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REGULATIONS CONCERNING RECOGNITION OF FUNCTIONAL INGREDIENTS AND STANDARDS AND SPECIFICATIONS FOR HEALTH FUNCTIONAL FOODS

Notice No. 201426, Feb. 12, 2014

Amended by Notice No. 2016141, Dec. 21, 2016

CHAPTER I GENERAL PROVISIONS
 Article 1 (Purpose)
The purpose of these Rules is to grant appropriate recognition by prescribing matters regarding standards and procedures for recognition; the scope of and requirements for data to be submitted; the principle of evaluation, etc., necessary for recognizing functional ingredients and standards and specifications for health functional foods pursuant to Articles 14 (2) and 15 (2) of the Health Functional Foods Act.
 Article 2 (Definitions)
(1) The definitions of the terms used in these Rules shall be as follows:
1. The term "functional ingredient" means a substance having a functionality used in manufacturing health functional foods, which falls under any of the following:
(a) Substances obtained by processing raw materials originated from animals, plants, microorganisms, water, etc. as they are;
(b) Extracts or refined substances from substances defined in item (a):
(i) The term "extract" means a substance extracted from raw materials originated from animals, plants, microorganisms, water, etc., by using a solvent or physically;
(ii) The term "refined substance" means a substance obtained by separating and refining a particular component contained in raw materials originated from animals, plants, microorganisms, water, etc.;
(c) Compounds of refined substances defined in item (b):
(i) The term "compound" means a substance obtained froma chemical reaction in a refined substance defined in item (b);
(d) Mixtures of substances defined in items (a) through (c);
2. The term "functional component" means a component indicating functionality contained in an ingredient;
3. The term "index component" means a component designated for quality management, among chemically defined components contained in an ingredient;
4. The term "raw material" means the original substance used for manufacturing an ingredient;
5. Deleted; <by Public Notice of the Korea Food and Drug Administration No. 2007-51, Jun. 28, 2007>
6. The term "hazardous substance" means microorganisms, heavy metals, pesticide residues, solvent residues, etc., harmful to the human body because such substances are likely to cause pollution or remain in raw materials or in the manufacturing process;
7. The term "experiment on human volunteers" means an experiment conducted on humans to demonstrate the safety and functionality of functional ingredients.
(2) Terms used in these Rules not otherwise defined herein, shall be as defined in the Health Functional Foods Act (hereinafter referred to as the "Act"); the Standards and Specifications for Health Functional Foods; and other relevant public notices.
 Article 3 (Ingredients or Foods Subject to Examination)
(1) Ingredients subject to examination as to whether to grant recognition of functional ingredients under Article 15 (2) of the Act, shall be as follows:
1. Ingredients not publicly notified in the Standards and Specification for Health Functional Foods;
2. Any additions of functional properties to a functional ingredient publicly notified in the Standards and Specifications for Health Functional Foods; or any alterations to the intake of such functional ingredient or to standards for manufacturing the functional ingredient;
3. Any alterations to, or additions of, matters affecting safety or functionality, such as any additions of functional properties to a functional ingredient recognized pursuant to Article 9 (1); and any alterations to the intake, manufacturing method, or specifications of such functional ingredient.
(2) Foods subject to examination as to whether to grant recognition of standards and specification for health functional foods (hereinafter referred to as "health functional foods") under Article 14 (2) of the Act shall be as follows: Provided, That the foregoing shall not apply to foods in which nutrients whose individual standards and specifications are prescribed in the Standards and Specifications for Health Functional Foods are used; health functional foods manufactured in the form of a product prescribed in the common manufacturing standards; foods for special purposes, alcoholic beverages, milk powders, prepared oils, etc.:
1. Foods manufactured or processed using functional ingredients publicly notified in the Standards and Specifications for Health Functional Foods;
2. Foods manufactured or processed by using functional ingredients recognized pursuant to Article 9 (1).
 Article 4 (Standards for Recognition)
Standards for recognizing functional ingredients subject to examination under Article 3 (1) and health functional foods subject to examination under Article 3 (2) shall be as follows:
1. Such functional ingredients and health functional foods shall conform to relevant laws;
2. Such functional ingredients and health functional foods shall be safe and functional.
CHAPTER II PROCEDURES FOR RECOGNITION
 Article 5 (Application for Recognition)
A person who intends to obtain recognition of functional ingredients or health functional foods pursuant to Article 14 (2) or 15 (2) of the Act shall submit an application for recognition in attached Form 1 or 2 (including an electronic application), to the Minister of Food and Drug Safety along with the following (including electronic documents):
1. One copy of data submitted pursuant to Article 12 (1) or 17;
2. One storage medium (CD, etc.) containing data submitted;
3. Any of the following ingredients, specimen of products, or pilot products:
(a) Where functional ingredients or health functional foods are manufactured in the Republic of Korea, a product submitted at random, among products manufactured in at least three lots by a specialized manufacturer of health functional foods defined in Article 4 of the Act or Article 2 of the Enforcement Decree of the same Act;
(b) Where functional ingredients or health functional foods are imported, a food, food additive, or health functional food imported to be distributed or sold in the Republic of Korea pursuant to the Special Act on Imported Food Safety Control; or a health functional food imported to be used for research or studies;
4. A standard product (a functional component or index component);
5. A test report on the standards, specifications, etc. for the relevant functional ingredient and raw materials, issued by a Korean or foreign testing or inspection agency designated or recognized by the Minister of Food and Drug Safety (Provided, That regarding specifications for a functional component or index component, limited to a test report issued by a testing or inspection agency conducting tests on health functional foods).
