Regulations on Approval of Functional Ingredients and Standards and Specifications of Health Functional Foods

Chapter 1: General Provisions

Article 1 (Purpose) The provisions of this regulation shall be based on the provisions of Article 14 (2) and 15 (2)
of the Act on Health Functional Foods. The purpose of this document is to determine the scope, requirements,
evaluation principles, etc. of the data, and to make appropriate the approval work.

Article 2 (Definition) ① The meanings of terms used in this regulation are as follows.
1. "Functional raw materials" means functional substances used in the manufacture of health functional foods,
which fall under any of the following items.
A). Processed raw materials of origin such as animals, plants, microorganisms, and water
B) A)’s Extract, purified
(1) "Extract" means a substance extracted or used physically from a raw material of origin such as animals,
plants, microorganisms and water.
(2) "Refined substance" means a substance that isolates and purifies specific components contained in raw
materials of origin such as animals, plants, microorganisms, and water.
C) Synthetic substance of Purified of B)’s.
(1) "Synthetic substance" refers to a substance obtained by chemical reaction with purified wood.
D) Complex from A) to C)

2. "Functional component" means the component which shows the functionality contained in the raw material.
3. "Indicator component" means a component determined for the purpose of quality control among chemically
identified components contained in raw materials.
4. "Raw material" means the source material used to manufacture the raw material.
5. Deleted (June 28, 2007)
6. “Hazardous Substances” refers to microorganisms, heavy metals, residual pesticides, residual solvents, etc.,
which are harmful to the human body due to the possibility of contamination or residue during raw materials or
manufacturing process.
7. "Human Application Test" means a human test to prove the safety and functionality of functional raw
materials.
② Definitions of terms not used otherwise in this regulation shall be in accordance with relevant notices such
as the Act on Health Functional Foods (hereinafter referred to as the Act) or the Standards and Specifications of
Health Functional Foods.

Article 3 (Objects for Examination) ① The subjects of examination for the recognition of functional raw
materials under Article 15 (2) of the Act shall be as follows.
1. Raw materials not disclosed in 「Standards and Specifications of Health Functional Food」
2. Addition of functional contents, changes in intake or manufacturing standards for functional ingredients as
disclosed in 「Standards and Specifications of Health Functional Foods」
3. Changes or additions to matters affecting safety and functionality, such as addition of functional content,
changes in intake, manufacturing methods and specifications for functional ingredients recognized under Article 9
(1).

② The subjects of examination for the recognition of the standards and specifications of health functional
foods (hereinafter referred to as "health functional foods") under Article 14 (2) of the Act shall be as follows.
However, foods using nutritional ingredients whose individual standards and specification are specified in the
standards and specifications of health functional foods, health functional foods manufactured in the form of
products specified in the common manufacturing standards of the standards and specifications of health
functional foods, or Special purpose foods, alcoholic beverages, powdered milks, and formulated milks under the
Food Standards and Specifications are excluded.
1. Foods manufactured and processed using functional ingredients declared in the Standards and Specifications
of Health Functional Foods.

2. Food products manufactured and processed using functional raw materials recognized under Article 9 (1).

Article 4 (Approval Criteria) The criteria for approval of functional raw materials and health functional foods
subject to evaluation under Article 3 (1) and (2) are as follows.
1. Must comply with the law.
2. Safety and functionality should be secured.

Chapter 2 approval procedure

Article 5 (Application for Approval) ① A person who intends to be recognized as a functional raw material or
health functional food pursuant to Article 14 (2) of the Act and Article 15 (2) of the Act shall apply for recognition
of the attached Form 1 or Attached Form 2 (electronic document) (Including electronic documents) should be
submitted to the Director General of Food and Drug Safety.

1.One copy of the submission as prescribed in Article 12 (1) or Article 17;

2. One storage medium (CD, etc.) containing the submitted data
3. Raw materials, products or prototypes according to the following items:
A) In case of functional raw materials and health functional foods manufactured in Korea, it shall be
submitted at random among products manufactured more than 3 lots in health functional foods establishments
pursuant to Article 4 of the Act and Article 2 of the Enforcement Decree of the same Act.
B) In the case of imported functional raw materials and health functional foods, they are imported as foods,
food additives, health functional foods, or health functional foods used for research and investigation, which
should be imported for domestic distribution and sale in accordance with the Special Act on Imported Food
Safety Management.

