Opportunities， challenges， and regulatory drivers for the commercial biomanufacturing of novel food ingredients： a case study of L-ergothioneine

WANG Qiqi; LIU Xuesong; ZHANG Yanfei; DU Li

doi:10.12211/2096-8280.2025-104

您当前的位置：

首页 >

文章列表页 >

Opportunities， challenges， and regulatory drivers for the commercial biomanufacturing of novel food ingredients： a case study of L-ergothioneine

Invited Review | 更新时间：2026-05-22

- Opportunities， challenges， and regulatory drivers for the commercial biomanufacturing of novel food ingredients： a case study of L-ergothioneine
- Synthetic Biology Journal Vol. 7, Issue 2, Pages: 408-423(2026)
- 作者机构：
  
  1.中国科学院天津工业生物技术研究所，中国科学院天津工业生物技术研究所-澳门大学中医药合成生物学联合实验室，天津 300308
  2.合成生物学海河实验室，天津 300308
  3.国家合成生物技术创新中心，天津 300308
  4.澳门大学法学院，澳门 999078
- 作者简介：
- 基金信息：
- DOI：10.12211/2096-8280.2025-104
  CLC： Q816
- Received：23 December 2025，
  
  Revised：2026-03-05，
  
  Published：30 April 2026
- 稿件说明：
移动端阅览
汪琪琦，刘雪松，张燕飞，杜立. 生物制造新食品原料产业化的机遇、挑战与监管驱动——以麦角硫因为例［J］. 合成生物学， 2026， 7（2）： 408-423

WANG Qiqi， LIU Xuesong， ZHANG Yanfei， DU Li. Opportunities， challenges， and regulatory drivers for the commercial biomanufacturing of novel food ingredients： a case study of L-ergothioneine［J］. Synthetic Biology Journal， 2026， 7（2）： 408-423
汪琪琦，刘雪松，张燕飞，杜立. 生物制造新食品原料产业化的机遇、挑战与监管驱动——以麦角硫因为例［J］. 合成生物学， 2026， 7（2）： 408-423 DOI： 10.12211/2096-8280.2025-104.

WANG Qiqi， LIU Xuesong， ZHANG Yanfei， DU Li. Opportunities， challenges， and regulatory drivers for the commercial biomanufacturing of novel food ingredients： a case study of L-ergothioneine［J］. Synthetic Biology Journal， 2026， 7（2）： 408-423 DOI： 10.12211/2096-8280.2025-104.

摘要

通过合成生物学和精准发酵技术生产新食品原料，已成为生物制造领域的重要发展方向，具有来源可控、纯度稳定和可规模化持续生产等优势，可有效突破传统农业提取模式在成本、资源与环境方面的限制。随着技术成熟度提升，生物制造食品原料逐步进入产业化阶段，但其市场转化仍受制于监管路径不够清晰、审批周期较长及公众认知不足等因素。本文以麦角硫因这一典型生物合成功能性氨基酸为例，比较分析欧美新食品审批经验与我国监管实践，系统梳理其在制度准入与社会接受层面的主要瓶颈。研究表明，当前制约生物制造原料商业化的关键不在技术能力，而在审批规则、风险评估机制与信任治理的适配不足。基于此，本文提出完善技术指南、实施风险分层审评、优化实质等同路径及加强风险沟通等政策建议，以构建兼顾安全与效率的适应性监管框架。本文旨在为推动我国新食品原料合规上市与生物制造产业高质量发展提供参考。

Abstract

Novel food ingredients produced through advanced synthetic biology and precision fermentation technologies are rapidly reshaping the landscape of global food manufacturing. Compared with traditional agricultural sourcing or extraction from natural resources

biomanufacturing offers a more sustainable

controllable

and scalable supply model that reduces dependence on seasons

land resources

and envi

ronmentally intensive production chains. Continuous breakthroughs in metabolic engineering and microbial cell factories have substantially improved production yields

purity

and cost efficiency

enabling many bio-derived ingredients to be ready for transition from laboratory research to industrial production. However

the commercialization of these innovative ingredients is not determined solely by technological readiness. Instead

it is increasingly constrained by regulatory policies

approval efficiency

and public acceptance

particularly in jurisdictions where existing food safety frameworks were originally designed for conventional products rather than emerging production systems. This study employs L-ergothioneine

a naturally occurring antioxidant amino acid as a representative product of synthetic biomanufacturing to examine the regulatory and governance challenges facing novel food ingredients. Traditionally extracted from limited biological sources such as edible fungi

