- 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.