The Swedish Environmental Code defines a genetically modified organism as 'an organism in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination. According to the legislation relating to genetic engineering are certain techniques and methods considered to result in genetic modification, whereas, others are not considered to do so.The following techniques are considered to result in genetic modification
1. Recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, produced 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.
The following are not regarded as involving genetic modification
The following techniques are not considered to result in genetic modification, provided that they do not involve the use of hybrid DNA molecules or GMOs:1. In vitro fertilisation.
2. Natural processes such as conjugation, transduction or transformation.
3. Polyploidy induction.
The following GMOs are excluded from certain rules
GMOs produced by the techniques below are excluded from some of the provisions of the Ordinances SFS 2000:271 and SFS 2002:1086, provided that they do not involve the use of recombinant nucleic acid molecules (hybrid DNA) or other GMOs:1. Mutagenesis.
2. Cell fusion of plant cells, if the resulting organisms also could be produced by traditional breeding methods.
The provisions of SFS 2002:1086 do not apply to genetically modified human beings.
As regards the contained use, section 3 of the Ordinance SFS 2000:271 also excludes the following:
1. Micro-organisms that are or have been produced by cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes, where the resulting micro-organism is unlikely to be harmful to human health or the environment.
2. Micro-organisms that are or have been produced by cell fusion (including protoplast fusion) of cells of eukaryotic species, including production of hybridomas and plant cell fusions.
3. Micro-organisms that are or have been produced by self-cloning in cells of the same species or in cells of phylogenetically closely related species which can exchange genetic material by natural physiological processes and where the resulting micro-organism is unlikely to be harmful to human health or the environment.
Certain GMMs can be exempted from the regulation on the basis of a specific decision, if they are regarded as safe in accordance with Directive 90/219/EEC. The Swedish Work Environment Authority is, according to the Ordinance SFS 2000:271, required to list the GMMs concerned. No decisions about such extemptions have been made in the EU.
