Requirements for field trials and marketing are changing

Requirements for field trials and marketing are changing

More information will be required in the applications regarding deliberate release of genetically modified organisms when the application is provided to the Board for Gene Technology. The relevant Decree 1105/2019 of the Ministry of Social Affairs and Health issued under the Gene Technology Act will enter into force on 5 December 2019. The Decree repeals the previous Decree 110/2005 of the Ministry of Social Affairs and Health.

When an operator applies for the authorisation of a field trial or of the marketing of GMOs, the Board for Gene Technology shall be provided with both experimental and statistical additional information in the application. The new requirements concern specifically genetically modified plants.

The Decree implements Commission Directive (EU) 2018/350 on the environmental assessment of genetically modified organisms. The guidelines on environmental risk assessment also apply to food, feed, pharmaceuticals and vaccines containing genetically modified organisms for which a marketing authorisation is applied for under legislation other than the Gene Technology Act.

The Decree also regulates the risk assessment of the deliberate release of genetically modified organisms, the monitoring plan when placing products on the market, and the reporting of results of the deliberate release of genetically modified organisms for purposes other than placing on the market (i.e. field trials).

There are currently no marketing authorisation applications pending in Finland. However, research and development tests on genetically modified organisms are carried out in Finland, which are covered by the provisions of the Decree. If you intend to submit a field trial application, please review the contents requirements described in the Decree and contact the Gene Technology Board.