On 9 October 2026 the EFSA Journal published the NDA Panel opinion on the safety of benfotiamine as a novel food under Regulation (EU) 2015/2283 and on bioavailability as a source of thiamine in the context of Directive 2002/46/EC (DOI 10.2903/j.efsa.2026.10301, adopted on 6 August 2026, applicant Gall Pharma GmbH). The Panel concluded that safety is not established under the proposed conditions of use. This is a dossier assessment, not an authorisation to place the substance on the market and not a clearance for a food supplement containing benfotiamine.
Benfotiamine is a synthetic derivative of thiamine (vitamin B1), CAS 22457-89-2, produced chemically from thiamine hydrochloride, with a purity of at least 98% w/w. The applicant proposed use in food supplements for the adult population (excluding pregnant and lactating women) up to a maximum dose of 300 mg per day. In 2008 the ANS Panel had already assessed benfotiamine as a source of vitamin B1 and likewise found the data insufficient (EFSA Journal 2008;6(11):864).
The opinion, and what it is not
| Element | What e10301 says | What must not be inferred |
|---|---|---|
| Legal status | Novel food in the category of Article 3(2)(a)(ix) of Regulation (EU) 2015/2283 (vitamins, minerals and other substances). Opinion adopted on 6 August 2026, published on 9 October 2026. | An authorisation on the Union list of novel foods, or permission to use the substance in food supplements. |
| Proposed conditions | Food supplements for adults (excluding pregnant and lactating women), maximum 300 mg/day. Purity ≥98% w/w. | A safe dose of 300 mg/day, or transfer of that dose to other populations. |
| Identity and nanoparticles | Data insufficient to demonstrate identity, including the possible presence of small particles and nanoparticles. Light-scattering methods are not appropriate (EFSA 2021 guidance). | Confirmation that nanoparticles are absent, or transfer of the finding to another batch. |
| Process and stability | The production process was not confirmed as reproducible at commercial scale. Microbiological stability: no conclusion (data for 3 batches only). | A guarantee of production repeatability, or a 60-month shelf life. |
| Bioavailability | Bioavailability of thiamine from benfotiamine may be higher than from water-soluble forms. It was not quantified enough to derive a conversion factor for labelling. | A conversion factor to thiamine on the label, or a claim of “better bioavailability” as a health claim. |
Glossary
- Benfotiamine
- A synthetic, lipophilic derivative of thiamine (vitamin B1), CAS 22457-89-2. It is not endogenous in humans. In the dephosphorylated form it is absorbed and bioavailable.
- Novel food
- A food or ingredient that had not been consumed to a significant degree in the EU before 15 May 1997. Benfotiamine falls under Article 3(2)(a)(ix) of Regulation (EU) 2015/2283.
- Thiamine (vitamin B1)
- A water-soluble vitamin. Benfotiamine may be a source of it, but the Panel did not derive a conversion factor.
- Nanoparticles
- Small particles whose presence the Panel could not exclude. Light-scattering methods are not appropriate for the assessment under the EFSA Scientific Committee 2021 guidance.
What to do after the opinion
- Treat benfotiamine as a novel food that requires a Commission authorisation. The opinion of 9 October 2026 does not close that path.
- Do not use the proposed dose of 300 mg/day as a safe dose. The Panel concluded that safety is not established under those conditions.
- Verify the identity data for the batch, including particle analysis. The absence of appropriate nanoparticle data was one reason for the negative assessment.
- Do not place a conversion factor to thiamine on the label. The Panel did not derive one from the bioavailability data.
- Keep the 2008 ANS opinion in view. It likewise found the data insufficient. The new opinion does not change that basic assessment.
Sources
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Safety of benfotiamine as a Novel food pursuant to Regulation (EU) 2015/2283 and the bioavailability of benfotiamine as a source of thiamin in the context of Directive 2002/46/EC on food supplements, EFSA Journal, published 9 October 2026, adopted 6 August 2026, doi:10.2903/j.efsa.2026.10301; publication page: Wiley / EFSA Journal. EFSA publications list: efsa.europa.eu/en/publications. Baseline ANS opinion 2008: EFSA Journal 2008;6(11):864, doi:10.2903/j.efsa.2008.864. Regulation (EU) 2015/2283, Articles 3 and 10. Directive 2002/46/EC.
This text is not legal advice in an individual matter. Entities: Supplemental.pl — the law practice; FOODLAW.ai — the tools; C.L.A.I.M.S. — a search tool for 2318 claims (2078 on-hold SANCO/11074/2013 + 240 from Regulation 432/2012), not a Commission register.