Food Safety Substance
PullulanE1204
Pullulan (E1204) is a food additive with PUBLISHED in the EU, FDA has no questions in the US, and data from 8 regulatory sources.
Substance Identity
Resolved identifiers used to render this food-safety record.
Multi-Jurisdiction Comparison
Side-by-side status rows for the same resolved substance across public food regulators.
| Jurisdiction | Authority | Status | Evidence |
|---|---|---|---|
| European Union | EU Commission | PUBLISHED | EU additive listing; Annex II entry |
| United States | FDA | FDA has no questions | GRAS notice |
| Canada | Health Canada | Listed | Food enzyme |
| Codex | Codex Alimentarius | Listed | Glazing agent; Thickener |
EU Food Additive Status
EU Commission food-additive listing rows from eu_food_additives.
| Jurisdiction | E-number | Status | Type | Name | Note |
|---|---|---|---|---|---|
| European Union | E1204 | PUBLISHED | substanceFAD | Pullulan | - |
EU Annex II Authorised Uses
Authorised additive rows and use conditions from EU Annex II tables.
| Jurisdiction | E-number | Name | INS | Policy item | Note |
|---|---|---|---|---|---|
| European Union | E1204 | Pullulan | - | POL-FAD-IMPORT-3313 | - |
Conditions and restrictions
| Jurisdiction | Food category | Restriction | Comment | Source |
|---|---|---|---|---|
| European Union | 5.2 Other confectionery including breath freshening micro-sweets | quantum satis | only breath freshening microsweets in the form of films | EU Annex II Union List |
| European Union | 17.1 food supplements supplied in a solid form excluding food supplements for infants and young children’, | quantum satis | only food supplements in capsule and tablet form | EU Annex II Union List |
| European Union | 5.2 Other confectionery including breath freshening micro-sweets | quantum satis | only breath freshening microsweets in the form of films | EU Food Additives Database |
| European Union | 17.1 food supplements supplied in a solid form excluding food supplements for infants and young children’, | quantum satis | only food supplements in capsule and tablet form | EU Food Additives Database |
Codex GSFA Status
Codex Alimentarius GSFA permissions and maximum-use rows.
| Jurisdiction | INS / E-number | Function | Food category | Max level | Notes |
|---|---|---|---|---|---|
| Codex | 1204 | Glazing agent; Thickener | 04.2.2.7 Fermented vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera) and seaweed products, excluding fermented soybean products of food categories 06.8.6, 06.8.7, 12.9.1, 12.9.2.1 and 12.9.2.3 | GMP | Excluding products conforming to the Standard for Pickled Fruits and Vegetables (CODEX STAN 260-2007).; Excluding products conforming to the Standard for Gochujang (CXS 294-2009). |
| Codex | 1204 | Glazing agent; Thickener | 06.2.1 Flours | GMP | Excluding products conforming to the Standard for Wheat Flour (CXS 152-1985).; For use at GMP in full fat soy flour only.; Excluding products conforming to the Regional Standard... |
| Codex | 1204 | Glazing agent; Thickener | 06.4.1 Fresh pastas and noodles and like products | GMP | For use in noodles only. |
| Codex | 1204 | Glazing agent; Thickener | 06.4.2 Dried pastas and noodles and like products | GMP | For use in noodles, gluten-free pasta and pasta intended for hypoproteic diets only. |
| Codex | 1204 | Glazing agent; Thickener | 09.2.2 Frozen battered fish, fish fillets, and fish products, including mollusks, crustaceans, and echinoderms | GMP | Excluding products conforming to the Standard for Quick Frozen Fish Sticks (Fish Fingers), Fish Portions and Fish Fillets – Breaded or in Batter (CODEX STAN 166-1989).; For use in... |
| Codex | 1204 | Glazing agent; Thickener | 09.2.3 Frozen minced and creamed fish products, including mollusks, crustaceans, and echinoderms | GMP | - |
| Codex | 1204 | Glazing agent; Thickener | 09.2.4.1 Cooked fish and fish products | GMP | For use in surimi products only. |
| Codex | 1204 | Glazing agent; Thickener | 09.2.4.3 Fried fish and fish products, including mollusks, crustaceans, and echinoderms | GMP | For use in breading or batter coatings only. |
| Codex | 1204 | Glazing agent; Thickener | 09.2.5 Smoked, dried, fermented, and/or salted fish and fish products, including mollusks, crustaceans, and echinoderms | GMP | Excluding products conforming to the Standard for Salted Atlantic Herring and Salted Sprat (CODEX STAN 244-2004).; Excluding products conforming to the Standard for Salted Fish... |
| Codex | 1204 | Glazing agent; Thickener | 10.2.2 Frozen egg products | GMP | - |
| Codex | 1204 | Glazing agent; Thickener | 11.4 Other sugars and syrups (e.g. xylose, maple syrup, sugar toppings) | GMP | Excluding maple syrup. |
| Codex | 1204 | Glazing agent; Thickener | 14.1.5 Coffee, coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages, excluding cocoa | GMP | For use in ready-to-drink products and pre-mixes for ready-to-drink products only. |
FDA GRAS Status
US FDA GRAS notice evidence from enriched and notice tables.
