HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 123/36
EN
Official Journal of the European Union
9.5.2012
DIRECTIVES
COMMISSION DIRECTIVE 2012/14/EU
of 8 May 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include methyl nonyl
ketone as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
the findings of the review were incorporated, within the
Standing Committee on Biocidal Products on
9 December 2011, in an assessment report.
Having regard to the Treaty on the Functioning of the European
Union,
(5) It
appears
from
the
evaluations
that
biocidal
products
used as repellents and containing methyl nonyl ketone
Having regard to Directive 98/8/EC of the European Parliament
may be expected to satisfy the requirements laid down in
and of the Council of 16 February 1998 concerning the placing
Article 5 of Directive 98/8/EC. It is therefore appropriate
of biocidal products on the market (
to include methyl nonyl ketone in Annex I to that

1 ), and in particular the
second subparagraph of Article 16(2) thereof,
Directive.
Whereas:
(6) Not
all
potential
uses
have
been
evaluated
at
Union
level.
It is therefore appropriate that Member States assess
those uses or exposure scenarios and those risks to
human populations and to environmental compartments
(1) Commission
Regulation
(EC)
No
1451/2007 of
that have not been representatively addressed in the
4 December 2007 on the second phase of the 10-year
Union level risk assessment and, when granting
work programme referred to in Article 16(2) of Directive
product authorisations, ensure that appropriate
98/8/EC of the European Parliament and of the Council
measures are taken or specific conditions imposed in
concerning the placing of biocidal products on the
order to reduce the identified risks to acceptable levels.
market ( 2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
Annex I, IA or IB to Directive 98/8/EC. That list
includes methyl nonyl ketone.
(7)
The provisions of this Directive should be applied at the
same time in all Member States in order to ensure equal
treatment on the Union market of biocidal products
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
methyl
containing the active substance methyl nonyl ketone
nonyl ketone has been evaluated in accordance with
and also to facilitate the proper operation of the
Article 11(2) of Directive 98/8/EC for use in product-
biocidal products market in general.
type 19, repellents and attractants, as defined in
Annex V to that Directive.
(8) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I to Directive
(3) Spain
was
designated
as
Rapporteur
Member
State
and
submitted the competent authority report, together with
98/8/EC, in order to permit Member States and interested
a recommendation, to the Commission on 8 April 2009
parties to prepare themselves to meet the new
in accordance with Article 14(4) and (6) of Regulation
requirements entailed and to ensure that applicants
(EC) No 1451/2007.
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
the date of inclusion.
(4) The
competent
authority
report
was
reviewed
by
the
Member States and the Commission. In accordance
with Article 15(4) of Regulation (EC) No 1451/2007,
(9) After
inclusion,
Member
States
should
be
allowed
a
( 1 ) OJ L 123, 24.4.1998, p. 1.
reasonable period to implement Article 16(3) of
( 2 ) OJ L 325, 11.12.2007, p. 3.
Directive 98/8/EC.

---

EN
9.5.2012 Official
Journal
of
the
European
Union L
123/37
(10) Directive
98/8/EC
should
therefore
be
amended
accord
reference on the occasion of their official publication. Member
ingly.
States shall determine how such reference is to be made.
(11) The
measures provided for in this Directive are in
2. Member
States
shall
communicate
to
the
Commission
the
accordance with the opinion of the Standing
text of the main provisions of national law which they adopt in
Committee on Biocidal Products,
the field covered by this Directive.
HAS ADOPTED THIS DIRECTIVE:
Article 3
This Directive shall enter into force on the twentieth day
Article 1
following that of its publication in the Official Journal of the
Annex I to Directive 98/8/EC is amended in accordance with
European Union.
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
April
2013
at the latest, the laws, regulations and administrative provisions
necessary to comply with this Directive.
Done at Brussels, 8 May 2012.
They shall apply those provisions from 1 May 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

---

L 123/38
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for compliance
with Article 16(3) (except
Minimum purity
for products containing
EN
of the active
more than one active

substance, for which the
No Common
Name
IUPAC Name
substance in the
Date of
Expiry date of
Identification Numbers
biocidal product
inclusion
deadline to comply with
inclusion
Product type Specific
provisions
(*)
as placed on the
Article 16(3) shall be the
market
one set out in the last of
the inclusion decisions
relating to its active
substances)
‘54 methyl
nonyl Undecan-2-one
975 g/kg 1
May
2014 30
April
2016 30
April
2024 19 The
Union
level
risk
assessment
was
based
on
indoor
use
ketone
by non-professional users. When assessing the appli
CAS No: 112-12-9
cation for authorisation of a product in accordance
Off
EC No: 203-937-5
with Article 5 and Annex VI, Member States shall
icial
assess, where relevant for the particular product, those
uses or exposure scenarios and those risks to human
Jour
populations and to environmental compartments that
have not been representatively addressed in the Union
nal
level risk assessment.’
of
the
(*) 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
European
Union
9.5.2012

---

Document Outline

• �

---