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.

CIRS Group managed the entire process, providing comprehensive regulatory support from submission to completion. The notice progressed from the initial FDA filing to the issuance of the "no questions" letter in just four months—a timeline that highlights CIRS Group's extensive regulatory expertise and efficient execution in food compliance.

GRAS is a safety assessment framework established by the U.S. Food and Drug Administration (FDA) under the U.S. Code of Federal Regulations (CFR) for food ingredients and food additives. A substance that has achieved GRAS status is generally recognized by qualified experts as safe under its intended conditions of use and may be legally marketed for use in food products in the United States. Due to its broad international recognition and regulatory credibility, FDA GRAS notice is widely regarded as an important gateway for food ingredients and additives entering the U.S. and global markets.

Psicose is a naturally occurring rare sugar that delivers a sweetness profile similar to sucrose while providing only approximately 0.4 kcal/g. Because it contributes minimal metabolizable energy, D-psicose has become one of the most promising next-generation sugar alternatives for reduced-calorie and sugar-reduced food and beverage applications. Leveraging its proprietary enzymatic bioconversion technology, Zhongda Hengyuan manufactures high-purity D-psicose using fructose as the starting material. The company has established a dedicated production facility with an annual production capacity of 10,000 metric tons, enabling continuous 24/7 commercial-scale manufacturing. Zhongda Hengyuan is also the first company in China to obtain production licenses for both D-psicose and the key enzyme preparation used in its manufacture, achieving full regulatory compliance throughout the entire industrial chain—from enzyme production to the finished ingredient. The successful completion of the FDA GRAS notice represents a major milestone in Zhongda Hengyuan’s global expansion strategy.

About Zhongda Hengyuan

Zhongda Hengyuan is focusing on providing natural colors, natural ingredients, functional sugars, functional lipids, and food-medicine homologous ingredients. Backed by a nationwide network of raw material production bases, the company provides customers with integrated clean-label solutions and one-stop services tailored to the food and health industries. With a robust quality assurance system, the company strictly adheres to international and domestic standards, ensuring the delivery of safe and high-quality products, and continuously enhancing market competitiveness of both products and those of customers.

What CIRS Can Do for You

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.