| Jurisdiction | GRN | Substance | FDA response | Intended use | Basis | Notifier |
|---|---|---|---|---|---|---|
| United States | 20 | Pullulanase derived from Bacillus subtilis carrying a gene encoding pullulanase from Bacillus naganoensis | FDA has no questions | Use in hydrolyzing starch and starch-related compounds in the production of corn sweeteners, baked goods, and alcoholic beverages at minimum levels necessary to accomplish the... | Scientific procedures | Enzyme Bio-Systems Ltd. |
| United States | 72 | Pullulanase derived from Bacillus licheniformis carrying a gene encoding pullulanase from B. deramificans | FDA has no questions | Use in the manufacture of starch hydrolysates and high fructose corn syrup as a processing aid at a minimum level necessary in accordance with good manufacturing practice | Scientific procedures | Genencor International Inc. |
| United States | 99 | Pullulan | FDA has no questions | Use in food in general, including meat products, for multiple technical effects | Scientific procedures | Hayashibara International |
| United States | 205 | Pullulanase enzyme preparation from Bacillus subtilis expressing the pullulanase gene from B. acidopullulyticus | FDA has no questions | As an enzyme in the brewing industry (to hydrolyze 1-6- alpha-D-glucosidic linkages in pullulan, amylopectin, and glycogen) | Scientific procedures | Novozymes North America Inc. |
| United States | 309 | Beta-glucan derived from Aureobasidium pullulans | FDA has no questions | Ingredient in baked goods and baking mixes, beverages and beverage bases, cereal and cereal products, dairy product analogs, milk and milk products, plant protein products... | Scientific procedures | Glucan Corporation, Limited |
| United States | 645 | Pullulanase from Bacillus deramificans and Bacillus acidopullulyticus expressed in Bacillus licheniformis | FDA has no questions | For use as a processing aid in the production of dextrose and maltose syrups. | Scientific procedures | Novozymes North America, Inc. |
| United States | 861 | Pullulanase from Bacillus deramificans produced in Bacillus subtilis | FDA has no questions | Intended for use as an enzyme in the saccharification of liquified starch in the production of dextrose and maltose syrups. | Scientific procedures | GenScript/Bestzyme |
| United States | 20 | Pullulanase derived from <i>Bacillus subtilis</i> carrying a gene encoding pullulanase from <i>Bacillus naganoensis</i> | FDA has no questions | Use in hydrolyzing starch and starch-related compounds in the production of corn sweeteners, baked goods, and alcoholic beverages at minimum levels necessary to accomplish the... | Scientific procedures | Enzyme Bio-Systems Ltd. |
| United States | 72 | Pullulanase derived from <i>Bacillus licheniformis</i> carrying a gene encoding pullulanase from <i>B. deramificans</i> | FDA has no questions | Use in the manufacture of starch hydrolysates and high fructose corn syrup as a processing aid at a minimum level necessary in accordance with good manufacturing practice | Scientific procedures | Genencor International Inc. |
| United States | 99 | Pullulan | FDA has no questions | Use in food in general, including meat products, for multiple technical effects | Scientific procedures | Hayashibara International |
| United States | 205 | Pullulanase enzyme preparation from <i>Bacillus subtilis</i> expressing the pullulanase gene from <i>B. acidopullulyticus</i> | FDA has no questions | As an enzyme in the brewing industry (to hydrolyze 1-6- alpha-D-glucosidic linkages in pullulan, amylopectin, and glycogen) | Scientific procedures | Novozymes North America Inc. |
| United States | 309 | Beta-glucan derived from <i>Aureobasidium pullulans</i> | FDA has no questions | Ingredient in baked goods and baking mixes, beverages and beverage bases, cereal and cereal products, dairy product analogs, milk and milk products, plant protein products... | Scientific procedures | Glucan Corporation, Limited |
| United States | 645 | Pullulanase from <I>Bacillus deramificans</i> and <I>Bacillus acidopullulyticus</I> expressed in <I>Bacillus licheniformis</I> | FDA has no questions | For use as a processing aid in the production of dextrose and maltose syrups. | Scientific procedures | Novozymes North America, Inc. |
| United States | 861 | Pullulanase from <i>Bacillus deramificans</i> produced in <i>Bacillus subtilis</i> | FDA has no questions (in PDF) | Intended for use as an enzyme in the saccharification of liquified starch in the production of dextrose and maltose syrups. | Scientific procedures | GenScript/Bestzyme |
Health Canada Status
Health Canada food-additive permissions by functional class and food scope.
