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23.8.2012 Official
Journal
of
the
European
Union L
227/7
DIRECTIVES
COMMISSION DIRECTIVE 2012/22/EU
of 22 August 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include
DDACarbonate as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Member States assess those uses or exposure scenarios
and those risks to human populations and to environ
mental compartments that have not been representatively
Having regard to the Treaty on the Functioning of the European
addressed in the Union level risk assessment and, when
Union,
granting product authorisations, ensure that appropriate
measures are taken or specific conditions imposed in
order to reduce the identified risks to acceptable levels.
Having regard to Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing
of biocidal products on the market ( 1 ), and in particular
Article 11(4) thereof,
(6) In
view
of
the
risks
identified
for
human
health,
for
industrial users it is appropriate to require that safe oper
ational procedures are established, and that products are
used with appropriate personal protective equipment,
Whereas:
unless it can be demonstrated in the application for
product authorisation that risks can be reduced to an
acceptable level by other means.
(1) The
United
Kingdom
received
on
17
January
2007
an
application from Lonza, in accordance with Article 11(1)
of Directive 98/8/EC, for the inclusion of the active
substance DDACarbonate in Annex I to that Directive
(7) In
view
of
the
risks
identified
for
the
aquatic
and
for use in product type 8, wood preservatives, as
terrestrial compartments, it is appropriate to require
defined in Annex V to Directive 98/8/EC. DDACarbonate
that industrial application is conducted within a
was not on the market on the date referred to in
contained area or on impermeable hard standing with
Article 34(1) of Directive 98/8/EC as an active
bunding, that freshly treated timber is stored after
substance of a biocidal product.
treatment under shelter or on impermeable hard
standing, or both, and that any losses from the appli
cation of products used as wood preservatives and
(2) After
carrying
out
an
evaluation,
the
United
Kingdom
containing DDACarbonate are collected for reuse
submitted its report, together with a recommendation,
or disposal.
to the Commission on 11 November 2010.
(3) The
report
was
reviewed
by
the
Member
States
and
the (8) Unacceptable
risks
for
the
environment
were
identified
Commission within the Standing Committee on Biocidal
for situations where wood treated by dipping with
Products on 2 March 2012, and the findings of the
DDACarbonate was continually exposed to the weather
review were incorporated in an assessment report.
or subject to frequent wetting (use class 3 as defined by
OECD ( 2 )), and where wood treated with DDACarbonate
was used for outdoor constructions near or above water
(4) It
appears
from
the
evaluations
that
biocidal
products
(the ‘bridge’ scenario in use class 3, as defined by
used as wood preservatives and containing DDACar
OECD ( 3 )) or was in contact with fresh water (use class
bonate may be expected to satisfy the requirements laid
4b as defined by OECD ( 4 )). It is therefore appropriate to
down in Article 5 of Directive 98/8/EC. It is therefore
require that products are not authorised for the treatment
appropriate to include DDACarbonate for use in product
of wood intended for those uses, unless data is submitted
type 8 in Annex I to that Directive.
demonstrating that the product will meet the
requirements of both Article 5 of and Annex VI to
Directive 98/8/EC, if necessary by the application of
appropriate risk mitigation measures.
(5) Not
all
potential
uses
have
been
evaluated
at
Union
level.
For example, use by non-professional users was not
assessed. It is therefore appropriate to require that
( 2 ) OECD series on emission scenario documents, Number 2, Emission
Scenario Document for Wood Preservatives, Part 2, p. 64.
( 3 ) Ibid.
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 4 ) Ibid.

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L 227/8
EN
Official Journal of the European Union
23.8.2012
(9) The
provisions
of
this
Directive
should
be
applied
simul
They shall apply those provisions from 1 February 2013.
taneously in all Member States in order to ensure equal
treatment on the Union market of biocidal products of
product type 8 containing the active substance DDACar
When Member States adopt those provisions, they shall contain
bonate and also to facilitate the proper operation of the
a reference to this Directive or be accompanied by such a
biocidal products market in general.
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(10) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I to Directive
2. Member
States
shall
communicate
to
the
Commission
the
98/8/EC in order to permit Member States to bring into
text of the main provisions of national law which they adopt in
force the laws, regulations and administrative provisions
the field covered by this Directive.
necessary to comply with this Directive.
(11) Directive 98/8/EC should therefore be amended
Article 3
accordingly.
This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
(12) The
measures provided for in this Directive are in
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, 22 August 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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23.8.2012 Off
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for
compliance with
Article 16(3) (except
EN
Minimum purity
for products containing

of the active
more than one active
No Common
Name
IUPAC Name
substance in the
substance, for which
Identification Numbers
biocidal product
Date of inclusion
the deadline to comply Expiry date of inclusion
Product
type
Specific provisions (*)
as placed on the
with Article 16(3) shall
market
be the one set out in
the last of the inclusion
decisions relating to its
active substances)
‘58 DDACarbonate Reaction
mass
of
N,N- Dry weight:
1 February 2013 Not
applicable 31
January
2023
8 The
Union
level
risk
assessment
did
not
address
all
Didecyl-N,N-dimethyl
740 g/kg
potential uses; certain uses, such as use by non-
ammonium Carbonate and
professionals, were excluded. When assessing the
N,N-Didecyl-N,N-dimethyl
application for authorisation of a product in
icial
ammonium Bicarbonate
accordance with Article 5 and Annex VI, Member
Jour
States shall assess, where relevant for the particular
EC No: 451-900-9
product, those uses or exposure scenarios and those
nal
CAS No: 894406-76-9
risks to human populations and to environmental
compartments that have not been representatively
of
addressed in the Union level risk assessment.
the
European
Member States shall ensure that authorisations are
subject to the following conditions:
Union
(1) for industrial users safe operational procedures
shall be established, and products shall be used
with appropriate personal protective equipment,
unless it can be demonstrated in the application
for product authorisation that risks can be
reduced to an acceptable level by other means;
(2) labels and, where provided, safety data sheets of
products authorised shall indicate that industrial
application shall be conducted within a
contained area or on impermeable hard
standing with bunding, that freshly treated
timber shall be stored after treatment under
shelter or on impermeable hard standing, or
L
both, to prevent direct losses to soil or water,
227/9
and that any losses from the application of the
product shall be collected for reuse or disposal;

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L 227/10
Deadline for
compliance with
Article 16(3) (except
Minimum purity
for products containing
of the active
more than one active
No Common
Name
IUPAC Name
substance in the
substance, for which
Identification Numbers
biocidal product
Date of inclusion
the deadline to comply Expiry date of inclusion
Product
type
Specific provisions (*)
as placed on the
with Article 16(3) shall
market
be the one set out in
EN
the last of the inclusion

decisions relating to its
active substances)
(3) products shall not be authorised for treatment
of wood that will be in contact with fresh water
or used for outdoor constructions near or above
water, or for treatment by dipping of wood that
will be continually exposed to the weather or
subject to frequent wetting, unless data is
submitted to demonstrate that the product
Off
will meet the requirements of Article 5 and
Annex VI, if necessary by the application of
icial
appropriate mitigation measures.’
Jour
(*) 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
nal
of
the
European
Union
23.8.2012

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