til forsiden
Skov- og Naturstyrelsen
Miljøministeriet
  International: English - Deutsch - Francais - Espanol Kontakt: find vej til styrelsen, pressekontakt, webredaktion, medarbejdere, sagsbehandlingstider Søg på hjemmesiden Oversigt: Find vej på hjemmesiden
International Kontakt Søg Oversigt 
For alle Erhverv og administration Nyheder Om Skov- og Naturstyrelsen Udgivelser Aktuelle emner
   

 

  Introduction

 

  Contact

 

  Legislation

 

  Bilateral, regional and multilateral agreements and arrangements

 

  Decisions on genetically modified organisms and risk assessments

 

  Experts

 

  Emergency measures taken

 

  Environmental reviews and reports

 

  Export of GMOs to Denmark

 

  Danish

 

  Home



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Danish Biosafety Clearing House

Legislation

The Danish legislation distinguishes primarily between 3 different uses of genetically modified organisms:

  1. Use of GMOs for experimental purposes
  2. Use of GMOs for placing on the market
  3. 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:

  1. 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.
  2. 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.