Opportunities challenges， and regulatory drivers for the Commercialization of Biomanufactured Noval Food Ingredients： A Case Study of L-Ergothioneine

WANG Qiqi; LIU Xuesong; ZHANG Yanfei; DU Li

doi:10.12211/2096-8280.2025-104

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Opportunities challenges， and regulatory drivers for the Commercialization of Biomanufactured Noval Food Ingredients： A Case Study of L-Ergothioneine

更新时间：2026-04-07

- Opportunities challenges， and regulatory drivers for the Commercialization of Biomanufactured Noval Food Ingredients： A Case Study of L-Ergothioneine
- Synthetic Biology Journal Pages: 1-17(2026)
- 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：
- 基金信息：
- DOI：10.12211/2096-8280.2025-104
  CLC： Q816
- Received：23 December 2025，
  
  Revised：2026-03-05，
  
  Online First：07 April 2026，
- 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

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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 .

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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

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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 .

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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 .

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