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Techniques for Genetic Modification, cf. Sections 1 and 4

Annex 1 to the Danish Working Environment Authority's Executive Order No. 910 of 11 September 2008 on Genetic Engineering and Working Environment.

Part A

Within the framework of the definition of genetically modified organisms in Section 4, genetic modification occurs, as a minimum, when the following techniques are applied:

  1. Recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation.
  2. Techniques involving the direct introduction into an organism of heritable material prepared outside the organism, including micro-injection, macro-injection and micro-encapsulation.
  3. Cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

Part B

The following techniques are not considered to result in genetic modification, on condition that they involve the use of recombinant-nucleic acid molecules or genetically modified organisms:

  1. In vitro fertilisation;
  2. Natural processes such as: conjugation, transduction, transformation; and
  3. Polyploidy induction.

Part C

The Executive Order does not apply to organisms produced using the following genetic modification techniques, provided that they do not involve the use of genetically modified organisms as recipient or parental organisms:

  1. mutagenesis;
  2. cell fusion (including protoplast fusion) of prokaryotic species which exchange genetic material by known physiological processes;
  3. cell fusion (including protoplast fusion) of cells from all eukaryotic species, including the production of hybridomas and plant cell fusions; and
  4. traditional breeding methods.

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