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9.2.2011 Official
Journal
of
the
European
Union L
34/45
COMMISSION DIRECTIVE 2011/11/EU
of 8 February 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include
(Z,E)-tetradeca-9,12-dienyl acetate as an active substance in Annexes I and IA thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
tetradeca-9,12-dienyl acetate may be expected to present
only low risk to humans, animals and the environment
and to satisfy the requirements laid down in Article 5 of
Having regard to the Treaty on the Functioning of the European
Directive 98/8/EC, in particular with regard to the use
Union,
which was examined and detailed in the assessment
report, i.e. in traps for indoor use containing a
Having regard to Directive 98/8/EC of the European Parliament
maximum of 2 mg of the active substance. It is
and of the Council of 16 February 1998 concerning the placing
therefore appropriate to include (Z,E)-tetradeca-9,12-
of biocidal products on the market ( 1 ), and in particular the
dienyl acetate in Annex IA to Directive 98/8/EC.
second subparagraph of Article 16(2) thereof,
(7) Not
all
potential
uses
have
been
evaluated
at
Union
level.
Whereas:
It is therefore appropriate that Member States, when
granting product authorisations, assess those uses or
(1) Commission
Regulation
(EC)
No
1451/2007 of
exposure scenarios and those risks to the environmental
4 December 2007 on the second phase of the 10-year
compartments and populations that have not been repre
work programme referred to in Article 16(2) of Directive
sentatively addressed in the Union level risk assessment
98/8/EC of the European Parliament and of the Council
and ensure that appropriate measures are taken or
concerning the placing of biocidal products on the
specific conditions imposed in order to reduce the
market ( 2 ) establishes a list of active substances to be
identified risks to acceptable levels.
assessed, with a view to their possible inclusion in
Annex I, IA or IB to Directive 98/8/EC. That list
includes (Z,E)-tetradeca-9,12-dienyl acetate.
(8) In the light of the assumptions made during the
evaluation, it is appropriate to require that (Z,E)-
tetradeca-9,12-dienyl acetate is not applied where food
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
(Z,E)-
or feed is stored unless the food or feed packaging is
tetradeca-9,12-dienyl acetate has been evaluated in
closed or re-closed. Labels should therefore indicate that
accordance with Article 11(2) of Directive 98/8/EC for
biocidal products containing (Z,E)-tetradeca-9,12-dienyl
use in product-type 19, repellents and attractants, as
acetate are not to be used in spaces where un-packaged
defined in Annex V to that Directive.
food or feed is kept.
(3) Austria
was
designated
as
Rapporteur
Member
State
and
submitted the competent authority report, together with
(9)
It is important that the provisions of this Directive be
a recommendation, to the Commission on 23 February
applied simultaneously in all Member States in order to
2009 in accordance with Article 14(4) and (6) of Regu
ensure equal treatment of biocidal products on the
lation (EC) No 1451/2007.
market containing the active substance (Z,E)-tetradeca-
9,12-dienyl acetate and also to facilitate the proper
operation of the biocidal products market in general.
(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,
(10) A
reasonable
period
should
be
allowed
to
elapse
before
the findings of the review were incorporated, within
an active substance is included in Annex I to Directive
the Standing Committee on Biocidal Products on
98/8/EC in order to permit Member States and the
24 September 2010, in an assessment report.
interested parties to prepare themselves to meet the
new requirements entailed and to ensure that applicants
(5) It
appears
from
the
evaluations
that
biocidal
products
who have prepared dossiers can benefit fully from the
used as attractants and containing (Z,E)-tetradeca-9,12-
10-year period of data protection, which, in accordance
dienyl acetate may be expected to satisfy the
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
requirements laid down in Article 5 of Directive
the date of inclusion.
98/8/EC. It is therefore appropriate to include (Z,E)-
tetradeca-9,12-dienyl acetate in Annex I to that Directive.
(11) After
inclusion,
Member States should
be allowed
a
reasonable period to implement Article 16(3) of
(6) It
also
appears
from
the
evaluations
that
biocidal
Directive 98/8/EC.
products used as attractants and containing (Z,E)-
( 1 ) OJ L 123, 24.4.1998, p. 1.
(12) Directive 98/8/EC should therefore be amended
( 2 ) OJ L 325, 11.12.2007, p. 3.
accordingly.

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L 34/46
EN
Official Journal of the European Union
9.2.2011
(13) The
measures provided for in this Directive are in
reference on the occasion of their official publication. Member
accordance with the opinion of the Standing
States shall determine how such reference is to be made.
Committee on Biocidal Products,
2. Member
States
shall
communicate
to
the
Commission
the
HAS ADOPTED THIS DIRECTIVE:
text of the main provisions of national law which they adopt in
the field covered by this Directive.
Article 1
Article 3
Annexes I and IA to Directive 98/8/EC are amended in
accordance with the Annex to this Directive.
This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
Article 2
Article 4
Transposition
This Directive is addressed to the Member States.
1. Member
States
shall
adopt
and
publish,
by
31
January
2012 at the latest, the laws, regulations and administrative
provisions necessary to comply with this Directive.
Done at Brussels, 8 February 2011.
They shall apply those provisions from 1 February 2013.
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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9.2.2011 Off
ANNEX
(1) 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
substance, for which the
No Common
Name
IUPAC Name
substance in the
Expiry date of
Product
Identification Numbers
biocidal product
Date of inclusion
deadline to comply with
inclusion
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)
‘39 (Z,E)-tetradeca-9, (9Z,12E)-Tetradeca-9,
977 g/kg 1
February
2013 31
January
2015 31
January
2023 19 When
assessing
the
application
for
authorisation
of
12-dienyl acetate
12-dien-1-yl acetate
a product in accordance with Article 5 and Annex
VI, Member States shall assess, when relevant for
EC No: n.a.
the particular product, those uses or exposure
icial
scenarios and those risks to environmental
Jour
CAS No: 30507-70-1
compartments and populations that have not been
representatively addressed in Union level risk
nal
assessment.
of
Member States shall ensure that authorisations are
the
subject to the following condition:
European
— Labels for biocidal products containing (Z,E)-
tetradeca-9,12-dienyl acetate shall indicate that
those products shall not be used in spaces
Union
where un-packaged food or feed is kept.’,
(*) 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
L
34/47

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L 34/48
(2) In Annex IA to Directive 98/8/EC, the following entry is added:
Deadline for compliance
with Article 16(3) (except
Minimum purity
for products containing
of the active
more than one active
substance, for which the
No Common
Name
IUPAC Name
substance in the
Expiry date of
Product
Identification Numbers
biocidal product
Date of inclusion
deadline to comply with
inclusion
type
Specific provisions (*)
EN
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)
‘2 (Z,E)-tetradeca-9, (9Z,12E)-tetradeca-9,
977 g/kg 1
February
2013 31
January
2015 31
January
2023 19 Member
States
shall
ensure
that
registrations
are
12-dienyl acetate
12-dien-1-yl acetate
subject to the following conditions:
EC No: n.a.
— Only for traps containing a maximum of 2 mg
of (Z,E)-Tetradeca-9,12-dienyl acetate for indoor
Off
CAS No: 30507-70-1
use,
icial
— Labels for biocidal products containing (Z,E)-
Jour
tetradeca-9,12-dienyl acetate shall indicate that
those products shall only be used indoors, and
nal
shall not be used in spaces where un-packaged
of
food or feed is kept.’,
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
9.2.2011

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