Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p54
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 145932–148857

Where the substance, in the form in which it will be present in food, is particulate in nature, the application must include information on particle size, size distribution and morphology in cases where the referenced specification does not include this information.

     B.7 Analytical method for detection of a novel food ingredient

The application must contain the following information:

This includes a method for detection and quantification of the novel food ingredient or its degradation products (where relevant) in the foods in which it will be used. Such analytical methods need to be robust and applicable for analytical laboratories to determine compliance of any limits prescribed in the Code.

     C Information on the safety of the novel food

Note:

FSANZ will undertake an assessment of all available reports of animal and human studies which provide information related to the toxicity of the novel food or novel food ingredient. The safety of the novel food will be assessed at the proposed levels of use, using both the technical information provided in section A of this Guideline (3.5.2) and the information specified in this section.

For a novel food ingredient, a safe level of intake will be established, if possible, from the available studies.

There are a number of categories of novel foods. The data required for a safety assessment will therefore vary depending on the nature of the novel foods. Factors. to consider in a safety assessment will include:

(a) the history of use as a food in other countries
    (b) the composition of the novel food, particularly the levels of anti-nutrients and naturally-occurring toxins
    (c) the method of preparation and specifications of a novel food ingredient
    (d) potential for allergenicity of the novel food
    (e) metabolism/toxicokinetic studies on the novel food ingredient
    (f) animal toxicity studies on the novel food ingredient
    (g) human toleration studies on the novel food ingredient

The nature of the information on the safety of the novel food to be submitted will depend on the category of the novel food as identified in subsection B.1 of this Guideline (3.5.3).

     C.1 Plants or animals (or their components)

An application for a novel food which is a plant or animal (or their components) must contain the following information:

     C.1.1 Information on the composition of the novel food

This includes information on the levels of anti-nutrients and naturally-occurring toxins in the plant or animal (or their components).

     C.1.2 Information on the effects of food processing or preparation

This includes information on methods of reducing the levels of anti-nutrients or naturally-occurring toxins during food processing or food preparation, if relevant.

     C.1.3 Information on the current use of this food or food component in population sub-groups or in other countries

This includes