10 clock-stopped issues across 8 opinions overall, but the 21% inadequacy rate — second highest of any section — reveals the real risk: when ADME data is needed and missing, it is rarely recoverable. For chemical-origin novel foods and nutrient sources, ADME is mandatory and its absence is an immediate blocker.
The specific issues EFSA most frequently flags in this section. Each of these has caused a clock stop in at least one published case.
For chemical/nutrient NFs: full ADME profile including absorption rate, tissue distribution, metabolic pathways, and excretion routes. For substances with known bioactivity: human pharmacokinetic data preferred. Bioavailability data alongside ADME. Comparison with structurally related substances already authorised. For new nutrient sources: relative bioavailability versus the existing authorised form.
Real findings from EFSA panel opinions. Each quote is verbatim from a published assessment.
“The Panel notes that the information provided on ADME is limited and inconsistent and does not allow conclusions to be drawn.”
“Following the evaluation of effects of allulose in subchronic and chronic toxicity studies, EFSA requested a human study to clarify the toxicokinetics of the NF in humans. No reply was received from the applicant.”
“The Panel therefore considers that no conclusions can be drawn from this study on the absorption of active nattokinase in rats.”
How this section plays out differently depending on your novel food type.
ADME is mandatory — without it, assessment cannot proceed. This is the single biggest blocker for substances like beta-NMN, benfothiamine, and ubiquinol acetate.
ADME requirements lighter because HMOs are naturally present in human milk. Focus shifts to metabolic fate in the infant gut.
Paste your absorption, distribution, metabolism and excretion (adme) section and Borgh will flag the gaps that matter.
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