Norwegian decision to prohibit deliberate releases of six genetically modified products approved for marketing in the EU

Directive 90/220/EEC on the deliberate release of GMOs is implemented in Norwegian law by the EEA Agreement Annex XX, chapter IV. The adaptation to Directive 90/220/EEC when it was incorporated into the EEA Agreement gives the EFTA States the possibility of prohibiting marketing on the basis of <national legislation..... in relation to other concerns than health and environment>. In accordance with the Norwegian Gene Technology Act, such concerns would include those related to sustainability, social benefit and ethics. The Norwegian decisions are pursuant to the EEA Agreement, Enclosure XX no.25, Directive 90/220, litra (b) and (c), and 10 of the Norwegian Gene Technology Act.

The Norwegian Government has, by decision of 4th September 1997, prohibiting deliberate release in Norway of six genetically modified vaccines towards rabies (COM (93) 572) and pseudorabies (COM (94) 505) and genetically modified maize (COM (96) 206), tobacco (COM (94) 385), chicory (COM (96) 424) and oil seed-rape (COM (96) 158).

The Norwegian Ministry of Environment has together with the Ministry of Health and Social Affairs and the Ministry of Agriculture evaluated the vaccines as implying risks to health and environment. With respect to the vaccines, the risks are related to the possible recombination of vaccine virus and non-target and long term effects. None of the diseases are registered in Norway today. The four plant products all have gene coding for antibiotic resistance and are as such representing a risk to human and animal health. There is a possibility of antibiotic resistance genes being transferred to pathogenic bacteria, and this may contribute to the world's increasing problem with antibiotic resistant bacteria. Further, the antibiotic resistance genes have no function in the commercial products, and techniques for removing them are available. The lack of benefits from including the genes in the products, and the possibility of using alternative marker genes indicate that there is no need to take any risk. Antibiotic resistance genes therefore implies an unacceptable risk to health. Against this background, none of the abovementioned six products fulfill the conditions listed in the Norwegian Gene Technology Act and approvement would not be in accordance with the precautionary principle.

The Norwegian decision reflects the decision made by the Norwegian Parliament in June recommending the Government to prohibit all genetically modified products with genes coding for antibiotic resistance, and work to establish an international ban in this field. Norway has already proposed an international ban both under the negotiations on a protocol for safe handling and use of GMOs under the Convention on Biological Diversity and under the revision of Directive 90/220/EEC.