Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p64
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 173428–176464

on consumer understanding and behaviour will vary depending on:

(a) the nature of the compositional change; and
(b) the foods to which it will apply.

Thus the amount of information necessary to address the impact on consumer understanding and behaviour will depend on the level of impact. Consultation with FSANZ may be necessary to examine the expected level of impact.

     3.6.2 Special purpose food – Infant formula products

Infant formula products comprise infant formula (0–12 months), follow-on formula (6–12 months) and infant formula for special dietary use (for infants aged 0–12 months).

An application to vary the Code is required to change the compositional or labelling requirements for infant formula products.

Compositional changes include: addition of a new substance not currently approved for use in infant formula products; an increase or decrease in the amount of a substance required for, or voluntarily added to, infant formula products. For the purposes of the Handbook, an increase or decrease in energy content or a macronutrient amount is considered to be a change to a nutritive substance.

The information requirements outlined below are in addition to those specified in Guideline 3.1.1 – General requirements and in other relevant guidelines in Part 3. The relevance of other guidelines is dependent on the proposed variation to the Code. Possible Guidelines include:

     * 3.3.1 for a food additive
     * 3.3.2 for a processing aid
     * 3.3.3 for a nutritive substance
     * 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

Note:

FSANZ is required by paragraph 18(2)(e) of the FSANZ Act to have regard to any written policy guidelines formulated by the Forum. The relevant Policy Guidelines for infant formula products are: the Regulation of Infant Formula Products, and Intent of Part 2.9 – Special Purpose Foods. These Policy Guidelines provide guidance on the composition, labelling, advertising and promotion of infant formula products.

Part 3 sets out the information requirements to enable FSANZ to have regard to these Policy Guidelines during the assessment of an application.

The Policy Guidelines are available on the FSANZ website at http://www.foodstandards.gov.au/code/fofr/fofrpolicy/Pages/default.aspx.

     A Information related to composition

     A.1 Purpose of the compositional change

The application must state the purpose of the compositional change to infant formula products.

This includes a brief description of all of the technological, nutritive or health-related function(s) of the substance at the proposed level in the relevant infant formula product(s). Where an added substance or compositional change has multiple purposes or functions, then these must be specified. This includes information on the target infant population(s) e.g. healthy term infants aged 0–12