Ingredients Usable for Foods with Function Claims|Conditions & Practice

In shortFoods with Function Claims is a system where businesses, under their own responsibility, display functionality based on scientific evidence and notify the Consumer Affairs Agency. The notification requires a clearly defined and standardized functional ingredient, plus scientific evidence for its safety and functionality (a research review or clinical trial).

Overview of the system

Unlike Foods for Specified Health Uses (Tokuho), which undergo individual government review, Foods with Function Claims use a notification system with no prior government review. However, the notification will not be accepted unless requirements are met, so scientific evidence and documentation are essential.

Conditions for usable ingredients

  • A clear functional ingredient that is quantifiable and standardized
  • Defined content specification and analytical method
  • Safety basis (intake history or safety testing)
  • Scientific evidence of functionality (research review or clinical trial)

Practice in ingredient selection

Choose ingredients with a clear content specification for the functional component, and confirm whether the supplier can provide the spec, analytical method, and safety/functionality evidence. Materials that are easy to standardize as functional components—such as GABA and various polyphenols—are widely used. See also FONTIA’s functional ingredients.

FAQ

Is there government review for the notification?
There is no prior government review—it is a notification system—but it will not be accepted unless requirements are met. Scientific evidence and documentation are prerequisites.
What can be a functional ingredient?
A component that can be quantified and standardized and for which safety and functionality evidence can be shown. Examples include GABA, indigestible dextrin, and various polyphenols.
Are documents from the ingredient maker necessary?
Yes. The spec, analytical method, and safety/functionality evidence serve as the basis for the notification.

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