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21.4.2011 Official
Journal
of
the
European
Union L
105/19
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2011/52/EU
of 20 April 2011
amending Council Directive 91/414/EEC to include carboxin 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
the
United
Kingdom,
Whereas:
which had been 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 appli
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
cation 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 (EC)
implementation of the second and third stages of the
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 carboxin.
(5) The
United
Kingdom
evaluated
the
additional
data
submitted by the applicant and prepared an additional
report. It communicated that report to the European
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No 1490/2002 the notifier withdrew its support of the
Food Safety Authority (hereinafter ‘the Authority’) and
inclusion of that active substance in Annex I to Directive
to the Commission on 4 December 2009. The
91/414/EEC within two months from receipt of the draft
Authority communicated the additional report to the
assessment report. Consequently, Commission Decision
other Member States and the applicant for comments
2008/934/EC of 5 December 2008 concerning the
and 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 (
carboxin to the Commission on 11 October 2010 ( 6 ).

4 ) was adopted on the non-inclusion
of carboxin.
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 format
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
of the Commission review report for carboxin.
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 carboxin. EFSA
( 3 ) OJ L 224, 21.8.2002, p. 23.
Journal 2010; 8(10):1857. [65 pp.]. doi:10.2903/j.efsa.2010.1857.
( 4 ) OJ L 333, 11.12.2008, p. 11.
Available online: www.efsa.europa.eu

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L 105/20
EN
Official Journal of the European Union
21.4.2011
(6)
It has appeared from the various examinations made that
longer period should be provided for the submission and
plant protection products containing carboxin may be
assessment of the complete Annex III dossier of each
expected to satisfy, in general, the requirements
plant protection product for each intended use in
laid down in Article 5(1)(a) and (b) of Directive
accordance with the uniform principles laid down in
91/414/EEC, in particular with regard to the uses
Directive 91/414/EEC.
which have been examined and detailed in the
Commission review report. It is therefore appropriate
to include carboxin in Annex I, in order to ensure that
in all Member States the authorisations of plant
(10) The
experience
gained
from
previous
inclusions
in
Annex
protection products containing this active substance can
I to Directive 91/414/EEC of active substances assessed
be granted in accordance with the provisions of that
in the framework of Commission Regulation (EEC)
Directive.
No 3600/92 of 11 December 1992 laying down the

detailed rules for the implementation of the first stage
of the programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing of
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
plant protection products on the market ( 6 ) has shown
obtain further information on certain specific points.
that difficulties can arise in interpreting the duties of
Article 6(1) of Directive 91/414/EEC provides that
holders of existing authorisations in relation to access
inclusion of a substance in Annex I may be subject to
to data. In order to avoid further difficulties it therefore
conditions. Therefore, it is appropriate to require that the
appears necessary to clarify the duties of the Member
applicant submit further confirmatory information as
States, especially the duty to verify that the holder of
regards: the specification of the technical material, as
an authorisation demonstrates access to a dossier
commercially manufactured, including appropriate
satisfying the requirements of Annex II to that Directive.
analytical data, the relevance of the impurities,
However, this clarification does not impose any new
comparison and verification of the test material used in
obligations on Member States or holders of author-
the mammalian toxicity and ecotoxicity dossiers against
isations compared to the Directives which have been
the specification of the technical material, analytical
adopted until now amending Annex I.
methods for the monitoring of the metabolite M6 ( 1 ) in
soil, groundwater and surface water and for the moni
toring of metabolite M9 ( 2 ) in groundwater, additional
values regarding the period required for 50 percent dissi
(11) It is therefore appropriate to amend Directive
pation in soil for the soil metabolites P/V-54 (
91/414/EEC accordingly.

3 ) and
P/V-55 ( 4 ), rotational crop metabolism, the long-term
risk to granivorous birds, granivorous mammals
and herbivorous mammals and the relevance for
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
ground water of the soil metabolites P/V-54, P/V-55
carboxin and the withdrawal of authorisations for plant
and M9 if carboxin is classified under Regulation (EC)
protection products containing that substance by
No 1272/2008 of the European Parliament and of the
31 December 2011. It is necessary to delete the line
Council ( 5 ) as ‘suspected of causing cancer’.
concerning carboxin in the Annex to that Decision.
(8) A
reasonable
period
should
be
allowed
to
elapse
before (13) It is therefore appropriate to amend Decision
an active substance is included in Annex I in order to
2008/934/EC accordingly.
permit Member States and the interested parties to
prepare themselves to meet the new requirements
which will result from the inclusion.
(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,
(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
allowed a period of six months after inclusion to
HAS ADOPTED THIS DIRECTIVE:
review existing authorisations of plant protection
products containing carboxin to ensure that the
requirements laid down by Directive 91/414/EEC, in
particular in its Article 13 and the relevant conditions
Article 1
set out in Annex I, are satisfied. Member States should
Annex I to Directive 91/414/EEC is amended as set out in the
vary, replace or withdraw, as appropriate, existing auth
Annex to this Directive.
orisations, in accordance with the provisions of Directive
91/414/EEC. By derogation from the above deadline, a
Article 2
( 1 ) 2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.
( 2 ) (2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide
The line concerning carboxin in the Annex to Decision
4-oxide.
2008/934/EC is deleted.
( 3 ) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.
( 4 ) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.
( 5 ) OJ L 353, 31.12.2008, p. 1.
( 6 ) OJ L 366, 15.12.1992, p. 10.

