CIRS Helps Zhongda Hengyuan’s D-allulose Rapidly Secure FDA GRAS Notification and China Substantial Equivalence as a New Food Ingredient

On November 9, 2026, China's National Health Commission (NHC) updated its list of approved New Food Ingredients with terminated reviews, adding D-allulose - produced by Henan Zhongda Hengyuan Biotechnology Stock Co., Ltd. (Zhongda Hengyuan) -into the list. The ingredient—derived from fructose using approved D-psicose 3-epimerase—received a review conclusion of substantial equivalence.

Previously, CIRS Group helped Zhongda Hengyuan secure U.S. FDA GRAS status (GRN 001309) for its D-allulose, taking the project from initial FDA filing acceptance to a "no questions" letter in just four months. For this domestic application, CIRS provided end-to-end technical support, enabling Zhongda Hengyuan to secure approval in under six months. Achieving both domestic and international regulatory clearances highlights Zhongda Hengyuan’s strong R&D and product quality, as well as CIRS’s expertise in global food compliance.

To date, CIRS Group has helped three companies obtain approval or substantial equivalence for D-allulose as a new food ingredient in China.

Compliance Timeline

Submission and acceptance: May 26, 2026—formally accepted by the National Health Commission.

Supplementary materials: September 20, 2026;

Formal acceptance: November 9, 2026 inclusion in the Catalog of New Food Ingredients Subject to Termination of Review.

The entire process, from submission to formal completion, took less than six months. This efficient process is the best testament to the professional capabilities and close collaboration between Zhongda Hengyuan and CIRS Group.

Background of the Application and Product Characteristics

Against the backdrop of the global epidemic of obesity and diabetes, reducing and controlling sugar intake has become an integral part of a healthy lifestyle worldwide. D-allulose plays a significant role in this global trend. Countries such as the United States were among the first to achieve industrial-scale production and have been applying it in the food industry for many years. While China’s production of D-allulose began relatively late, leading domestic enterprises have kept pace with international developments, and several companies have now established industrial operations.

1. allulose is a rare natural monosaccharide with a taste similar to sucrose but only about 0.4 kcal/g in calories. It provides very little energy after absorption by the human body, making it a high-quality sucrose substitute. Relying on its independently developed bio-enzyme conversion technology, Zhongda Hengyuan uses fructose as a raw material to produce high-purity D-allulose. The company has established a dedicated 10,000-metric-ton production line capable of 24-hour uninterrupted operation, ensuring large-scale production capacity.

About Zhongda Hengyuan

Henan Zhongda Hengyuan Biotechnology Stock Co., Ltd., located in the Industrial Cluster Zone of Linying County, Henan Province, specializes in the research and industrialization of natural (functional) plant extracts and biological fermentation systems. It is a National High-Tech Enterprise, a National “Single Champion” Enterprise in Manufacturing, a National Key Leading Enterprise in Agricultural Industrialization, and a National-Level Green Factory. It is the world’s largest producer of gardenia pigments and the world’s only manufacturer of natural pigments across the full color spectrum. The company has established 11 provincial and ministerial-level R&D platforms. Annual R&D investment consistently accounts for more than 4.0% of revenue. Its core products include natural pigments, natural flavorings and fragrances, natural functional active ingredients, natural sweeteners, natural antioxidants, and D-allulose, serving sectors such as food, health supplements, pharmaceuticals, pet food, and personal care products.

What Can CIRS 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, and 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 of 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 1 European Registered Toxicologist (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.