GMO /Genetically Edited Organisms

Japan has a high reliance on the import of food, with the food self-sufficiency rate remaining below 40% since 2011 (37% in 2020), which makes it a significant market for farmers in agricultural export countries applying biotechnology, such as GMO and Genome Editing.

Genetically Modified Organisms (GMO)

To obtain regulatory approval for placing GMOs on the Japanese market, companies have to  successfully complete safety assessments as required by the regulations for food (food sanitation law), feed (feed safety law) and the environment (Cartagena Act).

Geneome Editing

Genome Editing is a state of the art technology applied in the food, feed and agriculture areas. The first genome editing technologies were developed in the late 1990s. In agriculture, genome editing is applied to develop improved crops at reduced costs and in a shorter time through manipulating their specific genes.

In Japan, the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Agriculture, Forestry and Fisheries (MAFF) are in charge of notification approvals for genome edited organisms.

Our Services for Genetically Modified and Genetically Edited Crop

SCC offers support with all aspects of the submission and approval process for GM crop. For Japan’s unique requirement for in-country field trial (stage-3 trial), SCC liaises with local institutes (CRO) able to conduct in-country field trials for GM crop. We coordinate and monitor these trials on your behalf. We have experts with more than 10 years’ experience in biotech regulation and have strong and broad network with key stakeholders in Japan and beyond.

Our Services

  1. Geneticalls modified crop/ GMO
    • Providing advice on data requirements for food, feed and environmental safety assessments
    • Coordinating and monitoring stage-3 field trials
    • Preparing and submitting application dossiers
    • Coordinating and communicating with the respective authorities, as well as preparing response letters to the authorities and technical committees
  2. Genome Edited Crop
    • Offering guidance on data requirements for notification to MHLW and MAFF
    • Preparation of notification letters
    • Communication with the respective authorities, including preparation of response letters to regulatory authorities and technical committees
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