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

汪琪琦; 刘雪松; 张燕飞; 杜立

doi:10.12211/2096-8280.2025-104

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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

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- 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
- Opportunities challenges， and regulatory drivers for the Commercialization of Biomanufactured Noval Food Ingredients： A Case Study of L-Ergothioneine
- 合成生物学 2026年页码：1-17
- 作者机构：
  
  1.中国科学院天津工业技术研究所-澳门大学中医药合成生物学联合实验室，中国科学院天津工业生物技术研究所，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：
  
  汪琪琦（1983—），女，助理研究员。研究方向为科技政策与法规，生物制造产品科普与应用。
  刘雪松（1981—），男，高级工程师。在生物制造、医药、农业等创新领域深耕多年，拥有丰富的生物技术研发及科技成果转移转化经历，创立了国家级孵创平台BIOINN，培育硬科技创新企业数十家，主导成果转化产值数亿元。
  张燕飞（1981—），男，研究员，博士生导师。主要从事合成生物学与生物制造研究，聚焦麦角硫因生物合成技术，构建了甜菜碱驱动与无机硫协同的麦角硫因高效生物合成体系。近年来在Nature，Nature Communications，Nucleic Acids Research等国内外期刊发表论文40余篇，申请专利32项。
  杜立（1982—），男，副教授，博士生导师。长期专注于生物科技领域的法律与政策研究，主要研究方向包括：细胞培育肉与替代蛋白饲料的法律规制、人工智能赋能的辅助生殖技术伦理与法律问题、以及合成生物科技商业化进程中的合规挑战等，其研究成果屡见于国际顶尖的科学及法学权威期刊。
- 基金信息：
  
  天津市合成生物技术创新能力提升行动项目(TSBICIP-IJCP-004);合成生物学海河实验室自主立项项目(25HHSWSS00001);天津市2025未来产业科技重大专项项目(25ZXWCSY00240)
- DOI：10.12211/2096-8280.2025-104
  中图分类号： Q816
- 收稿：2025-12-23，
  
  修回：2026-03-05，
  
  网络首发：2026-04-07，
- 稿件说明：
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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. DOI： 10.12211/2096-8280.2025-104

WANG Qiqi， LIU Xuesong， ZHANG Yanfei， DU Li. Opportunities challenges， and regulatory drivers for the Commercialization of Biomanufactured Noval Food Ingredients： A Case Study of L-Ergothioneine［J］. Synthetic Biology Journal， 2026， 7. DOI： 10.12211/2096-8280.2025-104
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. DOI： 10.12211/2096-8280.2025-104 DOI：

WANG Qiqi， LIU Xuesong， ZHANG Yanfei， DU Li. Opportunities challenges， and regulatory drivers for the Commercialization of Biomanufactured Noval Food Ingredients： A Case Study of L-Ergothioneine［J］. Synthetic Biology Journal， 2026， 7. DOI： 10.12211/2096-8280.2025-104 DOI：

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、纯度稳定和规模化可持续生产等优势，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，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。本研究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 natural extraction

biomanufacturing offers a more sustainable

controllable

and scalable supply model that reduces dependence on seasonal variability

land resources

and environmentally 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 transition from laboratory research to industrial application. However

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

it is increasingly constrained by regulatory adaptability

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 and a representative product of synthetic biomanufacturing

as a case 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 pathways

including the U.S. GRAS system and the EU Novel Food framework

alongside China's pre-market authorization regime

this study identifies key structural barriers affecting domestic commercialization. These include ambiguous technical requirements

limited risk-tiered evaluation mechanisms

lengthy review timelines

and gaps between scientific evidence and consumer perception. Building on these findings

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

risk-proportionate assessment

optimization of substantial equivalence 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 authorization pathway

regulators can better balance innovation promotion with precautionary governance. This research 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. The findings offer policy insights for accelerating the compliant market entry of domestically developed bio-manufactured novel food ingredients and for fostering 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/OL ] . Systems Microbiology and Biomanufacturing , 2023 , 3 ( 1 ): 137 - 149 .

