Table 2     
Information Required in FOSHU Applications

  1. Name and date of birth of applicant (If the applicant is a corporate body, the corporate name and the name of representative)
  2. Name and address of head office and factory
  3. Name of product
  4. Expiration date
  5. Content amount
  6. Reason for seeking permission or approval
  7. Health claims and nutrition information on the label of the product
  8. List of ingredients and composition percentage
  9. Manufacturing process
  10. Certificate of nutrient analysis and amount of energy
  11. Explanation of how the product contributes to the improvement of one's diet and the maintenance/enhancement of health of the entire population
  12. Daily amount of intake
  13. Considerations and precautions at intake
  14. Instructions for preparation, storage, or intake of the product
  15. Other materials as appropriate*

* Attachments must contain the following information:

  1. Sample of the entire package with labels and claims
  2. Documentation that shows clinical and nutritional proof of the product's functional effects for the maintenance of health
  3. Documentation that shows clinical and nutritional proof of the intake amount of the product or its functional components
  4. Documentation concerning the safety of the product or its functional components
  5. Documentation of physicochemical properties and the test methods for the product's functional components
  6. Results of the quantitative and qualitative tests of components as nutrient constituents of the food, and their testing method
  7. Results of the tests of nutrient analysis and energy calculation
  8. Copy of the applying corporation's/organization's laws
  9. Description of the production method, factory equipment, and an explanation of the quality control system
  10. If the applicant is not the manufacturer of the product, a copy of the consignment contract
  11. Reasons for not attaching any of the above

Source: Japan Health Food & Nutrition Food Association