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27.4.2011 Official
Journal
of
the
European
Union L
106/5
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2011/55/EU
of 26 April 2011
amending Council Directive 91/414/EEC to include paclobutrazol 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
the
United
Kingdom,
Having regard to Council Directive 91/414/EEC of 15 July
which had been designated rapporteur Member State by
1991 concerning the placing of plant protection products on
Regulation (EC) No 1490/2002. The time period for the
the market (
accelerated procedure was respected. The specification of

1 ), and in particular Article 6(1) thereof,
the active substance and the supported uses are the same
as were the subject of Decision 2008/934/EC. That appli
cation also complies with the remaining substantive and
Whereas:
procedural requirements of Article 15 of Regulation (EC)
No 33/2008.
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and
1490/2002 ( 3 ) lay down the detailed rules for the imple
mentation of the third stage of the programme of work
(5) The
United
Kingdom
evaluated
the
additional
data
submitted by the applicant and prepared an additional
referred to in Article 8(2) of Directive 91/414/EEC and
report. It communicated that report to the European
establish a list of active substances to be assessed, with a
Food Safety Authority (hereinafter ‘the Authority’) and
view to their possible inclusion in Annex I to Directive
to the Commission on 20 November 2009. The
91/414/EEC. That list included paclobutrazol.
Authority communicated the additional report to the
other Member States and the applicant for comments
and forwarded the comments it had received to the
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
Commission. In accordance with Article 20(1) of Regu
1490/2002 the notifier withdrew its support of the
lation (EC) No 33/2008 and at the request of the
inclusion of that active substance in Annex I to
Commission, the Authority presented its conclusion on
Directive 91/414/EEC within two months from receipt
paclobutrazol to the Commission on 4 November
of the draft assessment report. Consequently,
2010 ( 6 ). The draft assessment report, the additional
Commission Decision 2008/934/EC of 5 December
report and the conclusion of the Authority were
2008 concerning the non-inclusion of certain active
reviewed by the Member States and the Commission
substances in Annex I to Council Directive 91/414/EEC
within the Standing Committee on the Food Chain and
and the withdrawal of authorisations for plant protection
Animal Health and finalised on 11 March 2011 in the
products containing these substances (
format of the Commission review report for paclo

4 ) was adopted on
the non-inclusion of paclobutrazol.
butrazol.
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
(6)
It has appeared from the various examinations made that
original notifier (hereinafter ‘the applicant’) submitted a
plant protection products containing paclobutrazol may
new application requesting the accelerated procedure to
be expected to satisfy, in general, the requirements laid
be applied, as provided for in Articles 14 to 19 of
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
Commission Regulation (EC) No 33/2008 of
in particular with regard to the uses which have been
17 January 2008 laying down detailed rules for the
examined and detailed in the Commission review report.
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 paclobutrazol.
( 3 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2010;8(11):1876. [60 pp.] doi:10.2903/j.efsa.2010.
( 4 ) OJ L 333, 11.12.2008, p. 11.
1876. Available online: www.efsa.europa.eu/efsajournal.htm