ergothioneine is now more efficiently produced

via

microbial fermentation

which provides higher purity

stable supply

and lower environmental impact. Despite international regulatory recognition and commercialization progress in regions such as the United States and the European Union

its market entry in China remains relatively slow. Through a comparative review of international approval processes

including the U.S. GRAS System and the EU Novel Food Framework

along with China’s pre-market approval system

this study identifies key structural barriers affecting the domestic commercialization of L-ergothioneine. These include ambiguous technical requirements

limited risk-tiered evaluation mechanisms

lengthy review timelines

and gaps between scientific evidence and consumer perception. Based on these circumstances

the paper proposes an adaptive regulatory framework that integrates four complementary dimensions: clarification of technical guidelines

risk-proportionate assessments

optimization of substantial equi

valence mechanisms

and strengthened science-based risk communication. Rather than advocating for accelerated approval alone

this framework emphasizes improving regulatory predictability

transparency

and trust while maintaining high safety standards. By embedding process-based risk evaluation and dynamic post-market monitoring into the licensing pathway

regulators can better balance innovation promotion with precautionary governance. This approach contributes both empirically and conceptually. Empirically

it provides a systematic analysis of the institutional constraints affecting the industrialization of biosynthesized ergothioneine in China. Conceptually

it advances a broader understanding of how food safety governance can evolve from static ingredient-based assessment toward adaptive oversight of novel production systems. These experiences offer policy insights for accelerating the compliant market entry of domestically developed bio-manufactured novel food ingredients to foster a resilient regulatory environment that aligns technological innovation with public health protection.

关键词

Keywords

references

ARUN K B , ANOOPKUMAR A N , SINDHU R , et al . Synthetic biology for sustainable food ingredients production: recent trends [J ] . Systems Microbiology and Biomanufacturing , 2023 , 3 ( 1 ): 137 - 149 .

中共中央关于制定国民经济和社会发展第十五个五年规划的建议 [EB/OL ] . [ 2025-11-07 ] . https://www.gov.cn/zhengce/202510/content_7046050.htm https://www.gov.cn/zhengce/202510/content_7046050.htm .

Recommendations of the Central Committee of the Communist Party of China on formulating the 15th five-year plan for national economic and social development [EB/OL ] . [ 2025-11-07 ] . https://www.gov.cn/zhengce/202510/content_7046050.htm https://www.gov.cn/zhengce/202510/content_7046050.htm .

LIU X , WU D , SHAO Y , et al . New food sources and production systems: a comparison of international regulations and China’s advancements in novel foods with synthetic biology [J ] . Food Science and Human Wellness , 2024 , 13 ( 5 ): 2519 - 2542 .

AMES B N . Prolonging healthy aging: longevity vitamins and proteins [J ] . Proceedings of the National Academy of Sciences of the United States of America , 2018 , 115 ( 43 ): 10836 - 10844 .

HALLIWELL B , CHEAH I K , TANG R M Y . Ergothioneine—a diet-derived antioxidant with therapeutic potential [J ] . FEBS Letters , 2018 , 592 ( 20 ): 3357 - 3366 .

HDIN Research . Ergothioneine global market insights 2025 , analysis and forecast to 2030 , by manufacturers, regions, technology, application[EB/OL ] . [ 2025-09-11 ] . https://www.hdinresearch.com/reports/155960 https://www.hdinresearch.com/reports/155960 .

PW Consulting . Global synthetic ergothioneine market size, share & trends analysis 2026 - 2032 [EB/OL ] [ 2026-02-26 ] . https://pmarketresearch.com/chemi/synthetic-ergothioneine-market/ https://pmarketresearch.com/chemi/synthetic-ergothioneine-market/ .

GRAS Notice No. 734 [EB/OL ] . [ 2025-09-29 ] . https://www.fda.gov/media/112276/download https://www.fda.gov/media/112276/download .

Publications Office of the European Union . Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance) [A/OL ] . ( 2015-11-25 )[ 2025-11-14 ] . http://data.europa.eu/eli/reg/2015/2283/oj http://data.europa.eu/eli/reg/2015/2283/oj .

EFSA Panel on Dietetic Products , Nutrition and Allergies (NDA) Products , Nutrition , et al . Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1) [J ] . EFSA Journal European Food Safety Authority , 2021 , 19 ( 3 ): e06555 .

U.S. FOOD & DRUG ADMINSTRATION . Generally recognized as safe (GRAS) [EB/OL ] . FDA , 2024 [ 2025-11-14 ] . https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras .

国家卫生健康委员会 . 新食品原料安全性审查管理办法 [EB/OL ] . [ 2025-10-15 ] . https://www.gov.cn/zhengce/2013-05/31/content_5713799.htm https://www.gov.cn/zhengce/2013-05/31/content_5713799.htm .

