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4.1.2011 Official
Journal
of
the
European
Union
L
1/5
DIRECTIVES
COMMISSION DIRECTIVE 2011/1/EU
of 3 January 2011
amending Council Directive 91/414/EEC to include 6-Benzyladenine as active substance and
amending 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
Having regard to the Treaty on the Functioning of the European
accelerated procedure was respected. The specification of
Union,
the active substance and the supported uses are the same
as were the subject of Decision 2008/941/EC. That appli
Having regard to Council Directive 91/414/EEC of 15 July
cation also complies with the remaining substantive and
1991 concerning the placing of plant protection products on
procedural requirements of Article 15 of Regulation (EC)
the market (
No 33/2008.

1 ), and in particular Article 6(1) thereof,
Whereas:
(5) The
United
Kingdom
evaluated
the
additional
data
(1) Commission
Regulations
(EC)
No
1112/2002
( 2 ) and (EC)
submitted by the applicant and prepared an additional
No 2229/2004 ( 3 ) lay down the detailed rules for the
report. It communicated that report to the European
implementation of the fourth stage of the programme
Food Safety Authority (hereinafter ‘the Authority’) and
of work referred to in Article 8(2) of Directive
to the Commission on 27 November 2009. The
91/414/EEC and establish a list of active substances to
Authority communicated the additional report to the
be assessed, with a view to their possible inclusion in
other Member States and the applicant for comments
Annex I to Directive 91/414/EEC. That list included
and forwarded the comments it had received to the
6-Benzyladenine.
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
(2) In
accordance
with
Article
24e
of
Regulation
(EC)
No 2229/2004 the notifier withdrew its support of the
on 6-Benzyladenine to the Commission on 27 August
inclusion of that active substance in Annex I to Directive
2010 ( 6 ). The draft assessment report, the additional
91/414/EEC within 2 months from receipt of the draft
report and the conclusion of the Authority were
assessment report. Consequently, Commission Decision
reviewed by the Member States and the Commission
2008/941/EC of 8 December 2008 concerning the
within the Standing Committee on the Food Chain and
non-inclusion of certain active substances in Annex I
Animal Health and finalised on 23 November 2010 in
to Council Directive 91/414/EEC and the withdrawal of
the format of the Commission review report for
authorisations for plant protection products containing
6-Benzyladenine.
these substances ( 4 ) was adopted on the non-inclusion
of 6-Benzyladenine.
(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 6-Benzyladenine
new application requesting the application of the accel
may be expected to satisfy, in general, the requirements
erated procedure provided for in Articles 14 to 19 of
laid down in Article 5(1)(a) and (b) of Directive
Commission Regulation (EC) No 33/2008 of 17 January
91/414/EEC, in particular with regard to the uses
2008 laying down detailed rules for the application of
which have been examined and detailed in the
Council Directive 91/414/EEC as regards a regular and an
Commission review report. It is therefore appropriate
accelerated procedure for the assessment of active
to include 6-Benzyladenine in Annex I, in order to
substances which were part of the programme of work
ensure that in all Member States the authorisations of
referred to in Article 8(2) of that Directive but have not
plant protection products containing this active
been included into its Annex I ( 5 ).
substance can be granted in accordance with the
provisions of that Directive.
( 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 6-benzyl-
( 4 ) OJ L 335, 13.12.2008, p. 91.
adenine. EFSA Journal 2010; 8(10):1716. [49 pp.].
( 5 ) OJ L 15, 18.1.2008, p. 5.
doi:10.2903/j.efsa.2010.1716. Available online: www.efsa.europa.eu.

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L 1/6
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Official Journal of the European Union
4.1.2011
(7) A
reasonable
period
should
be
allowed
to
elapse
before HAS ADOPTED THIS DIRECTIVE:
an active substance is included in Annex I in order to
permit Member States and the interested parties to
prepare themselves to meet the new requirements
which will result from the inclusion.
Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.
(8) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
allowed a period of 6 months after inclusion to review
Article 2
existing authorisations of plant protection products
containing 6-Benzyladenine to ensure that the
The line concerning 6-Benzyladenine in the Annex to Decision
requirements laid down by Directive 91/414/EEC, in
2008/941/EC is deleted.
particular in its Article 13 and the relevant conditions
set out in Annex I, are satisfied. Member States should
vary, replace or withdraw, as appropriate, existing au-
Article 3
thorisations, in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
Member States shall adopt and publish by 30 November 2011
deadline, a longer period should be provided for the
at the latest the laws, regulations and administrative provisions
submission and assessment of the complete Annex III
necessary to comply with this Directive. They shall forthwith
dossier of each plant protection product for each
communicate to the Commission the text of those provisions
intended use in accordance with the uniform principles
and a correlation table between those provisions and this
laid down in Directive 91/414/EEC.
Directive.
(9) The
experience
gained
from
previous
inclusions
in
Annex They shall apply those provisions from 1 December 2011.
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 rules for the implementation of the first stage
When Member States adopt those provisions, they shall contain
of the 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 of
reference on the occasion of their official publication. Member
plant protection products on the market ( 1 ) has shown
States shall determine how such reference is to be made.
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 it therefore
Article 4
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
1. Member States shall in accordance with Directive
an authorisation demonstrates access to a dossier
91/414/EEC, where necessary, amend or withdraw existing
satisfying the requirements of Annex II to that Directive.
authorisations for plant protection products containing
However, this clarification does not impose any new
6-Benzyladenine as an active substance by 30 November 2011.
obligations on Member States or holders of author-
isations 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 6-Benzyladenine are met,
(10) It is therefore appropriate to amend Directive
with the exception of those identified in part B of the entry
91/414/EEC accordingly.
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
(11) Decision
2008/941/EC
provides
for
the
non-inclusion
of
the conditions of Article 13 of that Directive.
6-Benzyladenine and the withdrawal of authorisation of
plant protection products containing that substance by
31 December 2011. It is necessary to delete the line
concerning 6-Benzyladenine in the Annex to that
2. By way of derogation from paragraph 1, for each au-
Decision.
thorised plant protection product containing 6-Benzyladenine
as either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
(12) It is therefore appropriate to amend Decision
91/414/EEC by 31 May 2011 at the latest, Member States
2008/941/EC accordingly.
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
(13) The
measures provided for in this Directive are in
III to that Directive and taking into account part B of the entry
accordance with the opinion of the Standing
in Annex I to that Directive concerning 6-Benzyladenine. On
Committee on the Food Chain and Animal Health,
the basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c), (d)
( 1 ) OJ L 366, 15.12.1992, p. 10.
and (e) of Directive 91/414/EEC.

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EN
4.1.2011 Official
Journal
of
the
European
Union
L
1/7
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 6-Benzyladenine as the
only active substance, where necessary, amend or withdraw
Article 6
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 6-Benzyladenine as one
of several active substances, where necessary, amend or
Done at Brussels, 3 January 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 1/8
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

‘322 6-Benzyladenine
N6 -benzyladenine
≥ 973 g/kg 1
June
2011 31
May
2021 PART
A
CAS No
Only uses as plant growth regulator may be authorised.
1214-39-7
CIPAC No 829
PART B
For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on 6-Benzyladenine, 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 attention to
icial
the protection of aquatic organisms. Risk mitigation measures such as
buffer zones shall be applied, where appropriate.’
Jour

nal
(1 ) Further details on identity and specification of active substance are provided in the review report.
of
the
European
Union
4.1.2011

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