Pullulan
9057-02-7 · Amylotriose · E 1204 · Maltotriose · PULLULAN · E1204 · 1204 · (2R,3R,4S,5S,6R)-2-[(2R,3S,4R,5R,6R)-4,5-dihydroxy-2-(hydroxymethyl)-6-[(2R,3S,4R,5R)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol · Pullulan · Pullulaan · Pullulaani · Pullulan · PULLULANO · Pullulāns · Pululan · Pululana · Pululanas · Pululano · Πουλουλάνη · ПулуланE number E1204INS 1204CAS 9057-02-7
Listed as a thickener and a glazing agent by Codex.
Listed as thickeners (Codex) · glazing and surface-finishing agents (Codex)
- Codex Alimentarius: Thickener — CXS 192-1995 Table One, INS 1204
- Codex Alimentarius: Glazing agent — CXS 192-1995 Table One, INS 1204
Pullulan is a fermentation-derived polysaccharide that forms clear, oxygen-tight films. It is used for breath-freshening strips and as a vegetarian capsule material.
Where it is and isn’t permitted
| Jurisdiction | Status | Scope and limits | Citation |
|---|---|---|---|
| Australia and New Zealand | No listed food uses foundThis site has not matched this substance to any food use on this jurisdiction’s list of authorised food additives. A food additive may be used only in foods that list names. Flavourings, enzymes, processing aids and added nutrients are regulated separately and do not appear on it. | ||
| Canada | No listing matchedHealth Canada’s lists name additives without E or INS numbers, so this site matches them by exact name. A substance listed there under a name this site does not recognise has no row here. | ||
| European Union | Permitted, with conditions | 2 food categories Show every food category
| Regulation (EC) No 1333/2008, Annex IIand 1 further provisionretrieved 2026-10-18 |
| Great Britain | Permitted, with conditions | 2 food categories Show every food category
| Assimilated Regulation (EC) No 1333/2008and 1 further provisionretrieved 2026-10-18 |
| Japan | No listing matchedThis site imports only Japan’s list of designated additives (Appended Table 1 to the Regulations for Enforcement of the Food Sanitation Act), matched by English name. Existing additives, natural flavouring agents and ordinary foods used as additives are permitted outside that list and are not imported, so an empty row does not show that Japan does not permit the substance. | ||
| South Korea | Permitted, with conditions | Designated food additive: Standards and Specifications for Food Additives, Part III, 1. …Designated food additive: Standards and Specifications for Food Additives, Part III, 1. 일반식품첨가물 (general food additives), 풀루란 (“Pullulan”, the English the Code prints beside it). Main use (주용도) of 풀루란: 피막제. Standard for use (사용기준) of 풀루란: (1) [to be used under the general standard for use in II. 2. 1), the minimum amount that achieves the technical effect, with no limit set for this additive in particular] “II. 2. 1)의 규정에 따라 사용하여야 한다.” The Korean is the standard as published. There is no official English translation of the current Code (the English version on MFDS’s website is the 2020 edition and has no legal effect); the English in square brackets is this site’s description of what each sentence does, not a translation of the foods or the levels. Compositional specifications (Part IV) are not imported, nor are the general standards in Part II, which apply to every additive. | Standards and Specifications for Food Additives (식품첨가물의 기준 및 규격), MFDS Notification, Part III (Standards for use, by item)retrieved 2026-10-18 |
| United States | Not listedDoes not appear on this jurisdiction’s permitted list. That is not the same as being prohibited. | ||
| Codex Alimentarius | Permitted, with conditions | 12 food categories no numerical limit (good manufacturing practice) Show every food category and its notes
| CXS 192-1995 Table Three, INS 1204and 12 further provisionsretrieved 2026-09-07 |
How much is permitted
A listing usually limits the quantity as well as the food. Only one of the forms that takes is a figure: quantum satis and good manufacturing practice permit the amount the technological effect requires and no more, which is a limit rather than the absence of one. Figures below are the range across every food category this page is listed in, and categories differ between regulators — see how much is permitted.
| European Union | — | 2 quantum satis |
|---|---|---|
| Great Britain | — | 2 quantum satis |
| South Korea | — | 1 no quantity stated |
| Codex Alimentarius | — | 13 GMP |
No regulator sets a figure for Pullulan. That is not an absence of control: where the listing says quantum satis or good manufacturing practice, the quantity is limited to what the effect requires.
GRAS notices to the FDA
A GRAS notice is a company’s conclusion that a substance is generally recognised as safe for the use it describes. FDA’s letter responds to that conclusion, for that notifier and that use. It is not a listing in 21 CFR, and it is not counted as a US permission above. The substance and use are as FDA’s inventory words them; this site matched the notice to this page by exact name.
GRN No. 99 · Pullulan · Hayashibara International
Intended use: Use in food in general, including meat products, for multiple technical effects
FDA’s response (2002-08-01): FDA has no questions
What it is made from
Produced by fermenting a starch syrup with the fungus Aureobasidium pullulans, then recovering and drying the polysaccharide.
