INGREDIENT INTELLIGENCE · SOURCE REVIEW 18 OCTOBER 2026
Benfotiamine EU Novel Food Status — EFSA Opinion October 2026
Can a supplier’s positive nutrient-source evidence settle whether a material belongs in your supplement? Read the scientific conclusion, proposed use and formal permissions as different questions.
Bioavailability is not a safety clearance.
EFSA’s opinion, published , assessed Gall Pharma’s synthetic benfotiamine dossier. Thiamin bioavailability was supported, but safety under the proposed conditions and a labelling conversion factor were not established. The proposed intake was 300 mg/day for adults, excluding pregnancy and lactation. These are scientific conclusions, not a ban, market authorisation or approved dose.
Do not let one positive answer fill the empty fields.
Record scientific safety, bioavailability, nutrient-source assessment, legal authorisation, label conversion and country requirements independently. For this dossier, unresolved characterisation, particle, process, microbiological stability, metabolism and toxicology questions mattered. Neither a familiar vitamin name nor a proposed intake resolves those gaps.
In Suppvera, formal EU and nutrient-source authorisation remain not established here, rather than automatically “not authorised”. A current legal-status check must follow its own sources; this article does not claim that search has been completed.
Ask for a material-specific evidence map.
- Identify the exact supplier material, manufacturing method and specification version; do not match only by ingredient name.
- Map available identity, particle, stability and toxicology documents to the gaps in the opinion; document what remains missing.
- Obtain the separate legal basis for the exact Novel Food and nutrient source, and assess the intended country and population.
- Do not calculate label thiamin or an authorised dose from a proposed intake or an unestablished conversion factor.
Use the checklist to organise a review with your supplier or regulatory adviser. It does not send a request, authenticate a document, validate a study or predict the outcome of a new application.
A useful internal handoff identifies the exact specification version, which question each document addresses, who owns the missing information and which intended use is being assessed. Keep assumptions visible instead of turning document receipt into a green result.
Review the benfotiamine record.
See the source, dossier scope, proposed use and unresolved permissions in one read-only profile. This is an evidence view, not an automatic product legality check.
Publication date is not the date of an authorisation.
EFSA Journal e10301 · original full text in PMCSections 1.1, 3.1, 3.8.4, 4 and 5; EFSA-Q-2024-00115; original EN ↗DOI 10.2903/j.efsa.2026.10301Opinion published 9 October 2026; article/source review 18 October 2026 ↗This is a dated interpretation of the published scientific opinion, not live monitoring, legal advice or a finding about every benfotiamine supplier. No formal EU or national market permission is established here. Return to ingredient evidence profiles →

