Japan
Country introduction:
Safety assessment of GM food is mandatory under the Food Sanitation Law in Japan. The Consumer Affairs Agency (CAA) legally imposes safety assessment of GM food so that those that have not undergone safety assessment would not be distributed in the country. The CAA receives application and requests the Food Safety Commission of Japan (FSCJ) to evaluate the safety of GM food in terms of human health. Safety assessment is carried out by the FSCJ.
Regulatory framework:
My country has a regulatory framework that requires the competent authority to conduct safety assessment of GM food.
Structure for GM food safety assessment:
My country has competent authority, agency, organization, ministry, department, committee, commission or a system/mechanism that is tasked to conduct or review GM food safety assessment.
Supplemental information (regulatory framework):
The safety assessment of GM food is mandatory under the Food Safety Basic Act. The Consumer Affairs Agency (CAA) receives application from Applicant and requests FSCJ to evaluate the safety of GM food in accordance with the Food Safety Basic Act, and the FSCJ evaluates the safety in terms of human health.
Relevant contact details:
FSCJ (http://www.fsc.go.jp/english/index.html),
CAA (https://www.caa.go.jp/en/policy/standards_evaluation/dna_techniques)
CAA (https://www.caa.go.jp/en/policy/standards_evaluation/dna_techniques)
GM food safety assessment guidelines:
My country follows the relevant Codex Guidelines or national/regional guidelines that are in line with the Codex Guidelines in conducting safety assessment of GM food.
Conduct of GM food safety assessment:
My country regularly conducts food safety assessment of GM food.
Supplemental information (assessment):
Within the FSCJ, the Expert Committee of Genetically Modified Foods conducts safety assessment based on following standards and policies
(1) Guidelines for the Safety Assessment of Genetically Modified Food (Seed Plant)
(2) Guidelines for the Safety Assessment of Food Additive Produced Using Genetically Modified Microorganism
(3) Stance on Safety Assessment of Genetically Modified Feed and Feed Additive
(4) Standards for Safety Assessment of Genetically Modified Food (Microorganism)
It is forbidden to import or sell genetically modified foods or food products made from such foods that have not undergone safety assessment. After the FSCJ submits a notification to CAA, CAA gives notice on the Official Gazette.
(1) Guidelines for the Safety Assessment of Genetically Modified Food (Seed Plant)
(2) Guidelines for the Safety Assessment of Food Additive Produced Using Genetically Modified Microorganism
(3) Stance on Safety Assessment of Genetically Modified Feed and Feed Additive
(4) Standards for Safety Assessment of Genetically Modified Food (Microorganism)
It is forbidden to import or sell genetically modified foods or food products made from such foods that have not undergone safety assessment. After the FSCJ submits a notification to CAA, CAA gives notice on the Official Gazette.
Regulation stacked events:
On a case-by-case basis, some stacked events may have reduced/simplified assessment requirements.
Supplemental information (stacked events):
With regard to stacked events, the FSCJ conducts the safety assessment that some products will be considered as new products and some will not, even if single events that are stacked have already approved.
Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.
https://www.caa.go.jp/policies/policy/standards_evaluation/bio/genetically_modified_food/assessment/assets/1_11.pdf
Article 6 was modified in 2014, and the modified version is available at the following URL.
https://www.caa.go.jp/policies/policy/standards_evaluation/bio/genetically_modified_food/assessment/assets/0000049695.pdf
Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.
https://www.caa.go.jp/policies/policy/standards_evaluation/bio/genetically_modified_food/assessment/assets/1_11.pdf
Article 6 was modified in 2014, and the modified version is available at the following URL.
https://www.caa.go.jp/policies/policy/standards_evaluation/bio/genetically_modified_food/assessment/assets/0000049695.pdf
GM food/feed production:
My country produces GM food or feed only for research purposes.
GM food/feed imports:
My country allows imports GM food or feed upon authorization.
Supplemental information (production and trade):
LLP/AP incidents:
My country has faced LLP/AP situations in the last 10 years.
Supplemental information (LLP/AP incidents):
Labelling requirement:
My country has a mandatory and positive labeling regulation & allows a voluntary and negative labeling on GM food.
Supplemental information (labelling requirement):
Relevant links:
Upload relevant documents: