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9.3.2011 Official
Journal
of
the
European
Union L
62/23
COMMISSION DIRECTIVE 2011/33/EU
of 8 March 2011
amending Council Directive 91/414/EEC to include 1-decanol as active substance and amending
Commission Decision 2008/941/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) The
application
was
submitted
to
the
United
Kingdom,
which had been designated rapporteur Member State by
Regulation (EC) No 2229/2004. The time period for the
accelerated procedure was respected. The specification of
Having regard to the Treaty on the Functioning of the European
the active substance and the supported uses are the same
Union,
as were the subject of Decision 2008/941/EC. That appli
cation also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation (EC)
Having regard to Council Directive 91/414/EEC of 15 July
No 33/2008.
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular Article 6(1) thereof,
(5) The
United
Kingdom
evaluated
the
additional
data
submitted by the applicant and prepared an additional
report. It communicated that report to the European
Whereas:
Food Safety Authority (hereinafter ‘the Authority’) and
to the Commission on 10 December 2009. The
Authority communicated the additional report to the
(1) Commission
Regulations
(EC)
No
1112/2002
( 2 ) and (EC)
other Member States and the applicant for comments
No 2229/2004 ( 3 ) lay down the detailed rules for the
and forwarded the comments it had received to the
implementation of the fourth stage of the programme
Commission. In accordance with Article 20(1) of Regu
of work referred to in Article 8(2) of Directive
lation (EC) No 33/2008 and at the request of the
91/414/EEC and establish a list of active substances to
Commission, the Authority presented its conclusion on
be assessed, with a view to their possible inclusion in
1-decanol to the Commission on 27 August 2010 ( 6 ).
Annex I to Directive 91/414/EEC. That list included 1-
The draft assessment report, the additional report and
decanol.
the conclusion of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 28 January 2011 in the format
(2) In
accordance
with
Article
24e
of
Regulation
(EC)
No
of the Commission review report for 1-decanol.
2229/2004 the notifier withdrew its support of the
inclusion of that active substance in Annex I to
Directive 91/414/EEC within two months from receipt
(6)
It has appeared from the various examinations made that
of the draft assessment report. Consequently,
plant protection products containing 1-decanol may be
Commission Decision 2008/941/EC of 8 December
expected to satisfy, in general, the requirements laid
2008 concerning the non-inclusion of certain active
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
substances in Annex I to Council Directive 91/414/EEC
in particular with regard to the uses which have been
and the withdrawal of authorisations for plant protection
examined and detailed in the Commission review report.
products containing these substances ( 4 ) was adopted on
It is therefore appropriate to include 1-decanol in Annex
the non-inclusion of 1-decanol.
I, in order to ensure that in all Member States the au-
thorisations of plant protection products containing this
active substance can be granted in accordance with the
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
provisions of that Directive.
original notifier (hereinafter ‘the applicant’) submitted a
new application requesting the application of the accel
erated procedure provided for in Articles 14 to 19 of
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
Commission Regulation (EC) No 33/2008 of 17 January
obtain further information on certain specific points.
2008 laying down detailed rules for the application of
Article 6(1) of Directive 91/414/EC provides that
Council Directive 91/414/EEC as regards a regular and an
inclusion of a substance in Annex I may be subject to
accelerated procedure for the assessment of active
conditions. Therefore, it is appropriate to require that the
substances which were part of the programme of work
applicant submit confirmatory information as regards the
referred to in Article 8(2) of that Directive but have not
risk to aquatic organisms and of information confirming
been included into its Annex I ( 5 ).
the groundwater, surface water and sediment exposure
assessments.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 168, 27.6.2002, p. 14.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 379, 24.12.2004, p. 13.
the pesticide risk assessment of the active substance 1-decanol. EFSA
( 4 ) OJ L 335, 13.12.2008, p. 91.
Journal 2010; 8(9):1715. [42 pp.] doi:10.2903/j.efsa.2010.1715.
( 5 ) OJ L 15, 18.1.2008, p. 5.
Available online: www.efsa.europa.eu/efsajournal.htm

