國際基因編輯食品發展及管理動態

Review of International Development and Management of Genome Editing Foods

林煒幀(WEI-CHENG LIN)；鄧嘉欣(CHIA-HSIN TENG)；汪佳穎(CHIA-YING WANG)；施孋恩(LI-EN SHIH)；鄭維智(WEI-CHIH CHENG)；闕麗卿(LI-CHING CHUEH)；蔡淑貞(SHU-CHEN TSAI)

基因編輯 ； 基因編輯食品 ； 永續農業 ； 實質等同 ； 新穎性食品 ； 精準生物技術農業應用 ； Genome editing ； Genome editing food ； Sustainable agriculture ； Substantial equivalence ； Novel food ； Precision Biotechnology Agricultural Applications

食品藥物研究年報

14期（2023 / 12 / 01）

405 - 411

繁體中文;英文

隨著國際間基因編輯技術衍生作物與食品之研發蓬勃發展，各國主管機關普遍認為，雖然基因編輯技術具有提升人類健康、促進永續農業發展，但若監管政策無法跟上，則可能成為產業發展阻礙。因此，即時地檢視目前的基因編輯作物管理規範，做必要的調整，同時與國際趨勢接軌是重要課題。衛生福利部食品藥物管理署（下稱食藥署）於2022年委託財團法人台灣經濟研究院執行「精進我國新興精準育種食品管理草案規劃」計畫，並完成「各國新興精準育種產品發展及其相關管理動態研析報告」。本文以此研析報告為架構並蒐集摘錄2023年國際最新動態，包含國際組織、「歐盟及英國」、「美國及加拿大」、日本及中國等農業大國。各國在基因編輯食品研發上，以農作物為主，但也不乏水產、畜產品的研究；管理方式上普遍具有上市前諮詢制度，並依現有食品安全管理相關法規或是增修基因改造食品管理辦法納管基因編輯食品。

With the internationally development of crops and foods derived from international genome editing technology booming, the competent authorities in various countries generally believe that genome editing technology has the ability to improve human health and promote the development of sustainable agriculture. However, if regulatory policies cannot keep up, it may become an obstacle to industrial development. It is important to review the current management norms relating to genome editing crop in real time, make necessary adjustments to the scope of management, and at the same time be in line with international trends. In 2022, TFDA commissioned the Taiwan Institute of Economic Research to conduct the project- "Improving the draft for management of emerging precision breeding foods," and completed the "Research Report on the Development of Emerging Precision Breeding Products and Related Management Trends in Various Countries". We compiled this report and the major updates on the global regulatory and product development in 2023, including international organizations, the European Union and United Kingdom, the United States and Canada, Japan and China. In the research and development of genome editing foods, crops are the major products, whereas several promising results for aquatic and livestock products have also been made; In terms of management and regulation, generally, there is an pre-marketing consultation system, and genome editing foods are managed according to the existing regulations and guidelines for food safety or the amended regulations derived from the act for genetically modified food.