*This article was originally published on May 25 and was updated on September 26, 2023. The updated contents related to human application test are as shown in the red frame below.
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 Food1 to help enterprises better understand the requirements and smoothly conduct functional ingredient application.
Under what situation shall enterprises apply for the recognition?
As specified in the Health Functional Food Act2, 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 Code3;
Addition of functionality or change of the intake amount or manufacturing standards for the functional ingredients notified in the Health Functional Food Code3;
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 Specification4.
What are the recognition standards？
Two essential principles of recognising functional ingredients are (1) compliance with the law and (2) comfirmed safety and functionality.
The “compliance with the law” means the ingredient or product shall be in compliance with the Health Functional Food Act2, 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 “comfirmed 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.
|MFDS issued the Health Functional Food Human Application Test Designation Guide on September 13, 2023, to provide assistance to enterprises facing difficulties in developing the functional ingredients.|
The human application test data is mandatory for functional ingredient recognition application. This guide outlines the considerations for designing human application tests. Key contents include:
- Criteria for selecting and excluding test subjects by functionality
- Basic characteristics to be investigated for test subjects
- Considerations for dietary intake surveys and dietary guidelines
- Guidelines for preparing relevant documents
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 test, animal test, 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 ingredient?
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
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
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 email@example.com for translation services.