中国政府网 . 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. Chinese Government Website. Recommendations of the Central Committee of the Communist Party of China on Formulating the 15th Five-Year Plan for National Economic and Social Development https://www.gov.cn/zhengce/202510/content_7046050.htm.ChineseGovernmentWebsite.RecommendationsoftheCentralCommitteeoftheCommunistPartyofChinaonFormulatingthe15thFive-YearPlanforNationalEconomicandSocialDevelopment [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/OL ] . Food Science and Human Wellness , 2024 , 13 ( 5 ): 2519 - 2542 . DOI: 10.26599/FSHW.2022.9250253 http://dx.doi.org/10.26599/FSHW.2022.9250253 .

AMES B N . Prolonging healthy aging: Longevity vitamins and proteins [J/OL ] . Proceedings of the National Academy of Sciences of the United States of America , 2018 , 115 ( 43 ): 10836 - 10844 . DOI: 10.1073/pnas.1809045115 http://dx.doi.org/10.1073/pnas.1809045115 .

HALLIWELL B , CHEAH I K , TANG R M Y . Ergothioneine-a diet-derived antioxidant with therapeutic potential [J/OL ] . FEBS Letters , 2018 , 592 ( 20 ): 3357 - 3366 . DOI: 10.1002/1873-3468.13123 http://dx.doi.org/10.1002/1873-3468.13123 .

TURCK D , BRESSON J L , BURLINGAME B , et al . Safety of synthetic l-ergothioneine (Ergoneine®) as a novel food pursuant to Regulation (EC) No 258 / 97 [J/OL ] . EFSA Journal , 2016 , 14 ( 11 ): e04629 . DOI: 10.2903/j.efsa.2016.4629 http://dx.doi.org/10.2903/j.efsa.2016.4629 .

GRAS Notices [EB/OL ] . [ 2025-09-29 ] . https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=734&sort=GRN_No&order=DESC&startrow=1&type=basic&search=734 https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=734&sort=GRN_No&order=DESC&startrow=1&type=basic&search=734 .

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 ] //OJ L: Vol. 184. (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 .

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 ] //OJ L: Vol. 327. (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 null , NDA A , 等 . 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 ) 2 [J/OL ] . EFSA journal . European Food Safety Authority, 2021 , 19 ( 3 ): e06555 . DOI: 10.2903/j.efsa.2021.6555 http://dx.doi.org/10.2903/j.efsa.2021.6555 .

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.National Health Commission of the People https://www.gov.cn/zhengce/2013-05/31/content_5713799.htm.NationalHealthCommissionofthePeople

's Republic of China . Measures for the Safety Review and Administration of New Food Raw MaterialsEB/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 .

ZHANG H , LIU Z , WANG Z , et al . A Review of Novel Antioxidant Ergothioneine: Biosynthesis Pathways, Production, Function and Food Applications [J/OL ] . Foods , 2025 , 14 ( 9 ): 1588 . DOI: 10.3390/foods14091588 http://dx.doi.org/10.3390/foods14091588 .

HARTMAN P E . [32] Ergothioneine as antioxidant [M/OL ] //Methods in Enzymology: Vol. 186 . Elsevier , 1990 : 310 - 318 [2025-08-07] . https://linkinghub.elsevier.com/retrieve/pii/007668799086124E. DOI:10.1016/0076-6879(90)86124-E https://linkinghub.elsevier.com/retrieve/pii/007668799086124E.DOI:10.1016/0076-6879(90)86124-E .

PAUL B D . Ergothioneine: A Stress Vitamin with Antiaging, Vascular, and Neuroprotective Roles? [J/OL ] . Antioxidants & Redox Signaling , 2022 , 36 ( 16-18 ): 1306 - 1317 . DOI: 10.1089/ars.2021.0043 http://dx.doi.org/10.1089/ars.2021.0043 .

CHEAH I K , TANG R M Y , YEW T S Z , 等 . Administration of Pure Ergothioneine to Healthy Human Subjects: Uptake, Metabolism, and Effects on Biomarkers of Oxidative Damage and Inflammation [J/OL ] . Antioxidants & redox signaling , 2017 , 26 ( 5 ): 193 - 206 . DOI: 10.1089/ars.2016.6778 http://dx.doi.org/10.1089/ars.2016.6778 .

LI A , LIU Y , YU P , 等 . Ergothioneine attenuates psoriasis symptoms through modulation of M1/M2 macrophage polarisation via the NF-κB/JAK-STAT3 pathway [J/OL ] . Frontiers in Pharmacology , 2025 , 16 [ 2026-01-16 ] . https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1521743/full https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1521743/full . DOI: 10.3389/fphar.2025.1521743 http://dx.doi.org/10.3389/fphar.2025.1521743 .

