Regulatory requirements for food and feed produced with genetically modified microorganisms and case studies for EU authorization

WEI Xiaolian; QIAN Zhiling; CHEN Qiaoqiao; YU Hongwei

doi:10.12211/2096-8280.2020-079

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Regulatory requirements for food and feed produced with genetically modified microorganisms and case studies for EU authorization

Invited Review | 更新时间：2025-03-20

- Regulatory requirements for food and feed produced with genetically modified microorganisms and case studies for EU authorization
- Synthetic Biology Journal Vol. 2, Issue 1, Pages: 121-133(2021)
- 作者机构：
  
  1.浙江新和成股份有限公司，浙江新昌 312500
  2.浙江大学化学工程与生物工程学院生物工程研究所，浙江杭州 310027
- 作者简介：
- 基金信息：
- DOI：10.12211/2096-8280.2020-079
  CLC： Q-1
- Received：21 October 2020，
  
  Revised：2021-01-11，
  
  Published：28 February 2021
- 稿件说明：
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魏笑莲, 钱智玲, 陈巧巧, 于洪巍. 遗传改造微生物制造食品和饲料的监管要求及欧盟授权案例分析[J]. 合成生物学, 2021, 2(1): 121-133

WEI Xiaolian, QIAN Zhiling, CHEN Qiaoqiao, YU Hongwei. Regulatory requirements for food and feed produced with genetically modified microorganisms and case studies for EU authorization[J]. Synthetic Biology Journal, 2021, 2(1): 121-133
魏笑莲, 钱智玲, 陈巧巧, 于洪巍. 遗传改造微生物制造食品和饲料的监管要求及欧盟授权案例分析[J]. 合成生物学, 2021, 2(1): 121-133 DOI： 10.12211/2096-8280.2020-079.

WEI Xiaolian, QIAN Zhiling, CHEN Qiaoqiao, YU Hongwei. Regulatory requirements for food and feed produced with genetically modified microorganisms and case studies for EU authorization[J]. Synthetic Biology Journal, 2021, 2(1): 121-133 DOI： 10.12211/2096-8280.2020-079.

摘要

随着现代遗传改造技术的发展，以基因重组、基因编辑、合成生物学等技术为代表的新兴生物技术为食品产业颠覆性变革奠定了重要基础。遗传改造微生物在食品领域的应用越来越广泛，遗传改造微生物发酵生产的产品在产业化过程中必须考虑各国监管法规的要求。不同国家历史文化背景、技术水平和公众对转基因食品的认知程度不同，对遗传改造微生物生产食品的监管也存在着截然不同的做法。本文介绍了欧盟、美国和中国对转基因食品的不同定义，并概述三者对于转基因食品的监管要求。以监管要求最为严格的欧盟为例，论述了欧盟的转基因食品监管体系及欧盟对遗传改造微生物发酵生产的食品、饲料的授权要求。以大肠杆菌为例，对欧盟遗传改造微生物发酵生产的产品授权实例进行分析汇总，并提出了遗传改造微生物发酵生产的食品和饲料在欧盟申请授权中的注意事项。

Abstract

With the rapid development of genetic modification technology in recent years

emerging biotechnology represented by gene recombination

gene editing

synthetic biology

etc

has laid the key foundation for subversive changes in the food industry. Genetically modified microorganisms (GMMs) are involved in the production of a variety of food and feed. At present

the application of GMMs in fermentation has become more and more extensive. The marketing of food and feed products produced by fermentation of GMMs falls under different legislative instruments for different countries. In the industrialization process using GMMs

it is necessary to consider the requirements of the laws and regulations in the countries for production and export. Different countries have different historical and cultural backgrounds

technical levels and public awareness of genetically modified foods. Therefore

there are different attitudes for the supervision of foods produced with GMMs. This article mainly discusses the regulatory requirements of food and feed produced with GMMs. For these products

if the components from genetically modified microorganisms (usually GMMs and recombinant DNA) can be detected in the final products

they will be classified as genetically modified foods (GMF) in the European Union and the United States. Therefore

they need to meet the regulatory requirements of relevant laws and regulations on genetically modified foods. In this article the different definitions of genetically modified food in European Union

the United States of America and China is firstly introduced

followed by a brief summary of the supervision requirements of genetically modified food in these three countries. Secondly

the EU

which has the strictest regulatory requirements

is examined for its regulatory system for GMF and the authorization requirements for food and feed fermented with GMMs. Finally

genetically modified

Escherichia coli

is taken as an example to study several EU

authorization cases. From these cases

recommendatory notes on applying for EU authorization of GMM fermented food and feed are briefly summarized.

关键词

Keywords

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