| Jurisdiction | Class | Permitted foods | Maximum level | List |
|---|---|---|---|---|
| Canada | Food enzyme | (a) Bread; White flour; Whole wheat flour | (a) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (b) Starch used in the manufacture of dextrins, dextrose, fructose syrups and solids, glucose, glucose solids or maltose | (b) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (c) Unstandardized bakery products | (c) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (a) Bread; White flour; Whole wheat flour | (a) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (b) Brewers' mash | (b) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (c) Starch used in the manufacture of dextrins, dextrose, fructose syrups and solids, glucose, glucose solids or maltose | (c) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (d) Unstandardized bakery products | (d) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (a) Bread; White flour; Whole wheat flour | (a) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (b) Brewers' mash | (b) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (c) Distillers' mash | (c) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (d) Starch used in the manufacture of dextrins, dextrose, fructose syrups and solids, glucose, glucose solids or maltose | (d) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (e) Unstandardized bakery products | (e) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (a) Brewers' mash | (a) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (b) Distillers' mash | (b) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (c) Starch used in the manufacture of dextrins, dextrose, glucose, glucose solids or maltose | (c) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (a) Beer | (a) Good Manufacturing Practice | List of Permitted Food Enzymes |
| Canada | Food enzyme | (b) Brewers' mash | (b) Good Manufacturing Practice | List of Permitted Food Enzymes |
JECFA ADI Values
JECFA ADI records and evaluation years.
| Jurisdiction | Chemical name | JECFA no. | CAS | ADI | ADI upper | Function | Evaluation year |
|---|---|---|---|---|---|---|---|
| JECFA | KLEBSIELLA AEROGENES PULLULANASE | - | - | no_data | - | - | 1981 |
| JECFA | PULLULANASE from KLEBSIELLA AEROGENES | - | - | no_data | - | ENZYME_PREPARATION | 1981 |
| JECFA | PULLULAN | - | - | NOT SPECIFIED | - | THICKENER, GLAZING_AGENT | 2011 |
| JECFA | PULLULANASE from BACILLUS DERAMIFICANS expressed in BACILLUS LICHENIFORMIS | - | - | NOT SPECIFIED | - | ENZYME_PREPARATION | 2011 |
Cross-Reference to Cosmetics / Chemicals / Pharma
Same-CAS public rows from adjacent Roots verticals where available.
Cross-Vertical Regulatory Divergence
This substance has different regulatory treatment across food, cosmetics, and industrial use.
Frequently Asked Questions
Food-use, safety, ADI, and cross-vertical answers mirrored into FAQPage JSON-LD.
What is Pullulan used for in food?
Pullulan appears in food-use rows as: stabilizer|thickener; Glazing agent; Thickener; Food enzyme.
Is Pullulan / E1204 safe?
This page does not assign a standalone safety verdict; it renders public regulatory evidence. ADI/reference value: ADI NOT SPECIFIED . EU status evidence: PUBLISHED. US/FDA evidence: FDA has no questions.
What is the ADI for Pullulan?
Pullulan has this ADI/reference value in the food-safety tables: ADI NOT SPECIFIED . Source: food_substances.
Is Pullulan also used in cosmetics?
Pullulan has a same-CAS cosmetics cross-reference: Pullulan, EU status permitted.