WANG Z , MA J , MIAO Z , 等 . Ergothioneine inhibits the progression of osteoarthritis via the Sirt6/NF-κB axis both in vitro and in vivo [J/OL ] . International Immunopharmacology , 2023 , 119 : 110211 . DOI: 10.1016/j.intimp.2023.110211 http://dx.doi.org/10.1016/j.intimp.2023.110211 .

TERUYA T , CHEN Y J , FUKUJI Y , 等 . Whole-blood metabolomics of dementia patients reveal classes of disease-linked metabolites [J/OL ] . Proceedings of the National Academy of Sciences , 2021 , 118 ( 37 ): e2022857118 . DOI: 10.1073/pnas.2022857118 http://dx.doi.org/10.1073/pnas.2022857118 .

Low plasma ergothioneine levels are associated. ..  : Free Radical Biology and Medicine [EB/OL ] // Ovid . [ 2026-01-16 ] . https://www.ovid.com/journals/frbm/fulltext/10.1016/j.freeradbiomed.2021.10.019~low-plasma-ergothioneine-levels-are-associated-with https://www.ovid.com/journals/frbm/fulltext/10.1016/j.freeradbiomed.2021.10.019~low-plasma-ergothioneine-levels-are-associated-with . DOI: 10.1016/j.freeradbiomed.2021.10.019 http://dx.doi.org/10.1016/j.freeradbiomed.2021.10.019 .

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/OL ] . Nutraceuticals , 2025 , 5 ( 3 ): 15 . DOI: 10.3390/nutraceuticals5030015 http://dx.doi.org/10.3390/nutraceuticals5030015 .

ISHIMOTO T , YAMASHITA R , MATSUMOTO R , et al . TrkB phosphorylation in serum extracellular vesicles correlates with cognitive function enhanced by ergothioneine in humans [J/OL ] . npj Science of Food , 2024 , 8 ( 1 ): 11 . DOI: 10.1038/s41538-024-00250-5 http://dx.doi.org/10.1038/s41538-024-00250-5 .

SMITH E , OTTOSSON F , HELLSTRAND S , et al . Ergothioneine is associated with reduced mortality and decreased risk of cardiovascular disease [J/OL ] . Heart , 2020 , 106 ( 9 ): 691 - 697 . DOI: 10.1136/heartjnl-2019-315485 http://dx.doi.org/10.1136/heartjnl-2019-315485 .

SERVILLO L , D'ONOFRIO N , BALESTRIERI M L . Ergothioneine Antioxidant Function: From Chemistry to Cardiovascular Therapeutic Potential [J/OL ] . Journal of Cardiovascular Pharmacology , 2017 , 69 ( 4 ): 183 . DOI: 10.1097/FJC.0000000000000464 http://dx.doi.org/10.1097/FJC.0000000000000464 .

FU T T , SHEN L . Ergothioneine as a Natural Antioxidant Against Oxidative Stress-Related Diseases [J/OL ] . Frontiers in Pharmacology , 2022 , 13 [ 2026-01-09 ] . https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.850813/full https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.850813/full . DOI: 10.3389/fphar.2022.850813 http://dx.doi.org/10.3389/fphar.2022.850813 .

KATSUBE M , ISHIMOTO T , FUKUSHIMA Y , et al . Ergothioneine promotes longevity and healthy aging in male mice [J/OL ] . GeroScience , 2024 , 46 ( 4 ): 3889 - 3909 . DOI: 10.1007/s11357-024-01111-5 http://dx.doi.org/10.1007/s11357-024-01111-5 .

PETROVIC D , SLADE L , PAIKOPOULOS Y , 等 . Ergothioneine improves healthspan of aged animals by enhancing cGPDH activity through CSE-dependent persulfidation [J/OL ] . Cell Metabolism , 2025 , 37 ( 2 ): 542 - 556.e14 . DOI: 10.1016/j.cmet.2024.12.008 http://dx.doi.org/10.1016/j.cmet.2024.12.008 .

APPAROO Y , WEI PHAN C , RANI KUPPUSAMY U , 等 . Potential role of ergothioneine rich mushroom as anti-aging candidate through elimination of neuronal senescent cells [J/OL ] . Brain Research , 2024 , 1824 : 148693 . DOI: 10.1016/j.brainres.2023.148693 http://dx.doi.org/10.1016/j.brainres.2023.148693 .

