Decree (2002:1086) on the release of genetically modified organisms into the environment.

The present Decree applies to the handling of genetically modified organisms (GMOs), with the exception of contained use in accordance with the Decree (2000:271) on the contained use of genetically modified organisms. It does not apply to genetically modified humans; organisms produced by mutagenesis; and organisms produced by cell fusion (including protoplast fusion) of plant cells in cases where the plant can also be produced by traditional processing methods. The Decree contains the following chapters: 1. Introductory provisions; 2. Deliberate release; 3. Placing on the market; 4. Labelling, registration and information to the public; 5. Other provisions.
Supervisory authorities and operators shall, in accordance with the precautionary principle, ensure that appropriate measures are taken to avoid such adverse effects on human health or the environment as may arise from the deliberate release or release of genetically modified organisms on the market. The mandatory risk assessment referred to in Ch. 13 Article 8 of the Environmental Code shall be carried out in accordance with Annex I of the present Decree. Particular attention should be paid to genetically modified organisms with genes that confer resistance to antibiotics used in medical or veterinary treatment. Detailed rules on the application and granting of the permits specified in Ch. 13 Article 12 of the Environmental Code are included. The supervisory authority shall notify the European Commission of the final decisions regarding permissions for deliberate release. Moreover, the Decree contains detailed rules on the labelling of products; registration obligations of the supervisory authority; the supervisory authority's obligation with regard to public information; mutual recognition; communication with the European Commission; transboundary movement of GMOs; cooperation with countries in the European Economic Area on GMOs; etc.
Annex 1 contains principles for risk assessment; Annex 2 concerns mandatory information in permit applications; Annex 3 rovides a general description of additional information to be provided in an application for a marketing authorization; Annex 4 concerns the monitoring plan.