Japan

[last updated: 06 May 2021]

Concluding a five-year review process, the Japanese Ministry of the Environment (MOE) published a decision regarding the regulation of genome edited plants in February 2019, that ‘some genome-edited organisms should be considered as LMOs while others are not subject to the Cartagena Act.’ (Tsuda et al., 2019)

Box: Excerpt from a flyer issued by the Japanese Ministry of the Environment, February 2019 (Japanese Ministry of the Environment, 2019):

To Genome Editing Technologies Users

Any organism that inserted intracellularly processed nucleic acid (including RNA) is regarded as a living modified organism (LMO), even those obtained using genome editing technologies, and is subject to the regulations stipulated in the Cartagena Act, in principle.
Such organisms are subject to the Cartagena Act unless complete removal of the inserted nucleic acid (including RNA), or its replicated product, is confirmed.
When using organisms obtained through genome editing technologies, please submit information to the competent government agencies […], even when the organism is not subject to the Cartagena Act.

Users of genome editing technologies are required to notify the government and provide information on unregulated end products created through genome editing technologies, including the details of their production and any knowledge of their impact on biodiversity prior to use (Tsuda et al., 2019). ^[1] No submission is required, if no change has been made to a previously submitted review, or if the genome-edited organisms are used in an environment, in which containment measures have been taken (Tsuda et al., 2019).

[1] Website: Human and Agriculture Gene Editing Regulations and Index – Japan: Crops/Food (accessed: 10^th March 2023)

[last updated: 06 May 2021]