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5.3.2011 Official
Journal
of
the
European
Union L
60/17
COMMISSION DIRECTIVE 2011/28/EU
of 4 March 2011
amending Council Directive 91/414/EEC to include indolylbutyric acid as active substance and
amending Commission Decision 2008/941/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
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
France,
which
had
been
designated rapporteur Member State by Regulation (EC)
No 2229/2004. 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 ( 1 ), and in particular Article 6(1) thereof,
the subject of Decision 2008/941/EC. That application
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
(EC) No 33/2008.
Whereas:
(5)
France 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
1112/2002
( 2 ) and (EC)
No 2229/2004 (
Authority (hereinafter ‘the Authority’) and to the

3 ) lay down the detailed rules for the
implementation of the fourth stage of the programme
Commission on 26 January 2010. The Authority
of work referred to in Article 8(2) of Directive
communicated the additional report to the other
91/414/EEC and establish a list of active substances to
Member States and the applicant for comments and
be assessed, with a view to their possible inclusion in
forwarded the comments it had received to the
Annex I to Directive 91/414/EEC. That list included
Commission. In accordance with Article 20(1) of Regu
indolylbutyric acid.
lation (EC) No 33/2008 and at the request of the

Commission, the Authority presented its conclusion on
indolylbutyric acid to the Commission on 3 September
2010 ( 6 ). The draft assessment report, the additional
report and the conclusion of the Authority were
(2) In
accordance
with
Article
24e
of
Regulation
(EC)
No
reviewed by the Member States and the Commission
2229/2004 the notifier withdrew its support of the
within the Standing Committee on the Food Chain and
inclusion of that active substance in Annex I to
Animal Health and finalised on 28 January 2011 in the
Directive 91/414/EEC within 2 months from receipt of
format of the Commission review report for indo
the draft assessment report. Consequently, Commission
lylbutyric acid.
Decision 2008/941/EC of 8 December 2008 concerning
the 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
(6)
It has appeared from the various examinations made that
these substances (
plant protection products containing indolylbutyric acid

4 ) was adopted on the non-inclusion
of indolylbutyric acid.
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
Commission review report. It is therefore appropriate
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
to include indolylbutyric acid in Annex I, in order to
original notifier (hereinafter ‘the applicant’) submitted a
ensure that in all Member States the authorisations of
new application requesting the application of the accel
plant protection products containing this active
erated procedure provided for in Articles 14 to 19 of
substance can be granted in accordance with the
Commission Regulation (EC) No 33/2008 of 17 January
provisions of that Directive.
2008 laying down detailed rules for the application of
Council Directive 91/414/EEC as regards a regular and an
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 1 ) OJ L 230, 19.8.1991, p. 1.
the pesticide risk assessment of the active substance indolylbutyric
( 2 ) OJ L 168, 27.6.2002, p. 14.
acid. EFSA Journal 2010;8(9):1720. [42 pp.]
( 3 ) OJ L 379, 24.12.2004, p. 13.
doi:10.2903/j.efsa.2010.1720. Available online: www.efsa.europa.
( 4 ) OJ L 335, 13.12.2008, p. 91.
eu/efsajournal.htm

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L 60/18
EN
Official Journal of the European Union
5.3.2011
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to (12) Decision
2008/941/EC
provides
for
the
non-inclusion
of
obtain further information on certain specific points.
indolylbutyric acid and the withdrawal of authorisation
Article 6(1) of Directive 91/414/EEC provides that
of 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 indolylbutyric acid in the Annex to that
applicant submit further information confirming: the
Decision.
absence of clastogenicity potential of indolylbutyric
acid, the vapour pressure of indolylbutyric acid and,
consequently, an inhalation toxicity study, and the
(13) It is therefore appropriate to amend Decision
natural background concentration of indolylbutyric acid
2008/941/EC accordingly.
in the soil.
(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 6 months after inclusion to review
existing authorisations of plant protection products
containing indolylbutyric acid 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 indolylbutyric acid in the Annex to
set out in Annex I, are satisfied. Member States should
Decision 2008/941/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 (
reference on the occasion of their official publication. Member

1 ) has
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 indo
new obligations on Member States or holders of auth
lylbutyric acid 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 indolylbutyric acid 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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EN
5.3.2011 Official
Journal
of
the
European
Union L
60/19
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
fixed for such an amendment or withdrawal in the
orised plant protection product containing indolylbutyric acid as
respective Directive or Directives which added the relevant
either the only active substance or as one of several active
substance or substances to Annex I to Directive
substances all of which were listed in Annex I to Directive
91/414/EEC, whichever is the latest.
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 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 indolylbutyric acid. 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 indolylbutyric acid as
Done at Brussels, 4 March 2011.
the 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 indolylbutyric acid as
one of several active substances, where necessary, amend or
The President
withdraw the authorisation by 31 May 2015 or by the date
José Manuel BARROSO

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L 60/20
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
‘333 Indolylbutyric
acid 4-(1H-indol-3-yl)butyric acid
≥ 994 g/kg 1
June
2011 31
May
2021 PART
A

CAS No 133-32-4
Only uses as plant growth regulator in ornamentals may be
authorised.
CIPAC No 830
PART B
For the implementation of the uniform principles of Annex
VI, the conclusions of the review report on indolylbutyric
acid, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain
Off
and Animal Health on 28 January 2011 shall be taken
icial
into account.
Jour
In this overall assessment Member States shall pay particular
attention to the operators and workers safety. Conditions of
nal
authorisation shall include the application of adequate
of
personal protective equipment and risk mitigation
the
measures to reduce the exposure.
European
The Member States concerned shall request the submission
of further information to confirm:
(a) the absence of clastogenicity potential of indolylbutyric
Union
acid;
(b) the vapour pressure of indolylbutyric acid and,
consequently, an inhalation toxicity study;
(c) the natural background concentration of indolylbutyric
acid in the soil.
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.
5.3.2011

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