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10.2.2012 Official
Journal
of
the
European
Union L
37/65
COMMISSION DIRECTIVE 2012/3/EU
of 9 February 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include bendiocarb as
an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
expected to satisfy the requirements laid down in
Article 5 of Directive 98/8/EC. It is therefore appropriate
to include bendiocarb in Annex I to that Directive.
Having regard to the Treaty on the Functioning of the European
Union,
(6) Not
all
potential
uses
have
been
evaluated
at
Union
level.
For example, the assessment only considers professional
Having regard to Directive 98/8/EC of the European Parliament
use, and does not cover direct application to soil or
and of the Council of 16 February 1998 concerning the placing
application on food or feedstuff or on surfaces that
of biocidal products on the market ( 1 ), and in particular the
will come in contact with food or feedstuff. It is
second subparagraph of Article 16(2) thereof,
therefore appropriate that Member States assess those
uses or exposure scenarios and those risks to human
populations and to environmental compartments that
Whereas:
have not been representatively addressed in the Union
level risk assessment and, when granting product auth
orisations, ensure that appropriate measures are taken or
specific conditions imposed in order to reduce the
(1) Commission
Regulation
(EC)
No
1451/2007 of
4 December 2007 on the second phase of the 10-year
identified risks to acceptable levels.
work programme referred to in Article 16(2) of Directive
98/8/EC of the European Parliament and of the Council
concerning the placing of biocidal products on the
market (
(7) In
view
of
the
risks
identified
for
the
aquatic

2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
environment due to wet cleaning of treated surfaces,
Annex I, IA or IB to Directive 98/8/EC. That list
resulting in emissions of a certain scale to surface
includes bendiocarb.
waters, it is appropriate to require that products not be

authorised for use on surfaces that are prone to frequent
wet cleaning, other than crack and crevice or spot treat
ments, unless data are submitted demonstrating that the
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
bendiocarb
product will meet the requirements of both Article 5 of
has been evaluated in accordance with Article 11(2) of
and Annex VI to Directive 98/8/EC, if necessary by the
Directive 98/8/EC for use in product type 18, insec
application of appropriate risk mitigation measures.
ticides, acaricides and products to control other arth
ropods, as defined in Annex V to that Directive.
(8) In
view
of
the
risks
identified
for
human
health,
it
is
(3) The
United
Kingdom
was
designated
as
rapporteur
appropriate to require that products authorised for
Member State and submitted the competent authority
industrial or professional use must be used with appro
report, together with a recommendation, to the
priate personal protective equipment, unless it can be
Commission on 1 April 2008 in accordance with
demonstrated in the application for product authori
Article 14(4) and (6) of Regulation (EC) No 1451/2007.
sation that risks to industrial or professional users can
be reduced to an acceptable level by other means.
(4) The
competent
authority
report
was
reviewed
by
the
Member States and the Commission. In accordance
(9) In
view
of
the
potential
risk
to
honey
bees,
it
is
appro
with Article 15(4) of Regulation (EC) No 1451/2007,
priate to require that, where relevant, action is taken to
the findings of the review were incorporated, within
prevent foraging bees gaining access to treated nests by
the Standing Committee on Biocidal Products on
removing the combs or blocking the nest entrances.
22 September 2011, in an assessment report.
(5) It
appears
from
the
evaluations
that
biocidal
products (10) The provisions of this Directive should be applied at the
used as insecticides, acaricides and products to control
same time in all Member States in order to ensure equal
other arthropods and containing bendiocarb may be
treatment on the Union market of biocidal products
containing the active substance bendiocarb and also to
( 1 ) OJ L 123, 24.4.1998, p. 1.
facilitate the proper operation of the biocidal products
( 2 ) OJ L 325, 11.12.2007, p. 3.
market in general.

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L 37/66
EN
Official Journal of the European Union
10.2.2012
(11) A
reasonable
period
should
be
allowed
to
elapse
before
They shall apply those provisions from 1 February 2014.
an active substance is included in Annex I to Directive
98/8/EC, in order to permit Member States and interested
parties to prepare themselves to meet the new
When Member States adopt those provisions, they shall contain
requirements entailed and to ensure that applicants
a reference to this Directive or be accompanied by such a
who have prepared dossiers can benefit fully from the
reference on the occasion of their official publication. Member
10-year period of data protection, which, in accordance
States shall determine how such reference is to be made.
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
the date of inclusion.
2. Member
States
shall
communicate
to
the
Commission
the
(12) After
inclusion,
Member States should
be allowed
a
text of the main provisions of national law which they adopt in
reasonable period to implement Article 16(3) of
the field covered by this Directive.
Directive 98/8/EC.
(13) Directive
98/8/EC
should
therefore
be
amended
accord
Article 3
ingly.
This Directive shall enter into force on the 20th day following
(14) The
measures provided for in this Directive are in
its publication in the Official Journal of the European Union.
accordance with the opinion of the Standing
Committee on Biocidal Products,
Article 4
HAS ADOPTED THIS DIRECTIVE:
This Directive is addressed to the Member States.
Article 1
Annex I to Directive 98/8/EC is amended in accordance with
the Annex to this Directive.
Done at Brussels, 9 February 2012.
Article 2
For the Commission
1. Member
States
shall
adopt
and
publish,
by
31
January
2013 at the latest, the laws, regulations and administrative
The President
provisions necessary to comply with this Directive.
José Manuel BARROSO

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10.2.2012 Off
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for compliance with
Minimum purity of
Article 16(3) (except for products
the active substance
containing more than one active
EN
No
Common
IUPAC Name
substance, for which the deadline
Expiry date of

Name
Identification Numbers
in the biocidal
Date of inclusion
product as placed
to comply with Article 16(3) shall
inclusion
Product type Specific
provisions
(*)
on the market
be the one set out in the last of
the inclusion decisions relating to
its active substances)
‘53 bendiocarb 2,2-dimethyl-1,3-
970 g/kg 1
February
2014 31
January
2016 31
January
2024 18 The
Union
level
risk
assessment
did
not
address
all
potential
benzodioxol-4-yl
uses, but concerned, for example, application by professionals
methylcarbamate
only, and excluded contact with feed or food and direct
application on soil. When assessing the application for auth
CAS-No: 22781-23-3
orisation of a product in accordance with Article 5 and
EC No: 245-216-8
Annex VI, Member States shall assess, where relevant for
the particular product, those uses or exposure scenarios and
icial
those risks to human populations and to environmental
compartments that have not been representatively addressed
Jour
in the Union level risk assessment.
nal
Member States shall ensure that authorisations are subject to
of
the following conditions:
the
European
Products shall not be used for the treatment of surfaces that
are prone to frequent wet cleaning, other than crack and
crevice or spot treatment, unless data are submitted demon
strating that the product will meet the requirements of
Union
Article 5 and Annex VI, if necessary by the application of
appropriate risk mitigation measures.
Products authorised for industrial or professional use shall be
used with appropriate personal protective equipment, unless
it can be demonstrated in the application for product auth
orisation that risks to industrial or professional users can be
reduced to an acceptable level by other means.
Where relevant, measures shall be taken to prevent foraging
bees from gaining access to treated nests by removing the
combs or blocking the nest entrances.’
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
L
37/67

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