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.
Figure 1: FDA has no questions letter
Earlier in July, 2025, Tianjin Hesheng’s 2'-FL was also successfully authorized as a new food additive in China, with the support of CIRS Group. Remarkably, it took only about seven months to complete both the FDA GRAS notice and China's new food additive registration, from submission to final approval.
The obtaining of these two certifications not only demonstrates the high quality and exceptional R&D capabilities of HS SynBio, but also showcases CIRS’s professional expertise in global new ingredient regulatory compliance.
Regulatory timeline of Hesheng’s 2'-FL
|
China new food additive |
FDA GRAS |
|
|---|---|---|
|
Submission & Acceptance |
2024.11.20 Officially accepted by the National Health Commission (NHC), Acceptance No.:卫食添新申字（2024）第0086号 |
2025.04.30 Officially received by the FDA |
|
Public Consultation |
2025.03.31 Public consultation released by the China National Center for Food Safety Risk Assessment |
/ |
|
Official Approval |
2025.07.02 Officially approved by NHC and published in Announcement No. 4 of 2025 |
2025.12.08 FDA sent “FDA has no questions” letter |
|
Duration |
≈7 months |
≈7 months |
About Tianjin Hesheng (HS SynBio) (Tianjin)
Tianjin Hesheng Biotechnology Co., Ltd., established in August 2023, is an innovative biotechnology company with the synthetic biology as its core technology. The company engages in the R&D, production, and sales of high-value products through green and sustainable biomanufacturing methods. Its products are widely applied in human nutrition and health, animal nutrition, and medical aesthetics and personal care industries.
The company possesses advanced capabilities in analyzing and developing microorganisms, including their key physiological traits, probiotic functions, and evolutionary mechanisms. It has built a Design-Build-Test-Learn (“DBTL”) technology platform and leverages a proprietary gene element database in conjunction with a self-developed AI algorithm platform, aiming to create “ultra-productive microbial strains (cell factories).”
The company has developed multiple synthetic biology products with strong commercial potential. The company is proficient in the R&D of probiotic combinations, functional foods, medical foods, nutritional interventions for chronic diseases, and more. It has established full-chain technical capabilities from upstream strain development, midstream large-scale production, to downstream product applications.
About CIRS Group
Established in 2007, CIRS Group is a leading product safety and regulatory consulting firm. CIRS has 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 applications, U.S. GRAS notices, EU novel food applications, and more. With extensive experience, the team has assisted thousands of clients in successfully obtaining the approvals.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
