Commission Directive 2008/78/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include propiconazole as an active substance in Annex I thereto (Text with EEA relevance)
Date: 2008-07-25
Institutions: European Commission
Subjects: chemical product, environmental protection, marketing, public health, wood industry

L 198/44

EN

Official Journal of the European Union

26.7.2008

COMMISSION DIRECTIVE 2008/78/EC

of 25 July 2008

amending Directive 98/8/EC of

the European Parliament and of

the Council

to include

propiconazole 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:

to

be

satisfy

expected

It appears from the examinations made that biocidal
products used as wood preservatives and containing
propiconazole may
the
requirements
laid down in Article 5 of Directive
98/8/EC. It is therefore appropriate to include propico­
nazole in Annex I for product type 8, in order to ensure
that
in all Member States authorisations for biocidal
products used as wood preservatives and containing
propiconazole can be granted, modified, or cancelled in
accordance with Article 16(3) of Directive 98/8/EC.
However, unacceptable risks were identified for the in
situ treatment of wood outdoors and for treated wood
exposed to weathering. Authorisation of these uses will
require the submission of data demonstrating that the
products can be used without unacceptable risks to the
environment.

(1)

(2)

(3)

(4)

(5)

(EC) No

1451/2007

Commission Regulation
of
4 December 2007 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 (2) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
list
Annex I,
includes propiconazole.

IB to Directive 98/8/EC. That

IA or

been

to Regulation (EC) No 1451/2007, propico­
Pursuant
nazole
accordance with
has
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.

evaluated

in

Finland was designated as Rapporteur Member State and
submitted the competent authority report, together with
a recommendation, to the Commission on 5 April 2006
in accordance with Article 14(4) and (6) of Regulation
(EC) No 1451/2007.

The competent authority report was reviewed by the
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
the Standing Committee on Biocidal Products on
29 November 2007, in an assessment report.

The review of propiconazole 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 Directive

2008/31/EC (OJ L 81, 20.3.2008, p. 57).

(2) OJ L 325, 11.12.2007, p. 3.

(7)

(8)

(9)

In the light of the findings of the assessment report, it is
appropriate to require that products containing propico­
nazole and used as wood preservatives must be used with
appropriate personal protective equipment, that risk miti­
gation measures are applied to protect
the soil and
aquatic compartments and that related instructions are
provided,
in accordance with Article 10(2)(i)(d) of
Directive 98/8/EC.

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

themselves

A reasonable period should be allowed to elapse before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
to meet
the new requirements
prepare
applicants who have
entailed and to ensure
that
fully from the 10-year
prepared dossiers can benefit
period of data protection, which,
in accordance with
Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the
date of inclusion.

(10) 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 propiconazole to ensure that
they
comply with Directive 98/8/EC.

26.7.2008

EN

Official Journal of the European Union

L 198/45

(11) Directive

98/8/EC should

therefore

be

amended

accordingly.

(12)

The measures provided for
accordance with
Committee on Biocidal Products,

the

opinion

in this Directive are in
Standing
the

of

HAS ADOPTED THIS DIRECTIVE:

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 1

Article 3

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

Transposition

Article 4

This Directive is addressed to the Member States.

the latest,

1. Member States shall adopt and publish, by 31 March
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 April 2010.

Done at Brussels, 25 July 2008.

For the Commission

Stavros DIMAS
Member of the Commission

L 198/46

EN

Official Journal of the European Union

26.7.2008

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