Pullulan | whatsinit

About

What it is and where it shows up.

Pullulan is a linear, neutral polysaccharide consisting mainly of maltotriose units connected by α-1,6 glycosidic bonds, produced by fermentation of food-grade hydrolysed starch using the non-toxin-producing fungus Aureobasidium pullulans. It is used as a film-forming, glazing, and coating agent — principally in capsule shells for food supplements and in breath-freshening confectionery microsweets.

Safety summary

The regulatory and scientific consensus.

JECFA (2005/2011) classified pullulan as a substance of low toxicity and assigned an ADI 'not specified', indicating no safety concern at normal dietary exposures. EFSA's 2025 re-evaluation confirmed there is no need for a numerical ADI, no genotoxicity concern, and no safety concern at currently permitted or proposed extended use levels. Mild gastrointestinal effects (abdominal fullness, flatulence, bloating, cramping) resembling those of other poorly digestible carbohydrate polymers may occur at doses of 10 g per day or greater.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Authorised under Regulation (EC) No 1333/2008, Annex II, at quantum satis (QS) in FC 5.2 (Other confectionery including breath-freshening microsweets) and FC 17.1 (Food supplements in solid form, excluding supplements for infants and young children). EFSA 2025 re-evaluation confirmed no numerical ADI required and no safety concern at current and proposed use levels. Extension of use to additional food categories was simultaneously evaluated and found to raise no safety concern.source
FDA (Food and Drug Administration) (United States)	Approved	GRAS (Generally Recognized as Safe) status for use as a film-forming coating agent in food; FDA issued a no-questions letter under GRAS Notice GRN 000457 (Hayashibara Co., Ltd.).source

Who should approach with care

Whose guidance would steer them away.

Infants — EU Regulation (EC) No 1333/2008 explicitly excludes food supplements for infants and young children from the authorised uses of pullulan (E 1204), reflecting a precautionary restriction for this sensitive population.

Ibs — Pullulan is poorly digestible and fermented by colonic bacteria; at doses ≥10 g/day it produces abdominal fullness, flatulence, bloating, and cramping similar to other fermentable polysaccharides, which may exacerbate IBS symptoms.

Ibd — As a fermentable polysaccharide generating short-chain fatty acids and colonic gas, high pullulan intake could potentially aggravate symptoms in individuals with inflammatory bowel disease, though dietary exposures from authorised uses are well below the 10 g/day threshold.

Research citations

The sources behind this verdict.

1EFSA. Re‐evaluation of pullulan (E 1204) as a food additive and new application for its extension of use, 2025. efsa.europa.eu
2PubMed. Re‐evaluation of pullulan (E 1204) as a food additive and new application for its extension of use, 2025. pmc.ncbi.nlm.nih.gov
3EFSA. Call for technical and toxicological data on pullulan (E 1204) authorised as a food additive in the EU, 2022. efsa.europa.eu
4WHO. JECFA 74th Meeting – Pullulan (INS 1204) monograph and specifications, 2011. fao.org
5EFSA. Opinion of the Scientific Panel AFC on Pullulan PI-20 for use as a new food additive, 2004. efsa.europa.eu

Independently researched5 citations