Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p22
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 58169–61170

for the substance or novel food, a simultaneous application may be required because the processes to amend the relevant standards are different.

There can be concurrent, but separate, applications for both a new substance or novel food and a new food-health relationship.

If a property of food is the subject of the food-health relationship, the application must also include:

(a) a summary of the source and specifications of the property of food
    (b) if permission to add the property of food to food is already in the Code, evidence to confirm that the property of food under consideration is the same as already in the Code
    (c) a description of the relative bioequivalence of the property of food when consumed in different food matrices, or of a relevant aspect of bioequivalence such as bioavailability or bioconversion
    (d) a robust analytical method suitable for analytical laboratories to use for detecting and quantifying the property of food in the foods in which it is present.

     B.1.2 A clear description of the health effect in the food-health relationship

The application must detail the health effect of the food or property of food and how it is measured.

     B.1.3 A clear description of the proposed food-health relationship

The application must contain a summary of the food-health relationship including the amount of food or property of food required to achieve the health effect, the nature and extent of the health effect, including its direction, and the target population group.

     B.2 Identifying and filtering literature for the proposed food-health relationship

The application must contain the information in either subsections B.2.1 or B.2.2 of this Guideline (3.2.6), whichever applies. Only original literature involving humans can be used as a basis to establish a food-health relationship or update an existing systematic review.

     B.2.1 A clear description of the search strategy used for food-health relationships examined using original literature only

If the proposed food-health relationship is being examined using the original literature, the application must contain a clear description of the search strategy used to capture the scientific evidence. This includes:

    (a) identification of the electronic databases (e.g. Medline, CINAHL, Cochrane Library, Embase and PsycINFO etc.) used for the search
    (b) the search parameters. including search terms, time period and languages
    (c) justification for excluding the use of any closely related ant search terms
    (d) reasons for choosing a specified time period
    (e) other restrictions placed on the search (e.g. language and study design)
    (f) a description of any manual (non-electronic) search techniques employed, including hand-searching, and the strategy used to identify any unpublished studies
    (g) a list of inclusion and exclusion criteria used to filter the literature
    (h) the number of studies identified from the search strategy, and