4. Standard product (functional ingredient or indicator ingredient)

5. Inspection by food specialty testing and inspection agencies designated by the Director of Food and Drug
Safety pursuant to Article 6 (3) 1 of the 「Act on Testing and Inspection of Food and Pharmaceutical Sectors, etc.」
or by overseas testing and inspection agencies under Article 8 of the same Act. Test report or inspection report,
such as functional ingredients, standards and specifications of raw materials (However, standards for functional
ingredients or indicator ingredients shall be issued by the testing and inspection agency performing the health
functional food inspection agency having GMP certification)

Article 6 (Processing Period) ① The period required for the approval of functional raw materials and health
functional food is as follows.
1. Article 3 (1) 1: Within 120 days from the date of receipt (individual recognition)
2. Article 3 (2) 1 and 2: Within 90 days from the date of receipt
3. Article 3 (1) 2 and 3: Within 60 days from the date of receipt
4. Changes in matters falling under any subparagraph of Article 11: Within 5 days from the date of receipt
② In spite of Paragraph (1) 1 and 2, if the functional ingredient of the functional ingredient is the same as
the functional ingredient and the test method approved by the Director of the Ministry of Food and Drug Safety
is applied, the processing period shall be shortened within the range of 1/2. Can be quickly reviewed.

Article 7 (Completion of Data, etc.) ① The Director General of Food and Drug Safety shall supplement the
data to the applicant by specifying the necessary matters and the time required for supplementation, if there is
any reason for any of the following items during the evaluation of the submitted data: The period required for
supplementation shall be in accordance with the Act on the Handling of Civil Complaints.

1.When the kind, scope, content, and requirements of the submitted data do not conform to Articles 12, 14,
17, and 19;
2. When it is deemed that additional data, etc., are necessary in particular for proper evaluation
② The Director of Food and Drug Safety may listen to the opinions on the materials submitted by the
applicant in any of the following cases.
1. When it is judged that the reliability of submitted data is not secured
2. When the scope, content, and requirements of the submitted documents do not conform to Articles 12, 14,
17, and 19, and need to be confirmed.

Article 8 (Refuse of Application Documents) The Director General of Food and Drug Safety shall return to the
applicant stating the reasons for any of the following.
1. When it is not suitable for the object of examination under Article 3
2. When it does not meet the approval standard of Article 4
3. When the applicant fails to submit the relevant data within the supplementary period under Article 7 (1).
4. If the data submitted pursuant to the application for approval under Article 5 is found to have been
submitted in a false or otherwise fraudulent manner;

Article 9 (Acknowledgment and Advisory) (1) When the Director General of Food and Drug Safety receives an
application for approval under Article 5, he / she shall review whether it meets the criteria for approval under
Article 4 according to Article 15 or Article 20, and the result of the review is appropriate. If approved, it should be
recognized as a functional ingredient or dietary supplement.
② If the Director General of Food and Drug Safety intends to recognize a functional ingredient or health
functional food under paragraph (1), he / she shall consult the Health Functional Food Review Committee under
Article 27 of the Act.

Article 9-2 (Cancellation of approval) (1) The Director General of Food and Drug Safety may immediately
cancel the recognition of functional ingredients and health functional foods in any of the following cases.
1. .If the data submitted pursuant to Article 5 is found to have been recognized as a functional ingredient or
health functional food in a false or otherwise fraudulent manner;
2. If the reevaluation under Article 15-2 of the Act indicates that there is a serious problem in safety and
functionality.
② If the Director General of Food and Drug Safety intends to revoke the recognition of functional ingredients
and health functional foods under paragraph (1), he / she shall consult the Health Functional Food Review
Committee under Article 27 of the Act.

Article 10 (Issuance and Collection of Certificates) (1) If the Director General of Food and Drug Safety is
recognized in accordance with Article 9 (1), he / she shall issue a certificate to the applicant.
② If the functional raw materials recognized in accordance with paragraph (1) fall under Article 3 (1) 2, the
Director General of Food and Drug Safety shall notify the standards and standards of health functional food.
③ When the Director of Food and Drug Safety issues an approval under paragraph (1), the following
matters shall be disclosed on the website.

1. Authorization number
2. Name of company or organization
3. Raw material name
4. Exporting country and name of exporting company
5. Functional Content
6. Daily Intake
7. Precautions when ingesting

(4) The Director General of Food and Drug Safety shall recover the certificate issued under paragraph (1) in
any of the following cases.
1. Where approval is canceled pursuant to Article 9-2;
2. If the standards and specifications for each functional ingredient are changed in 「Standards and
Standards of Health Functional Foods」 (KFDA Notification)

Chapter 3 Functional Raw Material Recognition

Article 12 (Scope of Submitted Data) ① Submitted data for recognition as functional raw materials shall be as
follows.
1. Executive summary of all submissions
2. Data on the origin, development status, domestic and foreign recognition and usage
 3. Data on manufacturing method
4. Data on the characteristics of raw materials
5. Data and test reports on standards and test methods for functional ingredients (or indicator components)
6. Data on standards and test methods for hazardous substances
7. Data on safety
8. Data on functional content
9. Data on intake amount, precautions for ingestion and setting
10. Data confirming that they are not the same or similar to a drug

(2) Notwithstanding paragraph (1), if the raw material for which the application for certification falls under
Article 3 (1) 2 or 3, only additional or changed data may be submitted.

