Is D-allulose approved in China, and what does the 2025 approval actually cover?
D-Allulose (D-阿洛酮糖) was approved as a new food ingredient in China by National Health Commission announcement No. 4 of 2025, published in July 2025. The approval is attached to a production route and a purity specification, and it does not automatically extend to every existing overseas use.
TL;DR — the short answer
- Approved by NHC announcement No. 4 of 2025, published July 2025.
- The approval is attached to a production route and a purity specification, not to the molecule in the abstract.
- Permitted food categories and use levels are set in the announcement; they do not mirror the US position.
- Importers need the Chinese-language specification and a GB 7718 compliant Chinese label.
- Sourcing an approved-grade powder is faster than arguing an equivalence case at the border.
Evidence and regulatory basis
The position above rests on the following public records. Each is linked in full at the end of this article so you can verify it yourself.
- National Health Commission announcement No. 4 of 2025 (July 2025) approved D-阿洛酮糖 as a new food ingredient, specifying the production route and specification.
- FDA has addressed how allulose is declared on US labels — it is not counted as total or added sugars and carries a lower calorie value; that treatment is US-specific.
- GB 2760 sets the use range and limits for sweeteners in China; GB 7718 governs the labelling of prepackaged foods.
- China requires food production and export registrations to be verifiable against the issuing authority before a shipment moves.
- Codex Alimentarius and JECFA publish specifications used by many regulators as a baseline for identity and purity.
What was actually approved
China’s new food ingredient system approves a substance together with its production process. That means the announcement specifies the manufacturing route — for D-allulose, enzymatic conversion — and the purity and impurity profile that the approved product must meet. A product made by a different route is not covered by that approval.
This is the single most important thing for a buyer to understand. ‘Allulose is approved in China’ is a true sentence, but it does not tell you whether a particular drum is compliant. The question to ask a supplier is whether their material is produced by the approved route and meets the announced specification.
In practice this pushes buyers toward fewer, larger, better-documented producers. The trading-company model that works for commodity sugars works much less well for a newly approved ingredient, because the documentation trail has to reach back to the plant.
Why the approval matters commercially
Before 2025 allulose sat in a grey area for the Chinese market: it was produced in China largely for export, and domestic use was constrained. The approval converted an export-only industrial product into a legitimate domestic food ingredient, which opens formulation work for beverage, bakery and dairy brands selling inside China.
For international buyers the effect is indirect but real. Approved domestic demand raises capacity utilisation and improves availability, while the existence of a published national specification gives everyone a common reference for assay, moisture and impurity limits.
The second-order effect is on price. As domestic demand develops, the export price and the domestic price converge, and the steep export discount that characterised the pre-approval years narrows.
How this differs from the US position
In the United States allulose reached the market through GRAS notices, and FDA has addressed how it is declared on the label: allulose is not counted as total or added sugars and is assigned a lower calorie value than a standard carbohydrate. That labelling treatment is a US-specific decision and should not be assumed to transfer.
A Chinese label and a US label for the same formulation can therefore carry different carbohydrate and energy figures. Brands running one artwork across both markets routinely get this wrong, and the error is expensive because it surfaces at customs rather than at the bench.
The safe practice is to treat every market’s nutrition panel as a separate calculation, using the calorie value and sugar definition that market applies, rather than copying a panel that was approved elsewhere.
What importers have to document
The practical document set is a certificate of analysis that matches the announced specification, a production route statement, and a Chinese-language label that complies with GB 7718. Where the ingredient is used in a food for export, the importing country’s rules apply instead.
Buyers should also confirm the supplier’s export registration. China requires food production and export registrations to be verifiable against the issuing authority, and a certificate issued in the name of a trading company rather than the producing plant is a common failure point at the border.
Finally, keep the review date on the specification sheet. New food ingredient approvals are sometimes amended, and a certificate that references a superseded announcement will not clear.
How to read the specification
The parameters that matter in a commercial transaction are assay by HPLC, moisture, ash, and the impurity profile arising from the enzymatic route. Buyers who only look at the assay number tend to miss the residual sugar profile, which affects both taste and any carbohydrate declaration.
