生物制造食品原料市场准入政策比较及对我国的建议  

Regulation and Guidance for Marketing of Food Ingredients from Biomanufacturing and Policy Suggestions for China

作　　者：李德茂[1,3] 曾艳 周桔[2] 王钦宏[1] 孙际宾[1] 江会锋[1] 马延和[1] LI Demao;ZENG Yan;ZHOU Ju;WANG Qinhong;SUN Jibin;JIANG Huifeng;MA Yanhe(Tianjin Institute of Industrial Biotechnology,Chinese Academy of Sciences,Tianjin 300308,China;Bureau of Science and Technology for Development,Chinese Academy of Sciences,Beijing 100864,China;Tianjin Key Laboratory for Industrial Biosystems and Bioprocessing Engineering,Tianjin 300308,China)

机构地区：[1]中国科学院天津工业生物技术研究所,天津300308 [2]中国科学院科技促进发展局,北京100864 [3]天津市工业生物系统与过程工程重点实验室,天津300308

出　　处：《中国科学院院刊》2020年第8期1041-1052,共12页Bulletin of Chinese Academy of Sciences

基　　金：中国科学院科技服务网络计划(STS)(KFJ-STS-ZDTP-065)。

摘　　要：生物制造食品原料市场准入的不畅已经制约了我国生物经济的发展。文章对欧盟、美国、日本和中国对生物制造食品原料的监管模式、法规、市场准入和许可上市产品等进行了深入对比研究。欧盟、美国和日本对经遗传改造微生物制造的食品原料的监管都非常关注,但是采取了截然不同的态度:欧盟持谨慎态度,美国持宽容接受态度,而日本则持相对折中的态度。中国多年以来一直收紧对经遗传改造微生物制造的食品原料审批。目前,全球正在积极应对新技术创制的食品原料及新型食品的监管与准入。建议中国也尽快制定积极的生物制造产品应用政策,明确申报与审批路径,统一市场准入标准和审查制度,简化审批手续,推动新产品进入市场。The tightening policy of market regulation for food ingredients and novel foods produced by genetically modified microorganisms has hindered the development of the bio-economy.Here,the comparative studies have been conducted on the market regulations of food ingredients and novel foods produced by biomanufacturing in EU,USA,Japan,and China.These countries are all very concerned about the regulation of food ingredients and novel foods from biomanufacturing,however,they adopt quite different polices.EU is cautious,USA is positive,and Japan is less cautious.Over the past decades,China has been tightening the approval of food ingredients and novel foods produced by genetically modified microorganisms.At present,the whole world is actively responding to the supervision and access of new food ingredients and foods produced by new technologies.It is suggested that a positive application and approval path should be established,unified,and simplified for promoting the marketing of new products in China.

关 键 词：生物制造 食品原料 新食品 基因编辑 合成生物学 市场准入 

分 类 号：F203[经济管理—国民经济] TS202.1[轻工技术与工程—食品科学]