Work which involves genetically modified organisms and gene therapy has to be approved by Arbejdstilsynet before the work may commence. The same applies to the facilities where the work is performed.
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You must use the same forms whether you are applying for approval of changes to an existing project or a new project involving genetic engineering. The same applies to classification of facilities and changes to them.
All work with GMOs must be reported to and approved by Arbejdstilsynet, the Danish Working Environment Authority, before the work may commence. In this context, work refers to all handling of GMOs including trials or testing, analyses, storage and production. No lower limit of quantity or dilution exists.
You have to submit two separate applications. Firstly, you must apply for classification of the facilities, which is followed by Arbejdstilsynet assigning a LAB-id to the laboratory, area or facility at which the work is going to take place. Secondly you must obtain approval of the working conditions and safety surrounding the specific work in the classified area.
Before you apply, you are obliged to assess the possible risks of the GMOs to human safety and health and to the external environment. You must also assess which risk class the GMOs belong to.
You may not begin work involving GMOs before you have received a classification from Arbejdstilsynet regarding the area where the work will be conducted.
When you apply for classification of the facilities, you must state which risk class the GMOs belong to according to your risk assessment.
Production involving GMOs must be approved both by Arbejdstilsynet and the Danish Environmental Protection Agency (EPA). Each competent authority requires an individual application, and they issue individual approvals. Research projects, including large-scale trials only have to be notified to Arbejdstilsynet, which will involve the EPA to the extent relevant.
When you apply, you must provide an outline of the result of the risk assessment in the application. You also have the option to attach it its entirety. The application must be approved, before you commence work.
Subsequent class 1 work must be reported to Arbejdstilsynet, but the work may commence immediately after applying.
You must apply for approval of all significant changes in the classified facilities as well as in the work itself. When you apply for approval of changes, you must use the same forms as for classification of facilities and approval of new projects.
A significant change to the facilities may be an expansion, with new premises or new equipment, an upgrade or downgrade or the termination of a facility.
A significant change to the work may be an extension, a relocation or an update of the risk assessment.
Work with gene therapy must be approved by Arbejdstilsynet, if it is part of a clinical trial or research project.
The nature of gene therapy implies an environmental risk and, as a consequence, Arbejdstilsynet will always involve the EPA, when processing applications for gene therapy projects.
When applying for approval you may use the application forms prepared by the European Commission. You can attach the relevant form, when submitting your application via Busnessindenmark.virk.dk: