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 such as synthetic biology, fermentation engineering, and genetic modification to produce substances including 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 traditional 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 contribute 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.

Key words: bio-manufactured, feed protein, feed raw materials or additives, market access, regulatory framework

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。

关键词: 生物制造, 饲料蛋白, 原料或者添加剂, 准入, 监管