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CIRS Assists Zhongda Hengyuan’s D-psicose in Achieving GRAS Notice
On July 6, Henan Zhongda Hengyuan Biotechnology Stock Co., Ltd. (Hengyuan) received a "no questions" letter from the FDA regarding the GRAS (Generally Recognized as Safe) notice for its D-psicose. Produced via an enzymatic bioconversion process, the ingredient's safety has now been officially recognized by the FDA.
United States
Food and Food Related Products
GRAS
Our Cases
CIRS Assists Zhongda Hengyuan’s D-psicose in Achieving GRAS Notice
United States
Food and Food Related Products
GRAS
Our Cases
CIRS Helps Shandong Freda’s SAMe-DT Successfully Complete FDA NDI Notification
Recently, S-adenosyl-L-methionine disulfate tosylate (SAMe-DT), independently developed by Shandong Freda Biotechnology Co., Ltd. (hereinafter refered to as Shandong Freda), has successfully completed FDA New Dietary Ingredient (NDI) notification, with the NDIN number being 1473, marking the ingredient’s compliance for entry into the U.S. dietary supplement market. CIRS Group provided full support throughout the notification process.
United States
Food Ingredients
Food and Food Related Products
Our Cases
CIRS Helps Shandong Freda’s SAMe-DT Successfully Complete FDA NDI Notification
United States
Food Ingredients
Food and Food Related Products
Our Cases
CIRS Supports Enhe Aiju’s ZeaVida® Zeaxanthin Obtain FDA GRAS Notice
Recently, Enhe Aiju (Hangzhou) Science and Technology Co., Ltd. (Enhe Aiju) has completed the FDA GRAS notice for its self-developed zeaxanthin, produced via fermentation using production strain Yarrowia lipolytica CGMCC 39021 (GRN No. 1300). This is the world’s first high-concentration crystalline zeaxanthin product manufactured at commercial scale using cell factory technology to receive GRAS, fully under the support of CIRS Group.
United States
Food Ingredients
Food and Food Related Products
GRAS
Our Cases
CIRS Supports Enhe Aiju’s ZeaVida® Zeaxanthin Obtain FDA GRAS Notice
United States
Food Ingredients
Food and Food Related Products
GRAS
Our Cases
CIRS Assists Shandong Weiyan in Obtaining GRAS Status for Its Astaxanthin
Recently, Shandong Weiyan Biotechnology Co., Ltd. (“Shandong Weiyan”) achieved a milestone in its international compliance journey for its product, astaxanthin. With comprehensive professional support from CIRS Group, the company’s astaxanthin has been concluded by GRAS Panel as Generally Recognized as Safe (GRAS).
United States
Food and Food Related Products
GRAS
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CIRS Assists Shandong Weiyan in Obtaining GRAS Status for Its Astaxanthin
United States
Food and Food Related Products
GRAS
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CIRS Assisted Meihua Group in Securing First NHC Approved 3’-SL
On February 5, 2026, China’s NHC issued the No.1 Announcement of 2026. 3’-SL was approved as a new food nutrition enhancer, becoming the third officially authorized human milk oligosaccharide (HMOs) following 2’-FL and LNnT.
China
Food Ingredients
Food and Food Related Products
Our Cases
CIRS Assisted Meihua Group in Securing First NHC Approved 3’-SL
China
Food Ingredients
Food and Food Related Products
Our Cases
CIRS Assists Runhan in Obtaining GRAS Status for Its GlcNac
Earlier in September 2025, Shandong Runhan Biotechnology Co., Ltd. (“Runhan”) achieved a milestone in its international compliance journey for its core product, GlcNac. With comprehensive professional support from CIRS Group and its U.S. subsidiary, the company’s GlcNac has been concluded by GRAS Panel as Generally Recognized as Safe (GRAS).
China
United States
Food and Food Related Products
GRAS
Our Cases
CIRS Assists Runhan in Obtaining GRAS Status for Its GlcNac
China
United States
Food and Food Related Products
GRAS
Our Cases
CIRS Assists VDK in Securing GRAS Status for β-carotene
Recently, VDK’s synthetically produced β-carotene, manufactured using synthetic biology technology, obtained self-GRAS notification. This milestone signifies the product’s approval as a safe food ingredient for sale and use in the American market, providing crucial support for VDK’s global expansion strategy. This notification was fully supported by CIRS Group.
United States
Food and Food Related Products
GRAS
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CIRS Assists VDK in Securing GRAS Status for β-carotene
United States
Food and Food Related Products
GRAS
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CIRS Helps Tianjin Hesheng Successfully Obtain US GRAS Notice and China New Food Additive Registration for Its 2’-FL
On December 8, 2025, Tianjin Hesheng Biotechnology Co., Ltd. (HS SynBio) (Tianjin) received “FDA has no questions” letter. This marks the official recognition of its HMO 2'-Fucosyllactose (2'-FL) as GRAS.
China
United States
Food Additives
Food and Food Related Products
GRAS
Our Cases
CIRS Helps Tianjin Hesheng Successfully Obtain US GRAS Notice and China New Food Additive Registration for Its 2’-FL
China
United States
Food Additives
Food and Food Related Products
GRAS
Our Cases
CIRS Helps Fushine Biotech Successfully Obtain Approval for China’s First Mycoprotein from Fusarium Venenatum
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.
China
Food Ingredients
Food and Food Related Products
Our Cases
CIRS Helps Fushine Biotech Successfully Obtain Approval for China’s First Mycoprotein from Fusarium Venenatum
China
Food Ingredients
Food and Food Related Products
Our Cases
CIRS Assists Shandong Fuyang in Quickly Obtaining Substantial Equivalence for D-Allulose as a New Food Ingredient!
On September 12, 2025, the National Health Commission (NHC) of China updated the List of New Food Ingredients Terminated from Review, adding two entries of D-allulose. Among them, the D-allulose application submitted by Shandong Fuyang Biotechnology Co., Ltd. (hereinafter referred to as “Shandong Fuyang”), represented by CIRS Group, was included.
China
Food Ingredients
Food Additives
Food and Food Related Products
Our Cases
CIRS Assists Shandong Fuyang in Quickly Obtaining Substantial Equivalence for D-Allulose as a New Food Ingredient!
China
Food Ingredients
Food Additives
Food and Food Related Products
Our Cases
US FDA GRAS Notice
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Genetically Modified Microorganism Food Additive Registration in China
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US FDA Dietary Supplement Structure/Function Claim Notification
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US FDA Registration of Food Facilities
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US Food Label/Advertisement Information Review
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EU Novel Food Application
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GACC Overseas Manufacturers Registration of Imported Food (GACC Decree No.248)
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MARA Imported Feed and Pet Food Registration
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US FDA GRAS Notice
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Genetically Modified Microorganism Food Additive Registration in China
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US FDA Dietary Supplement Structure/Function Claim Notification
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US FDA Registration of Food Facilities
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US Food Label/Advertisement Information Review
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EU Novel Food Application
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GACC Overseas Manufacturers Registration of Imported Food (GACC Decree No.248)
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MARA Imported Feed and Pet Food Registration
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