Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p55
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 148581–151578

on methods of reducing the levels of anti-nutrients or naturally-occurring toxins during food processing or food preparation, if relevant.

     C.1.3 Information on the current use of this food or food component in population sub-groups or in other countries

This includes information on the extent and history of use of the food in other countries; any particular preparation, processing or cooking practices normally used; and the level and purpose of consumption (e.g. staple food, ceremonial use). This evidence of safe use should include the frequency of consumption, the extent of the population using the food, and the period of use.

     C.1.4 Information regarding the potential adverse effects associated with the food or its ingredients

This includes published or unpublished reports of allergenicity or other adverse effects in humans associated with the food. If available, this also includes any reports of toxicity studies conducted in animals or toleration studies conducted in humans.

     C.2 Plant or animal extracts

An application for a novel food which is a plant or animal extract must contain all of the information in subsection C.1 Plants or animals (or their components) above, as well the following additional information:

     C.2.1 Information on the method of extraction and the composition of the concentrated extract

This includes the methodology used to prepare the extract and the composition of the extract. This must include information on the levels of potential contaminants from the extraction process.

     C.2.2 Information on the use of this plant or animal extract as a food in other countries

This includes information on the extent and history of use of the extract in other countries, together with reports of any adverse health effects.

Use of the plant or animal extract as a dietary supplement, natural medicine or complementary medicine in other countries should be provided. In some countries, this is regarded as food use, rather than medicinal use. If adverse effects are reported, the nature of the adverse event reporting scheme should be provided, if known.

     C.2.3 Information on the toxicity of the extract 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.2.4 Safety assessment reports prepared by international agencies or other national government agencies

This includes published safety assessment reports prepared by other agencies.

     C.3 Herbs (both non-culinary and culinary) including extracts

An application for a novel food which is a herb (both non-culinary and culinary) 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,