The EU began to elaborate legislation related to GMOs in the early 90’s, and specific regulations have been carried into effect in the interests of public health and protecting the environment.
The first piece of legislation (Directive 90/220/EEC), which regulates the deliberate release of GMOs into the environment, was adopted in 1990. According to the Directive, a preliminary authorisation procedure is required for genetically modified organisms.
Directive 2001/18/EC includes stricter regulations than its predecessor. It prescribes that an environmental risk assessment study must be performed before GMOs are deliberately released or placed on the market. The applicant must submit a detailed document, which must include: information related to the environmental risk assessment, and to the safety regulations it makes necessary, and in the case of a product recommendations relating to instructions for use and labelling. The environmental risk assessment also measures and analyses possible health risks, therefore only GMOs with no harmful effects on human health or on the environment can receive an authorisation. The Directive also prescribes the introduction of compulsory monitoring after GMOs have been placed on the market, to enable to reveal the possible long-term effects.
The authorisation of genetically modified microorganisms is regulated by Directive 90/219/EC, which was amended by Directive 98/81/EC, and is supplemented by Directive 2009/41/EC on the contained use of genetically modified microorganisms.
Other important pieces of legislation:
• Regulation 1829/2003/EC on genetically modified food and feed.
• Regulation 1830/2003/EC on the traceability and labelling of genetically modified organisms
• Regulation 1946/2003/EC on the transboundary movements of genetically modified organisms