HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 44/10
EN
Official Journal of the European Union
15.2.2013
COMMISSION DIRECTIVE 2013/4/EU
of 14 February 2013
amending Directive 98/8/EC of the European Parliament and of the Council to include
Didecyldimethylammonium Chloride as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(6)
Not all potential uses and exposure scenarios have been
evaluated at Union level. For example, neither use by
non-professionals, nor exposure of food or feeding
Having regard to the Treaty on the Functioning of the European
stuff was assessed. It is therefore appropriate to require
Union,
that Member States assess those uses or exposure
scenarios and those risks to human populations and to
environmental compartments that have not been repre
Having regard to Directive 98/8/EC of the European Parliament
sentatively addressed in the Union level risk assessment
and of the Council of 16 February 1998 concerning the placing
and, when granting product authorisations, ensure that
of biocidal products on the market ( 1 ), and in particular the
appropriate measures are taken or specific conditions
second subparagraph of Article 16(2) thereof,
imposed in order to reduce the identified risks to
acceptable levels.
Whereas:
(7) In
view
of
the
risks
identified
for
human
health,
it
is
appropriate to require that safe operational procedures
(1) Commission
Regulation
(EC)
No
1451/2007 of
are established, that products are used with appropriate
4 December 2007 on the second phase of the 10-year
personal protective equipment, and that products are not
work programme referred to in Article 16(2) of Directive
applied on wood with which children may enter in direct
98/8/EC of the European Parliament and of the Council
contact, unless it can be demonstrated in the application
concerning the placing of biocidal products on the
for product authorisation that risks can be reduced to an
market ( 2 ) establishes a list of active substances to be
acceptable level.
assessed, with a view to their possible inclusion in
Annex I, IA or IB to Directive 98/8/EC. That list
includes Didecyldimethylammonium Chloride.
(8)
In view of the risks identified for the environment, it is
appropriate to require that industrial or professional
application is conducted within a contained area or on
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
Didecyldi
impermeable hard standing with bunding, that freshly
methylammonium Chloride has been evaluated in
treated timber is stored after treatment on impermeable
accordance with Article 11(2) of Directive 98/8/EC for
hard standing to prevent direct losses to soil or water,
use in product type 8, wood preservatives, as defined in
and that any losses from the application of products used
Annex V to that Directive.
as wood preservatives and containing Didecyldimethyl
ammonium Chloride are collected for reuse or disposal.
(3) Italy
was
designated
as
Rapporteur
Member
State
and
submitted the competent authority report, together
(9) Unacceptable
risks
for
the
environment
were
identified
with a recommendation, to the Commission on
for situations where wood treated with Didecyldimethyl
14 August 2007 in accordance with Article 10(5) and
ammonium Chloride was continually exposed to the
(7) of Regulation (EC) No 1451/2007.
weather or subject to frequent wetting (use class 3 as
defined by OECD ( 3 )), was used for outdoor constructions
near or above water (the ‘bridge’ scenario in use class 3,
(4) The
competent
authority
report
was
reviewed
by
the
as defined by OECD (
Member States and the Commission. In accordance

4 )) or was in contact with fresh
water (use class 4b as defined by OECD (
with Article 15(4) of Regulation (EC) No 1451/2007,

5 )). It is
therefore appropriate to require that products are not
the findings of the review were incorporated, within
authorised for the treatment of wood intended for
the Standing Committee on Biocidal Products on
those uses, unless data is submitted demonstrating that
21 September 2012, in an assessment report.
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) It
appears
from
the
evaluations
that
biocidal
products
used as wood preservatives and containing Didecyldi
methylammonium Chloride may be expected to satisfy
(10) The
provisions
of
this
Directive
should
be
applied
simul
the requirements laid down in Article 5 of Directive
taneously in all Member States in order to ensure equal
98/8/EC. It is therefore appropriate to include Didecyldi
treatment on the Union market of biocidal products of
methylammonium Chloride for use in product type 8 in
Annex I to that Directive.
( 3 ) OECD series on emission scenario documents, Number 2, Emission
Scenario Document for Wood Preservatives, part 2, p. 64.
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 4 ) Ibid.
( 2 ) OJ L 325, 11.12.2007, p. 3.
( 5 ) Ibid.

