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11.5.2011 Official
Journal
of
the
European
Union L
122/71
DIRECTIVES
COMMISSION DIRECTIVE 2011/58/EU
of 10 May 2011
amending Council Directive 91/414/EEC to renew the inclusion of carbendazim as active substance
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
applicant on 14 December 2009. The Authority
presented its conclusion on the peer review of the risk
assessment of carbendazim ( 2 ) to the Commission on
Having regard to the Treaty on the Functioning of the European
30 April 2010. After the applicant had been given the
Union,
possibility to comment and taking into account its
comments delivered on 31 May 2010, the draft re-
assessment report and the conclusion from the
Authority were reviewed by the Member States and the
Having regard to Council Directive 91/414/EEC of 15 July
Commission within the Standing Committee on the Food
1991 concerning the placing of plant protection products on
Chain and Animal Health and finalised on 23 November
the market ( 1 ), and in particular Article 6(1) thereof,
2010 in the format of the Commission review report for
carbendazim.
Whereas:
(7)
It has appeared from the various examinations made that
(1) The
inclusion
of
carbendazim
in
Annex
I
to
Directive
plant protection products containing carbendazim may
91/414/EEC expires on 13 June 2011.
be expected to continue to satisfy the requirements laid
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
as regards the uses which were examined and detailed in
(2) On
request
the
inclusion
of
an
active
substance
may
be
the Commission review report. It is therefore appropriate
renewed for a period not exceeding ten years. On
to renew the inclusion of carbendazim in Annex I to
6 August 2007 the Commission received such a
Directive 91/414/EEC, in order to ensure that plant
request from the applicant regarding the renewal of the
protection products containing this active substance
inclusion for this substance.
may continue to be authorised where they comply with
that Directive. In addition to the uses supported for the
first inclusion, the applicant supports in its renewal
(3) On
10
January
2008,
the
applicant
submitted
to
the
dossier the use on fodder beet. Taking into consideration
rapporteur Member State Germany data in support of
the additional data submitted by the applicant, the use on
its request for renewal of the inclusion of carbendazim.
fodder beet should be added to the list of uses that may
be authorised.
(4) The
rapporteur
Member
State
prepared
a
draft
re-
assessment report which was commented by the
applicant on 13 May 2009 and after its finalisation
(8) Article
5(4)
of
Directive
91/414/EEC
provides
that
was submitted to the applicant and the Commission on
inclusion of a substance in Annex I may be subject to
24 July 2009. In addition to the assessment of the
restrictions. In order to correctly reflect the high level of
substance, that report includes a list of the studies the
protection of human and animal health and the
rapporteur Member State relied on for its assessment.
environment sought in the Union, it is necessary to
limit the uses of carbendazim to those that have
actually been assessed and which are considered to
(5) The
Commission
communicated
the
draft
re-assessment
comply with the conditions of Article 5(1) of Directive
report to the European Food Safety Authority (here
91/414/EEC. This implies that uses which are not part of
inafter: ‘the Authority’) and to the Member States on
the list of uses set out in Annex I to that Directive may
28 July 2009 for comments.
not be authorised unless they are first added to that list.
It is appropriate to set maximum limits for the presence
of two relevant impurities 2-amino-3-hydroxyphenazine
(AHP) and 2,3-diaminophenazine (DAP) in commercially
(6) At the request of the Commission, the draft re-
manufactured carbendazim.
assessment report was peer reviewed by the Member
States and the Authority and commented by the
( 2 ) European Food Safety Authority; Conclusion on the peer review of
the pesticide risk assessment of the active substance carbendazim
( 1 ) OJ L 230, 19.8.1991, p. 1.
EFSA Journal 2010; 8(5):1598.

