HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 243/10
EN
Official Journal of the European Union
21.9.2011
COMMISSION DIRECTIVE 2011/79/EU
of 20 September 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include fipronil as an
active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(6) Not
all
potential
uses
have
been
evaluated
in
the
Union
level assessment, which only addressed professional use
indoors by application in locations normally inaccessible
Having regard to the Treaty on the Functioning of the European
to man and domestic animals after application. It is
Union,
therefore appropriate to require that Member States
assess those uses or exposure scenarios and those risks
to human populations and to environmental
Having regard to Directive 98/8/EC of the European Parliament
compartments that have not been representatively
and of the Council of 16 February 1998 concerning the placing
addressed in the Union level risk assessment and, when
of biocidal products on the market ( 1 ), and in particular the
granting product authorisations, ensure that appropriate
second subparagraph of Article 16(2) thereof,
measures are taken or specific conditions imposed in
order to reduce the identified risks to acceptable levels.
Whereas:
(7)
The provisions of this Directive should be applied at the
same time in all Member States in order to ensure equal
(1) Commission
Regulation
(EC)
No
1451/2007 of
treatment on the Union market of biocidal products
4 December 2007 on the second phase of the 10-year
containing the active substance fipronil, and also to
work programme referred to in Article 16(2) of Directive
facilitate the proper operation of the biocidal products
98/8/EC of the European Parliament and of the Council
market in general.
concerning the placing of biocidal products on the
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
(8) A
reasonable
period
should
be
allowed
to
elapse
before
includes fipronil for use in product-type 18, insecticides,
an active substance is included in Annex I to Directive
acaricides and products to control other arthropods, as
98/8/EC in order to permit Member States and interested
defined in Annex V to the Directive.
parties to prepare themselves to meet the new
requirements entailed and to ensure that applicants
who have prepared dossiers can benefit fully from the
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
fipronil
has
10-year period of data protection, which, in accordance
been evaluated in accordance with Article 11(2) of
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
Directive 98/8/EC for use in product-type 18.
the date of inclusion.
(3) France
was
designated
as
Rapporteur
Member
State
and (9) After
inclusion,
Member
States
should
be
allowed
a
submitted the competent authority report, together with
reasonable period to implement Article 16(3) of
a recommendation, to the Commission in accordance
Directive 98/8/EC.
with Article 14(4) and (6) of Regulation (EC)
No 1451/2007 on 6 February 2009.
(10) Directive 98/8/EC should therefore be amended
(4) The
competent
authority
report
was
reviewed
by
the
accordingly.
Member States and the Commission. In accordance
with Article 15(4) of Regulation (EC) No 1451/2007,
the findings of the review were incorporated, within
(11) The
measures provided for in this Directive are in
the Standing Committee on Biocidal Products on
accordance with the opinion of the Standing
6 May 2011, in an assessment report.
Committee on Biocidal Products,
(5) It
appears
from
the
evaluations
that
biocidal
products
used as insecticides and containing fipronil may be
HAS ADOPTED THIS DIRECTIVE:
expected to satisfy the requirements laid down in
Article 5 of Directive 98/8/EC. It is therefore appropriate
to include fipronil in Annex I to that Directive.
Article 1
( 1 ) OJ L 123, 24.4.1998, p. 1.
Annex I to Directive 98/8/EC is amended in accordance with
( 2 ) OJ L 325, 11.12.2007, p. 3.
the Annex to this Directive.

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EN
21.9.2011 Official
Journal
of
the
European
Union L
243/11
Article 2
Article 3
1. Member
States
shall
adopt
and
publish,
by
30
September This Directive shall enter into force on the 20th day following
2012 at the latest, the laws, regulations and administrative
its publication in the Official Journal of the European Union.
provisions necessary to comply with this Directive.
Article 4
They shall apply those provisions from 1 October 2013.
This Directive is addressed to the Member States.
When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
Done at Brussels, 20 September 2011.
States shall determine how such reference is to be made.
For the Commission
2. Member
States
shall
communicate
to
the
Commission
the
text of the main provisions of national law which they adopt in
The President
the field covered by this Directive.
José Manuel BARROSO

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L 243/12
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for compliance with
Minimum purity of
Article 16(3) (except for products
EN
the active substance
containing more than one active

No
Common
IUPAC Name
substance, for which the deadline
Name
Identification Numbers
in the biocidal
Date of inclusion
Expiry date of inclusion Product-type Specific
provisions
(*)
product as placed
to comply with Article 16(3) shall
on the market
be the one set out in the last of
the inclusion decisions relating to
its active substances)
‘47 fipronil (±)-5-amino-1-(2,6- 950 g/kg 1
October
2013 30
September
2015 30
September
2023 18 Only
professional
use
indoors
by
application
in
dichloro-α,α,α,-
locations normally inaccessible after application to
trifluoro-p-tolyl)-4-
man and domestic animals has been addressed in
trifluoromethylsulfi
the Union level risk assessment. When assessing the
nylpyrazole-3-carbon
application for authorisation of a product in
Off
itrile (1:1)
accordance with Article 5 and Annex VI, Member
icial
States shall assess, where relevant for the particular
EC No: 424-610-5
product, those uses or exposure scenarios and those
Jour
CAS No: 120068-37-3
risks to human populations and to environmental
compartments that have not been representatively
nal
addressed in the Union 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
21.9.2011

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