National Health Commission of the People’s Republic of China . Measures for the safety review and administration of new food raw materials [EB/OL ] . [ 2025-10-15 ] . https://www.gov.cn/zhengce/2013-05/31/content_5713799.htm https://www.gov.cn/zhengce/2013-05/31/content_5713799.htm .

龙伽雯 , 李跃辉 . 新食品原料的审批及应用现状研究 [J ] . 食品与发酵工业 , 2025 , 51 ( 8 ): 394 - 404 .

LONG J W , LI Y H . Research on approval and application status of new food raw materials [J ] . Food and Fermentation Industries , 2025 , 51 ( 8 ): 394 - 404 .

ZHANG H J , LIU Z , WANG Z , et al . A review of novel antioxidant ergothioneine: biosynthesis pathways, production, function and food applications [J ] . Foods , 2025 , 14 ( 9 ): 1588 .

HARTMAN P E . Ergothioneine as antioxidant [J ] . Methods in Enzymology , 1990 , 186 : 310 - 318 .

PAUL B D . Ergothioneine: a stress vitamin with antiaging, vascular, and neuroprotective roles? [J ] . Antioxidants & Redox Signaling , 2022 , 36 ( 16/17/18 ): 1306 - 1317 .

CHEAH I K , TANG R M , YEW T S , et al . Administration of pure ergothioneine to healthy human subjects: uptake, metabolism, and effects on biomarkers of oxidative damage and inflammation [J ] . Antioxidants & Redox Signaling , 2017 , 26 ( 5 ): 193 - 206 .

LI A , LIU Y J , YU P L , et al . Ergothioneine attenuates psoriasis symptoms through modulation of M1/M2 macrophage polarisation via the NF-κB/JAK-STAT3 pathway [J ] . Frontiers in Pharmacology , 2025 , 16 : 1521743 .

WANG Z , MA J W , MIAO Z M , et al . Ergothioneine inhibits the progression of osteoarthritis via the Sirt6/NF-κB axis both in vitro and in vivo [J ] . International Immunopharmacology , 2023 , 119 : 110211 .

TERUYA T , CHEN Y J , KONDOH H , et al . Whole-blood metabolomics of dementia patients reveal classes of disease-linked metabolites [J ] . Proceedings of the National Academy of Sciences of the United States of America , 2021 , 118 ( 37 ): e2022857118 .

WU L Y , CHEAH I K , CHONG J R , et al . Low plasma ergothioneine levels are associated with neurodegeneration and cerebrovascular disease in dementia [J ] . Free Radical Biology & Medicine , 2021 , 177 : 201 - 211 .

ZAJAC I T , KAKOSCHKE N , KUHN-SHERLOCK B , et al . The effect of ergothioneine supplementation on cognitive function, memory, and sleep in older adults with subjective memory complaints: a randomized placebo-controlled trial [J ] . Nutraceuticals , 2025 , 5 ( 3 ): 15 .

ISHIMOTO T , YAMASHITA R , MATSUMOTO R , et al . TrkB phosphorylation in serum extracellular vesicles correlates with cognitive function enhanced by ergothioneine in humans [J ] . NPJ Science of Food , 2024 , 8 : 11 .

SMITH E , OTTOSSON F , HELLSTRAND S , et al . Ergothioneine is associated with reduced mortality and decreased risk of cardiovascular disease [J ] . Heart , 2020 , 106 ( 9 ): 691 - 697 .

SERVILLO L , DʼONOFRIO N , BALESTRIERI M L . Ergothioneine antioxidant function: from chemistry to cardiovascular therapeutic potential [J ] . Journal of Cardiovascular Pharmacology , 2017 , 69 ( 4 ): 183 - 191 .

FU T T , SHEN L . Ergothioneine as a natural antioxidant against oxidative stress-related diseases [J ] . Frontiers in Pharmacology , 2022 , 13 : 850813 .

KATSUBE M , ISHIMOTO T , FUKUSHIMA Y , et al . Ergothioneine promotes longevity and healthy aging in male mice [J ] . GeroScience , 2024 , 46 ( 4 ): 3889 - 3909 .

PETROVIC D , SLADE L , PAIKOPOULOS Y , et al . Ergothioneine improves healthspan of aged animals by enhancing cGPDH activity through CSE-dependent persulfidation [J ] . Cell Metabolism , 2025 , 37 ( 2 ): 542 - 556.e14 .

APPAROO Y , WEI PHAN C , RANI KUPPUSAMY U , et al . Potential role of ergothioneine rich mushroom as anti-aging candidate through elimination of neuronal senescent cells [J ] . Brain Research , 2024 , 1824 : 148693 .

TIAN X Y , THORNE J L , MOORE J B . Ergothioneine: an underrecognised dietary micronutrient required for healthy ageing? [J ] . The British Journal of Nutrition , 2023 , 129 ( 1 ): 104 - 114 .

冯路路 , 鄂恒超 , 张艳梅 , 等 . 食用菌中麦角硫因提取分离和检测方法研究进展 [J ] . 食用菌学报 , 2021 , 28 ( 1 ): 115 - 123 .

FENG L L , E H C , ZHANG Y M , et al . Research progress on extraction, separation and detection of ergothionine in edible fungi [J ] . Acta Edulis Fungi , 2021 , 28 ( 1 ): 115 - 123 .

海若镜 . Pre-A轮合成生物公司靠卖麦角硫因逆袭,月均GMV超 3000 万[EB/OL ] . [ 2025-09-02 ] . http://eu.36kr.com/zh/p/3301095415880457 http://eu.36kr.com/zh/p/3301095415880457 .

HAI R J . A pre-Series A synthetic biology company stages a comeback by selling ergothioneine, with monthly average GMV exceeding 30 million yuan [EB/OL ] . [ 2025-09-02 ] . http://eu.36kr.com/zh/p/3301095415880457 http://eu.36kr.com/zh/p/3301095415880457 .

王丽 , 王阳 , 李江华 , 等 . 产麦角硫因大肠杆菌工程菌株的构建与优化 [J ] . 生物工程学报 , 2022 , 38 ( 2 ): 796 - 806 .

WANG L , WANG Y , LI J H , et al . Construction and optimization of ergothioneine-producing Escherichia coli [J ] . Chinese Journal of Biotechnology , 2022 , 38 ( 2 ): 796 - 806 .

Advancing ergothioneine production with adsorption and separation technology [EB/OL ] . [ 2025-09-03 ] . https://www.seplite.com/advancing-ergothioneine-production-with-adsorption-and-separation-technology/ https://www.seplite.com/advancing-ergothioneine-production-with-adsorption-and-separation-technology/ .

JONES G W , DOYLE S , FITZPATRICK D A . The evolutionary history of the genes involved in the biosynthesis of the antioxidant ergothioneine [J ] . Gene , 2014 , 549 ( 1 ): 161 - 170 .

OSAWA R , KAMIDE T , SATOH Y , et al . Heterologous and high production of ergothioneine in Escherichia coli [J ] . Journal of Agricultural and Food Chemistry , 2018 , 66 ( 5 ): 1191 - 1196 .

YU Y H , PAN H Y , GUO L Q , et al . Successful biosynthesis of natural antioxidant ergothioneine in Saccharomyces cerevisiae required only two genes from Grifola frondosa [J ] . Microbial Cell Factories , 2020 , 19 ( 1 ): 164 .

XIONG K X , GUO H , XUE S Y , et al . Production optimization of food functional factor ergothioneine in wild-type red yeast Rhodotorula mucilaginosa DL-X01 [J ] . Journal of the Science of Food and Agriculture , 2024 , 104 ( 7 ): 4050 - 4057 .

YU Y H , LIU H Q , ZHANG S , et al . Highly efficient production of ergothioneine from glycerol through gene mining and CRISPR-Cas9 synthetic biology technology in Saccharomyces cerevisiae [J ] . ACS Sustainable Chemistry & Engineering , 2024 , 12 ( 43 ): 15901 - 15912 .

LIU K , XIANG G D , LI L K , et al . Engineering non-conventional yeast Rhodotorula toruloides for ergothioneine production [J ] . Biotechnology for Biofuels and Bioproducts , 2024 , 17 ( 1 ): 65 .

WANG L H , TIAN X Q , XUE P H , et al . Enhanced production of ergothioneine in Aspergillus oryzae [J ] . Applied Microbiology and Biotechnology , 2025 , 109 ( 1 ): 143 .

YAN J J , CHEN Y H , MA Y Y , et al . Efficient ergothioneine production through reconstruction of the methyl and sulfur supply systems in Escherichia coli [J ] . Trends in Biotechnology , 2026 , 44 ( 2 ): 477 - 495 .

朱华伟 , 李寅 . 合成生物制造2025 [J ] . 生物工程学报 , 2025 , 41 ( 1 ): 1 - 78 .

ZHU H W , LI Y . Biomanufacturing driven by engineered organisms [J ] . Chinese Journal of Biotechnology , 2025 , 41 ( 1 ): 1 - 78 .

