This document discusses Japan's regulatory policies for genome editing technology and genetically modified organisms (GMOs). It provides an overview of the country's regulatory framework for GMOs, which assesses impacts on biodiversity and requires food/feed safety assessments. Genome-edited organisms that do not contain foreign DNA or its remnants are not considered GMOs. The document outlines what information developers must provide to authorities for genome-edited foods, including the editing method, modified gene functions, and confirmation of no adverse health effects or foreign DNA. It aims to provide public understanding of genome-edited foods while still requiring a safety assessment for those containing extracellular DNA.

1. 地球と食料の未来のために
Japanese Regulatory Policy of Genome
Editing Technology
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2. Japanese Regulatory Framework of GMO
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Source: MOE, MHLW, MAFF
Impact Assessment on Biodiversity (Cartagena Act)
Type2 Use: Under the closed condition (e.g., in laboratory)
Type1 Use: Under the open condition (e.g., in confined field)
Food Safety Assessment
(Food Sanitation Act)
Commercialization
Non-Food
(Flower etc.)
Feed Safety Assessment
(Feed Safety Law)

3. Policy for the Regulation of Genome Editing Technology
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The organism is GMO The organism is non-GMO
Containmentmeasures
No
Type 1 Use: Use the organism by following the regulations
approved by the Minister based on the assessment of
adverse effect of biological diversity, in accordance with
Article 4 of the Act.
Use the organism after providing information concerning the
traits and discussions on adverse effect of biological diversity
of the organism to the competent government agencies.
Yes
Type 2 Use: Use the organism by taking the containment
measures stipulated in the ordinances based on Article 12 of
the Act or containment measures approved by the Minister
based on Article 13 of the Act
Use the organism by taking the containment measures
stipulated in the ordinances based on Article 12 of the Act or
measures approved by the competent government agencies
as measures that can prevent dispersal of the organism.
Is a foreign DNA introduced in organisms?
Is the DNA or its replicated product
still remains in the host genome?
Source: MOE
No
No
Yes
Yes

4. Specific Examples Indicating Whether a Genome
Edited Organism is GMO or non-GMO
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Source: MOE
Genome-edited organism (non-GMO)
GMO
DNA is cut with
artificial nucleases
Extracellularly
processed nucleic
acid is inserted
Inserted nucleic
acid is
incorporated
Deletion, insertion,
substitution during
the natural DNA
repairing
Artificial nuclease lacking
foreign nucleic acid
Artificial nuclease containing
foreign nucleic acid
Note: The organism is not regarded as a GMO, if it is confirmed that it
possesses no remnants of inserted nucleic acid or its replicated product.
DNA is cut with
artificial nucleases
DNA is cut with
artificial nucleases
Deletion, insertion,
substitution during
the natural DNA
repairing
XX
X

5. Information on the Items Should be Provided
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Source: MOE
The fact that the organism does not have foreign DNA or its replicated
product.
• Method to remove the integrated DNA.
• Method to confirm the absence of foreign DNA (a. PCR method, b.
Southern blotting, c. Others).
Taxonomical species of the modified organism.
Purpose of use of the organism.

6. Information on the Items Should be Provided
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Source: MOE
Method of genome editing used for the modification.
• Types of nucleases (a. CRISPR/Cas9, b. TALEN, c. ZFN, d. Others).
• Transfer method of nuclease (a. Transfer the artificial nuclease
composed only of protein into the host cell, b. Transfer the artificial
nuclease gene into the host cell for transient expression, c.
Integrate the artificial nuclease gene into the host genome, d.
Others).
Modified gene and its function.

7. Information on the Items Should be Provided
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Source: MOE
Change in traits added by genome editing.
• Types of mutations in the modified gene (a. Insertion, b. Deletion, c.
Substitution)
• Physiological and ecological characteristics of the modified
organisms.
Presence or absence of change in other traits.
Possible impacts on biodiversity when the organism is used.

8. Regulatory Policy for Genome Edited Food Products
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Source: MHLW
GM food Non-GM food
Foods that contain
extracellularly processed DNA.
Foods that does not contain that
contain extracellularly processed DNA,
even if foods that have naturally
occurring gene deletion, insertion of
one to several base pairs, and
substitution.
These foods are required to
undergo a food safety
assessment in accordance with
the Food Sanitation Act.
Developer are encouraged to provide
information on the foods, and some
of the information will be published
for public understanding.

9. Information That Should be Provided by Developers
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Source: MHLW
Crop type, cultivar name, how to use/eat, the purpose of use.
The method of genome editing, modified gene and its function.
Information confirming that the foods have no toxic substances or no
allergens as well as no adverse effect on human health.
Information confirming that the foods have no extracellularly processed
DNA.
Information on the changes in major components (e.g., nutrients.), if the metabolic
pathway that increase or decrease specific substances have been modified.

10. www.jircas.go.jpwww.jircas.go.jp
Thank you for your attention.
2019/10/10 10