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

doi:10.12211/2096-8280.2025-060

合成生物学

• •

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

陈吴西¹^,², 马龙雪¹^,², 杨洋¹^,², 朱振¹^,², 翟艺达¹, 段玉¹, 陈利梅¹^,², 李德茂¹^,²

^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

收稿日期:2025-06-13 修回日期:2025-08-21 出版日期:2025-08-22
通讯作者: 李德茂
作者简介:陈吴西（1984—），女，助理研究员，研究方向为微生物蛋白的生物制造。E-mail：chen_wx@tib.cas.cn
李德茂（1978—），男，研究员，博士生导师，研究领域：以发酵工程、化工过程控制与模拟、代谢工程等为技术手段，重点解决生物制造系统中的高效底物（农林废弃物、城市有机废弃物和C1气体等）利用、代谢途径的重塑与优化、过程模拟与放大等关键问题，实现替代蛋白/油脂的低碳生物制造。 E-mail：li_dm@tib.cas.cn
基金资助:
中国科学院关键核心技术攻坚先导专项（C类先导专项） “蛋白合成的生产菌种创制”(XDC0110300)

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

CHEN Wuxi¹^,², MA Longxue¹^,², YANG Yang¹^,², ZHU Zhen¹^,², ZHAI Yida¹, DUAN Yu¹, CHEN Limei¹^,², LI Demao¹^,²

^1.Tianjin Key Laboratory for Industrial Biological Systems and Bioprocessing Engineering，Tianjin Institute of Industrial Biotechnology，Chinese Academy of Sciences，Tianjin 300308，China
^2.National Center of Technology Innovation for Synthetic Biology，Tianjin 300308，China

Received:2025-06-13 Revised:2025-08-21 Online:2025-08-22
Contact: LI Demao

摘要/Abstract

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

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

中图分类号:

Q819

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, 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, DOI: 10.12211/2096-8280.2025-060.

图/表 12

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	Ministry of Agriculture and Rural Affairs of the People's Republic of China. Announcement No. 744 of the ministry of agriculture and rural affairs of the People's Republic of China [S]. Bulletin of the Ministry of Agriculture and Rural Affairs, 2024(2): 88-89.
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[100]	侯安会, 吴立新, 薛敏, 等. 乙醇梭菌蛋白的创制过程及在饲料中的应用进展 [J]. 大连海洋大学专栏, 2024(4): 105-107.
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原料	菌种	企业	国家	用途	工业化生产时间
CO₂	小球藻	台湾绿藻制造股份有限公司 Taiwan Chiorella Manufacturer Co., Ltd.	中国台湾	食用	1964^[22]
CO₂	螺旋藻	索萨・特斯科科股份有限公司 Sosa Texcoco, S.A.	西班牙	食用	1972^[23]
甲醇	甲基营养嗜甲基菌	英国帝国化学工业公司 Imperial Chemical Industries (ICI)	英国	饲料	1979^[24]
甲醇	甲基单胞菌	挪威水电公司与马拉博公司 Norsk Hydro and AB Marabou "Norprotein"	瑞典	食用和饲料	1974年开发工艺，工业化时间未知^{[25, 26]}
乙醇	产朊假丝酵母	哈金森公司 Pure Culture Products, Hutchinson	美国	食用	20世纪六七十年代^[27]
乙醇	假丝酵母	三菱石化公司 Mitsubishi Petro-chemical Co.	日本	食用和饲料	1979^[28]

原料	菌种	企业	国家	用途	工业化生产时间
CO₂	小球藻	台湾绿藻制造股份有限公司 Taiwan Chiorella Manufacturer Co., Ltd.	中国台湾	食用	1964^[22]
CO₂	螺旋藻	索萨・特斯科科股份有限公司 Sosa Texcoco, S.A.	西班牙	食用	1972^[23]
甲醇	甲基营养嗜甲基菌	英国帝国化学工业公司 Imperial Chemical Industries (ICI)	英国	饲料	1979^[24]
甲醇	甲基单胞菌	挪威水电公司与马拉博公司 Norsk Hydro and AB Marabou "Norprotein"	瑞典	食用和饲料	1974年开发工艺，工业化时间未知^{[25, 26]}
乙醇	产朊假丝酵母	哈金森公司 Pure Culture Products, Hutchinson	美国	食用	20世纪六七十年代^[27]
乙醇	假丝酵母	三菱石化公司 Mitsubishi Petro-chemical Co.	日本	食用和饲料	1979^[28]

类别	定义	典型案例	准入时间
I类	化学成分明确的纯化化合物及其混合物，GMMs和新引入的基因均已去除（例如氨基酸、维生素）	大肠杆菌NITEBP-02917生产的浓缩液态L-赖氨酸^[43]	2022年
II类	不含有GMMs和新引入基因的复杂产品（例如细胞提取物、大多数酶制剂）	Paenibacillus lentus DSM 33618 生产的 endo-1,4-β-甘露聚糖酶^[45]	2023年
III类	源自遗传改造物质的产品，其中不存在能够增殖或转移基因的遗传改造物质，但仍存在新引入的基因（例如热失活的发酵剂培养物）	基因改造后的PT73（TM）经过干燥热灭活细菌生物质^[46]	2017年
IV类	含有或含有能够繁殖或转移基因的遗传改造物质的产品（例如发酵食品和饲料的活发酵剂培养物）	—	—

类别	定义	典型案例	准入时间
I类	化学成分明确的纯化化合物及其混合物，GMMs和新引入的基因均已去除（例如氨基酸、维生素）	大肠杆菌NITEBP-02917生产的浓缩液态L-赖氨酸^[43]	2022年
II类	不含有GMMs和新引入基因的复杂产品（例如细胞提取物、大多数酶制剂）	Paenibacillus lentus DSM 33618 生产的 endo-1,4-β-甘露聚糖酶^[45]	2023年
III类	源自遗传改造物质的产品，其中不存在能够增殖或转移基因的遗传改造物质，但仍存在新引入的基因（例如热失活的发酵剂培养物）	基因改造后的PT73（TM）经过干燥热灭活细菌生物质^[46]	2017年
IV类	含有或含有能够繁殖或转移基因的遗传改造物质的产品（例如发酵食品和饲料的活发酵剂培养物）	—	—

年份	文件名称	主要内容
2003	(EC) No 1829/2003	这是欧盟关于转基因生物授权和监管的重要法规，规定了转基因生物包括转基因微生物的授权程序、风险评估要求以及转基因食品和饲料的标签等内容，旨在确保转基因产品在欧盟市场的安全使用和消费者的知情权。
2011	《转基因微生物及其用于食品和饲料产品的风险评估》	为评估转基因微生物及其产品在食品和饲料中的安全性提供了指导，包括对转基因微生物的特性、潜在风险以及风险评估方法等方面的阐述，确保转基因微生物在食品和饲料领域的安全应用^[47]。
2012	《转基因动物食品和饲料以及动物健康和福利方面的风险评估》	对转基因动物制成的食品和饲料的安全性以及对动物健康和福利的影响进行了评估指导，包括对转基因动物的遗传修饰、生理特性、食用安全性等方面的考虑，保障转基因动物产品的安全和可持续发展^[48]。
2014	《关于 EFSA 科学委员会在啮齿动物中进行全食物 / 饲料重复剂量 90 天经口毒性研究指南对 GMO 风险评估适用性的解释说明》	阐述了 90 天喂养研究在转基因食品风险评估中的应用，包括研究设计、实施和结果解读等方面的指导，帮助评估转基因食品对动物健康的长期影响^[49]。
2015	《根据 EC 1829/2003 法规授权的转基因食品和饲料续期申请指南》	明确了转基因食品和饲料在续期申请时需要提供的信息和数据要求，指导企业和申请人准备续期申请材料，确保转基因食品和饲料在市场上的持续安全供应^[50]。
2018	《用作饲料添加剂或生产生物的微生物特征描述指南》	规范了用作饲料添加剂或生产生物的转基因微生物的特征描述要求，有助于准确评估其安全性和有效性^[43]。
2022	《转基因植物来源饲料风险评估中的动物膳食暴露》	关注转基因植物来源饲料在动物饲养中的安全性，指导评估动物在食用转基因饲料时的膳食暴露情况，以及对动物健康和生产性能的影响^[51]。

