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19.4.2011 Official
Journal
of
the
European
Union L
103/109
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2011/49/EU
of 18 April 2011
amending Council Directive 91/414/EEC to include pencycuron as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
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
Netherlands,
which
had been designated rapporteur Member State by Regu
lation (EC) No 1490/2002. The time period for the accel
Having regard to Council Directive 91/414/EEC of 15 July
erated procedure was respected. The specification of the
1991 concerning the placing of plant protection products on
active substance and the supported uses are the same as
the market (
were the subject of Decision 2008/934/EC. That appli

1 ), and in particular Article 6(1) thereof,
cation also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation (EC)
No 33/2008.
Whereas:
(5) The
Netherlands
evaluated
the
additional
data
submitted
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
by the applicant and prepared an additional report. It
No 1490/2002 ( 3 ) lay down the detailed rules for the
communicated that report to the European Food Safety
implementation of the third stage of the programme of
Authority (hereinafter ‘the Authority’) and to the
work referred to in Article 8(2) of Directive 91/414/EEC
Commission on 4 December 2009. The Authority
and establish a list of active substances to be assessed,
communicated the additional report to the other
with a view to their possible inclusion in Annex I to
Member States and the applicant for comments and
Directive 91/414/EEC. That list included pencycuron.
forwarded the comments it had received to the
Commission. In accordance with Article 20(1) of Regu
lation (EC) No 33/2008 and at the request of the
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
Commission, the Authority presented its conclusion on
1490/2002 the notifier withdrew its support of the
pencycuron to the Commission on 24 September
inclusion of that active substance in Annex I to
2010 ( 6 ). The draft assessment report, the additional
Directive 91/414/EEC within 2 months from receipt of
report and the conclusion of the Authority were
the draft assessment report. Consequently, Commission
reviewed by the Member States and the Commission
Decision 2008/934/EC of 5 December 2008 concerning
within the Standing Committee on the Food Chain and
the non-inclusion of certain active substances in Annex I
Animal Health and finalised on 11 March 2011 in the
to Council Directive 91/414/EEC and the withdrawal of
format of the Commission review report for pencycuron.
authorisations for plant protection products containing
these substances ( 4 ) was adopted on the non-inclusion
of pencycuron.
(6)
It has appeared from the various examinations made that
plant protection products containing pencycuron may be
expected to satisfy, in general, the requirements laid
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
original notifier (hereinafter ‘the applicant’) submitted a
in particular with regard to the uses which have been
new application requesting the accelerated procedure to
examined and detailed in the Commission review report.
be applied, as provided for in Articles 14 to 19 of
It is therefore appropriate to include pencycuron in
Commission Regulation (EC) No 33/2008 of
Annex I, in order to ensure that in all Member States
17 January 2008 laying down detailed rules for the
the authorisations of plant protection products
application of Council Directive 91/414/EEC as regards
containing this active substance can be granted in
a regular and an accelerated procedure for the assessment
accordance with the provisions of that Directive.
of active substances which were part of the programme
( 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 pencycuron.
( 3 ) OJ L 224, 21.8.2002, p. 23.
Summary: EFSA Journal 2010; 8(10):1828. [53 pp.]. doi:10.
( 4 ) OJ L 333, 11.12.2008, p. 11.
2903/j.efsa.2010.1828. Available online: www.efsa.europa.eu

