Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p25
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
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Character Range: 66428–69354

may add to the weight of evidence in support of the food-health relationship.

     B.4 Assessment of the data from human studies

The application must include a scientific assessment about how the studies reviewed demonstrate, with a high degree of certainty, that a causal relationship exists between the food or property of food and the health effect.

Note:

Whether a causal relationship is likely to be established depends on the totality and weight of evidence that supports the proposed food-health relationship under investigation. The evidence would include consideration of a consistent association across all high quality studies that are independent of other factors, inclusion of well-conducted trials temporality and biological plausibility. It may be useful to consider if the relationship could be reversed by at least one additional high quality study.

     B.5 Information for setting conditions

The application must contain sufficient detail about the relationship to allow the amount of the food or property of food that is necessary to achieve the health effect, to be determined. Information about the likely dietary intake by the target population group (if there is one) or the whole population of the food or property of food must also be provided.

If the proposed food-health relationship covers. a wider target population group than the groups studied (for example, a wider age-sex range than covered by the included studies), the application must include justification of the validity of the extrapolation."

     Chapter 3.3

     Guidelines for applications for

     substances added to food

     3.3.1 Food additives

An application to vary the Code is required to approve the use of a new food additive in the food supply or to change the permissions for a currently used food additive. Permissions for use of food additives are specified in Schedule 15 – Substances that may be used as food additives.

The substance or preparation assessed should be representative of the commercial product for 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 is required.

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

     A Technical information on the food additive

The application must contain the following technical information:

Note:

FSANZ is required by paragraph 18(2)(e) of the FSANZ Act to have regard to any written policy guidelines formulated by the Forum.

For food additives, the relevant Guideline is the Addition to Food of Substances other than Vitamins and Minerals. Since food additives perform