HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 37/60
EN
Official Journal of the European Union
10.2.2012
DIRECTIVES
COMMISSION DIRECTIVE 2012/2/EU
of 9 February 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include copper (II)
oxide, copper (II) hydroxide and basic copper carbonate as active substances in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Article 15(4) of Regulation (EC) No 1451/2007, the
findings of the reviews were incorporated, within the
Standing Committee on Biocidal Products on
Having regard to the Treaty on the Functioning of the European
22 September 2011, in an assessment report.
Union,
Having regard to Directive 98/8/EC of the European Parliament
(5) It
appears
from
the
evaluations
that
biocidal
products
and of the Council of 16 February 1998 concerning the placing
used as wood preservatives and containing copper (II)
of biocidal products on the market (
oxide, copper (II) hydroxide or basic copper carbonate

1 ), and in particular the
second subparagraph of Article 16(2) thereof,
may be expected to satisfy the requirements laid down in
Article 5 of Directive 98/8/EC. It is therefore appropriate
to include copper (II) oxide, copper (II) hydroxide and
basic copper carbonate in Annex I to that Directive.
Whereas:


(1) Commission
Regulation
(EC)
No
1451/2007 of (6) Not
all
potential
uses
have
been
evaluated
at
Union
level.
4 December 2007 on the second phase of the 10-year
It is therefore appropriate to require that Member States
work programme referred to in Article 16(2) of Directive
assess those uses or exposure scenarios and those risks to
98/8/EC of the European Parliament and of the Council
human populations and to environmental compartments
concerning the placing of biocidal products on the
that have not been representatively addressed in the
market ( 2 ) establishes a list of active substances to be
Union level risk assessment and, when granting
assessed, with a view to their possible inclusion in
product authorisations, ensure that appropriate
Annex I, IA or IB to Directive 98/8/EC. That list
measures are taken or specific conditions imposed in
includes copper (II) oxide, copper (II) hydroxide and
order to reduce the identified risks to acceptable levels.
basic copper carbonate for use in product type 8,
wood preservatives, as defined in Annex V to that
Directive.
(7) In
view
of
the
risks
identified
for
human
health,
it
is
appropriate to require that safe operational procedures
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
copper
(II)
are established for products containing copper (II)
oxide, copper (II) hydroxide and basic copper carbonate
oxide, copper (II) hydroxide or basic copper carbonate
have been evaluated in accordance with Article 11(2) of
and authorised for industrial use, and that those products
Directive 98/8/EC for use in product type 8.
are used with appropriate personal protective equipment,
unless it can be demonstrated in the application for
product authorisation that risks to industrial users can
(3) France
was
designated
as
rapporteur
Member
State
and
be reduced to an acceptable level by other means.
submitted the competent authority reports, together with
recommendations, to the Commission in accordance
with Article 14(4) and (6) of Regulation (EC) No
1451/2007 on 10 May 2007 for copper (II) oxide, on
(8) Copper
(II)
hydroxide
and
basic
copper
carbonate
were
19 February 2008 for copper (II) hydroxide, and on
also evaluated for application by dipping, and should, in
10 May 2007 and 19 February 2008 for basic copper
view of the risks identified for human health, not be
carbonate.
authorised for that use, unless data is submitted to
demonstrate that the product will meet the requirements
of Article 5 and Annex VI, if necessary by the application
(4) The
competent
authority
reports
were
reviewed
by
the
of appropriate mitigation measures. For copper (II) oxide,
Member States and the Commission. In accordance with
application by dipping was not assessed, and it follows
from the requirement referred to in recital 6 that
( 1 ) OJ L 123, 24.4.1998, p. 1.
products cannot be authorised for such application
( 2 ) OJ L 325, 11.12.2007, p. 3.
unless the authorising Member State assesses it.

