Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p51
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 137766–140772

comparator as well as the range of natural variation.

In the case of herbicide-tolerant plants, the levels of each constituent in the food produced using gene technology must be determined using plants sprayed with the herbicide.

     C Information related to the nutritional impact of the food produced using gene technology

The application must contain the following information if the compositional analysis indicates biologically significant changes to the levels of certain nutrients in the food produced gene technology compared to the non-GM counterpart food:

    (a) data are required on the anticipated dietary intake of the GM food in relation to the overall diet, together with any information which may indicate a change to the bioavailability of the nutrients from the GM food
    (b) where the GM food contains an intended nutritional change, information, such as clinical trial data, must be provided to determine the nutritional impact of the GM food.

     D Other information

There is no requirement to conduct animal feeding or whole food toxicity studies on the food produced using gene technology. However, if a 90-day (or longer) whole food toxicity study in rodents has been provided to satisfy the data and information requirements of another jurisdiction, this should also be provided to FSANZ as additional supporting information.

     3.5.2 Novel foods

An application to vary the Code is required to approve the use of a new novel food or novel food ingredient. Permissions for use of novel foods or novel food ingredients are specified in Schedule 25 – Permitted novel foods.

Note:

For further information relating to the operation of Standard 1.5.1 – Novel foods, particularly in relation to whether a particular food would be regarded as novel, refer to the FSANZ website at http://www.foodstandards.gov.au/industry/novel/Pages/default.aspx.

The term novel food includes both whole foods and food ingredients – these terms are used either together or separately in this document, depending on the circumstances. When the novel food is clearly a food ingredient, only novel food ingredient is used.

FSANZ is required by paragraph 18(2)(e) of the FSANZ Act to have regard to any written policy guidelines formulated by the Forum.

In the case of an application seeking approval of a novel food or ingredient, the relevant Guidelines are Novel Foods, the Addition to Food of Substances other than Vitamins and Minerals and the Labelling of Foods produced or processed using New Technologies.

The Guidelines are available at http://www.foodstandards.gov.au/code/fofr/fofrpolicy/Pages/default.aspx.

The information requirements outlined below take each Policy Guideline into consideration.

The following information is required to support an application for a novel food. This information is in addition to that specified in Guideline 3.1.1 – General requirements.

     A Exclusive use of novel foods

This includes a statement as to whether the application