Article 13 (Preparation of Submitting documents) The method of preparing submitting documents under
Article 12 shall be as follows.
1. The index number and number of each catalog and data shall be labeled in the order of Article 14.
However, in the case where the data submitted in each subparagraph of Article 14 is exempted, omitted, or
unable to prepare the submitted data pursuant to Article 12 (2), the reasons shall be specified in detail and
attached to the order of the relevant items.
2. A summary summary should be attached to give an overview of the entire data, and the index number for
each article should be attached at the end of each section to make it easier to understand the relationship
between the contents of the summary and each detailed data.
3. If there are a lot of submitted data according to the written item, a detailed summary summary should be
attached at the beginning of the written item data so that the data can be easily identified.
4. All submitted materials must be submitted with original materials. In case of submitting foreign language
materials other than English, Korean translation must be submitted together.

Article 14 (Contents and Requirements of Submitted Data) The contents and requirements to be included in
the submitting documents of Article 12 are as follows.
1. Executive summary of all submissions (A brief summary of the contents of subparagraphs 2 through 10)
2. Beginning, development motivation, domestic and foreign recognition and usage data
A) Beginning and development motivation
Write the development story, when, in what country and in what way. In particular, when natural
ingredients are used as raw materials, describe the origin, scientific name, country of origin, and used part in
detail.
B) Domestic and Overseas approval and Permit Status
Accurately describe relevant contents such as the status of accreditation, approval, use standards and
specifications in domestic, foreign and international organizations. If it is under review by an international
organization such as the Codex Alimentarius Commission (CAC), data on the status of safety evaluation, criteria
for use, and specifications should be attached.

C) Domestic and Overseas Use Status

If there is a record of food use at home or abroad, attach data on the intended usage, distribution
volume, manufacturer, and intake status.

3. Data on manufacturing method

A) Specific manufacturing method by unit process such as manufacturing temperature, time and pressure
B) Manufacturing method and country of manufacture related to safety and functional evaluation such as
solvent, enzyme, microorganism, etc. used in manufacturing process
C) Detailed data on changes in content and yield of functional (or indicator) components by major
manufacturing steps (extraction, filtration, concentration, etc.)
D) Data on the name, compounding ratio and stability of each raw material when two or more raw
materials are mixed ratio.

In the case of imported health functional foods, the data from A) to D) issued by the manufacturer
E) In case of process consignment in some of the manufacturing methods, the data from items A) to D)
issued by the consignee (including overseas companies)

4. Data on the characteristics of raw materials

A) Data on properties, shapes, etc. that can characterize the raw material
B) Data on functional components (or indicator components) to confirm standardization of the raw
material
C) If there are raw materials that are difficult to distinguish from other raw materials with the naked eye,
data such as properties and indicator components can be distinguished.

5. Data and test reports on standards and test methods for functional ingredients (or indicator components)
A) Specification of functional ingredients (or indicator components)
(1) In consideration of the characteristics of the raw materials, such as the production of raw materials,
the manufacturing and processing processes and the stability of the raw materials, the results shall be established
on the basis of test results for products of more than 3 lots. However, it may be set by titer test if it is
inappropriate to set it.
(2) In principle, the lower limit and the upper limit of the value to be displayed considering the analysis
error should be 80 to 120% of the displayed amount. However, if there are valid reasons, it may be decided
differently.
(3) When two or more relevant ingredients are mixed, the standard of functional ingredient (or indicator
ingredient) of each ingredient should be set.

B) Test method of functional ingredient (or indicator ingredient)

(1) It should be suitable for analyzing the standard of functional ingredient (or indicator ingredient), and
the standard and specification of health functional food, standard and specification of food, standard and
specification of food additives, International Food Standards Committee Appropriate methods should be used
both domestically and internationally in accordance with the Codex Alimentarius Commission (CAC) regulations
and the AOAC method. At this time, the applied matrix of the submitted test method and the matrix of the
applied raw material should be the same. However, if there is no recognized method or more appropriate, the
test method suggested by the applicant may be used. In this case, the validity of the proposed test method
should be revealed with reference to Table 1.
 (2) When two or more relevant ingredients are mixed, the test method for functional ingredients (or
indicator components) of each ingredient should be established.

