Section 8 — studies on absorption, distribution, metabolism, and excretion of the novel food in the body.
ADME (absorption, distribution, metabolism, excretion) studies characterise how the novel food or its constituents behave in the body after ingestion. These studies help EFSA understand whether the novel food is absorbed, how it is metabolised, whether metabolites accumulate in specific tissues, and how it is eliminated.
ADME data is particularly important for novel foods of chemical origin — isolated compounds, synthetic nutrients, or chemically defined substances. For whole foods or complex biological matrices (such as insect flour or algal biomass), ADME studies may be less relevant, and EFSA may accept a reasoned justification for their omission.
Where ADME studies are required, EFSA expects in vitro and/or in vivo data covering gastrointestinal absorption (bioavailability), tissue distribution, metabolic pathways and identification of major metabolites, and excretion routes and rates. The study design should use the same test material as the toxicological studies.
The absence of ADME data when it is warranted is a known trigger for additional data requests, particularly for chemically defined novel foods where the metabolic fate is not predictable from existing literature.
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