CIRS Assists Shandong Fuyang in Quickly Obtaining Substantial Equivalence for D-Allulose as a New Food Ingredient!

On September 12, 2025, the National Health Commission (NHC) of China updated the List of New Food Ingredients Terminated from Review, adding two entries for D-allulose. Among them, the D-allulose application submitted by Shandong Fuyang Biotechnology Co., Ltd. (hereinafter referred to as “Shandong Fuyang”), represented by CIRS Group, was included.

CIRS and Shandong Fuyang worked closely together, promptly preparing materials in response to review comments. From the submission of supplementary documents to the official announcement of substantial equivalence, the entire process took just over one month. This made Shandong Fuyang’s product the first D-allulose to be listed in the termination directory following Announcement No. 4 of 2025 (NHC Newly Approved 5 New Food Raw Materials, 9 New Food Additives, and 6 Food-related Products).

1. Interpretation of Termination of Review

Original announcement restricted information on producing strains/enzymes for D-allulose

In Announcement No. 4 of 2025, D-allulose was formally approved as a new food ingredient for the first time, with two different production processes disclosed:

Method One involves using glucose or sucrose as raw materials, which are then fermented, purified, and dried using Escherichia coli AS10. Details of the strain were provided in Table B.1 of Appendix B.

Method Two uses fructose as the raw material, which is catalyzed by the permitted D-psicose 3-epimerase, followed by processes of decolorization, separation, purification, and crystallization. Details of the enzyme-producing strain were listed in Table B.2 of Appendix B.

The announcement restricted both the microbial strains and the enzyme-producing strains used in D-allulose production. Taking Method Two as an example, not only must the conversion be catalyzed by an approved D-psicose 3-epimerase, but the microbial source and donor of the enzyme must also match the announcement. This means that only D-allulose produced with already-approved enzyme preparations – whose production strain and donor information are consistent with the announcement –can be directly manufactured. Otherwise, a new food ingredient application with a safety evaluation is still required.

Table B.2 Details of the enzyme-producing strain

Shandong Fuyang’s product obtained substantial equivalence

Shandong Fuyang’s D-allulose was produced via enzymatic conversion (Method Two) but used a different D-psicose 3-epimerase. As the core enzyme in the enzymatic production of D-allulose, D-psicose 3-epimerase currently has three approved variants in China, derived from different sources and donors. Shandong Fuyang used the enzyme preparation approved under Announcement No. 5 of 2024.

As a promising sugar substitute, more than 20 companies in China are currently investing in D-allulose. Following Shandong Fuyang’s recognition as substantially equivalent and inclusion in the termination directory, other manufacturers should note: if the microbial source and donor of their enzyme preparation match those already approved for D-psicose 3-epimerase, they do not need to reapply as a new food ingredient and may directly apply for a food production license. In other words, D-allulose produced using the enzyme preparations approved under Announcement No. 3 of 2023 and Announcement No. 5 of 2024 does not require a new food ingredient application. However, D-allulose produced with the enzyme preparation from Announcement No. 2 of 2024 still requires application, as no corresponding approval information exists.

2. About Shandong Fuyang

Shandong Fuyang Biotechnology Co., Ltd. was established in 2009 and covers an area of about 400 acres. It is currently a national high-tech enterprise, a national key leading enterprise in agricultural industrialization, and a single champion demonstration enterprise in manufacturing. Based on the corn deep processing industry, the company adheres to the direction of biotechnology development, and has successively built an annual processing 1 million tons of corn industrialization project, sodium gluconate project, modified starch project, erythritol project. Among them, the sodium gluconate project is at a high level in terms of production capacity, technical level, cost control, and degree of automation; the modified starch project has the advantage of high-end customized services; the corn starch project has created a traditional industry in terms of intelligence. New kinetic energy. The company's products sell well all over the country and Southeast Asia, the Middle East, Europe, America, Africa, and other countries and regions.

The company adheres to the talent support and innovation-driven development strategy, has national post-doctoral research workstations, academician workstations, engineering laboratories and other provincial and ministerial scientific research and innovation platforms, and has registered and established a provincial-level bio-manufacturing engineering research institute. It has established industry-university-research cooperation with many well-known institutes. In recent years, it has undertaken a number of projects such as 863 plans and scientific and technological support plans, and has developed more than 20 modified starch, bio-organic acids, and sugar alcohol series products, and has successively won the first prize for technological invention in Shandong Province Provincial and other provincial and municipal science and technology awards.

As a domestic sodium gluconate production base, the company has been appointed as the executive director unit of China Starch Industry Association and the director unit of China Biological Fermentation Association, participating in the formulation of national standards for corn starch and gluconic acid.

In 2019, the company injected capital to establish the "Pingyuan County Fuyang Education Development Foundation", which is committed to the development of education in the county. In the future, the company will build a high-tech industrial park integrating innovation science and technology park, a university science and technology city and a comprehensive exchange center, and actively make new contributions to regional economic development.

About CIRS

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 domestic and international food companies achieve one-stop compliance solutions. CIRS offers a full range of regulatory services covering novel food applications, synthetic biology-derived foods, U.S. GRAS notice, EU novel food application, health food registration, and food for special medical purposes (FSMP).

Our food services in China include but not limited to:

• China new food raw materials registration
• China new food additive registration
• China health food (dietary supplement) registration/filing
• China health food testing service
• China new food contact substance registration
• China food for special medical purpose (FSMP) registration
• China infant formula milk powder registration

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