(2) Deleted. <by Public Notice of the Korea Food and Drug Administration No. 2010-76, Oct. 29, 2010>
 Article 6 (Processing Periods)
(1) The periods necessary for recognizing functional ingredients and health functional foods, shall be as follows:
1. Article 3 (1) 1: Within 120 days from the date of receipt;
2. Article 3 (2) 1 or 2: Within 90 days from the date of receipt;
3. Article 3 (1) 2 or 3: Within 60 days from the date of receipt;
4. Alterations to matters falling under any subparagraph of Article 11: Within 5 days from the date of receipt.
(2) Where a functional component of a functional ingredient is the same as such functional ingredient and a testing method recognized by the Minister of Food and Drug Safety is applied thereto, the processing period may be reduced by up to 1/2 to promptly conduct an examination, notwithstanding paragraph (1) 1 and 2.
 Article 7 (Supplementing, etc. Data)
(1) Where the Minister of Food and Drug Safety discovers a ground for any of the following, in the process of evaluating data submitted, he/she shall require an applicant to supplement data by specifying necessary matters and the period necessary to thereto; and the Civil Petitions Treatment Act shall apply to the period necessary to supplement data:
1. Where the types, scope, or details of data submitted, requirements therefor, etc. do not comply with Articles 12, 14, 17, and 19;
2. Where additional data, etc., are deemed essential to conduct appropriate evaluations.
(2) In any of the following cases, the Minister of Food and Drug Safety may hear opinions on data submitted by an applicant:
1. Where he/she deems data submitted are not reliable enough;
2. Where it is necessary to verify the facts because the scope and details of data submitted, requirements therefor, etc. do not comply with Articles 12, 14, 17, and 19.
 Article 8 (Return of Application Documents)
In any of the following cases, the Minister of Food and Drug Safety shall return application documents to the relevant applicant, stating the ground therefor:
1. Where an ingredient or food does not amount to a functional ingredient or health functional food subject to examination under Article 3;
2. Where an ingredient or food does not comply with standards for recognition under Article 4;
3. Where the applicant fails to submit the relevant data within the period for supplementing data under Article 7 (1).
 Article 9 (Recognition and Seeking Advice and Suggestions)
(1) Upon receipt of an application for recognition pursuant to Article 5, the Minister of Food and Drug Safety shall examine whether such application satisfies standards for recognition under Article 4 pursuant to Article 15 or 20; and where he/she deems that the application satisfies standards for recognition following examination thereof, he/she shall recognize the relevant ingredient as a functional ingredient, or food as health functional food.
(2) To recognize a functional ingredient or health functional food pursuant to paragraph (1), the Minister of Food and Drug Safety shall seek advice and suggestions from the Health Functional Food Deliberative Committee established under Article 27 of the Act.
 Article 9-2 (Revocation of Recognition)
(1) The Minister of Food and Drug Safety may revoke recognition of a functional ingredient or health functional food in the following cases:
1. Where the functional ingredient or health functional food is recognized as such by fraud or other improper means:
2. Where the safety and functionality of the functional ingredient or health functional food is deemed to have a substantial defect, in a reassessment conducted pursuant to Article 15-2 of the Act.
(2) To revoke recognition of a functional ingredient or health functional food pursuant to paragraph (1), the Minister of Food and Drug Safety shall seek advice and suggestions from the Health Functional Food Deliberative Committee established under Article 27 of the Act.
 Article 10 (Issuance and Recovery of Certificate of Recognition)
(1) Where the Minister of Food and Drug Safety grants recognition pursuant to Article 9 (1), he/she shall issue a certificate of recognition in attached Form 3 or 4, to an applicant.
(2) Where a functional ingredient recognized pursuant to paragraph (1) falls under Article 3 (1) 2, the Minister of Food and Drug Safety shall publicly notify such functional ingredient in the Standards and Specifications for Health Functional Foods.
(3) Where the Minister of Food and Drug Safety issues a certificate of recognition pursuant to paragraph (1), he/she shall make public the following matters on the website of the Ministry of Food and Drug Safety:
1. Recognition number;
2. Name of the company or institution;
3. Name of the ingredient;
4. Exporting country; and the name of the manufacturing company in the exporting country;
5. Functionality of the ingredient;
6. Recommended daily intake;
7. Cautions for ingestion.
(4) The Minister of Food and Drug Safety shall recover a certificate of recognition issued pursuant to paragraph (1) in the following cases:
1. Where recognition is revoked pursuant to Article 9-2;
2. Where the standards and specifications for each relevant functional ingredient are added to the Standards and Specifications for Health Functional Foods (Public Notice of the Ministry of Food and Drug Safety).