LIU Z , XIAO F X , ZHANG Y P , et al . Heterologous and high production of ergothioneine in Bacillus licheniformis by using genes from anaerobic bacteria [J ] . Metabolites , 2025 , 15 ( 1 ): 45 .

中新经纬 . 麦角硫因引爆A股,千亿新赛道,华熙生物领跑生物合成新蓝海 [EB/OL ] . [ 2025-08-08 ] . https://www.jwview.com/jingwei/html/m/05-16/622589.shtml https://www.jwview.com/jingwei/html/m/05-16/622589.shtml .

China News Service’s Economic View . Ergothioneine triggers a surge in A-shares, unveiling a multi-billion Yuan emerging sector; Bloomage Bio leads the new frontier in biosynthesis [EB/OL ] . [ 2025-08-08 ] . https://www.jwview.com/jingwei/html/m/05-16/622589.shtml https://www.jwview.com/jingwei/html/m/05-16/622589.shtml .

TURCK D , BRESSON J L , BURLINGAME B , et al . Safety of synthetic L-ergothioneine (Ergoneine ® ) as a novel food pursuant to Regulation (EC) No258/97 [J ] . EFSA Journal , 2016 , 14 ( 11 ): e04629 .

GRAS Notice No . GRN 001191 [EB/OL ] . [ 2025-09-29 ] . https://www.fda.gov/media/186855/download https://www.fda.gov/media/186855/download .

Govornment of Canada . Chemical substance-ergothioneine [EB/OL ] . [ 2025-11-28 ] . https://webprod.hc-sc.gc.ca/nhpid-bdipsn/ingredReq id=13222 https://webprod.hc-sc.gc.ca/nhpid-bdipsn/ingredReqid=13222 .

Austrilia Government Department of Health , Disability and Ageing . Australian Register of Therapeutic Goods (ARTG) [EB/OL ] // Therapeutic Goods Administration (TGA) . [ 2025-11-28 ] . https://www.tga.gov.au/resources/artg keywords=ergothioneine https://www.tga.gov.au/resources/artgkeywords=ergothioneine .

Publications Office of the European Union . Commission Implementing Decision (EU) 2017/1281 of 13 July 2017 authorising the placing on the market of L-ergothioneine as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 4844) [A/OL ] . ( 2017-07-13 )[ 2025-09-19 ] . http://data.europa.eu/eli/dec_impl/2017/1281/oj/eng http://data.europa.eu/eli/dec_impl/2017/1281/oj/eng .

EFSA Panel on Dietetic Products , Nutrition and Allergies (NDA) , TURCK D , et al . Statement on the safety of synthetic L-ergothioneine as a novel food-supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women | EFSA [EB/OL ] . ( 2017-11-13 )[ 2025-08-08 ] . https://www.efsa.europa.eu/en/efsajournal/pub/5060 https://www.efsa.europa.eu/en/efsajournal/pub/5060 .

U.S. Department of Agriculture . BE disclosure [EB/OL ] . [ 2025-11-14 ] . https://www.ams.usda.gov/rules-regulations/be https://www.ams.usda.gov/rules-regulations/be .

Blue California . Super antioxidant ergothioneine achieves GRAS status from FDA [EB/OL ] . [ 2025-08-08 ] . https://bluecal-ingredients.com/2020/09/super-antioxidant-ergothioneine-achieves-gras-status-from-fda/ https://bluecal-ingredients.com/2020/09/super-antioxidant-ergothioneine-achieves-gras-status-from-fda/ .

KOE T . Ergothioneine’s scientific evidence, longevity marketing spark debate in China [EB/OL ] . ( 2025-06-16 )[ 2025-08-08 ] . https://www.nutraingredients-asia.com/Article/2025/06/16/ergothioneines-scientific-evidence-marketing-spark-debate-in-china/ https://www.nutraingredients-asia.com/Article/2025/06/16/ergothioneines-scientific-evidence-marketing-spark-debate-in-china/ .

KUIPER H A , KLETER G A , NOTEBORN H P , et al . Substantial equivalence: an appropriate paradigm for the safety assessment of genetically modified foods? [J ] . Toxicology , 2002 , 181-182 : 427 - 431 .

OECD . Safety evaluation of foods derived by modern biotechnology: concepts and principles [EB/OL ] . [ 2025-11-27 ] . https://www.iatp.org/documents/safety-evaluation-of-foods-derived-by-modern-biotechnology-concepts-and-principles https://www.iatp.org/documents/safety-evaluation-of-foods-derived-by-modern-biotechnology-concepts-and-principles .