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L 103/110
EN
Official Journal of the European Union
19.4.2011
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
plant protection products containing that substance by
obtain further information on certain specific points.
31 December 2011. It is necessary to delete the line
Article 6(1) of Directive 91/414/EEC provides that
concerning pencycuron in the Annex to that Decision.
inclusion of a substance in Annex I may be subject to
conditions. Therefore, it is appropriate to require that the
applicant submit confirmatory information as regards the
(13) It is therefore appropriate to amend Decision
fate and behaviour in soil of the chlorophenyl and cyclo
2008/934/EC accordingly.
pentyl portions of pencycuron, the fate and behaviour in
natural surface water and sediment systems of the
chlorophenyl and phenyl portions of pencycuron, the
(14) The
measures provided for in this Directive are in
long-term risk to large omnivorous mammals.
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
HAS ADOPTED THIS DIRECTIVE:
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.
(9) 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
Article 2
allowed a period of 6 months after inclusion to review
existing authorisations of plant protection products
The line concerning pencycuron in the Annex to Decision
containing pencycuron to ensure that the requirements
2008/934/EC is deleted.
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
are satisfied. Member States should vary, replace or
Article 3
withdraw, as appropriate, existing authorisations, in
accordance with the provisions of Directive 91/414/EEC.
Member States shall adopt and publish by 30 November 2011
By derogation from the above deadline, a longer period
at the latest the laws, regulations and administrative provisions
should be provided for the submission and assessment of
necessary to comply with this Directive. They shall forthwith
the complete Annex III dossier of each plant protection
communicate to the Commission the text of those provisions
product for each intended use in accordance with the
and a correlation table between those provisions and this
uniform principles laid down in Directive 91/414/EEC.
Directive.
(10) 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
When Member States adopt those provisions, they shall contain
rules for the implementation of the first stage of the
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
Article 4
duties of holders of existing authorisations in relation
to access to data. In order to avoid further difficulties
1. Member States shall in accordance with Directive
it therefore appears necessary to clarify the duties of
91/414/EEC, where necessary, amend or withdraw existing
the Member States, especially the duty to verify that
authorisations for plant protection products containing
the holder of an authorisation demonstrates access to a
pencycuron as an active substance by 30 November 2011.
dossier satisfying the requirements of Annex II to that
Directive. However, this clarification does not impose any
new obligations on Member States or holders of au
By that date they shall in particular verify that the conditions in
thorisations compared to the directives which have
Annex I to that Directive relating to pencycuron are met, with
been adopted until now amending Annex I.
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
(11) It is therefore appropriate to amend Directive
requirements of Annex II to that Directive in accordance with
91/414/EEC accordingly.
the conditions of Article 13 of that Directive.
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
2. By way of derogation from paragraph 1, for each au
pencycuron and the withdrawal of authorisations for
thorised plant protection product containing pencycuron as
either the only active substance or as one of several active
( 1 ) OJ L 366, 15.12.1992, p. 10.
substances all of which were listed in Annex I to Directive

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EN
19.4.2011 Official
Journal
of
the
European
Union L
103/111
91/414/EEC by 31 May 2011 at the latest, Member States shall
date fixed for such an amendment or withdrawal in the
re-evaluate the product in accordance with the uniform prin
respective Directive or Directives which added the relevant
ciples provided for in Annex VI to Directive 91/414/EEC, on
substance or substances to Annex I to Directive
the basis of a dossier satisfying the requirements of Annex III to
91/414/EEC, whichever is the latest.
that Directive and taking into account part B of the entry in
Annex I to that Directive concerning pencycuron. On the basis
of that evaluation, they shall determine whether the product
Article 5
satisfies the conditions set out in Article 4(1)(b), (c), (d) and
This Directive shall enter into force on 1 June 2011.
(e) of Directive 91/414/EEC.
Article 6
Following that determination Member States shall:
This Directive is addressed to the Member States.
(a) in the case of a product containing pencycuron as the only
active substance, where necessary, amend or withdraw the
Done at Brussels, 18 April 2011.
authorisation by 31 May 2015 at the latest; or
For the Commission
(b) in the case of a product containing pencycuron as one of
several active substances, where necessary, amend or
The President
withdraw the authorisation by 31 May 2015 or by the
José Manuel BARROSO

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L 103/112
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
‘354 Pencycuron
1-(4-chlorobenzyl)-1-cyclo
≥ 980 g/kg 1
June
2011 31
May
2021 PART
A

pentyl-3-phenylurea
CAS No 66063-05-6
Only uses as fungicide may be authorised.
CIPAC No 402
PART B
For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on pencycuron, 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.
Off
In this overall assessment Member States shall pay particular
icial
attention to the protection of large omnivorous mammals.
Conditions of use shall include risk mitigation measures, where
Jour
appropriate.
nal
The Member States concerned shall request the submission of
of
confirmatory information as regards:
the
(1) the fate and behaviour in soil of the chlorophenyl and cyclo
European
pentyl portions of pencycuron;
(2) the fate and behaviour in natural surface water and sediment
systems of the chlorophenyl and phenyl portions of
Union
pencycuron;
(3) the long-term risk to large omnivorous mammals.
The Member States concerned shall ensure that the applicant
submits to the Commission the information set out in points
(1), (2) and (3) by 31 May 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
19.4.2011

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