C) Test report analyzed by domestic and overseas testing and inspection agencies
In order to examine the validity of the standards and test methods of the established functional
ingredients (or indicator ingredients), a food specialty testing and inspection agency under Article 6 (3) 1 of the
Act on the Testing and Inspection of Food and Pharmaceutical Products, etc. The test report or inspection report
of the test and inspection agency carrying out the health functional food inspection service among the overseas
test and inspection institutions under Article 8 shall be submitted.

6. Data on standards and test methods for hazardous substances

A) Hazardous Substances
It shall be set up in accordance with Table 2 to prevent the possibility of contamination or residual
of harmful substances due to raw materials or manufacturing process and to ensure safety. In this case, it is based
on the test results for products of more than 3 lots considering the properties of the raw materials.

B) Test method of hazardous substances

Standards and Specifications recognized in Korea and abroad in accordance with the standards and
specification of functional foods, standards and specifications of foods, standards and specifications of food
additives, Codex Alimentarius Commission (CAC) regulations, AOAC methods, etc. Should be used. However, if
there is no recognized method or more appropriate, the test method suggested by the applicant may be used. In
this case, the adequacy of the proposed test method should be revealed with reference to Table 1.

C). Test report analyzed by domestic and overseas testing and inspection agencies
In order to examine the validity of the standards and test methods of the established hazardous
substances, a food specialty testing and inspection organization under Article 6 (3) 1 of the Act on the Testing
and Inspection of Food and Pharmaceutical Fields, or an overseas test under Article 8 of the same Act. · The test
report or inspection report of the inspector shall be submitted. However, if there is a pesticide residue tolerance
standard in "Food Standards and Specifications", "Regulations on Inspection of Imported Foods, etc." [Appendix 3].
Test results and analytical data should be submitted for Lean, Dieldrin, Aldrin, BHC, DDT).

7. Data on safety
A) When the raw material is consumed according to the proposed method, scientific evidence should be
provided to confirm that the raw material is harmless to humans.
B) For safety data, reference table 3 can be used as evidence of ingestion, safety information data for the
relevant raw materials or ingredients, intake evaluation data, human application test data (mediation tests,
epidemiological investigations, etc.) and toxicity test data. .
C) The requirements of the safety data are:
(1) The evidence of ingestion shall be scientific data describing the method of manufacture, use,
intake, etc., as well as historical records of the use of the ingredient as deemed safe.
(2) The safety information data on the functional ingredient or related substance should be
published in domestic or foreign academic journals or received a certificate of publication, national or
international government report or international organization report, and relevant database search results.
(3) Intake evaluation data should be prepared using various scientific data (intake survey data,
statistical data, etc.).
(4) Data according to subparagraph 8 can also be used for human application test data related to
safety.
(5) Toxicity test data are in accordance with the OECD Test Guideline established by the Organization
for Economic Co-operation and Development (OECD) by organizations operated in accordance with Good
Laboratory Practice (GLP). It should be a tested report.

8. Data on functional content

A) Functional content
Describe the effects that are useful for the health application resulting from the consumption of the
material.
B) As data on functionality, human application tests, animal tests, and in vitro test data should be
submitted.
(1) Human application tests are to submit data from intervention studies or observational studies. In
particular, trials designed with Randomized Controlled Trial (Double-Blind) are preferred, and the results should be
universally applied to the public.
(2) Animal test and in vitro test should explain the mechanism of action of raw materials and ingredients
and support the results of human application test scientifically.
(3) Where two or more raw materials are mixed, their functionality should be demonstrated as mixed raw
materials, and the justification for their mixing and the scientific basis thereof shall be submitted.

C) The requirements of the functional data are as follows.

(1) <Deleted> (2010.10.29)
(2) <Deleted> (2010.10.29.)
(3) Animal test and in vitro test shall be published in academic journals equivalent to or above the
scientific and technical thesis index (including Science Citation Index (Expanded) and SCI (E)) or Korea Citation
Index (KCI). Certificate).
(4) The human application test must be approved by the Institutional Review Board Ethics Committee
(IRB) in accordance with the Guideline for Good Clinical Practice by International Conference on Harmonization
(ICH GCP). One of followings must be submitted.
1) Human application test plan and final report
2) It must be published in a journal that is equivalent to the Science Citation Index (Expanded) or
SCI (E) or equivalent to the Korean Citation Index (KCI) (including publication certificate). However, if submitted as
a paper published in a journal, the submission of a human test plan and final report may be requested.

