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 —

the potential for adverse effects in humans;

the composition or structure of the novel food or genetically modified food;

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

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

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

any other relevant matters.