Synthetic Biology Journal ›› 2020, Vol. 1 ›› Issue (5): 593-608.DOI: 10.12211/2096-8280.2020-041
• Invited Review • Previous Articles Next Articles
Li DU, Meng WANG
Received:
2020-04-07
Revised:
2020-09-16
Online:
2020-12-03
Published:
2020-10-31
Contact:
Li DU
杜立, 王萌
通讯作者:
杜立
作者简介:
杜立(1982—),男,博士生导师,助理教授。研究方向为生物科技法律与政策、国际法、卫生法。E-mail:CLC Number:
Li DU, Meng WANG. The legal issues about commercialization of food products employing synthetic biology strategies[J]. Synthetic Biology Journal, 2020, 1(5): 593-608.
杜立, 王萌. 合成生物学技术制造食品的商业化法律规范[J]. 合成生物学, 2020, 1(5): 593-608.
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URL: https://synbioj.cip.com.cn/EN/10.12211/2096-8280.2020-041
1 | 张先恩. 中国合成生物学发展回顾与展望[J]. 中国科学(生命科学), 2019, 49(12): 1543-1572. |
ZHANG Xian-en. Synthetic biology in China: review and prospects [J]. Scientia Sinica (Vitae), 2019, 49(12): 1543-1572. | |
2 | 孙明伟, 李寅, 高福. 从人类基因组到人造生命: 克雷格·文特尔领路生命科学[J]. 生物工程学报, 2010, 26(6): 697-706. |
SUN Mingwei, LI Yin, GAO Fu. From human genome to man-made life: J. Craig Venter leads the life sciences [J]. Chinese Journal of Biotechnology, 2010, 26(6): 697-706. | |
3 | McKinsey Global Institute. The Bio Revolution: Innovations transforming economies, societies, and our lives [EB/OL]. [2020-11-06]. . |
4 | Website Nature. The science events to watch for in 2020 [EB/OL]. [2020-11-06]. . |
5 | 中国科学院天津工业生物技术研究所. 国家合成生物技术创新中心/中科院天津工业生物所"未来食品"项目组招聘启事[EB/OL]. [2020-11-06]. . |
6 | 新浪财经. 肉类替代品公司Impossible Foods完成3亿美元融资[EB/OL]. [2020-11-06]. . |
7 | 崔金明, 张炳照, 马迎飞, 等. 合成生物学研究的工程化平台[J]. 中国科学院院刊, 2018, 33(11): 1249-1257. |
CUI J M, ZHANG B Z, MA Y F, et al. Engineering platforms for synthetic biology research [J]. Bulletin of Chinese Academy of Sciences, 2018, 33(11): 1249-1257. | |
8 | HAYRY M. Synthetic biology and ethics: past, present, and future [J]. Cambridge Quarterly of Healthcare Ethics, 2017, 26(2): 186-205. |
9 | Website Synbiobeta. Could fermentation power the future of plant-based foods? Motif FoodWorks thinks yes [EB/OL]. [2020-11-06]. . |
10 | Website Synbiobeta. Motif FoodWorks partners with the University of Massachusetts Amherst to optimize formulation processes for plant-based food proteins [EB/OL]. [2020-11-06]. . |
11 | Website Synbiobeta. The Good Food Institute awards $4.5M to fill gaps in plant-based and cultivated meat science in 2019 [EB/OL]. [2020-11-06]. . |
12 | 杜全生, 洪伟, 祖岩. 2010—2019年国家自然科学基金资助合成生物学领域情况[J]. 合成生物学, 2020, 1(3): 385-394. |
DU Quansheng, HONG Wei, ZU Yan. Grant and funding for synthetic biology at NSFC from 2010 to 2019 [J]. Synthetic Biology Journal, 2020, 1(3): 385-394. | |
13 | 中华人民共和国科学技术部. 国家重点研发计划"合成生物学"等重点专项2019年度项目申报指南[EB/OL].[2020-11-06]. . |
14 | 中华人民共和国科学技术部. 关于支持建设国家合成生物技术创新中心的函[EB/OL].[2020-11-06]. . |
15 | The Associated Press. China becoming battleground for plant-based meat makers [EB/OL]. [2020-11-06]. . |
16 | Good Food Institute Website. New GFI Report illustrates the State of China's plant-based meat industry [EB/OL]. [2020-11-06]. . |
17 | EPSTEIN M M, VERMEIRE T. Scientific opinion on risk assessment of synthetic biology [J]. Trends in Biotechnology, 2016, 34(8): 601-603. |
18 | 李真真, 董永亮, 高旖蔚. 设计生命: 合成生物学的安全风险与伦理挑战[J]. 中国科学院院刊, 2018(11): 1269-1276. |
LI Zhenzhen, DONG Yongliang, GAO Yiwei. Design life: Safety risks and ethical challenges in synthetic biology [J]. Bulletin of Chinese Academy of Sciences, 2018(11): 1269-1276. | |
19 | KUZMA J, TANJI T. Unpackaging synthetic biology: identification of policy problems and options [J]. Regulation & Governance, 2010, 4(1): 92-112. |
20 | The Secretariat of the Convention on Biological Diversity. Strategic plan for biodiversity2011-2020 [EB/OL]. [2020-11-06]. . |