 Article 11 (Simple Alterations to Recognized Matters)
(1) Where a person who obtains recognition of a functional ingredient or health functional food pursuant to Article 9 (1) intends to alter any of the following matters, he/she shall submit an application for alteration to recognized matters in attached Form 5 or 6, to the Minister of Food and Drug Safety (Provided, That the foregoing shall not apply to alterations to any matter deemed to potentially affect safety and functionality):
1. Representative;
2. Name of the company or institution;
3. Location;
4. Name of the ingredient or the name of the product;
5. Any other minor matter not affecting the safety and functionality of the functional ingredient or health functional food.
CHAPTER III RECOGNITION OF FUNCTIONAL INGREDIENTS
 Article 12 (Scope of Data to Be Submitted)
(1) Data to be submitted to be recognized as a functional ingredient shall be as follows:
1. An executive summary of all data submitted;
2. Data regarding the origin, the details of development, the current status of recognition and use of the functional ingredient in the Republic of Korea or abroad, etc.;
3. Data regarding manufacturing methods;
4. Data regarding the properties of the functional ingredient;
5. Data regarding specifications and testing methods for functional components (or index component), and a test report;
6. Data regarding specifications and testing methods for hazardous substances;
7. Data regarding safety;
8. Data regarding the details of functionality;
9. Data regarding the intake of the functional ingredient, cautions for ingestion; and the creation thereof;
10. Data verifying that the relevant ingredient is not identical or similar to a pharmaceutical drug.
(2) Notwithstanding paragraph (1), where an ingredient for whose recognition an application is filed falls under Article 3 (1) 2 or 3, only additional or altered data may be submitted.
 Article 13 (Preparation of Data to Be Submitted)
Methods for preparing data to be submitted under Article 12 shall be as follows:
1. An applicant shall provide a table of contents; and shall state index numbers and batch numbers for each set of data in order under the subparagraphs of Article 14: Provided, That where data to be submitted under the subparagraphs of Article 14, are exempted or omitted pursuant to Article 12 (2), or an applicant is unable to prepare data to be submitted, he/she shall mention grounds therefor specifically and attach a statement of such grounds to the table of contents of the relevant items prepared;
2. An applicant shall submit an executive summary so that the Minister of Food and Drug Safety may have an outline of all the data, and an applicant shall attach an index number at the end of each piece of content so that the Minister of Food and Drug Safety may identify the relationship between various content mentioned in the executive summary and each detailed piece of data;
3. Where a substantial amount of data is to be submitted according to the items to be prepared, an applicant shall attach to the front of such data, a detailed summary of the items prepared so the Minister of Food and Drug Safety may readily comprehend such data;
4. An applicant shall submit the original data, and where he/she submits data prepared in a foreign language other than English, he/she shall submit such data along with a Korean translation thereof.
 Article 14 (Details of and Requirements for Data to Be Submitted)
Details to be included in data to be submitted under Article 12 and requirements therefor, shall be as follows:
1. An executive summary of all data submitted (a brief summary prescribed in subparagraphs 2 through 10);
2. Data concerning the origin; the details of development; and the current status of the recognition and use a functional ingredient or health functional food in the Republic of Korea or abroad:
(a) Origin and details of development:
An applicant shall mention when, in which country, and how such functional ingredient or health functional food has been developed. Where a natural substance is specially used as a raw material, he/she shall specifically mention the origin, the scientific name, the country of origin of such natural substance, the part in which it is used, etc.;
(b) Current status of the recognition and use of a functional ingredient or health functional food in the Republic of Korea or abroad:
An applicant shall accurately mention related matters, such as the current status of the recognition and permission by the Republic of Korea, foreign countries and international organizations, standards, and specifications for use. Where such functional ingredient or health functional food is currently being examined by the Codex Alimentarius Commission (CAC), he/she shall submit data regarding the current status of the evaluation of safety, and standards and specifications for the use thereof;
(c) Current status of the use of a functional ingredient or health functional food in the Republic of Korea or abroad:
Where such functional ingredient or health functional food has been used as food, etc. in the Republic of Korea or a foreign country, an applicant shall submit data regarding its uses, the volume of distribution, the manufacturing company, ingestibility, etc.;
3. Data regarding manufacturing methods:
(a) Specific manufacturing methods for each unit process, such as manufacturing temperature, time and pressure;
(b) Manufacturing methods, manufacturing countries, etc. related to evaluating the safety and functionality of solvents, enzymes, microorganisms, etc. used in the manufacturing process;
(c) Detailed data regarding changes in the content and yield of a functional (or index) component, at each stage of manufacturing;
(d) Data regarding the name of each raw material, mixing ratio and its safety, if at least two raw materials have been mixed;
(e) The data specified in items (a) through (d) issued by the relevant manufacturing company, in cases of an imported health functional food;
(f) The data specified in items (a) through (d) issued by the relevant outsourcee (including foreign companies), if the manufacturing process has been partially outsourced, as a manufacturing method;
4. Data regarding the properties of the ingredients:
(a) Data regarding characteristic properties, physical properties, etc. that may characterize the relevant ingredient;
(b) Data regarding functional components (or index components) to verify the standardization of the relevant ingredient;
5. Data regarding specifications and testing methods for functional component (or index components), and test reports:
(a) Specifications for functional components (or index components):
(i) Specifications shall be established based on the results of tests conducted on at least three lots of products, based upon the properties of an ingredient, such as manufacturing raw materials, the manufacturing or processing process of the ingredient and the safety thereof: Provided, That in cases of an ingredient for which it is inappropriate to establish specifications for content of functional components (or index components), specifications may be established through a potency test;
(ii) In principle, the lower limit and the upper limit for the value an applicant intends to indicate based upon analytical errors, shall be 80 to 120 percent of the indicated amount: Provided, That where an adequate ground exists, the lower limit and the upper limit may be set otherwise;
