Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p21
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 55613–58415

their nutrient and other relevant compositional characteristics were determined
       (ii) a description of how the eligibility status of the range of foods tested was affected when evaluated under the current requirements and under the proposed variation.

FSANZ may request the applicant to supply the dataset containing the range of foods analysed in a form that enables FSANZ to review the data referred to in paragraph A.3(b) of this Guideline (3.2.6).

     A.4 Information related to variation of the required elements of a systematic review in Schedule 6

If the application seeks to vary any of the required elements of a systematic review as described in Schedule 6, the application must provide sufficient information to support the proposed variation, including an indication about how the proposed variation will deliver an equivalent level of rigour in evaluating the scientific information.

     B  Amendments to add food-health relationships to the tables to sectionsS4—4 or S4—5

If the application seeks to add a new food-health-relationship to either the tables to sections S4—4 or S4—5, the application must include suitable data, as described below, to assess the nominated food-health relationship and to permit determination of appropriate conditions for a claim based on the relationship.

If the application seeks to vary a food-health relationship already listed in the Code (Columns 1 and 2 in the tables to sections S4—4 or S4—5), then this is equivalent to a new relationship and appropriately suitable data must be provided, as outlined below.

     B.1  The scope of the food-health relationship

     B.1.1 A clear description of the food or property of food in the food-health relationship

The application must clearly characterise the food group, the food (e.g. genus, species, variety) or property of food that is the subject of the proposed health effect.

Note:

The food or property of food (see for example, Column 1 in the tables to sections S4—4 or S4—5) may include:

     * a food group (e.g. fruit)
     * a single ingredient food (e.g. banana)
     * a food with more than one ingredient (e.g. chewing gum, bread)
     * a property of food that may either be added or inherent (e.g. a nutrient, ingredient, a component of an ingredient, such as dietary fibre, or other substance or feature of food).

If the food or property of food is a substance or a novel food, a permission to add the substance to food or introduce a novel food must be present in the Code. If there is no permission in the Code for the substance or novel food, a simultaneous application may be required because the processes to amend the relevant standards are different.

There can be concurrent, but separate, applications for both a new substance or novel food and a new