Food & Food Contact Materials
CIRS Group
Chemicals
Food
Cosmetic
Medical Devices
Agrochemicals
Biocides
Carbon Neutrality
Testing
Search
Our Cases
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.
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.
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.
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).
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.
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).
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.
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.
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.
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.