A good supplier will state the method next to every number. ‘≥ 99.0 %’ without a method is not a specification, because HPLC and enzymatic assays can disagree by a meaningful margin on the same sample.
For beverage work, also ask for the conductivity or the ion-exchange completion indicator. Residual ionic content from the purification step is the usual cause of a hazy finished product.
What the approval does and does not cover
| Question | Position |
|---|---|
| Is D-allulose approved in China? | Yes — NHC announcement No. 4 of 2025 (July 2025) |
| Does it cover every production route? | No — the approval is tied to the specified production process |
| Does it permit every food category? | No — permitted categories and use levels are set in the announcement |
| Does the US labelling treatment apply? | No — sugar and calorie declaration rules are jurisdiction-specific |
| Can an overseas equivalence case be argued? | Slow and uncertain; sourcing an approved grade is faster |
Commercial specification fields for D-allulose
| Parameter | Typical value | Why it matters |
|---|---|---|
| D-Allulose assay (HPLC) | ≥ 99.0 % | Defines the grade |
| Appearance | White crystalline powder | Visual release check |
| Moisture | ≤ 1.0 % | Affects caking and shelf life |
| Ash | ≤ 0.1 % | Indicates ion-exchange completeness |
| Residual sugars | Declared by method | Affects taste and carbohydrate declaration |
| Heavy metals | Pb ≤ 0.5 mg/kg typical | Market food-grade limit |
| Microbiology | Plate count, yeast and mould, pathogens | Food-grade release requirement |
Case: a bakery group qualifying an allulose grade for two markets
A bakery group wanted to launch a reduced-sugar muffin in China and in the United States on the same production line. The formulation used D-allulose at 6 % of the batter for browning and moisture retention, plus a small amount of a high-intensity sweetener for the sweetness curve.
The US launch cleared on the existing GRAS position and the FDA labelling treatment for allulose, which let the group declare a lower added-sugar figure than a sugar-equivalent formulation would have allowed. The China launch required a different route: the group had to source an approved-grade powder made by the enzymatic route named in the announcement, and to recalculate the nutrition panel under GB 28050 rather than reusing the US panel.
The recalculation mattered. Because the US treatment excludes allulose from added sugars and the Chinese panel calculation does not apply the same exclusion, the two labels carried different carbohydrate figures for an identical product. The group printed separate artwork for the two markets.
The practical saving came from qualifying a single supplier that could document both markets from one plant. That removed a second qualification cycle and, more importantly, removed the risk of two lots with different impurity profiles behaving differently on the line.
| Step | United States | China |
|---|---|---|
| Legal basis | GRAS notice + FDA labelling treatment | NHC announcement No. 4 of 2025 |
| Grade required | 99 % crystalline | 99 % crystalline by the approved route |
| Nutrition panel | Allulose excluded from added sugars | Calculated under GB 28050 |
| Label artwork | One version | Separate version required |
| Documentation | COA + production route | COA + route + GB 7718 label + export registration |
How the number on the certificate is actually produced
The single most common source of a bad purchase decision in this category is two suppliers quoting the same figure for D-allulose (D-psicose) from two different analytical methods. The number is only meaningful together with the method that produced it. Ask for both, every time, before you compare prices.
The reference method for D-allulose (D-psicose) in D-allulose is HPLC with refractive index detection against a D-allulose external standard; enzymatic assay is used for rapid in-process screening but is not the reference method for a certificate. In practical terms that means the sample is dissolved, filtered, injected against a certified external standard, and quantitated on the peak area. Results are reported on the as-is basis unless the certificate states otherwise, which matters because a drum that has picked up moisture during a humid sea crossing will assay lower on the as-is basis while the chemistry is unchanged.
A competent supplier will also state the loss on drying, the heavy metals result, the microbiological counts and the residual solvent result on the same certificate. If any of those four is missing, you are not looking at a full certificate of analysis — you are looking at an assay report, and the difference matters the first time a customer auditor asks you for the full document.