- Vegan
- Vegetarian
Compare other additives on the dietary indexes.
- CAS registry number
- 9057-02-7
The two specifications, compared
The European Union sets identity and purity by regulation; JECFA publishes its own through FAO, advisory until a country adopts it. Both documents are below in full. These are the parameters each puts a number on.
| Parameter | European Union | JECFA |
|---|---|---|
| Assay | no less than 90 % | no less than 90 % |
| Loss on drying | no more than 6 % | no more than 6 % |
| Lead | no more than 1 mg/kg | no more than 1 mg/kg |
The two documents state the same figures for every parameter compared here.
How the EU defines it
The legal specification an additive must meet to be sold as this E number in the EU — what it is, how it may be made, and the purity it must reach. From Commission Regulation (EU) No 231/2012.
E 1204 Pullulan
Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography
Assay, identification and purity criteria
Description and assay
- Einecs
- 232-945-1
- Chemical formula
- (C₆H₁₀O₅)ₙ
- Assay
- Not less than 90 % of glucan on the dried basis
- Description
- White to off-white odourless powder
Identification
- Solubility
- Soluble in water, practically insoluble in ethanol
- pH
- 5,0 to 7,0 (10 % solution)
- Precipitation with polyethylene glycol 600
- Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed
- Depolymerisation with pullulanase
- Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1 ml pullulanase solution having activity 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25 °C for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution
- Viscosity
- 100 to 180 mm²/s (10 % w/w aqueous solution at 30 °C)
Purity criteria
- Loss on drying
- Not more than 6 % (90 °C, pressure not more than 50 mm Hg, 6 hours)
- Mono-, di- and oligosaccharides
- Not more than 10 % expressed as glucose
- Lead
- Not more than 1 mg/kg
- Microbiological criteria: Yeast and moulds
- Not more than 100 colonies per gram
- Microbiological criteria: Coliforms
- Absent in 25 g
- Microbiological criteria: Salmonella spp.
- Absent in 25 g
How JECFA defines it
The international specification for identity and purity, prepared by the Joint FAO/WHO Expert Committee on Food Additives and published by FAO. It is a different document from any above, written by a different body and revised on its own cycle; it is advisory, and a country adopts it or does not.
INS 1204 Pullulan
Linear, neutral glucan consisting mainly of maltotriose units connected by α -1,6 glycosidic bonds. It is produced by fermentation from a food grade hydrolysed starch using a non-toxigenic strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilized and pigments and other impurities are removed by adsorption and ion exchange chromatography.
Synonyms: INS No. 1204
Assay, identification and purity criteria
Description and assay
- Specification history
- Prepared at the 74th JECFA (2011) and published in FAO JECFA Monographs 11 (2011), superseding specifications prepared at the 65th JECFA (2005), published in the Combined Compendium of Food Additive Specifications, FAO JECFA Monographs 1 (2005). An ADI ‘not specified’ was established at the 65th JECFA (2005) and maintained at the 74th JECFA (2011).
- C.A.S. number
- 9057-02-7
- Chemical formula
- (C36H60O30)n
- Assay
- Not less than 90% of glucan on the dried basis
- DESCRIPTION
- White to off-white odourless powder
- FUNCTIONAL USES
- Glazing agent, film-forming agent, thickener
- METHOD OF ASSAY
- Calculate the percentage of pullulan on the dried basis, P, as the difference between 100% and the sum of the percentages of known impurities (mono-, di- and oligosaccharides). P (%) = [100 – C] where C is taken from the calculation for mono-, di- and oligosaccharides. 5 out of 5
Identification
- Solubility (Vol. 4)
- Soluble in water, practically insoluble in ethanol
- pH (Vol. 4)
- 5.0 - 7.0 (10% solution) 2 out of 5
- Precipitation with polyethylene glycol 600
- Add 2 ml of polyethylene glycol 600 to 10 ml of a 2% aqueous solution of pullulan. A white precipitate is formed.
- Depolymerization with pullulanase
- Prepare two test tubes each with 10 ml of a 10% pullulan solution. Add 0.1 ml pullulanase solution having activity 10 units/g (refer to pullulanase activity, under Methods for enzyme preparations in Volume 4) to one test tube, and 0.1 ml water to the other. After incubation at about 25° for 20 min, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution.
Purity criteria
- Loss on drying (Vol. 4)
- Not more than 6% (90°, pressure not more than 50 mmHg, 6 h)
- Mono-, di- and oligosaccharides
- Not more than 10% (expressed as glucose) on the dried basis See description under TESTS
- Viscosity
- 100 – 180 mm2/s (10% w/w aqueous solution at 30°) See description under TESTS
- Lead (Vol. 4)
- Not more than 1 mg/kg Determine using an AAS/ICP-AES technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the methods described in Volume 4 (under “General Methods, Metallic Impurities”).
