Commission Directive 2008/77/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include thiamethoxam 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

26.7.2008

EN

Official Journal of the European Union

L 198/41

COMMISSION DIRECTIVE 2008/77/EC

of 25 July 2008

amending Directive 98/8/EC of

the European Parliament and of

the Council

to include

thiamethoxam as an active substance in Annex I thereto

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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
Annex I,
list
includes thiamethoxam.

IB to Directive 98/8/EC. That

IA or

to Regulation (EC) No 1451/2007,

Pursuant
thia­
methoxam 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.

Spain was designated as Rapporteur Member State and
submitted the competent authority report, together with
a recommendation, to the Commission on 27 July 2007
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
22 February 2008, in an assessment report.

(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.

(6)

(7)

(8)

(9)

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

to include

It

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
to products
applied at product
containing thiamethoxam 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
compartments
these
compartments have been identified during the evaluation
and products intended for industrial and/or professional
protective
be
use
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 thiamethoxam
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.

L 198/42

EN

Official Journal of the European Union

26.7.2008

(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
they
type 8 containing thiamethoxam to ensure that
comply with Directive 98/8/EC.

(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

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.

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

Article 4

This Directive is addressed to the Member States.

Article 2

Transposition

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

Done at Brussels, 25 July 2008.

For the Commission

Stavros DIMAS
Member of the Commission

26.7.2008

EN

Official Journal of the European Union

L 198/43

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