Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p43
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population groups.

Where there is insufficient information on Australian and New Zealand consumer responses (or potential responses), as specified in Section F in this Guideline (3.3.3), FSANZ may request the applicant to conduct empirical research to address these points. FSANZ can provide guidance here.

     Chapter 3.4

     Guidelines for applications for

     contaminants and natural toxicants

     3.4.1 Chemical contaminant and natural toxicant maximum levels

An application to vary the Code is required to approve a new maximum level for a contaminant in food or to change the current maximum levels which are specified in Schedule 19 – Maximum levels of contaminants and natural toxicants.

The following information is required to support an application for a new maximum level for a contaminant or to change the current maximum level. This information is in addition to that specified in Guideline 3.1.1 – General requirements.

     A General information on the contaminant or natural toxicant

The application must contain the following:

     A.1 Nature of the contaminant or natural toxicant, including chemical and physical properties

This includes information on the nature of the contaminant or natural toxicant, its chemical and physical properties, the source of the contaminant or natural toxicant, the factors. that influence the level of contamination of food, the interaction of the contaminant or natural toxicant with the food, and current control measures and their effectiveness.

 In cases where particle characteristics may relate to the toxicity of the food contaminant, the application must include information on particle size and morphology.

     A.2 Analytical method for detection

This includes a method for detection and quantitation of the contaminant or natural toxicant in the foods in which it is found.

     B Information on the safety of the contaminant or natural toxicant

The application must contain the following:

     B.1 Information on the toxicokinetics and metabolism of the contaminant or natural toxicant and, if necessary, its degradation products

This includes published reviews or individual study reports on the metabolic fate of the contaminant or natural toxicant and, if necessary, its degradation products.

     B.2 Information from studies in animals that is relevant to the toxicity of the contaminant or natural toxicant and, if necessary, its degradation products

This includes published reviews or detailed reports of all in vitro and in vivo studies conducted in animals to examine the toxicity of the contaminant or natural toxicant.

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 contaminant, an explanatory statement should be provided.

     B.3 Information from human studies that is