Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p28
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 74640–77755

this purpose.

An application for a food additive must contain the following information:

     B.1 Information on the toxicokinetics and metabolism of the food additive and, if necessary, its degradation products or major metabolites

    (a) For an application for a new food additive, this includes detailed reports of all studies conducted in animals or humans to examine the metabolic fate of the food additive and, if necessary, its degradation products or major metabolites.

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

     B.2 Information on the toxicity of the food additive and, if necessary, its degradation products and major metabolites

    (a) For an application for a new food additive, this includes reports of all in vitro and in vivo studies conducted in animals or humans to examine the toxicity of the food additive and, if necessary, its metabolites or degradation products.

    The application should address the following categories of studies:

       (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 additive, an explanatory statement must be provided.

    (b) For an application to extend the use of a currently permitted food additive, this need only include the detailed reports of studies conducted since the last safety evaluation by FSANZ.

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

This includes safety assessment reports prepared by JECFA (unless provided under subsection B.2 of this Guideline (3.3.1)) or by other national or supranational agencies responsible for food safety.

     C Information related to the dietary exposure to the food additive

Note:

FSANZ may undertake a dietary exposure assessment for all food additive applications requesting changes to permissions in Schedule 15 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 chemical concentration data derived from either the 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 this assessment will be derived from different sources, including the application.

The application must contain the following information:

     C.1 A list of the food groups or foods proposed to contain the food additive, or changes to currently permitted foods

The food list should