HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 175/24
EN
Official Journal of the European Union
2.7.2011
COMMISSION DIRECTIVE 2011/69/EU
of 1 July 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include imidacloprid
as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
expected to satisfy the requirements laid down in
Article 5 of Directive 98/8/EC. It is therefore appropriate
to include imidacloprid in Annex I to that Directive.
Having regard to the Treaty on the Functioning of the European
Union,
(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 Directive 98/8/EC of the European Parliament
human populations and to environmental compartments
and of the Council of 16 February 1998 concerning the placing
that have not been representatively addressed in the
of biocidal products on the market ( 1 ), and in particular the
Union level risk assessment and, when granting
second subparagraph of Article 16(2) thereof,
product authorisations, ensure that appropriate
measures are taken or specific conditions imposed in
order to reduce the identified risks to acceptable levels.
Whereas:
(7) In
view
of
the
risks
identified
for
the
aquatic
compartment, it is appropriate to require that products
(1) Commission
Regulation
(EC)
No
1451/2007 of
4 December 2007 on the second phase of the 10-year
are not authorised for uses in animal housings where
work programme referred to in Article 16(2) of Directive
emission to a sewage treatment plant or direct
98/8/EC of the European Parliament and of the Council
emission to surface water cannot be prevented, unless
concerning the placing of biocidal products on the
data is submitted demonstrating that the product will
market (
meet the requirements of both Article 5 of and Annex

2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
VI to Directive 98/8/EC, if necessary by the application of
Annex I, IA or IB to Directive 98/8/EC. That list
appropriate risk mitigation measures.
includes imidacloprid.
(8)
In the light of the findings of the assessment report, it is
appropriate to require that risk mitigation measures are
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
imidacloprid
applied at product authorisation level. In particular, in
has been evaluated in accordance with Article 11(2) of
the light of the possible risk for non-professionals,
Directive 98/8/EC for use in product-type 18, insec
appropriate risk mitigation measures should be taken
ticides, acaricides and products to control other
to minimise the potential exposure of infants and
arthropods, as defined in Annex V to that Directive.
children.
(3) Germany
was
designated
as
rapporteur
Member
State
and (9)
In the light of the findings relating to possible indirect
submitted the competent authority report, together with
human exposure via consumption of food, it is appro
a recommendation, to the Commission on 15 September
priate to require, where relevant, verification of the need
2008 in accordance with Article 14(4) and (6) of Regu
to set new or amended existing maximum residue levels
lation (EC) No 1451/2007.
(MRLs) 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 estab
lishment of residue limits of pharmacologically active
(4) The
competent
authority
report
was
reviewed
by
the
substances in foodstuffs of animal origin, repealing
Member States and the Commission. In accordance
Council Regulation (EEC) No 2377/90 and amending
with Article 15(4) of Regulation (EC) No 1451/2007,
Directive 2001/82/EC of the European Parliament and
the findings of the review were incorporated, within
of the Council and Regulation (EC) No 726/2004 of
the Standing Committee on Biocidal Products on
the European Parliament and of the Council (
16 December 2010, in an assessment report.

3 ) or Regu

lation (EC) No 396/2005 of the European Parliament and
of the Council of 23 February 2005 on maximum
residue levels of pesticides in or on food and feed of
(5) It
appears
from
the
evaluations
that
biocidal
products
plant and animal origin and amending Council
used as insecticides, acaricides and products to control
Directive 91/414/EEC ( 4 ). Measures should be adopted
other arthropods and containing imidacloprid may be
ensuring that the applicable MRLs are not exceeded.
( 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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EN
2.7.2011 Official
Journal
of
the
European
Union L
175/25
(10) It is important that the provisions of this Directive be
Article 2
applied simultaneously in all Member States in order to
ensure equal treatment of biocidal products on the
Transposition
market containing the active substance imidacloprid
1. Member
States
shall
adopt
and
publish,
by
30
June
2012
and also to facilitate the proper operation of the
at the latest, the laws, regulations and administrative provisions
biocidal products market in general.
necessary to comply with this Directive.
(11) A
reasonable
period
should
be
allowed
to
elapse
before
They shall apply those provisions from 1 July 2013.
an active substance is included in Annex I to Directive
98/8/EC in order to permit Member States and interested
parties to prepare themselves to meet the new
When Member States adopt those provisions, they shall contain
requirements entailed and to ensure that applicants
a reference to this Directive or be accompanied by such a
who have prepared dossiers can benefit fully from the
reference on the occasion of their official publication. Member
10-year period of data protection, which, in accordance
States shall determine how such reference is to be made.
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
the date of inclusion.
2. Member
States
shall
communicate
to
the
Commission
the
text of the main provisions of national law which they adopt in
(12) After
inclusion,
Member States should
be allowed
a
the field covered by this Directive.
reasonable period to implement Article 16(3) of
Directive 98/8/EC.
Article 3
(13) Directive 98/8/EC should therefore be amended
This Directive shall enter into force on the 20th day following
accordingly.
its publication in the Official Journal of the European Union.
(14) The
measures provided for in this Directive are in
Article 4
accordance with the opinion of the Standing
Committee on Biocidal Products,
This Directive is addressed to the Member States.
HAS ADOPTED THIS DIRECTIVE:
Done at Brussels, 1 July 2011.
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

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L 175/26
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for compliance with
Minimum purity
Article 16(3) (except for
of the active
products containing more than
one active substance, for
No Common
name
IUPAC name,
substance in the
Expiry date of
EN
identification numbers
biocidal product Date of inclusion which the deadline to comply
inclusion
Product type Specific
provisions
(*)

as placed on the
with Article 16(3) shall be the
market
one set out in the last of the
inclusion decisions relating to
its active substances)
‘42 imidacloprid (2E)-1-[(6-chloropyridin-3-yl)
970 g/kg 1
July
2013 30
June
2015 30
June
2023 18 When
assessing
the
application
for
authorisation
of
a
methyl]-N-nitroimidazolidin-2-
product in accordance with Article 5 and Annex VI,
imine
Member States shall assess, when relevant for the
particular product, those uses or exposure scenarios
EC No: 428-040-8
and those risks to human populations and to envi
ronmental compartments that have not been repre
Off
CAS No: 138261-41-3
sentatively addressed in the Union level risk
assessment.
icial
Jour
Products shall not be authorised for uses in animal
housings where emission to a sewage treatment plant
nal
or direct emission to surface water cannot be
prevented, unless data is submitted demonstrating
of
that the product will meet the requirements of
the
Article 5 and Annex VI, if necessary by the appli
European
cation of appropriate risk mitigation measures.
Authorisations shall be subject to appropriate risk
mitigation measures. In particular, appropriate risk
Union
mitigation measures shall be taken to minimise the
potential exposure of infants and children.
For products containing imidacloprid that may lead
to residues in food or feed, Member States shall verify
the need to set new or amended 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 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
2.7.2011

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