TIAN X , THORNE J L , MOORE J B . Ergothioneine: an underrecognised dietary micronutrient required for healthy ageing? [J/OL ] . The British Journal of Nutrition , 129 ( 1 ): 104 - 114 . DOI: 10.1017/S0007114522003592 http://dx.doi.org/10.1017/S0007114522003592 .

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/OL ] . 食用菌学报 , 2021 , 37 ( 01 ): 115 - 123 . DOI: 10.16488/j.cnki.1005-9873.2021.01.016.FENG L L http://dx.doi.org/10.16488/j.cnki.1005-9873.2021.01.016.FENGLL ,

E H C , ZHANG Y M , et al . Research Progress on Extraction,Separation and Detection of Ergothionine in Edible Fungi [J/OL ] . Acta Edulis Fungi , 2021 , 37 ( 01 ): 115 - 123 . DOI: 10.16488/j.cnki.1005-9873.2021.01.016 http://dx.doi.org/10.16488/j.cnki.1005-9873.2021.01.016 .

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. Hai R J. A pre-Series A synthetic biology company stages a comeback by selling ergothioneine http://eu.36kr.com/zh/p/3301095415880457.HaiRJ.Apre-SeriesAsyntheticbiologycompanystagesacomebackbysellingergothioneine , 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/OL ] . 生物工程学报 , 2022 , 38 ( 2 ). DOI: 10.13345/j.cjb.210166.Wang L http://dx.doi.org/10.13345/j.cjb.210166.WangL ,

Wang Y , Li J H , et al . Construction and optimization of ergothioneine-producing Escherichia coli . 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/OL ] . Gene , 2014 , 549 ( 1 ): 161 - 170 . DOI: https://doi.org/10.1016/j.gene.2014.07.065 https://doi.org/10.1016/j.gene.2014.07.065 .

OSAWA R , KAMIDE T , SATOH Y , et al . Heterologous and High Production of Ergothioneine in Escherichia coli [J/OL ] . Journal of Agricultural and Food Chemistry , 2018 , 66 ( 5 ): 1191 - 1196 . DOI: 10.1021/acs.jafc.7b04924 http://dx.doi.org/10.1021/acs.jafc.7b04924 .

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/OL ] . Microbial Cell Factories , 2020 , 19 ( 1 ): 164 . DOI: 10.1186/s12934-020-01421-1 http://dx.doi.org/10.1186/s12934-020-01421-1 .

XIONG K , GUO H , XUE S , et al . Production optimization of food functional factor ergothioneine in wild-type red yeast Rhodotorula mucilaginosa DL-X01 [J/OL ] . Journal of the Science of Food and Agriculture , 2024 , 104 ( 7 ): 4050 - 4057 . DOI: 10.1002/jsfa.13287 http://dx.doi.org/10.1002/jsfa.13287 .

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/OL ] . ACS Sustainable Chemistry & Engineering , 2024 , 12 ( 43 ): 15901 - 15912 . DOI: 10.1021/acssuschemeng.4c03144 http://dx.doi.org/10.1021/acssuschemeng.4c03144 .

LIU K , XIANG G , LI L , et al . Engineering non-conventional yeast Rhodotorula toruloides for ergothioneine production [J/OL ] . Biotechnology for Biofuels and Bioproducts , 2024 , 17 ( 1 ): 65 . DOI: 10.1186/s13068-024-02516-2 http://dx.doi.org/10.1186/s13068-024-02516-2 .

WANG L , TIAN X , XUE P , et al . Enhanced production of ergothioneine in Aspergillus oryzae [J/OL ] . Applied Microbiology and Biotechnology , 2025 , 109 ( 1 ): 143 . DOI: 10.1007/s00253-025-13505-2 http://dx.doi.org/10.1007/s00253-025-13505-2 .

YAN J , CHEN Y , MA Y , et al . Efficient ergothioneine production through reconstruction of the methyl and sulfur supply systems in Escherichia coli [J/OL ] . Trends in Biotechnology , 2025 [ 2025-11-11 ] . https://www.sciencedirect.com/science/article/pii/S0167779925004020 https://www.sciencedirect.com/science/article/pii/S0167779925004020 . DOI: 10.1016/j.tibtech.2025.09.014 http://dx.doi.org/10.1016/j.tibtech.2025.09.014 .