Specification matrix: what each grade actually buys you
Grade names in this category are marketing shorthand, not a standard. One supplier’s ‘premium’ can be another’s mid-grade. What is comparable across suppliers is the analytical figure and the inclusion rate it lets you use. The matrix below maps the grades we run to the two numbers that decide your cost in use.
| Grade | Purity (HPLC) | Form | Typical use | Note |
|---|---|---|---|---|
| Crystalline 99.5 % | ≥ 99.5 % (dry basis) | Free-flowing crystal | Table-top, bakery, chocolate | Lowest moisture, best flow, highest cost per kg |
| Powder 99 % | ≥ 99.0 % (dry basis) | Spray-dried powder | Dry blends, sachets, beverage premix | Fastest dissolution; the standard workhorse |
| Powder 98 % | ≥ 98.0 % (dry basis) | Powder | Applications tolerant of trace sugars | Economy grade; check the residual fructose figure |
| Syrup 70 % | ≥ 70 % (dry basis), 70 °Brix | Liquid | Beverage, dairy, sauce | Pumped and metered; removes a dissolution step |
| Allulose + monk fruit co-blend | Bulk allulose + Mogroside V extract | Powder, sweetness matched 1:1 with sucrose | Ready-to-use sugar replacement | Removes the weighing step; sweetness tuned to your brief |
Read the last two columns together. A grade that costs more per kilogram but halves your inclusion rate can be cheaper per finished tonne, and it usually tastes cleaner because you are adding less of the non-sweet fraction. Run that arithmetic on your own formulation before you decide — the answer genuinely changes with the matrix.
Reading the certificate of analysis line by line
Below is the line structure we issue on D-allulose. Use it as a checklist when you compare two quotes: if one supplier’s document has fewer lines, the missing lines are usually the ones that would have shown a problem.
| Certificate line | Method | Typical result | Why it matters to you |
|---|---|---|---|
| Assay — D-allulose | HPLC-RI, external standard | 98.0–99.5 % (dry basis) | Sets the grade; drives price and labelling |
| Residual D-fructose | HPLC-RI | ≤ 0.5 % (premium grades) | The figure that separates economy from premium; matters for sugar-reduction claims |
| Loss on drying | 105 °C / 2 h | ≤ 1.0 % (crystal), ≤ 3.0 % (powder) | Drives caking behaviour and flow |
| Heavy metals (Pb, As) | ICP-MS | Pb ≤ 1 mg/kg, As ≤ 1 mg/kg | Standard import requirement in most destination markets |
| Microbiology (TPC, yeast & mould, Salmonella) | Plate count / PCR | TPC ≤ 1,000 cfu/g; Salmonella absent in 25 g | Required for beverage and dairy |
| Sulphated ash | Gravimetric, 550 °C | ≤ 0.1 % | A quick indicator of processing cleanliness |
| Particle size distribution | Laser diffraction or sieve | Stated on request for table-top grades | Decides flowability and dust in the plant |
Two lines deserve special attention. The first is the batch number: a sample that ships from a different batch than the certificate is not evidence of anything. The second is the retest date rather than a hard expiry — a retest date means the material can be released again after a passing re-assay, which is standard practice for stable powders and worth real money on slow-moving inventory.
Formulation notes by application
The same D-allulose behaves differently in different matrices. The starting points below are where our technical team opens a bench trial; treat them as a starting dose to optimise, not a finished formulation.
| Application | Starting inclusion rate | Why allulose works here | What to validate |
|---|---|---|---|
| Still beverages | 2–6 % | Clean sugar-like curve, no cooling effect | Sweetness at serving temperature; acidity interaction |
| Bakery | 5–15 % | Participates in Maillard browning unlike most polyols | Browning rate — allulose browns faster than sucrose |
| Dairy and frozen dessert | 3–8 % | Depresses freezing point, improves texture | Freezing curve and scoopability |
| Sauces and dressings | 3–8 % | Body and mouthfeel close to sucrose | Hot-fill stability and viscosity |
| Confectionery | 10–30 % | Can replace a large share of sucrose directly | Crystallisation behaviour and moisture pickup |
| Table-top | Bulk of the blend | 1:1 sweetness with monk fruit top-up | Flow, dust and dissolution speed |
Validate in the real matrix at the real serving temperature, and re-taste after accelerated storage. Sweetness perception shifts with acidity, fat, alcohol and temperature, and a dose that is correct in water is frequently 10–30 % off in the finished product.
