Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p58
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 157015–159967

on the presence of known allergens (see section 1.2.3—4 in the Code).

     C.6.2 Information on the composition of the novel food ingredient derived from a new source

This includes information on the levels of major components and nutrients in the final food.

     C.6.3 Information on the toxicity of the novel food ingredient derived from the new source

This includes any published or unpublished reports of toxicity studies conducted in animals. The application must also include any reports of toleration studies conducted in humans.

     C.6.4 Safety assessment reports prepared by international agencies or other national government agencies

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

     C.7 Foods produced by a process not previously applied to food

An application for a novel food which is produced by a process not previously applied to food must contain the following information:

     C.7.1 Details of the process not previously applied to food

This includes details of the new food processing technology and its impact on the composition of the food.

     C.7.2 Information on the toxicity of the novel food produced by a process not previously applied to food

This includes any published or unpublished reports of toxicity studies conducted in animals. The application must also include any reports of toleration studies conducted in humans. The nature of the toxicity or toleration studies to be submitted will depend on the category of the novel food as set out in B.1.

The application must include details on the presence of known allergens (see section 1.2.3—4 in the Code).

     C.7.3 Safety assessment reports prepared by international agencies or other national government agencies

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 exposure to the novel food

Note:

FSANZ may undertake a dietary exposure assessment for all novel foods applications. The type of dietary exposure assessment will vary depending on the nature of the novel food.

This may depend on whether the novel food is the final food, a major component of the final food or a minor component of the final food.

The dietary exposure assessment will use 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 the proposed levels of use provided by the applicant or other concentration data where relevant, for example data from analytical surveys.

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