Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p38
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 101814–104949

(IUPAC)); structural formula; common name and synonyms; manufacturers' code; marketing name; and CAS registry number. For biologically-derived nutritive substances, the source should be provided.

     B.2 Information on the chemical and physical properties of the nutritive substance

This includes detailed chemical and physical properties of the nutritive substance that are important for understanding how the substance is incorporated into the requested food matrices. Specifically, information and data must be provided on how the substance is incorporated in a uniform manner into the food matrices. Studies on the stability of the incorporated substance in particular detailing losses during food processing and storage to the end of shelf life must be provided for the different food matrices.

In cases where particle size is important to achieving the nutritive purpose or may relate to a difference in nutritional status or toxicity, the application must include information on particle size, size distribution, and morphology, as well as any size-dependent properties.

     B.3 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 nutritive substance preparation. Where possible, impurities should be identified by their CA or IUPAC names.

     B.4 Manufacturing process

This includes a description of the method of manufacture of the nutritive substance.

     B.5 Specification for identity and purity

This includes a specification from one of the published sources identified in Schedule 3 – Identity and purity. If a published specification is not available, a detailed specification should be provided.

     B.6 Analytical method for detection

This includes a method for detection and quantification of the nutritive substance or its degradation products in the foods in which it is proposed to be used. The application must include a robust analytical method suitable for analytical laboratories to determine compliance of any limits prescribed in the Code.

     B.7 Information on the proposed food label

This includes details of the proposed labelling statements relating to the presence of the nutritive substance in the food.

     C Information related to the safety of the nutritive substance

Note:

FSANZ will undertake an assessment of all available reports of animal and human toxicity studies related to the nutritive substance, where appropriate, and, if possible, establish a safe level of intake, or assess the safety of the use of the nutritive substance at the levels proposed in the food. Where an upper level of safety (UL) has been established, this will be considered. The NHMRC publication Nutrient Reference Values for Australia and New Zealand including Recommended Dietary Intakes contains ULs for a range of vitamins and minerals. This publication can be found at http://www.nhmrc.gov.au/publications/synopses/n35syn.htm.

The application must contain the following information:

     C.1 Information on the toxicokinetics and metabolism of