Stability, storage and shelf life
D-allulose is a stable powder when it is kept dry and sealed, and most of the shelf-life problems reported in this category are moisture and aroma problems rather than degradation of the sweetening compound itself. The data below is the basis for the shelf-life statement on our documentation.
| Condition | Duration | Observed result |
|---|---|---|
| Sealed, ≤ 25 °C, < 60 % RH | 24 months from manufacture | Assay, moisture and appearance within specification |
| Opened drum, ambient, resealed after use | Use within 6 months | Moisture pickup at the surface; caking possible |
| Accelerated 40 °C / 75 % RH | 6 months | No meaningful loss of assay; surface caking observed if unsealed |
| In solution, pH 3.0–7.0 | 12 weeks at ambient | Stable across the normal beverage pH range |
| Through UHT and pasteurisation | Process duration | No measurable degradation; suitable for hot fill |
| Through baking (180–200 °C) | Process duration | Stable; Maillard browning proceeds faster than with sucrose |
Store sealed, below 25 °C, away from direct sunlight and away from strongly aromatic material. Once opened, reseal immediately or transfer to a smaller container — the headspace in a half-empty drum is where caking starts. Material that has caked can usually be milled back to a free-flowing powder and re-assayed, but the assay should be re-run before it goes into a blend.
Six mistakes that cost buyers money in this category
These come up in almost every first conversation with a new account. None of them is expensive to avoid, and all of them are expensive to discover after the container has shipped.
- Comparing a syrup quote to a powder quote by weight. A 70 °Brix syrup is roughly 70 % solids. Restate both on the dry basis before you compare, or you will conclude the syrup is 30 % cheaper when it is not.
- Not asking for the residual fructose figure. Two lots both labelled ’99 % allulose’ can differ materially in what the remaining 1 % is, and that difference shows up in your sugar-reduction claim.
- Assuming the approval in one market transfers. D-allulose holds different statuses in different jurisdictions and the specifications attached to them differ. Confirm the status in your destination, not in the country of origin.
- Overlooking the browning rate. Allulose browns faster than sucrose. A straight swap in a baked good will darken the product — usually a pleasant change, occasionally not.
- Under-specifying the cold chain for syrup. Syrup grades are stable but are more sensitive to microbial contamination once diluted. Treat them as a food ingredient with a hygiene specification, not a dry powder.
- Skipping the label check on calorie declaration. Permitted calorie declaration values for allulose differ between the US and the EU. Using the US figure on an EU label is a compliance failure, not a rounding difference.
Glossary of terms used in this article
- D-allulose (D-psicose)
- A rare sugar and a C-3 epimer of D-fructose, occurring naturally in small amounts in wheat, figs and raisins. Approximately 70 % as sweet as sucrose with roughly 0.4 kcal/g.
- D-阿洛酮糖
- The Chinese name for D-allulose. It appears on Chinese new food ingredient documentation and on certificates of analysis from Chinese manufacturers.
- Rare sugar
- A monosaccharide that occurs in nature only in small quantities. D-allulose, D-tagatose and D-psicose all fall into this group.
- New food ingredient (新食品原料)
- China’s pre-market approval route for food ingredients without a history of consumption in China, administered by the National Health Commission. Distinct from a food additive approval under GB 2760.
- Novel food (EU)
- Under Regulation (EU) 2015/2283, an ingredient requiring pre-market authorisation before it can be sold in the EU. Allulose went through this route.
- Maillard browning
- The reaction between reducing sugars and amino acids that browns and flavours baked and cooked foods. Allulose participates in it, which is unusual among sugar replacers and is the reason it behaves like sugar in the oven.
- GRAS (Generally Recognized as Safe)
- The US FDA route by which a substance is accepted for use on the basis of expert consensus, published in the public GRAS Notice Inventory.
- C-3 epimer
- A molecule that differs from another at a single stereocentre — here, carbon 3. That one-position difference is why allulose tastes like sugar but is metabolised very differently.
- Brix
- A measure of dissolved solids in a liquid, used to state the concentration of syrup grades. A 70 °Brix syrup is approximately 70 % solids by weight.