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L 122/72
EN
Official Journal of the European Union
11.5.2011
(9)
Without prejudice to the conclusion set out in recital 8,
set out in Annex I to that Directive, continue to be
it is appropriate to obtain further information on certain
satisfied. As appropriate, Member States should renew,
specific points. Article 6(1) of Directive 91/414/EC
where appropriate with modifications, or refuse to
provides that inclusion of a substance in Annex I may
renew authorisations. By way of derogation from that
be subject to conditions. Therefore, it is appropriate to
deadline, a longer period should be provided for the
require that the applicant submits further information as
submission and assessment of the update of the
regards, the aerobic degradation in soil, the long-term
complete Annex III dossier of each plant protection
risk to birds and the relevance of a third impurity, for
product for each intended use in accordance with the
confidentiality reasons referred to as AEF037197. In
uniform principles laid down in Directive 91/414/EEC.
addition, the applicant should be requested to examine
the studies included in the list in the draft re-assessment
report of 16 July 2009 (Volume 1, Level 4 ‘Further
information’, pp. 155-157).
(14) It is therefore appropriate to amend Directive
91/414/EEC accordingly.
(10) Several Member States have expressed concerns as
(15) The
Standing
Committee
on
the
Food
Chain
and
Animal
regards the hazard profile of this substance. Similar
Health did not deliver an opinion within the time limit
concerns were expressed at the time of the first inclusion.
laid down by its Chair and the Commission therefore
The renewal dossier is, in part, based on toxicity data
submitted to the Council a proposal relating to these
used during the assessment of the dossier submitted for
measures. Since, on the expiry of the period laid down
the initial inclusion of this substance. The original
in the second subparagraph of Article 19(2) of Directive
inclusion was limited to a period of three years ( 1 ).
91/414/EEC, the Council had neither adopted the
Account should also be taken of the progressive under
proposed measures nor indicated its opposition to
standing of the need to ensure a high level of protection
them, these measures are to be adopted by the
of human and animal health and the sustainable
Commission,
environment. Therefore, it is appropriate to limit the
renewal period of the inclusion to three and half years.
HAS ADOPTED THIS DIRECTIVE:
(11) As
with
all
substances
included
in
Annex
I
to
Directive
91/414/EEC, the status of carbendazim could be
Article 1
reviewed under Article 5(5) of that Directive in the
light of any new data becoming available, such as its
Annex I to Directive 91/414/EEC is amended in accordance
currently ongoing evaluation in the framework of
with the Annex to this Directive.
Directive 98/8/EC of the European Parliament and the
Council of 16 February 1998 concerning the placing of
biocidal substances on the market ( 2 ) and from the
review of relevant scientific literature.
Article 2
Member States shall adopt and publish by 30 November 2011
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
(12) A
reasonable
period
should
be
allowed
to
elapse
before
communicate to the Commission the text of those provisions
the inclusion of an active substance in Annex I to
and a correlation table between those provisions and this
Directive 91/414/EEC is renewed in order to permit
Directive.
Member States and the interested parties to prepare
themselves to meet the new requirements resulting
from the renewal.
They shall apply those provisions from 1 December 2011.
(13) Without
prejudice
to
the
obligations
defined
by
Directive
When Member States adopt those provisions, they shall contain
91/414/EEC as a consequence of renewing the inclusion
a reference to this Directive or be accompanied by such a
of an active substance in Annex I thereto, Member States
reference on the occasion of their official publication. Member
should be allowed a period of six months after renewal
States shall determine how such reference is to be made.
to review authorisations of plant protection products
containing carbendazim to make sure that the
requirements laid down in Directive 91/414/EEC, in
particular in its Article 13, and the relevant conditions
Article 3
1. Member States shall in accordance with Directive
( 1 ) Commission Directive 2006/135/EC of 11 December 2006
91/414/EEC, where necessary, amend or withdraw existing
amending Council Directive 91/414/EEC to include carbendazim
as active substance (OJ L 349, 12.12.2006, p. 37).
authorisations for plant protection products containing
( 2 ) OJ L 123, 24.4.1998, p. 1.
carbendazim as an active substance by 1 December 2011.

