Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p70
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 190859–193941

for a nutritive substance (including an increase or decrease in energy content or macronutrient amount)
     * 3.4.2 microbiological limits
     * 3.5.2. for a novel food or novel food ingredient
     * 3.2.1 for general food labelling
     * 3.2.3 for food allergens
     * 3.2.4 for labelling for consumer information and choice
     * 3.2.5 for nutrition information labelling.

     A Information related to general compositional requirements

The application must contain the following information if it relates to a change to the general compositional requirements:

     A.1 Information on the identity and physical and physiological need of the target population

The application must include a description of the target population for the special purpose food. It must also include a description of the physical and physiological need of specific life stages e.g. infancy, physical disease, disorder and disability of the target population; or physical and physiological need of the target population that require altered energy or nutrient intake.

     A.2 Purpose of the compositional change

The application must include a brief description of all of the nutritive or health-related function(s) of the substance at the proposed level in the relevant food product(s). Where an added substance or compositional change has multiple purposes or functions, then these must be specified.

     A.3 Information related to the safety of the proposed compositional change

The application must include information related to the safety of a food additive, processing aid, novel food or novel food ingredient, or nutritive substance for the target population (Information to demonstrate safety is also requested elsewhere in Part 3).

     A.4 Information related to the nutritional impact or performance impact of the proposed compositional change

This demonstrates how the compositional change would contribute to achieving the intended purpose of the special purpose food.

The application must include clinical studies that examine the nutritional suitability of the food, for the target population.

This also includes information on the performance goals of sports people, if it relates to the addition of a nutritive substance or novel food ingredient to foods regulated under Standard 2.9.4 – Formulated Supplementary Sports Foods and Schedule 29 (sections S29—16 to S29—19).

Note:

With regard to performance goals of sports people, this should include, as a minimum, the results of a literature search on the potential for the nutritive substance or novel food ingredient to achieve specific nutritional or performance goals.

     B Information related to the dietary intake or dietary exposure

The application must contain the following information if it relates to a change to the general compositional requirements:

     B.1 Data to enable the dietary exposure of the target population to be estimated

This includes information on the dietary exposure of a food additive, processing aid, novel food or novel food ingredient, or dietary intake of