Commission Directive 2008/15/EC of 15 February 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include clothianidin as an active substance in Annex I thereto (Text with EEA relevance)
Date: 2008-02-15
Institutions: European Commission
Subjects: chemical product, environmental protection, marketing, public health, wood industry

16.2.2008

EN

Official Journal of the European Union

L 42/45

COMMISSION DIRECTIVE 2008/15/EC

of 15 February 2008

amending Directive 98/8/EC of the European Parliament and of the Council to include clothianidin
as an active substance in Annex I thereto

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing
of biocidal products on the market (1), and in particular the
second subparagraph of Article 16(2) thereof,

Whereas:

(1)

(2)

(3)

Commission Regulation (EC) No 2032/2003 of 4
November 2003 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 market and amending Regulation (EC) No
1896/2000 (2) establishes a list of active substances to
be assessed, with a view to their possible inclusion in
Annex I,
list
includes clothianidin.

IB to Directive 98/8/EC. That

IA or

Pursuant to Regulation (EC) No 2032/2003, clothianidin
has been evaluated in accordance with Article 11(2) of
Directive 98/8/EC for use in product
type 8, wood
preservatives, as defined in Annex V to Directive
98/8/EC.

Germany was designated as Rapporteur Member State
and submitted the competent authority report, together
with a recommendation,
to the Commission on 15
December 2005 in accordance with Article 10(5) and
(7) of Regulation (EC) No 2032/2003.

(4)

The competent authority report was reviewed by the
In accordance
Member States and the Commission.

(1) OJ L 123, 24.4.1998, p. 1. Directive as

last amended by
Commission Directive 2007/70/EC (OJ L 312, 30.11.2007, p. 26).
(2) OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regu-

lation (EC) No 1849/2006 (OJ L 355, 15.12.2006, p. 63).

(5)

(6)

(7)

(8)

with Article 11(4) of Regulation (EC) No 2032/2003, the
findings of
the review were incorporated, within the
Standing Committee on Biocidal Products on 21 June
2007, in an assessment report.

The review of clothianidin did not reveal any open
questions or concerns to be addressed by the Scientific
Committee on Health and Environmental Risks.

It appears from the examinations made that biocidal
products used as wood preservatives and containing
clothianidin may be expected to satisfy the requirements
laid down in Article 5 of Directive 98/8/EC. However,
unacceptable risks were identified for uses of
treated
wood outdoors but not in ground or water contact. It
is therefore appropriate to include clothianidin in Annex
I to Directive 98/8/EC,
in order to ensure that in all
Member States authorisations for biocidal products used
as wood preservatives and containing clothianidin can be
granted, modified, or cancelled in accordance with Article
16(3) of Directive 98/8/EC. Authorisations for products
to be used for the treatment of wood that will be used
outdoors will require the submission of data in order to
demonstrate that the products can be used without unac-
ceptable risks to the environment.

authorisation level

In the light of the findings of the assessment report, it is
appropriate to require that risk mitigation measures are
applied at product
to products
containing clothianidin and used as wood preservatives
to ensure that risks be reduced to an acceptable level in
accordance with Article 5 and Annex VI of Directive
98/8/EC. Special attention should be paid to measures
aimed at protecting
and
groundwater compartments since unacceptable risks in
these compartments have been identified during the
evaluation of the submitted dossier from certain uses.

surface water

soil,

the

It

level.

therefore

the
Not all potential uses have been evaluated at
Community
that
appropriate
is
Member States assess those risks to the compartments
and populations that have not been representatively
addressed in the Community level risk assessment and,
when granting product authorisations, ensure that appro-
priate measures are taken or specific conditions imposed
in order to mitigate the identified risks to acceptable
levels.

L 42/46

EN

Official Journal of the European Union

16.2.2008

(9)

It is important that the provisions of this Directive be
applied simultaneously in all the Member States in order
to ensure equal treatment of biocidal products on the
market containing the active substance clothianidin and
also to facilitate the proper operation of the biocidal
products market in general.

(10) A reasonable period should be allowed to elapse before
an active substance is included in Annex I to Directive
98/8/EC in order to permit Member States and the
interested parties to prepare themselves to meet
the
new requirements entailed and to ensure that applicants
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
the date of inclusion.

(11) After inclusion, Member States should be allowed a
reasonable period to implement Article 16(3) of
Directive 98/8/EC, and in particular, to grant, modify
or cancel authorisations of biocidal products in product
type 8 containing clothianidin to ensure that
they
comply with Directive 98/8/EC.

Article 2

Transposition

the latest,

1. Member States shall adopt and publish, by 31 January
the laws, regulations and administrative
2009 at
provisions necessary to comply with this Directive. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and
this Directive.

They shall apply those provisions from 1 February 2010.

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
States shall determine how such reference is to be made.

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 3

(12) Directive

98/8/EC should

therefore

be

amended

accordingly.

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

(13)

The measures provided for
accordance with
Committee on Biocidal Products,

the

opinion

in this Directive are in
Standing
the

of

Article 4

This Directive is addressed to the Member States.

HAS ADOPTED THIS DIRECTIVE:

Done at Brussels, 15 February 2008.

Article 1

Annex I to Directive 98/8/EC is amended in accordance with
the Annex to this Directive.

For the Commission

Stavros DIMAS
Member of the Commission

16.2.2008

EN

Official Journal of the European Union

L 42/47

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