(iii) Where an applicant has mixed at least two relevant ingredients, he/she shall establish specifications for functional components (or index components) of each ingredient;
(b) Testing methods for testing functional components (or index components):
(i) An applicant shall use methods suitable for analyzing specifications for functional components (or index components) and officially recognized in the Republic of Korea or a foreign country pursuant to the Standards and Specifications for Health Functional Foods; the Standards and Specifications for Foods; the Standards for Processing Livestock Products and Specifications for Components; the Standards and Specifications for Food Additives; the Regulations of the Codex Alimentarius Commission (CAC); Association of Official Agricultural Chemists (AOAC) methods, etc.: Provided, That where no officially recognized method exists or a testing method presented by an applicant is deemed more appropriate, such test method may be used. In such cases, he/she shall demonstrate the appropriateness of the testing method he/she has presented by referring to attached Table 1;
(ii) Where an applicant has mixed at least two relevant ingredients, he/she shall establish testing methods for functional components (or index components) of each ingredient;
(c) A test report on functional components (or index components) tested and analyzed by a Korean or foreign testing or inspection agency:
An applicant shall submit a test report and analytical data of a testing agency that conducts tests of health functional foods among Korean or foreign testing agencies designated or recognized by the Minister of Food and Drug Safety, in order to examine the appropriateness of specifications for functional components (or index components) and test methods established;
(d) Deleted; <by Public Notice of the Korea Food and Drug Administration No. 2010-76, Oct. 29, 2010>
6. Data regarding specifications and testing methods for hazardous substances:
(a) Specifications for hazardous substances:
An applicant shall establish specifications for hazardous substances pursuant to attached Table 2 so that he/she may prevent pollution from hazardous substances or the possibility of the residue thereof due to raw materials or a manufacturing process;
(b) Testing methods for hazardous substances:
An applicant shall use testing methods officially recognized in the Republic of Korea or a foreign country pursuant to the Standards and Specifications for Health Functional Foods; the Standards and Specifications for Foods; the Standards for Processing Livestock Products and Specifications for Components; the Standards and Specifications for Food Additives; the Regulations of the Codex Alimentarius Commission (CAC); Association of Official Agricultural Chemists (AOAC) methods, etc.: Provided, That where no officially recognized method exists or a testing method presented by an applicant is deemed more appropriate, such test method may be used. In such cases, he/she shall demonstrate the appropriateness of the testing method he/she has presented, by referring to attached Table 1;
(c) A test report on hazardous substances tested and analyzed by a Korean or foreign testing or inspection agency:
An applicant shall submit a test report and analytical data of a testing agency in the Republic of Korea or a foreign country designated or recognized by the Minister of Food and Drug Safety, in order to examine the appropriateness of specifications for hazardous substances and testing methods established: Provided, That where tolerances for pesticide residues are provided for in the Standards and Specifications for Foods, he/she shall submit a test report and analytical data on test items of pesticide residues subject to accurate testing, in attached Table 3 of the Rules on Inspection of Imported Foods, etc.; and where no tolerances for pesticide residues are provided in the Standards and Specifications for Foods, he/she shall submit a test report and analytical data on five pesticides (Endrin, Dieldrin, Aldrin, BHC, DDT);
7. Data regarding safety:
(a) An applicant shall submit scientific base data that may verify the relevant ingredient is harmless to the human body where ingested as proposed;
(b) An applicant may use, as data on safety, the base data for ingestion; safety information and data on the relevant ingredient or component; intake evaluation data; data from experiments on human volunteers (intervention studies, epidemiological research, etc.); toxicity test data, etc. by referring to attached Table 3;
(c) Requirements for safety data shall be as follows:
(i) Data that forms the foundation of ingestion shall not only be the historical use records through which the relevant ingredient is deemed safe, but also scientific data stating the manufacturing method, uses, an intake, etc.;
(ii) A safety data sheet on the relevant functional component or related substance shall be the safety data sheet published or certified as published in a Korean or foreign scientific journal, a report issued by the Korean government, a foreign government; or an international organization, the search results of related database, etc.;
(iii) Intake evaluation data shall be prepared using a wide variety of scientific data (data on fact-finding surveys of ingestion, statistical data, etc.);
(iv) The data specified in subparagraph 8 (c) shall also be used as data from experiments on human volunteers related to safety;
(v) Toxicity test data shall be contained in a report issued by an institution operated in accordance with Good Laboratory Practice (GLP) after conducting experiments in accordance with OECD Test Guidelines prescribed by the Organization for Economic Cooperation and Development (OECD):
a) Deleted; <by Public Notice of the Korea Food and Drug Administration No. 2010-76, Oct. 29, 2010>
b) Deleted; <by Public Notice of the Korea Food and Drug Administration No. 2007-51, Jun. 28, 2007>
8. Data regarding the details of functionality:
(a) Details of functionality:
An applicant shall state the effect on health by consuming the relevant ingredient;
(b) An applicant shall submit data from experiments on human volunteers, animal experimentation, in vitro experimentation, etc, as data on functionality:
(i) Regarding experiments on human volunteers, data on intervention studies or observational studies shall be submitted. In particular, a randomized, controlled, double-blind trial, among intervention studies, is desirable; and the results thereof shall be universally applicable to the general public;
(ii) Regarding animal experimentation and in vitro experimentation, the mechanism of action, etc. of an ingredient and component shall be explained to scientifically support the results of experiments on human volunteers;
(iii) Where at least two raw materials have been mixed, the functionality of each mixed ingredient shall be verified; and adequate and scientific grounds for mixing such raw materials shall be submitted;
(c) Data demonstrating functionality shall be a plan for, and final report on, experiments on human volunteers approved by an institutional review board (IRB) regarding experiments on human volunteers in accordance with the Guidelines for Good Clinical Practice by International Conference on Harmonization (ICH GCP); or those published in a scientific journal (including a certificate of publication) equivalent to the Science Citation Index (SCI, including SCIE) or the Korea Citation Index (KCI):