SCHAUZU M . The concept of substantial equivalence in safety assessment of foods derived from genetically modified organisms [J ] . AgBiotechNet , 2000 , 2: ABN 044.

The Principle of Substantial Equivalence is Unscientific and Arbitrary [EB/OL ] . [ 2026-01-21 ] . https://biosafety-info.net/articles/biosafety-science/general-biosafety-issues/the-principle-of-substantial-equivalence-is-unscientific-and-arbitrary/ https://biosafety-info.net/articles/biosafety-science/general-biosafety-issues/the-principle-of-substantial-equivalence-is-unscientific-and-arbitrary/ .

中食安信(北京)信息咨询有限公司 . 食品行业的“实质等同”,到底在“等同”什么? [EB/OL ] . [ 2026-01-21 ] . https://www.antion.net/Cn/News/viewkuaixun/id/pplGOu7ZmCIP3nKfS0oo00oRXQO0O0OO0O0O.html https://www.antion.net/Cn/News/viewkuaixun/id/pplGOu7ZmCIP3nKfS0oo00oRXQO0O0OO0O0O.html .

Antion Consulting . What exactly does the ‘substantive equivalence’ of the food industry mean? [EB/OL ] . [ 2026-01-21 ] . https://www.antion.net/Cn/News/viewkuaixun/id/pplGOu7ZmCIP3nKfS0oo00oRXQO0O0OO0O0O.html https://www.antion.net/Cn/News/viewkuaixun/id/pplGOu7ZmCIP3nKfS0oo00oRXQO0O0OO0O0O.html .

PW Consulting . Worldwide Ultrapure Ergothioneine Market Research Report 2025 , Forecast to 2031 PW Consulting[EB/OL ] . [ 2025-09-11 ] . https://pmarketresearch.com/product/worldwide-ultrapure-ergothioneine-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030/ https://pmarketresearch.com/product/worldwide-ultrapure-ergothioneine-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030/ .

“十四五”生物经济发展规划 [EB/OL ] . [ 2025-10-21 ] . https://www.gov.cn/zhengce/zhengceku/2022-05/10/content_5689556.htm https://www.gov.cn/zhengce/zhengceku/2022-05/10/content_5689556.htm .

14th Five-Year Plan for the Development of Bioeconomy [EB/OL ] . [ 2025-10-21 ] . https://www.gov.cn/zhengce/zhengceku/2022-05/10/content_5689556.htm https://www.gov.cn/zhengce/zhengceku/2022-05/10/content_5689556.htm .

动脉生物制造 . 国家两部门通知:征集生物制造创新技术应用,支持开展“三新食品”申报 [EB/O L ] . [ 2025-10-21 ] . https://i.cgeinc.com/no70/24063.html https://i.cgeinc.com/no70/24063.html .

Artery Bio-Manufacturing . Two national ministries issue notice: soliciting applications for innovative biomanufacturing technologies, supporting applications for the ‘three new foods’ category [EB/OL ] . [ 2025-10-21 ] . https://i.cgeinc.com/no70/24063.html https://i.cgeinc.com/no70/24063.html .

工业和信息化部 . 工业和信息化部办公厅国家卫生健康委办公厅关于开展食品加工领域生物制造创新技术应用方向征集工作的通知 [EB/OL ] . [ 2025-10-21 ] . https://www.miit.gov.cn/jgsj/xfpgys/wjfb/art/2025/art_f7fd30f4a2384b1ebb841c94cb410b35.html https://www.miit.gov.cn/jgsj/xfpgys/wjfb/art/2025/art_f7fd30f4a2384b1ebb841c94cb410b35.html .

Ministry of Industry and Information Technology of the People’s Republic of China . Notice of the General Office of the Ministry of Industry and Information Technology and the General Office of the National Health Commission on the Collection of Innovative Biotechnology Applications in the Food Processing Sector [EB/OL ] . [ 2025-10-21 ] . https://www.miit.gov.cn/jgsj/xfpgys/wjfb/art/2025/art_f7fd30f4a2384b1ebb841c94cb410b35.html https://www.miit.gov.cn/jgsj/xfpgys/wjfb/art/2025/art_f7fd30f4a2384b1ebb841c94cb410b35.html .

新华网 . 中粮集团酶法生产D-阿洛酮糖获批新食品原料 [EB/OL ] . [ 2025-11-28 ] . https://www.news.cn/20250702/c40fea9ec59c4678b34720aa0a3a0097/c.html https://www.news.cn/20250702/c40fea9ec59c4678b34720aa0a3a0097/c.html .

