Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p41
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 110132–113074

the nutritive substance is used, the use levels and consumption amounts in other countries.

This information provides an indication of the range of foods in Australia and New Zealand that might contain the used nutritive substance.

     D.6 For foods where consumption has changed in recent years, information on likely current food consumption

This includes any consumption information for foods where there has been a significant change in consumption since the most recent Australian and New Zealand NNSs which relate to the application. This can be based on market share data or sales data or on a similar market in another country.

     E Information related to the nutritional impact of a vitamin or mineral

The application must contain the following information:

     E.1 Information to demonstrate a need to permit the addition of a vitamin or mineral to food

This includes information addressing at least one of the following:

    (a) data to demonstrate clinical or sub-clinical evidence of deficiency or data to demonstrate low levels of intake in one or more population groups
    (b) data to demonstrate that deficiencies are likely to develop in one or more population groups because of changing food habits
    (c) generally accepted scientific evidence that an increase in the intake of a vitamin or mineral can deliver a health benefit
    (d) evidence that the reduced nutritional profile of a processed food can be substantially restored
    (e) evidence that the nutritional profile of the specified substitute food can be aligned with the primary food.

     E.2 Information to demonstrate the permitted addition of the vitamin or mineral has the potential to address the deficit or deliver a health benefit to the population or a population subgroup

This includes:

    (a) data on the level of absorption of the particular form of the vitamin or mineral from the specified food at normal levels of consumption
    (b) data on the metabolic fate of the vitamin or mineral under the conditions above
    (c) information on the food vehicle, including the presence of substances that will have an inhibitory or enhancing effect on absorption.

     F Information related to the nutritional impact of a nutritive substance other than vitamins and minerals

The application must contain the following information:

     F.1 Information related to the nutritional purpose of the use of the substance in each food

This includes data to demonstrate the nutritive substance is consistent with its proposed purpose as described in subsection A.1 in this Guideline (3.3.3) and must include:

    (a) the target population(s) be clearly stated
    (b) data to demonstrate that specific food(s) containing the form and amount of the nutritive substance can contribute to the nutritional purpose in the target population(s) at the anticipated level of intake. The total amount should include naturally-occurring