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

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

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批准时间	名称	用途
长期使用的传统蛋白	豆粕、菜籽粕、马铃薯蛋白、鱼粉等	用于饲料蛋白原料
1970年代至1980年代初	利用甲基营养型细菌（Methylophilus methylotrophus）以甲醇为碳源生产高蛋白饲料Pruteen	用于家禽和猪饲料^[58]
2016年	Methylococcus capsulatus以甲烷为碳源生产蛋白饲料	用于水产饲料^[59]
2017年	黑水虻蛋白	用于禽类和水产养殖^[60]
2021年	家蝇幼虫蛋白	用于家禽和猪的饲料^[61]
2014年	酿酒酵母 NCYCR404	用于奶牛饲料添加剂^[62]
2019年	解脂耶氏酵母生物质	用于饲料蛋白来源
2021年	地衣芽孢杆菌DSM 19670生产的丝氨酸蛋白酶	育肥鸡饲料添加剂^[63]
2024年	地衣芽孢杆菌DSM 33099蛋白酶	育肥家禽和饲养用于产蛋/繁殖家禽的饲料添加剂^[64]
2024年	缬氨酸（谷氨酸棒状菌CGMCC 18932）	所有动物氨基酸类营养添加剂
2024年	大肠杆菌NITEBP-02917生产的浓缩液态L-赖氨酸	营养添加剂^[44]

序号	制品名称	生产手段或特性	用途
01	浓缩、提取的谷氨酸发酵产物	将提取谷氨酸后剩余的液体，与用于生产谷氨酸的谷氨酸棒状杆菌（Corynebacterium glutamicum）混合而成	用作牛和家禽饲料的蛋白质来源
02	浓缩的氨化发酵乳清	乳清经德式乳杆菌（Lactobacillus delbrueckii）在加氨情况下发酵而成	用作牛饲料的蛋白质和非蛋白质氮的来源
03	γ-亚麻酸红花粉	异源表达异丝水霉（Saprolegnia diclina）delta-6-去饱和酶基因的红花（Carthamus tinctorius）种子，经去油后的粉状物	用作牛和家禽饲料的蛋白质来源
04	干燥的毕赤酵母	不具有活性的干燥后酵母（Komagataella pastoris）	用作鸡饲料的蛋白质来源
05	干燥的产朊假丝酵母	产朊假丝酵母（Candida utilis）经培养基分离后的干燥菌体，蛋白质含量不少于40%	用作饲料中蛋白质的来源
06	干燥的甲基杆菌	甲基杆菌（Methylobacterium extorquens）经发酵、离心、干燥得到的菌体蛋白	用作甲壳类、有鳍鱼类饲料的蛋白质来源
07	干燥的荚膜甲基球菌	在12周的连续发酵过程中每天收集荚膜甲基球菌（Methylococcus capsulatus）发酵液，经热处理及干燥等步骤所得菌体蛋白	用作鲑鱼饲料的蛋白质来源
08	干燥的黑曲霉	黑曲霉（Aspergillus niger）经发酵、干燥得到的菌体蛋白	用作饲料中蛋白质的来源
09	干燥的米曲霉	米曲霉（Aspergillus oryzae）经发酵、干燥得到的菌体蛋白	用作饲料中蛋白质的来源

分类	名称
植物性蛋白饲料	大豆粉、豌豆蛋白、马铃薯蛋白等
动物性蛋白饲料	虾粉、鱼粉、肉骨粉、酶处理鱼蛋白、浓缩乳清蛋白等
微生物蛋白饲料	谷氨酸发酵副产物、小球藻、饲料酵母（Torula yeast）等
饲料添加剂（16种）	甘氨酸、DL-丙氨酸、L-精氨酸、L-赖氨酸盐酸盐、L-谷氨酸钠、牛磺酸、2-脱氨基-2-羟基-甲硫氨酸、DL-色氨酸、L-色氨酸、L-苏氨酸、L-缬氨酸、DL-蛋氨酸、L-赖氨酸硫酸盐

