South Korea Updates Guideline for Functional Ingredient Recognition

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 applications.

Under what situation shall enterprises apply for the recognition?

As specified in the Health Functional Food Act, manufacturers, importers, R&D institutes, etc., can apply for the recognition of non-noticed functional ingredients. The recognition scope is as follows:

Ingredients not notified in the Health Functional Food Code;
Addition of functionality or change of the intake amount or manufacturing standards for the functional ingredients notified in the Health Functional Food Code;
Addition of functionality, and addition or change of intake amount, manufacturing method, specifications or other items that may affect the safety or function of the functional ingredients that have been recognized following Article 9 of the Regulation on Certification of Functional Ingredients and Specification.

What are the recognition standards？

Two essential principles of recognizing functional ingredients are (1) compliance with the law and (2) confirmed safety and functionality.

The “compliance with the law” means the ingredient or product shall be in compliance with the Health Functional Food Act, with aspects of the Act purpose to contribute to the improvement of public health and consumer protection, as well as the health functional food definition of food manufactured using raw materials or ingredients with functional properties beneficial to the human body.

The “confirmed safety and functionality\” refers to \”the ingredient\’s safety must be secured” and “functionality must be scientifically proven” respectively.

A thorough review of all the submitted dossiers, including the origin, development history, domestic and international recognition and use status, manufacturing method, characteristics of raw materials, traditional use, intake evaluation results, human application test results, and toxicity test results, will be reviewed by MFDS to make sure the safety of ingredient is secured.

As for the proof of functionality, the authority will comprehensively consider the research type and level, evidence number, the consistency and relevance of results, etc., of human application tests, animal tests, and in vitro studies. For human application test, the data must be demonstrated to be functional in human bodies by reviewing the appropriateness of the study design and test subjects, the presence of significant results, and whether functionality is achieved at the suggested daily intake.

How to get the recognition of functional ingredients?

To successfully get approved for functional ingredient recognition, the submission dossiers for MFDS review are of great importance. Applicants shall submit an application letter to MFDS, along with the samples, inspection report, and dossiers including:

A general summary of the entire submission
Data on origin, development history, domestic and international recognition status and use status, etc.
Data on the manufacturing method
Data on the characteristics of the raw material
Data on the specification and test methods of the functional ingredient (or indicator ingredient)
Data on the specification and test methods of hazardous substances
Safety data
Functionality data
Information on dosage, intake method, precautions and information on setting the items thereof

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

References

Regulation on Certification of Functional Ingredients and Specification

Toxicity Test Standards for Pharmaceutical Products

To be more specific, a checklist of submission dossiers, explanations of the detailed requirements for each item, and examples are included in the guideline. However, MFDS hasn\’t published an English version of the guideline. Don\’t hesitate to get in touch with us at customer@reach24h.com for translation services.

Source: ChemLinked

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