9. Data on intake amount, intake method, precautions for intake and setting
A) Based on safety and functional data, the daily intake or range in which the safety of the raw material is
guaranteed and functional is established.
B) Based on the functional data, describe the ingestion method that most effectively represents the
functionality of the material.
C) The precautions for ingestion should be described in consideration of the side effects of excessive
ingestion of the raw material, interaction with the food or drug components in use, and the vulnerable groups
(pregnant women, lactating women, children, the elderly, etc.).

10. Data confirming that they are not the same as or similar to the drug
It should be confirmed that it is not the same as or similar to the drug according to the standards
and specifications of dietary supplements.

Article 15 (Evaluation of Functional Ingredients) If the Director General of Food and Drug Safety wishes to
recognize a raw material or ingredient that can be used for health functional food pursuant to Article 15 (2) of
the Act, the safety and functionality of the ingredient or ingredient shall be Evaluate together.

1. Matters related to raw materials

A) Whether the genesis, scientific name, country of origin, and part used of the raw materials are
specifically stated
B) In the case of composite raw materials, is the content of item A) for each raw material properly
described or not.
C) Appropriateness of domestic and foreign accreditation and approval status and domestic and
foreign use status as food or food additives

2. Matters related to the manufacturing method

A) Whether the temperature, time, pressure, etc., during manufacturing are suitable for the production
of functional raw materials. (If necessary, the adequacy of the manufacturing process should be confirmed.)
B) Solvents, enzymes, etc. used in the manufacturing process of raw materials are listed in "Standards
and Specifications of Health Functional Foods" (KFDA), "Standards and Specifications of Food" (KFDA), "Standards
and Specifications of Food Additives" (KFDA) Used properly)
C) Whether the change in the content and yield of functional ingredients (or indicator components)
by manufacturing stage from raw materials to the applied raw materials has been properly analyzed
D) Whether stability can be ensured when two or more raw materials are mixed
E) In case of importation, whether the data from items A to D are issued by the manufacturer is
appropriate.
F) For some fair consignees, is it appropriate that the data from items A) to D) issued by the
consignee are appropriate?

3. Matters related to functional ingredients (or indicator components);

A) Whether the representativeness of the functional ingredient (or indicator ingredient) has been
secured based on the review of the properties of the functional ingredient
B) Whether the content, specifications and test methods for the functional ingredient (or indicator
ingredient) are set appropriately
C) A test that conducts the health functional food inspection service among food specialty testing
and inspection organizations under Article 6 (3) 1 of the Act on Testing and Inspection of Food and
Pharmaceutical Fields, or overseas testing and inspection agencies under Article 8 of the same Act. Whether the
test report of the inspection institution or the test report is suitable (confirmation test may be carried out if
necessary)

4. Specification of hazardous substances

A) Whether the possibility of contamination or residual of harmful substances due to raw materials or
manufacturing process is set properly according to Table 2.
B) Whether the test report or inspection report of a food specialty test / inspection institution under
Article 6 (3) 1 of the 「Act on the Testing and Inspection of Food and Pharmaceutical Sectors, etc.」 or an
overseas test / inspection institution under Article 8 of the same Act is appropriate ( Confirmation test can be
done if necessary.)

5. Matters related to safety

A) Whether it is a raw material recognized for domestic or foreign food use or whether it is suitable
for use
B) Intake assessment is appropriate
C) Are there any side effects, toxicity information, etc. as a result of safety data search
D) Toxic if submitting toxicology test data
E) Whether the standards for hazardous substances are set up to ensure safety
F) Safety test report or inspection report related to toxic substances of food testing and inspection
agency under Article 6 (3) 1 of the Act on Food and Pharmaceutical Field, etc. or overseas testing and inspection
agency under Article 8 of the same Act Is it suitable

6. Matters related to functionality

A) Whether it falls within the scope of functional recognition pursuant to Article 15 (2) of the Act
B) Whether the functionality has been individually evaluated according to the type and level of the
study
C) Whether the submitted data, such as functional related human application tests, are appropriately
set for the test design, subjects, etc. and whether they show significant results
D) Whether or not functionality is ensured in daily intake
E) Whether the functionality has been assessed taking into account the amount, consistency and
relevance of the total evidence
F) Adequacy of the functional recognition contents requested by the business operator in accordance
with the attached form 1

7. Whether the amount of intake, method of ingestion, and precautions for ingestion are set based on the
safety and functionality of the raw materials.
 8. Whether it is a pharmaceutical ingredient approved domestically or internationally, or is a raw material
currently under license.

9. Comprehensive Evaluation of Submitted Data

Review all the submitted data such as the genesis, development status and use status, domestic and
foreign recognition, manufacturing method, characteristics of raw materials, traditional use, intake evaluation
results, human application test results, toxicity test results, etc. Evaluate the safety and functionality of the
ingredients.