(i) and (ii) Deleted; <by Public Notice of the Korea Food and Drug Administration No. 2010-76, Oct. 29, 2010>
9. Data regarding a serving size, suggested use, cautions for ingestion, and the establishment thereof:
(a) An applicant shall establish a daily serving size or the limit on the daily serving size that ensures the safety of using the ingredient and demonstrates the functionality thereof based on data demonstrating the safety and functionality thereof;
(b) An applicant shall state the suggested use through which the functionality of the relevant ingredient is demonstrated most effectively;
(c) An applicant shall state cautions for ingestion, based upon side effects of the overdose of the relevant ingredient; interactions with components of food or medications being taken which relate to the functionality, the recognition of which he/she has applied for; vulnerable groups (pregnant women, nursing mothers, children, the elderly and infirm, etc.), etc.;
10. Data verifying that the ingredient is not identical or similar to a pharmaceutical drug:
An applicant shall verify that the ingredient is not identical or similar to a pharmaceutical drug pursuant to the Standards and Specifications for Health Functional Foods.
 Article 15 (Evaluation of Functional Ingredients)
To recognize any ingredient or component as an ingredient or component that may be used in health functional foods pursuant to Article 15 (2) of the Act, the Minister of Food and Drug Safety shall evaluate the safety, functionality, etc. of such ingredient or component as follows:
1. Matters relating to ingredients:
(a) Whether the origin, the scientific name, the country of origin of a raw material, the part of the raw material used, etc. are specifically stated;
(b) In cases of a mixed ingredient, whether the details specified in item (a) are properly stated for each raw material;
(c) Whether the status of the relevant ingredient or component recognized or permitted, or the status thereof used, as a food or food additive in the Republic of Korea or abroad, is appropriate;
2. Matters relating to manufacturing methods:
(a) Whether manufacturing temperature, time, pressure, etc. are appropriate for producing the relevant functional ingredient (the suitability of the manufacturing process must be verified, if necessary);
(b) Whether solvents, enzymes, etc. used in the manufacturing process of an ingredient have been used in compliance with the Standards and Specifications for Health Functional Foods (Public Notice of the Ministry of Food and Drug Safety); the Standards and Specifications for Foods (Public Notice of the Ministry of Food and Drug Safety); the Standards for Processing Livestock Products and Specifications for Components (Public Notice of the Ministry of Food and Drug Safety); and the Standards and Specifications for Food Additives (Public Notice of the Ministry of Food and Drug Safety);
(c) Whether changes in the content and yield of functional components (or index components) at each stage of manufacturing from raw materials to an ingredient for recognition of which an application was filed, have been properly analyzed;
(d) Whether safety is ensured, if at least two raw materials have been mixed;
(e) Where the data specified in items (a) through (d) issued by a manufacturing company are appropriate, if the relevant ingredient or component has been imported;
(f) Whether the data specified in items (a) through (d) issued by the relevant outsourcee is appropriate, if the manufacturing process has been partially outsourced;
3. Matters relating to functional components (or index components):
(a) Whether representation of a functional component (or index component) is secured based on an examination of the properties of the relevant functional ingredient;
(b) Whether the content, specifications, and testing methods for a functional component (or index component) have been properly set;
(c) Whether a test report of a testing or inspection agency dedicated to inspecting health functional foods, among Korean or foreign testing or inspection agencies designated or recognized by the Minister of Food and Drug Safety, is appropriate (verification tests may be conducted, if necessary);
4. Establishing specifications for hazardous substances:
(a) Whether pollution from hazardous substances or the possibility of the residue thereof due to raw materials or the manufacturing process, has been properly set pursuant to attached Table 2;
(b) Whether a test report of a testing or inspection agency dedicated to inspecting health functional foods, among Korean or foreign testing or inspection agencies designated or recognized by the Minister of Food and Drug Safety, is appropriate (verification tests may be conducted, if necessary);
5. Matters relating to safety:
(a) Whether the relevant ingredient or component is recognized as an edible raw material in the Republic of Korea and abroad; or whether it is suitable for use in food;
(b) Whether an intake evaluation is appropriate;
(c) Whether any side effects, information on toxicity, etc. are found as a result of searching safety data;
(d) Whether the relevant ingredient or component is toxic, if toxicity test data has been submitted;
(e) Whether the specifications for hazardous substances are established to ensure safety;
(f) Whether the results of safety tests on hazardous substances conducted by Korean or foreign testing or inspection agencies designated or recognized by the Minister of Food and Drug Safety, are appropriate;
6. Matters relating to functionality:
(a) Whether the relevant ingredient or component falls within the scope of recognition as to functionality under Article 15 (2) of the Act;
(b) Whether functionality has been individually evaluated according to types and levels of research;
(c) Whether test design, test subjects, etc. have been appropriately established in data submitted, such as experiments on human volunteers concerning functionality; and whether they yield meaningful results;
(d) Whether functionality is ensured in the suggested daily intake;
(e) Whether functionality has been evaluated based upon the volume of overall base data, consistency, and relevance;
(f) Whether the details of recognition of functionality for which a business entity has filed an application in attached Form 1, are appropriate;
7. Whether the intake, method of consumption, and cautions for ingestion have been established based on the safety and functionality of the relevant ingredient;
8. Whether the relevant component or ingredient is a component of medicines permitted in the Republic of Korea and abroad; or permission therefor is underway therein;
9. Comprehensive evaluation of data submitted:
All data submitted, such as the origin of the relevant ingredient, the details of development thereof, the status of the recognition and use thereof in the Republic of Korea and abroad; manufacturing methods; the properties and traditional use thereof; the result of the intake evaluation; the result of experiments on human volunteers; and the result of experiments on toxicity, shall be comprehensively examined to evaluate whether the safety and functionality of the relevant ingredient or component are ensured.
