CIRS Helps Fushine Biotech Successfully Obtain Approval for China’s First Mycoprotein from Fusarium Venenatum

On November 27, 2025, the National Health Commission issued Announcement No.7 of 2025, in which Mycoprotein from Fusarium venenatum is officially approved as a new food ingredient.

The recent approval of the Mycoprotein from Fusarium venenatum marks a significant milestone for Fushine Biotech. As the technical supporter, CIRS Group assisted the company throughout the entire application process. Previously, CIRS had already supported Fushine in securing U.S. market access for the same ingredient through the GRAS Notice. These approvals – both in China and the United States – not only reflect Fushine Biotech’s strong R&D capacity and high product quality, but also underscores CIRS Group’s professional expertise in global food regulatory compliance.

Compliance History

The compliance process for Mycoprotein from Fusarium venenatum (produced using Venetian Fusarium A3/5 strain) submitted by Fushine Biotech was as follows.

• 2025.02.07 Submission & Acceptance

NHC officially accepted the application, Acceptance No.: 卫食新申字(2025)第0010号

• 2025.07.10 Public Consultation

The China National Center for Food Safety Risk Assessment released the draft for public comment.

• 2025.11.27 Official Approval

The NHC issued Announcement No. 7 of 2025, approving Mycoprotein from Fusarium venenatum as a new food ingredient.

The entire process – from submission to final approval – was completed in just nine months. This rapid timeline showcased the strong professional capabilities and effective partnership between Fushine Biotech and CIRS Group.

Background

Protein is the core nutrient to maintain human health. As the world's most populous nation, China is currently the largest food importer globally, yet it still faces a significant gap in animal protein supply and inadequate self-sufficiency in high-quality protein. Thus, there is an urgent need to develop new alternative protein sources.

Fusarium venenatum, first developed in the UK in the 1950s as a protein substitute, has seen its products gain regulatory approval in multiple countries, including the EU, the US, Canada, and Australia-New Zealand. With over four decades of global consumption history, this innovative ingredient continues to be widely adopted.

Advantages of the Ingredient

Mycoprotein from Fusarium venenatum is a filamentous protein produced by fermentation technology. As an alternative microbial protein, its prominent advantages include:

• Superior nutrition: high protein, high dietary fiber, low fat, in line with the needs of modern healthy diet.
• Exceptional eating experience: The natural fiber structure mimics the texture and mouthfeel of animal meat. With added egg whites, artificial colors, and flavor enhancers, it delivers a more authentic meat-like experience. Additionally, it is rich in umami compounds, offering a rich and savory taste.
• Sustainable production model: Using large-scale fermentation tanks, vertical space utilization, far less land than crop planting or animal husbandry, and can be produced all year round, not affected by seasons and animal diseases, stable and efficient unit volume capacity, is an innovative choice to deal with resource and environmental challenges.

Figure 1: Mycoprotein from Fusarium venenatum

CIRS Opinions

As a high-protein, low-fat, palatable, and sustainable alternative protein, Mycoprotein from Fusarium venenatum is poised for widespread adoption in the food industry upon regulatory approval, emerging as an innovative solution to address global food crises and climate change. Driven by both policy support and technological advancements, this protein may soon become a new healthy dietary option, injecting fresh vitality into the sustainable development of the food sector.

About Fushine Biotech

Fushine Biotech has made remarkable achievements in the microbial protein sector, having successfully developed both dry and wet protein formulations while commercializing its research breakthroughs. The company currently operates a 1,200-ton microbial protein production line and is constructing a Phase I project with an annual output of 200,000 tons, along with a comprehensive resource utilization facility. Additionally, Fushine has obtained four major international food safety certifications (ISO22000, BRC, SQF, HACCP) and the HALAL certification. Looking ahead, the company will further increase R&D investments to optimize Weiran protein production technology and product quality, expand its application fields, and contribute to the innovative development of the global food industry.

About CIRS Group

Established in 2007, CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. The Food Business Division of CIRS Group was established in 2012. The team offers a full range of regulatory services, covering China's new food ingredient application, U.S. GRAS notice, EU novel food application, etc. With extensive experience, the team has assisted thousands of clients in successfully obtaining the approvals.