Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p37
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 99111–102133

consideration.

The following information is required to support an application for use of a new nutritive substance or to change the permissions for a use of a nutritive substance. This information is in addition to that specified in Guideline 3.1.1 – General requirements.

     A Information on the use of the nutritive substance

     A.1 Information on the purpose of the use of a nutritive substance in food

The application must state all of the purpose(s) of the use of the nutritive substance in food. If such a substance has multiple purposes or functions then these must all be briefly described.

When the purpose for using a nutritive substance in food (including special purpose foods) relates to a nutritional purpose to deliver a potential beneficial physiological or health-related outcome, the application must:

    (a) include a brief description of all of the 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

     A.2 General data requirements for supporting evidence

The nutritive substance 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.

Studies provided as evidence to support an application must contain sufficient detail to enable an independent assessment of the methods and results to confirm the study conclusions. The scientific evidence for a potential beneficial physiological or health-related outcome must:

    (a) be based on studies conducted on human subjects
    (b) be based on foods or food groups which contain the nutritive substance rather than the use of the substance alone
    (c) relate to normal use by the target population group and the foods must contribute to the demonstrated nutritional role relevant to that target population.
Note:

Refer to section E in Guideline 3.1.1 for further information regarding data quality.

     B  Technical information on the use of the nutritive substance

For an application to extend the use of a nutritive substance, this must indicate that the technical information required in subsections B.1–B.7 in this Guideline (3.3.3) meets the current identity and purity specifications.

The application must contain the following technical information:

     B.1 Information to enable identification of the nutritive substance

This includes the chemical name (according to both Chemical Abstracts (CA) and the International Union for Pure and Applied Chemistry (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