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L 62/24
EN
Official Journal of the European Union
9.3.2011
(8) A
reasonable
period
should
be
allowed
to
elapse
before (14) The measures provided for in this Directive are in
an active substance is included in Annex I in order to
accordance with the opinion of the Standing
permit Member States and the interested parties to
Committee on the Food Chain and Animal Health,
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
substance in Annex I, Member States should be
Annex I to Directive 91/414/EEC is amended as set out in the
allowed a period of six months after inclusion to
Annex to this Directive.
review existing authorisations of plant protection
products containing 1-decanol to ensure that the
Article 2
requirements laid down by Directive 91/414/EEC, in
particular in its Article 13 and the relevant conditions
The line concerning 1-decanol in the Annex to Decision
set out in Annex I, are satisfied. Member States should
2008/941/EC is deleted.
vary, replace or withdraw, as appropriate, existing au-
thorisations, in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
Article 3
deadline, a longer period should be provided for the
submission and assessment of the complete Annex III
Member States shall adopt and publish by 30 November 2011
dossier of each plant protection product for each
at the latest the laws, regulations and administrative provisions
intended use in accordance with the uniform principles
necessary to comply with this Directive. They shall forthwith
laid down in 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
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
a reference to this Directive or be accompanied by such a
programme of work referred to in Article 8(2) of
reference on the occasion of their official publication. Member
Council Directive 91/414/EEC concerning the placing
States shall determine how such reference is to be made.
of plant protection products on the market ( 1 ) has
shown that difficulties can arise in interpreting the
duties of holders of existing authorisations in relation
Article 4
to access to data. In order to avoid further difficulties
it therefore appears necessary to clarify the duties of
1. Member States shall in accordance with Directive
the Member States, especially the duty to verify that
91/414/EEC, where necessary, amend or withdraw existing
the holder of an authorisation demonstrates access to a
authorisations for plant protection products containing
dossier satisfying the requirements of Annex II to that
1-decanol as an active substance by 30 November 2011.
Directive. However, this clarification does not impose any
new obligations on Member States or holders of au-
thorisations compared to the Directives which have
By that date they shall in particular verify that the conditions in
been adopted until now amending Annex I.
Annex I to that Directive relating to 1-decanol are met, with 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
(11) It is therefore appropriate to amend Directive
Annex II to that Directive in accordance with the conditions of
91/414/EEC accordingly.
Article 13 of that Directive.
2. By way of derogation from paragraph 1, for each au-
(12) Decision
2008/941/EC
provides
for
the
non-inclusion
of
thorised plant protection product containing 1-decanol as
1-decanol and the withdrawal of authorisation of plant
either the only active substance or as one of several active
protection products containing that substance by
substances all of which were listed in Annex I to Directive
31 December 2011. It is necessary to delete the line
91/414/EEC by 31 July 2011 at the latest, Member States
concerning 1-decanol in the Annex to that Decision.
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
III to that Directive and taking into account part B of the entry
(13) It is therefore appropriate to amend Decision
in Annex I to that Directive concerning 1-decanol. On the basis
2008/941/EC accordingly.
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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EN
9.3.2011 Official
Journal
of
the
European
Union L
62/25
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 1-decanol as the only
Article 6
active substance, where necessary, amend or withdraw the
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 1-decanol as one of
several active substances, where necessary, amend or
Done at Brussels, 8 March 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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L 62/26
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
(*) Entry
into
force Expiration
of
inclusion Specific
provisions
EN
‘340 1-decanol
Decan-1-ol
≥ 960 g/kg 1
June
2011 31
May
2021 PART
A

CAS No: 112-30-1
Only uses as plant growth regulator.
CIPAC No: 831
PART B
For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on 1-decanol, 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.
In this overall assessment Member States shall pay particular attention to:
Off
— the risk to consumers from residues in case of use on food or feed crops,
icial
— the risk for operator and ensure that conditions of use prescribe the
Jour
application of adequate personal protective equipment where appropriate,
nal
— the protection of groundwater when the active substance is applied in
regions with vulnerable soil and/or climatic conditions,
of
the
— the risk to aquatic organisms,
European
— the risk to non-target arthropods and bees that may be exposed to the
active substance by visiting flowering weeds present in the crop at time of
application.
Union
Risk mitigation measures shall be applied, where appropriate.
The Member States concerned shall request the submission of confirmatory
information, as regards the risk to aquatic organisms and of information
confirming the groundwater, surface water and sediment exposure
assessments.
The Member States concerned shall ensure that the applicant submits such
confirmatory information to the Commission by 31 May 2013.’
(*) Further details on identity and specification of active substance are provided in the review report.
9.3.2011

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