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

特约评述 | 更新时间：2026-05-22

- 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 commercial biomanufacturing of novel food ingredients： a case study of L-ergothioneine
- 合成生物学 2026年7卷第2期页码：408-423
- 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：
  
  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。 E-mail：wangqq@tib.cas.cn
  刘雪松（1981—），男，高级工程师。研究方向：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。 E-mail：liuxs@tib.cas.cn
  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。 E-mail：zhangyf@tib.cas.cn
  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、合成生物科技商业化进程中的合规挑战等。 E-mail：stephendu@um.edu.mo
- 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(25ZXWCSY00240)
- DOI：10.12211/2096-8280.2025-104
  中图分类号： Q816
- 收稿：2025-12-23，
  
  修回：2026-03-05，
  
  纸质出版：2026-04-30
- 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

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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 https://yanfa.foodmate.net/news/show-1819.html .

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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 .

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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 .

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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 .

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