21 | YOU Chun, SHI Ting, LI Yunjie, et al. An in vitro synthetic biology platform for the industrial biomanufacturing of myo-inositol from starch [J]. Biotechnology and Bioengineering, 2017, 114(8): 1855-1864. |
22 | FRENCH K E. Harnessing synthetic biology for sustainable development [J]. Nature Sustainability, 2019, 2(4): 250-252. |
23 | GARFINKLE M, KNOWLES L. Biology Synthetic, Biosecurity, and Biosafety [M]// SANDLER R L. Ethics and Emerging Technologies. London: Palgrave MacMillan, 2014: 533-547. |
24 | VORDERMAYER M. The extraterritorial application of multilateral environmental agreements [J]. Harvard International Law Journal, 2018, 59(1): 59-124. |
25 | The Secretariat of the Convention on Biological Diversity. Article 6 of the Cartagena Protocol on Biosafety [EB/OL]. [2020-11-06]. . |
26 | The Secretariat of the Convention on Biological Diversity. Article 20 of the Cartagena Protocol on Biosafety [EB/OL]. [2020-11-06]. . |
27 | 欧亚昆, 雷瑞鹏. 合成生物学自我管治的伦理探析[J]. 伦理学研究, 2018(2): 53-58. |
Yakun OU, LEI Ruipeng. An ethical analysis of the issue of self-governance in synthetic biology [J]. Studies in Ethics, 2018(2): 53-58. | |
28 | The Publications Office of the European Union. Council Directive90/219of /EEC 23 April 1990 on the contained use of genetically modified micro-organisms [EB/OL]. [2020-11-06]. . |
29 | The Publications Office of the European Union. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive90/220/EEC [EB/OL]. [2020-11-06]. . |
30 | The Publications Office of the European Union. Consolidated text: Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive90/220/EEC [EB/OL]. [2020-11-06]. . |
31 | The National Academies of Sciences, Engineering, and Medicine. Biodefense in the age of synthetic biology [EB/OL]. [2020-11-06]. . |
32 | AHTEENSUU M. Synthetic biology, genome editing, and the risk of bioterrorism [J]. Science and Engineering Ethics, 2017, 23(6): 1541-1561. |
33 | 中国人大网. 中华人民共和国生物安全法[EB/OL]. [2020-11-06]. . |
34 | 中国科学技术部. 《中华人民共和国生物安全相关法律法规规章汇编》正式出版发行[EB/OL]. [2020-11-06]. . |
35 | 中国科学技术部. 基因工程安全管理办法[EB/OL]. [2020-11-06]. . |
36 | 中国科学技术部. 生物技术研究开发安全管理办法[EB/OL]. [2020-11-06]. . |
37 | Alimentarius Codex. Biotechnology [EB/OL]. [2020-11-06]. . |
38 | The Publications Office of the European Union. Regulation (EC) No1829/2003of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [EB/OL]. [2020-11-06]. . |
39 | The Publications Office of the European Union. Regulation (EC) No1830/2003of the European parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [EB/OL]. [2020-11-06]. . |
40 | 联合国教科文组织. 世界人类基因组与人权宣言[EB/OL]. [2020-11-06]. . |
41 | 联合国教科文组织. 世界生物伦理和人权宣言[EB/OL]. [2020-11-06]. . |
42 | FARZADFARD F, LU T K. Genomically encoded analog memory with precise in vivo DNA writing in living cell populations [J]. Science, 2014, 346(6211): 825. |
43 | TOWNEND D. EU laws on privacy in genomic databases and biobanking [J]. Journal of Law, Medicine and Ethics, 2016, 44(1): 128-142. |
44 | Website Refworld. Treaty of Lisbon [EB/OL]. [2020-11-06]. . |
45 | Government Publishing Office US. Code of Federal Regulations, Title 45 Welfare Public, Part 46 Protection of Human Subjects [EB/OL]. [2020-11-06]. . |
46 | LEE P. Innovation and the firm: a new synthesis [J]. Stanford Law Review, 2018, 70(5): 1431-1502. |
47 | U. S. Department of Health and Human Services (DHHS). Public Health Service Policies on Research Misconduct [EB/OL]. [2020-11-06]. . |
48 | 中华人民共和国中央人民政府网. 中华人民共和国科学技术进步法[EB/OL]. [2020-11-06]. . |
49 | 新华社. 习近平: 紧密结合"不忘初心、牢记使命"主题教育 推动改革补短板强弱项激活力抓落实[EB/OL]. [2020-11-06]. . |
50 | Digest GovLab. How the enlightenment ends [EB/OL]. [2020-11-06]. . |
51 | 马诗雯, 王国豫. 如何应对合成生物学的不确定性——《合成生物学的监管: 生物砖, 生物朋克与生物企业》评介[J]. 科学与社会, 2019(3): 124-136. |