 Article 16 (Recognition of Functional Properties of Functional Ingredients)
The Minister of Food and Drug Safety shall classify the functionality of ingredients in accordance with the result of the evaluation thereof under Article 15 as follows; and the details of recognized functionality shall be as specified in attached Table 4:
1. Where data demonstrating functionality submitted indicate a decrease in the risk of disease, and the level of scientific base data secured is sufficiently high to meet Significant Scientific Agreement, "function that decreases the risk of occurrence of a disease";
2. Where data demonstrating functionality submitted indicate the contribution to health, improvement in function or the maintenance or improvement of health due to a particular effect on the normal function or the biological activity of the human body, "physiological function".
CHAPTER IV RECOGNITION OF HEALTH FUNCTIONAL FOODS
 Article 17 (Data to Be Submitted)
Data to be submitted in order to be recognized as a health functional food under Article 3 (2), shall be as follows:
1. An executive summary of all data submitted;
2. Data regarding the type of food;
3. Data regarding the name and content of mixed ingredients;
4. Data regarding manufacturing methods;
5. Data regarding standards and specifications;
6. Data regarding safety;
7. Data regarding the details of functionality;
8. Data regarding nutritional components.
 Article 18 (Preparation of Data to Be Submitted)
The Article 13 shall apply mutatis mutandis to the method of preparing data to be submitted under Article 17.
 Article 19 (Details of Data to Be Submitted and Requirements Therefor)
Details to be included in data to be submitted under Article 17 and requirements therefor shall be as follows:
1. An executive summary of all data submitted (data in which matters under subparagraphs 2 through 8 are briefly summarized);
2. Data regarding the type of food:
Health functional food which an applicant intends to manufacture shall comply with the type prescribed by the Standards and Specifications for Foods, the Standards for Processing Livestock Products and Specifications for Components, etc.; and he/she shall submit data meeting such requirements;
3. Data regarding the name and content of mixed ingredients:
An applicant shall submit the name of the ingredient and the mixing ratio. Furthermore, other ingredients used shall be appropriate for other ingredients under subparagraph 2. 1. 3) of the Standards and Specifications for Health Functional Foods;
4. Data regarding manufacturing methods;
5. Data regarding standards and specifications:
(a) Data regarding specifications for functional components (or index components) of health functional food an applicant intends to manufacture;
(b) Testing methods for (limited to where testing methods for functional components used are not appropriate for the analysis thereof) functional components (or index components):
Testing methods shall be appropriate for analyzing specifications for functional components (or index components), and an applicant shall use testing methods officially recognized in the Republic of Korea and foreign countries in accordance with the Standards and Specifications for Health Functional Foods; the Standards and Specifications for Foods; the Standards for Processing Livestock Products and Specifications for Components; the Standards and Specifications for Food Additives; the Regulations of the Codex Alimentarius Commission (CAC); AOAC methods, etc.: Provided, That where no officially recognized testing method exists or a testing method presented by an applicant is deemed more appropriate, he/she may use the testing method he/she has proposed. In such cases, he/she shall demonstrate the appropriateness of the testing method which he/she has presented by referring to attached Table 1;
(c) Data regarding specifications for hazardous substances:
An applicant shall establish specifications for hazardous substances of health functional food by referring to specifications for hazardous substances established on functional ingredients; the Standards and Specifications for Foods; and the Standards for Processing Livestock Products and Specifications for Components;
(d) Data regarding standards and specifications for components other than functional components (or index components):
An applicant shall submit data that can verify compliance with standards and specifications for components for each type of food under the Standards and Specifications for Foods, the Standards for Processing Livestock Products and Specifications for Components, etc.;
(e) A test report on functional components (or index components) tested and analyzed by a Korean or foreign testing or inspection agency:
An applicant shall submit test results and analytical data provided by a Korean or foreign testing or inspection agency designated or officially recognized by the Minister of Food and Drug Safety. (Provided, That regarding specifications for functional components or index components, limited to a test report issued by a testing or inspection agency testing health functional foods);
6. Data regarding safety:
Data used to verify whether the amount of a functional ingredient to be consumed is the amount that can be used to ensure safety, such as the amount not exceeding the maximum intake of the functional ingredient, acceptable daily intake (ADI), etc. In such cases, an applicant shall take into consideration all amounts ingested from the total diet, such as ingestion from general foods, and ingestion from dietary supplements;
7. Data regarding the details of functionality:
(a) An applicant shall submit data used to verify functionality through the scientific method, such as experiments on human volunteers, to verify the relevant functionality of health functional food under Article 3 (2);
(b) Where an applicant intends to submit data regarding experiments on human volunteers under item (a), data shall accompany a plan for, and final report on, experiments on human volunteers approved by the IRB regarding experiments on human volunteers in accordance with the ICH GCP; or data published in a scientific journal (including a certificate of publication) equivalent to the Science Citation Index (SCI, including SCIE) or the Korea Citation Index (KCI);
8. Data regarding nutritional components:
An applicant shall submit a test result and analytical data provided by a Korean or foreign testing or inspection agency designated or officially recognized by the Minister of Food and Drug Safety concerning calories, fat content, saturated fat content, trans fat content, cholesterol content, sugar content, and sodium content.