Article 16 (Approval of Functional Contents of Functional Ingredients) According to the evaluation results of
Article 15, the Director General of Food and Drug Safety classifies the functionalities of ingredients as follows, and
the contents of functional certification are shown in Annex 4.

1. If the submitted functional data indicates a reduction in the risk of developing disease, and the level of
scientific evidence obtained is high enough to reach a Significant Scientific Agreement, the 'reduction of disease
risk function'
2. If the submitted functional data have a special effect on the normal function or biological activity of the
human body, indicating a contribution to health, functional improvement, or health maintenance and
improvement, 'physiologically active function'

Chapter 4 Health Functional Food Approval

Article 17 (Submitted Data) The submitted data documents for approval as a health functional food under Article
3 (2) is as follows.
1. Executive summary of all submissions
2. Data on food types
3. Data on Name and Content of Blended Ingredients
4. Data on Manufacturing Method
5. Data on standards and specifications
6. Safety data
7. Data on functional content
8. Nutritional Information

Article 18 (Preparation of Submitted Data) Article 13 shall apply mutatis mutandis to the method for preparing
submitted data documents under Article 17.
Article 19 (Contents and Requirements of Submitted Data) The contents and requirements to be included in the
submitted data documents under Article 17 are as follows.
1. Executive summary of all submissions (A brief summary of the contents of subparagraphs 2 through 8)
2. Data on food types
Health functional foods to be manufactured should follow the types set forth in the `` Standards and
Specifications of Food '', etc., and the relevant data should be submitted.
3. Data on Name and Content of Blended Ingredients
The name of the raw material and the proportion should be submitted. Other raw materials used are
「Standards and Specifications of Health Functional Food」, Section 2. 1.3) It should be suitable for other raw
materials.
4. Data on Manufacturing Method

5. Data on standards and specifications

A) Data on the functional ingredient (or indicator ingredient) standard of the dietary supplement
B) Functional ingredient (or indicator ingredient) test method, provided that the test method of the
functional ingredient used is not suitable for analysis
It should be suitable for analyzing the specification of functional ingredient (or indicator ingredient),
and the standards and specifications of health functional food, standards and specifications of food, standards
and specifications of food additives, Codex Alimentarius In accordance with Commission, CAC, AOAC method, etc.,
the method approved domestically and internationally should be used. However, if there is no recognized method
or more appropriate, the test method suggested by the applicant may be used. In this case, the adequacy of the
proposed test method should be revealed with reference to Table 1.

C) Hazardous Material Specification

Set the hazardous substance specifications of health functional food by referring to the standard of
hazardous substance set in functional raw material and 「Food standard and specifications」.
D) Data on standards and specifications other than functional ingredients (or indicator components)
Data that confirms the conformity to the standards and specifications of each type according to ``
Food Standards and Specifications '' should be submitted.

E) Test report analyzed by domestic and overseas testing and inspection agencies
The test report or inspection report of a food specialty testing and inspection institution under Article
6 (3) 1 of the 「Act on the Testing and Inspection of Food and Pharmaceutical Sectors, etc.」 or an overseas test
and inspection institution under Article 8 of the same Act shall be submitted. (However, the specification of
functional ingredient or indicator ingredient shall be issued by the testing / inspecting institution that performs
the health functional food inspection service.)

6. Safety data
Data that can prove that the amount of functional raw materials to be ingested does not exceed the upper
limit of the intake of functional raw materials and the acceptable daily intake (ADI). In this case, all the intakes
from the total diet, such as from general foods and from supplements, should be considered.
7. Data on functional content
A). The verification of the functional functionality of health functional foods under Article 3 (2) shall provide
data that can be proved by scientific methods such as human application tests.
B) The human trial should be approved by the Human Ethics Committee (IRB) in accordance with the
Guideline for Good Clinical Practice by International Conference on Harmonization (ICH GCP), and must submit
one of the following details: do.
(1) Human application test plan and final report
(2) It must be published in a journal that is equal to or higher than the Science Citation Index (Expanded,
SCI (E)) or the Korean Citation Index (KCI) (including publication certificate). However, if submitted as a paper
published in a journal, the submission of a human test plan and final report may be requested.

8. Nutritional Information
Food specialized test / inspection institution under Article 6 (3) 1 of the 「Act on the Testing and Inspection
of Food and Pharmaceutical Sector, etc.」 on calorie, fat, saturated fat, trans fat, cholesterol, sugar and sodium
content The test report or inspection report of the overseas test and inspection organization under Article 8 shall
be submitted.

Article 20 (Health functional food evaluation) The Director General of Food and Drug Safety evaluates whether the
safety and functionality of health functional foods are secured in accordance with Article 4 (2) as follows.

