Directive 2001/18/EC on the "deliberate release of GMOs into the
environment" regulates the releases of GMOs into the environment,
be it for experimental purposes (field trials) or for commercial
purposes (placing on the market).
Directive 2001/18/EC provides for the Community procedure for
granting consent for deliberate release of GMOs into the
environment. Its key provisions include:
- The EU definition of a GMO (see article 2): a genetically
modified organism (GMO) means an organism, with the exception of
human beings, in which the genetically material has been altered in
a way that does not occur naturally by mating and/or natural
recombination.
- Common methodology and principles for environmental risk
assessment (see Annex II) before any GMO release into the
environment
- Mandatory labelling and traceability of GMOs at all stages of the
placing on the market
- Mandatory post-market monitoring requirements, including on
long-term effects associated with the interaction with other GMOs
and the environment
- Approvals for the release of GMOs to be limited to a maximum of
ten years (renewable)
- Mandatory information to the public, including public registers
for recording information on deliberate release of GMOs into the
environment
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