Research on market access and regulation of global bio-manufactured feed protein materials and additives

CHEN Wuxi; MA Longxue; YANG Yang; ZHU Zhen; ZHAI Yida; DUAN Yu; CHEN Limei; LI Demao

doi:10.12211/2096-8280.2025-060

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Research on market access and regulation of global bio-manufactured feed protein materials and additives

Invited Review | 更新时间：2025-11-12

- Research on market access and regulation of global bio-manufactured feed protein materials and additives
- Synthetic Biology Journal Vol. 6, Issue 5, Pages: 1255-1273(2025)
- 作者机构：
  
  1.中国科学院天津工业生物技术研究所，天津市工业生物系统与过程工程重点实验室，天津 300308
  2.国家合成生物技术创新中心，天津 300308
- 作者简介：
- 基金信息：
- DOI：10.12211/2096-8280.2025-060
  CLC： Q819
- Received：13 June 2025，
  
  Revised：2025-08-21，
  
  Published：31 October 2025
- 稿件说明：
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陈吴西，马龙雪，杨洋，朱振，翟艺达，段玉，陈利梅，李德茂. 全球生物制造饲料蛋白原料及添加剂市场准入与监管研究［J］. 合成生物学， 2025， 6（5）： 1255-1273

CHEN Wuxi， MA Longxue， YANG Yang， ZHU Zhen， ZHAI Yida， DUAN Yu， CHEN Limei， LI Demao. Research on market access and regulation of global bio-manufactured feed protein materials and additives［J］. Synthetic Biology Journal， 2025， 6（5）： 1255-1273
陈吴西，马龙雪，杨洋，朱振，翟艺达，段玉，陈利梅，李德茂. 全球生物制造饲料蛋白原料及添加剂市场准入与监管研究［J］. 合成生物学， 2025， 6（5）： 1255-1273 DOI： 10.12211/2096-8280.2025-060.

CHEN Wuxi， MA Longxue， YANG Yang， ZHU Zhen， ZHAI Yida， DUAN Yu， CHEN Limei， LI Demao. Research on market access and regulation of global bio-manufactured feed protein materials and additives［J］. Synthetic Biology Journal， 2025， 6（5）： 1255-1273 DOI： 10.12211/2096-8280.2025-060.

摘要

随着生物技术的快速发展，越来越多的生物制造饲料原料及添加剂研发成功。这些产品不仅能提高饲料的营养价值，还可以降低生产成本、提高养殖效益。然而，生物制造饲料原料及添加剂在生产工艺和质量标准方面与传统产品存在较大差异，造成市场准入障碍，制约了饲料及畜牧业的高效发展。本文系统梳理了欧盟、美国、日本和中国的生物制造饲料蛋白原料和添加剂的市场准入与监管机制，包括相关法规政策依据、审批流程及标准要求。欧盟的审批流程相对严谨，对产品的安全性评估更为全面，但审批时间较长；美国的准入制度较为灵活，三种多元化的准入途径，但对于“一般公认安全”（Generally Recognized as Safe， GRAS）物质的认定存在一定的主观性；日本的法规较为完善，兼顾社会伦理与市场实际，形成了一套严谨且灵活的体系。近年来，中国在生物制造饲料原料或者添加剂市场准入与监管方面，规范了审批流程和标准，缩短了审批周期，但在产品评价方法、评价程序等方面仍存在一些问题。本文针对性地提出了优化建议，旨在助力生物制造在饲料养殖行业的高质量发展。

Abstract

With the rapid development of biotechnology

an increasing number of bio-manufactured feed materials and additives have been successfully developed. These innovative products leverage cutting-edge biotechnologies including synthetic biology

fermentation engineering

and genetic modification to produce substances such as single-cell proteins

bioactive peptides

and probiotics. For instance

single-cell proteins derived from yeast or algae are rich in essential amino acids

vitamins

and minerals

significantly enhancing the nutritional value of feed. Moreover

bio-manufacturing often utilizes renewable resources and operates under milder conditions

reducing production costs compared to conventional chemical synthesis methods. In addition

by precisely controlling the production process

bio-manufactured additives can improve animal digestion and absorption

thereby boosting breeding efficiency and promoting sustainable livestock production. However

significant differences in production processes and quality standards between bio-manufactured and traditional feed ingredients and additives have resulted in multiple market-access challenges

hindering the rapid development of the bioeconomy. This paper systematically reviews the market access mechanisms for bio-manufactured protein feed materials and additives in the European Union

the United States

Japan

and China

including relevant regulatory frameworks

approval procedures

and standard requirements. In China

despite progress in developing of bio-manufactured feed materials and additives

there are still several issues with market access and regulation. For example

the safety evaluation system for microorganisms used in bio-manufacturing lacks specific and detailed guidelines. There have been cases where innovative bio-manufactured feed additives experienced long-term delays in the approval process due to unclear evaluation criteria. The product evaluation procedures are complex and time-consuming

involving multiple departments and repetitive reviews

which increase the cost and time for enterprises to enter the market. Additionally

the research and development of synthetic biotechnology in the feed industry lags behind that of developed countries

and the approval process for new bio-manufactured products is relatively conservative

slowing down product listing and marketing. This study proposes optimization strategies

including strengthening safety evaluation requirements for microorganisms and their products for feeding

simplifying the product evaluation procedures

and accelerating the research and development of synthetic biotechnology as well as the approval of the listing and marketing of products. The ultimate objective of this study is to provide insights that will facilitate the smoother integration and high-quality development of bio-manufacturing applications within the feed and livestock industries

supporting their sustainable evolution.

关键词

Keywords

references

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