Commission Directive 2008/85/EC of 5 September 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include thiabendazole as an active substance in Annex I thereto (Text with EEA relevance)
Date: 2008-09-05
Institutions: European Commission
Subjects: chemical product, environmental protection, marketing, public health, wood industry

L 239/6

EN

Official Journal of the European Union

6.9.2008

DIRECTIVES

COMMISSION DIRECTIVE 2008/85/EC

of 5 September 2008

amending Directive 98/8/EC of

the European Parliament and of

the Council

to include

thiabendazole as an active substance in Annex I thereto

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

the Standing Committee on Biocidal Products on
22 February 2008, in an assessment report.

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:

(EC) No

1451/2007

of
Commission Regulation
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
Annex I,
list
includes thiabendazole.

IB to Directive 98/8/EC. That

IA or

been

to Regulation (EC) No 1451/2007,
has

thiaben­
Pursuant
dazole
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.

evaluated

in

Spain was designated as Rapporteur Member State and
submitted the competent authority report, together with
a recommendation, to the Commission on 9 May 2006
in accordance with 14(4) and (6) of Regulation (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,
the review were incorporated, within
the findings of

(8)

(1) OJ L 123, 24.4.1998, p. 1.
(2) OJ L 325, 11.12.2007, p. 3.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

It appears from the examinations made that biocidal
products used as wood preservatives and containing thia­
bendazole may be expected to satisfy the requirements
laid down in Article 5 of Directive 98/8/EC.
is
in
appropriate
therefore
Annex I,
in order to ensure that in all Member States
authorisations for biocidal products used as wood preser­
vatives and containing thiabendazole can be granted,
modified, or cancelled in accordance with Article 16(3)
of Directive 98/8/EC.

It
thiabendazole

to include

However, unacceptable risks were identified for the in situ
treated wood
treatment of wood outdoors and for
exposed to weathering. Therefore, authorisations
for
these uses should not be granted unless data have been
submitted in order to demonstrate that the products can
be used without unacceptable 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 thiabendazole and used as wood preservatives
to ensure that risks are reduced to an acceptable level in
accordance with Article 5 of Directive 98/8/EC and
In particular, appropriate measures
Annex VI
and aquatic
should be
these
compartments
compartments have been identified during the evaluation
and products intended for industrial and/or professional
be
use
protective
equipment
the risk identified for industrial and/or
professional users cannot be reduced by other means.

the
unacceptable

taken to protect

should
if

soil
risks

used with

appropriate

thereto.

since

in

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

6.9.2008

EN

Official Journal of the European Union

L 239/7

(9)

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
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.

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

authorisations of biocidal products

cancel

(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:

Article 1

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.

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, 5 September 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

L 239/8

EN

Official Journal of the European Union

6.9.2008

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