E1204 — Pullulan
Why it’s used
A neutral, water-soluble polysaccharide produced by fermenting hydrolyzed starch with the fungus Aureobasidium pullulans. Used to make edible, oxygen-barrier films and coatings (including breath strips and capsule shells), as a low-viscosity thickener/binder, and as a glaze for confectionery.
Other names
Poly-alpha-1,6-maltotriose, Aureobasidium pullulans exopolysaccharide
Diet flags
Regulatory status
Cleared as GRAS through the notification program (GRN 000099) for use in food in general, including meat products, for multiple technical effects — a broad, category-unrestricted clearance. Source (2026-07-24)
Authorized under Annex II/III to Regulation (EC) No 1333/2008 only for specific applications — food supplement capsules and tablets, and edible film coatings — not general food use; re-evaluated by EFSA in 2025 alongside a new extension-of-use application. Source (2026-07-24)
Regulatory status by region
FDA's GRN 000099 grants pullulan broad GRAS status for general food use across categories. The EU, by contrast, authorizes pullulan (E1204) only for specific applications under Annex II/III to Regulation (EC) No 1333/2008 — food supplement capsules/tablets and edible film coatings — following its 2004 EU listing under Directive 2006/52/EC and a 2025 EFSA re-evaluation considering a further extension of use. So US clearance is broader in scope than the EU's category-restricted authorization.
The EU's category-restricted authorization — limited to capsules, tablets, and edible film coatings under Annex II/III to Regulation (EC) No 1333/2008 — contrasts with FDA's broader general-food-use GRAS clearance for the same substance under GRN 000099.
Safety review
- GRN 99 — FDA has no questions
A GRAS notice status is FDA’s response to a company’s own self-determination that an ingredient is safe — not an independent FDA safety review.
Matched to FDA’s record for “Pullulan”. GRAS Notice Inventory (checked 2026-08-01)
Found in these products
None of the products in our database currently contain E1204.