HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
4.3.2011 Official
Journal
of
the
European
Union L
59/37
COMMISSION DIRECTIVE 2011/26/EU
of 3 March 2011
amending Council Directive 91/414/EEC to include diethofencarb as active substance and amending
Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
Having regard to the Treaty on the Functioning of the European
(EC) No 33/2008.
Union,
(5)
France evaluated the additional data submitted by the
applicant and prepared an additional report. It
Having regard to Council Directive 91/414/EEC of 15 July
communicated that report to the European Food Safety
1991 concerning the placing of plant protection products on
Authority (hereinafter ‘the Authority’) and to the
the market ( 1 ), and in particular Article 6(1) thereof,
Commission on 21 December 2009. The Authority
communicated the additional report to the other
Whereas:
Member States and the applicant for comments and
forwarded the comments it had received to the
Commission. In accordance with Article 20(1) of Regu
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
lation (EC) No 33/2008 and at the request of the
No 1490/2002 ( 3 ) lay down the detailed rules for the
Commission, the Authority presented its conclusion on
implementation of the third stage of the programme of
diethofencarb to the Commission on 7 September
work referred to in Article 8(2) of Directive 91/414/EEC
2010 (
and establish a list of active substances to be assessed,

6 ). The draft assessment report, the additional
report and the conclusion of the Authority were
with a view to their possible inclusion in Annex I to
reviewed by the Member States and the Commission
Directive 91/414/EEC. That list included diethofencarb.
within the Standing Committee on the Food Chain and
Animal Health and finalised on 28 January 2011 in the
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
format of the Commission review report for dietho
1490/2002 the notifier withdrew its support of the
fencarb.
inclusion of that active substance in Annex I to
Directive 91/414/EEC within 2 months from receipt of
(6)
It has appeared from the various examinations made that
the draft assessment report. Consequently, Commission
plant protection products containing diethofencarb may
Decision 2008/934/EC of 5 December 2008 concerning
be expected to satisfy, in general, the requirements laid
the non-inclusion of certain active substances in Annex I
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
to Council Directive 91/414/EEC and the withdrawal of
in particular with regard to the uses which have been
authorisations for plant protection products containing
examined and detailed in the Commission review report.
these substances ( 4 ) was adopted on the non-inclusion
It is therefore appropriate to include diethofencarb in
of diethofencarb.
Annex I, in order to ensure that in all Member States
the authorisations of plant protection products
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
containing this active substance can be granted in
original notifier (hereinafter ‘the applicant’) submitted a
accordance with the provisions of that Directive.
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
Commission Regulation (EC) No 33/2008 of
obtain further information on certain specific points.
17 January 2008 laying down detailed rules for the
Article 6(1) of Directive 91/414/EC provides that
application of Council Directive 91/414/EEC as
inclusion of a substance in Annex I may be subject to
regards a regular and an accelerated procedure for the
conditions. Therefore, it is appropriate to require that the
assessment of active substances which were part of the
applicant submit further information confirming the
programme of work referred to in Article 8(2) of that
potential uptake of the metabolite 6-NO 2 -DFC in
Directive but have not been included into its Annex I ( 5 ).
succeeding crops and the risk assessment for non-target
arthropod species.
(4) The
application
was
submitted
to
France,
which
had
been
designated rapporteur Member State by Regulation (EC)
(8) A
reasonable
period
should
be
allowed
to
elapse
before
No 1490/2002. The time period for the accelerated
an active substance is included in Annex I in order to
procedure was respected. The specification of the active
permit Member States and the interested parties to
substance and the supported uses are the same as were
prepare themselves to meet the new requirements
the subject of Decision 2008/934/EC. That application
which will result from the inclusion.
( 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
( 3 ) OJ L 224, 21.8.2002, p. 23.
diethofencarb. EFSA Journal 2010;8(9):1721. [55 pp.] doi:10.2903/
( 4 ) OJ L 333, 11.12.2008, p. 11.
j.efsa.2010.1721. Available online: www.efsa.europa.eu/efsajournal.
( 5 ) OJ L 15, 18.1.2008, p. 5.
htm.

