Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p19
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 50477–53414

factor

The application must include information on the following matters. where relevant:
    (a) justification for and limitations of the evidence and methods used to substantiate the individual components of the energy factor equation
    (b) whether the GE of the food ingredient is constant or varies with different proportions of constituent compounds
    (c) any variation in the digestion and absorption related to the variation in the composition of the food ingredient
    (d) effects of habituation/adaptation to consumption of the food ingredient
    (e) dose dependency
    (f) the nature of the background diet (e.g. high or low in one or more of fat, fibre or protein)
    (g) individual variability.

     3.2.6 Nutrition content and health claims

The following information is required to amend Standard 1.2.7 – Nutrition, health and related claims, Schedule 4 – Nutrition, health and related claims, or Schedule 6 –Required elements of a systematic review. This information is required in addition to that specified in Guidelines 3.1.1 – General requirements and 3.2.1 – General food labelling.

This Guideline (3.2.6) is divided into two parts. Section A addresses the application requirements for amendments to Standard 1.2.7. Section B is for applications to add a new food-health relationship to the table to section S4—4 (high level health claims) or to the table to section S4—5 (general level health claims) in the Code.

Note:

Applications to make a change in Schedule 4 to the list of high level health claims in section S4—4 and to add a general level health claim to section S4—5 are required to be considered using the high level health claim variation procedure. Other applications seeking to amend Standard 1.2.7 will be assessed using the general, minor or major procedure as applicable. If a single application seeks a high level or general level health claim variation as well another variation, then FSANZ will automatically progress the different variations under separate applications, each using the relevant procedure.

     A  Amendments to Standard 1.2.7 or Schedule 4, other than adding new food-health relationships to the tables to sections S4—4 and 5

     A.1 Information related to nutrition content claims in the table to section S4—3

If the application relates to nutrition content claims in the table to section S4—3, the following information must be provided:

    (a) consideration of the following in relation to any proposed changes to the claim conditions related to the property of food and each descriptor:

       (i) the nutrient composition of foods likely to carry the nutrition content claim as described in response to subsection A.2 in Guideline 3.2.1
       (ii) any relevant reference values pertaining to the property of food
       (iii) whether the conditions are achievable in the Australian and New Zealand food supply.

If the application is for new claim