Xinhua Net . COFCO’s Enzymatic production of D-allulose approved as new food raw material [EB/OL ] . [ 2025-11-28 ] . https://www.news.cn/20250702/c40fea9ec59c4678b34720aa0a3a0097/c.html https://www.news.cn/20250702/c40fea9ec59c4678b34720aa0a3a0097/c.html .

证券时报 . 富祥药业威尼斯镰刀菌蛋白获新食品原料认证,开启蛋白产业新纪元 [EB/OL ] . [ 2025-11-28 ] . https://stcn.com/article/detail/3516504.html https://stcn.com/article/detail/3516504.html .

Securities Times . Fuxiang Pharma’s Fusarium venenatum prot ein granted new food raw material certification, ushering in a new era for the protein industry [EB/OL ] . [ 2025-11-28 ] . https://stcn.com/article/detail/3516504.html https://stcn.com/article/detail/3516504.html .

食品研发服务中心 . 别让“长寿维生素”麦角硫因,成为下一个被资本抛弃的白藜芦醇! [EB/OL ] . [ 2025-12-05 ] . https://yanfa.foodmate.net/news/show-1819.html https://yanfa.foodmate.net/news/show-1819.html .

Food Research and Development Service Center . Don’t let ergothioneine, the “longevity vitamin,” become the next resveratrol abandoned by capital! [EB/OL ] . [ 2025-12-05 ] . https://yanfa.foodmate.net/news/show-1819.html https://yanfa.foodmate.net/news/show-1819.html .

国家卫生健康委员会 . 解读《关于“三新食品”目录及适用的食品安全标准的公告》(2023年第4号) [EB/OL ] . [ 2025-10-15 ] . https://zwfw.nhc.gov.cn/kzx/tzgg/sptjjxpzsp_224/202305/t20230515_2518.html https://zwfw.nhc.gov.cn/kzx/tzgg/sptjjxpzsp_224/202305/t20230515_2518.html .

National Health Commission of the People’s Republic of China . Interpretation of the “announcement on the catalog of ‘three new foods’ and applicable food safety standards ”[EB/OL ] . [ 2025-10-15 ] . https://zwfw.nhc.gov.cn/kzx/tzgg/sptjjxpzsp_224/202305/t20230515_2518.html https://zwfw.nhc.gov.cn/kzx/tzgg/sptjjxpzsp_224/202305/t20230515_2518.html .

国家食品安全风险评估中心 . 关于完善“三新食品”安全性评价资料要求的通知 [EB/OL ] . [ 2025-09-29 ] . https://www.cfsa.net.cn/zxdt/tzgg/2024/14077.shtml https://www.cfsa.net.cn/zxdt/tzgg/2024/14077.shtml .

China National Center for Food Safety Risk Assessment . Notice on improving the requirements for safety evaluation documentation of “three new foods” [EB/OL ] . [ 2025-09-29 ] . https://www.cfsa.net.cn/zxdt/tzgg/2024/14077.shtml https://www.cfsa.net.cn/zxdt/tzgg/2024/14077.shtml .

Zmuni Compliance Centre . New food ingredient applications updates in China — first half of 2025 [EB/OL ] . ( 2025-07-14 )[ 2025-08-22 ] . https://www.zmuni.com/en/news/new-food-ingredient-applications-updates-in-china-first/ https://www.zmuni.com/en/news/new-food-ingredient-applications-updates-in-china-first/ .

国家食品安全风险评估中心 . “三新食品”与食药物质常见问题解析 [EB/OL ] . [ 2026-02-03 ] . https://www.cifst.org.cn/a/news/fagui/20240902/3127.html https://www.cifst.org.cn/a/news/fagui/20240902/3127.html .

China National Center for Food Safety Risk Assessment . Analysis of common problems with “three new foods” and food and drug substances [EB/OL ] . [ 2026-02-03 ] . https://www.cifst.org.cn/a/news/fagui/20240902/3127.html https://www.cifst.org.cn/a/news/fagui/20240902/3127.html .

戴为卿 . 国际新兴食品领域的法律监管及其借鉴 [J ] . 食品与机械 , 2025 , 41 ( 3 ): 62 - 66 .

DAI W Q . Legal supervision of international emerging food fields and its reference [J ] . Food & Machinery , 2025 , 41 ( 3 ): 62 - 66 .

Novel food applications for synthetic biology-derived products under the new EU regulations [EB/OL ] . ( 2025-02-24 )[ 2026-01-21 ] . http://www.cirs-group.com/en/food/novel-food-applications-for-synthetic-biology-derived-products-under-the-new-eu-regulations http://www.cirs-group.com/en/food/novel-food-applications-for-synthetic-biology-derived-products-under-the-new-eu-regulations .

