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20.4.2011 Official
Journal
of
the
European
Union L
104/41
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2011/50/EU
of 19 April 2011
amending Council Directive 91/414/EEC to include carbetamide as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of
Commission Regulation (EC) No 33/2008 of
17 January 2008 laying down detailed rules for the
Having regard to the Treaty on the Functioning of the European
application of Council Directive 91/414/EEC as regards
Union,
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 Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular Article 6(1) thereof,
(4) The
application
was
submitted
to
France,
which
had
been
Whereas:
designated rapporteur Member State by Regulation (EC)
No 1490/2002. The time period for the accelerated
procedure was respected. The specification of the active
substance and the supported uses are the same as were
the subject of Decision 2008/934/EC. That application
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
also complies with the remaining substantive and
No 1490/2002 ( 3 ) lay down the detailed rules for the
procedural requirements of Article 15 of Regulation
implementation of the second and third stages of the
(EC) No 33/2008.
programme of work referred to in Article 8(2) of
Directive 91/414/EEC and establish a list of active
substances to be assessed, with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. That list
included carbetamide.
(5)
France evaluated the additional data submitted by the
applicant and prepared an additional report. It
communicated that report to the European Food Safety
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No 1490/2002 the notifier withdrew its support of the
Authority (hereinafter ‘the Authority’) and to the
inclusion of that active substance in Annex I to Directive
Commission on 12 February 2010. The Authority
91/414/EEC within 2 months from receipt of the draft
communicated the additional report to the other
assessment report. Consequently, Commission Decision
Member States and the applicant for comments and
2008/934/EC of 5 December 2008 concerning the
forwarded the comments it had received to the
non-inclusion of certain active substances in Annex I
Commission. In accordance with Article 20(1) of Regu
to Council Directive 91/414/EEC and the withdrawal of
lation (EC) No 33/2008 and at the request of the
authorisations for plant protection products containing
Commission, the Authority presented its conclusion on
these substances (
carbetamide to the Commission on 22 November

4 ) was adopted on the non-inclusion
of carbetamide.
2010 (


6 ). The draft assessment report, the additional
report and 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 11 March 2011 in the
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
format of the Commission review report for carbetamide.
original notifier (hereinafter ‘the applicant’) submitted a
( 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 carbetamide.
( 3 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2010; 8(12):1913. [57 pp.]. doi:10.2903/j.
( 4 ) OJ L 333, 11.12.2008, p. 11.
efsa.2010.1913. Available online: www.efsa.europa.eu

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L 104/42
EN
Official Journal of the European Union
20.4.2011
(6)
It has appeared from the various examinations made that
(11) Decision
2008/934/EC
provides
for
the
non-inclusion
of
plant protection products containing carbetamide may be
carbetamide and the withdrawal of authorisations for
expected to satisfy, in general, the requirements laid
plant protection products containing that substance by
down in Article 5(1)(a) and (b) of Directive
31 December 2011. It is necessary to delete the line
91/414/EEC, in particular with regard to the uses
concerning carbetamide in the Annex to that Decision.
which have been examined and detailed in the
Commission review report. It is therefore appropriate
to include carbetamide in Annex I, in order to ensure
(12) It is therefore appropriate to amend Decision
that in all Member States the authorisations of plant
2008/934/EC accordingly.
protection products containing this active substance can
be granted in accordance with the provisions of that
Directive.
(13) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(7) A
reasonable
period
should
be
allowed
to
elapse
before
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
HAS ADOPTED THIS DIRECTIVE:
which will result from the inclusion.
Article 1
(8) Without
prejudice
to
the
obligations
defined
by
Directive Annex I to Directive 91/414/EEC is amended as set out in the
91/414/EEC as a consequence of including an active
Annex to this Directive.
substance in Annex I, Member States should be
allowed a period of 6 months after inclusion to review
existing authorisations of plant protection products
containing carbetamide to ensure that the requirements
Article 2
laid down by Directive 91/414/EEC, in particular in its
The line concerning carbetamide in the Annex to Decision
Article 13 and the relevant conditions set out in Annex I,
2008/934/EC is deleted.
are satisfied. Member States should vary, replace or
withdraw, as appropriate, existing authorisations, in
accordance with the provisions of Directive
Article 3
91/414/EEC. By derogation from the above deadline, a
longer period should be provided for the submission and
Member States shall adopt and publish by 30 November 2011
assessment of the complete Annex III dossier of each
at the latest the laws, regulations and administrative provisions
plant protection product for each intended use in
necessary to comply with this Directive. They shall forthwith
accordance with the uniform principles laid down in
communicate to the Commission the text of those provisions
Directive 91/414/EEC.
and a correlation table between those provisions and this
Directive.
(9) 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
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
appears necessary to clarify the duties of the Member
Article 4
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
carbetamide 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 carbetamide are met, with
the exception of those identified in Part B of the entry
(10) 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
20.4.2011 Official
Journal
of
the
European
Union L
104/43
2. By
way
of
derogation
from
paragraph
1,
for
each
au-
withdraw the authorisation by 31 May 2015 or by the
thorised plant protection product containing carbetamide as
date fixed for such an amendment or withdrawal in the
either the only active substance or as one of several active
respective Directive or Directives which added the relevant
substances all of which were listed in Annex I to Directive
substance or substances to Annex I to Directive
91/414/EEC by 31 May 2011 at the latest, Member States
91/414/EEC, whichever is the latest.
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 carbetamide. On the
This Directive shall enter into force on 1 June 2011.
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 carbetamide as the only
Done at Brussels, 19 April 2011.
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 carbetamide as one of
The President
several active substances, where necessary, amend or
José Manuel BARROSO

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L 104/44
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
‘356 Carbetamide
(R)-1-(Ethylcarbamoyl)ethyl
≥ 950 g/kg 1
June
2011 31
May
2021 PART
A

carbanilate
CAS No: 16118-49-3
Only uses as herbicide may be authorised.
CIPAC No: 95
PART B
For the implementation of the uniform principles of Annex VI the conclusions
of the review report on carbetamide, 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:
Off
(a) the protection of groundwater, when the active substance is applied in
icial
regions with vulnerable soil and/or climatic conditions;
Jour
(b) the risk to non-target plants;
nal
(c) the risk to aquatic organisms.
of
Conditions of use shall include risk mitigation measures, where appropriate.’
the
European
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
20.4.2011

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