Contained use of genetically modified micro-organisms
According to the definition of the Gene Technology Act, micro-organism means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture and human cells and human tissues in culture.
Genetically modified micro-organism (GMM) means a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination. Techniques that produce GMMs within the scope of Gene Technology Act are listed in the Government Decree on Gene Technology (928/2004).
Instructions on contained use of GMMs
If you are going to use GMMs in Finland you should first find out how your establishment has organised its notifications. The operator defined by the Gene Technology Act (377/1995) can be for example an institute, its division or an individual research group. Explore the possibility to work under a previously existing notification especially if your contained use is class 1. If in any doubt, contact the Board for Gene Technology before submitting any new documents. The Board collects a charge from the operator for processing notifications/applications.
The contained use of GMMs is classified into four classes based on the risk assessment. The notification procedure depends on the class as follows:
The operator must have a notification of the premises (section 14). The first use may be commenced when the notification has been submitted to the Board for Gene Technology. Later use does not require any notification, but the operator must keep a record of the risk assessment.
The operator must have a notification of the premises (section 14) and a notification of the use of GMMs (section 14 a). The first use may be commenced after the expiry of a 45-day waiting period. Later use may require a new notification depending on the characteristics of the new GMMs.
Class 3 and 4
The operator must have a notification of the premises (section 14) and also submit an application for the use of GMOs (section 14 b). The use may be commenced only after the Board has granted a written consent. Any later use requires a new consent.
Further provisions on contained use and notification procedures are given in the Government Decree on Gene Technology (928/2004), Ministry of Social Affairs and Health Decree on the principles of the risk assessment of contained use of genetically modified organisms, on the classification of contained use as well as on containment and other protective measures (1053/2005), and Ministry of Social Affairs and Health Decree 272/2006 addressing the notification procedures and record-keeping. Unofficial English translations of these statutes are available (see Finnish legislation).
The Board provides guidelines on the contained use of GMMs and virus vectors, these documents are currently available only in Finnish. Risk Assessment Form for Genetically Modified Micro-organisms is available also in English (see Forms). For English guidance on how to perform the risk assessment you can also have a look at Commission Decision 2000/608/EC.
Production and research use of medicinal products containing GMOs from the perspective of the Gene Technology Act (guideline)
Notification/application forms for GMMs
Please, read carefully all relevant instructions before filling the form. The notification/application must usually be written in Finnish or Swedish. However, the operators can fill the notification forms in English if neither the person with main responsibility nor his/her deputy are native Finnish or Swedish speakers, and neither of them have sufficient skills in these languages to provide information required by the gene technology regulations. This policy applies only to contained use notifications concerning work with class 1 or 2 GM microbes and plants or class 1 GM animals.
Documents can be sent to the Board via mail or e-mail.
- Risk Assessment Form for Genetically Modified Micro-organisms (Word file )
- Instructions for completing the Risk Assessment Form (Word file)