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; 傅雄飞; 杜立

doi:10.12211/2096-8280.2021-101

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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

特约评述 | 更新时间：2025-03-20

- 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
- 合成生物学 2022年3卷第1期页码：209-223
- 作者机构：
  
  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
- 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" ]
- 基金信息：
  
  深圳合成生物学创新研究院创新项目(CP-030-2021)
- DOI：10.12211/2096-8280.2021-101
  中图分类号： D920.4;Q1
- 收稿：2021-11-02，
  
  修回：2022-01-14，
  
  纸质出版：2022-02-28
- 稿件说明：
移动端阅览
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

LI Yujuan， FU Xiongfei， DU Li. 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
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 DOI： 10.12211/2096-8280.2021-101.

LI Yujuan， FU Xiongfei， DU Li. 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 DOI： 10.12211/2096-8280.2021-101.

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。

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 re

levant 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.

关键词

Keywords

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