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EN
10.2.2012 Official
Journal
of
the
European
Union L
37/61
(9) Unacceptable
risks
for
the
environment
were
identified
in (14) Directive
98/8/EC
should
therefore
be
amended
accord
the case of wood treated with copper (II) oxide, copper
ingly.
(II) hydroxide or basic copper carbonate and used for
outdoor constructions near or above water (the ‘bridge’
scenario in use class 3, as defined by OECD (
(15) The
measures provided for in this Directive are in

1 )). For basic
copper carbonate and copper (II) oxide, unacceptable
accordance with the opinion of the Standing
risks were also found for in-service use of treated
Committee on Biocidal Products,
wood in contact with fresh water (use class 4b as
defined by OECD). It is therefore appropriate to require
HAS ADOPTED THIS DIRECTIVE:
that products are not authorised for the treatment of
wood intended for those uses, unless data is submitted
demonstrating that the product will meet the
Article 1
requirements of both Article 5 of and Annex VI to
Directive 98/8/EC, if necessary by the application of
Annex I to Directive 98/8/EC is amended in accordance with
appropriate risk mitigation measures. For copper (II)
the Annex to this Directive.
hydroxide, wood in contact with fresh water was not
assessed, and it follows from the requirement referred
Article 2
to in recital 6 above that products cannot be authorised
for that use unless the authorising Member State assesses
1. Member
States
shall
adopt
and
publish,
by
31
January
it.
2013 at the latest, the laws, regulations and administrative
provisions necessary to comply with this Directive.
(10) In
view
of
the
risks
identified
for
the
aquatic
and
soil
compartments, it is appropriate to require that freshly
They shall apply those provisions from 1 February 2014.
treated timber is stored after treatment under shelter or
on impermeable hard standing, or both, and that any
losses from the application of products used as wood
When Member States adopt those provisions, they shall contain
preservatives and containing copper (II) oxide, copper
a reference to this Directive or be accompanied by such a
(II) hydroxide or basic copper carbonate are collected
reference on the occasion of their official publication. Member
for reuse or disposal.
States shall determine how such reference is to be made.
(11) The
provisions
of
this
Directive
should
be
applied
at
the
2. Member
States
shall
communicate
to
the
Commission
the
same time in all Member States in order to ensure equal
text of the main provisions of national law which they adopt in
treatment on the Union market of biocidal products
the field covered by this Directive.
containing the active substances copper (II) oxide,
copper (II) hydroxide and basic copper carbonate, and
also to facilitate the proper operation of the biocidal
Article 3
products market in general.
This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
(12) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I to Directive
98/8/EC in order to permit Member States and interested
Article 4
parties to prepare themselves to meet the new
This Directive is addressed to the Member States.
requirements entailed and to ensure that applicants
who have prepared dossiers can benefit fully from the
10-year period of data protection, which, in accordance
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
Done at Brussels, 9 February 2012.
the date of inclusion.
For the Commission
(13) After
inclusion,
Member States should
be allowed
a
reasonable period to implement Article 16(3) of
The President
Directive 98/8/EC.
José Manuel BARROSO
( 1 ) OECD series on emission scenario documents, Number 2, Emission
Scenario Document for Wood Preservatives, part 2, p. 64.

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L 37/62
ANNEX
In Annex I to Directive 98/8/EC, the following entries are added:
Minimum
Deadline for compliance with
purity of the
Article 16(3) (except for
active
products containing more than
EN
one active substance, for which

No
Common
IUPAC name,
substance in
Expiry date of
Product
name
identification numbers
the biocidal
Date of inclusion
the deadline to comply with
inclusion
type
Specific provisions (*)
product as
Article 16(3) shall be the one set
placed on the
out in the last of the inclusion
market
decisions relating to its active
substances)
‘50 Copper Copper (II) hydroxide 965 g/kg 1
February
2014 31
January
2016 31
January
2024
8 When
assessing
the
application
for
authorisation
of
a
product
in
hydroxide
accordance with Article 5 and Annex VI, Member States shall
EC No: 243-815-9
assess, where relevant for the particular product, those uses or
exposure scenarios and those risks to human populations and to
Off
CAS No: 20427-59-2
environmental compartments that have not been representatively
addressed in the Union level risk assessment.
icial
Member States shall ensure that authorisations are subject to the
Jour
following conditions:
nal
of
(1) Products shall not be authorised for application by dipping,
unless data have been submitted in the application for
the
product authorisation demonstrating that that application
European
meets the requirements of Article 5 and Annex VI, if
necessary by the application of appropriate risk mitigation
measures.
Union
(2) For products authorised for industrial use, 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 to industrial users can be reduced to an acceptable
level by other means.
(3) Labels and, where provided, safety data sheets of products
authorised shall indicate that freshly treated timber shall be
stored after treatment under shelter or on impermeable hard
standing, or both, to prevent direct losses to soil or water,
and that any losses from the application of the product shall
be collected for reuse or disposal.
(4) Products shall not be authorised for treatment of wood that
will be used in outdoor constructions near or above water,
unless data is submitted to demonstrate that the product will
10.2.2012
meet the requirements of Article 5 and Annex VI, if
necessary by the application of appropriate mitigation
measures.

