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

魏笑莲; 钱智玲; 陈巧巧; 于洪巍

doi:10.12211/2096-8280.2020-079

您当前的位置：

首页 >

文章列表页 >

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

特约评述 | 更新时间：2025-03-20

- 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
- Regulatory requirements for food and feed produced with genetically modified microorganisms and case studies for EU authorization
- 合成生物学 2021年2卷第1期页码：121-133
- 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：
  
  [ "魏笑莲（1989—），女，硕士，工程师。主要研究方向为食品、饲料、化工品的国际注册。E-mail：w.xiaolian@cnhu.com" ]
- 基金信息：
- DOI：10.12211/2096-8280.2020-079
  中图分类号： Q-1
- 收稿：2020-10-21，
  
  修回：2021-01-11，
  
  纸质出版：2021-02-28
- 稿件说明：
移动端阅览
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

references

EFSA Panel on Genetically Modified Organisms GMO) . Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use [J ] . EFSA Journal , 2011 , 9 ( 6 ): 2193 .

周小宁 . 两类转基因食品安全原则的对立及伦理考量 [J ] . 前沿 , 2013 , ( 7 ): 57 - 59 .

ZHOU X N . Opposition and ethical consideration of safety principles of two kinds of genetically modified foods [J ] . Forward Position , 2013 , ( 7 ): 57 - 59 .

周超 . 欧美转基因食品法律规范的比较研究 [J ] . 管理现代化 , 2012 , ( 5 ): 94 - 96 .

ZHOU C . Comparative study on legal norms of genetically modified food in Europe and America [J ] . Modernization of Management , 2012 , ( 5 ): 94 - 96 .

张振霞 . 转基因食品的安全综合评价与监管优化路径 [J ] . 食品与机械 , 2016 , 32 ( 2 ): 222 - 225 .

ZHANG Z X . Comprehensive evaluation of safety and supervision path of genetically modified food [J ] . Food and Machinery , 2016 , 32 ( 2 ): 222 - 225 .

王扬 . 我国转基因食品安全监管问题研究 [J ] . 广西社会科学 , 2015 ( 4 ): 162 - 167 .

WANG Y . Research on safety supervision of genetically modified food in China [J ] . Social Sciences in Guangxiv , 2015 ( 4 ): 162 - 167 .

胡旭 . 我国转基因食品安全监管的制度完善 [J ] . 理论与改革 , 2017 ( 3 ): 94 - 100 .

HU X . Perfection of safety supervision system of genetically modified food in China [J ] . Theory and Reform , 2017 ( 3 ): 94 - 100 .

EFSA Panel on Genetically Modified Organisms GMO) . Guidance on the environmental risk assessment of genetically modified plants [J ] . EFSA Journal , 2010 , 8 ( 11 ): 1879 .

EFSA Panel on Genetically Modified Organisms GMO) . Guidance for risk assessment of food and feed from genetically modified plants [J ] . EFSA Journal , 2011 , 9 ( 5 ): 2150 .

EFSA Panels on Genetically Modified Organisms GMO) and Animal Health and Welfare AHAW) . Guidance on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects [J ] . EFSA Journal , 2012 , 10 ( 1 ): 2501 .

EFSA Panel on Genetically Modified Organisms GMO) . Guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003 [J ] . EFSA Journal , 2015 , 13 ( 6 ): 4129 .

EFSA Panel on Genetically Modified Organisms GMO) , NAEGELI H , BIRCH A N , et al . Guidance on allergenicity assessment of genetically modified plants [J ] . EFSA Journal , 2017 , 15 ( 6 ): e04862 .

EFSA Panel on Genetically Modified Organisms GMO) , NAEGELI H , BIRCH A N , et al . Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003 [J ] . EFSA Journal , 2017 , 15 ( 11 ): e05048 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , Rychen G , Aquilina G , et al . Guidance on the characterisation of microorganisms used as feed additives or as production organisms [J ] . EFSA Journal , 2018 , 16 ( 3 ): e05206 .

