As consumer demand for low-calorie, low-sugar products intensifies, manufacturers in the food, beverage and supplement sectors are increasingly formulating with D-Allulose to balance taste and health. The Global D-Allulose Regulatory Approval Guide in 2026 provides detailed approval status of D-Allulose in nine major markets, including the United States, China, the European Union, Canada, Australia and New Zealand, Mexico, Japan, Korea and Singapore. With these insights, you can plan product launches and label claims with confidence.
BSH Ingredients is one of China’s largest D-Allulose suppliers, exporting over 3 000 tons of bulk allulose powder and liquid annually at competitive wholesale pricing. Whether you are developing a reduced-sugar beverage, a keto-friendly snack or a functional supplement, understanding both the sweetener’s benefits and its regulatory landscape is essential for success.
| Country/Region | Approval Status | Safety-Evaluation Pathway | Approval Date | Allowed Use or Limits |
|---|---|---|---|---|
| United States | Allowed in foods | GRAS notification | From 2012; label update 2019 | Can be used across many food categories as a sweetener under GMP; exempted from “added sugar” labeling since Oct 2019 . |
| China | Approved as a new food material | New-Food-Material review | July 2, 2025 | Permitted in ordinary foods as a functional sweetener; recommended ≤20 g/day; not for infants, pregnant or lactating women . |
| European Union | Not yet approved | Novel-Food evaluation | — | Not allowed until EFSA and EC authorization; EFSA June 5 2025 opinion: “insufficient data to confirm safety” . |
| Canada | Partial approval | Novel-Food review (pending); NHP ingredient | 2018–2024 | Not yet approved for ordinary foods (must complete Novel Food review); allowed as a non-medicinal ingredient in Natural Health Products . |
| Australia & New Zealand | Approved as novel food | FSANZ Novel-Food review | Aug 2024 | Permitted in specified food categories with maximum use levels; label warning if overconsumed . |
| Mexico | Approved in foods | Food additive review | ≈2018–2019 | COFEPRIS classifies it as a non-caloric sweetener for foods and beverages; exempt from “total sugar” and “added sugar” labels . |
| Japan | Widely used without special approval | Treated as ordinary ingredient | Since 2010s | Freely added to any food; energy factor set to 0 kcal/g; industry self-limits daily intake to ~30 g . |
| Korea | Approved in foods | Novel-Food/ingredients listing | 2016–2018 | Listed in food-ingredients catalog; energy factor 0 kJ/g; since 2020 allowed in alcoholic beverages; no specific use limit . |
| Singapore | Approved in foods | Internal safety review | ≈2020 | Treated as a general food ingredient without specific use limits; labeling follows international practice (exclude from “sugars”) . |
United States
D-Allulose (also known as D-Psicose) is officially recognized as GRAS by FDA. Below is a summary of every no-objection letter on file:
| GRN No. | Notifier | Date of FDA Letter | GRAS Notice Link |
|---|---|---|---|
| 400 | CJ Cheiljedang, Inc. | June 18 2012 | Gras Notices |
| 498 | Matsutani Chemical Industry Company, Ltd. | June 12 2014 | Search GRN 498 in FDA Inventory (U.S. Food and Drug Administration) |
| 647 | Samyang Corporation | October 11 2016 | GRAS Notices |
| 693 | Samyang Corporation | August 28 2017 | GRAS Notices |
| 755 | Samyang Corp. | May 10 2018 | GRAS Notices |
| 828 | Samyang Corporation | March 2 2020 | GRAS Notices |
| 893 | Tate & Lyle | June 5 2020 | GRAS Notices |
| 1024 | Blue California | March 2 2023 | GRAS Notices |
| 1029 | L&P Food Ingredient Co., Ltd. | August 4 2023 | GRAS Notices |
| 1057 | Tate & Lyle | January 25 2024 | GRAS Notices |
| 1148 | Daesang Corporation | September 30 2024 | GRAS Notices |
| 1188 | Shandong Starlight So True Biological Technology Co., Ltd. | November 19 2024 | GRAS Notices |
| 1193 | Sichuan Ingia Biosynthetic Co., Ltd. | December 12 2024 | GRAS Notices |
Source: FDA GRAS Notice Inventory (U.S. Food and Drug Administration)
Safety Evaluation
All GRAS submissions for D-Allulose include comprehensive toxicology, mutagenicity, and human tolerance studies. FDA reviewers concluded that intakes up to approximately 0.5–0.6 g per kg body weight per day are safe; for a 60 kg adult this corresponds to about 33–36 g daily without adverse effects.