1. Matters related to safety

A) Whether the intake of functional ingredients, such as general foods and supplements, from total meals
exceeds the maximum daily intake or daily intake
B) To prevent nutritional imbalances, whether total fat, saturated fat, trans fat, sugars and sodium meet the
nutritional content standards in [Annex 5].
C) Whether the other raw materials used in the manufacturing process conform to the standards and
specifications of health functional foods, standards and specifications of foods, standards and specifications of
food additives, etc.
D) Whether the health functional food to be manufactured is suitable for the hazardous substance standard,
food type standard and specification and the test method

2. Matters related to functionality

A) Whether functional ingredients, etc., are maintained to ensure functionality within the daily intake of the
final product
B) Whether the daily intake of the product to ensure functionality is the amount that can be ingested
through normal diet
C). Whether the functional ingredient (or indicator ingredient) specification of the functional ingredient and
the test method are suitable among the health functional foods to be manufactured.
D) Whether the test design, test subjects, etc. are properly set up in the data submitted pursuant to Article
19 (7) A and have significant results

Article 21 <Deleted> (2016.12.21.)

Chapter 5 Supplementary Provisions

Article 22 (Disclosure of Approval Examination Information) The Director General of the Korea Food and Drug
Administration may disclose evaluation information evaluated in accordance with Articles 15 and 20 on the
homepage on functional ingredients or health functional foods recognized under Article 9.

Article 23 (Request for Data, etc.) The Director-General of Food and Drug Safety shall apply to Article 14 (2) of the
Act if it falls under any of the following subparagraphs for the health functional food safety management of
functional ingredients or health functional foods recognized under Article 9. In accordance with Article 15 (2),
data may be requested from a person who has been recognized as a functional ingredient or health functional
food.

1.When new scientific findings on safety or functionality are revealed, or when abnormal cases have increased
rapidly, it is necessary to confirm safety and functional data.

2. Where the Commissioner of the Korea Food and Drug Administration requires the standard product for
inspection in accordance with Article 20 of the functional ingredient (or indicator ingredient) law of functional
ingredients and health functional food (except commercially available standard products).

Article 24 (Re-examination of Regulations) In accordance with Article 8 of the Framework Act on Administrative
Regulation and Regulations on Issuance and Management of Instructions, Regulations, etc. (Presidential Decree
No. 248), At the end of each year (which means until December 31st of every third year), the feasibility shall be
reviewed and measures for improvement.
[Annex table 1]
Definition and application of test method validity (validation) review items (related to Article 14 (5), (6) and 19 (5))

Application

Functional ingredient
Hazardous
Item Definition (or Indicator component) Substances

Quantitative Confirmation (Quantitative

test test testing)

The ability to selectively and accurately

특이성 measure analytes in the presence of
impurities, degradation products, and Yes Yes Yes
(Specificity) blended ingredients

정확도
How close the measured value is to a Yes No Yes
(Accuracy) known true or standard value

Proximity (degree of dispersion) between

정밀도 each measured value when a sample
obtained by taking several times from a Yes No Yes
(Precision) uniform sample is measured according to
a predetermined condition.

정량한계 Minimum amount of analyte in a sample

that can be expressed as a quantitative No No Yes
(Quantitation Limit) value with appropriate precision and
accuracy
 직선성 Ability to obtain linear measurements of
the amount (or concentration) of analyte Yes No Yes
(Linearity) in a range of samples that can provide
adequate precision and accuracy.

[Annex Table 2]
Hazardous Substance Standard Setting Items (Related to Article 14 (6))

Materials Items Specification Remark

Lead < 10.8㎍/day

Total arsenic < 150㎍/day

Heavy Metal
Cadmium < 3.0㎍/day
All Materials
Total Mercury < 2.1㎍/day

coliform group Negative

microbe
Limited to liquid
Germ count ≤ 100/g
products

Hexane < 0.005g/kg

Isopropyl Alcohol

Ethyl acetate ≤ 0.05g/kg

Raw material Residual
using solvent solvent Methyl alcohol

Acetone ≤ 0.03g/kg

Methylene Chloride,
Ethylene Trichloride ≤ 0.03g/kg
(Single or combined)

Raw materials Veterinary Medicine According to

whose
standards are Total Aflatoxin (Total of “food standards
Mold Toxins and
set in "Food B1, B2, G1 및 G2 )
Standards and specifications”
Patulin
Specifications"
Okratoxin

Other Mold Toxins

131
I
Radioactive
contamination 134
Cs+137Cs

** In addition, if necessary according to the characteristics of the raw material, manufacturing method, the
hazardous substance specification may be further set.

