Commission Directive 2008/80/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include cyclohexylhydroxydiazene 1-oxide, potassium salt (K-HDO) as an active substance in Annex I thereto (Text with EEA relevance)
Date: 2008-07-28
Institutions: European Commission
Subjects: chemical product, environmental protection, health risk, marketing, wood industry

29.7.2008

EN

Official Journal of the European Union

L 200/15

COMMISSION DIRECTIVE 2008/80/EC

of 28 July 2008

amending Directive 98/8/EC of
to include
cyclohexylhydroxydiazene 1-oxide, potassium salt (K-HDO) as an active substance in Annex I
thereto

the European Parliament and of

the Council

(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)

(4)

(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
Annexes I,
includes cyclohexylhydroxydiazene 1-oxide, potassium
salt (K-HDO).

IA or IB to Directive 98/8/EC. That

Pursuant to Regulation (EC) No 1451/2007, K-HDO 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 22 March
2006 in accordance with Article 14(4) and (6) of Regu­
lation (EC) No 1451/2007.

The competent authority report was reviewed by the
In accordance
Member States and the Commission.
with Article 15(4) of Regulation (EC) No 1451/2007,

(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.

(5)

(6)

(7)

(8)

(9)

the findings of the review were incorporated, within the
Standing
on
22 February 2008, in an assessment report.

Committee

Products

Biocidal

on

Although the risk assessment was limited to very specific
application systems,
it appears from the examinations
made that biocidal products used as wood preservatives
and containing K-HDO may be expected to satisfy the
requirements laid down in Article 5 of Directive 98/8/EC.
It is therefore appropriate to include K-HDO in Annex I,
in order to ensure that in all Member States authorisa­
tions for biocidal products used as wood preservatives
and containing K-HDO can be granted, modified or
cancelled in accordance with Article 16(3) of Directive
98/8/EC.

It

level.

therefore

the
Not all potential uses have been evaluated at
Community
that
appropriate
is
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.

In particular, in view of the possible risks for the envi­
ronment and workers, authorisations for products to be
used in other systems than industrial, fully automated
and closed ones should not be granted unless the appli­
cation for product authorisation demonstrates that risks
can be reduced to acceptable levels in accordance with
Article 5 of Directive 98/8/EC and Annex VI thereto.

In the light of the findings of the assessment report, it is
appropriate to require that products containing K-HDO
be used with appropriate protective equipment. In view
of the risks identified for infants, it is also appropriate to
require that K-HDO not be used for the treatment of
wood that may come in direct contact with infants.

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 K-HDO and
also to facilitate the proper operation of the biocidal
products market in general.

L 200/16

EN

Official Journal of the European Union

29.7.2008

themselves

(10) 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
the new requirements
to meet
prepare
applicants who have
that
entailed and to ensure
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.

(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
in
or
product-type 8 containing K-HDO to ensure that they
comply with Directive 98/8/EC.

authorisations of biocidal products

cancel

(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

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 July 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.

HAS ADOPTED THIS DIRECTIVE:

Article 1

Article 4

This Directive is addressed to the Member States.

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

Done at Brussels, 28 July 2008.

Article 2

Transposition

1. Member States shall adopt and publish, by 30 June 2009
at the latest, the laws, regulations and administrative provisions

For the Commission

Stavros DIMAS
Member of the Commission

29.7.2008

EN

Official Journal of the European Union

L 200/17

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