细胞培养肉商业化的法律规范与监管：外国经验及对我国启示

doi:10.12211/2096-8280.2021-101

合成生物学 ›› 2022, Vol. 3 ›› Issue (1): 209-223.DOI: 10.12211/2096-8280.2021-101

细胞培养肉商业化的法律规范与监管：外国经验及对我国启示

李玉娟¹^,², 傅雄飞², 杜立¹

^1.澳门大学法学院，澳门 999078
^2.中国科学院深圳先进技术研究院，深圳合成生物学创新研究院，中国科学院定量工程生物学重点实验室，广东深圳 518055

收稿日期:2021-11-02 修回日期:2022-01-14 出版日期:2022-02-28 发布日期:2022-03-14
通讯作者: 杜立
作者简介:李玉娟（1989—），女，博士研究生。研究方向为生物科技法与医疗法、国际法。E-mail：yc17213@um.edu.mo
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：stephendu@um.edu.mo
基金资助:
深圳合成生物学创新研究院创新项目(CP-030-2021)

Regulating the commercialization of cell-cultured meat: practices in selected jurisdictions and their implications for China

Yujuan LI¹^,², Xiongfei FU², Li DU¹

^1.Faculty of Law，University of Macau，Macau SAR 999078，China
^2.CAS Key Laboratory of Quantitative Engineering Biology，Shenzhen Institute of Synthetic Biology，Shenzhen Institutes of Advanced Technology，Chinese Academy of Sciences，Shenzhen 518055，Guangdong，China

Received:2021-11-02 Revised:2022-01-14 Online:2022-02-28 Published:2022-03-14
Contact: Li DU

摘要/Abstract

摘要：

细胞培养肉有望改进当前肉类生产体系，缓解未来粮食资源短缺、公共卫生及动物福利等问题。无论是在研究领域还是在产业市场，细胞培养肉已成为当前热点。欧美国家纷纷启动相关战略部署，大力推动细胞培养肉的发展。然而，细胞培养肉的研发与商业化过程对现行相关法律规范与监管制度带来挑战。欧盟、美国及新加坡等国家及地区积极探寻细胞培养肉在法律规范与监管制度方面的完善与更新。2020年，新加坡更是率先批准细胞培养肉产品入市并发布具体监管措施。我国细胞培养肉在生产技术研发方面已不断取得突破，但在法律规范与监管制度方面的研究探讨相对不足。在此背景下，本文结合细胞培养肉的研究进展与发展现状，重点考察欧美及新加坡细胞培养肉商业化相关法律规范，识别法律法规挑战，并为我国细胞培养肉的研发与商业化法律规范、监管制度建设提供建议。

关键词: 细胞培养肉, 商业化, 法律规范, 法律挑战, 法律对策

Abstract:

Cell-cultured meat offers a potential solution for traditional meat production systems to address the supply uncertainties of meet and related products, public health risks, and animal welfares. Cell-cultured meat has become a hot topic in both research and investment domains. The United States and some European countries have launched a series of development strategies, promoting the national and regional research and development of cell-cultured meat. All over the world, since 2018, research achievements in the area of cell-cultured meat have shown a rapid growth trend. Industrial investment and capital have increased significantly. However, the commercialization of cell-cultured meat confronts various challenges. Other than technical bottlenecks, regulatory challenges are the main ones. In recent years, the European Union and the United States have been working on developing regulations for cell-cultured meat. Based on the context of Regulation 2015/2283/EU on novel food, the European Union has announced a Guidance on the preparation and submission of an application for the novel food. The FDA/USDA has released a joint regulatory framework for cell-cultured meat and has conducted a series of public hearings to accelerate the development and implementation of relevant regulations. In 2020, Singapore became the first country that approves the marketing of a type of cell-cultured meat. The government also issued measures on the safety assessment of cell-cultured meat. China has made fast technical progress in cell-cultured meat research and development. However, legal and regulatory issues associated with the commercialization of cell-cultured meat are still not well addressed. In this context, based on the exploration of research progress and development of cell-cultured meat, this paper explores regulatory frameworks for cell-cultured meat in the European Union, the United States, and Singapore. Further, it identifies legal challenges for the commercialization of cell-cultured meat. It finds that definitions of "meat" and "meat products" vary in different countries and regions, and no uniform definition has been developed for cell-cultured meat. Moreover, the labelling of cell-cultured meat is controversial, and it has been regulated differently in the examined countries and regions. In addition, pre-market approval and post-market supervisions are not well established for the commercialization process of cell-cultured meat. Following the analysis of these legal frameworks and challenges, this paper proposes recommendations for improving regulations on cell-cultured meat in China.

