HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 243/16
EN
Official Journal of the European Union
21.9.2011
COMMISSION DIRECTIVE 2011/81/EU
of 20 September 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include deltamethrin
as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(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
Having regard to the Treaty on the Functioning of the European
human populations and to environmental compartments
Union,
that have not been representatively addressed in the
Union level risk assessment and, when granting
product authorisations, ensure that appropriate
Having regard to Directive 98/8/EC of the European Parliament
measures are taken or specific conditions imposed in
and of the Council of 16 February 1998 concerning the placing
order to reduce the identified risks to acceptable levels.
of biocidal products on the market ( 1 ), and in particular the
second subparagraph of Article 16(2) thereof,
(7) In the light of the risks identified for the aquatic
Whereas:
ecosystem when products were used for indoor barrier
treatment, resulting in emissions of a certain scale to a
sewage treatment plant, it is appropriate to require that
(1) Commission
Regulation
(EC)
No
1451/2007 of
products are not authorised for uses resulting in such
4 December 2007 on the second phase of the 10-year
emissions, unless data are submitted demonstrating that
work programme referred to in Article 16(2) of Directive
the product will meet the requirements of both Article 5
98/8/EC of the European Parliament and of the Council
of and Annex VI to Directive 98/8/EC, if necessary by the
concerning the placing of biocidal products on the
application of appropriate risk mitigation measures.
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 deltamethrin.
(8)
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,
deltamethrin
containing the active substance deltamethrin and also
has been evaluated in accordance with Article 11(2) of
to facilitate the proper operation of the biocidal
Directive 98/8/EC for use in product-type 18, insec
products market in general.
ticides, acaricides and products to control other
arthropods, as defined in Annex V to that Directive.
(9) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I to Directive
(3) Sweden
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 27 June 2008
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
(4) The
competent
authority
report
was
reviewed
by
the
the date of inclusion.
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
(10) After
inclusion,
Member States should
be allowed
a
the Standing Committee on Biocidal Products on
reasonable period to implement Article 16(3) of
6 May 2011, in an assessment report.
Directive 98/8/EC.
(5) It
appears
from
the
evaluations
that
biocidal
products
used as insecticides, acaricides and products to control
(11) Directive 98/8/EC should therefore be amended
other arthropods and containing deltamethrin may be
accordingly.
expected to satisfy the requirements laid down in
Article 5 of Directive 98/8/EC. It is therefore appropriate
to include deltamethrin in Annex I to that Directive.
(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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EN
21.9.2011 Official
Journal
of
the
European
Union L
243/17
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 20th day following
its publication in the Official Journal of the European Union.
Article 2
1. Member
States
shall
adopt
and
publish,
by
30
September
Article 4
2012 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 October 2013.
Done at Brussels, 20 September 2011.
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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L 243/18
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for compliance
with Article 16(3) (except
for products containing
EN
Minimum purity of the
more than one active

No
Common
IUPAC Name
active substance in the
substance, for which the
Name
Identification Numbers
biocidal product as
Date of inclusion
deadline to comply with Expiry date of inclusion Product
type
Specific provisions (*)
placed on the market
Article 16(3) shall be the
one set out in the last of the
inclusion decisions relating
to its active substances)
‘49 deltamethrin (S)-α-cyano-3-phenoxybenzyl
985 g/kg 1
October
2013 30
September
2015 30
September
2023 18 When
assessing
the
application
for
authori
(1R,3R)-3-(2,2-dibromovinyl)-2,2-
sation of a product in accordance with
dimethylcyclopropane carboxylate
Article 5 and Annex VI, Member States shall
assess, where relevant for the particular
Off
CAS-No: 52918-63-5
product, those uses or exposure scenarios and
icial
those risks to human populations and to envi
EC No: 258-256-6
ronmental compartments that have not been
Jour
representatively addressed in the Union level
risk assessment.
nal
of
Products shall not be authorised for indoor
the
treatments resulting in sewage treatment plant
emissions of the scale for which the Union
European
level risk assessment showed unacceptable
risks, unless data are submitted demonstrating
that the product will meet the requirements of
Article 5 and Annex VI, if necessary by the
Union
application of appropriate risk mitigation
measures.’
(*) 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
21.9.2011

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