Commission Directive 2006/140/EC of 20 December 2006 amending Directive 98/8/EC of the European Parliament and of the Council to include sulfuryl fluoride as an active substance in Annex I thereto Text with EEA relevance
Date: 2006-12-20
Institutions: European Commission
Subjects: insecticide, market approval, plant health control

L 414/78

EN

Official Journal of the European Union

30.12.2006

COMMISSION DIRECTIVE 2006/140/EC

of 20 December 2006

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

(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 Article
16(2) second subparagraph thereof,

Whereas:

(1)

(2)

(3)

(4)

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
Annex I,
list
includes sulfuryl fluoride.

IB to Directive 98/8/EC. That

IA or

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

In accordance with Article 5(2) of Regulation (EC) No
2032/2003, Sweden was designated as Rapporteur
competent
Member
State.
authority report,
to
the Commission on 19 April 2005 in accordance with
Article 10(5) and (7) of that Regulation.

Sweden
together with a recommendation,

submitted

the

The competent authority report has been reviewed by the
Member States and the Commission. In accordance with
Article 11(4) of Regulation (EC) No 2032/2003,
the
the review were incorporated, within the
findings of
Standing Committee on Biocidal
Products on 8
September 2006, in an assessment report.

(1) OJ L 123, 24.4.1998, p. 1. Directive as

last amended by
Commission Directive 2006/50/EC of 29 May 2006 (OJ L 142,
30.5.2006, p. 6).

(2) OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regu-

lation (EC) No 1048/2005 (OJ L 178, 9.7.2005, p. 1).

(5)

(6)

(7)

(8)

(9)

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

It appears from the various examinations made that
biocidal products used as wood preservatives
and
containing sulfuryl fluoride may be expected to satisfy
the requirements laid down in Article 5 of Directive
in particular with regard to the uses which
98/8/EC,
were examined and detailed in the assessment report. It
is therefore appropriate to include sulfuryl fluoride in
Annex I,
in order to ensure that in all Member States
authorisations for biocidal products used as wood preser-
vatives and containing sulfuryl fluoride can be granted,
modified, or cancelled in accordance with Article 16(3)
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 sulfuryl fluoride
and also to facilitate the proper operation of the biocidal
products market in general.

In the light of the findings of the assessment report, it is
appropriate to require that such products be authorised
only for use by trained professionals, in accordance with
Article 10(2)(i)(e) of Directive 98/8/EC, and that risk
mitigation measures are designed to ensure the safety
of operators and bystanders, in accordance with Article
10(2)(i)(f) of Directive 98/8/EC.

In addition, it is appropriate to require continuous moni-
toring, as well as the provision of further information on
certain specific points detailed in the assessment report,
in accordance with Article 10(2)(i)(f) of Directive
98/8/EC.

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
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(c)(ii) of Directive 98/8/EC, starts from the
date of inclusion.

30.12.2006

EN

Official Journal of the European Union

L 414/79

(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
in
fluoride to ensure
product-type 8 containing sulfuryl
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

HAS ADOPTED THIS DIRECTIVE:

Article 1

They shall apply those provisions from 1 January 2009.

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
the European
that of
Union.

its publication in the Official

Journal of

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

Article 4

Article 2

Transposition

the latest,

1. Member States shall adopt and publish, by 31 December
2007 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.

This Directive is addressed to the Member States.

Done at Brussels, 20 December 2006.

For the Commission

Stavros DIMAS
Member of the Commission

L 414/80

EN

Official Journal of the European Union

30.12.2006

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