Regulation No. 212 of 4 October 2005 on the release and placing on the market of genetically modified organisms.

This Regulation determines the: mandatory information contained in the technical dossier of the application for release of genetically modified organisms (GMOs) into the environment (also necessary for granting the related authorization/permit); information on the results of the release of GMOs into the environment with regards to the risks to human health and environment; traceability rules for GMOs marketed as products or as ingredients of specific products; rules for the creation of the unique code for the identification of GMOs intended to be marketed as products or constituents of products; minimum content of GMOs for which the labelling rules do not apply.
The Annex is also part of this text.