- Microbiological criteria (Vol. 4)
- Yeast and moulds: Not more than 100 CFU/g Coliforms: Negative in 25 g Salmonella: Negative in 25 g
- Test: Mono-, di- and oligosaccharides
- Principle The soluble mono-, di- and oligosaccharides of pullulan are measured using the anthrone-sulfuric acid method after pullulan has been precipitated with methanol and KCl. Equipment Spectrophotometer capable of measuring absorbance at 620 nm Procedure Preparation of standard: Weigh accurately 0.2 g glucose, dissolve in water and make up to 1 l. 3 out of 5 Measurement of mono-, di- and oligosaccharides: Weigh accurately 0.8 g sample previously dried and dissolve in water to make 100 ml (stock solution). Place 1 ml of the stock solution in a centrifuge tube. Add 0.1 ml saturated potassium chloride solution. Add 3 ml methanol and mix vigorously for 20 sec. Centrifuge at 11000 rpm for 10 minutes. Add 0.2 ml of the supernatant to 5 ml modified anthrone solution (0.2 g anthrone in 100 g 75% (v/v) sulfuric acid, freshly prepared). Add 0.2 ml of glucose standard solution and 0.2 ml water (blank control) to separate 5 ml portions of modified anthrone solution. Mix rapidly. Place samples in a 90° water bath and incubate for 15 min. Measure absorbance of the test solution at 620 nm. Calculate the percent of mono-, di- and oligosaccharides expressed as glucose, C, in the sample: C (%) = [(At – Ab) × 0.41 × G × 100] / (As – Ab) × W where At is absorbance of the test solution; Ab is absorbance of the water blank; As is absorbance of the standard solution; G is weight of the glucose (g); and W is weight of the sample (g).
- Test: Viscosity
- Dry the sample for 6 h at 90º under reduced pressure (50 mm Hg). Weigh 10.0 g of the sample and dissolve in water to yield 100 g of solution. Use an Ubbelohde-type (falling-ball) viscometer. Charge the viscometer with sample in the manner dictated by the design of the instrument. Immerse the viscometer vertically in the thermostatic tank at 30 ± 0.1° and allow to stand for 20 min so that the sample equilibrates with the temperature in the tank. Adjust the meniscus of the column of liquid in the capillary tube to a position about 5 mm above of the first mark. With the sample flowing freely, measure, in seconds, the time required for the meniscus to pass from the first to the second mark. Calculate the viscosity, V: V (mm2/s) = C × t where C is the calibration constant of the viscometer (mm2/s2); and t is the flow time (s). 4 out of 5
Every name it appears under
20 recorded names. A label may use any of them.
E number
- E1204
INS number
- 1204
CAS registry number
- 9057-02-7
As it appears in regulation
- Pullulan
Other names
- Amylotriose
- E 1204
- Maltotriose
- PULLULAN
Systematic names
- (2R,3R,4S,5S,6R)-2-[(2R,3S,4R,5R,6R)-4,5-dihydroxy-2-(hydroxymethyl)-6-[(2R,3S,4R,5R)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol
Hazard reference values
EFSA and JECFA have both assessed Pullulan and their conclusions are not two comparable figures — EFSA records not allocated, JECFA not specified. An acceptable daily intake is a reference value set by a committee, not a threshold above which harm begins. “Not specified”, “not limited” and “not allocated” are conclusions, not missing data, and they are shown in the words each body used rather than reduced to a number. See where the two committees differ.
| Type | Value | Population | Assessed by | Opinion |
|---|---|---|---|---|
| ADI | not allocated | consumers | EFSA FAF | 2025 |
| ADI | not specified | — | JECFA | 2011 |
Evidence and how bodies read it
What assessing bodies concluded
Each conclusion is paraphrased in the body's own framing, from the published opinion linked beneath it. Where bodies differ, both stand; this site does not adjudicate between them or add a view of its own.
EFSA 2025
The FAF Panel found no genotoxicity concern for pullulan (E 1204) and concluded that no numerical ADI is needed and there is no safety concern at reported uses or proposed extended uses. It noted that high consumers, mainly via food supplements, may experience mild gastrointestinal symptoms.
Common questions
Assembled from what is above, in the words the questions are usually asked in. Each answer is the same statement the relevant section makes, with the same citations behind it.
- What is E 1204?
- E 1204 is Pullulan. Pullulan is a fermentation-derived polysaccharide that forms clear, oxygen-tight films. It is used for breath-freshening strips and as a vegetarian capsule material.
- What is Pullulan used for in food?
- It is listed as a thickener and a glazing agent — the role Codex assigns it. This page shows every function each regulator records, with the citation for each.
- Where is Pullulan permitted?
- Of the seven regulators this site reads, the EU, Great Britain, South Korea and the Codex standard permit it. Each permission is for named foods at named levels, not a blanket one; the table on this page gives them with citations.
- Is Pullulan vegan?
- Yes. Pullulan is not derived from animals, and is suitable for vegetarians. This page says what it is made from and how.
Sources for this page
- eu retrieved 2026-10-18
- gb retrieved 2026-10-18
- kr retrieved 2026-10-18
- gsfa retrieved 2026-09-07
- euspecs retrieved 2026-10-18
- jecfaspecs retrieved 2026-09-23
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