Labeling Update
On April 17 2019, FDA announced it will exercise enforcement discretion to exclude D-Allulose from the “Total Sugars” and “Added Sugars” lines on Nutrition and Supplement Facts labels, while still counting it under “Total Carbohydrate” and applying a caloric factor of 0.4 kcal/g.
Use Scope
Under GMP principles, D-Allulose is now used broadly across baked goods, beverages, dairy products, confections, cereals and more. FDA has not set a fixed maximum use level; manufacturers reference the GRAS notices above for guidance on safe use levels.
EU (European Union)
Status
D-Allulose is not currently approved for sale as a food ingredient in the European Union. In the EU, it is classified as a “novel food,” which means it requires a specific authorization under Regulation (EU) 2015/2283 before it can be marketed.
Novel Food Classification
Because D-Allulose was not widely consumed in the EU before 15 May 1997, it falls under the Novel Food Regulation (EU) 2015/2283. Any applicant wishing to place D-Allulose on the EU market must submit a dossier demonstrating its safety under the conditions of intended use.
Authorization Process
- An application must be submitted to the European Commission, including full data on identity, production process, compositional specifications, proposed uses and use levels.
- EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) conducts a safety assessment and publishes a Scientific Opinion.
- If EFSA’s opinion is positive, the Commission drafts an implementing act to authorize D-Allulose across the Union; if negative, the application is halted or sent back for further data.
Safety Assessment by EFSA
- EFSA published its Scientific Opinion (adopted 6 May 2025), concluding that the safety of D-Allulose could not be established due to critical gaps in the toxicological data—particularly the absence of a combined chronic toxicity and carcinogenicity study and insufficient human data on long-term consumption .
- EFSA requested the applicant to provide additional studies on genotoxicity, chronic toxicity, carcinogenicity and human tolerance. To date, those data have not been submitted.
Potential Benefits
D-Allulose is under investigation as a low-calorie sugar substitute that may help manage post-prandial blood glucose and support caloric reduction without compromising taste. Its proposed applications span beverages, baked goods, dairy and confectionery.
Ongoing Efforts
A consortium of ingredient producers and academic partners has formed to coordinate the compilation of a complete dossier and streamline the Novel Food application process. Industry sources report continued dialogue with EFSA to address outstanding data gaps.
Authority Links
- Regulation (EU) 2015/2283 (Novel Foods)
https://eur-lex.europa.eu/eli/reg/2015/2283/oj - EFSA Scientific Opinion on D-Allulose (NDA Q-2018-00756)
https://doi.org/10.2903/j.efsa.2025.9468 - EFSA Novel Food Catalogue
https://ec.europa.eu/food/safety/novel_food/catalogue/search/public/index.cfm
Outlook
If the applicant submits the requested toxicological and human studies in full, EFSA may re-evaluate the dossier and a positive authorization could be anticipated within 2–3 years.
China
Approval Status
On July 2, 2025, China’s National Health Commission published the “Announcement on 20 New ‘Three-Category Foods’ Such as D-Allulose” (2025 No. 4), formally approving D-Allulose as a new food raw material under the “Three New” review process. This marks the first sugar-type raw material produced via microbial fermentation to receive approval in China (nhc.gov.cn, BSH Ingredients LIMITED).
Safety Evaluation
- Application timeline: Accepted November 18 2020; opened for public comment March 21 2025; approved July 2 2025 (BSH Ingredients LIMITED).
- Production methods:
- Microbial fermentation using Escherichia coli AS10 with glucose or sucrose substrate
- Enzymatic conversion of fructose via a permitted D-Allulose 3-epimerase
- Composition & purity: ≥ 98 g D-Allulose per 100 g
- Toxicology & digestibility: Comprehensive toxicology data reviewed; no safety concerns at intended use levels
- Intake recommendation: Maximum 20 g per day for general population; infants, pregnant women and lactating mothers are advised not to consume due to limited safety data (BSH Ingredients LIMITED).