 Article 20 (Evaluation of Health Functional Foods)
The Minister of Food and Drug Safety shall evaluate whether the safety and functionality of health functional foods have been ensured as follows, pursuant to subparagraph 2 of Article 4:
1. Matters related to safety:
(a) Whether an intake of a functional ingredient ingested through all meals, such as regular food and dietary supplements, exceeds the maximum intake thereof or the acceptable daily intake thereof;
(b) Whether the total fats, saturated fats, trans fats, sugars and sodium meet the standards for content of nutritional components under attached Table 5 for preventing nutritional imbalance;
(c) Whether other ingredients used in the manufacturing process meet the Standards and Specifications for Health Functional Foods; the Standards and Specifications for Foods; the Standards for Processing Livestock Products and Specifications for Components; the Standards and Specifications for Food Additives, etc.;
(d) Whether among health functional foods an applicant intends to manufacture, specifications for hazardous substances, standards and specifications for foods by type, and the testing method therefor, are appropriate;
2. Matters related to functionality:
(a) Whether a functional ingredient, etc. is maintained so that such functional ingredient, etc. may ensure the functionality thereof within a daily intake of the end product;
(b) Whether a daily intake of a product designed to secure the functionality thereof is the amount that can be ingested through a normal diet;
(c) Whether, among health functional foods which an applicant intends to manufacture, specifications for functional components (or index components) of an functional ingredient and the testing method therefor are appropriate;
(d) Whether test design, test subjects, etc. have been appropriately established in data submitted pursuant to subparagraph 7 (a) of Article 19; and whether they yield meaningful results.
 Article 21 Deleted. <by Public Notice of the Ministry of Food and Drug Safety No. 2016-141, Dec. 21, 2016>
CHAPTER V SUPPLEMENTARY PROVISIONS
 Article 22 (Disclosure of Information on Examination concerning Recognition)
The Minister of Food and Drug Safety may make public, through the website, etc. of the Ministry of Food and Drug Safety, the information on evaluations conducted under Articles 15 and 20 regarding functional ingredients recognized pursuant to Article 9.
 Article 23 (Request for Data, etc.)
The Minister of Food and Drug Safety may request persons who have obtained recognition of functional ingredients or health functional foods pursuant to Article 14 (2) or 15 (2) of the Act, to provide data, etc. regarding functional ingredients recognized pursuant to Article 9, in the following cases as he/she deems necessary for safety management of health functional foods:
1. Where new scientific findings about safety or functionality have been identified or abnormalities have sharply increased necessitating verifying data on safety and functionality;
2. Where the Minister of Food and Drug Safety requests the provision of the relevant standard product to examine a functional component (or index component) of a functional ingredient or health functional food pursuant to Article 20 of the Act (excluding standard products purchasable in the market).
 Article 24 (Review of Regulation)
The appropriateness of regulation shall be reviewed every three years (referring to December 31 of every third year) counting from January 1, 2017; and measures shall be taken, such as making improvements, pursuant to Article 8 of the Framework Act on Administrative Regulations and the Rules on the Issuance and Management of Directives and Established Rules (Presidential Directive No. 248).
ADDENDA
(1) (Enforcement Date) This Public Notice shall enter into force on the date it is publicly notified.
(2) (Transitional Measures concerning Ingredients Being Examined as to Whether to Grant Recognition)
The previous Public Notice shall apply to matters being examined as to whether to grant recognition as at the time this Public Notice enters into force, after an application for the recognition thereof is filed before this Public Notice enters into force.
(3) (Transitional Measures concerning Functional Ingredients for Which Standards and Specifications Have not Been Recognized)
With regard to a functional ingredient, safety and functionality of which have been recognized pursuant to the Rules on Recognition of Functional Ingredients for Health Functional Foods (enacted by Public Notice No. 2004-12 of the Korea Food and Drug Administration, Jan. 31, 2004), but for which standards and specifications have not been established, an applicant may file an application for standards and specifications for such functional ingredient in accordance with this Public Notice.
