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| 題名: | 歐盟對應用特定新興基因技術管理規則之研究
A Study on the Regulation of Certain New Genomic Techniques Application in the EU |
| 作者: | 尚子雅
Shang, Tzu-Ya |
| 貢獻者: | 楊培侃
Yang, Pei-Kan
尚子雅
Shang, Tzu-Ya |
| 關鍵詞: | 基因改造生物
歐盟
基因編輯
新興基因技術
C-528/16判決
GMO
Genome Editing
European Union
New Genomic Techniques
Case C-528/16 |
| 日期: | 2025 |
| 上傳時間: | 2025-09-01 14:54:26 (UTC+8) |
| 摘要: | 本文以2023年7月5日歐盟執委會發布之《應用特定新興基因技術之植物及其食品與飼料草案》（以下簡稱規則草案）為核心，探討歐盟對於新興基因技術（NGT）之監管態度與政策調整。
本文首先介紹歐盟對基因改造生物（GMO）與NGT之定義、分類及相關監管規範，並觀察到現行GMO法規已不足以規範NGT植物及其產物，特別是歐洲法院於C-528/16判決中將基因編輯等新型誘變技術產物納入GMO指令之管制範圍。為解決監管落差、法律不確定性等問題，歐盟執委會針對特定NGT植物及其產物制定新法規，即本規則草案。
本文詳細介紹規則草案之內容，評析其能否有效回應C-528/16判決遺留之問題，解決歐盟既有GMO規範對於NGT管理不足之問題，以及規則草案是否會產生國際貿易障礙等疑慮。最後，本文認為規則草案能合理監管NGT，且並未造成不必要之國際貿易障礙，整體而言有助於歐盟促進技術創新及確保食品安全與環境永續發展之政策目標。
This study focuses on the Proposal for a Regulation of the European Parliament and of the Council on Plants Obtained by Certain New Genomic Techniques and Their Food and Feed, and Amending Regulation (EU) 2017/625, published by the European Commission on July 5, 2023 (hereinafter referred to as “the Proposal”). It examines the European Union’s (EU) regulatory approach to new genomic techniques (NGT) and recent policy developments.
The study first explains how the EU defines and classifies genetically modified organisms (GMO) and NGT, and describes the current rules. It points out that the existing GMO laws are not enough to properly regulate NGT plants and products. This issue became clear after the European Court of Justice’s 2018 decision in Case C-528/16, which ruled that plants made with new mutagenesis techniques, like genome editing, must be treated as GMO under the EU law. To fix the legal gaps and uncertainty, the European Commission proposed new rules for certain NGT plants and products.
This study closely examines the Proposal to see if it solves the problems left by the C-528/16 decision, improves the EU’s ability to manage NGT, and avoids creating unnecessary barriers to international trade. The study finds that the Proposal offers a reasonable way to regulate NGT and supports the EU’s goals of encouraging innovation, protecting food safety, and promoting environmental sustainability. |
| 參考文獻: | 一、中文文獻
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（四）網路資料
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（五）法規
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二、外文文獻
（一）期刊論文
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（二）WTO 協定、案例與相關文件
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（三）外國法規、條約與案例
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（四）機構文件
COUNCIL DECISION (EU) 2019/1904, 2019 OFFICIAL JOURNAL OF THE EUROPEAN UNION (L 293), 103.
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（五）網路資料
27 EU-agri-food Value Chain Partners Signed a Joint Position on NGT Traceability and Labelling, EUROSEEDS (2025), https://euroseeds.eu/news/27-eu-agri-food-value-chain-partners-signed-a-joint-position-on-ngt-traceability-and-labelling/#:~:text=Rejection%20of%20Mandatory%20Traceability%20and,enforcement%20challenges%2C%20and%20trade%20disruptions.
A New Era of Mitochondrial Genome Editing Has Begun, INSTITUTE FOR BASIC SCIENCE (Apr. 26, 2022), https://www.ibs.re.kr/cop/bbs/BBSMSTR_000000000611/selectBoardArticle.do? nttId=21219.
ACSH, EU Continues Its Unscientific, Anti-Innovation Regulation of Genetic Engineering, AM. COUNCIL ON SCI. & HEALTH (Apr. 16, 2024), https://www.acsh.org/news/2024/04/16/eu-continues-its-unscientific-anti-innovation-regulation-genetic-engineering-17725.
Alan Bullion & Bharti Malhotra, Gene-edited crops market growth spurred by regulatory progress and approvals, S&P GLOBAL (Jan. 17, 2023), https://www.spglobal.com/commodity-insights/en/research-analytics/gene-edited-crops-market-growth-spurred-by-regulatory-progress#:~:text=private%20and%20public%20sectors%20to,commercialization.
Amanda Carlota, Ignacio Carreño García & Tobias Dolle, EU Institutions divided on patentability of plants obtained by certain new genomic techniques (NGTs), FRATINIVERGANO (Apr. 21, 2025), https://www.fratinivergano.eu/en/trade-perspectives/21-april-2025/#genome.
Biotechnologies: Commission seeks open debate on New Genomic Techniques as study shows potential for sustainable agriculture and need for new policy, EUROPEAN COMMISSION (Apr. 29, 2021), https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_21_1985/IP_21_1985_EN.pdf#:~:text=The%20main%20findings%20of%20the,agricultural%20inputs%20such%20as%20pesticides.
