E-numbers / E1204 Other

Pullulan

fungal fermentationVegan ✓Vegetarian ✓Halal - checkKosher - check
The short version

A natural polysaccharide made by fermenting starch with a fungus, used to form edible films in breath-freshening strips and to coat food supplement capsules.

What is it?

Pullulan is a water-soluble polysaccharide (long-chain sugar molecule) produced when the fungus Aureobasidium pullulans ferments starch. It forms a clear, tasteless, odourless film and is resistant to oil and grease. It is not chemically modified; it is harvested directly from the fermentation broth and purified.

What does it do?

Pullulan forms thin, flexible, water-soluble films that dissolve quickly on contact with saliva. In breath-freshening microsweets it creates the dissolving strip that delivers the flavour or active ingredient. In food supplements it provides a plant-derived alternative to gelatin capsule shells. It also acts as a film-former and coating agent, protecting tablet surfaces and controlling the release of ingredients.

Where you will see it

Found mainly in fast-dissolving breath-freshening oral strips and in vegetarian or vegan capsules for food supplements. Look for it on the label as 'pullulan' or 'E1204' in the ingredients list of supplement capsules and dissolvable film products.

What the science says

Digestive effects at high intake

Pullulan is not digested in the small intestine and passes through to the large intestine, where gut bacteria ferment it. Human volunteer studies found that doses of 10 grams a day or more can cause abdominal fullness, flatulence, bloating and cramping. At typical dietary exposures from breath strips this dose is not reached, but heavy users of food supplements at the high end of the intake range may approach it.

Human volunteer studies identified mild gastrointestinal symptoms including abdominal fullness, flatulence, bloating and cramping at pullulan doses of 10g per day and above.

EFSA Panel on Food Additives and Flavourings (FAF), re-evaluation of pullulan (E 1204), EFSA Journal 2025, 23(3):92672025RCT

High-exposure individuals consuming food supplements may experience mild gastrointestinal effects at currently reported use levels; no such concern was identified for breath-freshening film uses.

EFSA Panel on Food Additives and Flavourings (FAF), re-evaluation of pullulan (E 1204), EFSA Journal 2025, 23(3):92672025regulatory review

Genotoxicity and longer-term toxicity

EFSA's 2025 re-evaluation confirmed that pullulan raises no genotoxicity concern, meaning there is no credible evidence it damages DNA. Animal and longer-term studies did not identify organ toxicity at levels relevant to food use. No numerical acceptable daily intake was considered necessary.

EFSA confirmed that pullulan (E 1204) is of no concern for genotoxicity based on available in vitro and in vivo data.

EFSA Panel on Food Additives and Flavourings (FAF), re-evaluation of pullulan (E 1204), EFSA Journal 2025, 23(3):92672025regulatory review

No numerical ADI was set for pullulan; the panel concluded no safety concern exists at currently reported uses and use levels.

EFSA Panel on Food Additives and Flavourings (FAF), re-evaluation of pullulan (E 1204), EFSA Journal 2025, 23(3):92672025regulatory

Where it stands with the regulators

Status
Approved for use in the UK and EU
Legal basis
UK FSA Register of Food Additive Authorisations (data.food.gov.uk, authorised, last updated 01 April 2025, applies England, Scotland, Wales) and assimilated EU Regulation 1333/2008 (Annex II); purity criteria in Commission Regulation (EU) No 231/2012
Permitted foods
Other confectionery including breath-freshening microsweets (film form only); Food supplements in solid form (capsules and tablets), excluding those for infants and young children
Maximum levels
Quantum satis (minimum amount technically necessary) for both current permitted categories
Safe-intake limit (ADI)
No numerical ADI set
History
Pullulan was first authorised in the EU for breath-freshening films and supplement capsules. EFSA issued a call for toxicological data in 2022 and published a full re-evaluation in March 2025, confirming the current two-category authorisation at quantum satis raises no safety concern. In the same opinion EFSA assessed an applicant's request to extend permitted use to approximately 26 additional food categories including dairy, cereals, edible ices and cocoa products, and concluded that the proposed extension raises no safety concern at the exposure levels assessed. A formal legislative amendment to EU Regulation 1333/2008 would be required before those additional categories become authorised; that amendment had not been made as of mid-2026. The UK FSA register reflects the existing two-category authorisation unchanged.

Who should be careful

People who experience bloating or digestive discomfort from fibre-like compounds may notice symptoms if they consume large quantities of pullulan-containing food supplements daily. No specific population group is required to avoid it under current regulations. Look for 'pullulan' or 'E1204' on supplement capsule labels.

The honest read

Cutting through the noise

Pullulan is a fermentation-derived carbohydrate with a long history of use in Japan before its EU authorisation. The science around it is straightforward: it behaves like a fermentable dietary fibre, with well-understood gut fermentation and a clear dose threshold for digestive discomfort around 10g a day. The 2025 EFSA re-evaluation, the most thorough to date, found no genotoxicity concern, no organ toxicity at food-relevant levels, and no reason for a numerical ADI. The only real-world consideration is digestive comfort at the high end of supplement use.

Related additives

Common questions

Is E1204 banned in the UK?

No. Pullulan is permitted in the UK under the assimilated EU Regulation 1333/2008. It is authorised in breath-freshening film confectionery and food supplement capsules and tablets, both at quantum satis.

Can pullulan cause digestive problems?

Human volunteer studies found that doses of 10g a day or more can cause bloating, flatulence and abdominal cramping. This dose is not reached from breath strips but may be approached by people taking multiple high-dose supplement capsules daily. At typical exposure levels these effects are not expected.

What foods contain E1204?

Currently authorised in fast-dissolving breath-freshening oral strips and in food supplement capsules and tablets. It is not permitted in general foods such as drinks, bread or dairy under current UK/EU rules. EFSA found no safety concern with a proposed extension to many further categories in 2025, but a formal legislative amendment would be required before any new uses become lawful.

Is E1204 vegan?

Yes. Pullulan is produced by fermenting starch using the fungus Aureobasidium pullulans. No animal-derived ingredients are involved in its production, and it is widely used as a vegan and vegetarian alternative to gelatin in supplement capsules.

Sources

Last reviewed: 20 June 2026

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