Health Functional Food
Decision Tree for Safety Evaluation of Functional Ingredients for Health Functional Foods
* Source: Appendix 3 of the Regulations on Approval of Functional Ingredients and Standards and Specifications for Health Functional Foods
| Safety Data to be Submitted | A | B | C |
|---|---|---|---|
| Not eligible for application as a functional ingredient for Health Functional Foods | ○ | ||
| Data on History of Consumption | ○ | ○ | |
| Safety Information on the Functional Ingredient or Related Substances | ○ | ○ | |
| Intake Assessment Data | ○ | ○ | |
| Human Application Study Data | ○ | ||
| Toxicity Study Data | ○ |
Required Toxicity Study Items
| Study Item | Basic Study Items | Additional Study Items |
|---|---|---|
| Single-Dose Toxicity Studies (Rodents and Non-Rodents) | ○ | |
| 3-Month Repeated-Dose Toxicity Study (Rodents) | ○ | |
| Genotoxicity Studies (Reverse Mutation, Chromosomal Aberration, and Micronucleus Tests) | ○ | |
| Reproductive and Developmental Toxicity Studies | ○ | |
| Antigenicity Test | ○ | |
| Immunotoxicity Study | ○ | |
| Carcinogenicity Study | ○ |