Key words: cell-cultured meat, commercialization, regulation, legal challenges, regulatory responses

中图分类号:

D920.4

李玉娟, 傅雄飞, 杜立. 细胞培养肉商业化的法律规范与监管：外国经验及对我国启示[J]. 合成生物学, 2022, 3(1): 209-223.

Yujuan LI, Xiongfei FU, Li DU. Regulating the commercialization of cell-cultured meat: practices in selected jurisdictions and their implications for China[J]. Synthetic Biology Journal, 2022, 3(1): 209-223.

图/表 9

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评估内容	备注说明
关于整个制造过程的描述	所需信息可能会随着细胞培养肉的生产技术发展而变化
培养肉制品的特征
所使用的细胞系和培养基的相关信息
关于支架材料的信息（如有使用）
关于在制造过程中如何保存细胞培养物的纯度和遗传稳定性的信息
安全评估，涵盖培养肉类生产过程中可能产生的危害
支撑安全性的其他评估，如消化率测定、过敏原分析、基因测序等

评估内容	备注说明
关于整个制造过程的描述	所需信息可能会随着细胞培养肉的生产技术发展而变化
培养肉制品的特征
所使用的细胞系和培养基的相关信息
关于支架材料的信息（如有使用）
关于在制造过程中如何保存细胞培养物的纯度和遗传稳定性的信息
安全评估，涵盖培养肉类生产过程中可能产生的危害
支撑安全性的其他评估，如消化率测定、过敏原分析、基因测序等

机构	肉	肉制品
欧盟^[37]	动物的任何可食用部分，包括家养和野味动物的血液	加工肉类或进一步加工而产生的加工产品。此类加工产品不再具有鲜肉的特性
美国^[49-50]	牛、绵羊、猪或山羊肌肉的任何一部分	能够用作人类食品的产品，其全部或部分由肉类任何部分制成……牛、绵羊、猪或山羊的尸体的任何一部分
新加坡^[51]	供人食用的屠宰家禽、牛、羊、羊、猪、野味或其他动物的任何部分	供人食用的以下任何产品：胴体的内脏或其他部分；加工或保存肉类而制成的任何产品；任何含有肉类的产品
中国^[52-53]	活畜（猪、牛、羊、兔等）、禽（鸡、鸭、鹅等）宰杀、加工后的肉	以畜禽肉及其他食用副产品为主要原料，添加或者不添加辅料，经过腌、卤、酱、蒸、煮、熏、烤、烘焙、干燥、油炸、成型、发酵、调制等有关生产工艺加工而成的生或者熟的肉类制品

机构	肉	肉制品
欧盟^[37]	动物的任何可食用部分，包括家养和野味动物的血液	加工肉类或进一步加工而产生的加工产品。此类加工产品不再具有鲜肉的特性
美国^[49-50]	牛、绵羊、猪或山羊肌肉的任何一部分	能够用作人类食品的产品，其全部或部分由肉类任何部分制成……牛、绵羊、猪或山羊的尸体的任何一部分
新加坡^[51]	供人食用的屠宰家禽、牛、羊、羊、猪、野味或其他动物的任何部分	供人食用的以下任何产品：胴体的内脏或其他部分；加工或保存肉类而制成的任何产品；任何含有肉类的产品
中国^[52-53]	活畜（猪、牛、羊、兔等）、禽（鸡、鸭、鹅等）宰杀、加工后的肉	以畜禽肉及其他食用副产品为主要原料，添加或者不添加辅料，经过腌、卤、酱、蒸、煮、熏、烤、烘焙、干燥、油炸、成型、发酵、调制等有关生产工艺加工而成的生或者熟的肉类制品

[1]	张璨, 施李杨, 戴建武. 细胞培养肉用生物材料的设计[J]. 合成生物学, 2022, 3(4): 676-689.
[2]	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.

细胞培养肉商业化的法律规范与监管：外国经验及对我国启示

Regulating the commercialization of cell-cultured meat: practices in selected jurisdictions and their implications for China

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