彭勃文 , 黄季焜 . 中国消费者对转基因食品的认知和接受程度 [J ] . 农业经济与管理 , 2015 ( 1 ): 33 - 39, 63 .

PENG B W , HUANG J K . Chinese consumers’ knowledge and acceptances of genetically modified food [J ] . Agricultural Economics and Management , 2015 ( 1 ): 33 - 39, 63 .

CUI K , SHOEMAKER S P . Public perception of genetically-modified (GM) food: a nationwide Chinese consumer study [J ] . NPJ Science of Food , 2018 , 2 : 10 .

证券时报 . 饶毅:75岁董事长秀肌肉代言的是“假药”!公司最新回应! [EB/OL ] . [ 2025-10-20 ] . http://stcn.com/article/detail/1862445.html http://stcn.com/article/detail/1862445.html .

Securities Times . Rao Yi: the 75-year-old chairman’s bodybuilding photo endorses a “fake drug”! The company’s latest response! [EB/OL ] . [ 2025-10-20 ] . http://stcn.com/article/detail/1862445.html http://stcn.com/article/detail/1862445.html .

李佳英 . 麦角硫因陷多重争议,究竟是有效产品还是营销噱头? [EB/OL ] . [ 2025-10-21 ] . https://www.21jingji.com/article/20250606/herald/ee46031a7e4b0eaea2e36675e32e0ba6.html https://www.21jingji.com/article/20250606/herald/ee46031a7e4b0eaea2e36675e32e0ba6.html .

LI J Y . Is ergothioneine, embroiled in multiplecontroversies, an effective product or a marketing gimmick [EB/OL ] . [ 2025-10-21 ] . https://www.21jingji.com/article/20250606/herald/ee46031a7e4b0eaea2e36675e32e0ba6.html https://www.21jingji.com/article/20250606/herald/ee46031a7e4b0eaea2e36675e32e0ba6.html .

齐鲁晚报 . 麦角硫因陷争议:抗衰“神药”还是营销噱头? [EB/OL ] . [ 2025-10-21 ] . https://www.xinhuanet.com/finance/20250617/9862989e1dbf4c7abdcb331e98e4730c/c.html https://www.xinhuanet.com/finance/20250617/9862989e1dbf4c7abdcb331e98e4730c/c.html .

Qilu Evening News . Ergothioneine mired in controversy: anti-aging “miracle drug” or marketing gimmick [EB/OL ] . [ 2025-10-21 ] . https://www.xinhuanet.com/finance/20250617/9862989e1dbf4c7abdcb331e98e4730c/c.html https://www.xinhuanet.com/finance/20250617/9862989e1dbf4c7abdcb331e98e4730c/c.html .

GIULIA I . China's Health Supplements Market: Trends and Opportunities [EB/OL ] // China Briefing News . ( 2024-07-16 )[ 2025-09-30 ] . https://www.china-briefing.com/news/chinas-health-supplements-market-trends-and-opportunities-for-businesses/ https://www.china-briefing.com/news/chinas-health-supplements-market-trends-and-opportunities-for-businesses/ .

EFSA . Novel food [EB/OL ] .[ 2026-02-07 ] . https://www.efsa.europa.eu/en/topics/topic/novel-food https://www.efsa.europa.eu/en/topics/topic/novel-food .

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

AI + synthetic biology： a paradigm shift in biomanufacturing

Intellectual property protection for synthetic biomanufacturing： current status， challenges， and suggestions

Standardization for biomanufacturing: global landscape, critical challenges, and pathways forward

Rewiring and application of Yarrowia lipolytica chassis cell

One-carbon bioconversion based on microbial electrosynthesis

Related Author

WANG Qiqi

LIU Xuesong

ZHANG Yanfei

DU Li

LAN Jinggang

FU Xiongfei

WANG Xiaowo

ZHANG Xian-En

Related Institution

TIB-UM Joint Laboratory of Synthetic Biology for Traditional Chinese Medicine， Tianjin Institute of Industrial Biotechnology， Chinese Academy of Sciences

Faculty of Law， University of Macau， E32， Avenida da Universidade， Taipa， Macau

Faculty of Synthetic Biology， Shenzhen University of Advanced Technology

State Key Laboratory for Quantitative Synthetic Biology， Shenzhen Institute of Synthetic Biology， Shenzhen Institutes of Advanced Technology， Chinese Academy of Sciences

Department of Automation， Tsinghua University， Center for Synthetic and Systems Biology， Ministry of Education Key Laboratory of Bioinformatics， Beijing National Research Center for Information Science and Technology

⁰