EFSA Panelon Genetically Modified Organisms GMO) , Casacuberta J , Nogue F , et al . Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants [J ] . EFSA Journal , 2018 , 16 ( 7 ): e05345 .

祁浩 . 大肠杆菌表达系统和酵母表达系统的研究进展 [J ] . 安徽农业科学 , 2016 , 44 ( 17 ): 4 - 6 .

QI H . Research progress of Escherichia coli expression system and yeast expression system [J ] . Journal of Anhui Agricultural Sciences , 2016 , 44 ( 17 ): 4 - 6 .

EFSA Panel on Biological Hazards BIOHAZ) , Koutsoumanis K , Allende A , et al . Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA (2017—2019) [J ] . EFSA Journal , 2020 , 18 ( 2 ): e05966 .

EFSA Panel on Biological Hazards BIOHAZ) , Ricci A , Allende A , et al . Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA [J ] . EFSA Journal , 2017 , 15 ( 3 ): e04664 .

EFSA Panel on Biological Hazards BIOHAZ) , Koutsoumanis K , Allende A , et al . Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 12: suitability of taxonomic units notified to EFSA until March 2020 [J ] . EFSA Journal , 2020 , 18 ( 7 ): e06174 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , Rychen G , Aquilina G , et al . Safety and efficacy of l-threonine produced by fermentation with Escherichia coli CGMCC 11473 for all animal species [J ] . EFSA Journal , 2017 , 15 ( 7 ): e04939 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , Bampidis V , Azimonti G , et al . Safety of l-threonine produced by fermentation with Escherichia coli CGMCC 11473 as a feed additive for all animal species [J ] . EFSA Journal , 2019 , 17 ( 11 ): e05885 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , Bampidis V , Azimonti G , et al . Safety and efficacy of l-cysteine hydrochloride monohydrate produced by fermentation using Escherichia coli KCM80180 and Escherichia coli KCCM 80181 as a flavourinadditive for all animal species [J ] . EFSA Journal , 2020 , 18 ( 2 ): e06003 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , Bampidis V , Azimonti G , et al . Safety and efficacy of l-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli (NITE BP-02526) for all animal species [J ] . EFSA Journal , 2019 , 17 ( 8 ): e05785 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , Bampidis V , Azimonti G , et al . Safety and efficacy of l-leucine produced by fermentation with Escherichia coli NITE BP-02351 for all animal species [J ] . EFSA Journal , 2019 , 17 ( 5 ): e05689 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , Bampidis V , de Lourdes Bastos M , et al . Safety and efficacy of l-tryptophan produced by fermentation with Escherichia coli KCCM 80135 for all animal species [J ] . EFSA Journal , 2019 , 17 ( 5 ): e05694 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , Bampidis V , Azimonti G , et al . Safety and efficacy of l-tryptophan produced by fermentation with Escherichia coli KCCM 80152 for all animal species [J ] . EFSA Journal , 2019 , 17 ( 5 ): e05695 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , BAMPIDIS V , AZIMONTI G , et al . Safety and efficacy of l-tryptophan produced by fermentation with Escherichia coli CGMCC 7.248 for all animal species [J ] . EFSA Journal , 2019 , 17 ( 2 ): e05601 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , Bampidis V , Azimonti G , et al . Safety and efficacy of l-threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species [J ] . EFSA Journal , 2018 , 16 ( 10 ): e05458 .

EFSA Panel on Additives and Products or Substances used in Animal Feed FEEDAP) , Rychen G , Aquilina G , et al . Safety and efficacy of l-arginine produced by fermentation with Escherichia coli NITE BP-02186 for all animal species [J ] . EFSA Journal , 2018 , 16 ( 5 ): e05276 .

浏览量

下载量

CSCD

文章被引用时，请邮件提醒。

提交

工具集

关联资源

大肠杆菌生产饲用氨基酸的研究进展

底盘-回路耦合：合成基因回路设计新挑战

大肠杆菌合成生物基1，4-丁二醇的研究进展与发展趋势