Use Scope
D-Allulose may be added to ordinary foods as a functional sweetener under Good Manufacturing Practice. There are no category-specific use limits, but product labels must:
- State the maximum daily intake (20 g)
- Advise that infants, pregnant women and lactating mothers should avoid consumption (BSH Ingredients LIMITED).
Authority Links
- National Health Commission announcement (2025 No. 4 Novel Foods): https://www.nhc.gov.cn/sps/c100088/202507/63194b55e9fd4a6daa74f59a06cfd792.shtml (nhc.gov.cn)
- Interpretation of the announcement: https://www.nhc.gov.cn/sps/c100087/202507/f7de435b03e049d3a5b3acd8f6eabd72.shtml (nhc.gov.cn)
- BSH Ingredients summary: https://www.bshingredients.com/national-health-commission-of-the-prc-approves-d-allulose-powder-as-new-food-ingredient/ (BSH Ingredients LIMITED)
Prediction
With formal approval now in place and rising demand for low-calorie sweeteners, China’s D-Allulose market is expected to expand rapidly over the next two to three years, driving wider adoption in beverages, baked goods, dairy products and nutritional supplements.
Canada
Approval Status
D-Allulose is not approved for use in ordinary foods in Canada and remains under Health Canada’s Novel Food assessment. However, the Natural Health Products Directorate lists D-Allulose (as “D-Psicose”) as an acceptable non-medicinal ingredient in Natural Health Products (dietary supplements)
Novel Food Classification
- D-Allulose is classified as a novel food because it was not widely consumed in Canada before May 15, 1997.
- Under Canada’s Food and Drug Regulations, novel foods must undergo a pre-market safety assessment by Health Canada’s Food Directorate before they can be authorized for sale as food
Safety Evaluation
- As of mid-2025, no completed assessment for D-Allulose appears on Health Canada’s “Completed Safety Assessments of Novel Foods” list.
- Health Canada requires comprehensive data on identity, production methods, composition, toxicology and human tolerance.
- In the absence of a finalized review, foods containing D-Allulose cannot be marketed, though imported products sometimes circulate in a regulatory gray zone
Natural Health Products Listing
- The Natural Health Products Ingredients Database (NHPID) lists D-Psicose as a pre-cleared non-medicinal ingredient for oral use only, subject to NHP quality and labeling standards
- This listing permits D-Allulose in supplements but does not extend to ordinary food products
Market Availability and Legal Status
- D-Allulose is not banned in Canada and can be purchased online (for example, via Amazon.ca), but such products lack formal approval and Canadian bilingual labeling
- Any imported allulose-containing food may fail to meet Canadian packaging and nutrient-content requirements
Authority Links
- Health Canada Novel Foods – Approved Products
https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/approved-products.html - Natural Health Products Ingredients Database (NHPID)
https://webprod.hc-sc.gc.ca/nhpid-bdipsn/ - Sugar Substitutes Approved in Canada
https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/sugar-substitutes.html
Market Outlook
With approvals in the United States, Japan, Korea and Australia, Canada’s Novel Food review is likely to conclude within the next two to three years. Once authorized, D-Allulose is expected to see rapid uptake in low-calorie foods and beverages as consumer demand for sugar-reduced and glycemic-friendly products continues to grow.
Australia & New Zealand
Approval Status
FSANZ approved D-Allulose as a Novel Food ingredient on 7 August 2024 (Food Standards Australia New Zealand).
Use Conditions
Allowed as a table-top sweetener and in specified food categories (flavored beverages, bakery goods, ice cream, confectionery, yogurt, breakfast cereals) with maximum use levels (≤ 3.5 % in beverages; ≤ 10 % in bakery; ≤ 1.9 % in ice cream) and a mandatory warning “Excess consumption may cause laxative effects” (Food Standards Australia New Zealand).
