Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p39
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 104620–107795

for Australia and New Zealand including Recommended Dietary Intakes contains ULs for a range of vitamins and minerals. This publication can be found at http://www.nhmrc.gov.au/publications/synopses/n35syn.htm.

The application must contain the following information:

     C.1 Information on the toxicokinetics and metabolism of the nutritive substance and, if necessary, its degradation products and major metabolites

For an application for use of a new nutritive substance, this includes published reviews or individual study reports on the metabolic fate of the nutritive substance and, if necessary, its degradation products and major metabolites.

For an application to extend the use of a currently permitted form of a nutritive substance, this need only include the studies conducted since the last safety evaluation by FSANZ. If no previous evaluation by FSANZ is available, this should include published papers. or a comprehensive review article on this matter.

     C.2 Information from studies in animals or humans that is relevant to the toxicity of the nutritive substance and, if necessary, its degradation products and major metabolites

    (a) For an application for the use of a new nutritive substance, this includes published reviews or detailed reports of all in vitro and in vivo studies conducted in animals or humans to examine the toxicity of the nutritive substance and, where necessary, its metabolites or degradation products.

    The following categories of studies need to be considered:

    (a) acute toxicity
    (b) short-term toxicity
    (c) long-term toxicity and carcinogenicity
    (d) reproductive toxicity
    (e) developmental toxicity
    (f) genotoxicity
    (g) special studies such as neurotoxicity or immunotoxicity.

    Where data are not available or are not considered relevant to the safety assessment of the nutritive substance, an explanatory statement should be provided.

    (b) For an application to extend the use of a currently permitted form of a nutritive substance, this need only include the original reports of studies conducted since the last safety evaluation by FSANZ. If no previous evaluation by FSANZ is available, published papers. or a comprehensive review article on this matter should be included.

     C.3 Safety assessment reports prepared by international agencies or other national government agencies, if available

This includes safety assessment reports prepared by the WHO or by other national or supranational agencies responsible for food safety or public health.

     D Information on dietary intake of the nutritive substance

Note:

FSANZ may undertake a dietary exposure assessment for all nutritive substance applications using a custom-made computer program, HARVEST, which combines food consumption data from the latest Australian and New Zealand National Nutrition Surveys, together with food nutrient concentration data derived from naturally-occurring concentrations, proposed levels of use, the current permissions for use specified in the Code, analytical data derived from surveys or data on use provided by the manufacturers. The information required to undertake