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9.5.2012 Official
Journal
of
the
European
Union L
123/39
COMMISSION DIRECTIVE 2012/15/EU
of 8 May 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include margosa
extract 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 insecticides, acaricides and products to control
other arthropods and containing margosa extract 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 include margosa extract in Annex I to that Directive.
Having regard to Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing
(6) Not
all
potential
uses
have
been
evaluated
at
Union
level.
of biocidal products on the market ( 1 ), and in particular the
It is therefore appropriate that Member States assess
second subparagraph of Article 16(2) thereof,
those uses or exposure scenarios and those risks to
human populations and to environmental compartments
that have not been representatively addressed in the
Whereas:
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
view
of
the
risks
identified
for
surface
water,
sediment
market (
and non-target arthropods, it is appropriate to require

2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
that product authorisations are subject to appropriate
Annex I, IA or IB to Directive 98/8/EC. That list
risk mitigation measures.
includes margosa extract.
(8)
The provisions of this Directive should be applied at the
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
margosa
same time in all Member States in order to ensure equal
extract has been evaluated in accordance with
treatment on the Union market of biocidal products
Article 11(2) of Directive 98/8/EC for use in product-
containing the active substance margosa extract and
type 18, insecticides, acaricides and products to control
also to facilitate the proper operation of the biocidal
other arthropods, as defined in Annex V to that
products market in general.
Directive. The evaluation concerned margosa extract
from the kernels of Azadirachta indica extracted with
water and further processed with organic solvents. Any
(9) A
reasonable
period
should
be
allowed
to
elapse
before
possible other substances complying with the definition
an active substance is included in Annex I to Directive
of margosa extract in the list of active substances to be
98/8/EC, in order to permit Member States and interested
assessed in Regulation (EC) No 1451/2007 have not
parties to prepare themselves to meet the new
been evaluated, and should therefore not be included in
requirements entailed and to ensure that applicants
Annex I to Directive 98/8/EC based on this evaluation.
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
(3) Germany
was
designated
as
rapporteur
Member
State
and
the date of inclusion.
submitted the competent authority report, together with
a recommendation, to the Commission on
26 November 2009 in accordance with Article 14(4)
and (6) of Regulation (EC) No 1451/2007.
(10) After
inclusion,
Member States should
be allowed
a

reasonable period to implement Article 16(3) of
Directive 98/8/EC.
(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,
(11) Directive
98/8/EC
should
therefore
be
amended
accord
the findings of the review were incorporated, within
ingly.
the Standing Committee on Biocidal Products on
9 December 2011, in an assessment report.
(12) The
measures provided for in this Directive are in
( 1 ) OJ L 123, 24.4.1998, p. 1.
accordance with the opinion of the Standing
( 2 ) OJ L 325, 11.12.2007, p. 3.
Committee on Biocidal Products,

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L 123/40
EN
Official Journal of the European Union
9.5.2012
HAS ADOPTED THIS DIRECTIVE:
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.
Article 1
Annex I to Directive 98/8/EC is amended in accordance with
Article 3
the Annex to this Directive.
This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
Article 2
European Union.
1. Member
States
shall
adopt
and
publish,
by
30
April
2013
Article 4
at the latest, the laws, regulations and administrative provisions
necessary to comply with this Directive.
This Directive is addressed to the Member States.
They shall apply those provisions from 1 May 2014.
Done at Brussels, 8 May 2012.
When Member States adopt those provisions, they shall contain
For the Commission
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
The President
States shall determine how such reference is to be made.
José Manuel BARROSO

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9.5.2012 Off
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
Product
Identification Numbers
biocidal product
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)
‘55 margosa
extract IUPAC
name:
Not
applicable
1 000 g/kg 1
May
2014 30
April
2016 30
April
2024 18 When
assessing
the
application
for
authorisation
of
a
product in accordance with Article 5 and Annex VI,
CAS-No: 84696-25-3
Member States shall assess, where relevant for the
particular product, those uses or exposure scenarios
EC No: 283-644-7
icial
and those risks to human populations and to environ
Description: margosa extract
mental compartments that have not been represen
Jour
from the kernels of Azadirachta
tatively addressed in the Union level risk assessment.
nal
indica extracted with water and
Member States shall ensure that authorisations are
further processed with organic
of
subject to appropriate risk mitigation measures for the
solvents
the
protection of surface water, sediment and non-target
arthropods.’
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
L
123/41

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