时间	名称	过程特征	申报类别
2025年公告921号	解脂耶氏酵母蛋白	以煤化工或天然气化工产生的CO₂和H₂为主要原料，通过热醋穆尔氏菌(Moorella thermoacetica, CGMCC 28818)发酵得到含乙酸的发酵液，解脂耶氏酵母(Yarrowia lipolytica, CGMCC 25047)利用乙酸进行发酵，收集解脂耶氏酵母菌体细胞，经分离、灭活、干燥等工艺制得	饲料原料^[84]
2024年公告862号	红色无定形态单质硒	以枯草芽孢杆菌(Bacillus sabtilis, CGMCCNo.11741）为菌种，经液体发酵，对培养基中的亚硒酸钠进行还原，再经离心分离、添加载体、喷雾干燥和辐照灭菌等工艺制得	饲料添加剂^[85]
2024年公告809号	吡咯并喹啉醌二钠	以脱氮生丝微菌(Hyphomicrobium denitrificans, FJNU-R8)为生产菌种，经液体发酵、分离、纯化制得	饲料添加剂^[86]
2023年公告744号	荚膜甲基球菌蛋白	以英膜甲基球菌(Methylococcus capsulatus, CIcC11106s )为主要生产菌株，以 (Cupriavidus cauae, CICC11107s)、丹麦解硫胺素芽孢杆菌(Aneurinibacillus danicu, CICC11108s )和土壤短芽孢杆菌( Brevibacillus agri, CICC11109s)为辅助菌株，以天然气中的甲烷为主要原料，经液体连续发酵、固液分离和干燥等工艺制得。终产品不含生产菌株活细胞	饲料原料^[87]
2023年公告692号	马克斯克鲁维酵母	以马克斯克鲁维酵母(Kluyveromyces marxianus,CGMCC 10621)为生产菌种，经液体发酵、过滤浓缩、制粒、干燥等工艺制得	饲料添加剂^[88]
2022年公告614号	枯草三十七肽	以枯草芽孢杆菌(Bacillus Subtilis, CGMCC15404)为生产菌种，经液体发酵、膜分离、浓缩、干燥等工艺制得	饲料添加剂^[89]
2022年公告614号	腺苷七肽	以约氏乳杆菌(Lactobacillus johnsoni, CGMCC19858)为菌种，经液体发酵、提取、添加载体进行喷雾干燥，再添加稀释剂制得	饲料添加剂^[89]
2021年公告465号	乙醇梭菌蛋白	以乙醇梭菌(Clostridium autoethanogenum, CICC11088s)为发酵菌种，以钢铁工业转炉气中的 CO 为主要原料，采用液体发酵，生产乙醇后的剩余物，经分离、喷雾干燥等工艺制得。终产品不含生产菌株活细胞	饲料原料^[90]

评价内容	直接饲喂微生物		发酵制品生产菌株
评价内容	细菌	酵母和丝状真菌	细菌	酵母和丝状真菌
微生物鉴定	√	√	√	√
产毒能力和致病性	√	√	√	√
抗菌药物敏感性	√		√
抗菌药物产生	√	√	√	√
生产菌株的遗传修饰	仅适用于转基因微生物	仅适用于转基因微生物	仅适用于转基因微生物	仅适用于转基因微生物
发酵制品中无生产菌株活细胞评价			√	√
发酵制品中生产菌株DNA 检测			必要时	必要时

年份	项目内容	应用类型
2024	重组地衣芽孢杆菌 S10-34zEK4表达的角蛋白酶生产应用	饲料添加剂
	重组地衣芽孢杆菌 SJ10402表达的 α-淀粉酶生产应用	饲料添加剂
	重组米曲霉 JaL339表达的木聚糖酶生产应用	饲料添加剂
	重组李氏木霉 Morph-Y5#2表达的木聚糖酶生产应用	饲料添加剂
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	重组毕赤酵母GS115（pPIC9-XynNA）表达的木聚糖酶生产应用	饲料添加剂
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2023	重组毕赤酵母 GS115（pPIC9-agaF75）表达的α-半乳糖苷酶生产应用	饲料添加剂
	重组毕赤酵母 GS115（pPIC9-MAN1）表达的β-甘露聚糖酶生产应用	饲料添加剂
	重组米曲霉COls741表达的植酸酶生产应用	饲料添加剂
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	重组毕赤酵母GS115（pPIC9-Chi92）表达的几丁质酶 Chi92 生产应用	饲料添加剂

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