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

作　　者：魏笑莲 钱智玲 陈巧巧 于洪巍[2] WEI Xiaolian;QIAN Zhiling;CHEN Qiaoqiao;YU Hongwei(Zhejiang NHU Company Ltd.,Xinchang 312500,Zhejiang,China;Institute of Bioengineering,College of Chemical and Biological Engineering,Zhejiang University,Hangzhou 310027,Zhejiang,China)

机构地区：[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

出　　处：《合成生物学》2021年第1期121-133,共13页Synthetic Biology Journal

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。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 authorizat

关 键 词：转基因食品 遗传改造微生物 监管 食品饲料 大肠杆菌 

分 类 号：Q-1[生物学]