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Notification and Approval of Research Projects, Other Laboratory Tasks, Large-Scale Testing and Production, Which Includes Genetically Modified Organisms, cf. Sections 15, Subsection 1, and 21, Subsection 1

Annex 4 to the Danish Working Environment Authority's Executive Order No. 910 of 11 September 2008 on Genetic Engineering and Working Environment.

Part A General principles

Information required in connection with the notification at issue in Section 15, Subsection 1 and Section 21, Subsection 1:

  1. Date of the classification or submission of notification referred to in Section 7, Subsection 1;
  2. Names of persons responsible for supervision and security, as well as information about their education and qualifications;
  3. Recipient(s) used, donors and/or parental organisms or, where appropriate, the host vector system(s) used;
  4. Origin of the genetic material involved in the genetic modifications and the intended function of that material;
  5. Identity and characteristics of the genetically modified organism;
  6. Purpose of the contained use, including the expected results;
  7. Approximate culture volume associated with activities involving micro-organisms;
  8. Description of the planned containment and other protective measures, including information on the management of the waste generated, its treatment, final form and determination;
  9. A copy of the assessment referred to in Section 6;
  10. The information that the Danish Working Environment Authority needs in order to evaluate the emergency response plans that have been prepared in accordance with Section 28, Subsections 2 and 3.

Part B

Notification of research projects in Classes 3 and 4 as well as large-scale testing and production.

The notification must contain information as mentioned in Annex 4, Part A.

In addition, the following points must be provided:

  • The culture volume to be used;
  • Description of the containment and other protective measures that will be applied, including information about waste management, including the type and form of waste that will be generated, its treatment, final form and determination;
  • Description of the facility’s parts;
  • Information about accident prevention and any emergency response plans;
  • Specific risks due to the location of the facility;
  • The preventive measures applied such as safety equipment, alarm systems and containment methods;
  • Procedures and plans for verifying the effectiveness of containment measures;
  • A description of the information provided to workers, including safety regulations;

If it is not technically possible or is not considered necessary to provide some of the information, the reasons for this must be stated.

For productions, the level of detail required in answering the individual points varies according to the nature and scope of the proposed production. In particular, it is not normally necessary to provide detailed biological information about host organisms previously recognised as Class 1.

If some of the required information has previously been submitted to the Danish Working Environment Authority, the notification may refer to this information.

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