Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p44
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 118474–121465

(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 relevant to the toxicity of the contaminant or natural toxicant and, if applicable, its degradation products

The includes reviews or reports on human epidemiology studies or individual case studies related to the contaminant or natural toxicant, particularly reports of potential adverse effects on population sub-groups at the levels found in food.

     C Information on dietary exposure to the contaminant or natural toxicant

The application must contain the following information:

     C.1 The foods or food groups) where a maximum level is proposed, or where a change to the maximum level is proposed

This includes information on the full range of foods likely to contain the contaminant or natural toxicant.

     C.2 Surveys on the levels of the contaminant or natural toxicant in foods

This includes the details of any surveys which have been conducted in Australia or New Zealand on the levels found in foods.

If data derived from an analytical survey are used, details of how the survey was conducted and the analytical methods used must be provided. These details should include the sampling plan, the number of samples, where the samples were collected, whether the analysis was conducted on composite or individual samples, the method of analysis, the limits of detection/quantification/reporting (LOD, LOQ, LOR) for the analytical method used, whether the foods were prepared/cooked before analysis, whether the samples were from the edible portion only, and whether the sampling was targeted or randomly sampled.

If applicable, details of any surveys conducted in other countries must be included.

     C.3 For foods or food groups not currently listed in the most recent Australian or New Zealand National Nutrition Surveys (NNSs), information on the likely level of consumption

This includes any consumption information for food groups not included in the most recent Australian or New Zealand NNSs which relate to the application. Data distinguishing likely consumption levels among target and non-target groups are preferred.

Note:

Information on likely consumption can be based on proposed levels of consumption (grams per day) or on consumption data for these foods from a similar market in another country. The most recent NNSs are the 2011–12 National Nutrition and Physical Activity Survey (NNPAS) component of the 2011–13 Australian Health Survey  (2 years. and above), the 2008–09 New Zealand NNS (15 years. and above) and the 2002 New Zealand Children's NNS (5–14 years).

The application should include the following information:

     C.4 For foods where consumption has changed in recent years, information on likely current food consumption

This includes any