In 2025, the U.S. Congress introduced three proposals related to food substances “Generally Recognized As Safe” (GRAS): S.2341, H.R.4958, and S.3122. These proposals all focus on improving the GRAS evaluation process, substance safety, and regulatory requirements for self-GRAS.

Driven by a global wave of food innovation, regulatory compliance and market access for novel food ingredients and additives have become critical hurdles for companies expanding internationally. Under this circumstance, CIRS Group has prepared the White Paper Series on Global Novel Food and Feed Ingredient Submissions, with the aim to help businesses navigate the evolving global regulations and accelerate global expansion.

Recently, HHS/FDA updated the GRAS reform rule entry in the Federal Register’s “Uniform Agenda”, adjusting the proposed rule’s publication date to December of this year. More importantly, this update not only reflects a change in the timeline but also reveals the design philosophy behind the rule.

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.

With the first half of 2026 concluded, Chinese ingredient companies are demonstrating strong momentum in GRAS notices; the number of approvals secured in this period alone (16) rivals the total for the entire year of 2025 (19). Drawing on publicly available FDA GRAS notice data, CIRS Group has compiled updates from January to June. By systematically reviewing metrics such as total volume, ingredient categories, outcomes, and the origins of applicants, CIRS provides valuable insights for food ingredient companies looking to enter the U.S. market.

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.