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A genetically modified organism (GMO) is defined in the relevant European legislation as any organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.

In practice, the legislation currently applies mainly to the deliberate release into the environment of GMOs, for example the cultivation of GM plants such as maize and the import, distribution and industrial processing of GM food and animal feed.

It is important to ensure that all use of GMOs accords with the precautionary principle in order to protect human health and the environment. Therefore the authorisation of GMOs for deliberate release into the environment requires a thorough environmental and health risk assessment. The European Food Safety Authority (EFSA) adopts scientific opinions concerning the safety of each GMO, on the basis of which the Commission makes its proposals regarding authorisation. Authorised GMOs are subject to systematic post-marketing monitoring, labelling and traceability requirements.

The deliberate release of GMOs into the environment, including through cultivation, is regulated by Directive 2001/18/EC. Use as or in food and feed is regulated by Regulation (EC) No 1829/2003. An applicant (notifier) has two options when applying to cultivate a GM plant:  to apply under the Directive or, where the cultivation is linked to its subsequent use for food or feed, under the Regulation. DG Environment shares the responsibility for implementing the GMO legislation with DG SANCO.

The GMO legislation also includes: the Directive on the contained use of GM micro-organisms (90/219/EEC), the Regulation for traceability and labelling of GMOs (1830/2003) and the Regulation on the transboundary movement of GMOs (1946/2003). Rules for the transboundary movement of GMOs are established in line with the provisions of the Cartagena Protocol.