On July 2, 2025, the National Health Commission issued the “Announcement on 20 New ‘Third-Category Foods’ Such as D-Allulose” (2025 No. 4), adding 5 new food raw materials, 9 new food additives, and 6 new food-related products.
The Commission first accepted the application for D-allulose as a new food raw material on November 18, 2020. After multiple extensions, it was finally opened for public comment on March 21 of this year. Today, the five-year compliance process for D-allulose has at last reached its conclusion.
D-allulose is a six-carbon ketose that occurs naturally in small amounts in foods such as figs, kiwifruit, and wheat; its energy coefficient is approximately 1.67 kJ/g. The declared product is produced by either microbial fermentation or enzymatic conversion.
- Microbial fermentation uses glucose or sucrose as the substrate; fermentation is carried out with Escherichia coli AS10, followed by purification, crystallization, and drying.
- Enzymatic conversion uses fructose as the substrate; it is converted by a permitted D-allulose 3-epimerase, then subjected to decolorization, separation, purification, crystallization, and drying.
The declared product contains ≥ 98 g D-allulose per 100 g and has a recommended maximum intake of 20 g per day. In view of insufficient safety data for infants, pregnant women, and lactating women, and following the precautionary principle, these groups are advised not to consume it.
I. D-Allulose
Chinese name
D-阿洛酮糖
English name
D-allulose / D-psicose
Basic information
- Structural formula: (not shown)
- CAS No.: 551-68-8
- Molecular formula: C₆H₁₂O₆
- Relative molecular mass: 180.16
Production process summary
- Process I (microbial fermentation):
- Substrate: glucose or sucrose
- Microorganism: Escherichia coli AS10
- Steps: fermentation → purification → crystallization → drying
- Process II (enzymatic conversion):
- Substrate: fructose
- Enzyme: permitted D-allulose-3-epimerase
- Steps: enzymatic conversion → decolorization → separation → purification → crystallization → drying
Recommended maximum intake
≤ 20 g per day
Other notes
- Not suitable for infants, pregnant women, or lactating women; labels and instructions must indicate these inadvisable groups and the intake limit.
- Quality specifications and food-safety indices are provided in the appendix.
Appendix
1. Sensory requirements
Sensory characteristics shall meet the specifications in Table 1.
| Item | Requirement |
|---|---|
| Color | White |
| Taste | Sweet |
| Odor | Characteristic odor of the product, no off-odors |
| Form | Powder or granules, free from visible foreign matter |
Test method:
Place an appropriate amount of sample in a clean, dry white porcelain dish or beaker. Under natural light, observe color and form, smell for odor, and taste for sweetness.
2. Physicochemical indices
Physicochemical indices shall meet the specifications in Table 2.
Table 2 Physicochemical Parameters
| Item | Limit | Test Method |
|---|---|---|
| D-allulose, g/100 g | ≥ 98.0 | Appendix A |
| Specific rotation, ° | + 4.5 – + 5.5 | GB/T 20880 |
| Moisture, g/100 g | ≤ 1.0 | GB 5009.3 |
| Ash, g/100 g | ≤ 0.5 | GB 5009.4 |
| pH | 3.0 – 7.0 | GB/T 20882.2 |
| Lead (Pb), mg/kg | ≤ 0.5 | GB 5009.12 |
| Cadmium (Cd), mg/kg | ≤ 0.5 | GB 5009.15 |
| Total mercury (Hg), mg/kg | ≤ 0.1 | GB 5009.17 |
| Total arsenic (As), mg/kg | ≤ 0.5 | GB 5009.11 |
| Residual protein, mg/kg a | ≤ 100 | NHFPC 2023 No. 8; see Appendix A.4 |
a. The residual-protein limit applies only to D-allulose produced via Process I (microbial fermentation).
3. Microbiological Parameters
Microbial counts shall comply with Table 3.
Table 3 Microbiological Parameters
| Item | Limit | Test Method |
|---|---|---|
| Total plate count, CFU/g | ≤ 1 000 | GB 4789.2 |
| Coliforms, CFU/g | ≤ 10 | GB 4789.3 |
| Yeasts & molds, CFU/g | ≤ 50 | GB 4789.15 |
| Salmonella, /25 g | Not detected | GB 4789.4 |
| Staphylococcus aureus, /25 g | Not detected | GB 4789.10 |
Appendix A – Determination of D-Allulose Content by HPLC
A.1 Principle
After dissolving the sample in water, separation is achieved on a calcium-type cation-exchange column, with detection by differential refractive‐index detector. Quantification is by external standard.
A.2 Reagents and Materials
- All reagents, unless otherwise noted, are analytical grade; water meets GB/T 6682 Type I.
- A.2.1 D-allulose standard (CAS 551-68-8), purity ≥ 99.0%.
- A.2.2 Aqueous microporous filter membrane, 0.22 μm.
A.3 Instruments and Equipment
- A.3.1 Analytical balance, readability 0.0001 g.
- A.3.2 HPLC system with differential refractive‐index detector.
A.4 Analytical Procedure
- A.4.1 Standard solution preparation
- A.4.1.1 Stock standard solution
Accurately weigh 1.0 g D-allulose (±0.0001 g) into a beaker, dissolve in water, transfer to a 50 mL volumetric flask and dilute to volume. Filter through a 0.22 μm membrane to obtain a 20.0 mg/mL stock solution. Store in a capped plastic vial at 4 °C for up to 7 days. - A.4.1.2 Calibration standards
Pipette 0.25, 1.00, 2.50, 5.00 and 10.00 mL of stock solution into separate 10 mL volumetric flasks; dilute to volume with water and mix. These give 0.5, 2.0, 5.0, 10.0 and 20.0 mg/mL standards. Under the reference chromatographic conditions (A.4.3), inject each and plot peak area versus concentration. The calibration curve must have an r ≥ 0.999.
- A.4.1.1 Stock standard solution
- A.4.2 Sample solution preparation
Weigh 1.0 g sample (±0.0001 g), dissolve in water, transfer to a 100 mL volumetric flask and dilute to volume. Filter through a 0.22 μm membrane. - A.4.3 Reference chromatographic conditions
- Column: calcium-type cation-exchange, 300 mm × 6.5 mm, 10 μm (or equivalent)
- Detector temperature: 40 °C
- Flow rate: 0.6 mL/min
- Column temperature: 80 °C
- Injection volume: 10 μL
- Mobile phase: water
A.5 Determination
Inject calibration standards and sample solution sequentially. Calculate D-allulose content in the sample by reference to the calibration curve.
A.6 Calculation
Use the formula: X=C×V×100/m×1000
where
- X = D-allulose content (g/100 g)
- C = concentration of D-allulose in sample solution (mg/mL)
- V = final volume of sample solution (mL)
- m = mass of sample (g)
- 100 and 1000 are unit-conversion factors
Report the average of two independent determinations (repeatability), rounded to one decimal place.
A.7 Detection and Quantitation Limits
For a 1.0 g sample diluted to 100 mL, the method detection limit is 0.1 g/100 g and the quantitation limit is 0.3 g/100 g.
A.8 Precision
Under repeatability conditions, the absolute difference between two independent results shall not exceed 1 % of their arithmetic mean.
A.9 Chromatogram
(A representative chromatogram under the above conditions.)
With this domestic approval, BSH Ingredient is positioned as China’s leading D-allulose powder supplier and is ready to expand production to meet increasing market demand. We are optimistic that as consumers and manufacturers adopt this low-calorie sweetener, demand for D-allulose in China will grow strongly in 2025 and beyond.
