§ 105 — Meaning of “pre-market approval”

105. 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.