth
orisations, in accordance with the provisions of Directive
Article 3
91/414/EEC. By derogation from the above deadline, a
Member States shall adopt and publish by 30 November 2011
longer period should be provided for the submission and
at the latest the laws, regulations and administrative provisions
assessment of the complete Annex III dossier of each
necessary to comply with this Directive. They shall forthwith
plant protection product for each intended use in
communicate to the Commission the text of those provisions
accordance with the uniform principles laid down in
and a correlation table between those provisions and this
Directive 91/414/EEC.
Directive.
(10) The
experience
gained
from
previous
inclusions
in
Annex
I to Directive 91/414/EEC of active substances assessed
They shall apply those provisions from 1 December 2011.
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 of the
When Member States adopt those provisions, they shall contain
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
reference on the occasion of their official publication. Member
of plant protection products on the market ( 1 ) has
States shall determine how such reference is to be made.
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
Article 4
it therefore appears necessary to clarify the duties of
the Member States, especially the duty to verify that
1. Member States shall in accordance with Directive
the holder of an authorisation demonstrates access to a
91/414/EEC, where necessary, amend or withdraw existing
dossier satisfying the requirements of Annex II to that
authorisations for plant protection products containing
Directive. However, this clarification does not impose any
fenbutatin oxide as an active substance by 30 November 2011.
new obligations on Member States or holders of auth
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 fenbutatin oxide 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.

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L 61/16
EN
Official Journal of the European Union
8.3.2011
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 fenbutatin oxide 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 fenbutatin oxide. On
This Directive shall enter into force on 1 June 2011.
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 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 fenbutatin oxide as the
Done at Brussels, 7 March 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 fenbutatin oxide as one
The President
of several active substances, where necessary, amend or
José Manuel BARROSO

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8.3.2011 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, Identifi
cation Numbers
IUPAC Name Purity
(1 ) Entry
into
force
Expiration of
inclusion
Specific provisions
EN
‘338 Fenbutatin
oxide
bis[tris(2-methyl-2-phenylpropyl)-
≥ 970 g/kg
1 June 2011 31
May
2021 PART
A

CAS No: 13356-08-6 tin]oxide
Impurities:
Only uses as acaricide in greenhouses may be authorised.
CIPAC No: 359
bis[hydroxybis(2-methyl-2-
phenylpropyl)tin]oxide (SD
31723): not more than
PART B
3 g/kg
For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on fenbutatin oxide, and in
particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 28 January
2011 shall be taken into account.
icial
In this overall assessment Member States shall pay particular attention
Jour
to:
nal
— the technical specification of the impurity content,
of
— the residue levels in small tomato varieties (cherry tomatoes),
the
— the operator safety. Conditions of use shall prescribe the appli
European
cation of adequate personal protective equipment, where appro
priate,
— the risk to aquatic organisms.
Union
Conditions of authorisation shall include risk mitigation measures,
where appropriate.
The Member States concerned shall request the submission of
information confirming the results of the risk assessment, on the
basis of most recent scientific knowledge, as regards the impurity
SD 31723. That information shall concern the following points:
(a) genotoxicological potential;
(b) ecotoxicological relevance;
(c) spectra, storage stability and methods of analysis in the formu
lation.
The Member States concerned shall ensure that the applicant submits
such confirmatory information to the Commission by 31 May 2013.’
L
(1 ) Further details on identity and specification of active substance are provided in the review report.
61/17

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