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.

The New York State Assembly passed the Food Safety and Chemical Disclosure Act (Bill No. S1239F/A1556G) on April 21, which has now been sent to Governor for signature. If the governor officially signs it, this will be the first state law in the United States requiring businesses to publicly disclose safety evidence for self-GRAS substances to the state government.

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).

In recent years, the number of GRAS notices submitted to the U.S. FDA has been on a steady upward trend. Since 2026, the U.S. FDA has been continuously updating its inventory of GRAS notices. CIRS Group has conducted a detailed statistical analysis and summary of FDA GRAS notices from January 2026 to March 2026, which is provided here for companies’ reference.

There are more than 200 types of HMOs, each with specific structures and functions, enabling applications across different fields. As a result, regulatory submissions for HMOs are rapidly increasing worldwide, with commercialization first initiated in Europe and the United States. In 2015, the U.S. Food and Drug Administration (FDA) recognized the first HMO—chemically synthesized 2’-fucosyllactose (2’-FL) submitted by Glycom A/S—as Generally Recognized as Safe (GRAS). Since then, multiple HMOs have successively obtained GRAS status in the United States.

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.

In 2025, GRAS notice remained highly active. To provide a comprehensive overview of the annual trends, CIRS Group conducted a systematic review and analysis of GRAS notice in 2025, offering insights and references for enterprises.

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.

In recent years, the enthusiasm for GRAS Notices to the U.S. FDA has remained strong. From July 2025 to the present, the FDA has released a large-scale update to the GRAS inventory. CIRS Group has conducted a detailed analysis and summary of GRAS submissions from July to September 2025, to help enterprises stay informed and make strategic reference. It is important to note that updates on the FDA website are often delayed – many substances may have already completed the GRAS review and received “no questions” letters, but their public status remains unchanged. CIRS Group closely monitors FDA updates, and this report summarizes the information newly released in Q3 2025.