[Annex Table3]
Decision Diagram for Safety Evaluation of Functional Foods
(Related to Article 14 (7) B)

[1. Scope of safety data to be submitted]

(1) "Standards and specifications of health functional foods", "Standards and specifications of foods", "Standards
and specifications of food additives" data as evidence of the experience of ingestion; Scientific or historical
records of daily (over 25 years), traditional use; Authorized documents of foreign government agencies

(2) Data obtained from various documents or databases regarding the toxicity, safety, or interaction with other
ingredients (nutritional ingredients, pharmaceutical ingredients, etc.)

(3) Comparison and analysis of average intake and suggested intake based on the results of the National Health
and Nutrition Survey, intake survey results, and data distributed and sold in Korea for the past five years. However,
raw materials without food experience will be excluded.

(4) Data confirming safety and functionality tested with raw materials (human application test data)

(5) Toxicity test data are based on single-dose toxicity test, 90-day repeated dose toxicity test, genotoxicity test
(combination and details of genotoxicity test follow the Toxicity Test Standards of Drugs, etc.). By. However, in case
of abnormality related to raw materials observed in basic toxicity test (single, repeated, genotoxicity), it is
necessary to confirm the toxicity or if safety is not confirmed by submitted safety data, additional toxicity test in
addition to basic toxicity test. Data (reproductive and developmental toxicity, antigenicity, immunotoxicity,
carcinogenicity) may be required
[2. Key considerations when making a decision]

①「Standards and Specifications of Health Functional Foods」 Article 2. Common Standards and Specifications 1-1
Check if the raw materials correspond to the raw materials that cannot be used in the manufacture of health
functional foods.

② Check whether raw materials such as animals, plants, algae, and microorganisms that have been ingested are
manufactured through physical changes such as drying and simple grinding without processing such as extraction
and fermentation (eg raw material dry powder). The intake experience at this time is a raw material listed in
"Standards and Specifications of health functional food", "Standards and Specifications of food", "Standards and
Specifications of food additives"; Raw materials allowed for food by foreign government agencies; Confirmed by
evidence from scientific sources that evidence of traditional use

③ Search the database for data indicating that the raw material itself contains toxic or side effects or that
contains substances that harm humans.

④ If raw materials were used as foods, check whether the intake of the proposed raw material is more than three
times the average intake of the raw materials consumed routinely (more than 25 years) or more than the extreme
amount (95 percentile), and consume the raw materials for medicinal purposes. If so, check whether the intake of
the proposed raw material is higher than the average intake of the raw material. If there is insufficient evidence to
determine whether the intake changes, it is determined that the intake has changed.

⑤ Check whether the raw material is manufactured through processing process such as extraction, fermentation,
separation, decomposition, etc.

⑥ Check whether the animal, plant, algae, microorganism, etc., which has experience of ingestion, is a physical
extract using compression, osmotic pressure, etc. box. It is confirmed that raw materials by the following
manufacturing methods do not correspond to this.
n Raw materials extracted using solvents other than water, spirits, and carbon dioxide, other standards and
standards of health functional foods.
n Raw materials obtained by separating and purifying specific components or modified materials after
separation
n Raw materials to which processes other than extraction (eg fermentation, etc.) have been applied
n

⑦ Check whether it can be used as food or food additive

⑧ Check whether the raw material is synthesized using chemical composition

⑨ It is not a raw material that can be used as a food or food additive, but it is confirmed that it is the same as
the ingredient present in nature.
⑩ All raw materials except raw materials corresponding to ①②⑤⑧.

※ In the case of composite raw materials, the decision data is applied to each raw material to submit the safety
data of the raw materials, and additional data that can prove that the safety problems are not caused by
interactions (conventional evidence, functional tests, etc.) The safety test data conducted, etc.) should be
submitted.

※ Raw materials falling under the 「Regulations on Safety Evaluation and Evaluation of Genetically Modified
Foods」 (Notice of KFDA) must first undergo a safety evaluation according to the relevant regulations.

[Annex Table 4]
Functional Approval content of Functional Raw Materials (Related to Article 16)

[Annex Table 5]
Nutritional Standards of Functional Foods (Article 20, No. 1 B)

1. Common Criteria
A) Each food type should meet the content criteria of each nutrient.
B) The nutritional content standard for each food shall be based on the standard amount of one serving of the
food. However, 50 g (mL) should be used if the serving limit is 30 g or less, and 100 g (mL) should be used if
there is no single serving and the amount of trans fat in edible oils and fats.

2. Nutritional Content Criteria by Food

- skipped -

[Attached Form 1]
Functional food functional ingredient certification application

[Attached Form 2]
Health functional food approval application

[Attached Form 3]
Health functional food functional raw material certificate