---

L 59/38
EN
Official Journal of the European Union
4.3.2011
(9) Without
prejudice
to
the
obligations
defined
by
Directive
Article 2
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
The line concerning diethofencarb in the Annex to Decision
allowed a period of 6 months after inclusion to review
2008/934/EC is deleted.
existing authorisations of plant protection products
containing diethofencarb to ensure that the requirements
Article 3
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
Member States shall adopt and publish by 30 November 2011
are satisfied. Member States should vary, replace or
at the latest the laws, regulations and administrative provisions
withdraw, as appropriate, existing authorisations, in
necessary to comply with this Directive. They shall forthwith
accordance with the provisions of Directive 91/414/EEC.
communicate to the Commission the text of those provisions
By derogation from the above deadline, a longer period
and a correlation table between those provisions and this
should be provided for the submission and assessment of
Directive.
the complete Annex III dossier of each plant protection
product for each intended use in accordance with the
They shall apply those provisions from 1 December 2011.
uniform principles laid down in Directive 91/414/EEC.
When Member States adopt those provisions, they shall contain
(10) The
experience
gained
from
previous
inclusions
in
Annex
a reference to this Directive or be accompanied by such a
I to Directive 91/414/EEC of active substances assessed
reference on the occasion of their official publication. Member
in the framework of Commission Regulation (EEC) No
States shall determine how such reference is to be made.
3600/92 of 11 December 1992 laying down the detailed
rules for the implementation of the first stage of the
Article 4
programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing
1. Member States shall in accordance with Directive
of plant protection products on the market ( 1 ) has
91/414/EEC, where necessary, amend or withdraw existing
shown that difficulties can arise in interpreting the
authorisations for plant protection products containing dietho
duties of holders of existing authorisations in relation
fencarb as an active substance by 30 November 2011.
to access 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
By that date they shall in particular verify that the conditions in
the holder of an authorisation demonstrates access to a
Annex I to that Directive relating to diethofencarb are met, with
dossier satisfying the requirements of Annex II to that
the exception of those identified in part B of the entry
Directive. However, this clarification does not impose any
concerning that active substance, and that the holder of the
new obligations on Member States or holders of auth
authorisation has, or has access to, a dossier satisfying the
orisations compared to the Directives which have been
requirements of Annex II to that Directive in accordance with
adopted until now amending Annex I.
the conditions of Article 13 of that Directive.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
(11) It is therefore appropriate to amend Directive
orised plant protection product containing diethofencarb as
91/414/EEC accordingly.
either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
91/414/EEC by 31 May 2011 at the latest, Member States
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
diethofencarb and the withdrawal of authorisations for
shall re-evaluate the product in accordance with the uniform
plant protection products containing that substance by
principles provided for in Annex VI to Directive 91/414/EEC,
31 December 2011. It is necessary to delete the line
on the basis of a dossier satisfying the requirements of Annex
concerning diethofencarb in the Annex to that Decision.
III to that Directive and taking into account part B of the entry

in Annex I to that Directive concerning diethofencarb. On the
basis of that evaluation, they shall determine whether the
(13) It is therefore appropriate to amend Decision
product satisfies the conditions set out in Article 4(1)(b), (c),
2008/934/EC accordingly.
(d) and (e) of Directive 91/414/EEC.
Following that determination Member States shall:
(14) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(a) in the case of a product containing diethofencarb as the
only active substance, where necessary, amend or
withdraw the authorisation by 31 May 2015 at the latest; or
HAS ADOPTED THIS DIRECTIVE:
(b) in the case of a product containing diethofencarb as one of
Article 1
several active substances, where necessary, amend or
withdraw the authorisation by 31 May 2015 or by the
Annex I to Directive 91/414/EEC is amended as set out in the
date fixed for such an amendment or withdrawal in the
Annex to this Directive.
respective Directive or Directives which added the relevant
substance or substances to Annex I to Directive
( 1 ) OJ L 366, 15.12.1992, p. 10.
91/414/EEC, whichever is the latest.

---

EN
4.3.2011 Official
Journal
of
the
European
Union L
59/39
Article 5
This Directive shall enter into force on 1 June 2011.
Article 6
This Directive is addressed to the Member States.
Done at Brussels, 3 March 2011.
For the Commission
The President
José Manuel BARROSO

---

L 59/40
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
‘331 Diethofencarb
isopropyl 3,4-diethoxycarbanilate ≥ 970 g/kg
1 June 2011 31
May
2021 PART
A

Impurities:
CAS No: 87130-20-9
Only uses as fungicide may be authorised.
Toluene: not more than 1 g/kg
CIPAC No: 513
PART B
For the implementation of the uniform principles of Annex
VI the conclusions of the review report on diethofencarb,
and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal
Health on 28 January 2011, shall be taken into account.
Off
icial
In this overall assessment Member States shall pay particular
attention to the risk to aquatic organisms and non-target
Jour
arthropods and shall ensure that conditions of use include
the application of adequate risk mitigation measures.
nal
of
The Member States concerned shall request the submission
the
of confirmatory information as regards:
European
(a) the potential uptake of the metabolite 6-NO 2-DFC in
succeeding crops;
(b) the risk assessment for non-target arthropod species.
Union
The Member States concerned shall ensure that the
applicant submits such information to the Commission by
31 May 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
4.3.2011

---