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10.2.2012 Off
Minimum
Deadline for compliance with
purity of the
Article 16(3) (except for
active
products containing more than
one active substance, for which
No
Common
IUPAC name,
substance in
Expiry date of
Product
name
identification numbers
the biocidal
Date of inclusion
the deadline to comply with
inclusion
type
Specific provisions (*)
product as
Article 16(3) shall be the one set
placed on the
out in the last of the inclusion
market
decisions relating to its active
substances)
EN

51 Copper
(II)
Copper (II) oxide
976 g/kg 1
February
2014 31
January
2016 31
January
2024
8 When
assessing
the
application
for
authorisation
of
a
product
in
oxide
accordance with Article 5 and Annex VI, Member States shall
EC No: 215-269-1
assess, where relevant for the particular product, those uses or
exposure scenarios and those risks to human populations and to
CAS No: 1317-38-0
environmental compartments that have not been representatively
addressed in the Union level risk assessment.
Member States shall ensure that authorisations are subject to the
following conditions:
icial
(1) For products authorised for industrial use, safe operational
Jour
procedures shall be established, and products shall be used
with appropriate personal protective equipment unless it can
nal
be demonstrated in the application for product authorisation
of
that risks to industrial users can be reduced to an acceptable
the
level by other means.
European
(2) Labels and, where provided, safety data sheets of products
authorised shall indicate that freshly treated timber shall be
stored after treatment under shelter or on impermeable hard
Union
standing, or both, to prevent direct losses to soil or water,
and that any losses from the application of the product shall
be collected for reuse or disposal.
(3) Products shall not be authorised for treatment of wood that
will be used in outdoor constructions near or above water or
for the treatment of wood in contact with fresh water, unless
data is submitted to demonstrate that the product will meet
the requirements of Article 5 and Annex VI, if necessary by
the application of appropriate mitigation measures.
52 Basic
Copper(II) carbonate- 957 g/kg 1
February
2014 31
January
2016 31
January
2024
8 When
assessing
the
application
for
authorisation
of
a
product
in
copper
copper(II) hydroxide
accordance with Article 5 and Annex VI, Member States shall
carbonate
(1:1)
assess, where relevant for the particular product, those uses or
exposure scenarios and those risks to human populations and to
environmental compartments that have not been representatively
EC No: 235-113-6
addressed in the Union level risk assessment.
L
37/63
CAS No: 12069-69-1

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L 37/64
Minimum
Deadline for compliance with
purity of the
Article 16(3) (except for
active
products containing more than
one active substance, for which
No
Common
IUPAC name,
substance in
Expiry date of
Product
name
identification numbers
the biocidal
Date of inclusion
the deadline to comply with
inclusion
type
Specific provisions (*)
product as
Article 16(3) shall be the one set
placed on the
out in the last of the inclusion
market
decisions relating to its active
substances)
EN

Member States shall ensure that authorisations are subject to the
following conditions:
(1) Products shall not be authorised for application by dipping,
unless data have been submitted in the application for
product authorisation demonstrating that that application
meets the requirements of Article 5 and Annex VI, if
necessary by the application of appropriate risk mitigation
measures.
Off
icial
(2) For products authorised for industrial use, safe operational
procedures shall be established, and products shall be used
Jour
with appropriate personal protective equipment unless it can
be demonstrated in the application for product authorisation
nal
that risks to industrial users can be reduced to an acceptable
of
level by other means.
the
European
(3) Labels and, where provided, safety data sheets of products
authorised shall indicate that freshly treated timber shall be
stored after treatment under shelter or on impermeable hard
standing, or both, to prevent direct losses to soil or water,
Union
and that any losses from the application of the product shall
be collected for reuse or disposal.
(4) Products shall not be authorised for treatment of wood that
will be used in outdoor constructions near or above water,
or for the treatment of wood in direct contact with fresh
water, unless data is submitted to demonstrate that the
product will meet the requirements of Article 5 and Annex
VI, if necessary by the application of appropriate mitigation
measures.’
(*) 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
10.2.2012

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