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L 106/6
EN
Official Journal of the European Union
27.4.2011
It is therefore appropriate to include paclobutrazol in
Council Directive 91/414/EEC concerning the placing of
Annex I, in order to ensure that in all Member States
plant protection products on the market ( 1 ) has shown
the authorisations of plant protection products
that difficulties can arise in interpreting the duties of
containing this active substance can be granted in
holders of existing authorisations in relation to access
accordance with the provisions of that Directive.
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
an authorisation demonstrates access to a dossier
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
satisfying the requirements of Annex II to that Directive.
obtain further information on certain specific points.
However, this clarification does not impose any new
Article 6(1) of Directive 91/414/EC provides that
obligations on Member States or holders of authori
inclusion of a substance in Annex I may be subject to
sations compared to the directives which have been
conditions. Therefore, it is appropriate to require that the
adopted until now amending Annex I.
applicant submit confirmatory information as regards the
specification of the technical material, as commercially
manufactured, the analytical methods in soil and
(11) It is therefore appropriate to amend Directive
surface water for the metabolite NOA457654, the risk
91/414/EEC accordingly.
assessment for aquatic organisms, the residues of triazole
derivative metabolites (TDMs) in primary crops,
rotational crops and products of animal origin, and the
potential endocrine disrupting properties. Paclobutrazol
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
and its metabolite CGA 149907 is a mixture of several
paclobutrazol and the withdrawal of authorisations for
optical structures of the same molecule. Depending of
plant protection products containing that substance by
the environmental conditions, these structures may
31 December 2011. It is necessary to delete the line
break down differently in the environmental
concerning paclobutrazol in the Annex to that Decision.
compartments soil, water and air. Further information
should be submitted by the applicant as regards the
potential effect of this phenomenon under realistic
(13) It is therefore appropriate to amend Decision
conditions of use.
2008/934/EC accordingly.
(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
91/414/EEC as a consequence of including an active
Article 1
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 paclobutrazol to ensure that the
requirements laid down by Directive 91/414/EEC, in
particular in its Article 13 and the relevant conditions
Article 2
set out in Annex I, are satisfied. Member States should
The line concerning paclobutrazol in the Annex to Decision
vary, replace or withdraw, as appropriate, existing auth
2008/934/EC is deleted.
orisations, in accordance with the provisions of Directive
91/414/EEC. By derogation from the above deadline, a
longer period should be provided for the submission and
assessment of the complete Annex III dossier of each
Article 3
plant protection product for each intended use in
Member States shall adopt and publish by 30 November 2011
accordance with the uniform principles laid down in
at the latest the laws, regulations and administrative provisions
Directive 91/414/EEC.
necessary to comply with this Directive. They shall forthwith
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
3600/92 of 11 December 1992 laying down the detailed
They shall apply those provisions from 1 December 2011.
rules for the implementation of the first stage of the
programme of work referred to in Article 8(2) of
( 1 ) OJ L 366, 15.12.1992, p. 10.

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EN
27.4.2011 Official
Journal
of
the
European
Union L
106/7
When Member States adopt those provisions, they shall contain
Following that determination Member States shall:
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(a) in the case of a product containing paclobutrazol as the
only active substance, where necessary, amend or
withdraw the authorisation by 31 May 2015 at the latest; or
Article 4
1. Member States shall in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing paclo
(b) in the case of a product containing paclobutrazol as one of
butrazol as an active substance by 30 November 2011.
several active substances, where necessary, amend or
withdraw the authorisation by 31 May 2015 or by the
date fixed for such an amendment or withdrawal in the
respective Directive or Directives which added the relevant
By that date they shall in particular verify that the conditions in
substance or substances to Annex I to Directive
Annex I to that Directive relating to paclobutrazol are met, with
91/414/EEC, whichever is the latest.
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 Annex II to that Directive in accordance with
Article 5
the conditions of Article 13 of that Directive.
This Directive shall enter into force on 1 June 2011.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing paclobutrazol as
Article 6
either the only active substance or as one of several active
This Directive is addressed to the Member States.
substances all of which were listed in Annex I to Directive
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,
Done at Brussels, 26 April 2011.
on the basis of a dossier satisfying the requirements of Annex
III to that Directive and taking into account part B of the entry
in Annex I to that Directive concerning paclobutrazol. On the
For the Commission
basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c),
The President
(d) and (e) of Directive 91/414/EEC.
José Manuel BARROSO

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L 106/8
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
‘353 Paclobutrazol
(2RS,3RS)-1-(4-chloro
≥ 930 g/kg 1
June
2011 31
May
2021 PART
A

phenyl)-4,4-dimethyl-2-
CAS No: 76738-62-0 (1H-1,2,4-triazol-1-
Only uses as plant growth regulator may be authorised.
yl)pentan-3-ol
CIPAC No: 445
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review
report on paclobutrazol, 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 the risk to aquatic plants
and ensure that conditions of use include the risk mitigation measures, where appropriate.
Off
icial
The Member States concerned shall request the submission of confirmatory information as
regards:
Jour
(1) the specification of the technical material, as commercially manufactured;
nal
(2) the analytical methods in soil and surface water for the metabolite NOA457654;
of
the
(3) the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and
European
products of animal origin;
(4) the potential endocrine disrupting properties of paclobutrazol;
(5) the potential adverse effects of breakdown products of the different optical structures of
Union
paclobutrazol and its metabolite CGA 149907 on the environmental compartments soil,
water and air.
The Member States concerned shall ensure that the applicant submits to the Commission the
information set out in points (1) and (2) by 30 November 2011, the information set out in points
(3) by 31 May 2013, the information set out in point (4) within two years after the adoption of
the OECD test guidelines on endocrine disruption and the information set out in point (5) 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.
27.4.2011

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