朱华伟 , HUAWEI Z H U , 李寅 , 等 . 合成生物制造2025 [EB/OL ] . 生物工程学报 , 2025 [ 2026-02-04 ] . https://cjb.ijournals.cn/html/cjbcn/2025/1/02241014.htm https://cjb.ijournals.cn/html/cjbcn/2025/1/02241014.htm . DOI: 10.13345/j.cjb.241014 http://dx.doi.org/10.13345/j.cjb.241014 .

LIU Z , XIAO F , ZHANG Y , et al . Heterologous and High Production of Ergothioneine in Bacillus licheniformis by Using Genes from Anaerobic Bacteria [J/OL ] . Metabolites , 2025 , 15 ( 1 ): 45 . DOI: 10.3390/metabo15010045 http://dx.doi.org/10.3390/metabo15010045 .

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.China News Service https://www.jwview.com/jingwei/html/m/05-16/622589.shtml.ChinaNewsService

's JWealth . 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 .

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/ingredReq?id=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/artg?keywords=ergothioneine .

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 .

PUBLICATIONS OFFICE OF THE EUROPEAN UNION . Commission Implementing Regulation (EU) 2018 / 462 of 20 March 2018 authorising an extension of use of L-ergothioneine as a novel food under Regulation (EU) 2015 / 2283 of the European Parliament and of the Council, and amendi ng Commission Implementing Regulation(EU) 2017 / 2470 (relevanceTextwith EEA.)[EB/OL ] . [ 2025-09-19 ] . https://eur-lex.europa.eu/eli/reg_impl/2018/462/oj/eng https://eur-lex.europa.eu/eli/reg_impl/2018/462/oj/eng .

EFSA PANEL ON ADDITIVES AND PRODUCTS OR SUBSTANCES USED IN ANIMAL FEED FEEDAP) , RYCHEN G , AQUILINA G , 等 . Guidance on the characterisation of microorganisms used as feed additives or as production organisms [J/OL ] . EFSA journal . European Food Safety Authority, 2018 , 16 ( 3 ): e05206 . DOI: 10.2903/j.efsa.2018.5206 http://dx.doi.org/10.2903/j.efsa.2018.5206 .

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 ] // Blue California . [ 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 ] // NutraIngredients-Asia .com. ( 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 J M , et al . Substantial equivalence—an appropriate paradigm for the safety assessment of genetically modified foods? [J/OL ] . Toxicology , 2002 , 181-182 : 427 - 431 . DOI: 10.1016/S0300-483X(02)00488-2 http://dx.doi.org/10.1016/S0300-483X(02)00488-2 .

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 ABN , 2000 , 2 .

The Principle of Substantial Equivalence is Unscientific and Arbitrary « Biosafety Information Centre [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/ .

原创】食品行业的"实质等同", 到底在"等同"什么?_中食安信(北京)信息咨询有限公司 [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 .

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 .

POLARIS MARKET RESEARCH . L-ergothioneine Market Forecast $644.90 Mn by 2032 , 36.4% CAGR[EB/OL ] // Polaris . [ 2025-08-08 ] . https://www.polarismarketresearch.com/press-releases/l-ergothioneine-market https://www.polarismarketresearch.com/press-releases/l-ergothioneine-market .

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/ .

PW Consulting . Synthetic Ergothioneine Market [EB/OL ] // PW Consulting Chemical & Energy Research Center . ( 2024-10-08 )[ 2025-09-11 ] . https://pmarketresearch.com/chemi/synthetic-ergothioneine-market/ https://pmarketresearch.com/chemi/synthetic-ergothioneine-market/ .

