Classification
Product TypeIngredient
Product FormPowder
Industry PositionFood additive (hydrocolloid / glazing agent / thickener)
Market
In the United States, pullulan is used as a food ingredient/additive for multiple technical effects; FDA’s GRAS Notice GRN 99 (Pullulan) closed with an FDA “no questions” letter for use in food in general, including meat products. Internationally, pullulan is listed in the Codex GSFA (INS 1204) with functional classes including glazing agent and thickener, and it has JECFA specifications. As an imported or domestically distributed ingredient, U.S. market access is primarily governed by FDA import requirements (facility registration, prior notice, and importer verification under FSMA/FSVP) and standard customs entry processes. Commercial use in the U.S. therefore depends less on seasonality or agriculture and more on regulatory fit-for-use, documentation, and supply assurance for food manufacturers.
Market RoleDomestic consumer and formulation market (GRAS-notified food additive/ingredient)
Domestic RoleFunctional ingredient used by U.S. food manufacturers across multiple categories where glazing, film-forming, or thickening effects are desired
Specification
Physical Attributes- White to off-white, odourless powder
Compositional Metrics- Assay: not less than 90% of glucan on the dried basis (JECFA specification)
- Soluble in water; practically insoluble in ethanol (JECFA specification)
- CAS: 9057-02-7 (JECFA specification)
Grades- Food additive/ingredient grade conforming to JECFA specifications (INS 1204) and consistent with U.S. GRAS-notified use (GRN 99)
Supply Chain
Value Chain- Fermentation production (Aureobasidium pullulans) → microfiltration cell removal → heat sterilization → purification (adsorption and ion exchange) → drying to powder → packaging → international shipment to U.S. importer/distributor → U.S. food manufacturer use
Risks
Regulatory Compliance HighU.S. market access can be blocked or severely disrupted if pullulan shipments or intended uses fall outside a supportable U.S. legal basis (e.g., GRAS scope/support) or if FDA import requirements are not met (facility registration where required, prior notice, and FSVP obligations). Non-compliance can result in port delays, detention, or refusal.Maintain a documented regulatory position for intended U.S. uses (including GRN 99 context where applicable), ensure accurate prior notice submissions, confirm facility registration applicability, and implement a complete FSVP program with supplier verification and recordkeeping.
Documentation Gap MediumInadequate or inaccurate FDA Prior Notice for imported food can trigger refusal/hold actions and delay clearance, disrupting supply continuity for U.S. customers.Standardize pre-shipment checks for prior notice data fields (product identity, manufacturer, shipper, arrival details) and align broker/importer workflows with FDA’s prior notice filing guidance.
Enforcement MediumFDA may apply import enforcement tools (including detention without physical examination under Import Alerts) when products show a history of violations; this can create sudden clearance risk even when the product itself is generally permissible.Continuously monitor FDA import enforcement signals for the specific manufacturer/product context, and maintain robust COA, GMP evidence, and corrective-action documentation to address any appearance-of-violation concerns.
FAQ
Is pullulan permitted for use in foods in the United States?Pullulan is listed in FDA’s GRAS Notice Inventory as GRN No. 99, and FDA closed the notice with a “no questions” response for use in food in general, including meat products, for multiple technical effects.
What are the key U.S. import compliance steps for pullulan as a food ingredient?FDA import requirements commonly include ensuring food facility registration applies (including for foreign facilities where required), submitting FDA Prior Notice before arrival, and meeting FSMA Foreign Supplier Verification Program (FSVP) obligations for risk-based supplier verification and records. Customs entry/entry summary filings to CBP are also part of the standard import process.
What internationally recognized functions and specifications exist for pullulan?Codex GSFA lists pullulan as INS 1204 and identifies functional classes including glazing agent and thickener, with use under GMP provisions by food category. JECFA specifications describe pullulan as a white to off-white, odourless powder with an assay not less than 90% glucan (dry basis) and include solubility characteristics.