Summary
The EFSA NDA Panel conducted a regulatory assessment of benfotiamine (a synthetic thiamine derivative) proposed for use in food supplements for adults. Whilst bioavailability data suggest benfotiamine may deliver thiamine more effectively than conventional water-soluble forms, the Panel identified critical deficiencies in product characterisation, manufacturing process validation, and toxicological evidence that preclude a positive safety opinion under the proposed conditions of use. The Panel also noted that the quantitative advantage in bioavailability had not been sufficiently characterised to permit derivation of a conversion factor for nutritional labelling purposes.
Regional applicability
This is a European Food Safety Authority regulatory opinion directly applicable to EU food law and the European Economic Area. The findings will inform decisions on novel food authorisations in the United Kingdom through retained EU law or through equivalent UKCA (UK Conformity Assessed) pathways if divergence occurs; however, the UK Food Standards Agency would need to make its own determination should benfotiamine be re-evaluated under post-Brexit UK legislation.
Key measures
Safety characterisation, product identity, manufacturing reproducibility, microbiological stability, bioavailability of thiamine, toxicological data adequacy
Outcomes reported
The EFSA Panel assessed the safety of benfotiamine as a novel food for use in food supplements at up to 300 mg/day and evaluated its bioavailability as a thiamine source. The Panel concluded that safety cannot be established due to insufficient characterisation, unresolved uncertainties regarding nanoparticles, and limitations in toxicological data.
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