EU SCIENTIFIC EVIDENCE PROFILE
A dossier-scoped EFSA opinion separates thiamin bioavailability from unresolved safety and labelling conversion. Formal market permission is a separate question.
This profile records the cited evidence at the stated date. Re-check the authority source before a final formula, claim, artwork or market-access decision.
INGREDIENT EVIDENCE · SCIENTIFIC OPINION · REFERENCE ONLY
Benfotiamine — regulatory review required. Opinion published ; source reviewed . Original EN · EU · EFSA-Q-2024-00115 · Gall Pharma GmbH.
Chemically synthesised benfotiamine, proposed purity at least 98% w/w. Proposed intake: 300 mg/day — applicant proposal, not an approved dose. Adults; pregnancy and lactation excluded.
| Evidence area | Status | What it means |
|---|---|---|
| Novel Food authorisation | NOT ESTABLISHED | The scientific opinion is not a Commission authorisation; no current legal permission is established here. Not assessed here. |
| Safety assessment | NOT ESTABLISHED | Safety could not be established for the material and proposed conditions in this dossier. |
| Nutrient source | ASSESSED | Assessed as a thiamin source. This is not an Annex II permission to use it in supplements. |
| Thiamin bioavailability | ESTABLISHED | Positive scientific conclusion on thiamin availability; not efficacy or product safety. |
| Labelling conversion | NOT ESTABLISHED | No sufficiently supported conversion factor could be derived for labelling. |
| Country-specific requirements | REVIEW REQUIRED | No national market-access determination is made. Check the exact product and country separately. Not assessed here. |
This dossier outcome is not a ban, a finding of harm at every dose, or approval of 300 mg/day. Positive bioavailability does not establish safety or market permission.
Recorded gaps: Material characterisation and particle/nanoparticle evidence; Reproducible manufacture and microbiological stability; Metabolic fate, bioaccumulation and adequate toxicology. These observations concern the submitted dossier, not every supplier material.
This is a preparation checklist, not an upload, supplier request, safety validation or legal approval.
View EFSA evidence — original article in PMC ↗ · Read the benfotiamine status guide →
Point-in-time reference, not live monitoring or a complete current-law check. Working summaries are not decision sources; no product, supplier or operator entitlement has been assessed.
IDENTITY BEFORE STATUS
CLAIMS
Positive bioavailability is not an authorised health claim or a finished-product efficacy finding.
RESTRICTIONS
300 mg/day is the applicant-proposed intake for adults, excluding pregnancy and lactation; it is not an approved dose or safe upper limit.
This dossier outcome is not a ban, a finding of harm at every dose, or approval of 300 mg/day. Positive bioavailability does not establish safety or market permission.
No labelling conversion factor is established; missing data is not a zero conversion.
Match the exact material and intended use to separate current Novel Food, nutrient-source and national legal evidence before a market decision.
POLISH NOTES
This page does not establish Polish market access, a national limit or notification acceptance. The original opinion is English-language EU scientific evidence, not a Polish legal decision.
PRIMARY SOURCES
Scientific opinion, question EFSA-Q-2024-00115; material, proposed use, separate safety/bioavailability/conversion conclusions. Reviewed 18 October; not an authorisation record.
Publisher reference; full text reviewed through PMC, not a verified legal permission.