Commission Directive 2008/16/EC of 15 February 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include etofenprox 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

L 42/48

EN

Official Journal of the European Union

16.2.2008

COMMISSION DIRECTIVE 2008/16/EC

of 15 February 2008

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

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)

(4)

(5)

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
list
Annex I,
includes etofenprox.

IB to Directive 98/8/EC. That

IA or

Pursuant to Regulation (EC) No 2032/2003, etofenprox
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.

Austria was designated as Rapporteur Member State and
submitted the competent authority report, together with
a recommendation, to the Commission on 11 October
2005 in accordance with Article 10(5) and (7) of Regu-
lation (EC) No 2032/2003.

The competent authority report was reviewed by the
In accordance
Member States and the Commission.
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 2006, in an assessment report.

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

(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).

It appears from the examinations made that biocidal
products used as wood preservatives and containing
etofenprox may be expected to satisfy the requirements
laid down in Article 5 of Directive 98/8/EC. However,
acceptable risks to human health were only identified for
seasonal and intermittent (up to three months per year)
use. It is therefore appropriate to include etofenprox 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 etofenprox
can be granted, modified, or cancelled in accordance
with Article 16(3) of Directive 98/8/EC. Authorisations
for products to be used year-round will require the
submission of dermal absorption data in order
to
demonstrate that the products can be used without unac-
ceptable risks to human health.

In the light of the findings of the assessment report, and
in particular of the risk identified for workers, it is appro-
priate to require that products containing etofenprox and
intended for industrial use as wood preservatives be used
with appropriate protective equipment.

It

level.

therefore

the
Not all potential uses have been evaluated at
that
appropriate
is
Community
Member States pay particular attention to the 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 appropriate measures are taken or specific
conditions imposed in order to mitigate the identified
risks to acceptable levels.

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 etofenprox and
also to facilitate the proper operation of the biocidal
products market in general.

(7)

(8)

(9)

(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
the
interested parties to prepare themselves to meet
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.

16.2.2008

EN

Official Journal of the European Union

L 42/49

(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 etofenprox to ensure that they comply
with Directive 98/8/EC.

(12) Directive

98/8/EC should

therefore

be

amended

accordingly.

(13)

The measures provided for
accordance with
Committee on Biocidal Products,

the

opinion

in this Directive are in
Standing
the

of

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

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

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

Article 4

Article 2

Transposition

This Directive is addressed to the Member States.

Done at Brussels, 15 February 2008.

the latest,

1. Member States shall adopt and publish, by 31 January
2009 at
the laws, regulations and administrative
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.

For the Commission

Stavros DIMAS
Member of the Commission

L 42/50

EN

Official Journal of the European Union

16.2.2008

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