Deliberate release of genetically modified organisms
The deliberate release into the environment of GMOs is either carried out as so-called field trials (also referred to as deliberate release for any other purpose than for placing on the market) or as placing on the market of a product. Deliberate release has to be authorised and requires thorough risk assessment of possible health or environmental effects of the organism. The consent for field trials is granted by the Board for Gene Technology in Finland. The consent for GMO products to be placed on the market is granted through a centralised authorisation procedure in the EU. The authorised products can be marketed in the whole area of the EU with the exception of genetically modified plants approved for cultivation that may be subject to national cultivation bans or restrictions.
Field trials of genetically modified organisms
In the Gene Technology Act field trials are referred to as "deliberate release into the environment for any other purpose than for placing on the market". There are very different types of field trials, such as experimental cultivation of a crop variety or clinical testing of a vaccine for humans.
The operator must apply for a consent from the Board for Gene Technology for a field trial to be carried out in Finland. The processing of the application always includes a public consultation on the planned field trial. The Board for Gene Technology also requests expert statements concerning the application. The consent for a trial is granted only if no hazard to human or animal health has been detected in the risk assessment.
Placing on the market of GMO products
The GMO products intended as food or feed are currently authorised in the EU through a centralised procedure under the Regulation (EC) No 1829/2003. In such cases, the risk assessment of the product is carried out by the European Food Safety Authority (EFSA). National competent authorities, such as the Board for Gene Technology, may comment on the applications submitted to EFSA after EFSA has found the applications to be valid. At a later stage when Finland's position on the authorisation of a product is decided, the opinion of the Board is also taken into consideration.
Products containing living genetically modified organisms not intended as food or feed are authorised to be placed on the EU market through the procedure pursuant to the Directive 2001/18/EC (the former directive 90/220/EEC). The consent for medicinal substances is granted through a centralised procedure through the European Medicines Agency (EMA).