生物制造食品原料市场准入政策比较及对我国的建议(已在2020年第8期出版)

Regulation and Guidance for Marketing of Food Ingredients from Biomanufacturing and Policy Suggestions for China
作者
        李德茂 曾 艳 周 桔 王钦宏 孙际宾 江会锋 马延和
中文关键词
         生物制造,食品原料,新食品,基因编辑,合成生物学,市场准入
英文关键词
        biomanufacturing, food ingredient, novel food, gene editing, synthetic biology, marketing
中文摘要
        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。
英文摘要
        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.
作者简介
李德茂
中国科学院天津工业生物技术研究所研究员。主要研究方向为工业生物制造。发表论文88篇,申请发明专利20项,已获授权16项。
E-mail: li_dm@tib.cas.cn
LI Demao
Professor of Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences (CAS). His research area is industrial bio-manufacturing. 88 articles have been published and 16 patents have been authorized.
E-mail: li_dm@tib.cas.cn

曾 艳
中国科学院科技促进发展局生物技术处副研究员,工业生物催化专业博士。主要从事生物技术领域科研管理及成果转化等工作。
E-mail: zengyan@cashq.ac.cn
ZENG Yan
Associate Professor of Bureau of Science and Technology for Development, Chinese Academy of Sciences (CAS). Ph.D. of biocatalysis. She is mainly responsible for biotechnology projects management, tech-transfer, etc.
E-mail: zengyan@cashq.ac.cn

马延和
中国科学院天津工业生物技术研究所所长、研究员、博士生导师,工业酶国家工程实验室主任。主要从事极端微生物与生物工程的研究与应用。已发表SCI论文250多篇,申请发明专利170多项,已获授权70余项。
E-mail: ma_yh@tib.cas.cn
MA Yanhe
Professor, Doctoral Supervisor and Director of Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences (CAS). He is mainly engaged in the research and application of extreme microorganisms and bioengineering. More than 250 SCI papers have been published. More than 170 invention patents have been applied, in which more than 70 of them have been authorized.
E-mail: ma_yh@tib.cas.cn
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