Approval for the development and experimentation of living modified organisms for experimental and r

Approval for development and experimentation using living modified organisms for testing and research purposes

Where microorganisms are used that are not specified down to the species level, and for which the pathogenicity to humans has not been established
Where genes with the ability to produce proteolytic toxins that have a lethal dose of less than 100 ng per 50% of body weight per 1 kg of vertebrates are used
- Integrated Announcement of the Living Modified Organisms Act [Appendix 2-1] Botulinum toxins (types A, B, C, D, E, F), tetanus toxin, dysenteric neurotoxin, diphtheria toxin, etc.
Where antibiotic resistance genes are deliberately transmitted to microorganisms in a manner that does not occur naturally
- Integrated Announcement of the Living Modified Organisms Act [Appendix 2-2]Antibiotic resistance genes exempt from approval
  : living modified microorganisms developed using host-vector systems that confer resistance to ampicillin, chloramphenicol, hygromycin, kanamycin, neomycin, puromycin, spectinomycin, streptomycin, tetracycline, or zeocin
In cases where the genes of pathogenic microorganisms that require national management for public health are directly utilized or synthesized for use.
- Unified Notice for the Act on the Transboundary Movement, Etc. of Living Modified Organisms [Annex Table 2-3] [View table]

Imports of commercially available living modified animal and plant cell lines must be reported to the Ministry of Science and ICT.
Even where only cultivation (propagation) is conducted using living modified organisms that have received import approval, development and experiment approval is required.

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(If there is a period for supplementation of materials, the supplementation period is not included in the processing deadline.)

Scope of change notification and change approval

Change notification, Change approval Table
Change notification	Change approval
If it falls under “minor matters” as stated in Article 8 (3) of the LMO Act, it is subject to change notification. Change in quantity of non-microbial LMO imported (volume or mass) to less than 1/100 of the original amount Change of importer’s name, address, or contact information	Matters that do not fall under “minor matters”