Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p52
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 140516–143419

information is required to support an application for a novel food. This information is in addition to that specified in Guideline 3.1.1 – General requirements.

     A Exclusive use of novel foods

This includes a statement as to whether the application is seeking exclusive permission for the novel food. If exclusive permission is sought, the application must include details of the following:

(a) the specific class of food
(b) the brand of the food, including the name the food will be marketed under (if known).

Exclusive permission can only be sought if requested by the applicant at the time the application is received by FSANZ.

     B Technical information on the novel food

The substance or preparation assessed should be representative of the commercial product on which approval is sought. A statement to that effect must be made in the application. If this situation is not the case for any of the relevant studies, then a justification and explanation must be provided.

The application must contain the following information:

     B.1 Information on the type of novel food

This includes a brief description of the novel food, including the name the food will be marketed under (if known), and whether it falls within one of the following major identified categories:

     * plants or animals and their components
     * plant or animal extracts
     * herbs (both non-culinary and culinary) including extracts
     * single chemical entities
     * dietary macro-components
     * microorganisms (including probiotics)
     * food ingredients derived from new sources
     * foods produced by a process not previously applied to food.

Note:

These categories are provided as a guide based on previous experience and knowledge of the nature of products from enquiries received by FSANZ. It is anticipated that most novel foods will fall under one of these categories, however, this may not always be the case and the categories listed are not intended to be exhaustive.

The term dietary macro-component generally refers. to those dietary components which constitute a significant proportion of the food, such as fats, sugars, proteins and polysaccharides. Novel macro-components are used to replace the naturally-occurring components, either for a functional purpose or to reduce the energy value of the food. Examples include tagatose, cyclodextrin, diacylglycerol oil, trehalose, resistant starches.

The term 'single chemical entity' generally refers. to a substance, however derived, that is added to food but not consumed as food in its own right. It is intended for addition to food at levels consistent with use as a food ingredient. For the purposes of Standard 1.5.1, a single chemical entity does not include a substance used for a technological purpose.

A novel food may fit under more than one category above. In this case, all applicable requirements for each