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List of relevant Danish legislation
Decision procedure in Denmark for applications
for experimental releases
Decision procedure in Denmark for applications
for contained use
Placing on the market – a joint EU decision
The Danish legislation distinguishes primarily between 3
different uses of genetically modified organisms:
- Use of GMOs for experimental purposes
- Use of GMOs for placing on the market
- Contained use of GMOs
The use of genetic engineering is regulated in Denmark by the
Act on the Environment and Genetic Engineering. The purpose of the
Act is to contribute to safeguarding nature and the environment,
thus ensuring sustainable social development in respect of human
conditions of life and for the protection of flora and fauna. The
Act shall also seek to protect human health in connection with
genetic engineering.
The Danish Act on Environment and Genetic Engineering is the
national implementation of EU Directive 2001/18/EC of 12 March
2001 on the deliberate release into the environment of genetically
modified organisms and repealing Directive 90/220/EEC. In addition
to that the Act also implements EU Directive 90/219/EEC on the
contained use of GMO as amended by Directive 98/81/EC.
The Directive on the deliberate release was latest amended in
2001. This amendment came into force on 17 October 2001. To be in
accordance with the obligations in the Directive 2001/18/EC,
Denmark undertook a revision of the Act on the Environment and
Genetic Engineering in the spring of 2002. See Act – Consolidated
Act No. 981 of 3 December 2002
on the Environment and Genetic Engineering.
Thus the regulation of GMOs in Denmark is harmonised with the
regulations of other EU Member States. However, the scope of
application for the Danish Act is broader as the Act also contains
provisions on transport, import and the contained use of plants
and animals. Three new Statutory Orders came into force together
with the new Act; two Statutory Orders on the approval of
production using genetically modified micro-organisms as well as
plants and animals. The third Statutory Order concerns the
deliberate release of genetically modified organisms. This
Statutory Order contains the more detailed provisions of the
Directive 2001/18/EC.
The regulation of the contained use of GMOs in Denmark is also
harmonised with the regulations of other EU Member States. The
provisions can be found in Statutory
Order No. 829 of 3 October 2002
on the approval of production using genetically modified
plants and animals, and Statutory
Order No. 830 of 3 October 2002 on the approval of
production using genetically modified micro-organisms. Both
Statutory Orders are based on Article 8 in the Act – Consolidated
Act No. 981 of 3 December 2002 on the Environment and
Genetic Engineering in force.
Provisions concerning definitions, exceptions, requirements for
the applications, notification, approval, fees, supervision and
enforcement are described in more detail in the Danish
legislation.
List of relevant Danish legislation
Decision procedure in Denmark – Experimental release
Decisions on experimental releases of GMOs are made at a
national level. This means that it is up to the individual EU
Member State whether or not it will allow an experimental release
to take place. The EU Member States keep each other informed on
which releases that are projected in their countries. All Member
States have the possibility to comment on projected experimental
releases in other Member States through an electronic
communication system (the SNIF system), that is administered by
the Joint Research Centre (JCR) under the European Commission. (Click
here for more information on the JCR).
The EU Member States make their decisions on experimental
releases on the basis of harmonised regulation that can be found
in Part B of Directive 2001/18/EC. The provisions of the Directive
concerning experimental releases are implemented in Denmark in
Statutory Order on the deliberate release into the environment of
genetically modified organisms.
DANISH
PROCEDURE FOR EXPERIMENTAL RELEASES
Decision procedure in Denmark – Contained use
Decisions on the contained use of GMOs are, like decisions on
experimental releases, made at a national level. There are,
however, harmonised EU provisions on how to make such decisions,
that is EU Directive 90/219/EEC on the contained use of
genetically modified organisms as amended by Directive 98/81/EC.
The Danish regulation of contained use distinguishes between:
- Applications for research and large scale experiments. Such
applications are processed by the Danish Working Environment
Authority and include consultation of the Danish Forest and
Nature Agency.
- Applications for production of GMOs that are processed by
the Danish Forest and Nature Agency.
An "approval for production with GMOs" includes an
approval of both the production plant and the production organism.
When the plant has been approved, subsequent notifications can be
notified after simplified procedures. The Danish Forest and Nature
Agency also makes decisions on notifications.
(Model under construction)
Placing on the market – a joint EU decision
Approvals for placing on the market of GMOs are joint EU
decisions. This means that a GMO can not be placed on the market
in only one EU Member State. It must be approved for placing on
the market in all EU Member States. After that the GMO can be
placed on the market and cultivated anywhere at the Internal
European Market.
The placing on the market of GMOs requires an approval after
the provisions in the EU Directive on the deliberate release
(Directive 2001/18/EC). Genetically modified food however, must be
approved according to the regulation concerning novel foods and
novel food ingredients (Regulation 258/97).
"The placing on the market" of GMOs is in Article 2,
4 of the Directive on the deliberate release defined as:
"making available to third parties, whether in return for
payment or free of charge."
GMOs within the scope of the Directive on the contained use of
GMOs (Directive 90/219/EEC as amended by Directive 98/81/EC) are
not included in the definition of the placing on the market.
Equally, making available GMOs for experimental purposes only is
not included in the definition of the placing on the market.
GMOs that are placed on the European market with a view to be
sold for cultivation must also have an approval after the variety
catalogue.
An approval for placing on the market of GMOs within the EU
must be renewed after 10 years.
Companies applying for an approval for placing on the European
market of GMOs shall send an application to the competent
authority in that EU Member State where they first want to market
the GMO. The further processing of the application takes place in
the rest of the Member States together with the European
Commission. Read more about placing on the market of GMOs within
the EU at the web site of the European Commission or read
here.
New EU legislation has recently been adopted. The new
legislation introduces new procedures for approvals for placing on
the European market of GMOs. The legislation will, most likely,
apply from the spring of 2004.
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