HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 327/28
EN
Official Journal of the European Union
27.11.2012
COMMISSION DIRECTIVE 2012/41/EU
of 26 November 2012
amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion
in Annex I thereto of the active substance nonanoic acid to product type 2
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
and other biocidal products as defined in Annex V to
Directive 98/8/EC and containing nonanoic acid may be
Having regard to the Treaty on the Functioning of the European
expected to satisfy the requirements laid down in
Union,
Article 5 of Directive 98/8/EC. It is therefore appropriate
to extend the inclusion of nonanoic acid in Annex I to
Having regard to Directive 98/8/EC of the European Parliament
that Directive to product type 2.
and of the Council of 16 February 1998 concerning the placing
of biocidal products on the market ( 1 ), and in particular the
(7) Not
all
potential
uses
have
been
evaluated
at
Union
level.
second subparagraph of Article 16(2) thereof,
It is therefore appropriate to require that Member States
assess those uses or exposure scenarios and those risks to
Whereas:
human populations and to environmental compartments
that have not been representatively addressed in the
(1) Commission
Regulation
(EC)
No
1451/2007 of
Union level risk assessment and, when granting
4 December 2007 on the second phase of the 10-year
product authorisations, ensure that appropriate
work programme referred to in Article 16(2) of Directive
measures are taken or specific conditions imposed in
98/8/EC of the European Parliament and of the Council
order to reduce the identified risks to acceptable levels.
concerning the placing of biocidal products on the
market ( 2 ) establishes a list of active substances to be
(8)
In view of the irritant properties of the substance, it is
assessed, with a view to their possible inclusion in
appropriate to require that exposure during non-profes
Annex I, IA or IB to Directive 98/8/EC. That list
sional use is minimised through the design of the pack
includes nonanoic acid.
aging, unless it can be demonstrated in the application
for product authorisation that risks for human health can
(2) Commission
Directive
2011/13/EU
of
8
February
2011
be reduced to acceptable levels by other means.
amending Directive 98/8/EC of the European Parliament
and of the Council to include nonanoic acid as an active
substance in Annex I thereto (
(9) The
provisions
of
this
Directive
should
be
applied
simul

3 ) included nonanoic acid
as an active substance in Annex I to Directive 98/8/EC
taneously in all Member States in order to ensure equal
for use in product type 19, repellents and attractants, as
treatment on the Union market of biocidal products of
defined in Annex V to Directive 98/8/EC.
product type 2 containing the active substance nonanoic

acid and also to facilitate the proper operation of the
biocidal products market in general.
(3) Pursuant
to
Regulation
(EC)
No
1451/2007,
nonanoic
acid has now been evaluated in accordance with
Article 11(2) of Directive 98/8/EC for use in product
(10) A
reasonable
period
should
be
allowed
to
elapse
before
type 2, private area and public health area disinfectants
an active substance is included in Annex I to Directive
and other biocidal products, as defined in Annex V to
98/8/EC, in order to permit Member States and interested
that Directive.
parties to prepare themselves to meet the new
requirements entailed and to ensure that applicants
(4) Austria
was
designated
as
Rapporteur
Member
State
and
who have prepared dossiers can benefit fully from the
submitted the competent authority report, together with
10-year period of data protection, which, in accordance
a recommendation, to the Commission on 6 August
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
2010 in accordance with Article 14(4) and (6) of Regu
the date of inclusion.
lation (EC) No 1451/2007.
(11) After
inclusion,
Member States should
be allowed
a
(5) The
competent
authority
report
was
reviewed
by
the
reasonable period to implement Article 16(3) of
Member States and the Commission. In accordance
Directive 98/8/EC.
with Article 15(4) of Regulation (EC) No 1451/2007,
the findings of the review were incorporated, within
(12) Directive
98/8/EC
should
therefore
be
amended
accord
the Standing Committee on Biocidal Products on
ingly.
25 May 2012, in an assessment report.
(6) It
appears
from
the
evaluations
that
biocidal
products (13) In
accordance
with
the
Joint
Political
Declaration
of
used as private area and public health area disinfectants
Member States and the Commission on explanatory
documents of 28 September 2011 ( 4 ), Member States
have undertaken to accompany, in justified cases, the
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 2 ) OJ L 325, 11.12.2007, p. 3.
( 3 ) OJ L 34, 9.2.2011, p. 52.
( 4 ) OJ C 369, 17.12.2011, p. 14.

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EN
27.11.2012 Official
Journal
of
the
European
Union L
327/29
notification of their transposition measures with one or
reference on the occasion of their official publication. Member
more documents explaining the relationship between the
States shall determine how such reference is to be made.
components of a directive and the corresponding parts of
national transposition instruments.
2. Member
States
shall
communicate
to
the
Commission
the
text of the main provisions of national law which they adopt in
(14) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
the field covered by this Directive.
Committee on Biocidal Products,
Article 3
HAS ADOPTED THIS DIRECTIVE:
This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
Article 1
European Union.
Annex I to Directive 98/8/EC is amended in accordance with
the Annex to this Directive.
Article 4
Article 2
This Directive is addressed to the Member States.
1. Member
States
shall
adopt
and
publish,
by
30
September
2013 at the latest, the laws, regulations and administrative
provisions necessary to comply with this Directive.
Done at Brussels, 26 November 2012.
They shall apply those provisions from 1 October 2014.
For the Commission
When Member States adopt those provisions, they shall contain
The President
a reference to this Directive or be accompanied by such a
José Manuel BARROSO

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L 327/30
ANNEX
The following is added to entry ‘No 41’ in Annex I to Directive 98/8/EC:
Minimum
Deadline for compliance with
purity of the
Article 16(3) (except for
active
products containing more
EN
than one active substance, for

No
Common
IUPAC Name
substance in
Name
Identification Numbers
the biocidal
Date of inclusion
which the deadline to comply Expiry date of inclusion Product type Specific
provisions
(*)
product as
with Article 16(3) shall be the
placed on the
one set out in the last of the
market
inclusion decisions relating to
its active substances)
‘1 October 2014 30
September
2016 30
September
2024
2 When
assessing
the
application
for
authorisation
of
a
product in accordance with Article 5 and Annex VI,
Member States shall assess, where relevant for the particular
product, those uses or exposure scenarios and those risks to
human populations and to environmental compartments
Off
that have not been representatively addressed in the
icial
Union level risk assessment.
Jour
Member States shall ensure that authorisations of products
for non-professional use are subject to the packaging being
nal
designed to minimise user exposure, unless it can be
of
demonstrated in the application for product authorisation
the
that risks for human health can be reduced to acceptable
levels by other means.’
European
(*) 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
Union
27.11.2012

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Document Outline

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