Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p26
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 69101–72149

paragraph 18(2)(e) of the FSANZ Act to have regard to any written policy guidelines formulated by the Forum.

For food additives, the relevant Guideline is the Addition to Food of Substances other than Vitamins and Minerals. Since food additives perform a technological purpose in food the specific order policy principles relevant for food additives are the five listed under Technological Function within this Guideline.

FSANZ will have regard to these policy principles during the assessment of the application. The Guideline is available at http://www.foodstandards.gov.au/code/fofr/fofrpolicy/Pages/default.aspx.

The information requirements outlined below take the Policy Guideline into consideration.

     A.1 Nature and technological purpose of the additive

This includes information related to the technological purpose of the food additive and includes the following specific information:

    (a) each of the technological purposes listed in Schedule 14 – Technological purposes performed by substances used as food additives that the additive fulfils
    (b) the reason why the food additive is needed to fulfil these purposes in each of the foods in which it is proposed to be used
    (c) evidence that the amounts proposed to be added are consistent with achieving the technological purpose
    (d) if the food additive is a preservative, data to demonstrate its effectiveness in each of the food groups in which it is proposed to be used
    (e) information is required on how the food additive is incorporated homogenously and stably into the different food matrices to which it is proposed to be added.

Data should also be provided to address losses of the substance from the foods during normal shelf life conditions.

     A.2 Information to enable identification of the additive

This includes the chemical name (according to both Chemical Abstracts (CA) and the International Union of Pure and Applied Chemistry (IUPAC)); structural formula; common name and synonyms; manufacturers' code; marketing name; and Chemical Abstract Service (CAS) registry number. For new food additives, a common name should be proposed.

For additives that are not single chemicals, the name should describe the additive as completely as possible. The sources of the additive should be provided, together with either sufficient compositional data to accurately identify the additive, or reference to its common name in other publications used by regulatory agencies. For additives that are derived from animals, plants or microorganisms, the source should be provided.

     A.3 Information on the chemical and physical properties of the additive

This includes sufficiently detailed information to enable the technological properties of the additive in a food matrix to be characterised, such as how it may interact with different foods, as well as providing general information on the likely metabolic fate of the additive following consumption.

In cases where particle size is important to achieving the technological purpose or may