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EN
21.4.2011 Official
Journal
of
the
European
Union L
105/21
Article 3
satisfying the requirements of Annex III to that Directive and
taking into account part B of the entry in Annex I to that
Member States shall adopt and publish by 30 November 2011
Directive concerning carboxin. On the basis of that evaluation,
at the latest the laws, regulations and administrative provisions
they shall determine whether the product satisfies the conditions
necessary to comply with this Directive. They shall forthwith
set out in Article 4(1)(b), (c), (d) and (e) of Directive
communicate to the Commission the text of those provisions
91/414/EEC.
and a correlation table between those provisions and this
Directive.
Following that determination Member States shall:
They shall apply those provisions from 1 December 2011.
(a) in the case of a product containing carboxin as the only
When Member States adopt those provisions, they shall contain
active substance, where necessary, amend or withdraw the
a reference to this Directive or be accompanied by such a
authorisation by 31 May 2015 at the latest; or
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(b) in the case of a product containing carboxin as one of
several active substances, where necessary, amend or
Article 4
withdraw the authorisation by 31 May 2015 or by the
1. Member States shall in accordance with Directive
date fixed for such an amendment or withdrawal in the
91/414/EEC, where necessary, amend or withdraw existing
respective Directive or Directives which added the relevant
authorisations for plant protection products containing
substance or substances to Annex I to Directive
carboxin as an active substance by 30 November 2011.
91/414/EEC, whichever is the latest.
By that date they shall in particular verify that the conditions in
Article 5
Annex I to that Directive relating to carboxin are met, with the
This Directive shall enter into force on 1 June 2011.
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 the conditions of
Article 6
Article 13 of that Directive.
This Directive is addressed to the Member States.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
Done at Brussels, 20 April 2011.
orised plant protection product containing carboxin as 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
For the Commission
31 May 2011 at the latest, Member States shall re-evaluate the
product in accordance with the uniform principles provided for
The President
in Annex VI to Directive 91/414/EEC, on the basis of a dossier
José Manuel BARROSO

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L 105/22
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
‘357 Carboxin
5,6-dihydro-2-methyl-1,4-
≥ 970 g/kg 1
June
2011 31
May
2021 PART
A

oxathiine-3-carboxanilide
CAS No: 5234-68-4
Only uses as fungicide for seed treatment may be authorised.
CIPAC No: 273
Member States shall ensure that authorisations provide that seed coating be
performed exclusively in professional seed treatment facilities and that these
facilities apply the best available techniques to exclude the release of dust
clouds during storage, transport and application.
PART B
Off
icial
For the implementation of the uniform principles of Annex VI, the conclusions
of the review report on carboxin, and in particular Appendices I and II thereof,
Jour
as finalised in the Standing Committee on the Food Chain and Animal Health
on 11 March 2011 shall be taken into account.
nal
of
In this overall assessment Member States shall pay particular attention to:
the
(a) the risk to operators;
European
(b) the protection of groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions;
Union
(c) the risk to birds and mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of confirmatory
information as regards:
(a) the specification of the technical material, as commercially manufactured,
including appropriate analytical data;
(b) the relevance of the impurities;
(c) comparison and verification of the test material used in the mammalian
toxicity and ecotoxicity dossiers against the specification of the technical
material;
21.4.2011
(d) analytical methods for the monitoring of the metabolite M6 (*) in soil,
groundwater and surface water and for the monitoring of metabolite
M9 (**) in groundwater;

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21.4.2011 Off
No
Common name,
identification numbers
IUPAC name Purity
(1 ) Entry
into
force
Expiration of
inclusion
Specific provisions
(e) additional values regarding the period required for 50 percent dissipation
in soil for the soil metabolites P/V-54 (***) and P/V-55 (****);
(f) rotational crop metabolism;
EN
(g) the long-term risk to granivorous birds, granivorous mammals and

herbivorous mammals;
(h) the relevance for ground water of the soil metabolites P/V-54, P/V-55 and
M9 if carboxin is classified under Regulation (EC) No 1272/2008 as
“suspected of causing cancer”.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (a), (b) and (c) by 1 December
2011, the information set out in points (d), (e), (f) and (g) by 31 May 2013
and the information set out in point (h) within six months after the
notification of the Decision classifying carboxin.’
icial
(1 ) Further details on identity and specification of active substance are provided in the review report.
Jour
(*) 2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.
nal
(**) (2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.
(***) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.
of
(****) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.
the
European
Union
L
105/23

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