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24.11.2012 Official
Journal
of
the
European
Union L
326/13
DIRECTIVES
COMMISSION DIRECTIVE 2012/38/EU
of 23 November 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include
cis-Tricos-9-ene as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) It
appears
from
the
evaluations
that
biocidal
products
used as attractants and containing cis-Tricos-9-ene may
be expected to satisfy the requirements laid down in
Having regard to the Treaty on the Functioning of the European
Article 5 of Directive 98/8/EC. It is therefore appropriate
Union,
to include cis-Tricos-9-ene in Annex I to that Directive.
Having regard to Directive 98/8/EC of the European Parliament
(6)
Not all potential uses and exposure scenarios have been
and of the Council of 16 February 1998 concerning the placing
evaluated at Union level. For example, outdoor use and
of biocidal products on the market ( 1 ), and in particular the
exposure of food or feeding stuff were not assessed. It is
second subparagraph of Article 16(2) thereof,
therefore appropriate to require that Member States
assess those uses or exposure scenarios and those risks
to human populations and to environmental
compartments that have not been representatively
Whereas:
addressed in the Union level risk assessment and, when
granting product authorisations, ensure that appropriate
measures are taken or specific conditions imposed in
(1) Commission
Regulation
(EC)
No
1451/2007 of
order to reduce the identified risks to acceptable levels.
4 December 2007 on the second phase of the 10-year
work programme referred to in Article 16(2) of Directive
98/8/EC of the European Parliament and of the Council
concerning the placing of biocidal products on the
(7) In
the
light
of
the
possible
indirect
human
exposure
via
market (
consumption of food as a result of those uses repre

2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
sented in the assessment, it is appropriate to require,
Annex I, IA or IB to Directive 98/8/EC. That list
where relevant, verification of the need to set new or
includes cis-Tricos-9-ene.
to amend existing maximum residue levels according to
Regulation (EC) No 470/2009 of the European
Parliament and of the Council of 6 May 2009 laying
down Community procedures for the establishment of
(2) Pursuant
to
Regulation
(EC)
No
1451/2007, cis-Tricos-9-
residue limits of pharmacologically active substances in
ene has been evaluated in accordance with Article 11(2)
foodstuffs of animal origin, repealing Council Regulation
of Directive 98/8/EC for use in product-type 19,
(EEC) No 2377/90 and amending Directive 2001/82/EC
repellents and attractants, as defined in Annex V to
of the European Parliament and of the Council and Regu
that Directive.
lation (EC) No 726/2004 of the European Parliament and
of the Council ( 3 ) or Regulation (EC) No 396/2005 of the
European Parliament and of the Council of 23 February
(3) Austria
was
designated
as
Rapporteur
Member
State
and
2005 on maximum residue levels of pesticides in or on
submitted the competent authority report, together with
food and feed of plant and animal origin and amending
a recommendation, to the Commission on 11 November
Council Directive 91/414/EEC ( 4 ). Measures should be
2009 in accordance with Article 14(4) and (6) of Regu
adopted ensuring that the applicable maximum residue
lation (EC) No 1451/2007.
levels are not exceeded.
(4) The
competent
authority
report
was
reviewed
by
the (8) The
provisions
of
this
Directive
should
be
applied
simul
Member States and the Commission. In accordance
taneously in all Member States in order to ensure equal
with Article 15(4) of Regulation (EC) No 1451/2007,
treatment on the Union market of biocidal products of
the findings of the review were incorporated, within
product-type 19 containing the active substance cis-
the Standing Committee on Biocidal Products on
Tricos-9-ene and also to facilitate the proper operation
25 May 2012, in an assessment report.
of the biocidal products market in general.
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 3 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) OJ L 325, 11.12.2007, p. 3.
( 4 ) OJ L 70, 16.3.2005, p. 1.

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L 326/14
EN
Official Journal of the European Union
24.11.2012
(9) 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
30
September
parties to prepare themselves to meet the new
2013 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 October 2014.
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
(10) After
inclusion,
Member States should
be allowed
a
reference on the occasion of their official publication. Member
reasonable period to implement Article 16(3) of
States shall determine how such reference is to be made.
Directive 98/8/EC.
2. Member
States
shall
communicate
to
the
Commission
the
(11) Directive
98/8/EC
should
therefore
be
amended
accord
text of the main provisions of national law which they adopt in
ingly.
the field covered by this Directive.
(12) In
accordance
with
the
Joint
Political
Declaration
of
Member States and the Commission on explanatory
Article 3
documents of 28 September 2011 ( 1 ), Member States
This Directive shall enter into force on the twentieth day
have undertaken to accompany, in justified cases, the
following that of its publication in the Official Journal of the
notification of their transposition measures with one or
European Union.
more documents explaining the relationship between the
components of a directive and the corresponding parts of
national transposition instruments.
Article 4
This Directive is addressed to the Member States.
(13) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on Biocidal Products,
Done at Brussels, 23 November 2012.
HAS ADOPTED THIS DIRECTIVE:
Article 1
For the Commission
Annex I to Directive 98/8/EC is amended in accordance with
The President
the Annex to this Directive.
José Manuel BARROSO
( 1 ) OJ C 369, 17.12.2011, p. 14.

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24.11.2012 Off
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
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
Name
IUPAC Name
substance in
Date of
Expiry date of
Identification Numbers
the biocidal
inclusion
which the deadline to comply
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)
‘59 cis-tricos-9-ene cis-Tricos-9-ene; (Z)-Tricos-9-ene
801 g/kg 1
October 30 September 2016 30
September 19 The
Union
level
risk
assessment
did
not
address
all
(Muscalure)
2014
2024
potential uses and exposure scenarios; certain uses
EC No: 248-505-7
and exposure scenarios, such as outdoor use and
exposure of food or feed, were excluded. When
CAS No: 27519-02-4
assessing the application for authorisation of a
product in accordance with Article 5 and Annex VI,
icial
Member States shall assess, where relevant for the
particular product, those uses or exposure scenarios
Jour
and those risks to human populations and to environ
mental compartments that have not been represen
nal
tatively addressed in the Union level risk assessment.
of
the
For products containing cis-tricos-9-ene that may lead
to residues in food or feed, Member States shall verify
European
the need to set new or to amend existing maximum
residue levels (MRLs) according to Regulation (EC) No
470/2009 or Regulation (EC) No 396/2005, and take
any appropriate risk mitigation measures ensuring that
Union
the applicable MRLs are not exceeded.’
(*) 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
326/15

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