"Deliberate release" means “any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with the general population and the environment”.
The deliberate release of GMOs covers activities for research and development purposes (e.g. field trials with GM plants, some clinical trials with GMOs) and placing on the market of GMOs (e.g. commercial cultivation of GM plants, commercialisation of GM food and feed, commercialisation of medicinal products for human or veterinary use containing or consisting in GMOs).
In Belgium, as elsewhere in the European Union, a GMO cannot be deliberately released into the environment without first obtaining an authorisation from the competent authority. This authorisation is delivered following a notification procedure involving a case-by-case assessment of the risks to human health and the environment associated with the use of the GMO.
The current legislative framework is the Royal Decree of 21 February 2005 (in French and Dutch) (Moniteur Belge/Belgisch Staatsblad of 24.02.2005, p. 7129). This Decree transposes the European Directive 2001/18/EC.
It has been modified by
- the Royal Decree of 19 February 2020 (in French and Dutch) (Moniteur Belge/Belgisch Staatsblad of 02.03.2020, p. 12666), which transposes the Commission Directive (EU) 2018/350 as regards the environmental risk assessment of GMOs.
- the Royal Decree of 27 May 2021 (in French and Dutch) (Moniteur Belge/Belgisch Staatsblad of 23.06.2021, p. 64589), which introduces certain provisions related to the Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain.
A consolidated version is available in French and Dutch. The Decree is completed by a Decree of 18 October 2006 related to the designation of a Control Unit as foreseen in article 2, 19°, of the abovementioned Decree (Moniteur Belge/Belgisch Staatsblad of 07.11.2006, p. 59018).
The general frame of reference supporting the transposition at Belgian level of European legislation on the deliberate release of GMOs is the Law of 20 July 1991 concerning social and miscellaneous provisions (Loi du 20 juillet 1991 portant des dispositions sociales et diverses / Wet van 20 juli 1991 houdende sociale en diverse bepalingen - Moniteur belge/Belgisch Staatsblad of 1.08.1991, p. 17002). Article 132 thereof states that "in order to ensure the fulfilment of obligations resulting from international agreements or treaties regarding the deliberate release of genetically modified organisms, the King, by means of a decree deliberated in the Council of Ministers, regulates the deliberate release of genetically modified organisms".
This law has been supplemented by the Law of 22 February 1998 (Loi du 22 février 1998 portant des dispositions sociales / Wet van 22 februari 1998 houdende sociale bepalingen - Moniteur belge/Belgisch Staatsblad of 3.03.1998, p. 5683). Article 222 of this Law provides for the charging of fees in aid of Sciensano and Article 226 confers special powers to officials responsible for overseeing compliance with the legal provisions regarding the deliberate release of GMOs.