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EN
11.5.2011 Official
Journal
of
the
European
Union L
122/73
By that date they shall in particular verify that the conditions in
satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e)
Annex I to that Directive relating to carbendazim are met, with
of Directive 91/414/EEC. Following that determination Member
the exception of those identified in part B of the entry
States shall, where necessary, amend or withdraw the authori
concerning that active substance, and that the holder of the
sation by 1 December 2013.
authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
the conditions of Article 13 of that Directive.
Article 4
This Directive shall enter into force on 1 June 2011.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing carbendazim as
either the only active substance or as one of several active
Article 5
substances, all of which were listed in Annex I to Directive
This Directive is addressed to the Member States.
91/414/EEC by 1 June 2011 at the latest, Member States
shall, where necessary, re-evaluate the products, to take into
account developments occurred in the scientific and technical
Done at Brussels, 10 May 2011.
knowledge and 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 III to
For the Commission
that Directive and taking into account part B of the entry in
Annex I to that Directive concerning carbendazim. On the basis
The President
of that evaluation, they shall determine whether the product still
José Manuel BARROSO

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L 122/74
ANNEX
In Annex I to Directive 91/414/EEC, row No 149 is replaced by the following:
No
Common name,
identification numbers
IUPAC name Purity
(1 ) Entry
into
force Expiration
of
inclusion Specific
provisions
EN
‘149 Carbendazim
Methyl benzimidazol-2- ≥ 980 g/kg
1 June 2011 30
November
PART A

CAS No 10605-21-7
ylcarbamate
Relevant impurities
2014
CIPAC No 263
2-amino-3-hydroxyphenazine
Only uses as fungicide on the following crops may be authorised:
(AHP): not more than 0,0005 g/kg
2,3-diaminophenazine (DAP): not
— cereals,
more than 0,003 g/kg
— rape seed,
— sugar and fodder beet,
Off
— maize,
icial
Jour
at rates not exceeding:
nal
— 0,25 kg active substance per hectare per application for cereals
of
and rape seed,
the
European
— 0,075 kg active substance per hectare per application for sugar
and fodder beet,
— 0,1 kg active substance per hectare per application for maize.
Union
The following uses must not be authorised:
— air application,
— knapsack and handheld applications neither by amateur nor
by professional users,
— home gardening.
Member States shall ensure that all appropriate risk mitigation
measures are applied. Particular attention must be paid to the
protection of:
— aquatic organisms. Appropriate drift mitigation measures must
11.5.2011
be applied to minimise the exposure of surface water bodies.
This should include keeping a distance between treated areas
and surface water bodies alone or in combination with the use
of drift-reducing techniques or devices,

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11.5.2011 Off
No
Common name,
identification numbers
IUPAC name Purity
(1 ) Entry
into
force Expiration
of
inclusion Specific
provisions
— earthworms and other soil macro-organisms. Conditions of
authorisation shall include risk mitigation measures, such as
the selection of the most appropriate combination of numbers
and timing of application, and, if necessary, the degree of
concentration of the active substance,
EN

— birds (long-term risk). Depending on the results of the risk
assessment for specific uses, targeted mitigation measures to
minimise the exposure may become necessary,
— operators, who must wear suitable protective clothing, in
particular gloves, coveralls, rubber boots and face protection
or safety glasses during mixing, loading, application and
cleaning of the equipment, unless the exposure to the
substance is adequately precluded by the design and
construction of the equipment itself or by the mounting of
specific protective components on such equipment.
icial
PART B
Jour
For the implementation of the uniform principles of Annex VI,
nal
the conclusions of the review report on carbendazim, and in
particular Appendices I and II thereof, shall be taken into account.
of
the
The Member States concerned shall request that the applicant
European
provides the following to the Commission:
— by 1 December 2011 at the latest, information as regards the
toxicological and ecotoxicological relevance of the impurity
Union
AEF037197,
— by 1 June 2012 at the latest, the examination of the studies
included in the list in the draft re-assessment report of 16 July
2009 (Volume 1, Level 4 “Further information”, pp. 155-157),
— by 1 June 2013 at the latest, information on the fate and
behaviour (route of aerobic degradation in soil) and the
long-term risk to birds.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
122/75

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