Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p56
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 151324–154386

including extracts must contain the following information:

     C.3.1.1 Information on the history of use of the herb

This includes information on the use of the herb as a complementary medicine in Australia or as a dietary supplement in New Zealand, or as a food or medicine in other countries. The plant part(s) used must also be specified.

     C.3.2 Information on the composition of the herb

This includes information on the levels of active constituents in the herbs or herbal extracts, and information on their potential adverse effects.

     C.3.3 For a herbal extract, information on the method of extraction and the composition of the concentrated extract

This includes detailed information on the plant part(s) used to prepare the extract, the method used to prepare the extract and the composition of the extract. The application must include information on the levels of potential contaminants from the extraction process.

     C.3.4 Information on the use of this herbal extract as a food in other countries

This includes information on the extent and history of use of the herbal extract in other countries, together with reports of any adverse health effects. The nature of the adverse event reporting scheme in that country should be detailed, if available.

     C.3.5 Information regarding the potential allergenicity of the herb or herbal extract

This includes reports of allergenicity associated with the herb or herbal extract.

     C.3.6 Information on the toxicity of the herb, or herbal extract, or any key constituents obtained from studies conducted in animals or humans

This includes reports of toxicity studies conducted in animals. The application must also include any reports of toleration studies conducted in humans.

     C.3.7 Safety assessment reports prepared by international agencies or other national government agencies

This includes published safety assessment reports prepared by other agencies.

     C.4 Single chemical entities and Dietary macro-components

An application for a novel food which is a single chemical entity or a dietary macro-component must contain the following information:

     C.4.1 Information on the toxicokinetics and metabolism of the single chemical entity and, where appropriate, its degradation products and major metabolites

This includes reports of all studies conducted in animals or humans to examine the metabolic fate of the single chemical entity or dietary macrocomponent and, where necessary, its degradation products and major metabolites.

     C.4.2 Information from studies in animals or humans that is relevant to the toxicity of the single chemical entity and, where appropriate, its degradation products and major metabolites

This includes detailed reports of all in vitro and in vivo toxicity studies conducted in animals or humans to examine the toxicity of the single chemical entity or dietary macro-component and, where necessary, its metabolites or degradation products.

The application should address the following categories of