What to ask a supplier before you commit volume
- Confirm the material is produced by the route named in NHC announcement No. 4 of 2025.
- Obtain the assay by HPLC with the method stated, not just a minimum number.
- Obtain moisture, ash and the residual sugar profile — these drive taste and the carbohydrate declaration.
- Verify the producing plant’s food production licence and export registration.
- Prepare a GB 7718 compliant Chinese label where the product is sold domestically.
- Recalculate the nutrition panel per market rather than copying an approved overseas panel.
Where to source it
Frequently asked questions
When was D-allulose approved in China?
It was approved by National Health Commission announcement No. 4 of 2025, published in July 2025, as a new food ingredient.
Does the approval cover all allulose?
No. The approval is attached to a production route and a purity specification. Ask your supplier whether their material is made by the approved route and meets the announced specification.
Can I use the US label values in China?
No. Sugar and calorie declaration rules are jurisdiction-specific. Allulose is not counted as added sugars in the United States; that treatment should not be assumed for the Chinese market.
What purity should I buy?
Crystalline powder at 99 % assay by HPLC is the standard trading grade. Below that, residual sugars start to affect both taste and any carbohydrate declaration on the label.
What documents does an import need?
A certificate of analysis matching the announced specification, a production route statement, a GB 7718 compliant Chinese label where sold domestically, and a verifiable export registration.
Is syrup available as well as powder?
Both forms trade, but the specification and the use levels differ. Confirm which form the approval covers for your food category before committing volume.
Does the approval change the export price?
Indirectly. Approved domestic demand raises capacity utilisation and narrows the export discount that characterised the pre-approval years, so export quotes tend to firm rather than fall.
Is D-allulose the same as erythritol?
No. Erythritol is a sugar alcohol (polyol) with a pronounced cooling effect and 0 kcal/g. Allulose is a rare sugar with no cooling effect, roughly 0.4 kcal/g and 70 % of the sweetness of sucrose. They behave differently in formulation and are declared differently on a label.
Does allulose show up as sugar on a nutrition panel?
This is jurisdiction-specific and one of the most common labelling errors in exports. In the United States, allulose may be excluded from total and added sugars declaration under FDA guidance. In the EU, the treatment differs. Confirm the current rule in your destination before you print a panel.
Why does allulose brown faster than sucrose?
Because it is a reducing sugar and participates in Maillard browning. In a baked good, expect a darker crust and slightly faster colour development at the same temperature. Most formulators find this desirable; it does need validating.
Can allulose be used 1:1 with sucrose?
On sweetness, not quite — it is roughly 70 % as sweet, so a straight gram-for-gram swap tastes lighter. In practice it is used 1:1 on volume with a high-intensity sweetener such as monk fruit extract topping up the sweetness, which is what our co-blend does.
Is allulose suitable for keto and low-GI positioning?
It contributes roughly 0.4 kcal/g and does not raise blood glucose in the way sucrose does, which is why it is widely used in keto and reduced-sugar products. The exact claims you can make depend on your market’s nutrition and health claim rules.
What is the difference between enzymatic conversion and fermentation routes?
Commercial allulose is produced by enzymatic epimerisation of fructose, using an immobilised D-tagatose 3-epimerase or a similar enzyme. The route affects the impurity profile and the residual fructose level, which is what you see on the certificate — not the identity of the molecule.
How should allulose be declared on an ingredient list?
Most markets accept ‘allulose’ or ‘D-allulose’. Some require the class name or a qualifying statement. Check the destination’s labelling standard — for the Gulf, the relevant GSO labelling standard; for the EU, Regulation (EU) No 1169/2011.
Is allulose halal and kosher?
The molecule is plant-derived and the enzymatic route uses no animal inputs, so it is a favourable starting point. Certification is still what buyers ask for, so request the certificates with the shipment rather than retrofitting them.
Official sources
- National Health Commission — announcements
- State Administration for Market Regulation — standards
- National food safety standard full-text public system
- FDA — guidance on the declaration of allulose
- Codex Alimentarius
Regulatory status changes. The position above was last reviewed in October 2026 against the official sources listed. Confirm the current text with your own regulatory adviser before making a label claim.