Scope of Data to Be Submitted-----------------
Data to be submitted to be recognized as a functional ingredient shall be as follows: |
1. | An executive summary of all data submitted; |
2. | Data regarding the origin, the details of development, the current status of recognition and use of the functional ingredient in the Republic of Korea or abroad, etc.; |
3. | Data regarding manufacturing methods; |
4. | Data regarding the properties of the functional ingredient; |
5. | Data regarding specifications and testing methods for functional components (or index component), and a test report; |
6. | Data regarding specifications and testing methods for hazardous substances; |
7. | Data regarding safety; |
8. | Data regarding the details of functionality; |
9. | Data regarding the intake of the functional ingredient, cautions for ingestion; and the creation thereof; |
10. | Data verifying that the relevant ingredient is not identical or similar to a pharmaceutical drug. |
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