中国政府网 . " 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.Chinese Government Website. 14th Five-Year Plan for the Development of Bioeconomy https://www.gov.cn/zhengce/zhengceku/2022-05/10/content_5689556.htm.ChineseGovernmentWebsite.14thFive-YearPlanfortheDevelopmentofBioeconomy [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/OL ] . [ 2025-10-21 ] . https://i.cgeinc.com/no70/24063.html. Artery Bio-Manufacturing. Two National Ministries Issue Notice: Soliciting Applications for Innovative Biomanufacturing Technologies https://i.cgeinc.com/no70/24063.html.ArteryBio-Manufacturing.TwoNationalMinistriesIssueNotice:SolicitingApplicationsforInnovativeBiomanufacturingTechnologies , 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. Ministry of Industry and Information Technology of the People https://www.miit.gov.cn/jgsj/xfpgys/wjfb/art/2025/art_f7fd30f4a2384b1ebb841c94cb410b35.html.MinistryofIndustryandInformationTechnologyofthePeople

'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. Xinhua Net. COFCO https://www.news.cn/20250702/c40fea9ec59c4678b34720aa0a3a0097/c.html.XinhuaNet.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. Securities Times. Fuxiang Pharma https://stcn.com/article/detail/3516504.html.SecuritiesTimes.FuxiangPharma

's Fusarium venenatum Protein 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. Food Research and Development Service Center. Don https://yanfa.foodmate.net/news/show-1819.html.FoodResearchandDevelopmentServiceCenter.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 .

中国镇江金山网 . 2025麦角硫因产业全景报告:合成生物学驱动下的行业新生态 [EB/OL ] . [ 2025-12-05 ] . https://www.jsw.com.cn/2025/0926/1921117.shtml.Zhenjiang Jinshan Network. The2025 Ergothioneine Industry Panoramic Report: A New Industry Ecosystem Drivenby Synthetic Biology https://www.jsw.com.cn/2025/0926/1921117.shtml.ZhenjiangJinshanNetwork.The2025ErgothioneineIndustryPanoramicReport:ANewIndustryEcosystemDrivenbySyntheticBiology [EB/OL ] . [ 2025-12-05 ] . https://www.jsw.com.cn/2025/0926/1921117.shtml https://www.jsw.com.cn/2025/0926/1921117.shtml .

国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. National Health Commission of the People https://zwfw.nhc.gov.cn/kzx/tzgg/sptjjxpzsp_224/202305/t20230515_2518.html.NationalHealthCommissionofthePeople

'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. China National Center for Food Safety Risk Assessment. Notice on Improving the Requirements for Safety Evaluation Documentation of https://www.cfsa.net.cn/zxdt/tzgg/2024/14077.shtml.ChinaNationalCenterforFoodSafetyRiskAssessment.NoticeonImprovingtheRequirementsforSafetyEvaluationDocumentationof "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 .

戴为卿 , WEIQING D a . I . 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 .

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 .

[CJ-15-3 ] 中国消费者对转基因食品的认知和接受程度_中文文章_北京大学中国农业政策研究中心 [EB/OL ] . [ 2026-02-05 ] . http://www.ccap.pku.edu.cn/yjcg/zwwz/22zgnyzcyjzx244463.htm http://www.ccap.pku.edu.cn/yjcg/zwwz/22zgnyzcyjzx244463.htm .

CUI K , SHOEMAKER S P . Public perception of genetically-modified (GM) food: A Nationwide Chinese Consumer Study [J/OL ] . npj Science of Food , 2018 , 2 ( 1 ): 10 . DOI: 10.1038/s41538-018-0018-4 http://dx.doi.org/10.1038/s41538-018-0018-4 .

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. Securities Times. Rao Yi: The 75-Year-Old Chairman http://stcn.com/article/detail/1862445.html.SecuritiesTimes.RaoYi:The75-Year-OldChairman '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 .

DATAINTELO . Ergothioneine (EGT) Market Report | Global Forecast From 2025 To 2033 [EB/OL ] . [ 2025-09-30 ] . https://dataintelo.com/report/global-ergothioneine-egt-market https://dataintelo.com/report/global-ergothioneine-egt-market .

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.Li J Y. Is Ergothioneine https://www.21jingji.com/article/20250606/herald/ee46031a7e4b0eaea2e36675e32e0ba6.html.LiJY.IsErgothioneine ,

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. Qilu Evening News. Ergothioneine Mired in Controversy: Anti-Aging https://www.xinhuanet.com/finance/20250617/9862989e1dbf4c7abdcb331e98e4730c/c.html.QiluEveningNews.ErgothioneineMiredinControversy: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/ .

Novel food | EFSA [EB/OL ] . ( 2025-12-17 )[ 2026-02-07 ] . https://www.efsa.europa.eu/en/topics/topic/novel-food https://www.efsa.europa.eu/en/topics/topic/novel-food .

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