Commission Directive 2007/69/EC of 29 November 2007 amending Directive 98/8/EC of the European Parliament and of the Council to include difethialone as an active substance in Annex I thereto (Text with EEA relevance)
Date: 2007-11-29
Institutions: European Commission
Subjects: Council of the European Union, EC Directive, European Parliament, approximation of laws, chemical product, marketing, rodent

30.11.2007

EN

Official Journal of the European Union

L 312/23

DIRECTIVES

COMMISSION DIRECTIVE 2007/69/EC

of 29 November 2007

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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)

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 difethialone.

IB to Directive 98/8/EC. That

IA or

Pursuant to Regulation (EC) No 2032/2003, difethialone
has been evaluated in accordance with Article 11(2) of
Directive 98/8/EC for use in product-type 14, roden-
ticides, as defined in Annex V to Directive 98/8/EC.

Norway was designated as Rapporteur and submitted the
competent authority report, together with a recommen-
dation,
to the Commission on 11 October 2005 in
accordance with Article 10(5) and (7) of Regulation
(EC) No 2032/2003.

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

2007/47/EC (OJ L 247, 21.9.2007, p. 21).

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

lation (EC) No 1849/2006 (OJ L 355, 15.12.2006, p. 63).

(5)

(6)

(7)

(8)

The competent authority report was reviewed by the
Member States and the Commission.
In accordance
with Article 11(4) of Regulation (EC) No 2032/2003,
the findings of
the review were incorporated, within
the Standing Committee on Biocidal Products on 21
June 2007, in an assessment report.

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

It appears from the examinations made that biocidal
products used as rodenticides and containing difethialone
may be expected not to present a risk to humans except
for accidental
incidents with children. Regarding non-
target animals and the environment a risk has been iden-
tified. However, difethialone is
the time being
considered essential
for reasons of public health and
hygiene. It is therefore justified to include difethialone
in Annex I,
in all Member
States authorisations for biocidal products used as roden-
ticides and containing difethialone can be granted,
modified, or cancelled in accordance with Article 16(3)
of Directive 98/8/EC.

in order to ensure that

for

specific

to require

In the light of the findings of the assessment report, it is
appropriate
risk mitigation
that
measures are applied at product authorisation level to
products containing difethialone and used as roden-
ticides. Such measures should be aimed at limiting the
risk of primary and secondary exposure of humans and
non-target animals as well as the long term effects of the
substance on the environment.

Because of
the identified risks and its characteristics,
which render it potentially persistent, liable to bioaccu-
mulate and toxic, or very persistent and very liable to
bioaccumulate difethialone should be included in Annex
I for five years only and should be made subject to a
comparative risk assessment
in accordance with the
second subparagraph of Article 10(5)(i) of Directive
98/8/EC before its inclusion in Annex I is renewed.

L 312/24

EN

Official Journal of the European Union

30.11.2007

(9)

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

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
entailed and to ensure
applicants who have
that
fully from the 10-year
prepared dossiers can benefit
in accordance with
period of data protection, which,
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
or
in
product-type 14 containing difethialone 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

Article 2

Transposition

the latest,

1. Member States shall adopt and publish, by 31 October
the laws, regulations and administrative
2008 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 November 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

Article 4

This Directive is addressed to the Member States.

HAS ADOPTED THIS DIRECTIVE:

Done at Brussels, 29 November 2007.

Article 1

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

For the Commission

Stavros DIMAS
Member of the Commission

30.11.2007

EN

Official Journal of the European Union

L 312/25

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