Vietnam Sanitary and Phytosanitary Notification Authority and Enquiry Point

This draft Decree includes the following key updates:

•   Clarifies the definition of "products of genetically modified organisms" as products derived from GMOs that contain genetic material or proteins resulting from the

  modified gene;

•   Defines "Genetic technology" as the application of molecular biology to directly

  intervene in the genetic material of organisms, including gene editing techniques and

  genetic recombination techniques;

•   Defines "Gene-edited organism" as an organism whose genetic material has been

  modified through gene-editing techniques and does not contain new genetic material from another species or from synthetic sources that are not equivalent in composition and structure to that of the species;

•   Article 3a is added to establish a clear basis for distinguishing between genetically modified organisms (GMOs) and gene-edited organisms (GEs) for biosafety management. GMOs continue to be subject to existing risk assessment and risk management procedures under Decree No. 69/2010/ND-CP. GEs are managed in accordance with existing regulations on production and business, with organizations and individuals responsible for determining and publicly declaring classification results, reporting to the Ministry of Agriculture and Environment, and maintaining relevant documentation for 10 years from the date of declaration. The amendment aims to clarify classification criteria, ensure consistency with current legislation, simplify administrative procedures, and strengthen accountability in biosafety management.

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