Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p53
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 143175–146185

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 category should be addressed.

     B.2 Information on the purpose of adding a novel food ingredient to food

The application must state the purpose(s) of the addition of the novel food ingredient to food. If an added substance has multiple purposes or functions then these must all be specified.

If the purpose for adding a novel food ingredient to food (including special purpose foods) relates to a potential beneficial physiological or health-related outcome, the purpose must:

    (a) include a brief description of any physiological or health-related function(s) of the substance at the proposed level
    (b) be stated in a way that can be measured i.e. as an outcome in clinical studies
    (c) provide supporting evidence that the form and total amount of the novel food ingredient added to the food vehicle(s) delivers. the stated purpose in the target population group. The total amount should include naturally-occurring amounts. The target population must be clearly stated.

     B.3 Information on the physical and chemical properties of the novel food or novel food ingredient

This includes detailed information on the physical and chemical properties of the novel food or novel food ingredient including, where relevant, chemical name, CAS registry number, empirical and structural formula, molecular weight, chemical stability, thermal stability, solubility in water and melting point.

In cases where particle size is important to achieving the functionality 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.4 Information on the impurity profile for a typical preparation

This includes details on the nature and amounts (by weight) of all impurities, including isomers. and manufacturing by-products, present in the novel food ingredient preparation. Impurities should be identified by their Chemical Abstract (CA) or International Union of Pure and Applied Chemists (IUPAC) names.

     B.5 Manufacturing process for a novel food ingredient

This includes a comprehensive outline of the method of manufacture of the novel food ingredient.

     B.6 Specification for identity and purity for a novel food ingredient

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 must be provided. 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