Clement Dionglay, Japan's Three Genome-Edited Food Products Reach Consumers, ISAAA (Dec. 12,2024), https://www.isaaa.org/blog/entry/default.asp?BlogDate=1/19/2022.
Dr Jörg Thomaier, Banning patents on plants produced by NGTs could damage innovation and jobs in Europe, THE PATENT LAWYER (Mar. 5, 2024), https://patentlawyermagazine.com/banning-patents-on-plants-produced-by-ngts-could-damage-innovation-and-jobs-in-europe/.
EC study on new genomic techniques, EUROPEAN COMMISSION, https://food.ec.europa.eu/plants/genetically-modified-organisms/new-techniques-biotechnology/ec-study-new-genomic-techniques_en.
Elizabeth Crawford, Exclusive: Pairwise stops marketing gene-edited Conscious Greens to focus on new high-value, gene-edited crops, FOODNAVIGATOR (Feb. 13, 2024), https://www.foodnavigator-usa.com/Article/2024/02/13/Exclusive-Pairwise-stops-marketing-gene-edited-Conscious-Greens-to-focus-on-new-high-value-gene-edited-crops/.
Euroseeds welcomes European Commission proposal on NGTs, EUROSEEDS (2023), https://euroseeds.eu.
Final Negotiations Start on GMO Deregulation, SAVE OUR SEEDS, Apr. 28, 2025, https://www.saveourseeds.org/news/final-negotiations-start-on-gmo-deregulation/.
Henry Miller & Robert Wager, Viewpoint: Optimism fades that Europe will significantly reform its current near-ban on gene-edited crops, GENETIC LITERARY PROJECT, May 23, 2024, https://geneticliteracyproject.org/2024/05/23/viewpoint-optimism-fades-that-europe-will-significantly-reform-its-current-near-ban-on-gene-edited-crops/.
Human Genome Editing, WORLD HEALTH ORG., https://www.who.int/health-topics/human-genome-editing#tab=tab_1.
Jenny Brunton, EU Member States agree mandate on new genomic techniques, BRITISH AGRICULTURE BUREAU: REPRESENTING UK FARMERS AND GROWERS (Mar. 14, 2025), https://www.britishagriculturebureau.co.uk/updates-and-information/eu-member-states-agree-mandate-on-new-genomic-techniques/#:~:text=MEPs%20want%20to%20keep%20mandatory,after%20its%20entry%20into%20force.
Krämer L., Legal questions concerning new methods for changing the genetic conditions in plants, http://www.testbiotech. org/sites/default/files/Kraemer_Legal%20 questions_new%20methods_0.pdf (2015).
Lauren Lewis, What are New Genomic Techniques?, FOODUNFOLDED (Dec. 23, 2024), https://www.foodunfolded.com/article/what-are-new-genomic-techniques#:~:text=The%20European%20Food%20Safety%20Authority,bring%20NGT%20foods%20to%20market.
Legislation for Plants Produced by Certain New Genomic Techniques, EUROPEAN COMMISSION, https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-produced-by-certain-new-genomic-techniques/public-consultation_en.
New genomic techniques, EFSA (Jan. 22, 2025), https://www.efsa.europa.eu/en/topics/new-genomic-techniques.
NGTs: A Step in the Right Direction by the European Commission, FARM EUROPE (June, 20, 2023), https://www.farm-europe.eu/news/ngts-a-step-in-the-right-direction-by-the-european-commission/.
Questions and Answers: Study on New Genomic Techniques, EUROPEAN COMMISSION, https://food.ec.europa.eu/plants/genetically-modified-organisms/new-techniques-biotechnology/ec-study-new-genomic-techniques/questions-and-answers_en.
Samantha van Dijk, Claudia Mendes Pinto & Jacqueline Mailly, New Genomic Techniques: EU proposal both promising and controversial, HOGAN LOVELLS, Mar. 6, 2024, https://www.engage.hoganlovells.com/knowledgeservices/insights-and-analysis/new-genomic-techniques-eu-proposal-both-promising-and-controversial.
Start of Trilogue Negotiations on the Regulation of New Genetic Engineering, EUR. NON-GMO INDUS. ASS'N, May 14, 2025, https://www.ohnegentechnik.org/en/news/article/start-of-trilogue-negotiations-on-the-regulation-of-new-genetic-engineering.
Wolfgang Schönig, Julia Ratajczak, Liz Freeman Rosenzweig & Deborah A. Pohlmann, April 2025 Update on Regulation of New Genomic Techniques in the EU, LEXOLOGY (Apr. 25, 2025), https://www.lexology.com/library/detail.aspx?g=86ab7ea1-33b7-4a53-bc4d-2a436f897fbb#:~:text=On%20March%2014%2C%202025%2C%20EU%20Member%20States%20agreed,collectively%20termed%20%E2%80%9C%20new%20genomic%20techniques%20%E2%80%9D%20%28NGTs%29.
（六）書籍
Gall, M. D., Borg, W. R., & Gall, J. P., Educational research: An introduction (6th ed.), Longman Publishing (1996). |
| 描述: | 碩士
國立政治大學
國際經營與貿易學系
108351041 |
| 資料來源: | http://thesis.lib.nccu.edu.tw/record/#G0108351041 |
| 資料類型: | thesis |
| 顯示於類別: | [國際經營與貿易學系 ] 學位論文
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