Commission Directive 2008/75/EC of 24 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include carbon dioxide as an active substance in Annex I thereto (Text with EEA relevance)
Date: 2008-07-24
Institutions: European Commission
Subjects: chemical product, environmental protection, greenhouse gas, marketing, public health

L 197/54

EN

Official Journal of the European Union

25.7.2008

DIRECTIVES

COMMISSION DIRECTIVE 2008/75/EC

of 24 July 2008

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Directive 98/8/EC, only for use in ready-for-use gas
canisters functioning together with a trapping device.

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 carbon dioxide.

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

been

Pursuant
to Regulation (EC) No 1451/2007, carbon
accordance with
evaluated
dioxide
has
Article 11(2) of Directive 98/8/EC for use in product-
type 14,
rodenticides, as defined in Annex V to
Directive 98/8/EC.

in

France was designated as Rapporteur Member State and
submitted the competent authority report, together with
a recommendation, to the Commission on 15 May 2006
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
report, with a
in an assessment
21 June 2007,
to include carbon dioxide in Annex IA to
proposal

(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)

An active substance listed in Annex IA should normally
also be listed in Annex I. Inclusion in Annex I would
cover those uses for which products may be expected to
satisfy the requirements of Article 5 of Directive 98/8/EC,
but not those of low-risk products. Such is the case of
certain biocidal products used as
and
containing carbon dioxide. It is therefore appropriate to
include carbon dioxide in Annex I for product-type 14,
in order to ensure that in all Member States authorisa­
tions for biocidal products used as rodenticides and
containing carbon dioxide can be granted, modified, or
cancelled in accordance with Article 16(3) of Directive
98/8/EC.

rodenticides

The assessment report was modified accordingly, and was
reviewed by the Standing Committee on Biocidal
Products on 29 November 2007.

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

The evaluation at the Community level was carried out
for one specific use.
in accordance with
In addition,
Article 8(5) of the Directive, some information was not
submitted, and thus not assessed. It is therefore appro­
priate that Member States assess those risks to the
compartments and populations that have not been repre­
sentatively 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.

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

25.7.2008

EN

Official Journal of the European Union

L 197/55

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
or
in
product-type 14 containing carbon dioxide to ensure
that they comply with Directive 98/8/EC.

authorisations of biocidal products

cancel

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.

(12) Directive

98/8/EC should

therefore

be

amended

accordingly.

Article 3

(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

This Directive shall enter into force on the twentieth day
following that of 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, 24 July 2008.

Article 2

Transposition

1. Member States shall adopt and publish, by 31 March
the laws, regulations and administrative
2009 at

the latest,

For the Commission

Stavros DIMAS
Member of the Commission

L 197/56

EN

Official Journal of the European Union

25.7.2008

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