Legislation regarding genetically modified organisms

The use of genetically modified organisms (GMOs) is subject to both national and international legislation. The statutes pertain to contained use and deliberate releases of GMOs as well as their transboundary movements.

Finnish legislation regarding the use of genetically modified organisms

The Gene Technology Act (377/1995) regulates the use of GMOs in Finland. The aim of the Act is to promote the safe use and development of gene technology in accordance with the precautionary principle and in an ethically acceptable way, and to protect human and animal health and the environment when contained use or deliberate release into the environment of GMOs is carried out. The organisms referred to in the Gene Technology Act do not include human beings.

The Gene Technology Act is based on the EU Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and on the Directive 2009/41/EC on the contained use of genetically modified micro-organisms (the former Directive 90/219/EEC). The Gene Technology Act pertains also to the contained use of GM plants and animals, thus differing from the latter Directive.

The Gene Technology Act is supplemented by Government Decrees and Decrees of the Ministry of Social Affairs and Health. The statutes have been amended several times after the year 1995. The list below contains the unofficial translations of the statutes in force at present.

  • Gene Technology Act ( 377/1995)
  • Government Decree on Gene Technology ( 928/2004)
  • Decree of the Ministry of Social Affairs and Health on the deliberate release of genetically modified organisms ( 110/2005)
  • Decree of the Ministry of Social Affairs and Health on the differentiated procedure relating to the deliberate release of genetically modified organisms ( 90/2005)
  • Decree of the Ministry of Social Affairs and Health on principles of risk assessment of the contained use of genetically modified micro-organisms, on classification of the contained use, and on containment and other protective measures ( 1053/2005)
  • Decree of the Ministry of Social Affairs and Health on notifications and applications relating to the contained use of genetically modified organisms, on keeping a record of the contained use and on an emergency plan ( 272/2006)
  • Decree of the Ministry of Social Affairs and Health on Inspection Procedures under the Gene Technology Act ( 198/2007)
  • Government Decree on Chargeable Performances under the Gene Technology Act (1539/2015)
  • Decree of the Ministry of Social Affairs and Health on principles of risk assessment of the contained use of genetically modified animals, on classification of the contained use, and on containment and other protective measures ( 771/2014)

Finnish legislation includes also other statutes pertaining to GMOs.

EU legislation regarding genetically modified organisms

Please, note that this is not an exhaustive listing of EU legislation relating to GMOs.

The directives and other legislation regarding the use of GMOs in the EU aim to ensure that the use of gene technology does not cause harm to human health or the environment.

Contained use of genetically modified micro-organisms

  • Directive 2009/41/EC of the European Parliament and of the Council on the contained use of genetically modified micro-organisms ( PDF file 883 kB)
  • Commission Decision 2000/608/EC concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms ( PDF file 112 kB)
  • Commission Decision 2005/174/EC establishing guidance notes supplementing part B of Annex II to Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms ( PDF file 64 kB)

Deliberate release of genetically modified organisms

  • Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (PDF file)
  • Council Decision 2002/813/EC establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market ( PDF file 625 kB)
  • Council Decision 2002/812/EC establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products ( PDF file 656 kB)
  • Council Decision 2002/811/EC establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC ( PDF file 143 kB)
  • Commission Decision 2002/623/EC establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC ( PDF file 163 kB)
  • Commission Decision 2003/701/EC establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market ( PDF file 452 kB)
  • Commission Decision 2004/204/EC laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council  ( PDF file 106 kB)
  • Commission Regulation (EC) No 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms ( PDF file 142 kB)
  • Commission Decision 2009/770/EC establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council ( PDF file 801 kB)

Further information on legislation

  • FINLEX - Finlex Data Bank
  • EUR-Lex - Access to European Union law