Authority Links
- Approval Report A1247 (PDF): https://www.foodstandards.gov.au/sites/default/files/2024-08/A1247%20Approval%20Report.pdf (Food Standards Australia New Zealand)
- Application A1247 webpage: https://www.foodstandards.gov.au/food-standards-code/applications/A1247-D-allulose-as-a-novel-food (Food Standards Australia New Zealand)
Market Outlook
With rising demand for low-calorie sweeteners, Australia and New Zealand are set to expand D-Allulose use across mainstream beverages, dairy and bakery over the next two years.
Mexico
Approval Status
COFEPRIS approved D-Allulose as a non-caloric sweetener around 2018–2019 (BSH Ingredients LIMITED).
https://www.gob.mx/cms/uploads/attachment/file/628596/ANEXO%20VII.pdf
Labeling
Exempt from “Total Sugar” and “Added Sugar” declarations; treated like erythritol or other sugar alcohols under GMP with no strict use limits.
Industry Impact
Ingredion opened a local allulose production plant in 2019 to supply the Americas, boosting regional availability and encouraging product development (Powder & Bulk Solids).
Authority Links
- COFEPRIS approved list (ANEXO VII PDF): https://www.gob.mx/cms/uploads/attachment/file/628596/ANEXO%20VII.pdf
- https://www.sweeteners.org/wp-content/uploads/2020/09/allulose-technical-factsheet.pdf
Market Outlook
As Latin America’s leading sweetener market, Mexico is likely to drive broader D-Allulose adoption in beverages and dairy over the next 3–5 years.
Japan
Approval Status
Treated as an ordinary food ingredient since the 2010s with no special approval required; set at 0 kcal/g for nutrition labelling
Use Scope
Freely added to any food or beverage. Industry practice recommends limiting daily intake to 30 g to avoid possible abdominal discomfort.
Authority Links
- Ministry of Health, Labour and Welfare Nutrition Labelling Standards: https://www.mhlw.go.jp/english/topics/foodsafety/faq/07.html
Market Outlook
Japan’s mature market and high consumer awareness will support continued growth in premium low-calorie foods and functional products over the next five years.
Korea
Approval Status
MFDS listed D-Allulose as a food ingredient in 2018 and set its energy factor to 0 kJ/g in 2016; since 2020 it is permitted even in alcoholic beverages (MFDS).
Use Scope
Permitted in all foods under GMP with no specific maximum levels; alcoholic beverage producers may use D-Allulose to reduce fermentable sugars (MFDS).
Authority Links
- MFDS draft amendment adding Allulose as a raw material (PDF): https://www.mfds.go.kr/brd/m_1200/down.do?brd_id=exp013&data_tp=A&file_seq=1&seq=350 (MFDS)
Market Outlook
Korea’s proactive regulation and domestic production capacity point to rapid D-Allulose integration across beverages, confectionery and fermented foods within two years.
Singapore
Approval Status
Recognized as a general food ingredient since around 2020 following an internal safety review by the Singapore Food Agency (Food Research Lab).
Use Scope
No category-specific limits. Labelling follows international norms by counting D-Allulose in total carbohydrates but exempting it from “sugars” where applicable (Default).
Authority Links
- SFA Food Additives Search: https://www.sfa.gov.sg/tools-and-resources/food-additives-search (Default)
- Food Additives Permitted under the Singapore Food Regulations (PDF): https://www.sfa.gov.sg/docs/default-source/tools-and-resources/list-of-food-additives-permitted-under-food-regulations673e4fa37bb7440d9c23905a343796fe.pdf (Default)
Market Outlook
Singapore’s role as a regional hub and lack of use restrictions will accelerate D-Allulose uptake in RTD beverages and functional snacks over the next 2–3 years.
Summary
Global D-Allulose Regulatory Approval Guide 2025 provides a clear overview of D-Allulose approval status in the United States, China, European Union, Canada, Australia & New Zealand, Mexico, Japan, Korea and Singapore. You’ll find GRAS notices, Novel Food evaluations, safety data, use conditions, labeling requirements and official authority links to help you ensure compliance. BSH Ingredients, one of China’s largest suppliers, exports over 3 000 tons of bulk D-Allulose powder and liquid annually at competitive wholesale prices.
