Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p27
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 71887–74914

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 relate to a difference in toxicity, the application must include information on particle size, size distribution, and morphology, as well as any size-dependent properties.

     A.4 Information on the impurity profile

This includes details on the nature and amounts (by weight) of all impurities, including isomers. and manufacturing by-products, present in the additive preparation. Where possible, impurities should be identified by their CA or IUPAC names.

     A.5 Manufacturing process

This includes a description of the method of manufacture of the food additive.

     A.6 Specification for identity and purity

This includes a specification from one of the published sources identified in Schedule 3 – Identity and purity. If there is no published specification in one of the identified sources, a detailed specification must be provided. Specifications should include information on the name of the food additive, its chemical and physical properties, its purity, acceptable levels of impurities, the method of preparation, and analytical methods of determining purity.

Information is also required for the presence of known allergens (see section 1.2.3—4 in the Code) in the commercial product.

     A.7 Information for food labelling

This includes information on the class of the food additive and, if available, the code number for the additive.

     A.8 Analytical method for detection

An analytical method must be provided for detecting and quantifying the additive, or its degradation products, in the foods in which it will be used.

This includes information on available methodology for detecting and quantifying the additive, or its degradation products, in the foods in which it will be used. The application must include a robust analytical method suitable for analytical laboratories to determine compliance of any limits prescribed in the Code.

     A.9 Potential additional purposes of the food additive when added to food

This includes a brief description about any additional purposes, such as a nutritive or health-related purpose, of the food additive at the levels proposed to be added.

     B Information related to the safety of the food additive

Note:

FSANZ will undertake a safety assessment using the detailed study reports, where possible, of all animal and human toxicity studies related to the food additive and, if applicable, establish an acceptable daily intake (ADI) for the food additive, if the studies are suitable for this purpose.

An application for a food additive must contain the following information:

     B.1 Information on the toxicokinetics and metabolism of the food additive and, if necessary, its degradation products or major metabolites

    (a) For an application for a new