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EN
15.2.2013 Official
Journal
of
the
European
Union L
44/11
product type 8 containing the active substance Didecyldi
HAS ADOPTED THIS DIRECTIVE:
methylammonium Chloride and also to facilitate the
proper operation of the biocidal products market in
Article 1
general.
Annex I to Directive 98/8/EC is amended in accordance with
the Annex to this Directive.
(11) A
reasonable
period
should
be
allowed
to
elapse
before
Article 2
an active substance is included in Annex I to Directive
98/8/EC, in order to permit Member States and interested
1. Member
States
shall
adopt
and
publish,
by
31
January
parties to prepare themselves to meet the new
2014 at the latest, the laws, regulations and administrative
requirements entailed and to ensure that applicants
provisions necessary to comply with this Directive.
who have prepared dossiers can benefit fully from the
10-year period of data protection, which, in accordance
They shall apply those provisions from 1 February 2015.
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
the date of inclusion.
When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
(12) After
inclusion,
Member States should
be allowed
a
States shall determine how such reference is to be made.
reasonable period to implement Article 16(3) of
Directive 98/8/EC.
2. Member
States
shall
communicate
to
the
Commission
the
text of the main provisions of national law which they adopt in
the field covered by this Directive.
(13) Directive
98/8/EC
should
therefore
be
amended
accord
ingly.
Article 3

This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
(14) In
accordance
with
the
Joint
Political
Declaration
of
European Union.
28 September 2011 of Member States and the
Commission on explanatory documents
( 6 ), Member
Article 4
States have undertaken to accompany, in justified cases,
This Directive is addressed to the Member States.
the notification of their transposition measures with one
or more documents explaining the relationship between
the components of a directive and the corresponding
parts of national transposition instruments.
Done at Brussels, 14 February 2013.
For the Commission
(15) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
The President
Committee on Biocidal Products,
José Manuel BARROSO
( 6 ) OJ C 369, 17.12.2011, p. 14.

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L 44/12
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Minimum
Deadline for compliance with
degree of
Article 16(3), unless one of
No Common
Name
IUPAC Name
Identification Numbers
purity of the
Date of inclusion
the exceptions indicated in Expiry date of inclusion Product
type Specific
provisions
(***)
EN
active
the footnote to this heading

substance (*)
applies (**)
‘61 Didecyldi
N,N-Didecyl-N,N-dimethyl Dry weight:
1 February 2015 31
January
2017 31
January
2025
8 The
Union
level
risk
assessment
did
not
address
all
methylam
ammonium Chloride
870 g/kg
potential uses and exposure scenarios; certain uses
monium
and exposure scenarios, such as use by non-profes
Chloride;
EC No:
sionals and exposure of food or feed, were excluded.
230-525-2
When assessing the application for authorisation of a
DDAC
product in accordance with Article 5 and Annex VI,
CAS No:
Member States shall assess, where relevant for the
7173-51-5
particular product, those uses or exposure scenarios
Off
and those risks to human populations and to envi
icial
ronmental compartments that have not been repre
sentatively addressed in the Union level risk
Jour
assessment.
nal
Member States shall ensure that authorisations are
of
subject to the following conditions:
the
European
(1) For industrial or professional users safe oper
ational procedures shall be established, and
products shall be used with appropriate personal
protective equipment, unless it can be demon
Union
strated in the application for product authori
sation that risks can be reduced to an acceptable
level by other means.
(2) Products shall not be used for treatment of wood
with which children may enter in direct contact,
unless it can be demonstrated in the application
for product authorisation that risks can be
reduced to an acceptable level.
(3) Labels and, where provided, safety data sheets of
products authorised shall indicate that industrial
or professional application shall be conducted
within a contained area or on impermeable hard
standing with bunding, and that freshly treated
timber shall be stored after treatment on imper
meable hard standing to prevent direct losses to
15.2.2013
soil or water, and that any losses from the appli
cation of the product shall be collected for reuse
or disposal.

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15.2.2013 Off
Minimum
Deadline for compliance with
degree of
Article 16(3), unless one of
No Common
Name
IUPAC Name
Identification Numbers
purity of the
Date of inclusion
the exceptions indicated in Expiry date of inclusion Product
type Specific
provisions
(***)
active
the footnote to this heading
substance (*)
applies (**)
(4) Products shall not be authorised for treatment of
wood that will be in contact with fresh water or
EN
used for outdoor constructions near or above

water, continually exposed to the weather or
subject to frequent wetting, 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.’
(*) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11. The active substance in the product placed on the market can be of equal or
different purity if it has been proven technically equivalent with the evaluated substance.
(**) For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first
authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the
granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for
icial
which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in
accordance with the second subparagraph of Article 4(4).
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
L
44/13

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Document Outline

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