On May 22, 2023, the Ministry of Food and Drug Safety (MFDS) updated the Guideline on Preparing Dossiers for Functional Ingredient Recognition of Health Functional Food to help enterprises better understand the requirements and smoothly conduct functional ingredient application.
The preparation methods of the proper dossiers are listed in the guideline. The contents are as below:
I. Overview of Recognition Application Overview
II. Submission Dossiers for Application for Recognition of Functional Ingredients
1. Summary of Submission Dossiers
2. Data on origin, development history, domestic and international recognition status and usage status, etc.
3. Manufacturing method and related materials
4. Data on the characteristics of raw materials
5. Data on the specification and test methods of the functional ingredient (or indicator ingredient)
6. Data on the specification and test methods of hazardous substances
7. Safety data
8. Function data
9. information on dosage, intake method, precautions and information on setting the items thereof
Regulation on Certification of Functional Ingredients and Specification
Toxicity Test Standards for Pharmaceutical Products