Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p68
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 184807–187844

must be provided:

(a) Tolerance of the proposed compositional change

    Evidence to support tolerance must include appropriate human studies. This includes an explanation of the way in which this evidence relates to infants.

(b) Efficacy of the proposed compositional change

    If the food additive also provides a nutritive or health-related function, the information requirements listed in component (I) for efficacy of proposed change must be met. If the function is purely technological, there are no further requirements in this section.

     B  Information related to the dietary intake or dietary exposure

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

The application must meet the information requirements for the dietary exposure of a food additive, processing aid, novel food or novel food ingredient, or dietary intake of a nutritive substance (including energy or macronutrient), as outlined in these application guidelines. The information provided must have a focus on infants.

     B.2 Data on the recommended level of formula consumption for the target population

The application must contain the following information:

    (i) the capacity of the product scoop (in grams of product)
(ii) the number of scoops required per feed
(iii) the volume of water required per feed
(iv) total volume of the made-up feed
    (v) recommended number of feeds per day relevant to each age group in the relevant target population.

     B.3 Information relating to the substance

The application should also contain information or references on the levels (naturally occurring or naturally occurring and added) of the proposed substance in other foods that infants are likely to consume.

     C  Information related to labelling requirements under Part 2.9 of the Code

     C.1 Information related to safety or nutritional impact of the proposed labelling change

The application must include information to support the proposed labelling change. For example, the inclusion of (or change to) a warning or advisory statement, directions for use, or conditions.

     C.2 Information to demonstrate that the proposed labelling change will be understood and will assist consumers

This should include consumer research information to demonstrate the anticipated consumer response to the proposed change, or data obtained from an overseas market where the proposed labelling is already in place.

Note:

The extent of the impact of a labelling change on consumer understanding and behaviour will vary depending on:

(a) the nature of the labelling 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.

     D  Information related to internationally recognised standards, codes of practice, recommendations AND guidelines

The application must