MA Shiwen, WANG Guoyu. How to compromise the uncertainty of synthetic biology? A review of regulation of synthetic biology: BioBricks, Biopunks and Bioentrepreneurs [J]. Science and Society, 2019(3): 124-136. | |
52 | TAGLIABUE G. The EU legislation on "GMOs" between nonsense and protectionism: an ongoing Schumpeterian chain public choices [J]. GM Crops & Food, 2016, 8(1): 57-73. |
53 | The Publications Office of the European Union. Regulation (EU) No1291/2013of the European Parliament and of the Council of 11 December 2013 Horizon establishing 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC Text with EEA relevance [EB/OL]. [2020-11-06]. . |
54 | Website Nature. The scientists who feed US [EB/OL]. [2020-11-06]. . |
55 | Government Publishing Office US. Code of Federal Regulations, Title 21 Food and Drug, Parts 170 Food Additives (includes Threshold of Regulation and Premarket Notifications) [EB/OL]. [2020-11-06]. . |
56 | Food and Drug Administration (FDA). The federal food, drug, and cosmetic act [EB/OL]. [2020-11-06]. . |
57 | JOHNSON R. The federal food safety system: a primer [EB/OL]. [2020-11-06]. . |
58 | Meat + Poultry Website. FDA: Impossible Foods' use of heme is safe [EB/OL]. [2020-11-06]. . |
59 | The Publications Office of the European Union. Regulation (EU)2015/2283of the European parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 [EB/OL]. [2020-11-06]. . |
60 | Food and Drug Administration (FDA). Generally recognized as safe (GRAS) [EB/OL]. [2020-11-06]. . |
61 | The Publications Office of the European Union. Regulation (EC) No178/2002of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [EB/OL]. [2020-11-06]. . |
62 | GOSTEK K. Genetically modified organisms: how the United States' and the European Union's regulations affect the economy [J]. Michigan State International Law Review, 2016, 24(3): 761-800. |
63 | The Publications Office of the European Union. Regulation (EC) No852/2004of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs [EB/OL]. [2020-11-06]. . |
64 | Transparency Market Research. Synthetic biology market [EB/OL]. [2020-11-06]. . |
65 | 中国经济网. 中科院预测中心: 2020年中国粮食产量预计将持平或略减[EB/OL]. [2020-11-06]. . |
66 | 国家统计局. 中华人民共和国2019年国民经济和社会发展统计公报[EB/OL]. [2020-11-06]. . |
67 | 国家统计局. 2020年8月份居民消费价格同比上涨2.4%[EB/OL]. [2020-11-06]. . |
68 | 中国产业信息网. 2019年中国肉类产量、进出口量及消费量分析[EB/OL]. [2020-11-06]. . |
69 | Website Synbiobeta. Protecting intellectual property in China: A Synbiobeta panel set for June in Beijing [EB/OL]. [2020-11-06]. . |
70 | 中华人民共和国农业农村部网站. 农业转基因生物安全管理条例 (2017年10月7日修订版)[EB/OL].[2020-11-06]. . |
71 | Food and Drug Administration (FDA). Regulatory procedures manual: chapter 7-recall procedures [EB/OL]. [2020-11-06]. . |
72 | European Scientific Committee. Opinion on synthetic biology I definition [EB/OL]. [2020-11-06]. . |
73 | FATEHI L, HALL R F. Synthetic biology in the FDA realm: Toward productive oversight assessment [J]. Food and Drug Law Journal, 2015, 70(2): 339 |
-iv. | |
74 | 中华人民共和国中央人民政府网. 食品添加剂新品种管理办法[EB/OL]. [2020-11-06]. . |
75 | KAGEYAMA M. Bio-property contracts in new ecosystem: genetic resources access and benefit sharing [J]. Washington Journal of Law, Technology & Arts, 2018, 13(2): 109-140. |
76 | International Risk Governance Council. Guidelines for the appropriate risk governance of synthetic biology [EB/OL]. [2020-11-06]. . |
77 | Project Synenergene. Adaptive biosafety assessment as a learning process-strategy paper (2017) [EB/OL]. [2020-11-06]. . |
78 | GREWAL D S. Before peer production: Infrastructure gaps and the architecture of openness in synthetic biology [J]. Stanford Technology Law Review, 2017, 20(1): 143-212. |
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