Section 105 — Meaning of “pre-market approval”

In this Part, “pre‑market approval” means an approval granted under this Part for a novel food or a genetically modified food to be available for consumption as food by the general public, after the Agency makes an assessment of the public health and safety considerations having regard to —

(a)the potential for adverse effects in humans;

(b)the composition or structure of the novel food or genetically modified food;

(c)the process by which the novel food or genetically modified food has been prepared;

(d)the source from which the novel food or genetically modified food is derived;

(e)the likely patterns and levels of consumption of the novel food or genetically modified food; and

(f)any other relevant matters.