ADDENDUM <Public Notice of the Korea Food and Drug Administration No. 2008-72, Nov. 17, 2008>
This Public Notice shall enter into force on the date it is publicly notified.
ADDENDA <Public Notice of the Korea Food and Drug Administration No. 2009-39, Jun. 29, 2009>
Article 1 (Enforcement Date)
This Public Notice shall enter into force on the date it is publicly notified.
Article 2 (Applicability)
The amended provision of subparagraph 7 (c) of Article 13 shall also apply to a functional ingredient for recognition of which, an application is filed and received, which is being examined, as at the time this Public Notice enters into force.
ADDENDUM <Public Notice of the Korea Food and Drug Administration No. 2009-176, Dec. 22, 2009>
This Public Notice shall enter into force on the date it is publicly notified.
ADDENDA <Public Notice of the Korea Food and Drug Administration No. 2010-76, Oct. 29, 2010>
Article 1 (Enforcement Date)
This Public Notice shall enter into force on the date it is publicly notified: Provided, That the amended provisions related to Article 17 (Recognition Rating of Functionality) shall enter into force on November 1, 2011.
Article 2 (Applicability)
The amended provisions of subparagraph 6 (c) of Article 13 and subparagraph 7 (c) of the aforesaid Article shall also apply to a functional ingredient for recognition of which, an application is filed and received, which is being examined, as at the time this Public Notice enters into force.
Article 3 (Transitional Measures)
Any products (including ingredients) already manufactured or imported pursuant to the previous provisions, before the amended provisions related to Article 17 (Recognition Rating of Functionality) enter into force, which may be sold until the expiry date of the relevant products.
ADDENDA <Public Notice of the Korea Food and Drug Administration No. 2011-34, Jul. 8, 2011>
Article 1 (Enforcement Date)
This Public Notice shall enter into force on August 8, 2011.
Article 2 (Repeal of Other Public Notice)
The Rules on Recognition of Standards and Specifications for Health Functional Foods (Public Notice No. 2009-177 of the Korea Food and Drug Administration) are repealed.
Article 3 (Transitional Measures)
Any functional ingredients and health functional foods recognized pursuant to the previous Rules on Recognition of Functional Ingredients for Health Functional Foods and the previous Rules on Recognition of Standards and Specifications for Health Functional Foods, as at the time this Public Notice enters into force, shall be deemed recognized in accordance with this Public Notice.
Article 4 (Deadline for Re-Examination)
The deadline for taking measures, such as repealing or amending this Public Notice, shall be August 7, 2014, reviewing the changes in the statutes or the actual conditions after the issuance of this Public Notice, in accordance with the Rules on the Issuance and Management of Directives and Established Rules (Presidential Directive No. 248).
ADDENDA <Public Notice of the Korea Food and Drug Administration No. 2012-107, Oct. 30, 2012>
Article 1 (Enforcement Date)
This Public Notice shall enter into force on the date it is publicly notified.
Article 2 (Applicability)
This Public Notice shall begin to apply from the first application for the recognition of a functional ingredient for health functional food, received after this Public Notice enters into force.
Article 3 (Transitional Measures)
The previous provisions shall apply to matters being examined, which were received as a functional ingredient for health functional foods, as at the time this Public Notice enters into force.
ADDENDUM <Public Notice of the Ministry of Food and Drug Safety No. 2013-10, Apr. 5, 2013>
This Public Notice shall enter into force on the date it is publicly notified.
ADDENDA <Public Notice of the Ministry of Food and Drug Safety No. 2013-217, Sep. 11, 2013>
Article 1 (Enforcement Date)
This Public Notice shall enter into force on the date it is publicly notified.
Article 2 (Applicability)
This Public Notice shall begin to apply from the first application for recognition submitted to the Minister of Food and Drug Safety after this Public Notice enters into force.
ADDENDA <Public Notice of the Ministry of Food and Drug Safety No. 2016-141, Dec. 21, 2016>
Article 1 (Enforcement Date)
(1) This Public Notice shall enter into force on the date it is publicly notified.
(2) Notwithstanding paragraph (1), the amended provisions of Articles 14, 16, and 19 and attached Tables 1, 2, 3, and 4 shall enter into force six months after the date it is publicly notified.
Article 2 (Applicability to Application for Recognition and to Alteration of Application for Recognition)
This Public Notice shall begin to apply from the first application for recognition (including an application for alteration) filed with the Minister of Food and Drug Safety, after this Public Notice enters into force.
Article 3 (Transitional Measures)
(1) A health functional food (including ingredients) recognized as having obtained a grade of physiological function under the previous provisions, as at the time this Public Notice enters into force, may be manufactured or imported (based on the shipment date) until December 31, 2018. In such cases, the health functional food may be sold until its expiry date.
(2) Notwithstanding paragraph (1), a functional ingredient which has obtained grade 3 physiological function under the previous provisions of Article 16 and attached Table 4, may be manufactured or imported (based on the shipment date) for up to three years after this Public Notice enters into force; and in such cases, the functional ingredient may be sold until its expiry date.